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Clinical Trial Results:
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Effect of Long-Term Treatment with BELVIQ (lorcaserin HCl) on the Incidence of Major Adverse Cardiovascular Events and Conversion to Type 2 Diabetes Mellitus in Obese and Overweight Subjects with Cardiovascular Disease or Multiple Cardiovascular Risk Factors

Summary
EudraCT number	2013-000324-34
Trial protocol	PL
Global end of trial date	14 May 2018

Results information
Results version number	v2(current)
This version publication date	13 Jul 2019
First version publication date	30 May 2019
Other versions	v1
Version creation reason	Changes to summary attachments Updates to be made in the time frame of 2 endpoints and 1 analysis population description.

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

APD356-G000-401

ISRCTN number

US NCT number

NCT02019264

WHO universal trial number (UTN)

Sponsor organisation name

Eisai Ltd.

Sponsor organisation address

European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire, United Kingdom, AL10 9SN

Public contact

Eisai Medical Information, Eisai Ltd., +1 888-274-2378, esi_medinfo@eisai.com

Scientific contact

Eisai Medical Information, Eisai Ltd., +1 888-274-2378, esi_medinfo@eisai.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

14 May 2018

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

14 May 2018

Was the trial ended prematurely?

Main objective of the trial

To demonstrate that, in obese and overweight subjects with cardiovascular (CV) disease and/or multiple CV risk factors, lorcaserin hydrochloride (HCl) 10 milligram (mg) administered twice daily (BID) does not increase the incidence of major adverse cardiovascular events (MACE) (myocardial infarction [MI], or stroke, or CV death) compared to placebo, with a noninferiority margin for the hazard ratio (HR) of 1.4, and in obese and overweight subjects with CV disease and/or multiple CV risk factors, lorcaserin HCl 10 mg BID reduces the incidence of MACE+ (MACE or hospitalization for unstable angina or heart failure [HF], or any coronary revascularization) compared to placebo

Protection of trial subjects

This study was conducted in accordance with standard operating procedures (SOPs) of the sponsor (or designee), which are designed to ensure adherence to Good Clinical Practice (GCP) guidelines as required by the following: - Principles of the World Medical Association Declaration of Helsinki (World Medical Association, 2008) - International Council on Harmonisation (ICH) E6 Guideline for GCP (CPMP/ICH/135/95) of the European Agency for the Evaluation of Medicinal Products, Committee for Proprietary Medicinal Products, International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use - Title 21 of the United States (US) Code of Federal Regulations (US 21 CFR) regarding clinical studies, including Part 50 and Part 56 concerning informed subject consent and Institutional Review Board (IRB) regulations and applicable sections of US 21 CFR Part 312 - European Good Clinical Practice Directive 2005/28/EC and Clinical Trial Directive 2001/20/EC for studies conducted within any European Union (EU) country. All suspected unexpected serious adverse reactions were reported, as required, to the Competent Authorities of all involved EU member states. - Article 14, Paragraph 3, and Article 80-2 of the Pharmaceutical Affairs Law (Law No. 145, 1960) for studies conducted in Japan, in addition to Japan’s GCP Subject Information and Informed Consent.

Background therapy

Evidence for comparator

Actual start date of recruitment

24 Jan 2014

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

Australia: 535

Country: Number of subjects enrolled

Bahamas: 10

Country: Number of subjects enrolled

Canada: 1165

Country: Number of subjects enrolled

Chile: 107

Country: Number of subjects enrolled

Mexico: 255

Country: Number of subjects enrolled

New Zealand: 316

Country: Number of subjects enrolled

Poland: 985

Country: Number of subjects enrolled

United States: 8627

Worldwide total number of subjects

12000

EEA total number of subjects

985

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)

6257

From 65 to 84 years

5699

85 years and over

Subject disposition

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Recruitment details

Subjects took part in the study at investigative sites in the United States, Bahamas, Canada, Mexico, Chile, New Zealand, Poland, and Australia from 24 Jan 2014 to 14 May 2018.

Screening details

A total of 14,673 subjects were screened and enrolled, of which 2673 subjects were screen failures and 12,000 were randomized to receive lorcaserin HCl or placebo.

Period 1 title

Overall Study (overall period)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator

Are arms mutually exclusive

Yes

Placebo

Arm description

Subjects received lorcaserin HCL placebo-matching, tablets, orally, twice daily for up to 52 months.

Arm type

Placebo

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Lorcaserin HCL placebo-matching, tablets, orally, twice daily for up to 52 months.

Lorcaserin 10 mg

Arm description

Subjects received lorcaserin HCL 10 mg, tablets, orally, twice daily for up to 52 months.

Arm type

Experimental

Investigational medicinal product name

Lorcaserin

Investigational medicinal product code

Other name

APD356, BELVIQ

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Lorcaserin HCL 10 mg, tablets, orally, twice daily for up to 52 months.

Number of subjects in period 1	Placebo	Lorcaserin 10 mg
Started	6000	6000
Completed	5752	5793
Not completed	248	207
Not Treated	6	4
Withdrawal by subjects	142	117
Lost to follow-up	50	47
Missing	14	11
Administrative reason	36	28

Baseline characteristics

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Reporting group title

Placebo

Reporting group description

Subjects received lorcaserin HCL placebo-matching, tablets, orally, twice daily for up to 52 months.

Reporting group title

Lorcaserin 10 mg

Reporting group description

Subjects received lorcaserin HCL 10 mg, tablets, orally, twice daily for up to 52 months.

Reporting group values	Placebo	Lorcaserin 10 mg	Total
Number of subjects	6000	6000	12000
Age categorical
Units: Subjects
In utero			0
Preterm newborn infants (gestational age < 37 wks)			0
Newborns (0-27 days)			0
Infants and toddlers (28 days-23 months)			0
Children (2-11 years)			0
Adolescents (12-17 years)			0
Adults (18-64 years)			0
From 65-84 years			0
85 years and over			0
Age continuous
Units: years
arithmetic mean (standard deviation)	63.7 ( 8.31 )	63.5 ( 8.33 )	-
Gender categorical
Units: Subjects
Female	2186	2112	4298
Male	3814	3888	7702
Ethnicity (NIH/OMB)
Units: Subjects
Hispanic or Latino	536	502	1038
Not Hispanic or Latino	5464	5498	10962
Unknown or Not Reported	0	0	0
Race (NIH/OMB)
Units: Subjects
American Indian or Alaska Native	21	26	47
Asian	74	85	159
Native Hawaiian or Other Pacific Islander	23	30	53
Black or African American	466	454	920
White	5331	5309	10640
More than one race	85	96	181
Unknown or Not Reported	0	0	0

End points

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Reporting group title

Placebo

Reporting group description

Subjects received lorcaserin HCL placebo-matching, tablets, orally, twice daily for up to 52 months.

Reporting group title

Lorcaserin 10 mg

Reporting group description

Subjects received lorcaserin HCL 10 mg, tablets, orally, twice daily for up to 52 months.

Primary: Time From Randomization to First Occurrence of Major Adverse Cardiovascular Events (MACE) at Interim Analysis

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End point title

Time From Randomization to First Occurrence of Major Adverse Cardiovascular Events (MACE) at Interim Analysis

End point description

The MACE events involved MI, stroke, or CV death. The outcome data was assessed using Kaplan-Meier estimate and Greenwood Formula. The total time analysis set using the intent-to-treat (ITT) set, events were counted that occurred while subjects were on and off treatment. Subjects with no events were censored at their last study contact or at the visit following sponsor notification of study completion, whichever occurred first. Here "99999" refers to median time and 95% confidence interval which could not be calculated since quartile was not estimable due to higher number of censored subjects.

End point type

Primary

End point timeframe

Baseline up to Month 42

End point values	Placebo	Lorcaserin 10 mg
Number of subjects analysed	6000	6000
Units: days
median (confidence interval 95%)	99999 (99999 to 99999)	99999 (99999 to 99999)

Placebo, Lorcaserin 10 mg

Comparison groups

Placebo v Lorcaserin 10 mg

Number of subjects included in analysis

12000

Analysis specification

Pre-specified

Analysis type

non-inferiority ^[1]

P-value

< 0.0001

Method

Primary Analytic Method

Parameter type

Hazard ratio (HR)

Point estimate

1.005

Confidence interval

level

97.5%

sides

2-sided

lower limit

0.842

upper limit

1.198

Notes
[1] - Hazard ratio was based on Cox-regression model including treatment and CV strata as covariates. MACE met non-inferiority when the one-sided upper bound of 97.5% confidence interval of the HR was less than (<) 1.4 (the non-inferiority margin).

Primary: Time From Randomization to First Occurrence of MACE+

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End point title

Time From Randomization to First Occurrence of MACE+

End point description

The MACE+ events involved MI, stroke, or CV death or hospitalization for unstable angina or heart failure (HF), or any coronary revascularization. The outcome data was assessed using Kaplan-Meier estimate and Greenwood Formula. The total time analysis set used the ITT set, events were counted that occurred while subjects were on and off treatment. Subjects with no events were censored at their last study contact or at the visit following Sponsor Notification of Study Completion, whichever occurred first. Here “99999” refers to median time and 95% confidence interval which could not be calculated since quartile was not estimable due to higher number of censored subjects.

End point type

Primary

End point timeframe

Baseline up to end of study (Month 56)

End point values	Placebo	Lorcaserin 10 mg
Number of subjects analysed	6000	6000
Units: days
median (confidence interval 95%)	99999 (99999 to 99999)	99999 (99999 to 99999)

Placebo, Lorcaserin 10 mg

Comparison groups

Placebo v Lorcaserin 10 mg

Number of subjects included in analysis

12000

Analysis specification

Pre-specified

Analysis type

superiority ^[2]

P-value

= 0.5464

Method

Primary Analytic Method

Parameter type

Hazard ratio (HR)

Point estimate

0.969

Confidence interval

level

95%

sides

2-sided

lower limit

0.873

upper limit

1.074

Notes
[2] - Hazard ratio was based on Cox-regression model including treatment and CV strata as covariates.

Secondary: Time From Randomization to Conversion to Type 2 Diabetes Mellitus (T2DM) for Subjects With Prediabetes at Baseline

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End point title

Time From Randomization to Conversion to Type 2 Diabetes Mellitus (T2DM) for Subjects With Prediabetes at Baseline

End point description

Time from randomization to conversion to T2DM was defined as first occurrence of any component of the 2013 American Diabetes Association (ADA) Diagnostic Criteria (ADA, 2013) in subjects with prediabetes at baseline. The outcome data was assessed using Kaplan-Meier estimate and Greenwood Formula. Prediabetes and total time analysis set used ITT set: without a history of any type of diabetes and who were prediabetic at baseline; events were counted that occurred while subjects were on, off treatment; subjects with no events were censored at last study contact/at visit after notification of study completion, whichever occurred first. Here “99999” refers to median time and 95% confidence interval which could not be calculated since quartile was not estimable due to higher number of censored subjects.

End point type

Secondary

End point timeframe

Baseline up to end of study (Month 56)

End point values	Placebo	Lorcaserin 10 mg
Number of subjects analysed	1976	2015
Units: days
median (confidence interval 95%)	99999 (99999 to 99999)	99999 (99999 to 99999)

Placebo, Lorcaserin 10 mg

Comparison groups

Placebo v Lorcaserin 10 mg

Number of subjects included in analysis

3991

Analysis specification

Pre-specified

Analysis type

superiority ^[3]

P-value

= 0.038

Method

Primary Analytic Method

Parameter type

Hazard ratio (HR)

Point estimate

0.807

Confidence interval

level

95%

sides

2-sided

lower limit

0.659

upper limit

0.988

Notes
[3] - Hazard ratio was based on Cox-regression model including treatment as covariate.

Secondary: Time From Randomization to First Occurrence of the Individual Components of MACE+

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End point title

Time From Randomization to First Occurrence of the Individual Components of MACE+

End point description

The MACE+ events involved MI, stroke, or CV death or hospitalization for unstable angina or HF, or any coronary revascularization. The outcome data was assessed using Kaplan-Meier estimate and Greenwood Formula. The total time analysis set used the ITT set, events counted occurred while subjects were on and off treatment. Subjects with no events were censored at last study contact or at the visit following Sponsor Notification of Study Completion, whichever first. Here “99999” refers to median time and 95% confidence interval which could not be calculated since quartile was not estimable due to higher number of censored subjects.

End point type

Secondary

End point timeframe

Baseline up to end of study (Month 56)

End point values	Placebo	Lorcaserin 10 mg
Number of subjects analysed	6000	6000
Units: days
arithmetic mean (confidence interval 95%)
MI	99999 (99999 to 99999)	99999 (99999 to 99999)
Stroke	99999 (99999 to 99999)	99999 (99999 to 99999)
CV death	99999 (99999 to 99999)	99999 (99999 to 99999)
Hospitalization for unstable angina	99999 (99999 to 99999)	99999 (99999 to 99999)
HF	99999 (99999 to 99999)	99999 (99999 to 99999)
Coronary revascularization	99999 (99999 to 99999)	99999 (99999 to 99999)

Placebo, Lorcaserin 10 mg

Comparison groups

Placebo v Lorcaserin 10 mg

Number of subjects included in analysis

12000

Analysis specification

Pre-specified

Analysis type

non-inferiority ^[4]

P-value

= 0.0001

Method

Primary Analytic Method

Parameter type

Hazard ratio (HR)

Point estimate

0.991

Confidence interval

level

97.5%

sides

2-sided

lower limit

0.824

upper limit

1.191

Notes
[4] - MI: Hazard ratio was based on Cox-regression model including treatment and CV strata as covariates. 97.5% confidence interval refers to the upper limit of the displayed 2-sided 95% confidence interval.

Placebo, Lorcaserin 10 mg

Comparison groups

Placebo v Lorcaserin 10 mg

Number of subjects included in analysis

12000

Analysis specification

Pre-specified

Analysis type

non-inferiority ^[5]

P-value

= 0.0005

Method

Primary Analytic Method

Parameter type

Hazard ratio (HR)

Point estimate

0.856

Confidence interval

level

97.5%

sides

2-sided

lower limit

0.639

upper limit

1.145

Notes
[5] - Time to Stroke: Hazard ratio was based on Cox-regression model including treatment and CV strata as covariates. 97.5% confidence interval refers to the upper limit of the displayed 2-sided 95% confidence interval.

Placebo, Lorcaserin 10 mg

Comparison groups

Placebo v Lorcaserin 10 mg

Number of subjects included in analysis

12000

Analysis specification

Pre-specified

Analysis type

non-inferiority ^[6]

P-value

= 0.0262

Method

Primary Analytic Method

Parameter type

Hazard ratio (HR)

Point estimate

1.045

Confidence interval

level

97.5%

sides

2-sided

lower limit

0.778

upper limit

1.404

Notes
[6] - Cardiovascular Death: Hazard ratio was based on Cox-regression model including treatment and CV strata as covariates. 97.5% confidence interval refers to the upper limit of the displayed 2-sided 95% confidence interval.

Placebo, Lorcaserin 10 mg

Comparison groups

Placebo v Lorcaserin 10 mg

Number of subjects included in analysis

12000

Analysis specification

Pre-specified

Analysis type

superiority ^[7]

P-value

= 0.3243

Method

Primary Analytic Method

Parameter type

Hazard ratio (HR)

Point estimate

1.163

Confidence interval

level

95%

sides

2-sided

lower limit

0.861

upper limit

1.571

Notes
[7] - Hospitalization for Unstable Angina: Hazard ratio was based on Cox-regression model including treatment and CV strata as covariates.

Placebo, Lorcaserin 10 mg

Comparison groups

Placebo v Lorcaserin 10 mg

Number of subjects included in analysis

12000

Analysis specification

Pre-specified

Analysis type

superiority ^[8]

P-value

= 0.6758

Method

Primary Analytic Method

Parameter type

Hazard ratio (HR)

Point estimate

0.952

Confidence interval

level

95%

sides

2-sided

lower limit

0.757

upper limit

1.197

Notes
[8] - HF: Hazard ratio was based on Cox-regression model including treatment and CV strata as covariates.

Placebo, Lorcaserin 10 mg

Comparison groups

Placebo v Lorcaserin 10 mg

Number of subjects included in analysis

12000

Analysis specification

Pre-specified

Analysis type

superiority ^[9]

P-value

= 0.7817

Method

Primary Analytic Method

Parameter type

Hazard ratio (HR)

Point estimate

0.981

Confidence interval

level

95%

sides

2-sided

lower limit

0.856

upper limit

1.125

Notes
[9] - Coronary Revascularization: Hazard ratio was based on Cox-regression model including treatment and CV strata as covariates.

Secondary: Time From Randomization to Event of All-cause Mortality

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End point title

Time From Randomization to Event of All-cause Mortality

End point description

The outcome data was assessed using Kaplan-Meier estimate and Greenwood Formula. The total time analysis set used the ITT set, events were counted that occurred while subjects were on and off treatment. Subjects with no events were censored at their last study contact or at the visit following Sponsor Notification of Study Completion, whichever occurred first. Here “99999” refers to median time and 95% confidence interval which could not be calculated since quartile was not estimable due to higher number of censored subjects.

End point type

Secondary

End point timeframe

Baseline up to end of study (Month 56)

End point values	Placebo	Lorcaserin 10 mg
Number of subjects analysed	6000	6000
Units: days
median (confidence interval 95%)	99999 (99999 to 99999)	99999 (99999 to 99999)

Placebo, Lorcaserin 10 mg

Comparison groups

Placebo v Lorcaserin 10 mg

Number of subjects included in analysis

12000

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.4212

Method

Primary Analytic Method

Parameter type

Hazard ratio (HR)

Point estimate

1.082

Confidence interval

level

95%

sides

2-sided

lower limit

0.893

upper limit

1.31

Secondary: Time From Randomization to Conversion to Normal Glucose Homeostasis in Subjects With Prediabetes at Baseline

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End point title

Time From Randomization to Conversion to Normal Glucose Homeostasis in Subjects With Prediabetes at Baseline

End point description

Normal glucose homeostasis was defined as glycosylated hemoglobin (HbA1c) less than or equal to (<=) 5.6% and fasting plasma glucose (FPG) < 100 milligram per deciliter (mg/dL) without any antidiabetic treatment. The outcome data was assessed using Kaplan-Meier estimate and Greenwood Formula. The prediabetes analysis set included all subjects in the ITT set without a history of any type of diabetes and who were prediabetic at baseline. Here “99999” refers to median time and 95% confidence interval which could not be calculated since quartile was not estimable due to higher number of censored subjects.

End point type

Secondary

End point timeframe

Baseline up to end of study (Month 56)

End point values	Placebo	Lorcaserin 10 mg
Number of subjects analysed	1976	2015
Units: days
median (confidence interval 95%)	99999 (99999 to 99999)	99999 (99999 to 99999)

Placebo, Lorcaserin 10 mg

Comparison groups

Placebo v Lorcaserin 10 mg

Number of subjects included in analysis

3991

Analysis specification

Pre-specified

Analysis type

superiority ^[10]

P-value

= 0.181

Method

Primary Analytic Method

Parameter type

Hazard ratio (HR)

Point estimate

1.124

Confidence interval

level

95%

sides

2-sided

lower limit

0.947

upper limit

1.333

Notes
[10] - Hazard ratio was based on a Cox regression model including treatment as covariate.

Secondary: Time From Randomization to Conversion to T2DM for Subjects Without Any Type of Diabetes at Baseline

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End point title

Time From Randomization to Conversion to T2DM for Subjects Without Any Type of Diabetes at Baseline

End point description

The outcome data was assessed using Kaplan-Meier estimate and Greenwood Formula. The nondiabetes analysis set included all subjects in the ITT set without a history of any type of diabetes at baseline. Here “99999” refers to median time and 95% confidence interval which could not be calculated since quartile was not estimable due to higher number of censored subjects.

End point type

Secondary

End point timeframe

Baseline up to end of study (Month 56)

End point values	Placebo	Lorcaserin 10 mg
Number of subjects analysed	2569	2615
Units: days
median (confidence interval 95%)	99999 (99999 to 99999)	99999 (99999 to 99999)

Placebo, Lorcaserin 10 mg

Comparison groups

Placebo v Lorcaserin 10 mg

Number of subjects included in analysis

5184

Analysis specification

Pre-specified

Analysis type

superiority ^[11]

P-value

= 0.0116

Method

Primary Analytic Method

Parameter type

Hazard ratio (HR)

Point estimate

0.773

Confidence interval

level

95%

sides

2-sided

lower limit

0.633

upper limit

0.944

Notes
[11] - Hazard ratio was based on a Cox regression model including treatment as covariate.

Secondary: Change From Baseline in HbA1c at Month 6 in Subjects With T2DM at Baseline

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End point title

Change From Baseline in HbA1c at Month 6 in Subjects With T2DM at Baseline

End point description

The T2DM analysis set included all subjects in the ITT set who had T2DM at baseline. Here "n" was the T2DM analysis set where data was available at specified time points.

End point type

Secondary

End point timeframe

Baseline, and Month 6

End point values	Placebo	Lorcaserin 10 mg
Number of subjects analysed	3403	3362
Units: percentage of HbA1c
arithmetic mean (standard deviation)
Baseline (n=3403, 3362)	6.99 ( 1.066 )	7.01 ( 1.082 )
Change at Month 6 (n=3087, 3035)	0.06 ( 0.777 )	-0.33 ( 0.785 )

Placebo, Lorcaserin 10 mg

Comparison groups

Placebo v Lorcaserin 10 mg

Number of subjects included in analysis

6765

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001 ^[12]

Method

ANCOVA

Parameter type

Least square (LS) Mean Difference (Net)

Point estimate

-0.39

Confidence interval

level

95%

sides

2-sided

lower limit

-0.43

upper limit

-0.35

Notes
[12] - P-value was based on analysis of covariance (ANCOVA) model with treatment and stratification variable (presence of established CV disease or CV risk factors without established CV disease) as factors, and baseline HbA1c, as a covariate.

Secondary: Time From Randomization to Event of New Onset Renal Impairment or Worsening Existing Renal Impairment in All Subjects

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End point title

Time From Randomization to Event of New Onset Renal Impairment or Worsening Existing Renal Impairment in All Subjects

End point description

New onset/worsening of existing renal impairment was first occurrence of any events: microalbuminuria and macroalbuminuria, worsening albuminuria (microalbuminuria at Baseline developed macroalbuminuria, ACR increased >=30% from Baseline during treatment), newly developed chronic kidney disease (CKD) or worsening of CKD (based on National Kidney Foundation [NKF] Guidelines [2002]) worsened to higher CKD stages during treatment), or doubling of serum creatinine (creatinine value at least 2 times Baseline value and >=1.5 mg/dL during treatment.), or any of following: end-stage renal disease, renal transplant, renal death. Outcome data was assessed using Kaplan-Meier estimate and Greenwood Formula. ITT set included all randomized subjects regardless of whether they took study drug or not. This set was the same as full analysis set. "99999": Median time and 95% confidence interval which could not be calculated since quartile was not estimable due to higher number of censored subjects.

End point type

Secondary

End point timeframe

Baseline up to end of study (Month 56)

End point values	Placebo	Lorcaserin 10 mg
Number of subjects analysed	6000	6000
Units: days
median (confidence interval 95%)	99999 (99999 to 99999)	99999 (99999 to 99999)

Placebo, Lorcaserin 10 mg

Comparison groups

Placebo v Lorcaserin 10 mg

Number of subjects included in analysis

12000

Analysis specification

Pre-specified

Analysis type

superiority ^[13]

P-value

= 0.0054

Method

Primary Analytic Method

Parameter type

Hazard ratio (HR)

Point estimate

0.869

Confidence interval

level

95%

sides

2-sided

lower limit

0.787

upper limit

0.959

Notes
[13] - Hazard ratio was based on Cox-regression model including treatment and CV strata as covariates.

Secondary: Time From Randomization to Event of New Onset Renal Impairment or Worsening Existing Renal Impairment in Subjects With Prediabetes at Baseline

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End point title

Time From Randomization to Event of New Onset Renal Impairment or Worsening Existing Renal Impairment in Subjects With Prediabetes at Baseline

End point description

New onset/worsening of existing renal impairment was first occurrence of any events: microalbuminuria and macroalbuminuria, worsening albuminuria (microalbuminuria at Baseline developed macroalbuminuria, ACR increased >=30% from baseline during treatment),CKD as per NKF Guidelines [2002]) or worsening of CKD (CKD Stage1/higher as per NKF Guidelines [2002] worsened to higher CKD stages during treatment), or doubling serum creatinine(creatinine value at least twice baseline value and >=1.5 mg/dL during treatment.), or any of: end stage renal disease, renal transplant, renal death. Outcome data was assessed using Kaplan-Meier estimate and Greenwood Formula. ITT set included all subjects without a history of any type of diabetes and were prediabetic at baseline. This set was the same as full analysis set. Here “99999” refers to median time and 95% confidence interval which could not be calculated since quartile was not estimable due to higher number of censored subjects.

End point type

Secondary

End point timeframe

Baseline up to end of study (Month 56)

End point values	Placebo	Lorcaserin 10 mg
Number of subjects analysed	1976	2015
Units: days
median (confidence interval 95%)	99999 (99999 to 99999)	99999 (99999 to 99999)

Placebo, Lorcaserin 10 mg

Comparison groups

Placebo v Lorcaserin 10 mg

Number of subjects included in analysis

3991

Analysis specification

Pre-specified

Analysis type

superiority ^[14]

P-value

= 0.3661

Method

Primary Analytic Method

Parameter type

Hazard ratio (HR)

Point estimate

0.904

Confidence interval

level

95%

sides

2-sided

lower limit

0.727

upper limit

1.125

Notes
[14] - Hazard ratio on a Cox regression model including treatment as covariate.

Secondary: Time From Randomization to Event of New Onset Renal Impairment or Worsening Existing Renal Impairment in Subjects With T2DM at Baseline

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End point title

Time From Randomization to Event of New Onset Renal Impairment or Worsening Existing Renal Impairment in Subjects With T2DM at Baseline

End point description

New onset/worsening of existing renal impairment was first occurrence of any events: microalbuminuria and macroalbuminuria, worsening albuminuria (microalbuminuria at baseline developed macroalbuminuria, ACR increased>=30% from baseline during treatment), CKD as per NKF Guidelines [2002]) or worsening of CKD (CKD Stage 1/higher as per NKF Guidelines [2002] worsened to higher CKD stages during treatment), or doubling of serum creatinine (creatinine value at least 2 times baseline value and>=1.5 mg/dL during treatment.), or any of the following: end-stage renal disease, renal transplant, renal death. The outcome data was assessed using Kaplan-Meier estimate and Greenwood Formula. The T2DM analysis set had all subjects in the ITT set who had T2DM at baseline. Here “99999” refers to median time and 95% confidence interval which could not be calculated since quartile was not estimable due to higher number of censored subjects.

End point type

Secondary

End point timeframe

Baseline up to end of study (Month 56)

End point values	Placebo	Lorcaserin 10 mg
Number of subjects analysed	3403	3362
Units: days
median (confidence interval 95%)	99999 (99999 to 99999)	99999 (99999 to 99999)

Placebo, Lorcaserin 10 mg

Comparison groups

Placebo v Lorcaserin 10 mg

Number of subjects included in analysis

6765

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0082

Method

Primary Analytic Method

Parameter type

Hazard ratio (HR)

Point estimate

0.855

Confidence interval

level

95%

sides

2-sided

lower limit

0.762

upper limit

0.96

Secondary: Time From Randomization to Event of Improvement in Renal Function in Subjects With T2DM at Baseline

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End point title

Time From Randomization to Event of Improvement in Renal Function in Subjects With T2DM at Baseline

End point description

Improvement in renal function: first occurrence of regression of albuminuria/regression of CKD. Regression of albuminuria: when subjects with macroalbuminuria at baseline developed microalbuminuria or nonalbuminuria, or subjects with microalbuminuria at baseline became nonalbuminuric, and ACR value decreased >= 30% from previous assessment in treatment. Regression of CKD: when subjects with CKD Stage 1/higher at baseline improved to normal/lower stages by NKF guidelines in treatment. The outcome data was assessed using Kaplan-Meier estimate and Greenwood Formula. The T2DM analysis set included all subjects in ITT set who had T2DM at baseline. Here “99999” refers to median time and 95% confidence interval which could not be calculated since quartile was not estimable due to higher number of censored subjects.

End point type

Secondary

End point timeframe

Baseline up to end of study (Month 56)

End point values	Placebo	Lorcaserin 10 mg
Number of subjects analysed	3403	3362
Units: days
median (confidence interval 95%)	99999 (99999 to 99999)	99999 (99999 to 99999)

Placebo, Lorcaserin 10 mg

Comparison groups

Placebo v Lorcaserin 10 mg

Number of subjects included in analysis

6765

Analysis specification

Pre-specified

Analysis type

superiority ^[15]

P-value

= 0.0297

Method

Primary Analytic Method

Parameter type

Hazard ratio (HR)

Point estimate

1.182

Confidence interval

level

95%

sides

2-sided

lower limit

1.017

upper limit

1.375

Notes
[15] - Hazard ratio was based on Cox-regression model including treatment and CV strata as covariates.

Secondary: Percentage of Subjects Who Met FDA-Defined Valvulopathy in Echocardiographically Determined Heart Valve Changes

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End point title

Percentage of Subjects Who Met FDA-Defined Valvulopathy in Echocardiographically Determined Heart Valve Changes

End point description

The FDA-defined valvulopathy analysis set included all subjects in the ITT set without FDA-defined valvulopathy at baseline. Here “n” was the FDA-defined valvulopathy analysis set where data was available at specified time point.

End point type

Secondary

End point timeframe

Months 6 and 12

End point values	Placebo	Lorcaserin 10 mg
Number of subjects analysed	1935	1925
Units: percentage of subjects
number (not applicable)
Month 6 (n=1683, 1681)	1.4	2.1
Month 12 (n=1564, 1579)	1.5	1.8

Placebo, Lorcaserin 10 mg

Comparison groups

Placebo v Lorcaserin 10 mg

Number of subjects included in analysis

3860

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.5015 ^[16]

Method

Primary Analytic Method

Parameter type

Odds ratio (OR)

Point estimate

1.21

Confidence interval

level

95%

sides

2-sided

lower limit

0.69

upper limit

2.11

Notes
[16] - P-value was based on logistic regression including treatment as a factor and baseline body mass index (BMI) as a covariate.

Secondary: Percentage of Subjects With FDA-Defined Valvulopathy at Baseline Who Demonstrated Worsened FDA-Defined Valvulopathy

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End point title

Percentage of Subjects With FDA-Defined Valvulopathy at Baseline Who Demonstrated Worsened FDA-Defined Valvulopathy

End point description

The ITT analysis set in subjects with FDA-defined valvulopathy at baseline was used. Here “n” was the ITT analysis set in subjects with FDA-defined valvulopathy at baseline where data was available at specified time point.

End point type

Secondary

End point timeframe

Months 6 and 12

End point values	Placebo	Lorcaserin 10 mg
Number of subjects analysed	228	225
Units: percentage of subjects
number (not applicable)
Month 6 (n=194, 201)	2.1	3.5
Month 12 (n=180, 189)	1.7	2.1

Placebo, Lorcaserin 10 mg

Comparison groups

Placebo v Lorcaserin 10 mg

Number of subjects included in analysis

453

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.7249 ^[17]

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

1.31

Confidence interval

level

95%

sides

2-sided

lower limit

0.29

upper limit

5.98

Notes
[17] - P-value was based on logistic regression including treatment as a factor and baseline BMI as a covariate.

Secondary: Change From Baseline in Echocardiographically-Determined Pulmonary Arterial Systolic Pressure

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End point title

Change From Baseline in Echocardiographically-Determined Pulmonary Arterial Systolic Pressure

End point description

The ITT analysis set-subjects in ECHO substudy included all randomized subjects regardless of whether they took study drug or not. Here "n" was the ITT analysis set-subjects in the ECHO substudy, where data was available at specified time points.

End point type

Secondary

End point timeframe

Baseline, Month 12

End point values	Placebo	Lorcaserin 10 mg
Number of subjects analysed	2167	2151
Units: Millimeter of mercury (mmHg)
arithmetic mean (standard deviation)
Baseline (n=1368, 1358)	26.4354 ( 7.66312 )	26.2029 ( 7.54123 )
Change at Month 12 (n=882, 893)	-0.6418 ( 6.81716 )	-0.8223 ( 7.23770 )

Placebo, Lorcaserin 10 mg

Comparison groups

Lorcaserin 10 mg v Placebo

Number of subjects included in analysis

4318

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.2976 ^[18]

Method

Mixed-effects model

Parameter type

Mean difference (net)

Point estimate

-0.9036

Confidence interval

level

95%

sides

2-sided

lower limit

-1.2908

upper limit

-0.5163

Notes
[18] - P value was based on a mixed-effects model (unstructured covariance matrix) with repeated measures with treatment, month and treatment by month interaction as factors and baseline pulmonary arterial systolic pressure and baseline BMI as covariates.

Adverse events

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Timeframe for reporting adverse events

From baseline up to 30 days after last dose of study drug (approximately 56 months)

Adverse event reporting additional description

Adverse events were collected for the subject who were in the safety analysis set (all subjects who received at least 1 dose of study drug and had at least one post dose safety assessment).

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

19.0

Reporting group title

Placebo

Reporting group description

Subjects received lorcaserin HCL placebo-matching, tablets, orally, twice daily for up to 52 months.

Reporting group title

Lorcaserin 10 mg

Reporting group description

Subjects received lorcaserin HCL 10 mg, tablets, orally, twice daily for up to 52 months.

Serious adverse events	Placebo	Lorcaserin 10 mg
Total subjects affected by serious adverse events
subjects affected / exposed	2021 / 5992 (33.73%)	1974 / 5995 (32.93%)
number of deaths (all causes)	202	219
number of deaths resulting from adverse events	121	132
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute leukaemia
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (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 / 5992 (0.02%)	2 / 5995 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Adenocarcinoma
subjects affected / exposed	1 / 5992 (0.02%)	2 / 5995 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Adenocarcinoma gastric
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Adenocarcinoma of appendix
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Adenocarcinoma of colon
subjects affected / exposed	4 / 5992 (0.07%)	6 / 5995 (0.10%)
occurrences causally related to treatment / all	0 / 4	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Adenocarcinoma pancreas
subjects affected / exposed	1 / 5992 (0.02%)	2 / 5995 (0.03%)
occurrences causally related to treatment / all	0 / 1	1 / 2
deaths causally related to treatment / all	0 / 1	1 / 1
Adrenal adenoma
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Adrenal gland cancer
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Adrenal neoplasm
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (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	1 / 5992 (0.02%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Angiomyolipoma
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Appendix cancer
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Atypical fibroxanthoma
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
B-cell lymphoma
subjects affected / exposed	2 / 5992 (0.03%)	2 / 5995 (0.03%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 1	0 / 0
B-cell lymphoma stage III
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Basal cell carcinoma
subjects affected / exposed	4 / 5992 (0.07%)	3 / 5995 (0.05%)
occurrences causally related to treatment / all	0 / 4	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Benign gastric neoplasm
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Benign neoplasm of ampulla of Vater
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Benign neoplasm of bladder
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Benign neoplasm of thyroid gland
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Benign renal neoplasm
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Benign small intestinal neoplasm
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Biliary neoplasm
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Bladder cancer
subjects affected / exposed	5 / 5992 (0.08%)	4 / 5995 (0.07%)
occurrences causally related to treatment / all	0 / 5	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Bladder cancer recurrent
subjects affected / exposed	2 / 5992 (0.03%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Bladder neoplasm
subjects affected / exposed	2 / 5992 (0.03%)	4 / 5995 (0.07%)
occurrences causally related to treatment / all	0 / 2	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Bladder transitional cell carcinoma
subjects affected / exposed	2 / 5992 (0.03%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Bladder transitional cell carcinoma recurrent
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Bone cancer
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Bone cancer metastatic
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Brain cancer metastatic
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Brain neoplasm
subjects affected / exposed	0 / 5992 (0.00%)	2 / 5995 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Breast cancer
subjects affected / exposed	9 / 5992 (0.15%)	11 / 5995 (0.18%)
occurrences causally related to treatment / all	0 / 9	0 / 11
deaths causally related to treatment / all	0 / 0	0 / 0
Breast cancer in situ
subjects affected / exposed	1 / 5992 (0.02%)	2 / 5995 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Breast cancer metastatic
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cervix carcinoma
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cervix carcinoma stage IV
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Cholangiocarcinoma
subjects affected / exposed	1 / 5992 (0.02%)	4 / 5995 (0.07%)
occurrences causally related to treatment / all	0 / 1	0 / 4
deaths causally related to treatment / all	0 / 1	0 / 2
Choroid melanoma
subjects affected / exposed	1 / 5992 (0.02%)	2 / 5995 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Choroid neoplasm
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Chronic lymphocytic leukaemia
subjects affected / exposed	3 / 5992 (0.05%)	5 / 5995 (0.08%)
occurrences causally related to treatment / all	1 / 3	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 1
Chronic myeloid leukaemia
subjects affected / exposed	1 / 5992 (0.02%)	2 / 5995 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Clear cell renal cell carcinoma
subjects affected / exposed	3 / 5992 (0.05%)	2 / 5995 (0.03%)
occurrences causally related to treatment / all	1 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Colon adenoma
subjects affected / exposed	11 / 5992 (0.18%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	2 / 12	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Colon cancer
subjects affected / exposed	7 / 5992 (0.12%)	9 / 5995 (0.15%)
occurrences causally related to treatment / all	0 / 7	0 / 9
deaths causally related to treatment / all	0 / 0	0 / 0
Colon cancer metastatic
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Colon neoplasm
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Colorectal adenocarcinoma
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Colorectal cancer stage IV
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Diffuse large B-cell lymphoma
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Endometrial adenocarcinoma
subjects affected / exposed	5 / 5992 (0.08%)	4 / 5995 (0.07%)
occurrences causally related to treatment / all	0 / 5	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Endometrial cancer
subjects affected / exposed	7 / 5992 (0.12%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 7	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Extranodal marginal zone B-cell lymphoma (MALT type)
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Fibroadenoma of breast
subjects affected / exposed	1 / 5992 (0.02%)	2 / 5995 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Fibroma
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Follicular thyroid cancer
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastric cancer
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gastric cancer stage 0
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal stromal tumour
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Glioblastoma
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Glioblastoma multiforme
subjects affected / exposed	1 / 5992 (0.02%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 1
Hepatic cancer
subjects affected / exposed	2 / 5992 (0.03%)	2 / 5995 (0.03%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 1	0 / 1
Hepatic cancer metastatic
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (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	2 / 5992 (0.03%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hodgkin's disease
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Intestinal adenocarcinoma
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Intraductal papillary mucinous neoplasm
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Intraductal papillary-mucinous carcinoma of pancreas
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Intraductal papilloma of breast
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (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	1 / 5992 (0.02%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Invasive breast carcinoma
subjects affected / exposed	3 / 5992 (0.05%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Invasive ductal breast carcinoma
subjects affected / exposed	8 / 5992 (0.13%)	4 / 5995 (0.07%)
occurrences causally related to treatment / all	0 / 9	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Keratoacanthoma
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Kidney angiomyolipoma
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Lipoma
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Lung adenocarcinoma
subjects affected / exposed	3 / 5992 (0.05%)	3 / 5995 (0.05%)
occurrences causally related to treatment / all	0 / 3	0 / 3
deaths causally related to treatment / all	0 / 1	0 / 1
Lung adenocarcinoma stage 0
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Lung adenocarcinoma stage IV
subjects affected / exposed	1 / 5992 (0.02%)	2 / 5995 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 1	0 / 1
Lung cancer metastatic
subjects affected / exposed	3 / 5992 (0.05%)	2 / 5995 (0.03%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 1	0 / 1
Lung carcinoma cell type unspecified stage III
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Lung neoplasm
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Lung neoplasm malignant
subjects affected / exposed	6 / 5992 (0.10%)	13 / 5995 (0.22%)
occurrences causally related to treatment / all	0 / 6	0 / 13
deaths causally related to treatment / all	0 / 0	0 / 1
Lung squamous cell carcinoma stage II
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Lymphoma
subjects affected / exposed	4 / 5992 (0.07%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 4	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Malignant melanoma
subjects affected / exposed	17 / 5992 (0.28%)	20 / 5995 (0.33%)
occurrences causally related to treatment / all	0 / 21	0 / 24
deaths causally related to treatment / all	0 / 0	0 / 0
Malignant melanoma in situ
subjects affected / exposed	3 / 5992 (0.05%)	5 / 5995 (0.08%)
occurrences causally related to treatment / all	0 / 4	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Malignant melanoma stage I
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Malignant neoplasm of ampulla of Vater
subjects affected / exposed	0 / 5992 (0.00%)	2 / 5995 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 1
Malignant neoplasm of spinal cord
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Malignant neoplasm of unknown primary site
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Malignant sweat gland neoplasm
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Melanocytic naevus
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Meningioma
subjects affected / exposed	0 / 5992 (0.00%)	2 / 5995 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Meningioma benign
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Metastases to bone
subjects affected / exposed	6 / 5992 (0.10%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 6	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 0
Metastases to liver
subjects affected / exposed	1 / 5992 (0.02%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 1
Metastases to lung
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Metastases to lymph nodes
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Metastasis
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Metastatic carcinoma of the bladder
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Metastatic malignant melanoma
subjects affected / exposed	1 / 5992 (0.02%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 0
Metastatic renal cell carcinoma
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Metastatic squamous cell carcinoma
subjects affected / exposed	0 / 5992 (0.00%)	2 / 5995 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Mucinous cystadenocarcinoma ovary
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Mycosis fungoides
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Myelodysplastic syndrome
subjects affected / exposed	2 / 5992 (0.03%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Myxofibrosarcoma
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Nasopharyngeal cancer
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Neoplasm prostate
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Neoplasm skin
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Neuroendocrine carcinoma metastatic
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Neuroendocrine tumour
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (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	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Non-Hodgkin's lymphoma
subjects affected / exposed	2 / 5992 (0.03%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Non-small cell lung cancer
subjects affected / exposed	3 / 5992 (0.05%)	5 / 5995 (0.08%)
occurrences causally related to treatment / all	0 / 3	0 / 5
deaths causally related to treatment / all	0 / 1	0 / 1
Non-small cell lung cancer stage I
subjects affected / exposed	1 / 5992 (0.02%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Oesophageal adenocarcinoma
subjects affected / exposed	1 / 5992 (0.02%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 0
Oesophageal adenocarcinoma metastatic
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Oesophageal carcinoma
subjects affected / exposed	1 / 5992 (0.02%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Oropharyngeal cancer
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Ovarian adenoma
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Ovarian cancer metastatic
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Pancreatic carcinoma
subjects affected / exposed	0 / 5992 (0.00%)	5 / 5995 (0.08%)
occurrences causally related to treatment / all	0 / 0	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 4
Pancreatic carcinoma metastatic
subjects affected / exposed	0 / 5992 (0.00%)	3 / 5995 (0.05%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 3
Pancreatic neuroendocrine tumour
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Papillary serous endometrial carcinoma
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Papillary thyroid cancer
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Peritoneal carcinoma metastatic
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Pharyngeal cancer
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pituitary tumour benign
subjects affected / exposed	1 / 5992 (0.02%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Plasma cell myeloma
subjects affected / exposed	1 / 5992 (0.02%)	5 / 5995 (0.08%)
occurrences causally related to treatment / all	0 / 1	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 2
Polycythaemia vera
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Prostate cancer
subjects affected / exposed	51 / 5992 (0.85%)	50 / 5995 (0.83%)
occurrences causally related to treatment / all	0 / 51	1 / 50
deaths causally related to treatment / all	0 / 1	0 / 1
Prostate cancer metastatic
subjects affected / exposed	2 / 5992 (0.03%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 1
Prostate cancer recurrent
subjects affected / exposed	6 / 5992 (0.10%)	3 / 5995 (0.05%)
occurrences causally related to treatment / all	0 / 6	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 1
Prostate cancer stage II
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Prostatic adenoma
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Rectal adenocarcinoma
subjects affected / exposed	0 / 5992 (0.00%)	2 / 5995 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Rectal cancer
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Rectal cancer metastatic
subjects affected / exposed	0 / 5992 (0.00%)	2 / 5995 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Rectosigmoid cancer
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (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	0 / 5992 (0.00%)	2 / 5995 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Renal cell carcinoma
subjects affected / exposed	7 / 5992 (0.12%)	3 / 5995 (0.05%)
occurrences causally related to treatment / all	0 / 7	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Renal neoplasm
subjects affected / exposed	1 / 5992 (0.02%)	2 / 5995 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Salivary gland adenoma
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Salivary gland cancer
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Skin cancer
subjects affected / exposed	1 / 5992 (0.02%)	2 / 5995 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Skin squamous cell carcinoma metastatic
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Small cell carcinoma
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Small cell lung cancer
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Small cell lung cancer extensive stage
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Small cell lung cancer metastatic
subjects affected / exposed	2 / 5992 (0.03%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 1
Squamous cell carcinoma
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (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 of head and neck
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Squamous cell carcinoma of lung
subjects affected / exposed	0 / 5992 (0.00%)	6 / 5995 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 2
Squamous cell carcinoma of skin
subjects affected / exposed	5 / 5992 (0.08%)	2 / 5995 (0.03%)
occurrences causally related to treatment / all	0 / 5	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Squamous cell carcinoma of the oral cavity
subjects affected / exposed	0 / 5992 (0.00%)	2 / 5995 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Squamous cell carcinoma of the tongue
subjects affected / exposed	2 / 5992 (0.03%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Tongue neoplasm malignant stage unspecified
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Tonsil cancer
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Transitional cell carcinoma
subjects affected / exposed	4 / 5992 (0.07%)	5 / 5995 (0.08%)
occurrences causally related to treatment / all	0 / 4	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Ureteral neoplasm
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Urethral cancer
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Uterine cancer
subjects affected / exposed	2 / 5992 (0.03%)	2 / 5995 (0.03%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Uterine leiomyoma
subjects affected / exposed	3 / 5992 (0.05%)	4 / 5995 (0.07%)
occurrences causally related to treatment / all	0 / 3	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Vulval cancer stage 0
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Waldenstrom's macroglobulinaemia
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Vascular disorders
Accelerated hypertension
subjects affected / exposed	2 / 5992 (0.03%)	4 / 5995 (0.07%)
occurrences causally related to treatment / all	0 / 2	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Aortic aneurysm
subjects affected / exposed	11 / 5992 (0.18%)	6 / 5995 (0.10%)
occurrences causally related to treatment / all	0 / 11	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Aortic dissection
subjects affected / exposed	1 / 5992 (0.02%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Aortic stenosis
subjects affected / exposed	7 / 5992 (0.12%)	14 / 5995 (0.23%)
occurrences causally related to treatment / all	0 / 7	1 / 15
deaths causally related to treatment / all	0 / 0	0 / 1
Arterial occlusive disease
subjects affected / exposed	2 / 5992 (0.03%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Arterial stenosis
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Arteriosclerosis
subjects affected / exposed	1 / 5992 (0.02%)	2 / 5995 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 1	0 / 0
Arteriovenous fistula
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (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	0 / 5992 (0.00%)	2 / 5995 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Deep vein thrombosis
subjects affected / exposed	13 / 5992 (0.22%)	12 / 5995 (0.20%)
occurrences causally related to treatment / all	0 / 16	0 / 12
deaths causally related to treatment / all	0 / 0	0 / 0
Dry gangrene
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Haematoma
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hypertension
subjects affected / exposed	14 / 5992 (0.23%)	10 / 5995 (0.17%)
occurrences causally related to treatment / all	0 / 19	0 / 10
deaths causally related to treatment / all	0 / 0	0 / 1
Hypertensive crisis
subjects affected / exposed	7 / 5992 (0.12%)	8 / 5995 (0.13%)
occurrences causally related to treatment / all	0 / 7	0 / 8
deaths causally related to treatment / all	0 / 0	0 / 0
Hypertensive emergency
subjects affected / exposed	1 / 5992 (0.02%)	1 / 5995 (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	10 / 5992 (0.17%)	16 / 5995 (0.27%)
occurrences causally related to treatment / all	0 / 10	0 / 16
deaths causally related to treatment / all	0 / 0	0 / 0
Hypovolaemic shock
subjects affected / exposed	1 / 5992 (0.02%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Iliac artery disease
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Intermittent claudication
subjects affected / exposed	2 / 5992 (0.03%)	6 / 5995 (0.10%)
occurrences causally related to treatment / all	0 / 2	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Ischaemia
subjects affected / exposed	2 / 5992 (0.03%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Leriche syndrome
subjects affected / exposed	0 / 5992 (0.00%)	2 / 5995 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Lymphoedema
subjects affected / exposed	1 / 5992 (0.02%)	2 / 5995 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Malignant hypertension
subjects affected / exposed	3 / 5992 (0.05%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Microscopic polyangiitis
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Orthostatic hypotension
subjects affected / exposed	1 / 5992 (0.02%)	5 / 5995 (0.08%)
occurrences causally related to treatment / all	0 / 1	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Peripheral arterial occlusive disease
subjects affected / exposed	11 / 5992 (0.18%)	14 / 5995 (0.23%)
occurrences causally related to treatment / all	0 / 11	0 / 15
deaths causally related to treatment / all	0 / 0	0 / 1
Peripheral artery aneurysm
subjects affected / exposed	1 / 5992 (0.02%)	2 / 5995 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Peripheral artery dissection
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Peripheral artery occlusion
subjects affected / exposed	4 / 5992 (0.07%)	2 / 5995 (0.03%)
occurrences causally related to treatment / all	0 / 4	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Peripheral artery stenosis
subjects affected / exposed	4 / 5992 (0.07%)	3 / 5995 (0.05%)
occurrences causally related to treatment / all	0 / 7	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Peripheral artery thrombosis
subjects affected / exposed	1 / 5992 (0.02%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Peripheral ischaemia
subjects affected / exposed	2 / 5992 (0.03%)	2 / 5995 (0.03%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Peripheral vascular disorder
subjects affected / exposed	7 / 5992 (0.12%)	6 / 5995 (0.10%)
occurrences causally related to treatment / all	0 / 7	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Peripheral venous disease
subjects affected / exposed	0 / 5992 (0.00%)	2 / 5995 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Poor peripheral circulation
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Reperfusion injury
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Shock haemorrhagic
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Subclavian artery stenosis
subjects affected / exposed	1 / 5992 (0.02%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Subclavian vein thrombosis
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Thrombophlebitis superficial
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Thrombosis
subjects affected / exposed	2 / 5992 (0.03%)	3 / 5995 (0.05%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Venous thrombosis
subjects affected / exposed	1 / 5992 (0.02%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Venous thrombosis limb
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (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 / 5992 (0.02%)	0 / 5995 (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	5 / 5992 (0.08%)	9 / 5995 (0.15%)
occurrences causally related to treatment / all	0 / 5	0 / 10
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac death
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Chest discomfort
subjects affected / exposed	7 / 5992 (0.12%)	6 / 5995 (0.10%)
occurrences causally related to treatment / all	0 / 7	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Chest pain
subjects affected / exposed	21 / 5992 (0.35%)	16 / 5995 (0.27%)
occurrences causally related to treatment / all	0 / 22	0 / 16
deaths causally related to treatment / all	0 / 0	0 / 0
Complication associated with device
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (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	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Death
subjects affected / exposed	12 / 5992 (0.20%)	16 / 5995 (0.27%)
occurrences causally related to treatment / all	1 / 12	2 / 16
deaths causally related to treatment / all	1 / 12	2 / 16
Drug withdrawal syndrome
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Exercise tolerance decreased
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Fatigue
subjects affected / exposed	1 / 5992 (0.02%)	2 / 5995 (0.03%)
occurrences causally related to treatment / all	1 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Gait disturbance
subjects affected / exposed	2 / 5992 (0.03%)	3 / 5995 (0.05%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal complication associated with device
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Generalised oedema
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hernia pain
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hypothermia
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (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	2 / 5992 (0.03%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Implant site erosion
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Incarcerated hernia
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Infusion site extravasation
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Localised oedema
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Malaise
subjects affected / exposed	2 / 5992 (0.03%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Medical device site haemorrhage
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Multiple organ dysfunction syndrome
subjects affected / exposed	2 / 5992 (0.03%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 1
Non-cardiac chest pain
subjects affected / exposed	132 / 5992 (2.20%)	133 / 5995 (2.22%)
occurrences causally related to treatment / all	0 / 153	1 / 164
deaths causally related to treatment / all	0 / 0	0 / 0
Oedema peripheral
subjects affected / exposed	4 / 5992 (0.07%)	4 / 5995 (0.07%)
occurrences causally related to treatment / all	1 / 4	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Pain
subjects affected / exposed	0 / 5992 (0.00%)	2 / 5995 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Peripheral swelling
subjects affected / exposed	2 / 5992 (0.03%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pyrexia
subjects affected / exposed	2 / 5992 (0.03%)	3 / 5995 (0.05%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Stent-graft endoleak
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Sudden cardiac death
subjects affected / exposed	2 / 5992 (0.03%)	2 / 5995 (0.03%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 2	0 / 2
Sudden death
subjects affected / exposed	1 / 5992 (0.02%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 1
Systemic inflammatory response syndrome
subjects affected / exposed	1 / 5992 (0.02%)	2 / 5995 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Vascular stent occlusion
subjects affected / exposed	1 / 5992 (0.02%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Vascular stent restenosis
subjects affected / exposed	2 / 5992 (0.03%)	3 / 5995 (0.05%)
occurrences causally related to treatment / all	0 / 2	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Vascular stent thrombosis
subjects affected / exposed	0 / 5992 (0.00%)	2 / 5995 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Immune system disorders
Anaphylactic reaction
subjects affected / exposed	4 / 5992 (0.07%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	1 / 4	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Anaphylactic shock
subjects affected / exposed	0 / 5992 (0.00%)	2 / 5995 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Drug hypersensitivity
subjects affected / exposed	2 / 5992 (0.03%)	3 / 5995 (0.05%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Hypersensitivity
subjects affected / exposed	1 / 5992 (0.02%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Social circumstances
Convalescent
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Spousal abuse
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Reproductive system and breast disorders
Acquired hydrocele
subjects affected / exposed	1 / 5992 (0.02%)	3 / 5995 (0.05%)
occurrences causally related to treatment / all	0 / 1	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Adnexa uteri mass
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Benign prostatic hyperplasia
subjects affected / exposed	10 / 5992 (0.17%)	7 / 5995 (0.12%)
occurrences causally related to treatment / all	0 / 12	0 / 11
deaths causally related to treatment / all	0 / 0	0 / 0
Breast enlargement
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Breast fibrosis
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Breast hyperplasia
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Breast pain
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Breast ulceration
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cystocele
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Endometrial hyperplasia
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Erectile dysfunction
subjects affected / exposed	1 / 5992 (0.02%)	2 / 5995 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Female genital tract fistula
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Mastoptosis
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Orchitis noninfective
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Organic erectile dysfunction
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Ovarian cyst
subjects affected / exposed	1 / 5992 (0.02%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pelvic pain
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (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 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Penis disorder
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Postmenopausal haemorrhage
subjects affected / exposed	2 / 5992 (0.03%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Priapism
subjects affected / exposed	2 / 5992 (0.03%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	2 / 2	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Prostatism
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Prostatitis
subjects affected / exposed	2 / 5992 (0.03%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Prostatomegaly
subjects affected / exposed	1 / 5992 (0.02%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Scrotal haematocoele
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Uterine polyp
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Uterine prolapse
subjects affected / exposed	4 / 5992 (0.07%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 4	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Vaginal haemorrhage
subjects affected / exposed	0 / 5992 (0.00%)	2 / 5995 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Vaginal prolapse
subjects affected / exposed	0 / 5992 (0.00%)	3 / 5995 (0.05%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
subjects affected / exposed	3 / 5992 (0.05%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Acute respiratory distress syndrome
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Acute respiratory failure
subjects affected / exposed	28 / 5992 (0.47%)	35 / 5995 (0.58%)
occurrences causally related to treatment / all	1 / 31	0 / 37
deaths causally related to treatment / all	1 / 3	0 / 5
Allergic bronchitis
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Aspiration
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Asthma
subjects affected / exposed	9 / 5992 (0.15%)	12 / 5995 (0.20%)
occurrences causally related to treatment / all	0 / 11	0 / 15
deaths causally related to treatment / all	0 / 0	0 / 0
Atelectasis
subjects affected / exposed	4 / 5992 (0.07%)	2 / 5995 (0.03%)
occurrences causally related to treatment / all	0 / 4	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Bronchial hyperreactivity
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Bronchitis chronic
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (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 / 5992 (0.00%)	1 / 5995 (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	43 / 5992 (0.72%)	39 / 5995 (0.65%)
occurrences causally related to treatment / all	0 / 53	0 / 58
deaths causally related to treatment / all	0 / 3	0 / 0
Chronic respiratory failure
subjects affected / exposed	2 / 5992 (0.03%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cough
subjects affected / exposed	3 / 5992 (0.05%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Dyspnoea
subjects affected / exposed	38 / 5992 (0.63%)	27 / 5995 (0.45%)
occurrences causally related to treatment / all	1 / 40	0 / 27
deaths causally related to treatment / all	0 / 1	0 / 0
Dyspnoea exertional
subjects affected / exposed	11 / 5992 (0.18%)	5 / 5995 (0.08%)
occurrences causally related to treatment / all	0 / 11	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Emphysema
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Epistaxis
subjects affected / exposed	3 / 5992 (0.05%)	5 / 5995 (0.08%)
occurrences causally related to treatment / all	0 / 3	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Haemoptysis
subjects affected / exposed	2 / 5992 (0.03%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Haemothorax
subjects affected / exposed	0 / 5992 (0.00%)	2 / 5995 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Hiccups
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hypercapnia
subjects affected / exposed	1 / 5992 (0.02%)	2 / 5995 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Hypoxia
subjects affected / exposed	6 / 5992 (0.10%)	8 / 5995 (0.13%)
occurrences causally related to treatment / all	0 / 6	0 / 10
deaths causally related to treatment / all	0 / 0	0 / 0
Idiopathic pulmonary fibrosis
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Interstitial lung disease
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Laryngeal granuloma
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Laryngeal mass
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Lung disorder
subjects affected / exposed	1 / 5992 (0.02%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 0
Mediastinal haematoma
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Mediastinal haemorrhage
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Nasal obstruction
subjects affected / exposed	1 / 5992 (0.02%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Nasal polyps
subjects affected / exposed	0 / 5992 (0.00%)	2 / 5995 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Obstructive airways disorder
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pharyngeal fistula
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pickwickian syndrome
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pleural effusion
subjects affected / exposed	10 / 5992 (0.17%)	12 / 5995 (0.20%)
occurrences causally related to treatment / all	0 / 10	0 / 13
deaths causally related to treatment / all	0 / 0	0 / 0
Pleurisy
subjects affected / exposed	1 / 5992 (0.02%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pleuritic pain
subjects affected / exposed	2 / 5992 (0.03%)	3 / 5995 (0.05%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumonia aspiration
subjects affected / exposed	4 / 5992 (0.07%)	3 / 5995 (0.05%)
occurrences causally related to treatment / all	0 / 4	0 / 3
deaths causally related to treatment / all	0 / 1	0 / 0
Pneumonitis
subjects affected / exposed	0 / 5992 (0.00%)	2 / 5995 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumothorax
subjects affected / exposed	4 / 5992 (0.07%)	5 / 5995 (0.08%)
occurrences causally related to treatment / all	0 / 6	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 1
Pulmonary arterial hypertension
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pulmonary embolism
subjects affected / exposed	26 / 5992 (0.43%)	20 / 5995 (0.33%)
occurrences causally related to treatment / all	1 / 27	0 / 21
deaths causally related to treatment / all	0 / 1	0 / 3
Pulmonary fibrosis
subjects affected / exposed	1 / 5992 (0.02%)	2 / 5995 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 1	0 / 0
Pulmonary granuloma
subjects affected / exposed	0 / 5992 (0.00%)	2 / 5995 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Pulmonary haemorrhage
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pulmonary hypertension
subjects affected / exposed	14 / 5992 (0.23%)	14 / 5995 (0.23%)
occurrences causally related to treatment / all	4 / 14	1 / 14
deaths causally related to treatment / all	0 / 0	0 / 0
Pulmonary mass
subjects affected / exposed	4 / 5992 (0.07%)	2 / 5995 (0.03%)
occurrences causally related to treatment / all	0 / 4	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Pulmonary oedema
subjects affected / exposed	8 / 5992 (0.13%)	5 / 5995 (0.08%)
occurrences causally related to treatment / all	0 / 8	0 / 5
deaths causally related to treatment / all	0 / 2	0 / 0
Pulmonary sarcoidosis
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Respiratory arrest
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Respiratory distress
subjects affected / exposed	3 / 5992 (0.05%)	4 / 5995 (0.07%)
occurrences causally related to treatment / all	0 / 3	0 / 4
deaths causally related to treatment / all	0 / 1	0 / 0
Respiratory failure
subjects affected / exposed	14 / 5992 (0.23%)	14 / 5995 (0.23%)
occurrences causally related to treatment / all	1 / 14	0 / 15
deaths causally related to treatment / all	0 / 2	0 / 1
Sleep apnoea syndrome
subjects affected / exposed	2 / 5992 (0.03%)	2 / 5995 (0.03%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Tachypnoea
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Tonsillar hypertrophy
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Psychiatric disorders
Agitation
subjects affected / exposed	0 / 5992 (0.00%)	2 / 5995 (0.03%)
occurrences causally related to treatment / all	0 / 0	1 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Alcohol abuse
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Alcohol withdrawal syndrome
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Anger
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Anxiety
subjects affected / exposed	4 / 5992 (0.07%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 4	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Confusional state
subjects affected / exposed	3 / 5992 (0.05%)	12 / 5995 (0.20%)
occurrences causally related to treatment / all	0 / 3	1 / 12
deaths causally related to treatment / all	0 / 0	0 / 0
Delirium
subjects affected / exposed	3 / 5992 (0.05%)	2 / 5995 (0.03%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 1
Depression
subjects affected / exposed	5 / 5992 (0.08%)	2 / 5995 (0.03%)
occurrences causally related to treatment / all	0 / 5	1 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Hallucination
subjects affected / exposed	2 / 5992 (0.03%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Insomnia
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Major depression
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Mental disorder due to a general medical condition
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (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	6 / 5992 (0.10%)	10 / 5995 (0.17%)
occurrences causally related to treatment / all	0 / 6	0 / 12
deaths causally related to treatment / all	0 / 0	0 / 0
Nightmare
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Post-traumatic stress disorder
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Psychotic disorder
subjects affected / exposed	1 / 5992 (0.02%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Somatic delusion
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Suicidal ideation
subjects affected / exposed	4 / 5992 (0.07%)	9 / 5995 (0.15%)
occurrences causally related to treatment / all	3 / 4	6 / 9
deaths causally related to treatment / all	0 / 0	0 / 0
Suicide attempt
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Product issues
Device dislocation
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Device failure
subjects affected / exposed	2 / 5992 (0.03%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Device loosening
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Device malfunction
subjects affected / exposed	1 / 5992 (0.02%)	2 / 5995 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Device pacing issue
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Lead dislodgement
subjects affected / exposed	0 / 5992 (0.00%)	3 / 5995 (0.05%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatobiliary disorders
Autoimmune hepatitis
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Bile duct obstruction
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Bile duct stone
subjects affected / exposed	2 / 5992 (0.03%)	2 / 5995 (0.03%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Biliary colic
subjects affected / exposed	2 / 5992 (0.03%)	2 / 5995 (0.03%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Biliary dyskinesia
subjects affected / exposed	1 / 5992 (0.02%)	2 / 5995 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Cholangitis
subjects affected / exposed	3 / 5992 (0.05%)	3 / 5995 (0.05%)
occurrences causally related to treatment / all	1 / 3	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Cholecystitis
subjects affected / exposed	14 / 5992 (0.23%)	10 / 5995 (0.17%)
occurrences causally related to treatment / all	1 / 14	0 / 10
deaths causally related to treatment / all	0 / 0	0 / 0
Cholecystitis acute
subjects affected / exposed	14 / 5992 (0.23%)	12 / 5995 (0.20%)
occurrences causally related to treatment / all	0 / 14	0 / 12
deaths causally related to treatment / all	0 / 0	0 / 0
Cholecystitis chronic
subjects affected / exposed	1 / 5992 (0.02%)	2 / 5995 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Cholelithiasis
subjects affected / exposed	24 / 5992 (0.40%)	14 / 5995 (0.23%)
occurrences causally related to treatment / all	0 / 25	0 / 14
deaths causally related to treatment / all	0 / 0	0 / 0
Cholelithiasis obstructive
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Chronic hepatic failure
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Cirrhosis alcoholic
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cryptogenic cirrhosis
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Drug-induced liver injury
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatic cirrhosis
subjects affected / exposed	2 / 5992 (0.03%)	4 / 5995 (0.07%)
occurrences causally related to treatment / all	0 / 2	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 2
Hepatic cyst
subjects affected / exposed	1 / 5992 (0.02%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatic function abnormal
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatic mass
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatic steatosis
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatic vascular thrombosis
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Liver disorder
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Liver injury
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Non-alcoholic fatty liver
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Portal vein thrombosis
subjects affected / exposed	0 / 5992 (0.00%)	2 / 5995 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Investigations
Ammonia increased
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Aortic bruit
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Blood calcium decreased
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Blood creatinine increased
subjects affected / exposed	2 / 5992 (0.03%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Blood glucose increased
subjects affected / exposed	2 / 5992 (0.03%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Blood immunoglobulin G decreased
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Blood potassium increased
subjects affected / exposed	1 / 5992 (0.02%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Blood pressure increased
subjects affected / exposed	2 / 5992 (0.03%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Blood sodium increased
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Blood urea increased
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Blood urine present
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Body temperature increased
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac stress test abnormal
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Coagulation test abnormal
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
ECG signs of myocardial ischaemia
subjects affected / exposed	1 / 5992 (0.02%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Ejection fraction decreased
subjects affected / exposed	1 / 5992 (0.02%)	3 / 5995 (0.05%)
occurrences causally related to treatment / all	1 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Electrocardiogram QT prolonged
subjects affected / exposed	1 / 5992 (0.02%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 1	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Electrocardiogram ST segment depression
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Electrocardiogram abnormal
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Glycosylated haemoglobin increased
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Haemoglobin decreased
subjects affected / exposed	2 / 5992 (0.03%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Heart rate decreased
subjects affected / exposed	2 / 5992 (0.03%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatic enzyme increased
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
International normalised ratio abnormal
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
International normalised ratio increased
subjects affected / exposed	2 / 5992 (0.03%)	3 / 5995 (0.05%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Liver function test abnormal
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Liver function test increased
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
N-terminal prohormone brain natriuretic peptide increased
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Oxygen saturation decreased
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Platelet count decreased
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (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	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Prothrombin time prolonged
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pulmonary arterial pressure increased
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Troponin T increased
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Troponin increased
subjects affected / exposed	8 / 5992 (0.13%)	6 / 5995 (0.10%)
occurrences causally related to treatment / all	0 / 8	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
White blood cell count increased
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Injury, poisoning and procedural complications
Abdominal injury
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Accidental overdose
subjects affected / exposed	1 / 5992 (0.02%)	3 / 5995 (0.05%)
occurrences causally related to treatment / all	0 / 1	1 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Alcohol poisoning
subjects affected / exposed	2 / 5992 (0.03%)	4 / 5995 (0.07%)
occurrences causally related to treatment / all	0 / 2	1 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Anaemia postoperative
subjects affected / exposed	1 / 5992 (0.02%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Anastomotic ulcer haemorrhage
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Animal bite
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Ankle fracture
subjects affected / exposed	4 / 5992 (0.07%)	6 / 5995 (0.10%)
occurrences causally related to treatment / all	0 / 4	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Arterial bypass thrombosis
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Arterial injury
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Bladder injury
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Brain contusion
subjects affected / exposed	1 / 5992 (0.02%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Cardiac contusion
subjects affected / exposed	0 / 5992 (0.00%)	2 / 5995 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac valve replacement complication
subjects affected / exposed	2 / 5992 (0.03%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cartilage injury
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (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	2 / 5992 (0.03%)	5 / 5995 (0.08%)
occurrences causally related to treatment / all	0 / 2	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Chest injury
subjects affected / exposed	2 / 5992 (0.03%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Clavicle fracture
subjects affected / exposed	1 / 5992 (0.02%)	2 / 5995 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Concussion
subjects affected / exposed	1 / 5992 (0.02%)	4 / 5995 (0.07%)
occurrences causally related to treatment / all	0 / 1	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Contusion
subjects affected / exposed	3 / 5992 (0.05%)	3 / 5995 (0.05%)
occurrences causally related to treatment / all	0 / 3	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Craniocerebral injury
subjects affected / exposed	1 / 5992 (0.02%)	2 / 5995 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Cystitis radiation
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Delayed recovery from anaesthesia
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Extradural haematoma
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Facial bones fracture
subjects affected / exposed	1 / 5992 (0.02%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Fall
subjects affected / exposed	15 / 5992 (0.25%)	21 / 5995 (0.35%)
occurrences causally related to treatment / all	0 / 17	0 / 21
deaths causally related to treatment / all	0 / 0	0 / 0
Femoral neck fracture
subjects affected / exposed	4 / 5992 (0.07%)	2 / 5995 (0.03%)
occurrences causally related to treatment / all	0 / 4	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Femur fracture
subjects affected / exposed	2 / 5992 (0.03%)	10 / 5995 (0.17%)
occurrences causally related to treatment / all	0 / 2	0 / 11
deaths causally related to treatment / all	0 / 0	0 / 0
Fibula fracture
subjects affected / exposed	3 / 5992 (0.05%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Foot fracture
subjects affected / exposed	3 / 5992 (0.05%)	2 / 5995 (0.03%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Forearm fracture
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Fractured sacrum
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal stoma complication
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hand fracture
subjects affected / exposed	1 / 5992 (0.02%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Head injury
subjects affected / exposed	2 / 5992 (0.03%)	4 / 5995 (0.07%)
occurrences causally related to treatment / all	0 / 2	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Hip fracture
subjects affected / exposed	5 / 5992 (0.08%)	10 / 5995 (0.17%)
occurrences causally related to treatment / all	0 / 5	0 / 10
deaths causally related to treatment / all	0 / 0	0 / 0
Humerus fracture
subjects affected / exposed	6 / 5992 (0.10%)	6 / 5995 (0.10%)
occurrences causally related to treatment / all	0 / 6	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Ilium fracture
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Incarcerated incisional hernia
subjects affected / exposed	0 / 5992 (0.00%)	2 / 5995 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Incision site complication
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Incision site haemorrhage
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Incisional hernia
subjects affected / exposed	3 / 5992 (0.05%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Incomplete spinal fusion
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Intentional overdose
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Intestinal anastomosis complication
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Jaw fracture
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Joint capsule rupture
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Joint dislocation
subjects affected / exposed	3 / 5992 (0.05%)	4 / 5995 (0.07%)
occurrences causally related to treatment / all	0 / 4	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Joint dislocation postoperative
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Joint injury
subjects affected / exposed	2 / 5992 (0.03%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Kidney contusion
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Laceration
subjects affected / exposed	1 / 5992 (0.02%)	2 / 5995 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Ligament rupture
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Ligament sprain
subjects affected / exposed	2 / 5992 (0.03%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Limb injury
subjects affected / exposed	3 / 5992 (0.05%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Limb traumatic amputation
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Liver contusion
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Lower limb fracture
subjects affected / exposed	2 / 5992 (0.03%)	3 / 5995 (0.05%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Lumbar vertebral fracture
subjects affected / exposed	1 / 5992 (0.02%)	4 / 5995 (0.07%)
occurrences causally related to treatment / all	0 / 1	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Meniscus injury
subjects affected / exposed	2 / 5992 (0.03%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Mental status changes postoperative
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Multiple fractures
subjects affected / exposed	2 / 5992 (0.03%)	3 / 5995 (0.05%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Multiple injuries
subjects affected / exposed	1 / 5992 (0.02%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Muscle strain
subjects affected / exposed	1 / 5992 (0.02%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Patella fracture
subjects affected / exposed	2 / 5992 (0.03%)	3 / 5995 (0.05%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Pelvic fracture
subjects affected / exposed	3 / 5992 (0.05%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Periprosthetic fracture
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumonitis chemical
subjects affected / exposed	0 / 5992 (0.00%)	2 / 5995 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumothorax traumatic
subjects affected / exposed	1 / 5992 (0.02%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Post laminectomy syndrome
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Post procedural bile leak
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Post procedural complication
subjects affected / exposed	3 / 5992 (0.05%)	2 / 5995 (0.03%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 1
Post procedural discharge
subjects affected / exposed	1 / 5992 (0.02%)	1 / 5995 (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	2 / 5992 (0.03%)	6 / 5995 (0.10%)
occurrences causally related to treatment / all	0 / 2	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
Post procedural haematuria
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Post procedural haemorrhage
subjects affected / exposed	3 / 5992 (0.05%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Post procedural myocardial infarction
subjects affected / exposed	3 / 5992 (0.05%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Post procedural swelling
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Postoperative fever
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Postoperative ileus
subjects affected / exposed	1 / 5992 (0.02%)	5 / 5995 (0.08%)
occurrences causally related to treatment / all	0 / 1	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Postoperative renal failure
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Postoperative respiratory failure
subjects affected / exposed	2 / 5992 (0.03%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Postoperative thoracic procedure complication
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Postoperative wound complication
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Postpericardiotomy syndrome
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Procedural complication
subjects affected / exposed	0 / 5992 (0.00%)	2 / 5995 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Procedural haemorrhage
subjects affected / exposed	1 / 5992 (0.02%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Procedural hypotension
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (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	1 / 5992 (0.02%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Procedural pneumothorax
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pubis fracture
subjects affected / exposed	2 / 5992 (0.03%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pulmonary contusion
subjects affected / exposed	0 / 5992 (0.00%)	2 / 5995 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Radius fracture
subjects affected / exposed	2 / 5992 (0.03%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Rib fracture
subjects affected / exposed	9 / 5992 (0.15%)	9 / 5995 (0.15%)
occurrences causally related to treatment / all	0 / 9	0 / 9
deaths causally related to treatment / all	0 / 0	0 / 0
Road traffic accident
subjects affected / exposed	9 / 5992 (0.15%)	5 / 5995 (0.08%)
occurrences causally related to treatment / all	1 / 9	0 / 5
deaths causally related to treatment / all	0 / 2	0 / 3
Scapula fracture
subjects affected / exposed	1 / 5992 (0.02%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Seroma
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Shunt malfunction
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Shunt occlusion
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Skin abrasion
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Skull fracture
subjects affected / exposed	1 / 5992 (0.02%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Spinal compression fracture
subjects affected / exposed	0 / 5992 (0.00%)	2 / 5995 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Spinal fracture
subjects affected / exposed	3 / 5992 (0.05%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Splenic rupture
subjects affected / exposed	1 / 5992 (0.02%)	3 / 5995 (0.05%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 1
Stab wound
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Subdural haematoma
subjects affected / exposed	7 / 5992 (0.12%)	5 / 5995 (0.08%)
occurrences causally related to treatment / all	0 / 8	0 / 5
deaths causally related to treatment / all	0 / 1	0 / 0
Tendon rupture
subjects affected / exposed	1 / 5992 (0.02%)	3 / 5995 (0.05%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Tibia fracture
subjects affected / exposed	3 / 5992 (0.05%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Traumatic arthritis
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Traumatic haematoma
subjects affected / exposed	4 / 5992 (0.07%)	4 / 5995 (0.07%)
occurrences causally related to treatment / all	0 / 4	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Traumatic haemorrhage
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Traumatic haemothorax
subjects affected / exposed	3 / 5992 (0.05%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Traumatic intracranial haemorrhage
subjects affected / exposed	2 / 5992 (0.03%)	2 / 5995 (0.03%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Upper limb fracture
subjects affected / exposed	4 / 5992 (0.07%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 4	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Urinary retention postoperative
subjects affected / exposed	1 / 5992 (0.02%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Vascular pseudoaneurysm
subjects affected / exposed	2 / 5992 (0.03%)	3 / 5995 (0.05%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Vascular pseudoaneurysm ruptured
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Weaning failure
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Wound
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Wound dehiscence
subjects affected / exposed	1 / 5992 (0.02%)	2 / 5995 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 1
Wound haematoma
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Wrist fracture
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Congenital, familial and genetic disorders
Atrial septal defect
subjects affected / exposed	1 / 5992 (0.02%)	2 / 5995 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Choledochal cyst
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Developmental hip dysplasia
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal arteriovenous malformation
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hydrocele
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hypertrophic cardiomyopathy
subjects affected / exposed	2 / 5992 (0.03%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Microgenia
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac disorders
Acute coronary syndrome
subjects affected / exposed	14 / 5992 (0.23%)	11 / 5995 (0.18%)
occurrences causally related to treatment / all	0 / 14	0 / 11
deaths causally related to treatment / all	0 / 0	0 / 0
Acute left ventricular failure
subjects affected / exposed	3 / 5992 (0.05%)	3 / 5995 (0.05%)
occurrences causally related to treatment / all	0 / 3	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Acute myocardial infarction
subjects affected / exposed	117 / 5992 (1.95%)	105 / 5995 (1.75%)
occurrences causally related to treatment / all	1 / 131	0 / 118
deaths causally related to treatment / all	1 / 7	0 / 3
Angina pectoris
subjects affected / exposed	123 / 5992 (2.05%)	142 / 5995 (2.37%)
occurrences causally related to treatment / all	0 / 136	0 / 152
deaths causally related to treatment / all	0 / 0	0 / 0
Angina unstable
subjects affected / exposed	106 / 5992 (1.77%)	113 / 5995 (1.88%)
occurrences causally related to treatment / all	1 / 115	0 / 129
deaths causally related to treatment / all	0 / 1	0 / 0
Anginal equivalent
subjects affected / exposed	2 / 5992 (0.03%)	2 / 5995 (0.03%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Aortic valve disease
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Aortic valve incompetence
subjects affected / exposed	4 / 5992 (0.07%)	6 / 5995 (0.10%)
occurrences causally related to treatment / all	1 / 4	2 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Aortic valve stenosis
subjects affected / exposed	2 / 5992 (0.03%)	3 / 5995 (0.05%)
occurrences causally related to treatment / all	1 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Arrhythmia
subjects affected / exposed	2 / 5992 (0.03%)	3 / 5995 (0.05%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 1	0 / 0
Arteriosclerosis coronary artery
subjects affected / exposed	1 / 5992 (0.02%)	9 / 5995 (0.15%)
occurrences causally related to treatment / all	0 / 1	0 / 9
deaths causally related to treatment / all	0 / 0	0 / 1
Arteriospasm coronary
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Atrial fibrillation
subjects affected / exposed	102 / 5992 (1.70%)	105 / 5995 (1.75%)
occurrences causally related to treatment / all	2 / 122	3 / 120
deaths causally related to treatment / all	0 / 0	0 / 0
Atrial flutter
subjects affected / exposed	22 / 5992 (0.37%)	21 / 5995 (0.35%)
occurrences causally related to treatment / all	0 / 28	3 / 23
deaths causally related to treatment / all	0 / 0	0 / 0
Atrial tachycardia
subjects affected / exposed	2 / 5992 (0.03%)	3 / 5995 (0.05%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Atrioventricular block
subjects affected / exposed	0 / 5992 (0.00%)	4 / 5995 (0.07%)
occurrences causally related to treatment / all	0 / 0	1 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Atrioventricular block complete
subjects affected / exposed	7 / 5992 (0.12%)	4 / 5995 (0.07%)
occurrences causally related to treatment / all	1 / 7	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Atrioventricular block first degree
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Atrioventricular block second degree
subjects affected / exposed	3 / 5992 (0.05%)	7 / 5995 (0.12%)
occurrences causally related to treatment / all	1 / 3	1 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
Bradyarrhythmia
subjects affected / exposed	1 / 5992 (0.02%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Bradycardia
subjects affected / exposed	17 / 5992 (0.28%)	18 / 5995 (0.30%)
occurrences causally related to treatment / all	0 / 17	0 / 18
deaths causally related to treatment / all	0 / 0	0 / 1
Bundle branch block bilateral
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Bundle branch block left
subjects affected / exposed	1 / 5992 (0.02%)	2 / 5995 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Bundle branch block right
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac aneurysm
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (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	19 / 5992 (0.32%)	17 / 5995 (0.28%)
occurrences causally related to treatment / all	0 / 19	0 / 17
deaths causally related to treatment / all	0 / 11	0 / 11
Cardiac discomfort
subjects affected / exposed	7 / 5992 (0.12%)	3 / 5995 (0.05%)
occurrences causally related to treatment / all	0 / 7	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac disorder
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Cardiac failure
subjects affected / exposed	21 / 5992 (0.35%)	18 / 5995 (0.30%)
occurrences causally related to treatment / all	0 / 25	0 / 19
deaths causally related to treatment / all	0 / 1	0 / 1
Cardiac failure acute
subjects affected / exposed	5 / 5992 (0.08%)	3 / 5995 (0.05%)
occurrences causally related to treatment / all	0 / 6	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac failure chronic
subjects affected / exposed	2 / 5992 (0.03%)	3 / 5995 (0.05%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac failure congestive
subjects affected / exposed	106 / 5992 (1.77%)	91 / 5995 (1.52%)
occurrences causally related to treatment / all	2 / 139	3 / 124
deaths causally related to treatment / all	1 / 3	0 / 1
Cardiac perforation
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac tamponade
subjects affected / exposed	1 / 5992 (0.02%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac valve disease
subjects affected / exposed	0 / 5992 (0.00%)	2 / 5995 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac ventricular thrombosis
subjects affected / exposed	1 / 5992 (0.02%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cardio-respiratory arrest
subjects affected / exposed	6 / 5992 (0.10%)	7 / 5995 (0.12%)
occurrences causally related to treatment / all	0 / 6	1 / 7
deaths causally related to treatment / all	0 / 5	1 / 6
Cardiogenic shock
subjects affected / exposed	5 / 5992 (0.08%)	4 / 5995 (0.07%)
occurrences causally related to treatment / all	1 / 5	0 / 4
deaths causally related to treatment / all	1 / 3	0 / 2
Cardiomyopathy
subjects affected / exposed	4 / 5992 (0.07%)	5 / 5995 (0.08%)
occurrences causally related to treatment / all	0 / 4	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiopulmonary failure
subjects affected / exposed	2 / 5992 (0.03%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 2	0 / 1
Cardiovascular disorder
subjects affected / exposed	2 / 5992 (0.03%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 0
Cardiovascular insufficiency
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cor pulmonale
subjects affected / exposed	1 / 5992 (0.02%)	3 / 5995 (0.05%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Cor pulmonale acute
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cor pulmonale chronic
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (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	78 / 5992 (1.30%)	87 / 5995 (1.45%)
occurrences causally related to treatment / all	0 / 80	3 / 92
deaths causally related to treatment / all	0 / 0	0 / 8
Coronary artery occlusion
subjects affected / exposed	6 / 5992 (0.10%)	8 / 5995 (0.13%)
occurrences causally related to treatment / all	0 / 6	1 / 10
deaths causally related to treatment / all	0 / 0	0 / 0
Coronary artery perforation
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (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	13 / 5992 (0.22%)	17 / 5995 (0.28%)
occurrences causally related to treatment / all	0 / 13	1 / 17
deaths causally related to treatment / all	0 / 0	0 / 0
Diastolic dysfunction
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hyperdynamic left ventricle
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hypertensive heart disease
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Intracardiac thrombus
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Ischaemic cardiomyopathy
subjects affected / exposed	4 / 5992 (0.07%)	3 / 5995 (0.05%)
occurrences causally related to treatment / all	0 / 4	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Kounis syndrome
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Left atrial dilatation
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Left ventricular dysfunction
subjects affected / exposed	3 / 5992 (0.05%)	3 / 5995 (0.05%)
occurrences causally related to treatment / all	1 / 3	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Left ventricular failure
subjects affected / exposed	2 / 5992 (0.03%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Microvascular coronary artery disease
subjects affected / exposed	1 / 5992 (0.02%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 13
deaths causally related to treatment / all	0 / 0	0 / 0
Mitral valve disease
subjects affected / exposed	2 / 5992 (0.03%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	1 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Mitral valve incompetence
subjects affected / exposed	12 / 5992 (0.20%)	12 / 5995 (0.20%)
occurrences causally related to treatment / all	3 / 12	4 / 12
deaths causally related to treatment / all	0 / 0	0 / 0
Mitral valve prolapse
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Mitral valve stenosis
subjects affected / exposed	2 / 5992 (0.03%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	1 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Myocardial infarction
subjects affected / exposed	31 / 5992 (0.52%)	36 / 5995 (0.60%)
occurrences causally related to treatment / all	2 / 31	0 / 38
deaths causally related to treatment / all	1 / 9	0 / 4
Myocardial ischaemia
subjects affected / exposed	16 / 5992 (0.27%)	14 / 5995 (0.23%)
occurrences causally related to treatment / all	1 / 17	1 / 14
deaths causally related to treatment / all	0 / 0	1 / 3
Palpitations
subjects affected / exposed	5 / 5992 (0.08%)	6 / 5995 (0.10%)
occurrences causally related to treatment / all	0 / 5	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Pericardial cyst
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pericardial effusion
subjects affected / exposed	0 / 5992 (0.00%)	4 / 5995 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Pericardial haemorrhage
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pericarditis
subjects affected / exposed	2 / 5992 (0.03%)	2 / 5995 (0.03%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Pericarditis constrictive
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Prinzmetal angina
subjects affected / exposed	2 / 5992 (0.03%)	3 / 5995 (0.05%)
occurrences causally related to treatment / all	0 / 3	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Pulmonary valve incompetence
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pulseless electrical activity
subjects affected / exposed	2 / 5992 (0.03%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 2	1 / 1
deaths causally related to treatment / all	0 / 1	1 / 1
Right ventricular failure
subjects affected / exposed	1 / 5992 (0.02%)	3 / 5995 (0.05%)
occurrences causally related to treatment / all	0 / 1	1 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Sinus bradycardia
subjects affected / exposed	2 / 5992 (0.03%)	3 / 5995 (0.05%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Sinus node dysfunction
subjects affected / exposed	6 / 5992 (0.10%)	15 / 5995 (0.25%)
occurrences causally related to treatment / all	0 / 6	0 / 17
deaths causally related to treatment / all	0 / 0	0 / 0
Sinus tachycardia
subjects affected / exposed	1 / 5992 (0.02%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Stress cardiomyopathy
subjects affected / exposed	0 / 5992 (0.00%)	3 / 5995 (0.05%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 1
Supraventricular tachycardia
subjects affected / exposed	9 / 5992 (0.15%)	11 / 5995 (0.18%)
occurrences causally related to treatment / all	0 / 9	1 / 11
deaths causally related to treatment / all	0 / 0	0 / 0
Systolic dysfunction
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Tachycardia
subjects affected / exposed	1 / 5992 (0.02%)	5 / 5995 (0.08%)
occurrences causally related to treatment / all	0 / 1	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Tricuspid valve incompetence
subjects affected / exposed	7 / 5992 (0.12%)	6 / 5995 (0.10%)
occurrences causally related to treatment / all	3 / 7	2 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Ventricular arrhythmia
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Ventricular extrasystoles
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Ventricular fibrillation
subjects affected / exposed	8 / 5992 (0.13%)	3 / 5995 (0.05%)
occurrences causally related to treatment / all	0 / 8	0 / 4
deaths causally related to treatment / all	0 / 2	0 / 0
Ventricular tachyarrhythmia
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (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	22 / 5992 (0.37%)	13 / 5995 (0.22%)
occurrences causally related to treatment / all	0 / 27	0 / 14
deaths causally related to treatment / all	0 / 1	0 / 0
Nervous system disorders
Amnesia
subjects affected / exposed	1 / 5992 (0.02%)	1 / 5995 (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	1 / 5992 (0.02%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 1	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Balance disorder
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Basal ganglia haemorrhage
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Basal ganglia infarction
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Bickerstaff's encephalitis
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Brain injury
subjects affected / exposed	3 / 5992 (0.05%)	2 / 5995 (0.03%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 2	0 / 1
Brain stem haemorrhage
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Brain stem infarction
subjects affected / exposed	0 / 5992 (0.00%)	2 / 5995 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Brain stem stroke
subjects affected / exposed	3 / 5992 (0.05%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Carotid artery disease
subjects affected / exposed	2 / 5992 (0.03%)	3 / 5995 (0.05%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Carotid artery occlusion
subjects affected / exposed	2 / 5992 (0.03%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Carotid artery stenosis
subjects affected / exposed	17 / 5992 (0.28%)	15 / 5995 (0.25%)
occurrences causally related to treatment / all	0 / 19	0 / 15
deaths causally related to treatment / all	0 / 0	0 / 0
Carotid sinus syndrome
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Carpal tunnel syndrome
subjects affected / exposed	0 / 5992 (0.00%)	2 / 5995 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Central nervous system necrosis
subjects affected / exposed	1 / 5992 (0.02%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cerebellar infarction
subjects affected / exposed	1 / 5992 (0.02%)	2 / 5995 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Cerebral circulatory failure
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cerebral haemorrhage
subjects affected / exposed	2 / 5992 (0.03%)	2 / 5995 (0.03%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Cerebral infarction
subjects affected / exposed	4 / 5992 (0.07%)	9 / 5995 (0.15%)
occurrences causally related to treatment / all	0 / 4	0 / 9
deaths causally related to treatment / all	0 / 0	0 / 0
Cerebrospinal fluid leakage
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (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	41 / 5992 (0.68%)	29 / 5995 (0.48%)
occurrences causally related to treatment / all	3 / 42	1 / 31
deaths causally related to treatment / all	0 / 3	0 / 2
Cerebrovascular disorder
subjects affected / exposed	2 / 5992 (0.03%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cervical cord compression
subjects affected / exposed	1 / 5992 (0.02%)	2 / 5995 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Cervical myelopathy
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cervical radiculopathy
subjects affected / exposed	2 / 5992 (0.03%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cervicogenic headache
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Complex partial seizures
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cranial nerve palsies multiple
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cubital tunnel syndrome
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Dementia
subjects affected / exposed	2 / 5992 (0.03%)	2 / 5995 (0.03%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 1	0 / 0
Dementia Alzheimer's type
subjects affected / exposed	1 / 5992 (0.02%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Diabetic coma
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	2 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Dizziness
subjects affected / exposed	9 / 5992 (0.15%)	14 / 5995 (0.23%)
occurrences causally related to treatment / all	0 / 9	2 / 14
deaths causally related to treatment / all	0 / 0	0 / 0
Dizziness postural
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Dysarthria
subjects affected / exposed	1 / 5992 (0.02%)	2 / 5995 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Embolic cerebral infarction
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Embolic stroke
subjects affected / exposed	2 / 5992 (0.03%)	3 / 5995 (0.05%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Encephalopathy
subjects affected / exposed	2 / 5992 (0.03%)	4 / 5995 (0.07%)
occurrences causally related to treatment / all	0 / 2	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Epilepsy
subjects affected / exposed	1 / 5992 (0.02%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Facial paralysis
subjects affected / exposed	1 / 5992 (0.02%)	2 / 5995 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Frontal lobe epilepsy
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Guillain-Barre syndrome
subjects affected / exposed	0 / 5992 (0.00%)	2 / 5995 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Haemorrhage intracranial
subjects affected / exposed	2 / 5992 (0.03%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Haemorrhagic stroke
subjects affected / exposed	1 / 5992 (0.02%)	3 / 5995 (0.05%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 2
Headache
subjects affected / exposed	9 / 5992 (0.15%)	5 / 5995 (0.08%)
occurrences causally related to treatment / all	1 / 10	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Hemiparesis
subjects affected / exposed	2 / 5992 (0.03%)	2 / 5995 (0.03%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatic encephalopathy
subjects affected / exposed	0 / 5992 (0.00%)	3 / 5995 (0.05%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Hypertensive encephalopathy
subjects affected / exposed	2 / 5992 (0.03%)	3 / 5995 (0.05%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Hypoaesthesia
subjects affected / exposed	5 / 5992 (0.08%)	3 / 5995 (0.05%)
occurrences causally related to treatment / all	0 / 5	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Hypoxic-ischaemic encephalopathy
subjects affected / exposed	0 / 5992 (0.00%)	2 / 5995 (0.03%)
occurrences causally related to treatment / all	0 / 0	1 / 2
deaths causally related to treatment / all	0 / 0	1 / 1
IIIrd nerve paralysis
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Intracranial aneurysm
subjects affected / exposed	1 / 5992 (0.02%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 0
Ischaemic stroke
subjects affected / exposed	14 / 5992 (0.23%)	13 / 5995 (0.22%)
occurrences causally related to treatment / all	0 / 14	1 / 14
deaths causally related to treatment / all	0 / 1	0 / 1
Lacunar infarction
subjects affected / exposed	2 / 5992 (0.03%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Loss of consciousness
subjects affected / exposed	3 / 5992 (0.05%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Lumbar radiculopathy
subjects affected / exposed	4 / 5992 (0.07%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 4	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Lumbosacral radiculopathy
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Metabolic encephalopathy
subjects affected / exposed	2 / 5992 (0.03%)	5 / 5995 (0.08%)
occurrences causally related to treatment / all	0 / 2	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Migraine
subjects affected / exposed	5 / 5992 (0.08%)	5 / 5995 (0.08%)
occurrences causally related to treatment / all	0 / 5	1 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Migraine with aura
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Motor neurone disease
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Myasthenia gravis
subjects affected / exposed	1 / 5992 (0.02%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Myelomalacia
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (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	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Myoclonus
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (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	0 / 5992 (0.00%)	3 / 5995 (0.05%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Nerve root compression
subjects affected / exposed	2 / 5992 (0.03%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Neuralgia
subjects affected / exposed	1 / 5992 (0.02%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Neuromyelitis optica spectrum disorder
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Neuropathy peripheral
subjects affected / exposed	1 / 5992 (0.02%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Normal pressure hydrocephalus
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Paraesthesia
subjects affected / exposed	1 / 5992 (0.02%)	3 / 5995 (0.05%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Parkinson's disease
subjects affected / exposed	2 / 5992 (0.03%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Parkinsonism
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Peripheral sensory neuropathy
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Peroneal nerve palsy
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Petit mal epilepsy
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Presyncope
subjects affected / exposed	13 / 5992 (0.22%)	9 / 5995 (0.15%)
occurrences causally related to treatment / all	0 / 13	0 / 9
deaths causally related to treatment / all	0 / 0	0 / 0
Radial nerve palsy
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Radicular pain
subjects affected / exposed	1 / 5992 (0.02%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Sciatica
subjects affected / exposed	7 / 5992 (0.12%)	2 / 5995 (0.03%)
occurrences causally related to treatment / all	0 / 7	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Seizure
subjects affected / exposed	4 / 5992 (0.07%)	10 / 5995 (0.17%)
occurrences causally related to treatment / all	0 / 4	0 / 13
deaths causally related to treatment / all	0 / 1	0 / 0
Serotonin syndrome
subjects affected / exposed	3 / 5992 (0.05%)	3 / 5995 (0.05%)
occurrences causally related to treatment / all	4 / 4	3 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Simple partial seizures
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Slow speech
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Somnolence
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Spinal claudication
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Spinal cord disorder
subjects affected / exposed	0 / 5992 (0.00%)	2 / 5995 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Spondylitic myelopathy
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (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 / 5992 (0.03%)	9 / 5995 (0.15%)
occurrences causally related to treatment / all	0 / 2	0 / 9
deaths causally related to treatment / all	0 / 0	0 / 2
Superficial siderosis of central nervous system
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Superior sagittal sinus thrombosis
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Syncope
subjects affected / exposed	49 / 5992 (0.82%)	54 / 5995 (0.90%)
occurrences causally related to treatment / all	3 / 51	1 / 62
deaths causally related to treatment / all	0 / 0	0 / 1
Thalamus haemorrhage
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Toxic encephalopathy
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Transient global amnesia
subjects affected / exposed	2 / 5992 (0.03%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	1 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Transient ischaemic attack
subjects affected / exposed	38 / 5992 (0.63%)	46 / 5995 (0.77%)
occurrences causally related to treatment / all	0 / 39	3 / 55
deaths causally related to treatment / all	0 / 0	0 / 0
Transverse sinus thrombosis
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Tremor
subjects affected / exposed	0 / 5992 (0.00%)	4 / 5995 (0.07%)
occurrences causally related to treatment / all	0 / 0	1 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Trigeminal neuralgia
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Unresponsive to stimuli
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
VIth nerve paralysis
subjects affected / exposed	0 / 5992 (0.00%)	2 / 5995 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Vertebral artery dissection
subjects affected / exposed	1 / 5992 (0.02%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Vertebral artery thrombosis
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Vertebrobasilar insufficiency
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Vocal cord paralysis
subjects affected / exposed	1 / 5992 (0.02%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Blood and lymphatic system disorders
Abdominal lymphadenopathy
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Anaemia
subjects affected / exposed	19 / 5992 (0.32%)	12 / 5995 (0.20%)
occurrences causally related to treatment / all	0 / 19	0 / 14
deaths causally related to treatment / all	0 / 0	0 / 0
Anaemia macrocytic
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Autoimmune haemolytic anaemia
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Disseminated intravascular coagulation
subjects affected / exposed	1 / 5992 (0.02%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Febrile neutropenia
subjects affected / exposed	1 / 5992 (0.02%)	2 / 5995 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Haemorrhagic anaemia
subjects affected / exposed	7 / 5992 (0.12%)	3 / 5995 (0.05%)
occurrences causally related to treatment / all	0 / 7	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Iron deficiency anaemia
subjects affected / exposed	2 / 5992 (0.03%)	4 / 5995 (0.07%)
occurrences causally related to treatment / all	0 / 2	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Leukocytosis
subjects affected / exposed	3 / 5992 (0.05%)	5 / 5995 (0.08%)
occurrences causally related to treatment / all	0 / 3	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Leukopenia
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Lymphadenopathy
subjects affected / exposed	2 / 5992 (0.03%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Microcytic anaemia
subjects affected / exposed	2 / 5992 (0.03%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Neutropenia
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Normochromic normocytic anaemia
subjects affected / exposed	1 / 5992 (0.02%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Splenic haematoma
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Splenic infarction
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Spontaneous haematoma
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Thrombocytopenia
subjects affected / exposed	1 / 5992 (0.02%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Ear and labyrinth disorders
Tympanic membrane perforation
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Vertigo
subjects affected / exposed	8 / 5992 (0.13%)	9 / 5995 (0.15%)
occurrences causally related to treatment / all	0 / 8	0 / 9
deaths causally related to treatment / all	0 / 0	0 / 0
Vertigo positional
subjects affected / exposed	1 / 5992 (0.02%)	5 / 5995 (0.08%)
occurrences causally related to treatment / all	0 / 1	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Eye disorders
Cataract
subjects affected / exposed	3 / 5992 (0.05%)	2 / 5995 (0.03%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Charles Bonnet syndrome
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Deformity of orbit
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Macular oedema
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Oscillopsia
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Retinal artery occlusion
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Retinal vascular thrombosis
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Vision blurred
subjects affected / exposed	0 / 5992 (0.00%)	2 / 5995 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Vitreous adhesions
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Vitreous haemorrhage
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal disorders
Abdominal adhesions
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Abdominal discomfort
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Abdominal distension
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Abdominal fat apron
subjects affected / exposed	1 / 5992 (0.02%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Abdominal hernia
subjects affected / exposed	10 / 5992 (0.17%)	7 / 5995 (0.12%)
occurrences causally related to treatment / all	0 / 10	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
Abdominal hernia obstructive
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Abdominal incarcerated hernia
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (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	11 / 5992 (0.18%)	9 / 5995 (0.15%)
occurrences causally related to treatment / all	1 / 11	0 / 9
deaths causally related to treatment / all	0 / 0	0 / 0
Abdominal pain upper
subjects affected / exposed	7 / 5992 (0.12%)	6 / 5995 (0.10%)
occurrences causally related to treatment / all	0 / 7	1 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Abdominal wall haematoma
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Anal fissure
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Anal incontinence
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Anorectal varices
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Ascites
subjects affected / exposed	2 / 5992 (0.03%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Coeliac artery stenosis
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Colitis
subjects affected / exposed	8 / 5992 (0.13%)	4 / 5995 (0.07%)
occurrences causally related to treatment / all	0 / 8	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Colitis ischaemic
subjects affected / exposed	1 / 5992 (0.02%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Colitis microscopic
subjects affected / exposed	1 / 5992 (0.02%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 1	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Colitis ulcerative
subjects affected / exposed	0 / 5992 (0.00%)	2 / 5995 (0.03%)
occurrences causally related to treatment / all	0 / 0	1 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Colonic pseudo-obstruction
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Constipation
subjects affected / exposed	6 / 5992 (0.10%)	8 / 5995 (0.13%)
occurrences causally related to treatment / all	0 / 7	0 / 9
deaths causally related to treatment / all	0 / 0	0 / 0
Crohn's disease
subjects affected / exposed	1 / 5992 (0.02%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Diarrhoea
subjects affected / exposed	6 / 5992 (0.10%)	8 / 5995 (0.13%)
occurrences causally related to treatment / all	1 / 6	0 / 8
deaths causally related to treatment / all	0 / 0	0 / 0
Dieulafoy's vascular malformation
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Diverticular perforation
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Diverticulum
subjects affected / exposed	4 / 5992 (0.07%)	6 / 5995 (0.10%)
occurrences causally related to treatment / all	0 / 4	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Diverticulum intestinal haemorrhagic
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Duodenal ulcer
subjects affected / exposed	2 / 5992 (0.03%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Duodenal ulcer haemorrhage
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Duodenal ulcer perforation
subjects affected / exposed	1 / 5992 (0.02%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Duodenitis
subjects affected / exposed	2 / 5992 (0.03%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Duodenogastric reflux
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Dyspepsia
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (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	6 / 5992 (0.10%)	4 / 5995 (0.07%)
occurrences causally related to treatment / all	0 / 6	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Enteritis
subjects affected / exposed	0 / 5992 (0.00%)	2 / 5995 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Enterocele
subjects affected / exposed	1 / 5992 (0.02%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Erosive duodenitis
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Erosive oesophagitis
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Faecaloma
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Food poisoning
subjects affected / exposed	0 / 5992 (0.00%)	2 / 5995 (0.03%)
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	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastric disorder
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastric haemorrhage
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Gastric perforation
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gastric polyps
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastric ulcer
subjects affected / exposed	5 / 5992 (0.08%)	5 / 5995 (0.08%)
occurrences causally related to treatment / all	0 / 5	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Gastric ulcer haemorrhage
subjects affected / exposed	1 / 5992 (0.02%)	2 / 5995 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Gastritis
subjects affected / exposed	6 / 5992 (0.10%)	6 / 5995 (0.10%)
occurrences causally related to treatment / all	0 / 7	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Gastritis erosive
subjects affected / exposed	3 / 5992 (0.05%)	2 / 5995 (0.03%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal angiodysplasia haemorrhagic
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal haemorrhage
subjects affected / exposed	27 / 5992 (0.45%)	29 / 5995 (0.48%)
occurrences causally related to treatment / all	0 / 30	0 / 29
deaths causally related to treatment / all	0 / 1	0 / 1
Gastrointestinal necrosis
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal ulcer haemorrhage
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (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	9 / 5992 (0.15%)	11 / 5995 (0.18%)
occurrences causally related to treatment / all	0 / 10	0 / 11
deaths causally related to treatment / all	0 / 0	0 / 0
Haematochezia
subjects affected / exposed	2 / 5992 (0.03%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Haemorrhoidal haemorrhage
subjects affected / exposed	2 / 5992 (0.03%)	2 / 5995 (0.03%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Haemorrhoids
subjects affected / exposed	2 / 5992 (0.03%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hiatus hernia
subjects affected / exposed	5 / 5992 (0.08%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 5	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Ileus
subjects affected / exposed	1 / 5992 (0.02%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Impaired gastric emptying
subjects affected / exposed	0 / 5992 (0.00%)	2 / 5995 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Incarcerated umbilical hernia
subjects affected / exposed	1 / 5992 (0.02%)	2 / 5995 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Inguinal hernia
subjects affected / exposed	9 / 5992 (0.15%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 9	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Intestinal dilatation
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Intestinal haemorrhage
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Intestinal ischaemia
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Intestinal obstruction
subjects affected / exposed	3 / 5992 (0.05%)	7 / 5995 (0.12%)
occurrences causally related to treatment / all	0 / 3	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
Intestinal perforation
subjects affected / exposed	3 / 5992 (0.05%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Intra-abdominal haematoma
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Irritable bowel syndrome
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Large intestinal haemorrhage
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Large intestinal ulcer
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Large intestine perforation
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Large intestine polyp
subjects affected / exposed	2 / 5992 (0.03%)	5 / 5995 (0.08%)
occurrences causally related to treatment / all	0 / 3	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Lower gastrointestinal haemorrhage
subjects affected / exposed	9 / 5992 (0.15%)	2 / 5995 (0.03%)
occurrences causally related to treatment / all	0 / 9	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Megacolon
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Melaena
subjects affected / exposed	1 / 5992 (0.02%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Mesenteric artery stenosis
subjects affected / exposed	1 / 5992 (0.02%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Mesenteric panniculitis
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Nausea
subjects affected / exposed	3 / 5992 (0.05%)	8 / 5995 (0.13%)
occurrences causally related to treatment / all	0 / 3	0 / 8
deaths causally related to treatment / all	0 / 0	0 / 0
Obstruction gastric
subjects affected / exposed	1 / 5992 (0.02%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Odynophagia
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Oesophageal food impaction
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Oesophageal pain
subjects affected / exposed	1 / 5992 (0.02%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Oesophageal spasm
subjects affected / exposed	0 / 5992 (0.00%)	2 / 5995 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Oesophageal stenosis
subjects affected / exposed	1 / 5992 (0.02%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Oesophageal varices haemorrhage
subjects affected / exposed	0 / 5992 (0.00%)	2 / 5995 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Oesophagitis
subjects affected / exposed	2 / 5992 (0.03%)	2 / 5995 (0.03%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Omental infarction
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pancreatitis
subjects affected / exposed	14 / 5992 (0.23%)	13 / 5995 (0.22%)
occurrences causally related to treatment / all	5 / 15	0 / 14
deaths causally related to treatment / all	0 / 0	0 / 0
Pancreatitis acute
subjects affected / exposed	15 / 5992 (0.25%)	9 / 5995 (0.15%)
occurrences causally related to treatment / all	0 / 17	0 / 9
deaths causally related to treatment / all	0 / 1	0 / 0
Pancreatitis chronic
subjects affected / exposed	0 / 5992 (0.00%)	2 / 5995 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Pancreatitis relapsing
subjects affected / exposed	1 / 5992 (0.02%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Peptic ulcer
subjects affected / exposed	3 / 5992 (0.05%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Peptic ulcer haemorrhage
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (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	6 / 5992 (0.10%)	8 / 5995 (0.13%)
occurrences causally related to treatment / all	0 / 6	0 / 8
deaths causally related to treatment / all	0 / 0	0 / 0
Rectal polyp
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Retroperitoneal haemorrhage
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Salivary gland mass
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (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	18 / 5992 (0.30%)	11 / 5995 (0.18%)
occurrences causally related to treatment / all	0 / 22	0 / 16
deaths causally related to treatment / all	0 / 0	0 / 0
Tongue disorder
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (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	7 / 5992 (0.12%)	6 / 5995 (0.10%)
occurrences causally related to treatment / all	0 / 7	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Upper gastrointestinal haemorrhage
subjects affected / exposed	5 / 5992 (0.08%)	3 / 5995 (0.05%)
occurrences causally related to treatment / all	0 / 5	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Uvulitis
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Visceroptosis
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Vomiting
subjects affected / exposed	7 / 5992 (0.12%)	6 / 5995 (0.10%)
occurrences causally related to treatment / all	0 / 7	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
Skin and subcutaneous tissue disorders
Angioedema
subjects affected / exposed	2 / 5992 (0.03%)	3 / 5995 (0.05%)
occurrences causally related to treatment / all	0 / 2	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Decubitus ulcer
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Dermatitis atopic
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (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	4 / 5992 (0.07%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 4	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Diabetic ulcer
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Drug reaction with eosinophilia and systemic symptoms
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Excessive skin
subjects affected / exposed	0 / 5992 (0.00%)	2 / 5995 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Hyperhidrosis
subjects affected / exposed	1 / 5992 (0.02%)	2 / 5995 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Hypersensitivity vasculitis
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Neutrophilic dermatosis
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Petechiae
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pruritus
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Rash
subjects affected / exposed	1 / 5992 (0.02%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Rash erythematous
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Skin necrosis
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Skin ulcer
subjects affected / exposed	5 / 5992 (0.08%)	3 / 5995 (0.05%)
occurrences causally related to treatment / all	0 / 5	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Telangiectasia
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Urticaria
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Renal and urinary disorders
Acute kidney injury
subjects affected / exposed	57 / 5992 (0.95%)	57 / 5995 (0.95%)
occurrences causally related to treatment / all	1 / 64	0 / 61
deaths causally related to treatment / all	0 / 2	0 / 1
Acute prerenal failure
subjects affected / exposed	3 / 5992 (0.05%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Albuminuria
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Azotaemia
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Bladder disorder
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Bladder dysfunction
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (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	3 / 5992 (0.05%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Bladder necrosis
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Bladder outlet obstruction
subjects affected / exposed	0 / 5992 (0.00%)	2 / 5995 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Bladder prolapse
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Bladder stenosis
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Calculus urinary
subjects affected / exposed	1 / 5992 (0.02%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Chronic kidney disease
subjects affected / exposed	5 / 5992 (0.08%)	2 / 5995 (0.03%)
occurrences causally related to treatment / all	0 / 5	0 / 2
deaths causally related to treatment / all	0 / 1	0 / 0
Cystitis haemorrhagic
subjects affected / exposed	1 / 5992 (0.02%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Diabetic nephropathy
subjects affected / exposed	1 / 5992 (0.02%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
End stage renal disease
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Haematuria
subjects affected / exposed	7 / 5992 (0.12%)	5 / 5995 (0.08%)
occurrences causally related to treatment / all	0 / 10	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Haemorrhage urinary tract
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hydronephrosis
subjects affected / exposed	1 / 5992 (0.02%)	2 / 5995 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Lower urinary tract symptoms
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (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	18 / 5992 (0.30%)	11 / 5995 (0.18%)
occurrences causally related to treatment / all	0 / 18	0 / 11
deaths causally related to treatment / all	0 / 0	0 / 0
Obstructive uropathy
subjects affected / exposed	0 / 5992 (0.00%)	2 / 5995 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Oliguria
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Proteinuria
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Renal artery stenosis
subjects affected / exposed	0 / 5992 (0.00%)	2 / 5995 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Renal colic
subjects affected / exposed	2 / 5992 (0.03%)	5 / 5995 (0.08%)
occurrences causally related to treatment / all	0 / 2	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Renal failure
subjects affected / exposed	3 / 5992 (0.05%)	4 / 5995 (0.07%)
occurrences causally related to treatment / all	0 / 3	0 / 4
deaths causally related to treatment / all	0 / 1	0 / 0
Renal haemorrhage
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Renal impairment
subjects affected / exposed	2 / 5992 (0.03%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Renal infarct
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Renal mass
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Renal tubular necrosis
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Ureteral disorder
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Ureterocele
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Ureterolithiasis
subjects affected / exposed	6 / 5992 (0.10%)	7 / 5995 (0.12%)
occurrences causally related to treatment / all	0 / 6	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
Urethral stenosis
subjects affected / exposed	1 / 5992 (0.02%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Urinary bladder haemorrhage
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Urinary retention
subjects affected / exposed	6 / 5992 (0.10%)	6 / 5995 (0.10%)
occurrences causally related to treatment / all	0 / 9	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Urinary tract obstruction
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Endocrine disorders
Adrenal insufficiency
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (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	1 / 5992 (0.02%)	5 / 5995 (0.08%)
occurrences causally related to treatment / all	0 / 1	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Hyperparathyroidism
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hyperthyroidism
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hypothyroidism
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (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	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Thyrotoxic crisis
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Musculoskeletal and connective tissue disorders
Arthralgia
subjects affected / exposed	25 / 5992 (0.42%)	25 / 5995 (0.42%)
occurrences causally related to treatment / all	0 / 26	0 / 26
deaths causally related to treatment / all	0 / 0	0 / 0
Arthritis
subjects affected / exposed	16 / 5992 (0.27%)	19 / 5995 (0.32%)
occurrences causally related to treatment / all	0 / 19	0 / 20
deaths causally related to treatment / all	0 / 0	0 / 0
Arthritis reactive
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Arthropathy
subjects affected / exposed	2 / 5992 (0.03%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Back pain
subjects affected / exposed	15 / 5992 (0.25%)	16 / 5995 (0.27%)
occurrences causally related to treatment / all	0 / 15	0 / 16
deaths causally related to treatment / all	0 / 0	0 / 0
Bursitis
subjects affected / exposed	2 / 5992 (0.03%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cervical spinal stenosis
subjects affected / exposed	8 / 5992 (0.13%)	5 / 5995 (0.08%)
occurrences causally related to treatment / all	0 / 8	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Chondrocalcinosis pyrophosphate
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Costochondritis
subjects affected / exposed	0 / 5992 (0.00%)	2 / 5995 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Exostosis
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Fibromyalgia
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Flank pain
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Foot deformity
subjects affected / exposed	1 / 5992 (0.02%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Fracture delayed union
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Fracture malunion
subjects affected / exposed	1 / 5992 (0.02%)	2 / 5995 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Fracture nonunion
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gouty arthritis
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Haemarthrosis
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (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	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Intervertebral disc degeneration
subjects affected / exposed	5 / 5992 (0.08%)	3 / 5995 (0.05%)
occurrences causally related to treatment / all	0 / 6	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Intervertebral disc displacement
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (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	15 / 5992 (0.25%)	6 / 5995 (0.10%)
occurrences causally related to treatment / all	0 / 15	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Intervertebral disc space narrowing
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Limb discomfort
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Lumbar spinal stenosis
subjects affected / exposed	13 / 5992 (0.22%)	12 / 5995 (0.20%)
occurrences causally related to treatment / all	0 / 13	0 / 12
deaths causally related to treatment / all	0 / 0	0 / 0
Mobility decreased
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Monarthritis
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Muscle spasms
subjects affected / exposed	1 / 5992 (0.02%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Muscular weakness
subjects affected / exposed	2 / 5992 (0.03%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Musculoskeletal chest pain
subjects affected / exposed	13 / 5992 (0.22%)	10 / 5995 (0.17%)
occurrences causally related to treatment / all	0 / 13	0 / 10
deaths causally related to treatment / all	0 / 0	0 / 0
Musculoskeletal pain
subjects affected / exposed	7 / 5992 (0.12%)	2 / 5995 (0.03%)
occurrences causally related to treatment / all	0 / 7	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Myalgia
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Myositis
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Neck mass
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (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	3 / 5992 (0.05%)	4 / 5995 (0.07%)
occurrences causally related to treatment / all	0 / 3	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Neuropathic arthropathy
subjects affected / exposed	1 / 5992 (0.02%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Osteoarthritis
subjects affected / exposed	109 / 5992 (1.82%)	93 / 5995 (1.55%)
occurrences causally related to treatment / all	0 / 121	0 / 97
deaths causally related to treatment / all	0 / 0	0 / 0
Osteoarthropathy
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Osteolysis
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (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	2 / 5992 (0.03%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Osteoporosis
subjects affected / exposed	1 / 5992 (0.02%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pain in extremity
subjects affected / exposed	1 / 5992 (0.02%)	2 / 5995 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Pain in jaw
subjects affected / exposed	1 / 5992 (0.02%)	3 / 5995 (0.05%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Pathological fracture
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Plantar fasciitis
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Polyarthritis
subjects affected / exposed	1 / 5992 (0.02%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Polymyalgia rheumatica
subjects affected / exposed	2 / 5992 (0.03%)	1 / 5995 (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	3 / 5992 (0.05%)	3 / 5995 (0.05%)
occurrences causally related to treatment / all	0 / 3	1 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Rheumatoid arthritis
subjects affected / exposed	1 / 5992 (0.02%)	2 / 5995 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Rotator cuff syndrome
subjects affected / exposed	10 / 5992 (0.17%)	6 / 5995 (0.10%)
occurrences causally related to treatment / all	0 / 10	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Scoliosis
subjects affected / exposed	0 / 5992 (0.00%)	2 / 5995 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Soft tissue mass
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (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	10 / 5992 (0.17%)	5 / 5995 (0.08%)
occurrences causally related to treatment / all	0 / 11	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Spinal osteoarthritis
subjects affected / exposed	7 / 5992 (0.12%)	10 / 5995 (0.17%)
occurrences causally related to treatment / all	0 / 8	0 / 10
deaths causally related to treatment / all	0 / 0	0 / 0
Spinal pain
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Spondylitis
subjects affected / exposed	1 / 5992 (0.02%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Spondylolisthesis
subjects affected / exposed	5 / 5992 (0.08%)	6 / 5995 (0.10%)
occurrences causally related to treatment / all	0 / 5	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Synovial cyst
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (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 / 5992 (0.02%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Vertebral osteophyte
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Infections and infestations
Abdominal abscess
subjects affected / exposed	3 / 5992 (0.05%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Abdominal wall abscess
subjects affected / exposed	1 / 5992 (0.02%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Abscess limb
subjects affected / exposed	2 / 5992 (0.03%)	3 / 5995 (0.05%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Abscess neck
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Abscess of salivary gland
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Acute sinusitis
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Anal abscess
subjects affected / exposed	2 / 5992 (0.03%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Appendicitis
subjects affected / exposed	9 / 5992 (0.15%)	9 / 5995 (0.15%)
occurrences causally related to treatment / all	0 / 9	0 / 9
deaths causally related to treatment / all	0 / 0	0 / 0
Appendicitis perforated
subjects affected / exposed	1 / 5992 (0.02%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Arthritis bacterial
subjects affected / exposed	1 / 5992 (0.02%)	2 / 5995 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Arthritis infective
subjects affected / exposed	2 / 5992 (0.03%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Bacteraemia
subjects affected / exposed	6 / 5992 (0.10%)	3 / 5995 (0.05%)
occurrences causally related to treatment / all	0 / 6	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Bacterial infection
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Bacterial sepsis
subjects affected / exposed	2 / 5992 (0.03%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Bone abscess
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Bronchiolitis
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (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	26 / 5992 (0.43%)	18 / 5995 (0.30%)
occurrences causally related to treatment / all	0 / 26	0 / 19
deaths causally related to treatment / all	0 / 0	0 / 0
Bronchitis viral
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Campylobacter infection
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Campylobacter sepsis
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Catheter site infection
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (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	71 / 5992 (1.18%)	48 / 5995 (0.80%)
occurrences causally related to treatment / all	0 / 81	2 / 52
deaths causally related to treatment / all	0 / 0	0 / 0
Cellulitis pasteurella
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cellulitis staphylococcal
subjects affected / exposed	0 / 5992 (0.00%)	2 / 5995 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Cellulitis streptococcal
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Cholecystitis infective
subjects affected / exposed	1 / 5992 (0.02%)	2 / 5995 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Chronic sinusitis
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Chronic tonsillitis
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (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	2 / 5992 (0.03%)	2 / 5995 (0.03%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Clostridium difficile infection
subjects affected / exposed	2 / 5992 (0.03%)	4 / 5995 (0.07%)
occurrences causally related to treatment / all	0 / 2	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Colonic abscess
subjects affected / exposed	1 / 5992 (0.02%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cystitis
subjects affected / exposed	2 / 5992 (0.03%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Dengue fever
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Device related infection
subjects affected / exposed	7 / 5992 (0.12%)	4 / 5995 (0.07%)
occurrences causally related to treatment / all	0 / 8	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Device related sepsis
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (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 / 5992 (0.02%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Diabetic gangrene
subjects affected / exposed	2 / 5992 (0.03%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Diarrhoea infectious
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (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	17 / 5992 (0.28%)	23 / 5995 (0.38%)
occurrences causally related to treatment / all	0 / 22	0 / 26
deaths causally related to treatment / all	0 / 0	0 / 0
Emphysematous cystitis
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Empyema
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Encephalitis
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (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 / 5992 (0.02%)	4 / 5995 (0.07%)
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 / 5992 (0.00%)	1 / 5995 (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	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Escherichia bacteraemia
subjects affected / exposed	1 / 5992 (0.02%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Escherichia infection
subjects affected / exposed	2 / 5992 (0.03%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Escherichia sepsis
subjects affected / exposed	2 / 5992 (0.03%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Escherichia urinary tract infection
subjects affected / exposed	2 / 5992 (0.03%)	2 / 5995 (0.03%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Extradural abscess
subjects affected / exposed	1 / 5992 (0.02%)	1 / 5995 (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	1 / 5992 (0.02%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastroenteritis
subjects affected / exposed	13 / 5992 (0.22%)	10 / 5995 (0.17%)
occurrences causally related to treatment / all	0 / 13	1 / 10
deaths causally related to treatment / all	0 / 0	0 / 0
Gastroenteritis bacterial
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastroenteritis viral
subjects affected / exposed	3 / 5992 (0.05%)	7 / 5995 (0.12%)
occurrences causally related to treatment / all	0 / 3	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
Groin abscess
subjects affected / exposed	1 / 5992 (0.02%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Groin infection
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
H1N1 influenza
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatitis A
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatitis B
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Herpes zoster
subjects affected / exposed	1 / 5992 (0.02%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Human anaplasmosis
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Human ehrlichiosis
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Implant site infection
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Incision site abscess
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Incision site infection
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Infected skin ulcer
subjects affected / exposed	3 / 5992 (0.05%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 4	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Infectious colitis
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Infectious pleural effusion
subjects affected / exposed	2 / 5992 (0.03%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Infective exacerbation of chronic obstructive airways disease
subjects affected / exposed	2 / 5992 (0.03%)	3 / 5995 (0.05%)
occurrences causally related to treatment / all	0 / 3	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Infective tenosynovitis
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Influenza
subjects affected / exposed	10 / 5992 (0.17%)	12 / 5995 (0.20%)
occurrences causally related to treatment / all	0 / 10	0 / 12
deaths causally related to treatment / all	0 / 0	0 / 0
Kidney infection
subjects affected / exposed	2 / 5992 (0.03%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Klebsiella bacteraemia
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Labyrinthitis
subjects affected / exposed	1 / 5992 (0.02%)	2 / 5995 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Laryngitis
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Localised infection
subjects affected / exposed	5 / 5992 (0.08%)	3 / 5995 (0.05%)
occurrences causally related to treatment / all	0 / 6	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Lower respiratory tract infection
subjects affected / exposed	3 / 5992 (0.05%)	4 / 5995 (0.07%)
occurrences causally related to treatment / all	0 / 3	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Lower respiratory tract infection viral
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Lyme disease
subjects affected / exposed	2 / 5992 (0.03%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Lymphangitis
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Mastoiditis
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Necrotising fasciitis
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Neutropenic sepsis
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Oesophageal candidiasis
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Orchitis
subjects affected / exposed	1 / 5992 (0.02%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Osteomyelitis
subjects affected / exposed	13 / 5992 (0.22%)	11 / 5995 (0.18%)
occurrences causally related to treatment / all	0 / 14	0 / 12
deaths causally related to treatment / all	0 / 0	0 / 0
Osteomyelitis acute
subjects affected / exposed	1 / 5992 (0.02%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Parainfluenzae virus infection
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Paraspinal abscess
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pelvic abscess
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (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	1 / 5992 (0.02%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Peritonitis bacterial
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pharyngeal abscess
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pharyngitis
subjects affected / exposed	2 / 5992 (0.03%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumonia
subjects affected / exposed	86 / 5992 (1.44%)	92 / 5995 (1.53%)
occurrences causally related to treatment / all	1 / 90	0 / 105
deaths causally related to treatment / all	0 / 3	0 / 2
Pneumonia bacterial
subjects affected / exposed	3 / 5992 (0.05%)	2 / 5995 (0.03%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumonia legionella
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumonia mycoplasmal
subjects affected / exposed	2 / 5992 (0.03%)	2 / 5995 (0.03%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumonia pneumococcal
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (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	3 / 5992 (0.05%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumonia streptococcal
subjects affected / exposed	2 / 5992 (0.03%)	0 / 5995 (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	4 / 5992 (0.07%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 4	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Post procedural cellulitis
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Post procedural infection
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (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	2 / 5992 (0.03%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Postoperative wound infection
subjects affected / exposed	1 / 5992 (0.02%)	5 / 5995 (0.08%)
occurrences causally related to treatment / all	0 / 1	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 1
Pulmonary sepsis
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pyelonephritis
subjects affected / exposed	4 / 5992 (0.07%)	6 / 5995 (0.10%)
occurrences causally related to treatment / all	0 / 4	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Pyelonephritis acute
subjects affected / exposed	4 / 5992 (0.07%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 4	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Respiratory moniliasis
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (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	0 / 5992 (0.00%)	2 / 5995 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Respiratory tract infection
subjects affected / exposed	1 / 5992 (0.02%)	1 / 5995 (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 viral
subjects affected / exposed	2 / 5992 (0.03%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Rocky mountain spotted fever
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Rotavirus infection
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Scrotal abscess
subjects affected / exposed	1 / 5992 (0.02%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Sepsis
subjects affected / exposed	27 / 5992 (0.45%)	37 / 5995 (0.62%)
occurrences causally related to treatment / all	0 / 27	0 / 39
deaths causally related to treatment / all	0 / 3	0 / 4
Sepsis syndrome
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Septic arthritis staphylococcal
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Septic embolus
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (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	5 / 5992 (0.08%)	7 / 5995 (0.12%)
occurrences causally related to treatment / all	0 / 5	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 2
Sialoadenitis
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Sinusitis
subjects affected / exposed	3 / 5992 (0.05%)	3 / 5995 (0.05%)
occurrences causally related to treatment / all	0 / 3	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Staphylococcal bacteraemia
subjects affected / exposed	2 / 5992 (0.03%)	2 / 5995 (0.03%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Staphylococcal infection
subjects affected / exposed	3 / 5992 (0.05%)	6 / 5995 (0.10%)
occurrences causally related to treatment / all	0 / 3	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Staphylococcal osteomyelitis
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Staphylococcal sepsis
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Staphylococcal skin infection
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (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	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Streptococcal infection
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Subcutaneous abscess
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Tonsillitis
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Tooth abscess
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Tooth infection
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Tracheobronchitis
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Upper respiratory tract infection
subjects affected / exposed	3 / 5992 (0.05%)	2 / 5995 (0.03%)
occurrences causally related to treatment / all	1 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Urinary tract infection
subjects affected / exposed	40 / 5992 (0.67%)	30 / 5995 (0.50%)
occurrences causally related to treatment / all	2 / 41	0 / 30
deaths causally related to treatment / all	0 / 0	0 / 0
Urinary tract infection bacterial
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Urinary tract infection enterococcal
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Urosepsis
subjects affected / exposed	7 / 5992 (0.12%)	13 / 5995 (0.22%)
occurrences causally related to treatment / all	0 / 7	0 / 13
deaths causally related to treatment / all	0 / 0	0 / 0
Vascular stent infection
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Vestibular neuronitis
subjects affected / exposed	0 / 5992 (0.00%)	2 / 5995 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Viral infection
subjects affected / exposed	2 / 5992 (0.03%)	3 / 5995 (0.05%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Viral upper respiratory tract infection
subjects affected / exposed	2 / 5992 (0.03%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Vulvitis
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
West Nile viral infection
subjects affected / exposed	0 / 5992 (0.00%)	2 / 5995 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Wound abscess
subjects affected / exposed	1 / 5992 (0.02%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Wound infection
subjects affected / exposed	4 / 5992 (0.07%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 4	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Wound infection pseudomonas
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Wound infection staphylococcal
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Metabolism and nutrition disorders
Acidosis
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cholesterosis
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Decreased appetite
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Dehydration
subjects affected / exposed	21 / 5992 (0.35%)	13 / 5995 (0.22%)
occurrences causally related to treatment / all	0 / 21	0 / 14
deaths causally related to treatment / all	0 / 0	0 / 0
Diabetes mellitus
subjects affected / exposed	13 / 5992 (0.22%)	11 / 5995 (0.18%)
occurrences causally related to treatment / all	0 / 13	1 / 11
deaths causally related to treatment / all	0 / 0	0 / 0
Diabetes mellitus inadequate control
subjects affected / exposed	1 / 5992 (0.02%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Diabetic ketoacidosis
subjects affected / exposed	4 / 5992 (0.07%)	5 / 5995 (0.08%)
occurrences causally related to treatment / all	0 / 5	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 1
Electrolyte imbalance
subjects affected / exposed	2 / 5992 (0.03%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Fluid overload
subjects affected / exposed	5 / 5992 (0.08%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 5	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gout
subjects affected / exposed	6 / 5992 (0.10%)	6 / 5995 (0.10%)
occurrences causally related to treatment / all	0 / 6	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Hypercalcaemia
subjects affected / exposed	0 / 5992 (0.00%)	3 / 5995 (0.05%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Hyperglycaemia
subjects affected / exposed	1 / 5992 (0.02%)	5 / 5995 (0.08%)
occurrences causally related to treatment / all	0 / 1	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Hyperkalaemia
subjects affected / exposed	11 / 5992 (0.18%)	6 / 5995 (0.10%)
occurrences causally related to treatment / all	1 / 11	0 / 6
deaths causally related to treatment / all	0 / 1	0 / 0
Hyperosmolar hyperglycaemic state
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (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 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hyperphosphataemia
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (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	0 / 5992 (0.00%)	3 / 5995 (0.05%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Hypoglycaemia
subjects affected / exposed	7 / 5992 (0.12%)	18 / 5995 (0.30%)
occurrences causally related to treatment / all	1 / 7	3 / 19
deaths causally related to treatment / all	0 / 0	0 / 0
Hypokalaemia
subjects affected / exposed	5 / 5992 (0.08%)	10 / 5995 (0.17%)
occurrences causally related to treatment / all	0 / 6	0 / 10
deaths causally related to treatment / all	0 / 0	0 / 0
Hypomagnesaemia
subjects affected / exposed	1 / 5992 (0.02%)	4 / 5995 (0.07%)
occurrences causally related to treatment / all	1 / 1	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Hyponatraemia
subjects affected / exposed	4 / 5992 (0.07%)	5 / 5995 (0.08%)
occurrences causally related to treatment / all	0 / 4	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Hypophagia
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hypovolaemia
subjects affected / exposed	0 / 5992 (0.00%)	3 / 5995 (0.05%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Lactic acidosis
subjects affected / exposed	1 / 5992 (0.02%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Malnutrition
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Metabolic acidosis
subjects affected / exposed	2 / 5992 (0.03%)	0 / 5995 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Obesity
subjects affected / exposed	12 / 5992 (0.20%)	12 / 5995 (0.20%)
occurrences causally related to treatment / all	0 / 12	0 / 12
deaths causally related to treatment / all	0 / 1	0 / 0
Type 2 diabetes mellitus
subjects affected / exposed	11 / 5992 (0.18%)	7 / 5995 (0.12%)
occurrences causally related to treatment / all	0 / 11	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
Vitamin D deficiency
subjects affected / exposed	0 / 5992 (0.00%)	1 / 5995 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0

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

Non-serious adverse events	Placebo	Lorcaserin 10 mg
Total subjects affected by non serious adverse events
subjects affected / exposed	4788 / 5992 (79.91%)	4946 / 5995 (82.50%)
Nervous system disorders
Dizziness
subjects affected / exposed	340 / 5992 (5.67%)	537 / 5995 (8.96%)
occurrences all number	407	640
Headache
subjects affected / exposed	274 / 5992 (4.57%)	383 / 5995 (6.39%)
occurrences all number	316	445
General disorders and administration site conditions
Fatigue
subjects affected / exposed	302 / 5992 (5.04%)	496 / 5995 (8.27%)
occurrences all number	329	548
Oedema peripheral
subjects affected / exposed	340 / 5992 (5.67%)	267 / 5995 (4.45%)
occurrences all number	385	294
Gastrointestinal disorders
Constipation
subjects affected / exposed	248 / 5992 (4.14%)	336 / 5995 (5.60%)
occurrences all number	268	362
Diarrhoea
subjects affected / exposed	324 / 5992 (5.41%)	419 / 5995 (6.99%)
occurrences all number	362	478
Nausea
subjects affected / exposed	286 / 5992 (4.77%)	356 / 5995 (5.94%)
occurrences all number	329	398
Respiratory, thoracic and mediastinal disorders
Cough
subjects affected / exposed	303 / 5992 (5.06%)	376 / 5995 (6.27%)
occurrences all number	351	431
Dyspnoea
subjects affected / exposed	310 / 5992 (5.17%)	285 / 5995 (4.75%)
occurrences all number	347	312
Musculoskeletal and connective tissue disorders
Arthralgia
subjects affected / exposed	452 / 5992 (7.54%)	457 / 5995 (7.62%)
occurrences all number	542	544
Back pain
subjects affected / exposed	452 / 5992 (7.54%)	457 / 5995 (7.62%)
occurrences all number	496	496
Infections and infestations
Bronchitis
subjects affected / exposed	468 / 5992 (7.81%)	455 / 5995 (7.59%)
occurrences all number	584	536
Nasopharyngitis
subjects affected / exposed	338 / 5992 (5.64%)	353 / 5995 (5.89%)
occurrences all number	418	426
Upper respiratory tract infection
subjects affected / exposed	567 / 5992 (9.46%)	528 / 5995 (8.81%)
occurrences all number	690	659
Urinary tract infection
subjects affected / exposed	400 / 5992 (6.68%)	440 / 5995 (7.34%)
occurrences all number	575	593

More information

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Were there any global substantial amendments to the protocol? Yes

06 Aug 2015

Amendment 01: The secondary objective related to glycemic control was reclassified. The exploratory objective was added. Instructions that the first dose should be taken at Visit 2. Inclusion and exclusion criteria’s were updated. Renal impairment: defined with reference to estimated glomerular filtration rate rather than clearance. Cyproheptadine, amoxapine, tricyclic antidepressants, and mirtazapine was deleted from the list of drugs increasing the risk for cardiac valvulopathy/PH. List of prohibited drugs was revised and the restrictions on serotonergic drugs was clarified. An analysis of subjects having worsened valvulopathy at 1 year and yearly and had FDA-defined valvulopathy at Baseline was added as a secondary endpoint. Study population for conversion to diabetes was changed to prediabetes population. Confirmatory test was needed for subjects with new onset of diabetes. Dosing instructions was modified. It was clarified that nicotine use was not exclusionary. Hospitalizations for administration of study drug or insertion of access for administration of study drug was removed from the list of hospitalization that are not SAEs because it was not applicable to the study. Clarification on subjects who permanently discontinued study drug were to complete the EOT visit within 30 days. Euphoria and suicidal ideation was moved from study-specific AEs of interest to ‘SAEs and Events Associated with Special Situations’. It was added that renal function parameters and glycemic profile should be collected at all visits. It was specified that SAE collection for 30 days after the last drug dose applied only to subjects taking study drug at the time of study completion, since some subjects may have discontinued study drug before study completion. Revised footnote b in Schedule of Procedures/Assessments pertaining to unscheduled visits for assessments required by state-controlled substance requirements.

30 Mar 2017

Amendment 02: The primary objective of conversion to T2DM was changed to a secondary objective because the timelines to demonstrate the primary endpoint for conversion to Type 2 diabetes were not as initially projected, due to the low rate of conversion, Removed HbA1c from the exploratory objective in order to have a broader assessment of glycemic benefit in subjects with diabetes, Added FPG, fasting insulin levels, and homeostatic model assessment-insulin resistance (HOMA-IR) to better assess lorcaserin glycemic benefit, Multiple testing procedure was updated to reflect the change in the primary objective, The renal objective for the overall population was added and reorganized for clarification, Details of the interim analysis was outlined in the Study Integrity Charter, Removed the clarification of major adverse cardiovascular events (MACE)+ events accruing after 11 months after 460 MACE events have occurred, Updated the timing of the interim analysis date.

Were there any global interruptions to the trial? No

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

None reported

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Clinical trials

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Time From Randomization to First Occurrence of Major Adverse Cardiovascular Events (MACE) at Interim Analysis

Primary: Time From Randomization to First Occurrence of Major Adverse Cardiovascular Events (MACE) at Interim Analysis

Primary: Time From Randomization to First Occurrence of MACE+

Primary: Time From Randomization to First Occurrence of MACE+

Secondary: Time From Randomization to Conversion to Type 2 Diabetes Mellitus (T2DM) for Subjects With Prediabetes at Baseline

Secondary: Time From Randomization to Conversion to Type 2 Diabetes Mellitus (T2DM) for Subjects With Prediabetes at Baseline

Secondary: Time From Randomization to First Occurrence of the Individual Components of MACE+

Secondary: Time From Randomization to First Occurrence of the Individual Components of MACE+

Secondary: Time From Randomization to Event of All-cause Mortality

Secondary: Time From Randomization to Event of All-cause Mortality

Secondary: Time From Randomization to Conversion to Normal Glucose Homeostasis in Subjects With Prediabetes at Baseline

Secondary: Time From Randomization to Conversion to Normal Glucose Homeostasis in Subjects With Prediabetes at Baseline

Secondary: Time From Randomization to Conversion to T2DM for Subjects Without Any Type of Diabetes at Baseline

Secondary: Time From Randomization to Conversion to T2DM for Subjects Without Any Type of Diabetes at Baseline

Secondary: Change From Baseline in HbA1c at Month 6 in Subjects With T2DM at Baseline

Secondary: Change From Baseline in HbA1c at Month 6 in Subjects With T2DM at Baseline

Secondary: Time From Randomization to Event of New Onset Renal Impairment or Worsening Existing Renal Impairment in All Subjects

Secondary: Time From Randomization to Event of New Onset Renal Impairment or Worsening Existing Renal Impairment in All Subjects

Secondary: Time From Randomization to Event of New Onset Renal Impairment or Worsening Existing Renal Impairment in Subjects With Prediabetes at Baseline

Secondary: Time From Randomization to Event of New Onset Renal Impairment or Worsening Existing Renal Impairment in Subjects With Prediabetes at Baseline

Secondary: Time From Randomization to Event of New Onset Renal Impairment or Worsening Existing Renal Impairment in Subjects With T2DM at Baseline

Secondary: Time From Randomization to Event of New Onset Renal Impairment or Worsening Existing Renal Impairment in Subjects With T2DM at Baseline

Secondary: Time From Randomization to Event of Improvement in Renal Function in Subjects With T2DM at Baseline

Secondary: Time From Randomization to Event of Improvement in Renal Function in Subjects With T2DM at Baseline

Secondary: Percentage of Subjects Who Met FDA-Defined Valvulopathy in Echocardiographically Determined Heart Valve Changes

Secondary: Percentage of Subjects Who Met FDA-Defined Valvulopathy in Echocardiographically Determined Heart Valve Changes

Secondary: Percentage of Subjects With FDA-Defined Valvulopathy at Baseline Who Demonstrated Worsened FDA-Defined Valvulopathy

Secondary: Percentage of Subjects With FDA-Defined Valvulopathy at Baseline Who Demonstrated Worsened FDA-Defined Valvulopathy

Secondary: Change From Baseline in Echocardiographically-Determined Pulmonary Arterial Systolic Pressure

Secondary: Change From Baseline in Echocardiographically-Determined Pulmonary Arterial Systolic Pressure

Adverse events

Adverse events

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Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

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