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Clinical Trial Results:
A Clinical Outcomes Study to Evaluate the Effects of IL-6 Receptor Blockade With Tocilizumab (TCZ) in Comparison With Etanercept (ETA) on the Rate of Cardiovascular Events in Patients With Moderate to Severe Rheumatoid Arthritis (RA)

Summary
EudraCT number	2010-020065-24
Trial protocol	GB HU LV BE AT LT CZ DE ES NL GR IT
Global end of trial date	25 Mar 2016

Results information
Results version number	v1(current)
This version publication date	29 Jun 2017
First version publication date	29 Jun 2017
Other versions

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

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Trial information

Top of page

Sponsor protocol code

WA25204

ISRCTN number

-

US NCT number

-

WHO universal trial number (UTN)

-

Sponsor organisation name

Hoffmann-La Roche

Sponsor organisation address

Grenzacherstrasse 124, Basel,, Switzerland,

Public contact

Medical Communications, Hoffmann-La Roche, genentech@druginfo.com

Scientific contact

Medical Communications, Hoffmann-La Roche, genentech@druginfo.com

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

No

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

No

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

No

Analysis stage

Final

Date of interim/final analysis

25 Mar 2016

Is this the analysis of the primary completion data?

Yes

Primary completion date

25 Mar 2016

Global end of trial reached?

Yes

Global end of trial date

25 Mar 2016

Was the trial ended prematurely?

No

Main objective of the trial

The primary objective of this study was to compare prospectively in patients treated with TCZ or ETA, the time to first occurrence of any component of the composite of: • Cardiovascular (CV) death • Non-fatal myocardial infarction (MI) • Non-fatal stroke of all classifications (ischemic, hemorrhagic, or undetermined origin)

Protection of trial subjects

The study was conducted in accordance with the principles of the “Declaration of Helsinki” and Good Clinical Practice. Approval from the Independent Ethics Committee/Institutional Review Board was obtained before study start and was documented in a letter to the Investigator specifying the date on which the committee met and granted the approval.

Background therapy

-

Evidence for comparator

-

Actual start date of recruitment

02 Aug 2011

Long term follow-up planned

No

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

South Africa: 59

Country: Number of subjects enrolled

Spain: 88

Country: Number of subjects enrolled

Turkey: 10

Country: Number of subjects enrolled

United Kingdom: 62

Country: Number of subjects enrolled

United States: 671

Country: Number of subjects enrolled

Argentina: 313

Country: Number of subjects enrolled

Austria: 10

Country: Number of subjects enrolled

Belgium: 15

Country: Number of subjects enrolled

Bosnia and Herzegovina: 58

Country: Number of subjects enrolled

Canada: 79

Country: Number of subjects enrolled

Chile: 124

Country: Number of subjects enrolled

Croatia: 40

Country: Number of subjects enrolled

Czech Republic: 206

Country: Number of subjects enrolled

Ecuador: 40

Country: Number of subjects enrolled

France: 11

Country: Number of subjects enrolled

Germany: 65

Country: Number of subjects enrolled

Greece: 14

Country: Number of subjects enrolled

Hungary: 54

Country: Number of subjects enrolled

India: 31

Country: Number of subjects enrolled

Israel: 21

Country: Number of subjects enrolled

Italy: 18

Country: Number of subjects enrolled

Latvia: 41

Country: Number of subjects enrolled

Lithuania: 38

Country: Number of subjects enrolled

Malaysia: 18

Country: Number of subjects enrolled

Mexico: 335

Country: Number of subjects enrolled

Netherlands: 4

Country: Number of subjects enrolled

Philippines: 21

Country: Number of subjects enrolled

Poland: 215

Country: Number of subjects enrolled

Romania: 149

Country: Number of subjects enrolled

Russian Federation: 206

Country: Number of subjects enrolled

Serbia: 64

Worldwide total number of subjects

3080

EEA total number of subjects

1030

Number of subjects enrolled per age group

In utero

0

Preterm newborn - gestational age < 37 wk

0

Newborns (0-27 days)

0

Infants and toddlers (28 days-23 months)

0

Children (2-11 years)

0

Adolescents (12-17 years)

0

Adults (18-64 years)

2182

From 65 to 84 years

895

85 years and over

3

Subject disposition

Top of page

Recruitment details

A total of 3080 patients were enrolled from 353 sites, across 31 countries

Screening details

The target population was patients with moderate to severe rheumatoid arthritis ≥ 6 months duration and for whom non-biologic DMARD treatment or treatment with an anti-tumor necrosis factor (anti-TNF) agent was inadequate. Patients were required to be 50 years or older and to have at least one additional CV risk factor beyond RA.

Period 1 title

Overall Study (overall period)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Not blinded

Are arms mutually exclusive

Yes

Tocilizumab

Arm description

Participants received 8 mg/kg tocilizumab IV every 4 weeks until switch to another RA therapy or up to 4.9 years.

Arm type

Experimental

Investigational medicinal product name

Tocilizumab

Investigational medicinal product code

Other name

RoActemra, Actemra, RO4877533

Pharmaceutical forms

Solution for injection/infusion in pre-filled syringe

Routes of administration

Intravenous use

Dosage and administration details

Tocilizumab was administered at a dose of 8 mg/kg every 4 weeks.

Etanercept

Arm description

Participants received 50 mg etanercept subcutaneously weekly until switch to another RA therapy or up to 4.9 years.

Arm type

Active comparator

Investigational medicinal product name

Etanercept

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection/infusion in pre-filled syringe

Routes of administration

Subcutaneous use

Dosage and administration details

Participants received 50 mg etanercept subcutaneously weekly

Number of subjects in period 1	Tocilizumab	Etanercept
Started	1538	1542
Completed	1482	1475
Not completed	56	67
Adverse event, serious fatal	30	34
Consent withdrawn by subject	13	16
Info not recorded	10	16
Lost to follow-up	3	1

Baseline characteristics

Top of page

Reporting group title

Tocilizumab

Reporting group description

Participants received 8 mg/kg tocilizumab IV every 4 weeks until switch to another RA therapy or up to 4.9 years.

Reporting group title

Etanercept

Reporting group description

Participants received 50 mg etanercept subcutaneously weekly until switch to another RA therapy or up to 4.9 years.

Reporting group values	Tocilizumab	Etanercept	Total
Number of subjects	1538	1542	3080
Age categorical
Units: Subjects
In utero	0	0	0
Preterm newborn infants (gestational age < 37 wks)	0	0	0
Newborns (0-27 days)	0	0	0
Infants and toddlers (28 days-23 months)	0	0	0
Children (2-11 years)	0	0	0
Adolescents (12-17 years)	0	0	0
Adults (18-64 years)	1095	1087	2182
From 65-84 years	441	454	895
85 years and over	2	1	3
Age Continuous
Units: Years
arithmetic mean (standard deviation)	60.7 ± 7.4	60.7 ± 7.6	-
Gender, Male/Female
Units: Participants
Female	1193	1202	2395
Male	345	340	685

End points

Top of page

Reporting group title

Tocilizumab

Reporting group description

Participants received 8 mg/kg tocilizumab IV every 4 weeks until switch to another RA therapy or up to 4.9 years.

Reporting group title

Etanercept

Reporting group description

Participants received 50 mg etanercept subcutaneously weekly until switch to another RA therapy or up to 4.9 years.

Primary: Time to first Cardiovascular (CV) Events Adjudication Committee (EAC) (CV-EAC) Adjudicated Event

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End point title

Time to first Cardiovascular (CV) Events Adjudication Committee (EAC) (CV-EAC) Adjudicated Event

End point description

Prospective comparison of time to first occurrence of any component of the composite of CV death (including events adjudicated as 'Undetermined Cause of Death'), non-fatal myocardial infarction, or non-fatal stroke. Median time to event and 95% confidence intervals could not be estimated due to less than 50% of patients experiencing an event; percentage of patients with event is reported.

End point type

Primary

End point timeframe

Baseline up to 4.9 years

End point values	Tocilizumab	Etanercept
Number of subjects analysed	1538	1542
Units: Percentage of patients with event
number (not applicable)	5.4	5.1

Cox Regression

Statistical analysis description

The analysis assessed in the ITT population the hazard ratio of the primary endpoint in TCZ compared to ETA patients. This was done through a comparison of the hazard functions between TCZ and ETA patients. A stratified Cox proportional hazards regression model was used in evaluating the relative MACE rate of TCZ over ETA, with the following randomization factors used as strata: • Previous exposure to anti-TNF (Yes/No) • History of CV events (Yes/No)

Comparison groups

Tocilizumab v Etanercept

Number of subjects included in analysis

3080

Analysis specification

Pre-specified

Analysis type

^[1]

Method

Parameter type

Hazard ratio (HR)

Point estimate

1.05

Confidence interval

level

95%

sides

2-sided

lower limit

0.77

upper limit

1.43

Notes
[1] - In order to reject the null hypothesis and claim non-inferiority of TCZ compared to ETA, a HR point estimate of ≤ 1.278 and upper limit of 95% CI <1.8 was required.

Primary: Time to first CV-EAC Adjudicated Event - Sensitivity Analysis

Top of page

End point title

Time to first CV-EAC Adjudicated Event - Sensitivity Analysis

End point description

Prospective comparison of time to first occurrence of any component of the composite of CV death (including events adjudicated as 'Undetermined Cause of Death'), non-fatal myocardial infarction, or non-fatal stroke - Sensitivity Analysis. Median time to event and 95% confidence intervals could not be estimated due to less than 50% of patients experiencing an event; percentage of patients with event is reported.

End point type

Primary

End point timeframe

From Baseline up to 4.9 years

End point values	Tocilizumab	Etanercept
Number of subjects analysed	1538	1542
Units: Percentage of patients with event
number (not applicable)	3.7	3.4

Cox regression

Statistical analysis description

The analysis assessed in the OT population the hazard ratio of the primary endpoint in TCZ compared to ETA patients. This was done through a comparison of the hazard functions between TCZ and ETA patients. A stratified Cox proportional hazards regression model was used in evaluating the relative MACE rate of TCZ over ETA, with the following randomization factors used as strata: • Previous exposure to anti-TNF (Yes/No) • History of CV events (Yes/No)

Comparison groups

Tocilizumab v Etanercept

Number of subjects included in analysis

3080

Analysis specification

Pre-specified

Analysis type

^[2]

Method

Parameter type

Hazard ratio (HR)

Point estimate

1.11

Confidence interval

level

95%

sides

2-sided

lower limit

0.76

upper limit

1.62

Notes
[2] - The non-inferiority margin was only formally tested for the primary ITT analysis and not for the sensitivity analysis.

Primary: Time to first CV-EAC adjudicated event excluding undetermined cause of death - Sensitivity Analysis

Top of page

End point title

Time to first CV-EAC adjudicated event excluding undetermined cause of death - Sensitivity Analysis

End point description

Prospective comparison of time to first occurrence of any component of the composite of CV death (excluding events adjudicated as 'Undetermined Cause of Death'), non-fatal myocardial infarction, or non-fatal stroke - Sensitivity Analyses. Median time to event and 95% confidence intervals could not be estimated due to less than 50% of patients experiencing an event; percentage of patients with event is reported.

End point type

Primary

End point timeframe

From baseline up to 4.9 years

End point values	Tocilizumab	Etanercept
Number of subjects analysed	1538	1542
Units: Percentage of patients with an event
number (not applicable)	4.8	4.7

Cox regression

Statistical analysis description

The analysis assessed in the ITT population the hazard ratio of the primary endpoint in TCZ compared to ETA patients. This was done through a comparison of the hazard functions between TCZ and ETA patients. A stratified Cox proportional hazards regression model was used in evaluating the relative MACE rate of TCZ over ETA, with the following randomization factors used as strata: • Previous exposure to anti-TNF (Yes/No) • History of CV events (Yes/No)

Comparison groups

Tocilizumab v Etanercept

Number of subjects included in analysis

3080

Analysis specification

Pre-specified

Analysis type

^[3]

Method

Parameter type

Hazard ratio (HR)

Point estimate

1.01

Confidence interval

level

95%

sides

2-sided

lower limit

0.73

upper limit

1.4

Notes
[3] - The non-inferiority margin was only formally tested for the primary ITT analysis and not for the sensitivity analysis.

Primary: Time to first CV-EAC adjudicated event before last direct contact date - Sensitivity Analysis

Top of page

End point title

Time to first CV-EAC adjudicated event before last direct contact date - Sensitivity Analysis

End point description

Prospective comparison of time to first occurrence of any component of the composite of CV death (including events adjudicated as 'Undetermined Cause of Death'), non-fatal myocardial infarction, or non-fatal stroke before last direct contact date (i.e., latest date of visit, IVRS call, or site call). Median time to event and 95% confidence intervals could not be estimated due to less than 50% of patients experiencing an event; percentage of patients with event is reported.

End point type

Primary

End point timeframe

From Baseline up to 4.9 years

End point values	Tocilizumab	Etanercept
Number of subjects analysed	1538	1542
Units: Percentage of participants with an event
number (not applicable)	3.2	3

Cox regression

Statistical analysis description

The analysis assessed in the ITT population the hazard ratio of the primary endpoint in TCZ compared to ETA patients. This was done through a comparison of the hazard functions between TCZ and ETA patients. A stratified Cox proportional hazards regression model was used in evaluating the relative MACE rate of TCZ over ETA, with the following randomization factors used as strata: • Previous exposure to anti-TNF (Yes/No) • History of CV events (Yes/No)

Comparison groups

Tocilizumab v Etanercept

Number of subjects included in analysis

3080

Analysis specification

Pre-specified

Analysis type

^[4]

Method

Parameter type

Hazard ratio (HR)

Point estimate

1.04

Confidence interval

level

95%

sides

2-sided

lower limit

0.7

upper limit

1.56

Notes
[4] - The non-inferiority margin was only formally tested for the primary ITT analysis and not for the sensitivity analysis.

Secondary: The time to first occurrence of an expanded CV composite endpoint

Top of page

End point title

The time to first occurrence of an expanded CV composite endpoint

End point description

Prospective comparison of the time to first ccurrence of the expanded composite endpoint. The expanded composite endpoint is defined as the CV composite of the primary endpoint with the addition of non-elective coronary revascularization procedures and hospitalization for unstable angina. Median time to event and 95% confidence intervals could not be estimated due to less than 50% of patients experiencing an event; percentage of patients with event is reported.

End point type

Secondary

End point timeframe

From baseline up to 4.9 years

End point values	Tocilizumab	Etanercept
Number of subjects analysed	1538	1542
Units: Percentages of participants
number (not applicable)	5.5	5.4

Cox regression

Statistical analysis description

The analysis assessed in the ITT population the hazard ratio of the secondary endpoint in TCZ compared to ETA patients. This was done through a comparison of the hazard functions between TCZ and ETA patients. A stratified Cox proportional hazards regression model was used in evaluating the relative CV event rate of TCZ over ETA, with the following randomization factors used as strata: • Previous exposure to anti-TNF (Yes/No) • History of CV events (Yes/No)

Comparison groups

Tocilizumab v Etanercept

Number of subjects included in analysis

3080

Analysis specification

Pre-specified

Analysis type

non-inferiority ^[5]

Method

Parameter type

Hazard ratio (HR)

Point estimate

0.99

Confidence interval

level

95%

sides

2-sided

lower limit

0.73

upper limit

1.34

Notes
[5] - The non-inferiority margin was only formally tested for the primary ITT analysis

Secondary: Individual component of primary endpoint: Non-fatal Myocardial Infarction

Top of page

End point title

Individual component of primary endpoint: Non-fatal Myocardial Infarction

End point description

Prospective comparison of time to first occurrence of Individual component of primary endpoint: Non fatal Myocardial Infarction. Median time to event and 95% confidence intervals could not be estimated due to less than 50% of patients experiencing an event; percentage of patients with event is reported.

End point type

Secondary

End point timeframe

From baseline up to 4.9 years

End point values	Tocilizumab	Etanercept
Number of subjects analysed	1538	1542
Units: Percentage of participants
number (not applicable)	1.8	2

Cox regression

Statistical analysis description

The analysis assessed in the ITT population the hazard ratio of the secondary endpoint in TCZ compared to ETA patients. This was done through a comparison of the hazard functions between TCZ and ETA patients. A stratified Cox proportional hazards regression model was used in evaluating the relative CV event rate of TCZ over ETA, with the following randomization factors used as strata: • Previous exposure to anti-TNF (Yes/No) • History of CV events (Yes/No)

Comparison groups

Tocilizumab v Etanercept

Number of subjects included in analysis

3080

Analysis specification

Pre-specified

Analysis type

non-inferiority ^[6]

Method

Parameter type

Hazard ratio (HR)

Point estimate

0.89

Confidence interval

level

95%

sides

2-sided

lower limit

0.54

upper limit

1.49

Notes
[6] - The non-inferiority margin was only formally tested for the primary ITT analysis

Secondary: Individual component of primary endpoint: cardiovascular death

Top of page

End point title

Individual component of primary endpoint: cardiovascular death

End point description

Prospective comparison of time to first occurrence of Individual component of primary endpoint: cardiovascular death. Median time to event and 95% confidence intervals could not be estimated due to less than 50% of patients experiencing an event; percentage of patients with event is reported.

End point type

Secondary

End point timeframe

From baseline up to 4.9 years

End point values	Tocilizumab	Etanercept
Number of subjects analysed	1538	1542
Units: Percentage of participants
number (not applicable)	2.3	2.3

Cox regression

Statistical analysis description

The analysis assessed in the ITT population the hazard ratio of the secondary endpoint in TCZ compared to ETA patients. This was done through a comparison of the hazard functions between TCZ and ETA patients. A stratified Cox proportional hazards regression model was used in evaluating the relative CV event rate of TCZ over ETA, with the following randomization factors used as strata: • Previous exposure to anti-TNF (Yes/No) • History of CV events (Yes/No)

Comparison groups

Tocilizumab v Etanercept

Number of subjects included in analysis

3080

Analysis specification

Pre-specified

Analysis type

non-inferiority ^[7]

Method

Parameter type

Hazard ratio (HR)

Point estimate

1.03

Confidence interval

level

95%

sides

2-sided

lower limit

0.64

upper limit

1.63

Notes
[7] - The non-inferiority margin was only formally tested for the primary ITT analysis.

Secondary: Individual component of primary endpoint: non-fatal stroke

Top of page

End point title

Individual component of primary endpoint: non-fatal stroke

End point description

Prospective comparison of time to first occurrence of Individual component of primary endpoint: non-fatal stroke. Median time to event and 95% confidence intervals could not be estimated due to less than 50% of patients experiencing an event; percentage of patients with event is reported.

End point type

Secondary

End point timeframe

From baseline up to 4.9 years

End point values	Tocilizumab	Etanercept
Number of subjects analysed	1538	1542
Units: Percentage of participants with an event
number (not applicable)	1.6	1

Cox regression

Statistical analysis description

The analysis assessed in the ITT population the hazard ratio of the secondary endpoint in TCZ compared to ETA patients. This was done through a comparison of the hazard functions between TCZ and ETA patients. A stratified Cox proportional hazards regression model was used in evaluating the relative CV event rate of TCZ over ETA, with the following randomization factors used as strata: • Previous exposure to anti-TNF (Yes/No) • History of CV events (Yes/No)

Comparison groups

Tocilizumab v Etanercept

Number of subjects included in analysis

3080

Analysis specification

Pre-specified

Analysis type

non-inferiority ^[8]

Method

Parameter type

Hazard ratio (HR)

Point estimate

1.53

Confidence interval

level

95%

sides

2-sided

lower limit

0.8

upper limit

2.92

Notes
[8] - The non-inferiority margin was only formally tested for the primary ITT analysis

Secondary: Individual component of primary endpoint: All-cause mortality

Top of page

End point title

Individual component of primary endpoint: All-cause mortality

End point description

Prospective comparison of time to first occurrence of Individual component of primary endpoint: All-cause mortality. Median time to event and 95% confidence intervals could not be estimated due to less than 50% of patients experiencing an event; percentage of patients with event is reported.

End point type

Secondary

End point timeframe

From baseline up to 4.9 years

End point values	Tocilizumab	Etanercept
Number of subjects analysed	1538	1542
Units: Percenntage of participants
number (not applicable)	4.2	4.2

Cox regression

Statistical analysis description

The analysis assessed in the ITT population the hazard ratio of the secondary endpoint in TCZ compared to ETA patients. This was done through a comparison of the hazard functions between TCZ and ETA patients. A stratified Cox proportional hazards regression model was used in evaluating the relative CV event rate of TCZ over ETA, with the following randomization factors used as strata: • Previous exposure to anti-TNF (Yes/No) • History of CV events (Yes/No)

Comparison groups

Tocilizumab v Etanercept

Number of subjects included in analysis

3080

Analysis specification

Pre-specified

Analysis type

non-inferiority ^[9]

Method

Parameter type

Hazard ratio (HR)

Point estimate

0.99

Confidence interval

level

95%

sides

2-sided

lower limit

0.7

upper limit

1.41

Notes
[9] - The non-inferiority margin was only formally tested for the primary ITT analysis.

Adverse events

Top of page

Timeframe for reporting adverse events

Adverse events were collected throughout the entire course of the study.

Adverse event reporting additional description

Analyses were conducted on the On treatment safety (OTS) population.

Assessment type

Non-systematic

Dictionary name

MedDRA

Dictionary version

19.0

Reporting group title

Etanercept

Reporting group description

Participants received 50 mg etanercept subcutaneously weekly until switch to another RA therapy or up to 4.9 years.

Reporting group title

Tocilizumab

Reporting group description

Participants received 8 mg/kg tocilizumab IV every 4 weeks until switch to another RA therapy or up to 4.9 years.

Serious adverse events	Etanercept	Tocilizumab
Total subjects affected by serious adverse events
subjects affected / exposed	422 / 1542 (27.37%)	479 / 1538 (31.14%)
number of deaths (all causes)	69	67
number of deaths resulting from adverse events	10	14
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
ADENOCARCINOMA
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
ADENOCARCINOMA OF COLON
subjects affected / exposed	2 / 1542 (0.13%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
ANAL SQUAMOUS CELL CARCINOMA
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
BASAL CELL CARCINOMA
subjects affected / exposed	3 / 1542 (0.19%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 5	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
BENIGN ANORECTAL NEOPLASM
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
BENIGN NEOPLASM OF CERVIX UTERI
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
BLADDER CANCER
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
BLADDER TRANSITIONAL CELL CARCINOMA
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
BRAIN NEOPLASM
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	1 / 1
BREAST CANCER
subjects affected / exposed	3 / 1542 (0.19%)	3 / 1538 (0.20%)
occurrences causally related to treatment / all	1 / 3	2 / 4
deaths causally related to treatment / all	0 / 1	0 / 0
CARCINOID TUMOUR OF THE GASTROINTESTINAL TRACT
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
CARCINOID TUMOUR PULMONARY
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
CARDIAC MYXOMA
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
CENTRAL NERVOUS SYSTEM LYMPHOMA
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
CEREBRAL HAEMANGIOMA
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
CHOLANGIOCARCINOMA
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	1 / 1	0 / 0
COLON ADENOMA
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
COLON CANCER
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
COLON CANCER METASTATIC
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
COLORECTAL CANCER
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
DIFFUSE LARGE B−CELL LYMPHOMA
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
ENDOMETRIAL ADENOCARCINOMA
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
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 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
HAEMANGIOMA
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
INTESTINAL ADENOCARCINOMA
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
INTRADUCTAL PROLIFERATIVE BREAST LESION
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
LARYNGEAL CANCER
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
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	1 / 1542 (0.06%)	3 / 1538 (0.20%)
occurrences causally related to treatment / all	1 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 1
LUNG ADENOCARCINOMA STAGE IV
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
LUNG CANCER METASTATIC
subjects affected / exposed	2 / 1542 (0.13%)	2 / 1538 (0.13%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 2	0 / 2
LUNG NEOPLASM
subjects affected / exposed	1 / 1542 (0.06%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 0
LUNG NEOPLASM MALIGNANT
subjects affected / exposed	4 / 1542 (0.26%)	3 / 1538 (0.20%)
occurrences causally related to treatment / all	0 / 4	1 / 3
deaths causally related to treatment / all	0 / 2	1 / 3
MALIGNANT MELANOMA STAGE II
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
MARJOLIN’S ULCER
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
METASTASES TO BONE
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
METASTATIC GASTRIC CANCER
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
METASTATIC NEOPLASM
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
NEOPLASM MALIGNANT
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
NON−HODGKIN’S LYMPHOMA
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
OVARIAN ADENOMA
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
OVARIAN CANCER
subjects affected / exposed	0 / 1542 (0.00%)	2 / 1538 (0.13%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 2
PANCREATIC CARCINOMA METASTATIC
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	1 / 1
PANCREATIC NEOPLASM
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
PAPILLARY THYROID CANCER
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
PARAPROTEINAEMIA
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
PARATHYROID TUMOUR BENIGN
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
PHARYNGEAL NEOPLASM BENIGN
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
PITUITARY TUMOUR BENIGN
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
PLASMA CELL MYELOMA
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
PROSTATE CANCER
subjects affected / exposed	1 / 1542 (0.06%)	3 / 1538 (0.20%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
RENAL CANCER
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
RENAL CELL CARCINOMA
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (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
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (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 LUNG
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (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 THE TONGUE
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
SQUAMOUS ENDOMETRIAL CARCINOMA
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
THYROID ADENOMA
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
TONGUE NEOPLASM MALIGNANT STAGE UNSPECIFIED
subjects affected / exposed	1 / 1542 (0.06%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
TUMOUR INVASION
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (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	0 / 1542 (0.00%)	3 / 1538 (0.20%)
occurrences causally related to treatment / all	0 / 0	1 / 3
deaths causally related to treatment / all	0 / 0	0 / 1
Vascular disorders
AORTIC ANEURYSM
subjects affected / exposed	4 / 1542 (0.26%)	3 / 1538 (0.20%)
occurrences causally related to treatment / all	0 / 4	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
AORTIC ANEURYSM RUPTURE
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
AORTIC CALCIFICATION
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
AORTIC DISSECTION
subjects affected / exposed	1 / 1542 (0.06%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 1
AORTIC STENOSIS
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
DEEP VEIN THROMBOSIS
subjects affected / exposed	8 / 1542 (0.52%)	6 / 1538 (0.39%)
occurrences causally related to treatment / all	0 / 8	1 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
EMBOLISM ARTERIAL
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
FEMORAL ARTERY EMBOLISM
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (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 / 1542 (0.06%)	0 / 1538 (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	6 / 1542 (0.39%)	4 / 1538 (0.26%)
occurrences causally related to treatment / all	0 / 7	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
HYPERTENSIVE CRISIS
subjects affected / exposed	2 / 1542 (0.13%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 2	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
HYPERTENSIVE EMERGENCY
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
HYPOTENSION
subjects affected / exposed	1 / 1542 (0.06%)	2 / 1538 (0.13%)
occurrences causally related to treatment / all	1 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
INFARCTION
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
ORTHOSTATIC HYPOTENSION
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
PERIPHERAL ARTERIAL OCCLUSIVE DISEASE
subjects affected / exposed	2 / 1542 (0.13%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
PERIPHERAL ISCHAEMIA
subjects affected / exposed	2 / 1542 (0.13%)	3 / 1538 (0.20%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
PERIPHERAL VENOUS DISEASE
subjects affected / exposed	1 / 1542 (0.06%)	2 / 1538 (0.13%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 1
SUBCLAVIAN ARTERY OCCLUSION
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
RHEUMATOID VASCULITIS
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
THROMBOSIS
subjects affected / exposed	1 / 1542 (0.06%)	2 / 1538 (0.13%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
VARICOSE VEIN
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
VENOUS THROMBOSIS LIMB
subjects affected / exposed	1 / 1542 (0.06%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Surgical and medical procedures
ABDOMINAL HERNIA REPAIR
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
ANAL FISTULA EXCISION
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
ANGIOPLASTY
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
APPENDICECTOMY
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
CARDIAC PACEMAKER REPLACEMENT
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
COLOSTOMY CLOSURE
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
HIP ARTHROPLASTY
subjects affected / exposed	1 / 1542 (0.06%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
IMPLANTABLE DEFIBRILLATOR INSERTION
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
KNEE ARTHROPLASTY
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
LARGE INTESTINE ANASTOMOSIS
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
MITRAL VALVE REPLACEMENT
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
SEQUESTRECTOMY
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
UMBILICAL HERNIA REPAIR
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
General disorders and administration site conditions
CHEST PAIN
subjects affected / exposed	10 / 1542 (0.65%)	3 / 1538 (0.20%)
occurrences causally related to treatment / all	0 / 10	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
COMPLICATION ASSOCIATED WITH DEVICE
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
DEATH
subjects affected / exposed	4 / 1542 (0.26%)	3 / 1538 (0.20%)
occurrences causally related to treatment / all	0 / 4	0 / 3
deaths causally related to treatment / all	0 / 4	0 / 3
GENERAL PHYSICAL HEALTH DETERIORATION
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
IMPAIRED HEALING
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
LOCAL SWELLING
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
MULTIPLE ORGAN DYSFUNCTION SYNDROME
subjects affected / exposed	0 / 1542 (0.00%)	2 / 1538 (0.13%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 2
NON−CARDIAC CHEST PAIN
subjects affected / exposed	1 / 1542 (0.06%)	5 / 1538 (0.33%)
occurrences causally related to treatment / all	0 / 1	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
OEDEMA PERIPHERAL
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
PYREXIA
subjects affected / exposed	3 / 1542 (0.19%)	3 / 1538 (0.20%)
occurrences causally related to treatment / all	1 / 3	1 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
PAIN
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
SUDDEN DEATH
subjects affected / exposed	1 / 1542 (0.06%)	3 / 1538 (0.20%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 1	0 / 3
SWELLING
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Immune system disorders
DRUG HYPERSENSITIVITY
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
HYPERSENSITIVITY
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
OVERLAP SYNDROME
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
SARCOIDOSIS
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Reproductive system and breast disorders
ACQUIRED PHIMOSIS
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
BREAST FIBROSIS
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
CERVICAL DYSPLASIA
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
CERVICAL POLYP
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
CYSTOCELE
subjects affected / exposed	0 / 1542 (0.00%)	2 / 1538 (0.13%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
GENITAL PROLAPSE
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
METRORRHAGIA
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
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 / 1542 (0.06%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
OVARIAN CYST TORSION
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
RECTOCELE
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
SPERMATOCELE
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
UTERINE POLYP
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (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	1 / 1542 (0.06%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
VAGINAL HAEMATOMA
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
ACUTE PULMONARY OEDEMA
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
ACUTE RESPIRATORY DISTRESS SYNDROME
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
ACUTE RESPIRATORY FAILURE
subjects affected / exposed	1 / 1542 (0.06%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
ALVEOLITIS
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
ASTHMA
subjects affected / exposed	5 / 1542 (0.32%)	2 / 1538 (0.13%)
occurrences causally related to treatment / all	0 / 7	1 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
ASTHMATIC CRISIS
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
ATELECTASIS
subjects affected / exposed	1 / 1542 (0.06%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
BRONCHIAL HYPERREACTIVITY
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
BRONCHIAL OBSTRUCTION
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
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	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
BRONCHOSPASM
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
BRONCHOSTENOSIS
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
subjects affected / exposed	7 / 1542 (0.45%)	10 / 1538 (0.65%)
occurrences causally related to treatment / all	2 / 7	0 / 12
deaths causally related to treatment / all	0 / 0	0 / 2
CHRONIC RESPIRATORY FAILURE
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
DYSPNOEA
subjects affected / exposed	4 / 1542 (0.26%)	5 / 1538 (0.33%)
occurrences causally related to treatment / all	0 / 4	1 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
EMPHYSEMA
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
EPISTAXIS
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
HYDROTHORAX
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
INTERSTITIAL LUNG DISEASE
subjects affected / exposed	3 / 1542 (0.19%)	5 / 1538 (0.33%)
occurrences causally related to treatment / all	1 / 3	1 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
HYPOXIA
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
LUNG DISORDER
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
LUNG INFILTRATION
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
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	5 / 1542 (0.32%)	6 / 1538 (0.39%)
occurrences causally related to treatment / all	0 / 6	1 / 9
deaths causally related to treatment / all	0 / 0	0 / 0
PNEUMONIA ASPIRATION
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
PNEUMOTHORAX
subjects affected / exposed	2 / 1542 (0.13%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 2	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
PNEUMONITIS
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
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	11 / 1542 (0.71%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	2 / 11	0 / 1
deaths causally related to treatment / all	1 / 2	0 / 0
PULMONARY FIBROSIS
subjects affected / exposed	1 / 1542 (0.06%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 0
PULMONARY HYPERTENSION
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
PULMONARY GRANULOMA
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
PULMONARY MASS
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
PULMONARY OEDEMA
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
PULMONARY SARCOIDOSIS
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
RESPIRATORY DISTRESS
subjects affected / exposed	1 / 1542 (0.06%)	2 / 1538 (0.13%)
occurrences causally related to treatment / all	0 / 1	1 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
PULMONARY THROMBOSIS
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	1 / 1
RESPIRATORY FAILURE
subjects affected / exposed	6 / 1542 (0.39%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	2 / 6	0 / 1
deaths causally related to treatment / all	1 / 3	0 / 0
Psychiatric disorders
BURNOUT SYNDROME
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
CONFUSIONAL STATE
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
DELIRIUM
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
DELIRIUM TREMENS
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
DEPRESSION
subjects affected / exposed	2 / 1542 (0.13%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
MAJOR DEPRESSION
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
MENTAL DISORDER
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
MENTAL STATUS CHANGES
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
PSYCHOTIC DISORDER
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
SCHIZOAFFECTIVE DISORDER BIPOLAR TYPE
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
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	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
SUICIDE ATTEMPT
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
MANIA
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (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 BREAKAGE
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
DEVICE DISLOCATION
subjects affected / exposed	0 / 1542 (0.00%)	3 / 1538 (0.20%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
DEVICE FAILURE
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
DEVICE LOOSENING
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatobiliary disorders
BILE DUCT OBSTRUCTION
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
CHOLECYSTITIS
subjects affected / exposed	0 / 1542 (0.00%)	3 / 1538 (0.20%)
occurrences causally related to treatment / all	0 / 0	1 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
CHOLANGITIS ACUTE
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
CHOLECYSTITIS ACUTE
subjects affected / exposed	2 / 1542 (0.13%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
CHOLECYSTITIS CHRONIC
subjects affected / exposed	1 / 1542 (0.06%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
CHOLELITHIASIS
subjects affected / exposed	6 / 1542 (0.39%)	14 / 1538 (0.91%)
occurrences causally related to treatment / all	0 / 6	0 / 14
deaths causally related to treatment / all	0 / 0	0 / 0
HEPATIC VEIN THROMBOSIS
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
HEPATITIS
subjects affected / exposed	0 / 1542 (0.00%)	2 / 1538 (0.13%)
occurrences causally related to treatment / all	0 / 0	1 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
HEPATITIS ACUTE
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
POST CHOLECYSTECTOMY SYNDROME
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Investigations
EOSINOPHIL COUNT INCREASED
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
HAEMATOCRIT ABNORMAL
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
HAEMOGLOBIN ABNORMAL
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
LIVER FUNCTION TEST INCREASED
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
STAPHYLOCOCCUS TEST POSITIVE
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
SYNOVIAL FLUID WHITE BLOOD CELLS POSITIVE
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
TRANSAMINASES INCREASED
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
TROPONIN INCREASED
subjects affected / exposed	2 / 1542 (0.13%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Injury, poisoning and procedural complications
ACCIDENT AT WORK
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
ANAEMIA POSTOPERATIVE
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
ANKLE FRACTURE
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
ARTHROPOD STING
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
COMMINUTED FRACTURE
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
CONTUSION
subjects affected / exposed	1 / 1542 (0.06%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
DISLOCATION OF VERTEBRA
subjects affected / exposed	2 / 1542 (0.13%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
FALL
subjects affected / exposed	1 / 1542 (0.06%)	2 / 1538 (0.13%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
FEMORAL NECK FRACTURE
subjects affected / exposed	3 / 1542 (0.19%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	0 / 4	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
FEMUR FRACTURE
subjects affected / exposed	6 / 1542 (0.39%)	5 / 1538 (0.33%)
occurrences causally related to treatment / all	0 / 7	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
FOOT FRACTURE
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
FRACTURE DISPLACEMENT
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
GUN SHOT WOUND
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
HAND FRACTURE
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
HIP FRACTURE
subjects affected / exposed	12 / 1542 (0.78%)	4 / 1538 (0.26%)
occurrences causally related to treatment / all	0 / 12	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
HUMERUS FRACTURE
subjects affected / exposed	4 / 1542 (0.26%)	3 / 1538 (0.20%)
occurrences causally related to treatment / all	0 / 4	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
INFUSION RELATED REACTION
subjects affected / exposed	0 / 1542 (0.00%)	2 / 1538 (0.13%)
occurrences causally related to treatment / all	0 / 0	2 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
JOINT DISLOCATION
subjects affected / exposed	2 / 1542 (0.13%)	3 / 1538 (0.20%)
occurrences causally related to treatment / all	0 / 2	0 / 4
deaths causally related to treatment / all	0 / 1	0 / 0
JOINT INJURY
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
LIGAMENT INJURY
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
LOWER LIMB FRACTURE
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
OVERDOSE
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
PATELLA FRACTURE
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
PNEUMOTHORAX TRAUMATIC
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
POST PROCEDURAL FISTULA
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
POST PROCEDURAL HAEMATOMA
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
RADIUS FRACTURE
subjects affected / exposed	0 / 1542 (0.00%)	2 / 1538 (0.13%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
RESPIRATORY FUME INHALATION DISORDER
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
RIB FRACTURE
subjects affected / exposed	4 / 1542 (0.26%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 4	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
SPINAL COMPRESSION FRACTURE
subjects affected / exposed	1 / 1542 (0.06%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
SPINAL FRACTURE
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
STOMAL HERNIA
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
STRESS FRACTURE
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
SUBCUTANEOUS HAEMATOMA
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
SUBDURAL HAEMATOMA
subjects affected / exposed	0 / 1542 (0.00%)	2 / 1538 (0.13%)
occurrences causally related to treatment / all	0 / 0	0 / 20
deaths causally related to treatment / all	0 / 0	0 / 0
SYNOVIAL RUPTURE
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
TENDON RUPTURE
subjects affected / exposed	2 / 1542 (0.13%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
THORACIC VERTEBRAL FRACTURE
subjects affected / exposed	2 / 1542 (0.13%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
ULNA FRACTURE
subjects affected / exposed	1 / 1542 (0.06%)	2 / 1538 (0.13%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
UPPER LIMB FRACTURE
subjects affected / exposed	0 / 1542 (0.00%)	2 / 1538 (0.13%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
WOUND
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
WOUND DEHISCENCE
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
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	2 / 1542 (0.13%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Congenital, familial and genetic disorders
ATRIAL SEPTAL DEFECT
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
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 / 1542 (0.06%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac disorders
ACUTE CORONARY SYNDROME
subjects affected / exposed	1 / 1542 (0.06%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
ADAMS−STOKES SYNDROME
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
ACUTE MYOCARDIAL INFARCTION
subjects affected / exposed	9 / 1542 (0.58%)	7 / 1538 (0.46%)
occurrences causally related to treatment / all	1 / 9	1 / 7
deaths causally related to treatment / all	0 / 0	0 / 1
ANGINA PECTORIS
subjects affected / exposed	2 / 1542 (0.13%)	8 / 1538 (0.52%)
occurrences causally related to treatment / all	1 / 2	0 / 8
deaths causally related to treatment / all	0 / 0	0 / 0
ANGINA UNSTABLE
subjects affected / exposed	7 / 1542 (0.45%)	4 / 1538 (0.26%)
occurrences causally related to treatment / all	0 / 10	2 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
ATRIAL FLUTTER
subjects affected / exposed	0 / 1542 (0.00%)	2 / 1538 (0.13%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
ATRIAL FIBRILLATION
subjects affected / exposed	18 / 1542 (1.17%)	14 / 1538 (0.91%)
occurrences causally related to treatment / all	3 / 23	0 / 15
deaths causally related to treatment / all	0 / 0	0 / 0
ATRIOVENTRICULAR BLOCK SECOND DEGREE
subjects affected / exposed	2 / 1542 (0.13%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
BRADYARRHYTHMIA
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
BRADYCARDIA
subjects affected / exposed	2 / 1542 (0.13%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
BUNDLE BRANCH BLOCK LEFT
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
CARDIAC ARREST
subjects affected / exposed	4 / 1542 (0.26%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 4	0 / 1
deaths causally related to treatment / all	0 / 4	0 / 1
CARDIAC FAILURE
subjects affected / exposed	3 / 1542 (0.19%)	11 / 1538 (0.72%)
occurrences causally related to treatment / all	0 / 3	5 / 16
deaths causally related to treatment / all	0 / 1	1 / 3
CARDIAC FAILURE CHRONIC
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
CARDIAC FAILURE CONGESTIVE
subjects affected / exposed	8 / 1542 (0.52%)	7 / 1538 (0.46%)
occurrences causally related to treatment / all	2 / 11	0 / 7
deaths causally related to treatment / all	0 / 1	0 / 1
CARDIAC FIBRILLATION
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
CARDIAC TAMPONADE
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
CARDIOGENIC SHOCK
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
CARDIOMYOPATHY
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
CARDIOPULMONARY FAILURE
subjects affected / exposed	1 / 1542 (0.06%)	4 / 1538 (0.26%)
occurrences causally related to treatment / all	0 / 1	0 / 4
deaths causally related to treatment / all	0 / 1	0 / 4
CORONARY ARTERY DISEASE
subjects affected / exposed	3 / 1542 (0.19%)	9 / 1538 (0.59%)
occurrences causally related to treatment / all	0 / 4	0 / 9
deaths causally related to treatment / all	0 / 0	0 / 0
CORONARY ARTERY OCCLUSION
subjects affected / exposed	1 / 1542 (0.06%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
CORONARY ARTERY STENOSIS
subjects affected / exposed	2 / 1542 (0.13%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
HYPERTENSIVE HEART DISEASE
subjects affected / exposed	0 / 1542 (0.00%)	3 / 1538 (0.20%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
ISCHAEMIC CARDIOMYOPATHY
subjects affected / exposed	2 / 1542 (0.13%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
LEFT VENTRICULAR FAILURE
subjects affected / exposed	2 / 1542 (0.13%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
MITRAL VALVE INCOMPETENCE
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (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	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
MYOCARDIAL INFARCTION
subjects affected / exposed	15 / 1542 (0.97%)	10 / 1538 (0.65%)
occurrences causally related to treatment / all	2 / 15	0 / 10
deaths causally related to treatment / all	1 / 5	0 / 1
MYOCARDIAL ISCHAEMIA
subjects affected / exposed	3 / 1542 (0.19%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 3	1 / 1
deaths causally related to treatment / all	0 / 0	1 / 1
PALPITATIONS
subjects affected / exposed	1 / 1542 (0.06%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
POSTINFARCTION ANGINA
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
SILENT MYOCARDIAL INFARCTION
subjects affected / exposed	2 / 1542 (0.13%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
SINOATRIAL BLOCK
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
SINUS BRADYCARDIA
subjects affected / exposed	1 / 1542 (0.06%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
SINUS NODE DYSFUNCTION
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
SUPRAVENTRICULAR TACHYCARDIA
subjects affected / exposed	1 / 1542 (0.06%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
TACHYCARDIA
subjects affected / exposed	1 / 1542 (0.06%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
VENTRICULAR DYSFUNCTION
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
VENTRICULAR FIBRILLATION
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
VENTRICULAR TACHYCARDIA
subjects affected / exposed	2 / 1542 (0.13%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
CARDIO−RESPIRATORY ARREST
subjects affected / exposed	3 / 1542 (0.19%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	1 / 3	0 / 1
deaths causally related to treatment / all	1 / 3	0 / 1
Nervous system disorders
AMYOTROPHIC LATERAL SCLEROSIS
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
BALANCE DISORDER
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
BRAIN STEM INFARCTION
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
CAROTID ARTERY DISEASE
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
CAROTID ARTERY STENOSIS
subjects affected / exposed	1 / 1542 (0.06%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
CEREBRAL HAEMATOMA
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
CEREBRAL INFARCTION
subjects affected / exposed	2 / 1542 (0.13%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
CEREBRAL ISCHAEMIA
subjects affected / exposed	2 / 1542 (0.13%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
CEREBROVASCULAR ACCIDENT
subjects affected / exposed	8 / 1542 (0.52%)	14 / 1538 (0.91%)
occurrences causally related to treatment / all	0 / 8	2 / 15
deaths causally related to treatment / all	0 / 3	1 / 3
CEREBROVASCULAR DISORDER
subjects affected / exposed	1 / 1542 (0.06%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
CERVICAL CORD COMPRESSION
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
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	1 / 1542 (0.06%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
COMA
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
DEMENTIA
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
DEMENTIA ALZHEIMER’S TYPE
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
DIABETIC COMA
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
DYSARTHRIA
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
DYSKINESIA
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
EMBOLIC STROKE
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
ENCEPHALOPATHY
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
EPILEPSY
subjects affected / exposed	0 / 1542 (0.00%)	3 / 1538 (0.20%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
FACIAL PARALYSIS
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
GENERALISED TONIC−CLONIC SEIZURE
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
HAEMORRHAGIC STROKE
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
HEMIPARESIS
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
HEPATIC ENCEPHALOPATHY
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
HYPERTENSIVE ENCEPHALOPATHY
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
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	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
ISCHAEMIC STROKE
subjects affected / exposed	5 / 1542 (0.32%)	5 / 1538 (0.33%)
occurrences causally related to treatment / all	0 / 5	1 / 5
deaths causally related to treatment / all	0 / 1	0 / 0
LOSS OF CONSCIOUSNESS
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
METABOLIC ENCEPHALOPATHY
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
LUMBAR RADICULOPATHY
subjects affected / exposed	2 / 1542 (0.13%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
MIGRAINE
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
MYASTHENIA GRAVIS
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
PARKINSON’S DISEASE
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (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 / 1542 (0.06%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
PRESYNCOPE
subjects affected / exposed	2 / 1542 (0.13%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
REVERSIBLE ISCHAEMIC NEUROLOGICAL DEFICIT
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
RUPTURED CEREBRAL ANEURYSM
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
SCIATICA
subjects affected / exposed	3 / 1542 (0.19%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
SPINAL CORD COMPRESSION
subjects affected / exposed	0 / 1542 (0.00%)	2 / 1538 (0.13%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 1
SEIZURE
subjects affected / exposed	1 / 1542 (0.06%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
SUBARACHNOID HAEMORRHAGE
subjects affected / exposed	3 / 1542 (0.19%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 0
SYNCOPE
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
TRANSIENT GLOBAL AMNESIA
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
VASCULAR DEMENTIA
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
TRANSIENT ISCHAEMIC ATTACK
subjects affected / exposed	3 / 1542 (0.19%)	9 / 1538 (0.59%)
occurrences causally related to treatment / all	0 / 3	0 / 10
deaths causally related to treatment / all	0 / 0	0 / 0
Blood and lymphatic system disorders
ANAEMIA
subjects affected / exposed	9 / 1542 (0.58%)	5 / 1538 (0.33%)
occurrences causally related to treatment / all	0 / 9	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 1
AUTOIMMUNE HAEMOLYTIC ANAEMIA
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
COAGULOPATHY
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
GRANULOCYTOPENIA
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
LEUKOCYTOSIS
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
MICROCYTIC ANAEMIA
subjects affected / exposed	2 / 1542 (0.13%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
PANCYTOPENIA
subjects affected / exposed	4 / 1542 (0.26%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	1 / 4	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 0
THROMBOCYTOPENIA
subjects affected / exposed	0 / 1542 (0.00%)	2 / 1538 (0.13%)
occurrences causally related to treatment / all	0 / 0	1 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
LEUKOPENIA
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Ear and labyrinth disorders
DEAFNESS UNILATERAL
subjects affected / exposed	1 / 1542 (0.06%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
VERTIGO
subjects affected / exposed	1 / 1542 (0.06%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Eye disorders
CATARACT
subjects affected / exposed	2 / 1542 (0.13%)	2 / 1538 (0.13%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
CORNEAL PERFORATION
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
KERATITIS
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
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	1 / 1542 (0.06%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
RETINAL DETACHMENT
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
ULCERATIVE KERATITIS
subjects affected / exposed	1 / 1542 (0.06%)	2 / 1538 (0.13%)
occurrences causally related to treatment / all	0 / 1	1 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
SCLERITIS
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal disorders
ABDOMINAL ADHESIONS
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
ABDOMINAL HERNIA
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
ABDOMINAL PAIN
subjects affected / exposed	4 / 1542 (0.26%)	3 / 1538 (0.20%)
occurrences causally related to treatment / all	0 / 4	1 / 4
deaths causally related to treatment / all	0 / 0	0 / 1
ABDOMINAL PAIN UPPER
subjects affected / exposed	0 / 1542 (0.00%)	2 / 1538 (0.13%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
ACID PEPTIC DISEASE
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
ACUTE ABDOMEN
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
ASCITES
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
COLITIS
subjects affected / exposed	1 / 1542 (0.06%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
COLITIS ISCHAEMIC
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
COLITIS ULCERATIVE
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
CONSTIPATION
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
CROHN’S DISEASE
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
DIAPHRAGMATIC HERNIA
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
DIARRHOEA
subjects affected / exposed	4 / 1542 (0.26%)	2 / 1538 (0.13%)
occurrences causally related to treatment / all	1 / 4	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
DIVERTICULAR PERFORATION
subjects affected / exposed	1 / 1542 (0.06%)	6 / 1538 (0.39%)
occurrences causally related to treatment / all	0 / 1	6 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
DIVERTICULUM
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
DIVERTICULUM INTESTINAL
subjects affected / exposed	2 / 1542 (0.13%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
DIVERTICULUM INTESTINAL HAEMORRHAGIC
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
DUODENAL ULCER
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
ENTERITIS
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
ENTEROCOLITIS
subjects affected / exposed	0 / 1542 (0.00%)	2 / 1538 (0.13%)
occurrences causally related to treatment / all	0 / 0	1 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
FEMORAL HERNIA
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
GASTRIC ULCER HAEMORRHAGE
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
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	1 / 1542 (0.06%)	2 / 1538 (0.13%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
GASTRIC ULCER PERFORATION
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
GASTRITIS
subjects affected / exposed	2 / 1542 (0.13%)	4 / 1538 (0.26%)
occurrences causally related to treatment / all	0 / 2	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
GASTROINTESTINAL HAEMORRHAGE
subjects affected / exposed	4 / 1542 (0.26%)	4 / 1538 (0.26%)
occurrences causally related to treatment / all	0 / 4	1 / 4
deaths causally related to treatment / all	0 / 1	0 / 1
GASTRITIS HAEMORRHAGIC
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
GASTROINTESTINAL INFLAMMATION
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
GASTROINTESTINAL ULCER HAEMORRHAGE
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
GASTROOESOPHAGEAL REFLUX DISEASE
subjects affected / exposed	1 / 1542 (0.06%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
HAEMATEMESIS
subjects affected / exposed	0 / 1542 (0.00%)	2 / 1538 (0.13%)
occurrences causally related to treatment / all	0 / 0	1 / 2
deaths causally related to treatment / all	0 / 0	1 / 1
HAEMATOCHEZIA
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
INCARCERATED HIATUS HERNIA
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
HAEMORRHOIDS
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
INCARCERATED UMBILICAL HERNIA
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
INGUINAL HERNIA
subjects affected / exposed	1 / 1542 (0.06%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
INTESTINAL OBSTRUCTION
subjects affected / exposed	1 / 1542 (0.06%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	1 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
LARGE INTESTINAL STENOSIS
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
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	0 / 1542 (0.00%)	4 / 1538 (0.26%)
occurrences causally related to treatment / all	0 / 0	3 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
LARGE INTESTINE POLYP
subjects affected / exposed	2 / 1542 (0.13%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
LOWER GASTROINTESTINAL HAEMORRHAGE
subjects affected / exposed	2 / 1542 (0.13%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
MALLORY−WEISS SYNDROME
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
MELAENA
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
NAUSEA
subjects affected / exposed	0 / 1542 (0.00%)	2 / 1538 (0.13%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
OESOPHAGITIS
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
PALATAL DISORDER
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
PANCREATITIS
subjects affected / exposed	1 / 1542 (0.06%)	4 / 1538 (0.26%)
occurrences causally related to treatment / all	0 / 1	3 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
PANCREATITIS ACUTE
subjects affected / exposed	3 / 1542 (0.19%)	5 / 1538 (0.33%)
occurrences causally related to treatment / all	0 / 5	1 / 6
deaths causally related to treatment / all	0 / 0	0 / 1
PEPTIC ULCER
subjects affected / exposed	1 / 1542 (0.06%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
PEPTIC ULCER HAEMORRHAGE
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
RETROPERITONEAL FIBROSIS
subjects affected / exposed	1 / 1542 (0.06%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
UPPER GASTROINTESTINAL HAEMORRHAGE
subjects affected / exposed	2 / 1542 (0.13%)	2 / 1538 (0.13%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 1	0 / 0
VOMITING
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Skin and subcutaneous tissue disorders
ANGIOEDEMA
subjects affected / exposed	2 / 1542 (0.13%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
BLISTER
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
DECUBITUS ULCER
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
DERMAL CYST
subjects affected / exposed	1 / 1542 (0.06%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	1 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
DERMATITIS
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
DIABETIC FOOT
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
HYPERSENSITIVITY VASCULITIS
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	2 / 2	0 / 0
deaths causally related to treatment / all	1 / 1	0 / 0
PEMPHIGOID
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
RASH
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
RASH ERYTHEMATOUS
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
SKIN DISORDER
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (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 / 1542 (0.00%)	2 / 1538 (0.13%)
occurrences causally related to treatment / all	0 / 0	1 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
SKIN ULCER
subjects affected / exposed	1 / 1542 (0.06%)	4 / 1538 (0.26%)
occurrences causally related to treatment / all	1 / 1	2 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
URTICARIA
subjects affected / exposed	2 / 1542 (0.13%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	1 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
VASCULITIC ULCER
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Renal and urinary disorders
ACUTE KIDNEY INJURY
subjects affected / exposed	5 / 1542 (0.32%)	3 / 1538 (0.20%)
occurrences causally related to treatment / all	1 / 5	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
CALCULUS URINARY
subjects affected / exposed	2 / 1542 (0.13%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
CALCULUS BLADDER
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
CHRONIC KIDNEY DISEASE
subjects affected / exposed	1 / 1542 (0.06%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
CYSTITIS HAEMORRHAGIC
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
END STAGE RENAL DISEASE
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
GLOMERULONEPHRITIS CHRONIC
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
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 / 1542 (0.06%)	0 / 1538 (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	3 / 1542 (0.19%)	3 / 1538 (0.20%)
occurrences causally related to treatment / all	0 / 3	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
OBSTRUCTIVE NEPHROPATHY
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
PELVI−URETERIC OBSTRUCTION
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
RENAL COLIC
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
RENAL FAILURE
subjects affected / exposed	3 / 1542 (0.19%)	2 / 1538 (0.13%)
occurrences causally related to treatment / all	1 / 4	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
TUBULOINTERSTITIAL NEPHRITIS
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
URETERIC OBSTRUCTION
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
URETEROLITHIASIS
subjects affected / exposed	1 / 1542 (0.06%)	2 / 1538 (0.13%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
URETHRAL STENOSIS
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
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	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Endocrine disorders
GOITRE
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
HYPOTHYROIDISM
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
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 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Musculoskeletal and connective tissue disorders
ARTHRALGIA
subjects affected / exposed	1 / 1542 (0.06%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
ARTHRITIS
subjects affected / exposed	1 / 1542 (0.06%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
BACK PAIN
subjects affected / exposed	6 / 1542 (0.39%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	0 / 6	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
BURSITIS
subjects affected / exposed	2 / 1542 (0.13%)	2 / 1538 (0.13%)
occurrences causally related to treatment / all	1 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
COSTOCHONDRITIS
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
FASCIITIS
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
FINGER DEFORMITY
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
FISTULA
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
FOOT DEFORMITY
subjects affected / exposed	3 / 1542 (0.19%)	2 / 1538 (0.13%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
HAEMARTHROSIS
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
INTERVERTEBRAL DISC DISORDER
subjects affected / exposed	0 / 1542 (0.00%)	3 / 1538 (0.20%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
INTERVERTEBRAL DISC PROTRUSION
subjects affected / exposed	6 / 1542 (0.39%)	5 / 1538 (0.33%)
occurrences causally related to treatment / all	0 / 6	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
KNEE DEFORMITY
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
LIMB DEFORMITY
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
LUMBAR SPINAL STENOSIS
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
MORPHOEA
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
MUSCLE SPASMS
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
MUSCULOSKELETAL CHEST PAIN
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
MYALGIA
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
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	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
OSTEOARTHRITIS
subjects affected / exposed	22 / 1542 (1.43%)	14 / 1538 (0.91%)
occurrences causally related to treatment / all	0 / 24	0 / 14
deaths causally related to treatment / all	0 / 0	0 / 0
OSTEONECROSIS
subjects affected / exposed	4 / 1542 (0.26%)	2 / 1538 (0.13%)
occurrences causally related to treatment / all	1 / 4	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
OSTEONECROSIS OF JAW
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
OSTEOPOROSIS
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
OSTEOPOROTIC FRACTURE
subjects affected / exposed	2 / 1542 (0.13%)	1 / 1538 (0.07%)
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 / 1542 (0.06%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
PERIARTHRITIS
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
RHEUMATOID ARTHRITIS
subjects affected / exposed	15 / 1542 (0.97%)	12 / 1538 (0.78%)
occurrences causally related to treatment / all	0 / 19	2 / 15
deaths causally related to treatment / all	0 / 0	0 / 0
RHEUMATOID NODULE
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
ROTATOR CUFF SYNDROME
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
SPINAL OSTEOARTHRITIS
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
SPONDYLOLISTHESIS
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
SYNOVIAL CYST
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
SYNOVITIS
subjects affected / exposed	1 / 1542 (0.06%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
TENOSYNOVITIS
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Infections and infestations
ABSCESS
subjects affected / exposed	1 / 1542 (0.06%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 1	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
ABSCESS LIMB
subjects affected / exposed	0 / 1542 (0.00%)	6 / 1538 (0.39%)
occurrences causally related to treatment / all	0 / 0	3 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
ABSCESS ORAL
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
ABSCESS RUPTURE
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	1 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
ACUTE SINUSITIS
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
ANAL ABSCESS
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
APPENDICITIS
subjects affected / exposed	0 / 1542 (0.00%)	3 / 1538 (0.20%)
occurrences causally related to treatment / all	0 / 0	1 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
ARTHRITIS BACTERIAL
subjects affected / exposed	6 / 1542 (0.39%)	9 / 1538 (0.59%)
occurrences causally related to treatment / all	5 / 7	3 / 9
deaths causally related to treatment / all	0 / 0	0 / 0
ARTHRITIS INFECTIVE
subjects affected / exposed	1 / 1542 (0.06%)	2 / 1538 (0.13%)
occurrences causally related to treatment / all	1 / 1	1 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
ASPERGILLUS INFECTION
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
ATYPICAL PNEUMONIA
subjects affected / exposed	2 / 1542 (0.13%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	2 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
BILIARY SEPSIS
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
BRONCHITIS
subjects affected / exposed	4 / 1542 (0.26%)	5 / 1538 (0.33%)
occurrences causally related to treatment / all	1 / 4	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
BRONCHITIS VIRAL
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
BRONCHOPULMONARY ASPERGILLOSIS
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
BURSITIS INFECTIVE
subjects affected / exposed	0 / 1542 (0.00%)	2 / 1538 (0.13%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
CELLULITIS
subjects affected / exposed	8 / 1542 (0.52%)	24 / 1538 (1.56%)
occurrences causally related to treatment / all	5 / 8	13 / 26
deaths causally related to treatment / all	0 / 0	0 / 0
CELLULITIS STAPHYLOCOCCAL
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
CELLULITIS STREPTOCOCCAL
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
CERVICITIS
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
CHRONIC TONSILLITIS
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
CLOSTRIDIUM DIFFICILE COLITIS
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
CLOSTRIDIUM DIFFICILE INFECTION
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
COLONIC ABSCESS
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
DENGUE FEVER
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
DEVICE RELATED INFECTION
subjects affected / exposed	1 / 1542 (0.06%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	1 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
DEVICE RELATED SEPSIS
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
DISSEMINATED TUBERCULOSIS
subjects affected / exposed	1 / 1542 (0.06%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	1 / 1	0 / 1
deaths causally related to treatment / all	1 / 1	0 / 0
DIVERTICULITIS
subjects affected / exposed	1 / 1542 (0.06%)	10 / 1538 (0.65%)
occurrences causally related to treatment / all	1 / 1	5 / 10
deaths causally related to treatment / all	0 / 0	0 / 0
EMPYEMA
subjects affected / exposed	1 / 1542 (0.06%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 1	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
ENDOPHTHALMITIS
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
ENTERITIS INFECTIOUS
subjects affected / exposed	2 / 1542 (0.13%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
EPIDIDYMITIS
subjects affected / exposed	1 / 1542 (0.06%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 1	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
EPIGLOTTITIS
subjects affected / exposed	0 / 1542 (0.00%)	2 / 1538 (0.13%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
ERYSIPELAS
subjects affected / exposed	2 / 1542 (0.13%)	11 / 1538 (0.72%)
occurrences causally related to treatment / all	3 / 4	3 / 11
deaths causally related to treatment / all	0 / 0	0 / 0
ESCHERICHIA PYELONEPHRITIS
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
ESCHERICHIA SEPSIS
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
ESCHERICHIA URINARY TRACT INFECTION
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
FUNGAL SKIN INFECTION
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
GASTROENTERITIS
subjects affected / exposed	6 / 1542 (0.39%)	3 / 1538 (0.20%)
occurrences causally related to treatment / all	2 / 6	2 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
GASTROENTERITIS NOROVIRUS
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
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	1 / 1542 (0.06%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
GROIN ABSCESS
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
HAEMATOMA INFECTION
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
HAEMOPHILUS SEPSIS
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
HERPANGINA
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
HERPES ZOSTER
subjects affected / exposed	4 / 1542 (0.26%)	2 / 1538 (0.13%)
occurrences causally related to treatment / all	4 / 4	1 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
INFECTED DERMAL CYST
subjects affected / exposed	1 / 1542 (0.06%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
INFECTION
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
INFECTIOUS COLITIS
subjects affected / exposed	2 / 1542 (0.13%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	2 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
INFECTIOUS PLEURAL EFFUSION
subjects affected / exposed	1 / 1542 (0.06%)	3 / 1538 (0.20%)
occurrences causally related to treatment / all	1 / 1	1 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
INFECTIVE ANEURYSM
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
INFLUENZA
subjects affected / exposed	1 / 1542 (0.06%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
INJECTION SITE ABSCESS
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
INTERVERTEBRAL DISCITIS
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
LOCALISED INFECTION
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
LOWER RESPIRATORY TRACT INFECTION
subjects affected / exposed	2 / 1542 (0.13%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
LUDWIG ANGINA
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
LUNG ABSCESS
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
LUNG INFECTION
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
LUNG INFECTION PSEUDOMONAL
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
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 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
MENINGITIS
subjects affected / exposed	0 / 1542 (0.00%)	2 / 1538 (0.13%)
occurrences causally related to treatment / all	0 / 0	2 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
MUSCLE ABSCESS
subjects affected / exposed	1 / 1542 (0.06%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 1	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
NASAL ABSCESS
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
NEUROSYPHILIS
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
OESOPHAGEAL CANDIDIASIS
subjects affected / exposed	2 / 1542 (0.13%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
OPHTHALMIC HERPES SIMPLEX
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
OPHTHALMIC HERPES ZOSTER
subjects affected / exposed	1 / 1542 (0.06%)	2 / 1538 (0.13%)
occurrences causally related to treatment / all	0 / 1	2 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
OSTEOMYELITIS
subjects affected / exposed	2 / 1542 (0.13%)	2 / 1538 (0.13%)
occurrences causally related to treatment / all	1 / 2	2 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
OSTEOMYELITIS CHRONIC
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
OTITIS EXTERNA
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
PAPILLOMA VIRAL INFECTION
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
PERIHEPATIC ABSCESS
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
PERITONITIS
subjects affected / exposed	0 / 1542 (0.00%)	3 / 1538 (0.20%)
occurrences causally related to treatment / all	0 / 0	1 / 3
deaths causally related to treatment / all	0 / 0	0 / 1
PERITONSILLAR ABSCESS
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
PHARYNGITIS
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
PNEUMOCYSTIS JIROVECII PNEUMONIA
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	1 / 1	0 / 0
PNEUMONIA
subjects affected / exposed	41 / 1542 (2.66%)	47 / 1538 (3.06%)
occurrences causally related to treatment / all	18 / 46	20 / 53
deaths causally related to treatment / all	0 / 6	4 / 8
PNEUMONIA BACTERIAL
subjects affected / exposed	1 / 1542 (0.06%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 1	1 / 1
deaths causally related to treatment / all	0 / 1	0 / 0
PNEUMONIA INFLUENZAL
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (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	1 / 1542 (0.06%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
PNEUMONIA PNEUMOCOCCAL
subjects affected / exposed	0 / 1542 (0.00%)	1 / 1538 (0.07%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
PNEUMONIA STAPHYLOCOCCAL
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
PNEUMONIA VIRAL
subjects affected / exposed	1 / 1542 (0.06%)	0 / 1538 (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	0 / 1542 (0.00%)	2 / 1538 (0.13%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all