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Clinical Trial Results:
The ARRIVE Study (Aspirin to Reduce Risk of Initial Vascular Events) - A Randomized, Double-Blind, Placebo Controlled, Multicenter, Parallel Group Study to Assess the Efficacy (Reduction of Cardiovascular Disease Events) and Safety of 100 mg Enteric-Coated Acetylsalicylic Acid in Patients at Moderate Risk of Cardiovascular Disease

Summary
EudraCT number	2006-003622-29
Trial protocol	GB ES DE IE IT
Global end of trial date	15 Nov 2016

Results information
Results version number	v2(current)
This version publication date	13 Oct 2018
First version publication date	26 Nov 2017
Other versions	v1
Version creation reason

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

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Trial information

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Sponsor protocol code

BAYE4465/12198

ISRCTN number

US NCT number

NCT00501059

WHO universal trial number (UTN)

Sponsor organisation name

Bayer AG

Sponsor organisation address

Kaiser-Wilhelm-Allee, D-51368 Leverkusen, Germany,

Public contact

Therapeutic Area Head, Bayer AG, clinical-trials-contact@bayer.com

Scientific contact

Therapeutic Area Head, Bayer AG, clinical-trials-contact@bayer.com

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

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

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

Analysis stage

Final

Date of interim/final analysis

24 Jan 2017

Is this the analysis of the primary completion data?

Yes

Primary completion date

15 Nov 2016

Global end of trial reached?

Yes

Global end of trial date

15 Nov 2016

Was the trial ended prematurely?

Main objective of the trial

To evaluate the clinical effect of a 100 mg/day enteric coated aspirin vs placebo in the reduction of CVD events in patients at moderate risk of CHD events (approx 10 - 20% 10 year-risk). This corresponds to a patient population mean 10-year CVD risk of approx 30% based on the underlying assumption at study start.

Protection of trial subjects

The conduct of this clinical study met all local legal and regulatory requirements. The study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and the International Conference on Harmonization guideline E6: Good Clinical Practice. Before entering the study, the informed consent form was read by and explained to all subjects. Participating subjects signed informed consent form and could withdraw from the study at any time without any disadvantage and without having to provide a reason for this decision. Only investigators qualified by training and experience were selected as appropriate experts to investigate the study drug.

Background therapy

Evidence for comparator

Actual start date of recruitment

05 Jul 2007

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

Germany: 3050

Country: Number of subjects enrolled

Ireland: 112

Country: Number of subjects enrolled

Italy: 335

Country: Number of subjects enrolled

Poland: 3095

Country: Number of subjects enrolled

Spain: 412

Country: Number of subjects enrolled

United Kingdom: 5028

Country: Number of subjects enrolled

United States: 514

Worldwide total number of subjects

12546

EEA total number of subjects

12032

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

7029

From 65 to 84 years

5467

85 years and over

Subject disposition

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Recruitment details

The study was conducted at 501 centers in 7 countries between 05 Jul 2007 (first subject first visit) and 15 Nov 2016 (last subject last visit).

Screening details

Overall, 15823 subjects were screened. Of these, 3277 subjects were screening failures. The remaining 12546 subjects were randomized to treatment.

Period 1 title

Overall study (overall period)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

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

Are arms mutually exclusive

Yes

Acetylsalicylic acid (Aspirin, BAYE4465)

Arm description

Subjects received 1 tablet of enteric-coated acetylsalicylic acid [100 milligram (mg)] orally once daily.

Arm type

Experimental

Investigational medicinal product name

Enteric coated acetylsalicylic acid 100 mg tablets

Investigational medicinal product code

Other name

Pharmaceutical forms

Coated tablet

Routes of administration

Oral use

Dosage and administration details

Subjects were instructed to take 1 tablet daily before meals with a large glass of water.

Placebo

Arm description

Subjects received 1 tablets of matching placebo orally once daily.

Arm type

Placebo

Investigational medicinal product name

Matching placebo tablets

Investigational medicinal product code

Other name

Pharmaceutical forms

Coated tablet

Routes of administration

Oral use

Dosage and administration details

Subjects were instructed to take 1 tablet daily before meals with a large glass of water.

Number of subjects in period 1	Acetylsalicylic acid (Aspirin, BAYE4465)	Placebo
Started	6270	6276
Completed	4402	4384
Not completed	1868	1892
Consent withdrawn by subject	817	873
Reason not given	3	1
Non-compliant with study treatment	23	16
Insufficient therapeutic effect	4	5
Adverse Event	129	122
Clinical endpoint reached	110	123
Other	236	239
Death	140	137
Lost to follow-up	210	198
Missing end-of-study page	91	92
Not treated	25	17
Protocol deviation	80	69

Baseline characteristics

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Reporting group title

Acetylsalicylic acid (Aspirin, BAYE4465)

Reporting group description

Subjects received 1 tablet of enteric-coated acetylsalicylic acid [100 milligram (mg)] orally once daily.

Reporting group title

Placebo

Reporting group description

Subjects received 1 tablets of matching placebo orally once daily.

Reporting group values	Acetylsalicylic acid (Aspirin, BAYE4465)	Placebo	Total
Number of subjects	6270	6276
Age Categorical
Units: Subjects
Age Continuous
Units: years
arithmetic mean (standard deviation)	63.9 ± 7.1	63.9 ± 7.05	-
Gender Categorical
Units: Subjects
Female	1851	1857	3708
Male	4419	4419	8838

End points

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Reporting group title

Acetylsalicylic acid (Aspirin, BAYE4465)

Reporting group description

Subjects received 1 tablet of enteric-coated acetylsalicylic acid [100 milligram (mg)] orally once daily.

Reporting group title

Placebo

Reporting group description

Subjects received 1 tablets of matching placebo orally once daily.

Subject analysis set title

Intent-to-treat

Subject analysis set type

Intention-to-treat

Subject analysis set description

The intent-to-treat (ITT) group (N=12546) consists of all patients who were randomized to the assigned study drug.

Subject analysis set title

Per-protocol

Subject analysis set type

Per protocol

Subject analysis set description

Per-protocol (PP) group (N=7702) consists of all patients who had no protocol violation.

Primary: Time to the first occurrence of the composite outcome of MI (myocardial infarction), stroke, cardiovascular death, UA (unstable angina) or TIA (transient ischemic attack)

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End point title

Time to the first occurrence of the composite outcome of MI (myocardial infarction), stroke, cardiovascular death, UA (unstable angina) or TIA (transient ischemic attack)

End point description

The primary efficacy endpoint was a composite outcome consisting of the first occurrence of confirmed MI, stroke, cardiovascular death, UA, TIA. The time to event was defined as the number of days from the date of randomization to the date of the event confirmed by adjudication. The numbers of days for milestones when 1%, 2%, 3% and 4% of the subjects have reached endpoint events were estimated from Kaplan-Meier-Analyses.

End point type

Primary

End point timeframe

Until follow-up (approximate 6 years)

End point values	Acetylsalicylic acid (Aspirin, BAYE4465)	Placebo
Number of subjects analysed	6270 ^[1]	6276 ^[2]
Units: days
number (not applicable)
Days until 1% subjects had an efficacy event	528	381
Days until 2% subjects had an efficacy event	889	796
Days until 3% subjects had an efficacy event	1225	1134
Days until 4% subjects had an efficacy event	1630	1582

Notes
[1] - ITT
[2] - ITT

Statistics for primary composite outcome

Statistical analysis description

Primary efficacy analysis of time to the composite endpoint was conducted via a 2-sided log-rank test stratified for treatment, country, and sex. Results would be considered statistically significant and the primary objective of the study will have been met if the 2-sided P value is ≤0.05.

Comparison groups

Acetylsalicylic acid (Aspirin, BAYE4465) v Placebo

Number of subjects included in analysis

12546

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.597

Method

Logrank

Confidence interval

Secondary: Time to the first occurrence of the composite outcome of cardiovascular death, MI, or stroke (ischemic, hemorrhagic, or unknown)

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End point title

Time to the first occurrence of the composite outcome of cardiovascular death, MI, or stroke (ischemic, hemorrhagic, or unknown)

End point description

The time to Composite outcome consisting of the first occurrence of cardiovascular death, MI, or stroke (ischemic, hemorrhagic, or unknown) was defined as the number of days from the date of randomization to the date of the event confirmed by adjudication. The numbers of days for milestones when 1%, 2%, 3% and 4% of the subjects have reached endpoint events were estimated from Kaplan-Meier-Analyses.

End point type

Secondary

End point timeframe

Until follow-up (approximate 6 years)

End point values	Acetylsalicylic acid (Aspirin, BAYE4465)	Placebo
Number of subjects analysed	6270 ^[3]	6276 ^[4]
Units: Days
number (not applicable)
Days until 1% subjects had an efficacy event	678	522
Days until 2% subjects had an efficacy event	1167	1053
Days until 3% subjects had an efficacy event	1599	1501
Days until 4% subjects had an efficacy event	1949	1930

Notes
[3] - ITT
[4] - ITT

Statistics for secondary composite outcome

Statistical analysis description

Statistics for time to the composite endpoint was conducted via a 2-sided log-rank test stratified for treatment, country, and sex. Results would be considered statistically significant if the 2-sided P value is ≤0.05.

Comparison groups

Placebo v Acetylsalicylic acid (Aspirin, BAYE4465)

Number of subjects included in analysis

12546

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.6125

Method

Logrank

Confidence interval

Secondary: Time to the first occurrence of the individual components of the primary: non-fatal MI, total MI, non-fatal stroke, total stroke, cardiovascular death, UA and TIA

Top of page

End point title

Time to the first occurrence of the individual components of the primary: non-fatal MI, total MI, non-fatal stroke, total stroke, cardiovascular death, UA and TIA

End point description

The time to event was defined as the number of days from the date of randomization to the date of the event confirmed by adjudication. The numbers of days for milestones when 1%, 2%, 3% and 4% of the subjects have reached endpoint events were estimated from Kaplan-Meier-Analyses. "99999" indicates not applicable (NA) because these milestones did not occur before completion of the study.

End point type

Secondary

End point timeframe

Until follow-up (approximately 6 years)

End point values	Acetylsalicylic acid (Aspirin, BAYE4465)	Placebo
Number of subjects analysed	6270 ^[5]	6276 ^[6]
Units: Days
number (not applicable)
Days until 1% subjects had non-fatal MI	1309	1085
Days until 2% subjects had non-fatal MI	99999	2121
Days until 1% subjects had total MI	1216	1014
Days until 2% subjects had total MI	2128	1906
Days until 1% subjects had non-fatal stroke	1576	1650
Days until 2% subjects had non-fatal stroke	99999	99999
Days until 1% subjects had total stroke	1543	1627
Days until 2% subjects had total stroke	99999	99999
Days until 1% subjects had cardiovascular death	99999	99999
Days until 2% subjects had cardiovascular death	99999	99999
Days until 1% subjects had UA	99999	99999
Days until 2% subjects had UA	99999	99999
Days until 1% subjects had TIA	99999	99999
Days until 2% subjects had TIA	99999	99999

Notes
[5] - ITT
[6] - ITT

Statistics for time to non-fatal MI

Statistical analysis description

Statistics for time to non-fatal MI was conducted via a 2-sided log-rank test stratified for treatment, country, and sex. Results would be considered statistically significant if the 2-sided P value is ≤0.05.

Comparison groups

Acetylsalicylic acid (Aspirin, BAYE4465) v Placebo

Number of subjects included in analysis

12546

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.4505

Method

Logrank

Confidence interval

Statistics for time to total MI

Statistical analysis description

Statistics for time to total MI was conducted via a 2-sided log-rank test stratified for treatment, country, and sex. Results would be considered statistically significant if the 2-sided P value is ≤0.05.

Comparison groups

Acetylsalicylic acid (Aspirin, BAYE4465) v Placebo

Number of subjects included in analysis

12546

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.229

Method

Logrank

Confidence interval

Statistics for time to non-fatal stroke

Statistical analysis description

Statistics for time to non-fatal stroke was conducted via a 2-sided log-rank test stratified for treatment, country, and sex. Results would be considered statistically significant if the 2-sided P value is ≤0.05.

Comparison groups

Placebo v Acetylsalicylic acid (Aspirin, BAYE4465)

Number of subjects included in analysis

12546

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.3947

Method

Logrank

Confidence interval

Statistics for time to total stroke

Statistical analysis description

Statistics for time to total stroke was conducted via a 2-sided log-rank test stratified for treatment, country, and sex. Results would be considered statistically significant if the 2-sided P value is ≤0.05.

Comparison groups

Acetylsalicylic acid (Aspirin, BAYE4465) v Placebo

Number of subjects included in analysis

12546

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.5125

Method

Logrank

Confidence interval

Secondary: Time to all-cause mortality, the first occurrence of all cancers excluding non-melanoma skin cancer (NMSC) and the first occurrence of colon cancer

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End point title

Time to all-cause mortality, the first occurrence of all cancers excluding non-melanoma skin cancer (NMSC) and the first occurrence of colon cancer

End point description

End point type

Secondary

End point timeframe

Until follow-up (approximately 6 years)

End point values	Acetylsalicylic acid (Aspirin, BAYE4465)	Placebo
Number of subjects analysed	6270 ^[7]	6276 ^[8]
Units: Days
number (not applicable)
Days until 1% subjects had all-cause mortality	838	938
Days until 2% subjects had all-cause mortality	1493	1460
Days until 3% subjects had all-cause mortality	1970	1963
Days until 4% subjects had all-cause mortality	99999	99999
Days until 1% subjects had all cancer excl. NMSC	374	420
Days until 2% subjects had all cancer excl. NMSC	849	805
Days until 3% subjects had all cancer excl. NMSC	1164	1276
Days until 4% subjects had all cancer excl. NMSC	1542	1751
Days until 1% subjects had colon cancer	99999	99999
Days until 2% subjects had colon cancer	99999	99999
Days until 3% subjects had colon cancer	99999	99999
Days until 4% subjects had colon cancer	99999	99999

Notes
[7] - ITT
[8] - ITT

Statistics for time to all-cause mortality

Statistical analysis description

Analysis of time to all-cause mortality was conducted via a 2-sided log-rank test stratified for treatment, country, and sex. Results would be considered statistically significant if the 2-sided P value is ≤0.05.

Comparison groups

Acetylsalicylic acid (Aspirin, BAYE4465) v Placebo

Number of subjects included in analysis

12546

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.9544

Method

Logrank

Confidence interval

Statistics for time to 1st occurance colon cancer

Statistical analysis description

Analysis of time to the first occurance colon cancer was conducted via a 2-sided log-rank test stratified for treatment, country, and sex. Results would be considered statistically significant if the 2-sided P value is ≤0.05.

Comparison groups

Acetylsalicylic acid (Aspirin, BAYE4465) v Placebo

Number of subjects included in analysis

12546

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.611

Method

Logrank

Confidence interval

Statistics for the first occurrence of all cancers

Statistical analysis description

Analysis of time to the first occurrence of all cancers excluding non-melanoma skin cancer was conducted via a 2-sided log-rank test stratified for treatment, country, and sex. Results would be considered statistically significant if the 2-sided P value is ≤0.05.

Comparison groups

Acetylsalicylic acid (Aspirin, BAYE4465) v Placebo

Number of subjects included in analysis

12546

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.4422

Method

Logrank

Confidence interval

Secondary: Incidence of all-cause mortality, all cancers excluding non-melanoma skin cancer and colon cancer

Top of page

End point title

Incidence of all-cause mortality, all cancers excluding non-melanoma skin cancer and colon cancer

End point description

End point type

Secondary

End point timeframe

Until follow-up (approximately 6 years)

End point values	Acetylsalicylic acid (Aspirin, BAYE4465)	Placebo
Number of subjects analysed	6270 ^[9]	6276 ^[10]
Units: Percentage of subjects
number (not applicable)
all-cause mortality	2.55	2.57
all cancers excluding non-melanoma skin cancer	4.02	3.76
colon cancer	0.48	0.41

Notes
[9] - ITT
[10] - ITT

Statistics for all-cause mortality

Statistical analysis description

Analysis of incidence of all-cause mortality was conducted via a 2-sided log-rank test. Results would be considered statistically significant if the 2-sided P value is ≤0.05.

Comparison groups

Acetylsalicylic acid (Aspirin, BAYE4465) v Placebo

Number of subjects included in analysis

12546

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.9459

Method

Logrank

Parameter type

Cox proportional hazard

Point estimate

0.99

Confidence interval

level

95%

sides

2-sided

lower limit

0.8

upper limit

1.24

Secondary: Incidence of confirmed MI, stroke, cardiovascular death, UA and TIA separately

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End point title

Incidence of confirmed MI, stroke, cardiovascular death, UA and TIA separately

End point description

The percentages of subjects with the efficacy endpoints of confirmed MI, stroke, cardiovascular death, UA and TIA are reported separately. *all other CV death without fatal MI and fatal stroke

End point type

Secondary

End point timeframe

Until follow-up (approximately 6 years)

End point values	Acetylsalicylic acid (Aspirin, BAYE4465)	Placebo
Number of subjects analysed	6270 ^[11]	6276 ^[12]
Units: Percentage of subjects
number (not applicable)
MI	1.52	1.78
stroke	1.20	1.07
CV death*	0.61	0.62
UA	0.32	0.32
TIA	0.67	0.72

Notes
[11] - ITT
[12] - ITT

Statistics for MI

Statistical analysis description

Analysis of incidence of MI was conducted via a 2-sided log-rank test. Results would be considered statistically significant if the 2-sided P value is ≤0.05.

Comparison groups

Acetylsalicylic acid (Aspirin, BAYE4465) v Placebo

Number of subjects included in analysis

12546

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.2325

Method

Logrank

Parameter type

Cox proportional hazard

Point estimate

0.85

Confidence interval

level

95%

sides

2-sided

lower limit

0.64

upper limit

1.11

Statistics for stroke

Statistical analysis description

Analysis of incidence of stroke was conducted via a 2-sided log-rank test. Results would be considered statistically significant if the 2-sided P value is ≤0.05.

Comparison groups

Acetylsalicylic acid (Aspirin, BAYE4465) v Placebo

Number of subjects included in analysis

12546

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.5072

Method

Logrank

Parameter type

Cox proportional hazard

Point estimate

1.12

Confidence interval

level

95%

sides

2-sided

lower limit

0.8

upper limit

1.55

Statistics for cardiovascular death

Statistical analysis description

Analysis of incidence of cardiovascular death was conducted via a 2-sided log-rank test. Results would be considered statistically significant if the 2-sided P value is ≤0.05.

Comparison groups

Acetylsalicylic acid (Aspirin, BAYE4465) v Placebo

Number of subjects included in analysis

12546

Analysis specification

Pre-specified

Analysis type

other ^[13]

P-value

= 0.901

Method

Logrank

Parameter type

Cox proportional hazard

Point estimate

0.97

Confidence interval

level

95%

sides

2-sided

lower limit

0.62

upper limit

1.52

Notes
[13] - Analysis of incidence of cardiovascular death was conducted via a 2-sided log-rank test. Results would be considered statistically significant if the 2-sided P value is ≤0.05.

Statistics for UA

Statistical analysis description

Analysis of incidence of UA was conducted via a 2-sided log-rank test. Results would be considered statistically significant if the 2-sided P value is ≤0.05.

Comparison groups

Acetylsalicylic acid (Aspirin, BAYE4465) v Placebo

Number of subjects included in analysis

12546

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.9979

Method

Logrank

Parameter type

Cox proportional hazard

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

0.54

upper limit

1.86

Statistics for TIA

Statistical analysis description

Analysis of incidence of TIA was conducted via a 2-sided log-rank test. Results would be considered statistically significant if the 2-sided P value is ≤0.05.

Comparison groups

Acetylsalicylic acid (Aspirin, BAYE4465) v Placebo

Number of subjects included in analysis

12546

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.7455

Method

Logrank

Parameter type

Cox proportional hazard

Point estimate

0.93

Confidence interval

level

95%

sides

2-sided

lower limit

0.61

upper limit

1.42

Other pre-specified: Number of subjects with adjudicated GI bleeding by severity

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End point title

Number of subjects with adjudicated GI bleeding by severity

End point description

End point type

Other pre-specified

End point timeframe

Until follow-up (approximate 6 years)

End point values	Acetylsalicylic acid (Aspirin, BAYE4465)	Placebo
Number of subjects analysed	6270 ^[14]	6276 ^[15]
Units: Subjects
Total	61	29
Mild	42	22
Moderate	15	5
Severe	4	2

Notes
[14] - ITT
[15] - ITT

No statistical analyses for this end point

Other pre-specified: Incidence of Composite outcomes and non-fatal MI

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End point title

Incidence of Composite outcomes and non-fatal MI

End point description

End point type

Other pre-specified

End point timeframe

Until follow-up (approximate 6 years)

End point values	Acetylsalicylic acid (Aspirin, BAYE4465)	Placebo
Number of subjects analysed	6270 ^[16]	6276 ^[17]
Units: Percentage of subjects
number (not applicable)
MI, stroke, CV death, UA or TIA	4.29	4.48
MI, stroke or CV death	3.32	3.47
non-fatal MI	1.40	1.56

Notes
[16] - ITT
[17] - ITT

Statistics for composite outcome

Statistical analysis description

Analysis of incidence of composite outcome of MI, stroke, CV death, UA or TIA was conducted via a 2-sided log-rank test. Results would be considered statistically significant if the 2-sided P value is ≤0.05.

Comparison groups

Acetylsalicylic acid (Aspirin, BAYE4465) v Placebo

Number of subjects included in analysis

12546

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.6038

Method

Logrank

Parameter type

Cox proportional hazard

Point estimate

0.96

Confidence interval

level

95%

sides

2-sided

lower limit

0.81

upper limit

1.13

Statistics for composite outcome

Statistical analysis description

Analysis of incidence of composite outcome of MI, stroke or CV death was conducted via a 2-sided log-rank test. Results would be considered statistically significant if the 2-sided P value is ≤0.05.

Comparison groups

Acetylsalicylic acid (Aspirin, BAYE4465) v Placebo

Number of subjects included in analysis

12546

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.619

Method

Logrank

Parameter type

Cox proportional hazard

Point estimate

0.95

Confidence interval

level

95%

sides

2-sided

lower limit

0.79

upper limit

1.15

Statistics for non-fatal MI

Statistical analysis description

Analysis of incidence of non-fatal MI was conducted via a 2-sided log-rank test. Results would be considered statistically significant if the 2-sided P value is ≤0.05.

Comparison groups

Acetylsalicylic acid (Aspirin, BAYE4465) v Placebo

Number of subjects included in analysis

12546

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.4562

Method

Logrank

Parameter type

Cox proportional hazard

Point estimate

0.9

Confidence interval

level

95%

sides

2-sided

lower limit

0.67

upper limit

1.2

Other pre-specified: Incidence of Composite outcomes and individual outcomes in per-protocol population

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End point title

Incidence of Composite outcomes and individual outcomes in per-protocol population

End point description

*all other CV death without fatal MI and fatal stroke

End point type

Other pre-specified

End point timeframe

Until follow-up (approximate 6 years)

End point values	Acetylsalicylic acid (Aspirin, BAYE4465)	Placebo
Number of subjects analysed	3790 ^[18]	3912 ^[19]
Units: Percentage of subjects
number (not applicable)
MI, stroke, CV death, UA or TIA	3.40	4.19
MI, stroke or CV death	2.72	3.45
MI	0.98	1.84
Non-fatal MI	0.84	1.53
Stroke	1.06	0.95
CV death*	0.69	0.66
UA	0.21	0.28
TIA	0.50	0.49
All-cause mortality	2.85	2.58

Notes
[18] - PP
[19] - PP

Statistics for composite outcome

Statistical analysis description

Comparison groups

Acetylsalicylic acid (Aspirin, BAYE4465) v Placebo

Number of subjects included in analysis

7702

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.0756

Method

Logrank

Parameter type

Cox proportional hazard

Point estimate

0.81

Confidence interval

level

95%

sides

2-sided

lower limit

0.64

upper limit

1.02

Statistics for composite outcome

Statistical analysis description

Comparison groups

Acetylsalicylic acid (Aspirin, BAYE4465) v Placebo

Number of subjects included in analysis

7702

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.0661

Method

Logrank

Parameter type

Cox proportional hazard

Point estimate

0.79

Confidence interval

level

95%

sides

2-sided

lower limit

0.61

upper limit

1.02

Statistics for MI

Statistical analysis description

Analysis of incidence of MI was conducted via a 2-sided log-rank test. Results would be considered statistically significant if the 2-sided P value is ≤0.05.

Comparison groups

Acetylsalicylic acid (Aspirin, BAYE4465) v Placebo

Number of subjects included in analysis

7702

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.0014

Method

Logrank

Parameter type

Cox proportional hazard

Point estimate

0.53

Confidence interval

level

95%

sides

2-sided

lower limit

0.36

upper limit

0.79

Statistics for non-fatal MI

Statistical analysis description

Analysis of incidence of non-fatal MI was conducted via a 2-sided log-rank test. Results would be considered statistically significant if the 2-sided P value is ≤0.05.

Comparison groups

Acetylsalicylic acid (Aspirin, BAYE4465) v Placebo

Number of subjects included in analysis

7702

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.0056

Method

Logrank

Parameter type

Cox proportional hazard

Point estimate

0.55

Confidence interval

level

95%

sides

2-sided

lower limit

0.36

upper limit

0.84

Statistics for stroke

Statistical analysis description

Analysis of incidence of stroke was conducted via a 2-sided log-rank test. Results would be considered statistically significant if the 2-sided P value is ≤0.05.

Comparison groups

Acetylsalicylic acid (Aspirin, BAYE4465) v Placebo

Number of subjects included in analysis

7702

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.6291

Method

Logrank

Parameter type

Cox proportional hazard

Point estimate

1.12

Confidence interval

level

95%

sides

2-sided

lower limit

0.71

upper limit

1.75

Statistics for CV death

Statistical analysis description

Analysis of incidence of CV death was conducted via a 2-sided log-rank test. Results would be considered statistically significant if the 2-sided P value is ≤0.05.

Comparison groups

Acetylsalicylic acid (Aspirin, BAYE4465) v Placebo

Number of subjects included in analysis

7702

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.9161

Method

Logrank

Parameter type

Cox proportional hazard

Point estimate

1.03

Confidence interval

level

95%

sides

2-sided

lower limit

0.6

upper limit

1.77

Statistics for UA

Statistical analysis description

Analysis of incidence of UA was conducted via a 2-sided log-rank test. Results would be considered statistically significant if the 2-sided P value is ≤0.05.

Comparison groups

Acetylsalicylic acid (Aspirin, BAYE4465) v Placebo

Number of subjects included in analysis

7702

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.538

Method

Logrank

Parameter type

Cox proportional hazard

Point estimate

0.75

Confidence interval

level

95%

sides

2-sided

lower limit

0.3

upper limit

1.87

Statistics for TIA

Statistical analysis description

Analysis of incidence of TIA was conducted via a 2-sided log-rank test. Results would be considered statistically significant if the 2-sided P value is ≤0.05.

Comparison groups

Acetylsalicylic acid (Aspirin, BAYE4465) v Placebo

Number of subjects included in analysis

7702

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.9181

Method

Logrank

Parameter type

Cox proportional hazard

Point estimate

1.03

Confidence interval

level

95%

sides

2-sided

lower limit

0.55

upper limit

1.95

Statistics for all-cause mortality

Statistical analysis description

Analysis of incidence of all-cause mortality was conducted via a 2-sided log-rank test. Results would be considered statistically significant if the 2-sided P value is ≤0.05.

Comparison groups

Acetylsalicylic acid (Aspirin, BAYE4465) v Placebo

Number of subjects included in analysis

7702

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.4796

Method

Logrank

Parameter type

Cox proportional hazard

Point estimate

1.1

Confidence interval

level

95%

sides

2-sided

lower limit

0.84

upper limit

1.45

Adverse events

Top of page

Timeframe for reporting adverse events

Until follow-up (approximately 6 years)

Assessment type

Non-systematic

Dictionary name

MedDRA

Dictionary version

Reporting group title

Acetylsalicylic Acid

Reporting group description

Subjects received 1 tablet of enteric-coated acetylsalicylic acid [100 milligram (mg)] orally one daily.

Reporting group title

Placebo

Reporting group description

Subjects received 1 tablet of matching placebo orally one daily.

Serious adverse events	Acetylsalicylic Acid	Placebo
Total subjects affected by serious adverse events
subjects affected / exposed	1266 / 6270 (20.19%)	1311 / 6276 (20.89%)
number of deaths (all causes)	160	161
number of deaths resulting from adverse events	81	78
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acoustic neuroma
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Adenocarcinoma
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Adenocarcinoma gastric
subjects affected / exposed	0 / 6270 (0.00%)	2 / 6276 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 1
Adenocarcinoma of colon
subjects affected / exposed	6 / 6270 (0.10%)	6 / 6276 (0.10%)
occurrences causally related to treatment / all	0 / 6	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Adenocarcinoma pancreas
subjects affected / exposed	1 / 6270 (0.02%)	2 / 6276 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 1	0 / 1
Adenolymphoma
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Adenoma benign
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Adrenal adenoma
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Adrenal gland cancer metastatic
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Adrenocortical carcinoma
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Ameloblastoma
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Atypical fibroxanthoma
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
B-cell lymphoma
subjects affected / exposed	1 / 6270 (0.02%)	2 / 6276 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
B-cell lymphoma stage IV
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
B-cell unclassifiable lymphoma high grade
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (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	2 / 6270 (0.03%)	7 / 6276 (0.11%)
occurrences causally related to treatment / all	0 / 2	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
Basosquamous carcinoma of skin
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Benign anorectal neoplasm
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Benign lung neoplasm
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Benign mediastinal neoplasm
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Benign neoplasm of testis
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Benign neoplasm of thyroid gland
subjects affected / exposed	1 / 6270 (0.02%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Benign ovarian tumour
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Benign pancreatic neoplasm
subjects affected / exposed	0 / 6270 (0.00%)	2 / 6276 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Benign salivary gland neoplasm
subjects affected / exposed	2 / 6270 (0.03%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Bladder cancer
subjects affected / exposed	6 / 6270 (0.10%)	7 / 6276 (0.11%)
occurrences causally related to treatment / all	0 / 6	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 1
Bladder neoplasm
subjects affected / exposed	4 / 6270 (0.06%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 4	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Bladder papilloma
subjects affected / exposed	3 / 6270 (0.05%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Bladder transitional cell carcinoma
subjects affected / exposed	9 / 6270 (0.14%)	10 / 6276 (0.16%)
occurrences causally related to treatment / all	0 / 10	0 / 12
deaths causally related to treatment / all	0 / 0	0 / 0
Bladder transitional cell carcinoma metastatic
subjects affected / exposed	2 / 6270 (0.03%)	0 / 6276 (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 recurrent
subjects affected / exposed	3 / 6270 (0.05%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Bladder transitional cell carcinoma stage I
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Bowen's disease
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Brain cancer metastatic
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Brain neoplasm
subjects affected / exposed	1 / 6270 (0.02%)	2 / 6276 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 1
Brain neoplasm malignant
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Breast cancer
subjects affected / exposed	10 / 6270 (0.16%)	7 / 6276 (0.11%)
occurrences causally related to treatment / all	0 / 10	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
Breast cancer metastatic
subjects affected / exposed	4 / 6270 (0.06%)	2 / 6276 (0.03%)
occurrences causally related to treatment / all	0 / 4	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Breast neoplasm
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Bronchial carcinoma
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Carcinoid tumour of the caecum
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
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	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cervix carcinoma
subjects affected / exposed	1 / 6270 (0.02%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Chondroma
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Choroid melanoma
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Chronic lymphocytic leukaemia
subjects affected / exposed	4 / 6270 (0.06%)	4 / 6276 (0.06%)
occurrences causally related to treatment / all	0 / 5	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Clear cell renal cell carcinoma
subjects affected / exposed	2 / 6270 (0.03%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Colon adenoma
subjects affected / exposed	2 / 6270 (0.03%)	5 / 6276 (0.08%)
occurrences causally related to treatment / all	0 / 2	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Colon cancer
subjects affected / exposed	14 / 6270 (0.22%)	6 / 6276 (0.10%)
occurrences causally related to treatment / all	0 / 14	0 / 6
deaths causally related to treatment / all	0 / 2	0 / 1
Colon cancer metastatic
subjects affected / exposed	4 / 6270 (0.06%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 4	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Colon neoplasm
subjects affected / exposed	1 / 6270 (0.02%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Colorectal cancer
subjects affected / exposed	1 / 6270 (0.02%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Colorectal cancer metastatic
subjects affected / exposed	0 / 6270 (0.00%)	2 / 6276 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 2
Diffuse large B-cell lymphoma stage III
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
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	2 / 6270 (0.03%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Extraskeletal myxoid chondrosarcoma
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Fibroma
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastric cancer
subjects affected / exposed	3 / 6270 (0.05%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal cancer metastatic
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal carcinoma
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal neoplasm
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal stromal cancer
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Gastrointestinal stromal tumour
subjects affected / exposed	1 / 6270 (0.02%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal tract adenoma
subjects affected / exposed	0 / 6270 (0.00%)	2 / 6276 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Glottis carcinoma
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Haemangioma
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatic cancer
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Hepatic cancer metastatic
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Hepatocellular carcinoma
subjects affected / exposed	1 / 6270 (0.02%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hodgkin's disease
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Insulinoma
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Intracranial haemangioma
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Intraocular melanoma
subjects affected / exposed	1 / 6270 (0.02%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Invasive breast carcinoma
subjects affected / exposed	1 / 6270 (0.02%)	2 / 6276 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Invasive ductal breast carcinoma
subjects affected / exposed	5 / 6270 (0.08%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 5	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Laryngeal cancer
subjects affected / exposed	2 / 6270 (0.03%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Laryngeal cancer metastatic
subjects affected / exposed	1 / 6270 (0.02%)	2 / 6276 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 1	0 / 0
Laryngeal squamous cell carcinoma
subjects affected / exposed	0 / 6270 (0.00%)	2 / 6276 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Leiomyoma
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Lentigo maligna
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Lentigo maligna recurrent
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Lip squamous cell carcinoma
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Lipoma
subjects affected / exposed	2 / 6270 (0.03%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Liposarcoma
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Lung adenocarcinoma
subjects affected / exposed	2 / 6270 (0.03%)	2 / 6276 (0.03%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 2	0 / 0
Lung adenocarcinoma metastatic
subjects affected / exposed	1 / 6270 (0.02%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 1
Lung adenocarcinoma stage I
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Lung cancer metastatic
subjects affected / exposed	4 / 6270 (0.06%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 4	0 / 0
deaths causally related to treatment / all	0 / 3	0 / 0
Lung carcinoma cell type unspecified recurrent
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Lung neoplasm
subjects affected / exposed	1 / 6270 (0.02%)	1 / 6276 (0.02%)
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	10 / 6270 (0.16%)	3 / 6276 (0.05%)
occurrences causally related to treatment / all	0 / 10	0 / 3
deaths causally related to treatment / all	0 / 1	0 / 1
Lung squamous cell carcinoma metastatic
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Lymphangiosis carcinomatosa
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Malignant melanoma
subjects affected / exposed	9 / 6270 (0.14%)	4 / 6276 (0.06%)
occurrences causally related to treatment / all	0 / 9	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Malignant neoplasm of ampulla of Vater
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Malignant neoplasm of pleura metastatic
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Malignant neoplasm of unknown primary site
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Malignant nipple neoplasm
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Malignant pleural effusion
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Mantle cell lymphoma
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Melanoma recurrent
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Meningioma
subjects affected / exposed	2 / 6270 (0.03%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Meningioma benign
subjects affected / exposed	1 / 6270 (0.02%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Mesothelioma malignant
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Metastases to bone
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Metastases to central nervous system
subjects affected / exposed	0 / 6270 (0.00%)	2 / 6276 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 1
Metastases to liver
subjects affected / exposed	4 / 6270 (0.06%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 4	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 1
Metastases to lung
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Metastases to lymph nodes
subjects affected / exposed	0 / 6270 (0.00%)	2 / 6276 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Metastases to pleura
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Metastases to spine
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Metastatic bronchial carcinoma
subjects affected / exposed	3 / 6270 (0.05%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 3	0 / 0
Metastatic gastric cancer
subjects affected / exposed	1 / 6270 (0.02%)	3 / 6276 (0.05%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Metastatic malignant melanoma
subjects affected / exposed	3 / 6270 (0.05%)	2 / 6276 (0.03%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Metastatic neoplasm
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Metastatic renal cell carcinoma
subjects affected / exposed	2 / 6270 (0.03%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 2	0 / 0
Metastatic squamous cell carcinoma
subjects affected / exposed	0 / 6270 (0.00%)	2 / 6276 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 1
Mixed hepatocellular cholangiocarcinoma
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Myelodysplastic syndrome
subjects affected / exposed	0 / 6270 (0.00%)	2 / 6276 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Myxofibrosarcoma
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Neoplasm
subjects affected / exposed	2 / 6270 (0.03%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Neoplasm malignant
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Neoplasm prostate
subjects affected / exposed	1 / 6270 (0.02%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Neuroendocrine carcinoma of the skin
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Neurofibroma
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Non-Hodgkin's lymphoma stage II
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Non-small cell lung cancer
subjects affected / exposed	3 / 6270 (0.05%)	6 / 6276 (0.10%)
occurrences causally related to treatment / all	0 / 3	0 / 6
deaths causally related to treatment / all	0 / 1	0 / 2
Non-small cell lung cancer stage IIIB
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Non-small cell lung cancer stage IV
subjects affected / exposed	0 / 6270 (0.00%)	2 / 6276 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 1
Oesophageal adenocarcinoma
subjects affected / exposed	1 / 6270 (0.02%)	2 / 6276 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Oesophageal cancer metastatic
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Oesophageal carcinoma
subjects affected / exposed	1 / 6270 (0.02%)	2 / 6276 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 1
Oesophageal squamous cell carcinoma
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Oropharyngeal squamous cell carcinoma
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Osteosarcoma
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Ovarian adenoma
subjects affected / exposed	2 / 6270 (0.03%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Ovarian cancer
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Ovarian epithelial cancer metastatic
subjects affected / exposed	1 / 6270 (0.02%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 1
Pancreatic carcinoma
subjects affected / exposed	1 / 6270 (0.02%)	4 / 6276 (0.06%)
occurrences causally related to treatment / all	0 / 1	0 / 4
deaths causally related to treatment / all	0 / 1	0 / 3
Pancreatic carcinoma metastatic
subjects affected / exposed	3 / 6270 (0.05%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 1
Papillary cystadenoma lymphomatosum
subjects affected / exposed	1 / 6270 (0.02%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Papillary thyroid cancer
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Paraproteinaemia
subjects affected / exposed	1 / 6270 (0.02%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Parathyroid tumour benign
subjects affected / exposed	2 / 6270 (0.03%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pituitary tumour benign
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pleural mesothelioma
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Pleural mesothelioma malignant
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Prostate cancer
subjects affected / exposed	59 / 6270 (0.94%)	44 / 6276 (0.70%)
occurrences causally related to treatment / all	0 / 59	0 / 45
deaths causally related to treatment / all	0 / 0	0 / 0
Prostate cancer metastatic
subjects affected / exposed	4 / 6270 (0.06%)	2 / 6276 (0.03%)
occurrences causally related to treatment / all	0 / 4	0 / 2
deaths causally related to treatment / all	0 / 1	0 / 1
Prostate cancer recurrent
subjects affected / exposed	1 / 6270 (0.02%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Prostate cancer stage 0
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Prostate cancer stage I
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Prostate cancer stage III
subjects affected / exposed	1 / 6270 (0.02%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Prostatic adenoma
subjects affected / exposed	5 / 6270 (0.08%)	8 / 6276 (0.13%)
occurrences causally related to treatment / all	0 / 5	0 / 8
deaths causally related to treatment / all	0 / 0	0 / 0
Rectal adenocarcinoma
subjects affected / exposed	2 / 6270 (0.03%)	6 / 6276 (0.10%)
occurrences causally related to treatment / all	0 / 2	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Rectal cancer
subjects affected / exposed	2 / 6270 (0.03%)	4 / 6276 (0.06%)
occurrences causally related to treatment / all	0 / 2	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Rectal cancer metastatic
subjects affected / exposed	1 / 6270 (0.02%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Rectosigmoid cancer
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Rectosigmoid cancer metastatic
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Renal cancer
subjects affected / exposed	3 / 6270 (0.05%)	2 / 6276 (0.03%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Renal cancer metastatic
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Renal cell carcinoma
subjects affected / exposed	1 / 6270 (0.02%)	5 / 6276 (0.08%)
occurrences causally related to treatment / all	0 / 1	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Renal neoplasm
subjects affected / exposed	1 / 6270 (0.02%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Retroperitoneal neoplasm
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Sinonasal papilloma
subjects affected / exposed	1 / 6270 (0.02%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Small cell lung cancer
subjects affected / exposed	1 / 6270 (0.02%)	4 / 6276 (0.06%)
occurrences causally related to treatment / all	0 / 1	0 / 4
deaths causally related to treatment / all	0 / 1	0 / 2
Small cell lung cancer metastatic
subjects affected / exposed	1 / 6270 (0.02%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 1
Small intestine adenocarcinoma
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Soft tissue neoplasm
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Squamous cell carcinoma
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Squamous cell carcinoma of skin
subjects affected / exposed	1 / 6270 (0.02%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Squamous cell carcinoma of lung
subjects affected / exposed	1 / 6270 (0.02%)	2 / 6276 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Squamous cell carcinoma of the oral cavity
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (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 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Superficial spreading melanoma stage unspecified
subjects affected / exposed	0 / 6270 (0.00%)	2 / 6276 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Throat cancer
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Thymoma
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Thyroid adenoma
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Thyroid cancer metastatic
subjects affected / exposed	1 / 6270 (0.02%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 1
Tongue cancer metastatic
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
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 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Tonsil cancer
subjects affected / exposed	2 / 6270 (0.03%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Transitional cell cancer of the renal pelvis and ureter
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Transitional cell carcinoma
subjects affected / exposed	2 / 6270 (0.03%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Urinary bladder adenoma
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Uterine cancer
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Uterine leiomyoma
subjects affected / exposed	2 / 6270 (0.03%)	3 / 6276 (0.05%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Uterine neoplasm
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Vascular disorders
Aortic aneurysm
subjects affected / exposed	10 / 6270 (0.16%)	6 / 6276 (0.10%)
occurrences causally related to treatment / all	0 / 10	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Aortic aneurysm rupture
subjects affected / exposed	2 / 6270 (0.03%)	2 / 6276 (0.03%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 2	0 / 0
Aortic dilatation
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Aortic dissection
subjects affected / exposed	0 / 6270 (0.00%)	2 / 6276 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 1
Aortic stenosis
subjects affected / exposed	0 / 6270 (0.00%)	4 / 6276 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Arterial rupture
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Arteriosclerosis
subjects affected / exposed	0 / 6270 (0.00%)	2 / 6276 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 1
Bleeding varicose vein
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Circulatory collapse
subjects affected / exposed	4 / 6270 (0.06%)	3 / 6276 (0.05%)
occurrences causally related to treatment / all	0 / 4	1 / 3
deaths causally related to treatment / all	0 / 1	0 / 0
Deep vein thrombosis
subjects affected / exposed	5 / 6270 (0.08%)	8 / 6276 (0.13%)
occurrences causally related to treatment / all	0 / 5	0 / 8
deaths causally related to treatment / all	0 / 0	0 / 0
Dry gangrene
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Granulomatosis with polyangiitis
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Haematoma
subjects affected / exposed	1 / 6270 (0.02%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hypertension
subjects affected / exposed	3 / 6270 (0.05%)	8 / 6276 (0.13%)
occurrences causally related to treatment / all	0 / 3	0 / 8
deaths causally related to treatment / all	0 / 0	0 / 0
Hypertensive crisis
subjects affected / exposed	8 / 6270 (0.13%)	11 / 6276 (0.18%)
occurrences causally related to treatment / all	0 / 10	0 / 12
deaths causally related to treatment / all	0 / 0	0 / 0
Hypotension
subjects affected / exposed	3 / 6270 (0.05%)	3 / 6276 (0.05%)
occurrences causally related to treatment / all	0 / 3	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Hypovolaemic shock
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Iliac artery occlusion
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Intermittent claudication
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Labile hypertension
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Leriche syndrome
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Lymphoedema
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Malignant hypertension
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Orthostatic hypotension
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Peripheral arterial occlusive disease
subjects affected / exposed	5 / 6270 (0.08%)	12 / 6276 (0.19%)
occurrences causally related to treatment / all	0 / 6	0 / 12
deaths causally related to treatment / all	0 / 0	0 / 0
Peripheral artery aneurysm
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Peripheral artery occlusion
subjects affected / exposed	1 / 6270 (0.02%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Peripheral artery stenosis
subjects affected / exposed	1 / 6270 (0.02%)	2 / 6276 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Peripheral ischaemia
subjects affected / exposed	1 / 6270 (0.02%)	3 / 6276 (0.05%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Peripheral vascular disorder
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Peripheral venous disease
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Temporal arteritis
subjects affected / exposed	2 / 6270 (0.03%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Thrombophlebitis
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Thrombosed varicose vein
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Varicose vein
subjects affected / exposed	5 / 6270 (0.08%)	8 / 6276 (0.13%)
occurrences causally related to treatment / all	0 / 5	0 / 9
deaths causally related to treatment / all	0 / 0	0 / 0
Vasculitis
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Venous thrombosis
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
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 / 6270 (0.02%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Surgical and medical procedures
Arthrodesis
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac pacemaker insertion
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Dental operation
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Elbow operation
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hip arthroplasty
subjects affected / exposed	3 / 6270 (0.05%)	4 / 6276 (0.06%)
occurrences causally related to treatment / all	0 / 3	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Hip surgery
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Inguinal hernia repair
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Joint dislocation reduction
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Knee arthroplasty
subjects affected / exposed	0 / 6270 (0.00%)	4 / 6276 (0.06%)
occurrences causally related to treatment / all	0 / 0	1 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Knee operation
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Nephrectomy
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Parotidectomy
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Prostatic operation
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Removal of internal fixation
subjects affected / exposed	1 / 6270 (0.02%)	2 / 6276 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Spinal fusion surgery
subjects affected / exposed	1 / 6270 (0.02%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Thyroidectomy
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Transurethral prostatectomy
subjects affected / exposed	2 / 6270 (0.03%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Tympanoplasty
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Vaginal prolapse repair
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
General disorders and administration site conditions
Chest discomfort
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Chest pain
subjects affected / exposed	23 / 6270 (0.37%)	19 / 6276 (0.30%)
occurrences causally related to treatment / all	0 / 24	0 / 19
deaths causally related to treatment / all	0 / 0	0 / 0
Death
subjects affected / exposed	3 / 6270 (0.05%)	3 / 6276 (0.05%)
occurrences causally related to treatment / all	0 / 3	0 / 3
deaths causally related to treatment / all	0 / 3	0 / 3
Feeling abnormal
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hernia
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Impaired healing
subjects affected / exposed	1 / 6270 (0.02%)	2 / 6276 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Injection site injury
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Malaise
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Medical device pain
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
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	2 / 6270 (0.03%)	3 / 6276 (0.05%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 2	0 / 2
Non-cardiac chest pain
subjects affected / exposed	2 / 6270 (0.03%)	2 / 6276 (0.03%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Oedema
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Oedema peripheral
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Organ failure
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Performance status decreased
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Peripheral swelling
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (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	2 / 6270 (0.03%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Sudden cardiac death
subjects affected / exposed	2 / 6270 (0.03%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 2	0 / 1
Sudden death
subjects affected / exposed	1 / 6270 (0.02%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 1
Systemic inflammatory response syndrome
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Unevaluable event
subjects affected / exposed	2 / 6270 (0.03%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Vascular stent occlusion
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Vascular stent thrombosis
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Immune system disorders
Allergy to arthropod sting
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Anaphylactic reaction
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Drug hypersensitivity
subjects affected / exposed	1 / 6270 (0.02%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Reproductive system and breast disorders
Benign prostatic hyperplasia
subjects affected / exposed	10 / 6270 (0.16%)	20 / 6276 (0.32%)
occurrences causally related to treatment / all	0 / 10	0 / 20
deaths causally related to treatment / all	0 / 0	0 / 0
Breast enlargement
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Colpocele
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Epididymal cyst
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Erectile dysfunction
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gynaecomastia
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Ovarian cyst
subjects affected / exposed	0 / 6270 (0.00%)	3 / 6276 (0.05%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Postmenopausal haemorrhage
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Prostatic cyst
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Prostatic disorder
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Prostatic obstruction
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Prostatism
subjects affected / exposed	4 / 6270 (0.06%)	2 / 6276 (0.03%)
occurrences causally related to treatment / all	0 / 4	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Prostatitis
subjects affected / exposed	2 / 6270 (0.03%)	2 / 6276 (0.03%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Prostatomegaly
subjects affected / exposed	4 / 6270 (0.06%)	2 / 6276 (0.03%)
occurrences causally related to treatment / all	0 / 4	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Rectocele
subjects affected / exposed	2 / 6270 (0.03%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Testicular disorder
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Testis discomfort
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (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	3 / 6270 (0.05%)	2 / 6276 (0.03%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Uterovaginal prolapse
subjects affected / exposed	1 / 6270 (0.02%)	2 / 6276 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Vaginal haematoma
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Vaginal prolapse
subjects affected / exposed	5 / 6270 (0.08%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 5	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
subjects affected / exposed	1 / 6270 (0.02%)	2 / 6276 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 1	0 / 0
Asphyxia
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Asthma
subjects affected / exposed	2 / 6270 (0.03%)	3 / 6276 (0.05%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Atelectasis
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Bronchiectasis
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Chronic obstructive pulmonary disease
subjects affected / exposed	8 / 6270 (0.13%)	9 / 6276 (0.14%)
occurrences causally related to treatment / all	0 / 11	0 / 9
deaths causally related to treatment / all	0 / 0	0 / 0
Cough
subjects affected / exposed	1 / 6270 (0.02%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Dysphonia
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (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	6 / 6270 (0.10%)	5 / 6276 (0.08%)
occurrences causally related to treatment / all	0 / 6	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Emphysema
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Epistaxis
subjects affected / exposed	10 / 6270 (0.16%)	4 / 6276 (0.06%)
occurrences causally related to treatment / all	9 / 11	3 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Haemoptysis
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Haemothorax
subjects affected / exposed	3 / 6270 (0.05%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	1 / 3	0 / 0
deaths causally related to treatment / all	1 / 1	0 / 0
Interstitial lung disease
subjects affected / exposed	0 / 6270 (0.00%)	2 / 6276 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Laryngeal oedema
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (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 / 6270 (0.00%)	3 / 6276 (0.05%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Mediastinal cyst
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Nasal polyps
subjects affected / exposed	2 / 6270 (0.03%)	2 / 6276 (0.03%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Nasal septum deviation
subjects affected / exposed	0 / 6270 (0.00%)	3 / 6276 (0.05%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Nasal turbinate hypertrophy
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pharyngeal hypertrophy
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pharyngeal oedema
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pleural calcification
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pleural effusion
subjects affected / exposed	4 / 6270 (0.06%)	4 / 6276 (0.06%)
occurrences causally related to treatment / all	0 / 5	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Pleurisy
subjects affected / exposed	0 / 6270 (0.00%)	2 / 6276 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumonia aspiration
subjects affected / exposed	3 / 6270 (0.05%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumonitis
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumothorax
subjects affected / exposed	4 / 6270 (0.06%)	5 / 6276 (0.08%)
occurrences causally related to treatment / all	0 / 5	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Pulmonary cavitation
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pulmonary embolism
subjects affected / exposed	12 / 6270 (0.19%)	16 / 6276 (0.25%)
occurrences causally related to treatment / all	1 / 12	0 / 16
deaths causally related to treatment / all	0 / 1	0 / 0
Pulmonary fibrosis
subjects affected / exposed	1 / 6270 (0.02%)	2 / 6276 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 1	0 / 0
Pulmonary haemorrhage
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Pulmonary hypertension
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pulmonary mass
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pulmonary oedema
subjects affected / exposed	1 / 6270 (0.02%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Respiratory arrest
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Sleep apnoea syndrome
subjects affected / exposed	4 / 6270 (0.06%)	6 / 6276 (0.10%)
occurrences causally related to treatment / all	0 / 4	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Vocal cord disorder
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Vocal cord leukoplakia
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Vocal cord polyp
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Psychiatric disorders
Adjustment disorder with depressed mood
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Agitated depression
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Alcohol abuse
subjects affected / exposed	0 / 6270 (0.00%)	2 / 6276 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 1
Alcohol withdrawal syndrome
subjects affected / exposed	2 / 6270 (0.03%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Alcoholism
subjects affected / exposed	3 / 6270 (0.05%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Bipolar disorder
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Completed suicide
subjects affected / exposed	1 / 6270 (0.02%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 1
Confusional state
subjects affected / exposed	6 / 6270 (0.10%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 6	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Delirium
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (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	3 / 6270 (0.05%)	4 / 6276 (0.06%)
occurrences causally related to treatment / all	0 / 3	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Hallucination
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Major depression
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Phobia
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
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	2 / 6270 (0.03%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Withdrawal syndrome
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Product issues
Device dislocation
subjects affected / exposed	1 / 6270 (0.02%)	2 / 6276 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Device loosening
subjects affected / exposed	2 / 6270 (0.03%)	4 / 6276 (0.06%)
occurrences causally related to treatment / all	0 / 2	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Device malfunction
subjects affected / exposed	2 / 6270 (0.03%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Device occlusion
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Patient-device incompatibility
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatobiliary disorders
Alcoholic liver disease
subjects affected / exposed	1 / 6270 (0.02%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 1
Bile duct stone
subjects affected / exposed	4 / 6270 (0.06%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 4	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Biliary cirrhosis primary
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Biliary colic
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Biliary cyst
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Biliary dilatation
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Biliary fistula
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cholecystitis
subjects affected / exposed	13 / 6270 (0.21%)	8 / 6276 (0.13%)
occurrences causally related to treatment / all	0 / 13	0 / 9
deaths causally related to treatment / all	0 / 0	0 / 0
Cholecystitis acute
subjects affected / exposed	7 / 6270 (0.11%)	8 / 6276 (0.13%)
occurrences causally related to treatment / all	0 / 7	0 / 8
deaths causally related to treatment / all	0 / 0	0 / 0
Cholecystitis chronic
subjects affected / exposed	1 / 6270 (0.02%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cholelithiasis
subjects affected / exposed	24 / 6270 (0.38%)	17 / 6276 (0.27%)
occurrences causally related to treatment / all	0 / 24	0 / 17
deaths causally related to treatment / all	0 / 0	0 / 0
Cholestasis
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gallbladder enlargement
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gallbladder perforation
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gallbladder polyp
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatic cirrhosis
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatic pain
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (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	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatitis acute
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatotoxicity
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Jaundice
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Liver disorder
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Liver injury
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Investigations
Arteriogram coronary
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Biopsy prostate
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Blood pressure increased
subjects affected / exposed	2 / 6270 (0.03%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Electrocardiogram abnormal
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Haemoglobin decreased
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Liver function test abnormal
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Prostatic specific antigen increased
subjects affected / exposed	2 / 6270 (0.03%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Serum ferritin increased
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Weight decreased
subjects affected / exposed	1 / 6270 (0.02%)	3 / 6276 (0.05%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
White blood cell count increased
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Injury, poisoning and procedural complications
Accident at work
subjects affected / exposed	1 / 6270 (0.02%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Acetabulum fracture
subjects affected / exposed	1 / 6270 (0.02%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Alcohol poisoning
subjects affected / exposed	1 / 6270 (0.02%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Anaemia postoperative
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Ankle fracture
subjects affected / exposed	13 / 6270 (0.21%)	9 / 6276 (0.14%)
occurrences causally related to treatment / all	0 / 13	0 / 9
deaths causally related to treatment / all	0 / 0	0 / 0
Arterial bypass occlusion
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Bone contusion
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Carbon monoxide poisoning
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cervical vertebral fracture
subjects affected / exposed	2 / 6270 (0.03%)	2 / 6276 (0.03%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Chest injury
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Clavicle fracture
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Concussion
subjects affected / exposed	1 / 6270 (0.02%)	3 / 6276 (0.05%)
occurrences causally related to treatment / all	0 / 1	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Contusion
subjects affected / exposed	0 / 6270 (0.00%)	2 / 6276 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Craniocerebral injury
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Epicondylitis
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Extradural haematoma
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Eyelid injury
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Facial bones fracture
subjects affected / exposed	0 / 6270 (0.00%)	3 / 6276 (0.05%)
occurrences causally related to treatment / all	0 / 0	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Fall
subjects affected / exposed	4 / 6270 (0.06%)	7 / 6276 (0.11%)
occurrences causally related to treatment / all	0 / 4	0 / 8
deaths causally related to treatment / all	0 / 0	0 / 0
Femoral neck fracture
subjects affected / exposed	3 / 6270 (0.05%)	9 / 6276 (0.14%)
occurrences causally related to treatment / all	0 / 3	0 / 10
deaths causally related to treatment / all	0 / 0	0 / 0
Femur fracture
subjects affected / exposed	4 / 6270 (0.06%)	6 / 6276 (0.10%)
occurrences causally related to treatment / all	0 / 4	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Foot fracture
subjects affected / exposed	3 / 6270 (0.05%)	2 / 6276 (0.03%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Forearm fracture
subjects affected / exposed	1 / 6270 (0.02%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Foreign body
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Fractured ischium
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gas poisoning
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal anastomotic leak
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hand fracture
subjects affected / exposed	2 / 6270 (0.03%)	2 / 6276 (0.03%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Head injury
subjects affected / exposed	5 / 6270 (0.08%)	3 / 6276 (0.05%)
occurrences causally related to treatment / all	0 / 5	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Hip fracture
subjects affected / exposed	0 / 6270 (0.00%)	2 / 6276 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Humerus fracture
subjects affected / exposed	2 / 6270 (0.03%)	11 / 6276 (0.18%)
occurrences causally related to treatment / all	0 / 2	0 / 12
deaths causally related to treatment / all	0 / 0	0 / 0
Ilium fracture
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Incision site ulcer
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Incisional hernia
subjects affected / exposed	3 / 6270 (0.05%)	2 / 6276 (0.03%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Injury
subjects affected / exposed	1 / 6270 (0.02%)	2 / 6276 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 1
Intentional overdose
subjects affected / exposed	1 / 6270 (0.02%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Joint dislocation
subjects affected / exposed	0 / 6270 (0.00%)	2 / 6276 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Joint injury
subjects affected / exposed	2 / 6270 (0.03%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Kidney contusion
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Laceration
subjects affected / exposed	2 / 6270 (0.03%)	3 / 6276 (0.05%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Ligament rupture
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Ligament sprain
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Limb injury
subjects affected / exposed	1 / 6270 (0.02%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Lower limb fracture
subjects affected / exposed	1 / 6270 (0.02%)	2 / 6276 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Lumbar vertebral fracture
subjects affected / exposed	3 / 6270 (0.05%)	3 / 6276 (0.05%)
occurrences causally related to treatment / all	0 / 3	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Meniscus injury
subjects affected / exposed	10 / 6270 (0.16%)	11 / 6276 (0.18%)
occurrences causally related to treatment / all	0 / 10	0 / 11
deaths causally related to treatment / all	0 / 0	0 / 0
Multiple fractures
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Multiple injuries
subjects affected / exposed	1 / 6270 (0.02%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 0
Muscle rupture
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (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 / 6270 (0.02%)	2 / 6276 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Pelvic fracture
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Periprosthetic fracture
subjects affected / exposed	1 / 6270 (0.02%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Post concussion syndrome
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Post procedural discharge
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Post procedural haemorrhage
subjects affected / exposed	2 / 6270 (0.03%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Post procedural inflammation
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Post procedural myocardial infarction
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Procedural haemorrhage
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Procedural pain
subjects affected / exposed	0 / 6270 (0.00%)	3 / 6276 (0.05%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Radius fracture
subjects affected / exposed	2 / 6270 (0.03%)	7 / 6276 (0.11%)
occurrences causally related to treatment / all	0 / 2	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
Rib fracture
subjects affected / exposed	3 / 6270 (0.05%)	2 / 6276 (0.03%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Road traffic accident
subjects affected / exposed	0 / 6270 (0.00%)	4 / 6276 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 1
Scapula fracture
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Skull fracture
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Skull fractured base
subjects affected / exposed	1 / 6270 (0.02%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Spinal compression fracture
subjects affected / exposed	3 / 6270 (0.05%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Spinal fracture
subjects affected / exposed	0 / 6270 (0.00%)	4 / 6276 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Splenic rupture
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Stab wound
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Sternal fracture
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Stomal hernia
subjects affected / exposed	1 / 6270 (0.02%)	1 / 6276 (0.02%)
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	6 / 6270 (0.10%)	3 / 6276 (0.05%)
occurrences causally related to treatment / all	2 / 6	2 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Subcutaneous haematoma
subjects affected / exposed	2 / 6270 (0.03%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	1 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Subdural haematoma
subjects affected / exposed	2 / 6270 (0.03%)	3 / 6276 (0.05%)
occurrences causally related to treatment / all	2 / 2	0 / 3
deaths causally related to treatment / all	1 / 1	0 / 0
Subdural haemorrhage
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	1 / 1	0 / 0
Synovial rupture
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Tendon injury
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (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	4 / 6270 (0.06%)	5 / 6276 (0.08%)
occurrences causally related to treatment / all	0 / 4	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Thermal burn
subjects affected / exposed	1 / 6270 (0.02%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Thoracic vertebral fracture
subjects affected / exposed	4 / 6270 (0.06%)	2 / 6276 (0.03%)
occurrences causally related to treatment / all	0 / 4	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Tibia fracture
subjects affected / exposed	3 / 6270 (0.05%)	2 / 6276 (0.03%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Traumatic haemothorax
subjects affected / exposed	1 / 6270 (0.02%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Traumatic intracranial haemorrhage
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Ulna fracture
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Upper limb fracture
subjects affected / exposed	1 / 6270 (0.02%)	3 / 6276 (0.05%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Urinary retention postoperative
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Uveitis-glaucoma-hyphaema syndrome
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Vascular graft occlusion
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Wound complication
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Wrist fracture
subjects affected / exposed	2 / 6270 (0.03%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Congenital, familial and genetic disorders
Congenital cystic kidney disease
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Congenital urinary tract obstruction
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Familial tremor
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Haemophilia
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hydrocele
subjects affected / exposed	1 / 6270 (0.02%)	2 / 6276 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Myocardial bridging
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Odontogenic cyst
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Type IIa hyperlipidaemia
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (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	10 / 6270 (0.16%)	12 / 6276 (0.19%)
occurrences causally related to treatment / all	0 / 10	0 / 12
deaths causally related to treatment / all	0 / 0	0 / 0
Acute left ventricular failure
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Acute myocardial infarction
subjects affected / exposed	43 / 6270 (0.69%)	58 / 6276 (0.92%)
occurrences causally related to treatment / all	0 / 44	0 / 58
deaths causally related to treatment / all	0 / 4	0 / 5
Angina pectoris
subjects affected / exposed	20 / 6270 (0.32%)	14 / 6276 (0.22%)
occurrences causally related to treatment / all	0 / 20	0 / 15
deaths causally related to treatment / all	0 / 0	0 / 0
Angina unstable
subjects affected / exposed	15 / 6270 (0.24%)	19 / 6276 (0.30%)
occurrences causally related to treatment / all	0 / 17	0 / 20
deaths causally related to treatment / all	0 / 0	0 / 0
Aortic valve calcification
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Aortic valve disease
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Aortic valve disease mixed
subjects affected / exposed	0 / 6270 (0.00%)	2 / 6276 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Aortic valve incompetence
subjects affected / exposed	1 / 6270 (0.02%)	4 / 6276 (0.06%)
occurrences causally related to treatment / all	0 / 1	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Aortic valve stenosis
subjects affected / exposed	3 / 6270 (0.05%)	5 / 6276 (0.08%)
occurrences causally related to treatment / all	0 / 3	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Arteriosclerosis coronary artery
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Arteriospasm coronary
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Atrial fibrillation
subjects affected / exposed	37 / 6270 (0.59%)	40 / 6276 (0.64%)
occurrences causally related to treatment / all	0 / 39	0 / 41
deaths causally related to treatment / all	0 / 1	0 / 0
Atrial flutter
subjects affected / exposed	2 / 6270 (0.03%)	3 / 6276 (0.05%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Atrial thrombosis
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Atrioventricular block
subjects affected / exposed	2 / 6270 (0.03%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Atrioventricular block complete
subjects affected / exposed	2 / 6270 (0.03%)	4 / 6276 (0.06%)
occurrences causally related to treatment / all	0 / 2	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Atrioventricular block first degree
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Atrioventricular block second degree
subjects affected / exposed	0 / 6270 (0.00%)	8 / 6276 (0.13%)
occurrences causally related to treatment / all	0 / 0	0 / 8
deaths causally related to treatment / all	0 / 0	0 / 0
Bradycardia
subjects affected / exposed	0 / 6270 (0.00%)	4 / 6276 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Bundle branch block right
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
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 / 6270 (0.06%)	9 / 6276 (0.14%)
occurrences causally related to treatment / all	0 / 4	0 / 9
deaths causally related to treatment / all	0 / 2	0 / 5
Cardiac disorder
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac failure
subjects affected / exposed	7 / 6270 (0.11%)	3 / 6276 (0.05%)
occurrences causally related to treatment / all	0 / 7	0 / 3
deaths causally related to treatment / all	0 / 1	0 / 0
Cardiac failure acute
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac failure chronic
subjects affected / exposed	0 / 6270 (0.00%)	4 / 6276 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac failure congestive
subjects affected / exposed	1 / 6270 (0.02%)	3 / 6276 (0.05%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 1
Cardiac ventricular thrombosis
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiogenic shock
subjects affected / exposed	3 / 6270 (0.05%)	3 / 6276 (0.05%)
occurrences causally related to treatment / all	0 / 3	0 / 3
deaths causally related to treatment / all	0 / 3	0 / 1
Cardiopulmonary failure
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Congestive cardiomyopathy
subjects affected / exposed	2 / 6270 (0.03%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Coronary artery disease
subjects affected / exposed	46 / 6270 (0.73%)	61 / 6276 (0.97%)
occurrences causally related to treatment / all	0 / 46	0 / 63
deaths causally related to treatment / all	0 / 0	0 / 0
Coronary artery occlusion
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Coronary artery stenosis
subjects affected / exposed	1 / 6270 (0.02%)	3 / 6276 (0.05%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Coronary artery thrombosis
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Coronary ostial stenosis
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Dressler's syndrome
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Extrasystoles
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Left ventricular dysfunction
subjects affected / exposed	1 / 6270 (0.02%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Left ventricular failure
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Left ventricular hypertrophy
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Mitral valve incompetence
subjects affected / exposed	1 / 6270 (0.02%)	4 / 6276 (0.06%)
occurrences causally related to treatment / all	0 / 1	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Mitral valve prolapse
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Myocardial fibrosis
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Myocardial infarction
subjects affected / exposed	29 / 6270 (0.46%)	38 / 6276 (0.61%)
occurrences causally related to treatment / all	0 / 29	0 / 38
deaths causally related to treatment / all	0 / 2	0 / 8
Myocardial ischaemia
subjects affected / exposed	7 / 6270 (0.11%)	10 / 6276 (0.16%)
occurrences causally related to treatment / all	1 / 7	0 / 10
deaths causally related to treatment / all	0 / 0	0 / 1
Palpitations
subjects affected / exposed	1 / 6270 (0.02%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pericarditis
subjects affected / exposed	2 / 6270 (0.03%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Pleuropericarditis
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Prinzmetal angina
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Right ventricular failure
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
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	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Sinoatrial block
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Sinus bradycardia
subjects affected / exposed	1 / 6270 (0.02%)	1 / 6276 (0.02%)
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	2 / 6270 (0.03%)	2 / 6276 (0.03%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Sinus tachycardia
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (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 / 6270 (0.02%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Tachyarrhythmia
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Tachycardia paroxysmal
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Torsade de pointes
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Tricuspid valve incompetence
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Ventricular arrhythmia
subjects affected / exposed	2 / 6270 (0.03%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Ventricular extrasystoles
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (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	2 / 6270 (0.03%)	4 / 6276 (0.06%)
occurrences causally related to treatment / all	0 / 2	0 / 4
deaths causally related to treatment / all	0 / 1	0 / 0
Ventricular tachycardia
subjects affected / exposed	0 / 6270 (0.00%)	2 / 6276 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Nervous system disorders
Amnesia
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Amyotrophic lateral sclerosis
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Axonal neuropathy
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Basal ganglia haemorrhage
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Basilar artery aneurysm
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Brain injury
subjects affected / exposed	0 / 6270 (0.00%)	2 / 6276 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Brain stem infarction
subjects affected / exposed	2 / 6270 (0.03%)	2 / 6276 (0.03%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Brain stem stroke
subjects affected / exposed	1 / 6270 (0.02%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Carotid arteriosclerosis
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Carotid artery disease
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Carotid artery occlusion
subjects affected / exposed	1 / 6270 (0.02%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Carotid artery stenosis
subjects affected / exposed	5 / 6270 (0.08%)	9 / 6276 (0.14%)
occurrences causally related to treatment / all	0 / 5	0 / 9
deaths causally related to treatment / all	0 / 0	0 / 0
Carpal tunnel syndrome
subjects affected / exposed	1 / 6270 (0.02%)	2 / 6276 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Cauda equina syndrome
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cerebellar infarction
subjects affected / exposed	1 / 6270 (0.02%)	3 / 6276 (0.05%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Cerebral artery occlusion
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cerebral circulatory failure
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cerebral haematoma
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cerebral haemorrhage
subjects affected / exposed	3 / 6270 (0.05%)	2 / 6276 (0.03%)
occurrences causally related to treatment / all	3 / 3	1 / 2
deaths causally related to treatment / all	1 / 1	0 / 0
Cerebral infarction
subjects affected / exposed	8 / 6270 (0.13%)	5 / 6276 (0.08%)
occurrences causally related to treatment / all	0 / 9	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Cerebral ischaemia
subjects affected / exposed	2 / 6270 (0.03%)	4 / 6276 (0.06%)
occurrences causally related to treatment / all	0 / 2	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Cerebrovascular accident
subjects affected / exposed	10 / 6270 (0.16%)	9 / 6276 (0.14%)
occurrences causally related to treatment / all	0 / 10	1 / 9
deaths causally related to treatment / all	0 / 2	0 / 1
Cerebrovascular insufficiency
subjects affected / exposed	2 / 6270 (0.03%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cervical cord compression
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cervical myelopathy
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cervical radiculopathy
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cervicobrachial syndrome
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Chronic inflammatory demyelinating polyradiculoneuropathy
subjects affected / exposed	2 / 6270 (0.03%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Complex partial seizures
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cubital tunnel syndrome
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Dementia
subjects affected / exposed	1 / 6270 (0.02%)	2 / 6276 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Dementia Alzheimer's type
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Demyelinating polyneuropathy
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Dizziness
subjects affected / exposed	1 / 6270 (0.02%)	6 / 6276 (0.10%)
occurrences causally related to treatment / all	0 / 1	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Dysarthria
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Embolic cerebral infarction
subjects affected / exposed	0 / 6270 (0.00%)	2 / 6276 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Embolic stroke
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Epilepsy
subjects affected / exposed	2 / 6270 (0.03%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 0
Facial paresis
subjects affected / exposed	2 / 6270 (0.03%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Generalised tonic-clonic seizure
subjects affected / exposed	2 / 6270 (0.03%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Guillain-Barre syndrome
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Haemorrhage intracranial
subjects affected / exposed	1 / 6270 (0.02%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 1	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Haemorrhagic stroke
subjects affected / exposed	2 / 6270 (0.03%)	4 / 6276 (0.06%)
occurrences causally related to treatment / all	1 / 2	2 / 4
deaths causally related to treatment / all	0 / 0	0 / 1
Headache
subjects affected / exposed	1 / 6270 (0.02%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hemianaesthesia
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hemiparesis
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (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	1 / 6270 (0.02%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 4
deaths causally related to treatment / all	0 / 1	0 / 1
Hypoaesthesia
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Intercostal neuralgia
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Intracranial aneurysm
subjects affected / exposed	1 / 6270 (0.02%)	2 / 6276 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Ischaemic cerebral infarction
subjects affected / exposed	1 / 6270 (0.02%)	3 / 6276 (0.05%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 1
Ischaemic stroke
subjects affected / exposed	22 / 6270 (0.35%)	19 / 6276 (0.30%)
occurrences causally related to treatment / all	0 / 22	0 / 19
deaths causally related to treatment / all	0 / 0	0 / 1
Lacunar infarction
subjects affected / exposed	6 / 6270 (0.10%)	3 / 6276 (0.05%)
occurrences causally related to treatment / all	0 / 6	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Lacunar stroke
subjects affected / exposed	2 / 6270 (0.03%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Loss of consciousness
subjects affected / exposed	4 / 6270 (0.06%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 4	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Lumbar radiculopathy
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Migraine
subjects affected / exposed	1 / 6270 (0.02%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Morton's neuralgia
subjects affected / exposed	1 / 6270 (0.02%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Motor neurone disease
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Myasthenia gravis
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Nerve compression
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Neuralgic amyotrophy
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Neurodegenerative disorder
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Orthostatic intolerance
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Parkinson's disease
subjects affected / exposed	1 / 6270 (0.02%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Partial seizures
subjects affected / exposed	0 / 6270 (0.00%)	2 / 6276 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Polyneuropathy
subjects affected / exposed	2 / 6270 (0.03%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Posterior reversible encephalopathy syndrome
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Presyncope
subjects affected / exposed	1 / 6270 (0.02%)	5 / 6276 (0.08%)
occurrences causally related to treatment / all	0 / 1	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Quadriparesis
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Radicular syndrome
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Reversible ischaemic neurological deficit
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Ruptured cerebral aneurysm
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Sciatica
subjects affected / exposed	2 / 6270 (0.03%)	3 / 6276 (0.05%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Seizure
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Spinal cord compression
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Spinal vascular disorder
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Syncope
subjects affected / exposed	7 / 6270 (0.11%)	12 / 6276 (0.19%)
occurrences causally related to treatment / all	1 / 7	0 / 13
deaths causally related to treatment / all	0 / 0	0 / 0
Thalamic infarction
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Transient global amnesia
subjects affected / exposed	1 / 6270 (0.02%)	3 / 6276 (0.05%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Transient ischaemic attack
subjects affected / exposed	26 / 6270 (0.41%)	30 / 6276 (0.48%)
occurrences causally related to treatment / all	0 / 27	0 / 31
deaths causally related to treatment / all	0 / 0	0 / 0
Trigeminal neuralgia
subjects affected / exposed	1 / 6270 (0.02%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
VIIIth nerve lesion
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
VIth nerve paralysis
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
VIth nerve paresis
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Vascular encephalopathy
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Vasculitis cerebral
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Vertebrobasilar insufficiency
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Visual field defect
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Wernicke's encephalopathy
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Blood and lymphatic system disorders
Abdominal lymphadenopathy
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Anaemia
subjects affected / exposed	6 / 6270 (0.10%)	4 / 6276 (0.06%)
occurrences causally related to treatment / all	2 / 6	1 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Febrile neutropenia
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Haemorrhagic anaemia
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hypochromic anaemia
subjects affected / exposed	1 / 6270 (0.02%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Iron deficiency anaemia
subjects affected / exposed	3 / 6270 (0.05%)	3 / 6276 (0.05%)
occurrences causally related to treatment / all	3 / 3	1 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Leukocytosis
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Lymphadenitis
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Lymphadenopathy
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Neutropenia
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Thrombocytopenia
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Ear and labyrinth disorders
Deafness unilateral
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hypoacusis
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Inner ear disorder
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Meniere's disease
subjects affected / exposed	1 / 6270 (0.02%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Tinnitus
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Tympanic membrane perforation
subjects affected / exposed	2 / 6270 (0.03%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Vertigo
subjects affected / exposed	2 / 6270 (0.03%)	2 / 6276 (0.03%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Vertigo positional
subjects affected / exposed	1 / 6270 (0.02%)	2 / 6276 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Eye disorders
Amaurosis fugax
subjects affected / exposed	2 / 6270 (0.03%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cataract
subjects affected / exposed	8 / 6270 (0.13%)	5 / 6276 (0.08%)
occurrences causally related to treatment / all	0 / 10	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Chalazion
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Conjunctival haemorrhage
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Corneal degeneration
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Corneal disorder
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Endocrine ophthalmopathy
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Eye disorder
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Eye haemorrhage
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Eyelid dermatochalasis
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Eyelid ptosis
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Glaucoma
subjects affected / exposed	4 / 6270 (0.06%)	3 / 6276 (0.05%)
occurrences causally related to treatment / all	0 / 4	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Lacrimation increased
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Macular fibrosis
subjects affected / exposed	1 / 6270 (0.02%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Macular hole
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Optic ischaemic neuropathy
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Polypoidal choroidal vasculopathy
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Retinal artery embolism
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Retinal artery occlusion
subjects affected / exposed	0 / 6270 (0.00%)	2 / 6276 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Retinal detachment
subjects affected / exposed	3 / 6270 (0.05%)	3 / 6276 (0.05%)
occurrences causally related to treatment / all	0 / 3	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Retinal haemorrhage
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Retinal tear
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Retinal vein occlusion
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Retinal vein thrombosis
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Strabismus
subjects affected / exposed	1 / 6270 (0.02%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Vision blurred
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Vitreous haemorrhage
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal disorders
Abdominal discomfort
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Abdominal distension
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Abdominal hernia
subjects affected / exposed	1 / 6270 (0.02%)	3 / 6276 (0.05%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Abdominal pain
subjects affected / exposed	11 / 6270 (0.18%)	10 / 6276 (0.16%)
occurrences causally related to treatment / all	1 / 11	4 / 11
deaths causally related to treatment / all	0 / 0	0 / 0
Abdominal pain lower
subjects affected / exposed	0 / 6270 (0.00%)	2 / 6276 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Abdominal pain upper
subjects affected / exposed	1 / 6270 (0.02%)	2 / 6276 (0.03%)
occurrences causally related to treatment / all	0 / 1	1 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Anal fistula
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Anal haemorrhage
subjects affected / exposed	1 / 6270 (0.02%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Ascites
subjects affected / exposed	2 / 6270 (0.03%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Barrett's oesophagus
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Change of bowel habit
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Chronic gastritis
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Colitis
subjects affected / exposed	2 / 6270 (0.03%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Colitis ischaemic
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Colitis ulcerative
subjects affected / exposed	1 / 6270 (0.02%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Colon dysplasia
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Constipation
subjects affected / exposed	3 / 6270 (0.05%)	2 / 6276 (0.03%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Diarrhoea
subjects affected / exposed	3 / 6270 (0.05%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Diverticulum
subjects affected / exposed	4 / 6270 (0.06%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 4	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Diverticulum intestinal
subjects affected / exposed	2 / 6270 (0.03%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Duodenal stenosis
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Duodenal ulcer
subjects affected / exposed	1 / 6270 (0.02%)	3 / 6276 (0.05%)
occurrences causally related to treatment / all	1 / 1	2 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Duodenal ulcer haemorrhage
subjects affected / exposed	2 / 6270 (0.03%)	2 / 6276 (0.03%)
occurrences causally related to treatment / all	2 / 2	2 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Duodenal ulcer perforation
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Duodenitis
subjects affected / exposed	0 / 6270 (0.00%)	2 / 6276 (0.03%)
occurrences causally related to treatment / all	0 / 0	1 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Dyspepsia
subjects affected / exposed	1 / 6270 (0.02%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	1 / 1	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Dysphagia
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Enterovesical fistula
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Faecaloma
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Faeces discoloured
subjects affected / exposed	1 / 6270 (0.02%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	1 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Femoral hernia
subjects affected / exposed	0 / 6270 (0.00%)	3 / 6276 (0.05%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Food poisoning
subjects affected / exposed	0 / 6270 (0.00%)	3 / 6276 (0.05%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Gastric haemorrhage
subjects affected / exposed	0 / 6270 (0.00%)	2 / 6276 (0.03%)
occurrences causally related to treatment / all	0 / 0	2 / 2
deaths causally related to treatment / all	0 / 0	1 / 1
Gastric polyps
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastric ulcer
subjects affected / exposed	4 / 6270 (0.06%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	3 / 4	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastric ulcer haemorrhage
subjects affected / exposed	3 / 6270 (0.05%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	3 / 3	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastric ulcer perforation
subjects affected / exposed	2 / 6270 (0.03%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	2 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gastritis
subjects affected / exposed	2 / 6270 (0.03%)	2 / 6276 (0.03%)
occurrences causally related to treatment / all	0 / 2	2 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Gastritis erosive
subjects affected / exposed	2 / 6270 (0.03%)	3 / 6276 (0.05%)
occurrences causally related to treatment / all	1 / 2	3 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal angiodysplasia
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal disorder
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal haemorrhage
subjects affected / exposed	13 / 6270 (0.21%)	2 / 6276 (0.03%)
occurrences causally related to treatment / all	11 / 13	2 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal obstruction
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrooesophageal reflux disease
subjects affected / exposed	2 / 6270 (0.03%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	1 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Haematemesis
subjects affected / exposed	3 / 6270 (0.05%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	2 / 3	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Haematochezia
subjects affected / exposed	0 / 6270 (0.00%)	2 / 6276 (0.03%)
occurrences causally related to treatment / all	0 / 0	1 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Haemorrhagic erosive gastritis
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Haemorrhoidal haemorrhage
subjects affected / exposed	1 / 6270 (0.02%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 1	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Haemorrhoids
subjects affected / exposed	4 / 6270 (0.06%)	2 / 6276 (0.03%)
occurrences causally related to treatment / all	0 / 4	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Haemorrhoids thrombosed
subjects affected / exposed	0 / 6270 (0.00%)	3 / 6276 (0.05%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Hiatus hernia
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Ileus
subjects affected / exposed	0 / 6270 (0.00%)	2 / 6276 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Ileus paralytic
subjects affected / exposed	1 / 6270 (0.02%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Incarcerated inguinal hernia
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Inflammatory bowel disease
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
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	35 / 6270 (0.56%)	31 / 6276 (0.49%)
occurrences causally related to treatment / all	0 / 35	0 / 32
deaths causally related to treatment / all	0 / 0	0 / 0
Inguinal hernia strangulated
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Intestinal fibrosis
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Intestinal haemorrhage
subjects affected / exposed	2 / 6270 (0.03%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	2 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Intestinal ischaemia
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Intestinal obstruction
subjects affected / exposed	3 / 6270 (0.05%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 4	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Intestinal perforation
subjects affected / exposed	1 / 6270 (0.02%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Intestinal polyp
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Irritable bowel syndrome
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Large intestinal haemorrhage
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Large intestine perforation
subjects affected / exposed	3 / 6270 (0.05%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	1 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Large intestine polyp
subjects affected / exposed	4 / 6270 (0.06%)	2 / 6276 (0.03%)
occurrences causally related to treatment / all	0 / 6	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Leukoplakia oral
subjects affected / exposed	3 / 6270 (0.05%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Lower gastrointestinal haemorrhage
subjects affected / exposed	3 / 6270 (0.05%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	2 / 4	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Mallory-Weiss syndrome
subjects affected / exposed	2 / 6270 (0.03%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Mechanical ileus
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Melaena
subjects affected / exposed	2 / 6270 (0.03%)	2 / 6276 (0.03%)
occurrences causally related to treatment / all	2 / 2	1 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Mesenteric vein thrombosis
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Nausea
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Oesophageal achalasia
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Oesophageal obstruction
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Oesophageal stenosis
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Oesophageal ulcer
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Oesophageal ulcer haemorrhage
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Oesophageal varices haemorrhage
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Oesophagitis ulcerative
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Oral mucosal hypertrophy
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pancreatic pseudocyst
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pancreatitis
subjects affected / exposed	3 / 6270 (0.05%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pancreatitis acute
subjects affected / exposed	5 / 6270 (0.08%)	3 / 6276 (0.05%)
occurrences causally related to treatment / all	0 / 5	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Pancreatitis necrotising
subjects affected / exposed	1 / 6270 (0.02%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Rectal fissure
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Rectal haemorrhage
subjects affected / exposed	6 / 6270 (0.10%)	3 / 6276 (0.05%)
occurrences causally related to treatment / all	5 / 6	2 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Retroperitoneal haemorrhage
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Small intestinal obstruction
subjects affected / exposed	2 / 6270 (0.03%)	3 / 6276 (0.05%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Subileus
subjects affected / exposed	3 / 6270 (0.05%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Thrombosis mesenteric vessel
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Umbilical hernia
subjects affected / exposed	5 / 6270 (0.08%)	4 / 6276 (0.06%)
occurrences causally related to treatment / all	0 / 5	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Upper gastrointestinal haemorrhage
subjects affected / exposed	1 / 6270 (0.02%)	4 / 6276 (0.06%)
occurrences causally related to treatment / all	1 / 1	3 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Vomiting
subjects affected / exposed	2 / 6270 (0.03%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Skin and subcutaneous tissue disorders
Acute febrile neutrophilic dermatosis
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Angioedema
subjects affected / exposed	2 / 6270 (0.03%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	1 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Dermal cyst
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Dermatitis allergic
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Eczema
subjects affected / exposed	1 / 6270 (0.02%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Neurodermatitis
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Parapsoriasis
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pemphigoid
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Photosensitivity reaction
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Prurigo
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Psoriasis
subjects affected / exposed	2 / 6270 (0.03%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Rhinophyma
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Sebaceous hyperplasia
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Seborrhoeic dermatitis
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Skin discolouration
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Skin ulcer
subjects affected / exposed	1 / 6270 (0.02%)	2 / 6276 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Swelling face
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Urticaria
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Renal and urinary disorders
Acute kidney injury
subjects affected / exposed	8 / 6270 (0.13%)	7 / 6276 (0.11%)
occurrences causally related to treatment / all	0 / 8	0 / 7
deaths causally related to treatment / all	0 / 1	0 / 1
Bladder diverticulum
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Bladder neck sclerosis
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Bladder outlet obstruction
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Bladder sphincter atony
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Calculus bladder
subjects affected / exposed	3 / 6270 (0.05%)	2 / 6276 (0.03%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Calculus urinary
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Chronic kidney disease
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Dysuria
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (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 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Haematuria
subjects affected / exposed	7 / 6270 (0.11%)	3 / 6276 (0.05%)
occurrences causally related to treatment / all	1 / 7	3 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Hydronephrosis
subjects affected / exposed	1 / 6270 (0.02%)	3 / 6276 (0.05%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Incontinence
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Lower urinary tract symptoms
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Nephrolithiasis
subjects affected / exposed	6 / 6270 (0.10%)	7 / 6276 (0.11%)
occurrences causally related to treatment / all	0 / 7	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
Neurogenic bladder
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pollakiuria
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Prerenal failure
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Renal artery stenosis
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
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	8 / 6270 (0.13%)	8 / 6276 (0.13%)
occurrences causally related to treatment / all	0 / 8	0 / 8
deaths causally related to treatment / all	0 / 0	0 / 0
Renal cyst
subjects affected / exposed	1 / 6270 (0.02%)	2 / 6276 (0.03%)
occurrences causally related to treatment / all	0 / 4	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Renal cyst haemorrhage
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Renal failure
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Renal haematoma
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Renal impairment
subjects affected / exposed	0 / 6270 (0.00%)	2 / 6276 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Stress urinary incontinence
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Ureteric stenosis
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
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 / 6270 (0.02%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Urethral pain
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Urethral stenosis
subjects affected / exposed	2 / 6270 (0.03%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Urinary bladder haemorrhage
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Urinary incontinence
subjects affected / exposed	2 / 6270 (0.03%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Urinary retention
subjects affected / exposed	6 / 6270 (0.10%)	8 / 6276 (0.13%)
occurrences causally related to treatment / all	0 / 7	0 / 8
deaths causally related to treatment / all	0 / 0	0 / 0
Urine flow decreased
subjects affected / exposed	0 / 6270 (0.00%)	2 / 6276 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Endocrine disorders
Goitre
subjects affected / exposed	6 / 6270 (0.10%)	4 / 6276 (0.06%)
occurrences causally related to treatment / all	0 / 6	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Hyperparathyroidism
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hyperthyroidism
subjects affected / exposed	0 / 6270 (0.00%)	2 / 6276 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Thyroid cyst
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Toxic nodular goitre
subjects affected / exposed	3 / 6270 (0.05%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Musculoskeletal and connective tissue disorders
Arthralgia
subjects affected / exposed	3 / 6270 (0.05%)	10 / 6276 (0.16%)
occurrences causally related to treatment / all	0 / 3	0 / 10
deaths causally related to treatment / all	0 / 0	0 / 0
Arthritis
subjects affected / exposed	6 / 6270 (0.10%)	6 / 6276 (0.10%)
occurrences causally related to treatment / all	0 / 7	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Arthropathy
subjects affected / exposed	2 / 6270 (0.03%)	2 / 6276 (0.03%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Back pain
subjects affected / exposed	6 / 6270 (0.10%)	8 / 6276 (0.13%)
occurrences causally related to treatment / all	0 / 6	0 / 9
deaths causally related to treatment / all	0 / 0	0 / 0
Bone pain
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Bursitis
subjects affected / exposed	4 / 6270 (0.06%)	3 / 6276 (0.05%)
occurrences causally related to treatment / all	0 / 4	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Cervical spinal stenosis
subjects affected / exposed	1 / 6270 (0.02%)	2 / 6276 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Dupuytren's contracture
subjects affected / exposed	3 / 6270 (0.05%)	5 / 6276 (0.08%)
occurrences causally related to treatment / all	0 / 3	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Exostosis
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Facet joint syndrome
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
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 / 6270 (0.05%)	2 / 6276 (0.03%)
occurrences causally related to treatment / all	0 / 4	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Fracture nonunion
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gouty arthritis
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Groin pain
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Intervertebral disc compression
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Intervertebral disc degeneration
subjects affected / exposed	0 / 6270 (0.00%)	2 / 6276 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Intervertebral disc disorder
subjects affected / exposed	3 / 6270 (0.05%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Intervertebral disc protrusion
subjects affected / exposed	6 / 6270 (0.10%)	8 / 6276 (0.13%)
occurrences causally related to treatment / all	0 / 8	0 / 8
deaths causally related to treatment / all	0 / 0	0 / 0
Lumbar spinal stenosis
subjects affected / exposed	3 / 6270 (0.05%)	4 / 6276 (0.06%)
occurrences causally related to treatment / all	0 / 4	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Meniscal degeneration
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Mixed connective tissue disease
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Muscle haemorrhage
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (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 / 6270 (0.02%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Musculoskeletal pain
subjects affected / exposed	2 / 6270 (0.03%)	2 / 6276 (0.03%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Myalgia
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Neck pain
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Osteitis
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Osteoarthritis
subjects affected / exposed	104 / 6270 (1.66%)	103 / 6276 (1.64%)
occurrences causally related to treatment / all	0 / 114	0 / 109
deaths causally related to treatment / all	0 / 0	0 / 0
Osteochondritis
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Osteochondrosis
subjects affected / exposed	2 / 6270 (0.03%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Osteoporotic fracture
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pain in extremity
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Patellofemoral pain syndrome
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pathological fracture
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Peripheral arthritis
subjects affected / exposed	2 / 6270 (0.03%)	3 / 6276 (0.05%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Polymyalgia rheumatica
subjects affected / exposed	4 / 6270 (0.06%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 4	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pseudarthrosis
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Rhabdomyolysis
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
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	1 / 6270 (0.02%)	2 / 6276 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Rotator cuff syndrome
subjects affected / exposed	6 / 6270 (0.10%)	13 / 6276 (0.21%)
occurrences causally related to treatment / all	0 / 6	0 / 13
deaths causally related to treatment / all	0 / 0	0 / 0
Scoliosis
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Spinal column stenosis
subjects affected / exposed	4 / 6270 (0.06%)	7 / 6276 (0.11%)
occurrences causally related to treatment / all	0 / 4	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
Spinal deformity
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Spinal disorder
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Spinal osteoarthritis
subjects affected / exposed	0 / 6270 (0.00%)	2 / 6276 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Spinal pain
subjects affected / exposed	2 / 6270 (0.03%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Spondylolisthesis
subjects affected / exposed	2 / 6270 (0.03%)	2 / 6276 (0.03%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Synovial cyst
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Synovitis
subjects affected / exposed	0 / 6270 (0.00%)	2 / 6276 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Systemic lupus erythematosus
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Vertebral foraminal stenosis
subjects affected / exposed	0 / 6270 (0.00%)	2 / 6276 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Infections and infestations
Abdominal sepsis
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Abdominal wall abscess
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Acute sinusitis
subjects affected / exposed	2 / 6270 (0.03%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Anal abscess
subjects affected / exposed	1 / 6270 (0.02%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Anal fistula infection
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (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	9 / 6270 (0.14%)	9 / 6276 (0.14%)
occurrences causally related to treatment / all	0 / 9	0 / 10
deaths causally related to treatment / all	0 / 0	0 / 0
Appendicitis perforated
subjects affected / exposed	1 / 6270 (0.02%)	3 / 6276 (0.05%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Arthritis bacterial
subjects affected / exposed	0 / 6270 (0.00%)	2 / 6276 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Arthritis infective
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Atypical pneumonia
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Bacteraemia
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Bone tuberculosis
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Bronchitis
subjects affected / exposed	2 / 6270 (0.03%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Campylobacter gastroenteritis
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cellulitis
subjects affected / exposed	6 / 6270 (0.10%)	8 / 6276 (0.13%)
occurrences causally related to treatment / all	0 / 6	0 / 8
deaths causally related to treatment / all	0 / 0	0 / 0
Cellulitis orbital
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Chlamydial infection
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cholecystitis infective
subjects affected / exposed	1 / 6270 (0.02%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Chronic sinusitis
subjects affected / exposed	2 / 6270 (0.03%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Colonic abscess
subjects affected / exposed	2 / 6270 (0.03%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cystitis
subjects affected / exposed	2 / 6270 (0.03%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Device related infection
subjects affected / exposed	2 / 6270 (0.03%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Diverticulitis
subjects affected / exposed	5 / 6270 (0.08%)	7 / 6276 (0.11%)
occurrences causally related to treatment / all	1 / 5	0 / 8
deaths causally related to treatment / all	0 / 0	0 / 0
Diverticulitis intestinal haemorrhagic
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Dural abscess
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Ear infection
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Encephalitis
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Endocarditis
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Endocarditis bacterial
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Epididymitis
subjects affected / exposed	1 / 6270 (0.02%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Erysipelas
subjects affected / exposed	2 / 6270 (0.03%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Extradural abscess
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gangrene
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gastroenteritis
subjects affected / exposed	6 / 6270 (0.10%)	4 / 6276 (0.06%)
occurrences causally related to treatment / all	0 / 6	1 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Gastroenteritis norovirus
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gastroenteritis salmonella
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gastroenteritis viral
subjects affected / exposed	1 / 6270 (0.02%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Helicobacter gastritis
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Herpes zoster infection neurological
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Herpes zoster meningoencephalitis
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Infection
subjects affected / exposed	0 / 6270 (0.00%)	2 / 6276 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Infectious pleural effusion
subjects affected / exposed	1 / 6270 (0.02%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Infective exacerbation of chronic obstructive airways disease
subjects affected / exposed	7 / 6270 (0.11%)	4 / 6276 (0.06%)
occurrences causally related to treatment / all	0 / 11	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Kidney infection
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Labyrinthitis
subjects affected / exposed	3 / 6270 (0.05%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Lower respiratory tract infection
subjects affected / exposed	3 / 6270 (0.05%)	4 / 6276 (0.06%)
occurrences causally related to treatment / all	0 / 3	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Lower respiratory tract infection viral
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Meningitis meningococcal
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Meningitis viral
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Muscle abscess
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Neutropenic sepsis
subjects affected / exposed	2 / 6270 (0.03%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Ophthalmic herpes zoster
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Orchitis
subjects affected / exposed	0 / 6270 (0.00%)	3 / 6276 (0.05%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Osteomyelitis
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Otitis externa
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Otitis media chronic
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Pancreas infection
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Paronychia
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Perihepatic abscess
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Perineal abscess
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (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	4 / 6270 (0.06%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	1 / 4	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Peritonsillar abscess
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Peritonsillitis
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pharyngitis
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pilonidal cyst
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pleural infection
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumonia
subjects affected / exposed	26 / 6270 (0.41%)	19 / 6276 (0.30%)
occurrences causally related to treatment / all	0 / 28	0 / 19
deaths causally related to treatment / all	0 / 5	0 / 4
Pneumonia bacterial
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumonia influenzal
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumonia legionella
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Postoperative wound infection
subjects affected / exposed	2 / 6270 (0.03%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pseudomembranous colitis
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pseudomonal sepsis
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pulmonary sepsis
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pulmonary tuberculosis
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pyelocystitis
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pyelonephritis
subjects affected / exposed	2 / 6270 (0.03%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pyelonephritis acute
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Respiratory tract infection
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Rhinitis
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Scrotal abscess
subjects affected / exposed	1 / 6270 (0.02%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Sepsis
subjects affected / exposed	4 / 6270 (0.06%)	6 / 6276 (0.10%)
occurrences causally related to treatment / all	0 / 5	0 / 6
deaths causally related to treatment / all	0 / 2	0 / 0
Septic shock
subjects affected / exposed	0 / 6270 (0.00%)	3 / 6276 (0.05%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 1
Sinusitis
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Subcutaneous abscess
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Subdiaphragmatic abscess
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Upper respiratory tract infection
subjects affected / exposed	0 / 6270 (0.00%)	2 / 6276 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Urinary tract infection
subjects affected / exposed	9 / 6270 (0.14%)	7 / 6276 (0.11%)
occurrences causally related to treatment / all	0 / 9	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
Urosepsis
subjects affected / exposed	2 / 6270 (0.03%)	4 / 6276 (0.06%)
occurrences causally related to treatment / all	0 / 2	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Vestibular neuronitis
subjects affected / exposed	1 / 6270 (0.02%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Viral infection
subjects affected / exposed	1 / 6270 (0.02%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Wound infection
subjects affected / exposed	1 / 6270 (0.02%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Yersinia infection
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Metabolism and nutrition disorders
Dehydration
subjects affected / exposed	4 / 6270 (0.06%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 4	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 0
Diabetes mellitus
subjects affected / exposed	2 / 6270 (0.03%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Fluid retention
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gout
subjects affected / exposed	2 / 6270 (0.03%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hyperkalaemia
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hypoglycaemia
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hypokalaemia
subjects affected / exposed	2 / 6270 (0.03%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hyponatraemia
subjects affected / exposed	1 / 6270 (0.02%)	2 / 6276 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Lactic acidosis
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Metabolic acidosis
subjects affected / exposed	1 / 6270 (0.02%)	0 / 6276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Obesity
subjects affected / exposed	0 / 6270 (0.00%)	1 / 6276 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Type 2 diabetes mellitus
subjects affected / exposed	8 / 6270 (0.13%)	5 / 6276 (0.08%)
occurrences causally related to treatment / all	0 / 8	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 0

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

Non-serious adverse events	Acetylsalicylic Acid	Placebo
Total subjects affected by non serious adverse events
subjects affected / exposed	5059 / 6270 (80.69%)	5053 / 6276 (80.51%)
Vascular disorders
Hypertension
subjects affected / exposed	478 / 6270 (7.62%)	514 / 6276 (8.19%)
occurrences all number	526	578
Gastrointestinal disorders
Dyspepsia
subjects affected / exposed	374 / 6270 (5.96%)	362 / 6276 (5.77%)
occurrences all number	446	419
Respiratory, thoracic and mediastinal disorders
Cough
subjects affected / exposed	442 / 6270 (7.05%)	497 / 6276 (7.92%)
occurrences all number	556	601
Musculoskeletal and connective tissue disorders
Arthralgia
subjects affected / exposed	636 / 6270 (10.14%)	653 / 6276 (10.40%)
occurrences all number	816	803
Back pain
subjects affected / exposed	695 / 6270 (11.08%)	688 / 6276 (10.96%)
occurrences all number	897	908
Osteoarthritis
subjects affected / exposed	468 / 6270 (7.46%)	423 / 6276 (6.74%)
occurrences all number	548	517
Pain in extremity
subjects affected / exposed	354 / 6270 (5.65%)	359 / 6276 (5.72%)
occurrences all number	406	406
Infections and infestations
Bronchitis
subjects affected / exposed	514 / 6270 (8.20%)	482 / 6276 (7.68%)
occurrences all number	741	680
Lower respiratory tract infection
subjects affected / exposed	377 / 6270 (6.01%)	420 / 6276 (6.69%)
occurrences all number	650	703
Nasopharyngitis
subjects affected / exposed	421 / 6270 (6.71%)	407 / 6276 (6.49%)
occurrences all number	550	524
Upper respiratory tract infection
subjects affected / exposed	348 / 6270 (5.55%)	371 / 6276 (5.91%)
occurrences all number	443	491
Urinary tract infection
subjects affected / exposed	363 / 6270 (5.79%)	321 / 6276 (5.11%)
occurrences all number	549	474

More information

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Were there any global substantial amendments to the protocol? Yes

09 Apr 2008

Amendment #2: • Systolic blood pressure (SBP) limit of 170 mmHg has been added to the exclusion criteria • Exclusion of patients currently taking anticoagulant medication • A longer interval between the daily dose of study drug and ibuprofen • Revised wording in moderate risk definitions for coronary heart disease (CHD) and cerebrovascular disease (CVD): “To evaluate the clinical effects of a 100 mg/day enteric-coated acetylsalicylic acid versus placebo in the reduction of CVD events in patients at moderate risk of major CHD events (approximately 10 to 20% 10-year CHD risk; approximately 20 to 30% 10-year risk of CVD). This corresponds to a patient population mean 10-year CVD risk of approximately 30%.”

02 Jan 2009

Amendment #3: • Increase in the number of allowed risk factors for males, age is no longer a risk factor

02 Oct 2013

Amendment #4: • The primary endpoint is changed to include confirmed UA and TIA. • The estimated event rate is changed to 1.5% per year due to new information. • Effect size (risk reduction) changed from 14.9% to 17 to 18%. • Achieving 60,000 person-years instead of 1488 primary endpoint events • Additional treatment and follow-up for a maximum of another 12 months. • Change to reduced adverse event and concomitant therapy reporting

Were there any global interruptions to the trial? No

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

The reported analyses are limited to endpoint events that met strict criteria. Further blinded review of events is ongoing to identify endpoints based on pragmatic criteria. Interpretations for clinical decision making should await future reporting.

http://www.ncbi.nlm.nih.gov/pubmed/30158069

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Clinical trials

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Time to the first occurrence of the composite outcome of MI (myocardial infarction), stroke, cardiovascular death, UA (unstable angina) or TIA (transient ischemic attack)

Primary: Time to the first occurrence of the composite outcome of MI (myocardial infarction), stroke, cardiovascular death, UA (unstable angina) or TIA (transient ischemic attack)

Secondary: Time to the first occurrence of the composite outcome of cardiovascular death, MI, or stroke (ischemic, hemorrhagic, or unknown)

Secondary: Time to the first occurrence of the composite outcome of cardiovascular death, MI, or stroke (ischemic, hemorrhagic, or unknown)

Secondary: Time to the first occurrence of the individual components of the primary: non-fatal MI, total MI, non-fatal stroke, total stroke, cardiovascular death, UA and TIA

Secondary: Time to the first occurrence of the individual components of the primary: non-fatal MI, total MI, non-fatal stroke, total stroke, cardiovascular death, UA and TIA

Secondary: Time to all-cause mortality, the first occurrence of all cancers excluding non-melanoma skin cancer (NMSC) and the first occurrence of colon cancer

Secondary: Time to all-cause mortality, the first occurrence of all cancers excluding non-melanoma skin cancer (NMSC) and the first occurrence of colon cancer

Secondary: Incidence of all-cause mortality, all cancers excluding non-melanoma skin cancer and colon cancer

Secondary: Incidence of all-cause mortality, all cancers excluding non-melanoma skin cancer and colon cancer

Secondary: Incidence of confirmed MI, stroke, cardiovascular death, UA and TIA separately

Secondary: Incidence of confirmed MI, stroke, cardiovascular death, UA and TIA separately

Other pre-specified: Number of subjects with adjudicated GI bleeding by severity

Other pre-specified: Number of subjects with adjudicated GI bleeding by severity

Other pre-specified: Incidence of Composite outcomes and non-fatal MI

Other pre-specified: Incidence of Composite outcomes and non-fatal MI

Other pre-specified: Incidence of Composite outcomes and individual outcomes in per-protocol population

Other pre-specified: Incidence of Composite outcomes and individual outcomes in per-protocol population

Adverse events

Adverse events

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Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

Online references

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