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Clinical Trial Results:
A Clinical Outcomes Study of Darapladib versus Placebo in Subjects with Chronic Coronary Heart Disease to Compare the Incidence of Major Adverse Cardiovascular Events (MACE)

Summary
EudraCT number	2008-005575-96
Trial protocol	NL ES HU SE DE GB SK FR DK EE BE CZ PL BG IT GR
Global end of trial date	17 Oct 2013

Results information
Results version number	v1(current)
This version publication date	27 Apr 2016
First version publication date	11 Apr 2015
Other versions

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

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Trial information

Top of page

Sponsor protocol code

LPL100601

ISRCTN number

-

US NCT number

NCT00799903

WHO universal trial number (UTN)

-

Sponsor organisation name

GlaxoSmithKline

Sponsor organisation address

980 Great West Road, Brentford, Middlesex, United Kingdom,

Public contact

GSK Response Center, GlaxoSmithKline, 866 435-7343,

Scientific contact

GSK Response Center, GlaxoSmithKline, 866 435-7343,

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

No

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

No

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

No

Analysis stage

Final

Date of interim/final analysis

02 Dec 2013

Is this the analysis of the primary completion data?

No

Global end of trial reached?

Yes

Global end of trial date

17 Oct 2013

Was the trial ended prematurely?

No

Main objective of the trial

The primary objective of this study is to evaluate clinical efficacy of long-term treatment with darapladib Enteric Coated tablets, 160 mg (oral once daily dose) as compared to placebo when added to standard of care in a chronic Coronary Heart Disease (CHD) patient population on the incidence of first occurrence of the composite of Major Adverse Cardiovascular Events (MACE) (cardiovascular death, non-fatal Myocardial Infarction (MI), non-fatal stroke).

Protection of trial subjects

The secreted isoform of Lp-PLA2 was first identified on the basis of its in vitro ability to degrade platelet-activating factor (PAF), hence it is also known as PAF-acetylhydrolase (PAF-AH). Although the assertion that Lp-PLA2 degrades PAF in vivo remains unproven, PAF has been implicated in prothrombotic, allergic and inflammatory responses, suggesting that blocking its degradation in patients may be detrimental. Due to this theoretical concern, participants with severe asthma poorly controlled on pharmacotherapy and participants with a history of anaphylaxis, anaphylactoid (resembling anaphylaxis) reactions, or severe allergic responses were excluded from participating in the study.

Background therapy

-

Evidence for comparator

-

Actual start date of recruitment

17 Dec 2008

Long term follow-up planned

No

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

Estonia: 77

Country: Number of subjects enrolled

France: 250

Country: Number of subjects enrolled

Germany: 1089

Country: Number of subjects enrolled

Greece: 187

Country: Number of subjects enrolled

Hungary: 410

Country: Number of subjects enrolled

Italy: 256

Country: Number of subjects enrolled

Netherlands: 444

Country: Number of subjects enrolled

Norway: 113

Country: Number of subjects enrolled

Poland: 510

Country: Number of subjects enrolled

Romania: 411

Country: Number of subjects enrolled

Slovakia: 120

Country: Number of subjects enrolled

Spain: 474

Country: Number of subjects enrolled

Sweden: 299

Country: Number of subjects enrolled

United Kingdom: 184

Country: Number of subjects enrolled

Belgium: 202

Country: Number of subjects enrolled

Bulgaria: 222

Country: Number of subjects enrolled

Czech Republic: 774

Country: Number of subjects enrolled

Denmark: 102

Country: Number of subjects enrolled

Argentina: 542

Country: Number of subjects enrolled

Australia: 306

Country: Number of subjects enrolled

Brazil: 384

Country: Number of subjects enrolled

Canada: 780

Country: Number of subjects enrolled

Chile: 195

Country: Number of subjects enrolled

China: 369

Country: Number of subjects enrolled

Hong Kong: 117

Country: Number of subjects enrolled

India: 398

Country: Number of subjects enrolled

Japan: 318

Country: Number of subjects enrolled

Korea, Republic of: 503

Country: Number of subjects enrolled

Mexico: 141

Country: Number of subjects enrolled

New Zealand: 202

Country: Number of subjects enrolled

Pakistan: 250

Country: Number of subjects enrolled

Peru: 78

Country: Number of subjects enrolled

Philippines: 219

Country: Number of subjects enrolled

Russian Federation: 654

Country: Number of subjects enrolled

South Africa: 386

Country: Number of subjects enrolled

Taiwan: 200

Country: Number of subjects enrolled

Thailand: 207

Country: Number of subjects enrolled

Ukraine: 353

Country: Number of subjects enrolled

United States: 3102

Worldwide total number of subjects

15828

EEA total number of subjects

6124

Number of subjects enrolled per age group

In utero

0

Preterm newborn - gestational age < 37 wk

0

Newborns (0-27 days)

0

Infants and toddlers (28 days-23 months)

0

Children (2-11 years)

0

Adolescents (12-17 years)

0

Adults (18-64 years)

7701

From 65 to 84 years

8029

85 years and over

98

Subject disposition

Top of page

Recruitment details

The study consisted of a Screening Phase of up to 8 weeks duration, a Treatment Phase, an End-of-Treatment (EOT) visit, and a Follow-up visit scheduled for 35 +/- 7 days after last study drug intake. The median treatment duration was anticipated to be 2.75 years.

Screening details

During the Screening Phase of the study, participants presenting with chronic Coronary Heart Disease (CHD) were randomized within 8 weeks. In addition to chronic CHD, participants were required to have at least one additional predictor of cardiovascular risk specified in the protocol.

Period 1 title

Overall Study (overall period)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

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

Are arms mutually exclusive

Yes

Placebo

Arm description

Participants were randomized to receive matching placebo once daily.

Arm type

Placebo

Investigational medicinal product name

matching placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

enteric-coated, micronized, free-base tablet dosed once daily with food and swallowed whole (not crushed or chewed)

Darapladib

Arm description

Participants were randomized to receive darapladib 160 milligram (mg) enteric-coated tablets once daily.

Arm type

Experimental

Investigational medicinal product name

darapladib

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

160 milligram (mg) enteric-coated, micronized, free-base tablet dosed once daily with food and swallowed whole (not crushed or chewed)

Number of subjects in period 1	Placebo	Darapladib
Started	7904	7924
Completed	7631	7646
Not completed	273	278
Consent withdrawn by subject	179	175
Investigator Site Closed	25	23
Lost to follow-up	69	80

Baseline characteristics

Top of page

Reporting group title

Placebo

Reporting group description

Participants were randomized to receive matching placebo once daily.

Reporting group title

Darapladib

Reporting group description

Participants were randomized to receive darapladib 160 milligram (mg) enteric-coated tablets once daily.

Reporting group values	Placebo	Darapladib	Total
Number of subjects	7904	7924	15828
Age categorical
Units: Subjects
In utero			0
Preterm newborn infants (gestational age < 37 wks)			0
Newborns (0-27 days)			0
Infants and toddlers (28 days-23 months)			0
Children (2-11 years)			0
Adolescents (12-17 years)			0
Adults (18-64 years)			0
From 65-84 years			0
85 years and over			0
Age continuous
Units: years
arithmetic mean (standard deviation)	64.3 ( 9.39 )	64.5 ( 9.31 )	-
Gender categorical
Units: Subjects
Female	1506	1461	2967
Male	6398	6463	12861
Race, customized
Units: Subjects
White	6177	6233	12410
Japanese/East Asian (EA)/South EA Heritage (HER)	1017	1003	2020
Central/South Asian Heritage	347	347	694
Mixed Asian Heritage	2	1	3
African American (AA)/African Heritage (AH)	191	175	366
American Indian or Alaska Native	108	106	214
African American/African Heritage & White	36	37	73
American Indian or Alaska Native & White	12	11	23
Native Hawaiian or other Pacific Islander	11	4	15
AA/AH & American Indian or Alaksa Native	2	1	3
Asian & White	0	3	3
Native Hawaiian or other Pacific Islander & White	0	2	2
African American/African Heritage & Asian	1	0	1
American Indian or Alaska Native & Asian	0	1	1

End points

Top of page

Reporting group title

Placebo

Reporting group description

Participants were randomized to receive matching placebo once daily.

Reporting group title

Darapladib

Reporting group description

Participants were randomized to receive darapladib 160 milligram (mg) enteric-coated tablets once daily.

Primary: Number of participants with first occurrence of any component of the composite of major adverse cardiovascular events (cardiovascular [CV] death, non-fatal myocardial infarction [MI] or non-fatal stroke) during the time period for follow-up of CV events

Top of page

End point title

Number of participants with first occurrence of any component of the composite of major adverse cardiovascular events (cardiovascular [CV] death, non-fatal myocardial infarction [MI] or non-fatal stroke) during the time period for follow-up of CV events

End point description

CV death=death due to a CV cause, which included but was not limited to deaths resulting from stroke, arrhythmia, sudden death (witnessed/unwitnessed), MI, heart failure, pulmonary embolism, peripheral arterial disease, or complications of a CV procedure. Deaths not clearly attributable to non-CV causes are considered to be CV deaths. Acute MI=evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia. Prior MI diagnosed post-randomization (e.g., silent MI)=the development of new pathological Q waves with/without symptoms OR imaging evidence of a region of loss of viable myocardium that is thinned and fails to contract, in the absence of a non-ischemic cause (pre-event imaging data required for verification of new abnormality), OR pathological findings of a healed/healing MI. Stroke=presence of a new focal neurologic deficit thought to be of vascular origin, with signs/symptoms lasting >24 hours or results in death (in <24 hours).

End point type

Primary

End point timeframe

From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 4.25 years/average of 3.51 years)

End point values	Placebo	Darapladib
Number of subjects analysed	7904 ^[1]	7924 ^[2]
Units: participants	819	769

Notes
[1] - All Randomized (Intent-to-Treat [ITT]) Population: all randomized participants
[2] - All Randomized (Intent-to-Treat [ITT]) Population: all randomized participants

Statistical Analysis for Primary Endpoint

Comparison groups

Placebo v Darapladib

Number of subjects included in analysis

15828

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.199 ^[3]

Method

Cox proportional hazard regression model

Parameter type

Hazard ratio (HR)

Point estimate

0.94

Confidence interval

level

95.1%

sides

2-sided

lower limit

0.85

upper limit

1.03

Notes
[3] - Statistical significance of this P-value was based on the alpha-spending function of this study.

Secondary: Number of participants with first occurrence of any event in the composite of major coronary events (coronary heart disease [CHD] death, non-fatal MI, or urgent coronary revascularization [CR] for MI) during the time period for follow-up (FU) of CV events

Top of page

End point title

Number of participants with first occurrence of any event in the composite of major coronary events (coronary heart disease [CHD] death, non-fatal MI, or urgent coronary revascularization [CR] for MI) during the time period for follow-up (FU) of CV events

End point description

CHD death=occurrence of a fatal MI, death caused by documented cardiac arrest, death resulting from heart failure in a participant with known CHD, death from other forms of acute/chronic CHD, unwitnessed death of unknown origin, or sudden death. Acute MI=evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia. Prior MI diagnosed post-randomization (e.g.,silent MI)=the development of new pathological Q waves with/without symptoms OR imaging evidence of a region of loss of viable myocardium that is thinned and fails to contract, in the absence of a non-ischemic cause (pre-event imaging data required for verification of new abnormality), OR pathological findings of a healed/healing MI. Urgent CR for MI=ischemic discomfort at rest that prompted CR (percutaneous coronary intervention [PCI: any attempt at CR even if not successful] or coronary artery bypass graft) during the same hospitalization or resulted in hospital transfer for the purpose of CR.

End point type

Secondary

End point timeframe

From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 4.25 years/average of 3.51 years)

End point values	Placebo	Darapladib
Number of subjects analysed	7904 ^[4]	7924 ^[5]
Units: participants	814	737

Notes
[4] - All Randomized (ITT) Population
[5] - All Randomized (ITT) Population

Statistical Analysis for Secondary Endpoint #1

Comparison groups

Placebo v Darapladib

Number of subjects included in analysis

15828

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.045

Method

Cox proportional hazard regression model

Parameter type

Hazard ratio (HR)

Point estimate

0.9

Confidence interval

level

95%

sides

2-sided

lower limit

0.82

upper limit

1

Secondary: Number of participants with first occurrence of any event in the composite of total coronary events (CHD death, non-fatal MI, hospitalization for unstable angina, or any coronary revascularization procedure) during time period for FU of CV events

Top of page

End point title

Number of participants with first occurrence of any event in the composite of total coronary events (CHD death, non-fatal MI, hospitalization for unstable angina, or any coronary revascularization procedure) during time period for FU of CV events

End point description

CHD death, acute MI, and prior MI are defined in the previous secondary endpoint (major coronary events). Hospitalization for unstable angina=one of the following, but not fulfilling the criteria for MI: ischemic discomfort at rest associated with electrocardiogram (ECG) changes leading to hospitalization; ischemic discomfort at rest regardless of ECG changes leading to hospitalization and revascularization during the same admission; ischemic discomfort at rest in hospital associated with ECG changes; ischemic discomfort at rest in hospital without ECG changes resulting in revascularization during the same admission. NOTE: The event was not considered to be unstable angina if, after invasive/non-invasive testing or other diagnostic testing, the discomfort is found not to be caused by myocardial ischemia.

End point type

Secondary

End point timeframe

From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 4.25 years/average of 3.51 years)

End point values	Placebo	Darapladib
Number of subjects analysed	7904 ^[6]	7924 ^[7]
Units: participants	1269	1159

Notes
[6] - All Randomized (ITT) Population
[7] - All Randomized (ITT) Population

Statistical Analysis for Secondary Endpoint #2

Comparison groups

Placebo v Darapladib

Number of subjects included in analysis

15828

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.019

Method

Cox proportional hazards regression

Parameter type

Hazard ratio (HR)

Point estimate

0.91

Confidence interval

level

95%

sides

2-sided

lower limit

0.84

upper limit

0.98

Secondary: Number of participants with CV death during the time period for follow-up of CV events

Top of page

End point title

Number of participants with CV death during the time period for follow-up of CV events

End point description

CV death is defined as a death due to a CV cause, which included but was not limited to deaths resulting from stroke, arrhythmia, sudden death (witnessed/unwitnessed), MI, heart failure, pulmonary embolism, peripheral arterial disease, or complications of a CV procedure. Deaths not clearly attributable to non-CV causes are considered to be CV deaths.

End point type

Secondary

End point timeframe

From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 4.25 years/average of 3.51 years)

End point values	Placebo	Darapladib
Number of subjects analysed	7904 ^[8]	7924 ^[9]
Units: participants	373	359

Notes
[8] - All Randomized (ITT) Population
[9] - All Randomized (ITT) Population

Statistical Analysis for Secondary Endpoint #3

Comparison groups

Placebo v Darapladib

Number of subjects included in analysis

15828

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.594

Method

Cox proportional hazards regression

Parameter type

Hazard ratio (HR)

Point estimate

0.96

Confidence interval

level

95%

sides

2-sided

lower limit

0.83

upper limit

1.11

Secondary: Number of participants with first occurrence of MI (fatal/non-fatal) during the time period for follow-up of CV events

Top of page

End point title

Number of participants with first occurrence of MI (fatal/non-fatal) during the time period for follow-up of CV events

End point description

Acute MI is defined as evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia. Prior MI diagnosed post-randomization (e.g., silent MI)=the development of new pathological Q waves with/without symptoms OR imaging evidence of a region of loss of viable myocardium that is thinned and fails to contract, in the absence of a non-ischemic cause (pre-event imaging data required for verification of new abnormality), OR pathological findings of a healed/healing MI.

End point type

Secondary

End point timeframe

From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 4.25 years/average of 3.51 years)

End point values	Placebo	Darapladib
Number of subjects analysed	7904 ^[10]	7924 ^[11]
Units: participants	405	361

Notes
[10] - All Randomized (ITT) Population
[11] - All Randomized (ITT) Population

Statistical Analysis for Secondary Endpoint #4

Comparison groups

Darapladib v Placebo

Number of subjects included in analysis

15828

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.108

Method

Cox proportional hazards regression

Parameter type

Hazard ratio (HR)

Point estimate

0.89

Confidence interval

level

95%

sides

2-sided

lower limit

0.77

upper limit

1.03

Secondary: Number of participants with first occurrence of stroke (fatal/non-fatal) during the time period for follow-up of CV events

Top of page

End point title

Number of participants with first occurrence of stroke (fatal/non-fatal) during the time period for follow-up of CV events

End point description

Stroke is defined as the presence of a new focal neurologic deficit thought to be of vascular origin, with signs/symptoms lasting >24 hours or results in death (in <24 hours).

End point type

Secondary

End point timeframe

From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 4.25 years/average of 3.51 years)

End point values	Placebo	Darapladib
Number of subjects analysed	7904 ^[12]	7924 ^[13]
Units: participants	152	154

Notes
[12] - All Randomized (ITT) Population
[13] - All Randomized (ITT) Population

Statistical Analysis for Secondary Endpoint #5

Comparison groups

Placebo v Darapladib

Number of subjects included in analysis

15828

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.92

Method

Cox proportional hazards regression

Parameter type

Hazard ratio (HR)

Point estimate

1.01

Confidence interval

level

95%

sides

2-sided

lower limit

0.81

upper limit

1.27

Secondary: Number of participants with first occurrence of any component of the composite of all-cause mortality, non-fatal MI, or non-fatal stroke during the time period for follow-up of CV events

Top of page

End point title

Number of participants with first occurrence of any component of the composite of all-cause mortality, non-fatal MI, or non-fatal stroke during the time period for follow-up of CV events

End point description

Acute MI is defined as evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia. Prior MI diagnosed post-randomization (e.g., silent MI)=the development of new pathological Q waves with/without symptoms OR imaging evidence of a region of loss of viable myocardium that is thinned and fails to contract, in the absence of a non-ischemic cause (pre-event imaging data required for verification of new abnormality), OR pathological findings of a healed/healing MI. Stroke=presence of a new focal neurologic deficit thought to be of vascular origin, with signs/symptoms lasting >24 hours or results in death (in <24 hours).

End point type

Secondary

End point timeframe

From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 4.25 years/average of 3.51 years)

End point values	Placebo	Darapladib
Number of subjects analysed	7904 ^[14]	7924 ^[15]
Units: participants	962	926

Notes
[14] - All Randomized (ITT) Population
[15] - All Randomized (ITT) Population

Statistical Analysis for Secondary Endpoint #6

Comparison groups

Placebo v Darapladib

Number of subjects included in analysis

15828

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.397

Method

Cox proportional hazards regression

Parameter type

Hazard ratio (HR)

Point estimate

0.96

Confidence interval

level

95%

sides

2-sided

lower limit

0.88

upper limit

1.05

Secondary: Number of participants with all-cause mortality during the time period for vital status

Top of page

End point title

Number of participants with all-cause mortality during the time period for vital status

End point description

The number of participants with all-cause mortality was assessed.

End point type

Secondary

End point timeframe

From randomization until death or study completion (up to 4.49 years/average of 3.65 years)

End point values	Placebo	Darapladib
Number of subjects analysed	7904 ^[16]	7924 ^[17]
Units: participants	577	582

Notes
[16] - All Randomized (ITT) Population
[17] - All Randomized (ITT) Population

Statistical Analysis for Secondary Endpoint #7

Comparison groups

Placebo v Darapladib

Number of subjects included in analysis

15828

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.87

Method

Cox proportional hazards regression

Parameter type

Hazard ratio (HR)

Point estimate

1.01

Confidence interval

level

95%

sides

2-sided

lower limit

0.9

upper limit

1.13

Adverse events

Top of page

Timeframe for reporting adverse events

Start=Randomization; Stop=Longer of 35 days after last dose of IP or follow-up (FU) visit. “SAEs assessed as related to IP, study participation, or a GSK concomitant medication” and cancer/GI polyps/neoplasms were recorded up to/including any FU contact.

Adverse event reporting additional description

SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product. Post-randomization AEs have an onset date that is on or after the randomization date.

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

16.0

Reporting group title

Placebo

Reporting group description

Participants received matching placebo once daily.

Reporting group title

Darapladib

Reporting group description

Participants received darapladib 160 milligram (mg) enteric-coated tablets once daily.

Serious adverse events	Placebo	Darapladib
Total subjects affected by serious adverse events
subjects affected / exposed	3448 / 7890 (43.70%)	3369 / 7912 (42.58%)
number of deaths (all causes)	577	582
number of deaths resulting from adverse events
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acoustic neuroma
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Acute lymphocytic leukaemia
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	1 / 1	0 / 0
Acute myeloid leukaemia
subjects affected / exposed	0 / 7890 (0.00%)	6 / 7912 (0.08%)
occurrences causally related to treatment / all	0 / 0	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 5
Adenocarcinoma
subjects affected / exposed	1 / 7890 (0.01%)	4 / 7912 (0.05%)
occurrences causally related to treatment / all	0 / 1	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 2
Adenocarcinoma gastric
subjects affected / exposed	2 / 7890 (0.03%)	3 / 7912 (0.04%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 2	0 / 0
Adenocarcinoma of colon
subjects affected / exposed	4 / 7890 (0.05%)	10 / 7912 (0.13%)
occurrences causally related to treatment / all	1 / 4	4 / 11
deaths causally related to treatment / all	0 / 1	1 / 1
Adenocarcinoma pancreas
subjects affected / exposed	3 / 7890 (0.04%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 2
Adenoid cystic carcinoma
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (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	2 / 7890 (0.03%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Adrenocortical carcinoma
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Ameloblastoma
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Anaplastic astrocytoma
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Angiosarcoma
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
B-cell lymphoma
subjects affected / exposed	2 / 7890 (0.03%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 1
Basal cell carcinoma
subjects affected / exposed	8 / 7890 (0.10%)	3 / 7912 (0.04%)
occurrences causally related to treatment / all	0 / 10	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Benign anorectal neoplasm
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Benign breast neoplasm
subjects affected / exposed	1 / 7890 (0.01%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Benign hepatic neoplasm
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Benign lung neoplasm
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Benign neoplasm of bladder
subjects affected / exposed	2 / 7890 (0.03%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 2	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Benign neoplasm of thyroid gland
subjects affected / exposed	1 / 7890 (0.01%)	1 / 7912 (0.01%)
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 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Benign salivary gland neoplasm
subjects affected / exposed	4 / 7890 (0.05%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 4	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Bile duct adenocarcinoma
subjects affected / exposed	2 / 7890 (0.03%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Bile duct cancer
subjects affected / exposed	1 / 7890 (0.01%)	3 / 7912 (0.04%)
occurrences causally related to treatment / all	0 / 1	1 / 3
deaths causally related to treatment / all	0 / 0	1 / 2
Bladder cancer
subjects affected / exposed	19 / 7890 (0.24%)	21 / 7912 (0.27%)
occurrences causally related to treatment / all	1 / 20	1 / 25
deaths causally related to treatment / all	0 / 1	0 / 2
Bladder cancer recurrent
subjects affected / exposed	3 / 7890 (0.04%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Bladder neoplasm
subjects affected / exposed	2 / 7890 (0.03%)	5 / 7912 (0.06%)
occurrences causally related to treatment / all	0 / 2	1 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Bladder papilloma
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Bladder transitional cell carcinoma
subjects affected / exposed	2 / 7890 (0.03%)	3 / 7912 (0.04%)
occurrences causally related to treatment / all	0 / 2	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Bone cancer
subjects affected / exposed	1 / 7890 (0.01%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 0
Bone cancer metastatic
subjects affected / exposed	1 / 7890 (0.01%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 1
Bowen’s disease
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Brain cancer metastatic
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Brain neoplasm
subjects affected / exposed	2 / 7890 (0.03%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 0
Brain neoplasm benign
subjects affected / exposed	1 / 7890 (0.01%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Brain neoplasm malignant
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Breast cancer
subjects affected / exposed	7 / 7890 (0.09%)	9 / 7912 (0.11%)
occurrences causally related to treatment / all	0 / 8	0 / 10
deaths causally related to treatment / all	0 / 0	0 / 0
Breast cancer metastatic
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Breast cancer stage I
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Breast neoplasm
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Bronchial carcinoma
subjects affected / exposed	4 / 7890 (0.05%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 4	0 / 1
deaths causally related to treatment / all	0 / 3	0 / 1
Cancer pain
subjects affected / exposed	1 / 7890 (0.01%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Carcinoid tumour of the duodenum
subjects affected / exposed	0 / 7890 (0.00%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Carcinoid tumour of the gastrointestinal tract
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac myxoma
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cervix carcinoma
subjects affected / exposed	0 / 7890 (0.00%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Cholangiocarcinoma
subjects affected / exposed	3 / 7890 (0.04%)	4 / 7912 (0.05%)
occurrences causally related to treatment / all	0 / 3	1 / 4
deaths causally related to treatment / all	0 / 1	0 / 2
Cholesteatoma
subjects affected / exposed	2 / 7890 (0.03%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Chondrosarcoma
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Chronic leukaemia
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Chronic lymphocytic leukaemia
subjects affected / exposed	5 / 7890 (0.06%)	3 / 7912 (0.04%)
occurrences causally related to treatment / all	0 / 5	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 1
Chronic lymphocytic leukaemia stage 0
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Chronic myeloid leukaemia
subjects affected / exposed	3 / 7890 (0.04%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	1 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Clear cell renal cell carcinoma
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Colon adenoma
subjects affected / exposed	5 / 7890 (0.06%)	4 / 7912 (0.05%)
occurrences causally related to treatment / all	0 / 5	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Colon cancer
subjects affected / exposed	32 / 7890 (0.41%)	21 / 7912 (0.27%)
occurrences causally related to treatment / all	0 / 33	1 / 22
deaths causally related to treatment / all	0 / 5	0 / 6
Colon cancer metastatic
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Colon cancer stage 0
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Colon cancer stage II
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Colorectal adenocarcinoma
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Colorectal cancer
subjects affected / exposed	0 / 7890 (0.00%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Diffuse large B-cell lymphoma
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Endometrial adenocarcinoma
subjects affected / exposed	0 / 7890 (0.00%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 1
Endometrial cancer
subjects affected / exposed	1 / 7890 (0.01%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 1	1 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Endometrial cancer metastatic
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Gallbladder cancer
subjects affected / exposed	2 / 7890 (0.03%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 2	0 / 0
Gastric adenoma
subjects affected / exposed	0 / 7890 (0.00%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Gastric cancer
subjects affected / exposed	10 / 7890 (0.13%)	10 / 7912 (0.13%)
occurrences causally related to treatment / all	2 / 10	0 / 10
deaths causally related to treatment / all	1 / 6	0 / 6
Gastric cancer recurrent
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal carcinoma
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Gastrointestinal stromal cancer
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal tract adenoma
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Glioblastoma
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Glioma
subjects affected / exposed	1 / 7890 (0.01%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Glottis carcinoma
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Haemangioma
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatic cancer
subjects affected / exposed	6 / 7890 (0.08%)	7 / 7912 (0.09%)
occurrences causally related to treatment / all	0 / 6	0 / 7
deaths causally related to treatment / all	0 / 4	0 / 3
Hepatic cancer metastatic
subjects affected / exposed	3 / 7890 (0.04%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 3	0 / 1
Hepatic neoplasm
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (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 / 7890 (0.01%)	3 / 7912 (0.04%)
occurrences causally related to treatment / all	1 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 2
Hypopharyngeal cancer
subjects affected / exposed	0 / 7890 (0.00%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Hypopharyngeal cancer recurrent
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Intraductal papillary-mucinous carcinoma of pancreas
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Invasive ductal breast carcinoma
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Invasive lobular breast carcinoma
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Large intestine benign neoplasm
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Laryngeal cancer
subjects affected / exposed	1 / 7890 (0.01%)	8 / 7912 (0.10%)
occurrences causally related to treatment / all	0 / 1	1 / 8
deaths causally related to treatment / all	0 / 0	0 / 1
Laryngeal cancer recurrent
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Laryngeal squamous cell carcinoma
subjects affected / exposed	2 / 7890 (0.03%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Leiomyosarcoma
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
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 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Leukaemia
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Lip and/or oral cavity cancer
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Lip neoplasm malignant stage unspecified
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Lipoma
subjects affected / exposed	1 / 7890 (0.01%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Lung adenocarcinoma
subjects affected / exposed	3 / 7890 (0.04%)	6 / 7912 (0.08%)
occurrences causally related to treatment / all	0 / 3	2 / 7
deaths causally related to treatment / all	0 / 0	1 / 3
Lung adenocarcinoma metastatic
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Lung adenocarcinoma stage II
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Lung adenocarcinoma stage IV
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Lung cancer metastatic
subjects affected / exposed	7 / 7890 (0.09%)	6 / 7912 (0.08%)
occurrences causally related to treatment / all	0 / 7	0 / 6
deaths causally related to treatment / all	0 / 5	0 / 4
Lung carcinoma cell type unspecified recurrent
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Lung carcinoma cell type unspecified stage III
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Lung neoplasm
subjects affected / exposed	2 / 7890 (0.03%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 3	1 / 2
deaths causally related to treatment / all	0 / 0	0 / 1
Lung neoplasm malignant
subjects affected / exposed	37 / 7890 (0.47%)	33 / 7912 (0.42%)
occurrences causally related to treatment / all	0 / 38	0 / 33
deaths causally related to treatment / all	0 / 19	0 / 19
Lung squamous cell carcinoma
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Lymphangiosis carcinomatosa
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Lymphocytic lymphoma
subjects affected / exposed	2 / 7890 (0.03%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Lymphoma
subjects affected / exposed	4 / 7890 (0.05%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 4	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 1
Malignant melanoma
subjects affected / exposed	3 / 7890 (0.04%)	9 / 7912 (0.11%)
occurrences causally related to treatment / all	0 / 3	0 / 10
deaths causally related to treatment / all	0 / 0	0 / 1
Malignant melanoma in situ
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Malignant neoplasm of ampulla of Vater
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Malignant neoplasm of unknown primary site
subjects affected / exposed	2 / 7890 (0.03%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 2	0 / 1
Malignant palate neoplasm
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Malignant peritoneal neoplasm
subjects affected / exposed	0 / 7890 (0.00%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 1
Mantle cell lymphoma
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Mediastinum neoplasm
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (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 / 7890 (0.03%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Meningioma benign
subjects affected / exposed	3 / 7890 (0.04%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Mesothelioma
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Metastases to abdominal cavity
subjects affected / exposed	0 / 7890 (0.00%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 2
Metastases to adrenals
subjects affected / exposed	3 / 7890 (0.04%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 2	0 / 0
Metastases to biliary tract
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Metastases to bone
subjects affected / exposed	6 / 7890 (0.08%)	5 / 7912 (0.06%)
occurrences causally related to treatment / all	0 / 6	0 / 5
deaths causally related to treatment / all	0 / 4	0 / 4
Metastases to central nervous system
subjects affected / exposed	3 / 7890 (0.04%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 3	0 / 0
Metastases to liver
subjects affected / exposed	9 / 7890 (0.11%)	5 / 7912 (0.06%)
occurrences causally related to treatment / all	0 / 9	0 / 5
deaths causally related to treatment / all	0 / 5	0 / 3
Metastases to lung
subjects affected / exposed	7 / 7890 (0.09%)	3 / 7912 (0.04%)
occurrences causally related to treatment / all	0 / 7	0 / 3
deaths causally related to treatment / all	0 / 5	0 / 1
Metastases to lymph nodes
subjects affected / exposed	7 / 7890 (0.09%)	4 / 7912 (0.05%)
occurrences causally related to treatment / all	0 / 7	0 / 4
deaths causally related to treatment / all	0 / 4	0 / 3
Metastases to peritoneum
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Metastases to pleura
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Metastases to spine
subjects affected / exposed	4 / 7890 (0.05%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 4	0 / 0
deaths causally related to treatment / all	0 / 2	0 / 0
Metastases to the mediastinum
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	1 / 1	0 / 0
Metastatic bronchial carcinoma
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Metastatic carcinoma of the bladder
subjects affected / exposed	2 / 7890 (0.03%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Metastatic lymphoma
subjects affected / exposed	1 / 7890 (0.01%)	4 / 7912 (0.05%)
occurrences causally related to treatment / all	0 / 1	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 1
Metastatic malignant melanoma
subjects affected / exposed	0 / 7890 (0.00%)	4 / 7912 (0.05%)
occurrences causally related to treatment / all	0 / 0	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 3
Metastatic neoplasm
subjects affected / exposed	2 / 7890 (0.03%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 2	0 / 2
Metastatic salivary gland cancer
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Metastatic squamous cell carcinoma
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Morton’s neuroma
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Myelodysplastic syndrome
subjects affected / exposed	3 / 7890 (0.04%)	3 / 7912 (0.04%)
occurrences causally related to treatment / all	2 / 3	0 / 4
deaths causally related to treatment / all	1 / 1	0 / 0
Neoplasm malignant
subjects affected / exposed	2 / 7890 (0.03%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	1 / 2	0 / 0
deaths causally related to treatment / all	1 / 1	0 / 0
Neoplasm prostate
subjects affected / exposed	2 / 7890 (0.03%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Neurilemmoma benign
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Neuroendocrine carcinoma
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Non-Hodgkin’s lymphoma
subjects affected / exposed	2 / 7890 (0.03%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	1 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Non-small cell lung cancer
subjects affected / exposed	5 / 7890 (0.06%)	4 / 7912 (0.05%)
occurrences causally related to treatment / all	0 / 5	0 / 4
deaths causally related to treatment / all	0 / 2	0 / 4
Non-small cell lung cancer metastatic
subjects affected / exposed	1 / 7890 (0.01%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 1	0 / 0
Oesophageal adenocarcinoma
subjects affected / exposed	0 / 7890 (0.00%)	3 / 7912 (0.04%)
occurrences causally related to treatment / all	0 / 0	1 / 3
deaths causally related to treatment / all	0 / 0	1 / 1
Oesophageal carcinoma
subjects affected / exposed	5 / 7890 (0.06%)	4 / 7912 (0.05%)
occurrences causally related to treatment / all	0 / 6	0 / 5
deaths causally related to treatment / all	0 / 3	0 / 3
Optic nerve neoplasm
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Ovarian cancer
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Pancreatic carcinoma
subjects affected / exposed	8 / 7890 (0.10%)	17 / 7912 (0.21%)
occurrences causally related to treatment / all	2 / 8	0 / 17
deaths causally related to treatment / all	2 / 6	0 / 11
Pancreatic carcinoma metastatic
subjects affected / exposed	1 / 7890 (0.01%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	1 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Papillary thyroid cancer
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Papilloma
subjects affected / exposed	0 / 7890 (0.00%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Parathyroid tumour benign
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Penile cancer
subjects affected / exposed	3 / 7890 (0.04%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Peritoneal carcinoma metastatic
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Phaeochromocytoma malignant
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Pituitary tumour benign
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Plasma cell myeloma
subjects affected / exposed	4 / 7890 (0.05%)	3 / 7912 (0.04%)
occurrences causally related to treatment / all	0 / 4	0 / 3
deaths causally related to treatment / all	0 / 2	0 / 0
Pleural mesothelioma
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Polycythaemia vera
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Prostate cancer
subjects affected / exposed	64 / 7890 (0.81%)	67 / 7912 (0.85%)
occurrences causally related to treatment / all	1 / 64	1 / 67
deaths causally related to treatment / all	0 / 4	0 / 4
Prostate cancer metastatic
subjects affected / exposed	4 / 7890 (0.05%)	4 / 7912 (0.05%)
occurrences causally related to treatment / all	0 / 4	0 / 5
deaths causally related to treatment / all	0 / 2	0 / 3
Prostate cancer recurrent
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Prostatic adenoma
subjects affected / exposed	4 / 7890 (0.05%)	3 / 7912 (0.04%)
occurrences causally related to treatment / all	0 / 4	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Rectal adenocarcinoma
subjects affected / exposed	4 / 7890 (0.05%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 4	0 / 2
deaths causally related to treatment / all	0 / 1	0 / 0
Rectal cancer
subjects affected / exposed	10 / 7890 (0.13%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 14	0 / 2
deaths causally related to treatment / all	0 / 2	0 / 0
Rectosigmoid cancer
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Renal cancer
subjects affected / exposed	6 / 7890 (0.08%)	8 / 7912 (0.10%)
occurrences causally related to treatment / all	0 / 6	0 / 8
deaths causally related to treatment / all	0 / 2	0 / 1
Renal cancer metastatic
subjects affected / exposed	1 / 7890 (0.01%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Renal cell carcinoma
subjects affected / exposed	5 / 7890 (0.06%)	4 / 7912 (0.05%)
occurrences causally related to treatment / all	0 / 5	0 / 4
deaths causally related to treatment / all	0 / 1	0 / 3
Renal neoplasm
subjects affected / exposed	1 / 7890 (0.01%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 1
Salivary gland adenoma
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Salivary gland neoplasm
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Sarcoma
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Signet-ring cell carcinoma
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Skin cancer
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Small cell lung cancer
subjects affected / exposed	5 / 7890 (0.06%)	5 / 7912 (0.06%)
occurrences causally related to treatment / all	0 / 5	0 / 5
deaths causally related to treatment / all	0 / 4	0 / 2
Small cell lung cancer metastatic
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Small intestine adenocarcinoma
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Soft tissue cancer
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Squamous cell carcinoma
subjects affected / exposed	4 / 7890 (0.05%)	4 / 7912 (0.05%)
occurrences causally related to treatment / all	0 / 6	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Squamous cell carcinoma of lung
subjects affected / exposed	2 / 7890 (0.03%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Squamous cell carcinoma of the oral cavity
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Squamous cell carcinoma of the tongue
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Testicular malignant teratoma
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Throat cancer
subjects affected / exposed	0 / 7890 (0.00%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 1
Thymoma
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Thyroid adenoma
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (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 / 7890 (0.03%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Transitional cell cancer of the renal pelvis and ureter
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Transitional cell carcinoma
subjects affected / exposed	4 / 7890 (0.05%)	6 / 7912 (0.08%)
occurrences causally related to treatment / all	1 / 5	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Tumour haemorrhage
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Tumour invasion
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Ureteral neoplasm
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Ureteric cancer
subjects affected / exposed	1 / 7890 (0.01%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Urinary bladder adenoma
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Urinary tract neoplasm
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Uterine cancer
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Uterine leiomyoma
subjects affected / exposed	1 / 7890 (0.01%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Partial seizures with secondary generalisation
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Vascular disorders
Accelerated hypertension
subjects affected / exposed	0 / 7890 (0.00%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 0	1 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Aneurysm
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Aneurysm ruptured
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Angiopathy
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Aortic aneurysm
subjects affected / exposed	24 / 7890 (0.30%)	35 / 7912 (0.44%)
occurrences causally related to treatment / all	0 / 25	0 / 38
deaths causally related to treatment / all	0 / 0	0 / 2
Aortic aneurysm rupture
subjects affected / exposed	1 / 7890 (0.01%)	3 / 7912 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 3
Aortic arteriosclerosis
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Aortic calcification
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Aortic dilatation
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (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	4 / 7890 (0.05%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 4	0 / 1
deaths causally related to treatment / all	0 / 2	0 / 0
Aortic stenosis
subjects affected / exposed	15 / 7890 (0.19%)	16 / 7912 (0.20%)
occurrences causally related to treatment / all	0 / 15	0 / 16
deaths causally related to treatment / all	0 / 1	0 / 0
Aortic thrombosis
subjects affected / exposed	0 / 7890 (0.00%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Arterial disorder
subjects affected / exposed	1 / 7890 (0.01%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Arterial insufficiency
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Arterial occlusive disease
subjects affected / exposed	1 / 7890 (0.01%)	3 / 7912 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Arterial rupture
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Arterial stenosis
subjects affected / exposed	2 / 7890 (0.03%)	4 / 7912 (0.05%)
occurrences causally related to treatment / all	0 / 2	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Arteriosclerosis
subjects affected / exposed	6 / 7890 (0.08%)	7 / 7912 (0.09%)
occurrences causally related to treatment / all	0 / 6	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 3
Arteriovenous fistula
subjects affected / exposed	1 / 7890 (0.01%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Artery dissection
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Bleeding varicose vein
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Blood pressure fluctuation
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Circulatory collapse
subjects affected / exposed	10 / 7890 (0.13%)	6 / 7912 (0.08%)
occurrences causally related to treatment / all	0 / 10	0 / 6
deaths causally related to treatment / all	0 / 3	0 / 0
Deep vein thrombosis
subjects affected / exposed	17 / 7890 (0.22%)	10 / 7912 (0.13%)
occurrences causally related to treatment / all	1 / 17	2 / 10
deaths causally related to treatment / all	0 / 1	0 / 0
Diabetic vascular disorder
subjects affected / exposed	1 / 7890 (0.01%)	3 / 7912 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 5
deaths causally related to treatment / all	0 / 1	0 / 0
Embolism
subjects affected / exposed	1 / 7890 (0.01%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Embolism venous
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Extravasation blood
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Extremity necrosis
subjects affected / exposed	1 / 7890 (0.01%)	4 / 7912 (0.05%)
occurrences causally related to treatment / all	0 / 1	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 1
Femoral artery aneurysm
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Femoral artery occlusion
subjects affected / exposed	12 / 7890 (0.15%)	5 / 7912 (0.06%)
occurrences causally related to treatment / all	0 / 15	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
Haematocoele
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Haematoma
subjects affected / exposed	13 / 7890 (0.16%)	5 / 7912 (0.06%)
occurrences causally related to treatment / all	0 / 13	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 1
Haemorrhage
subjects affected / exposed	3 / 7890 (0.04%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 1	0 / 1
Hypertension
subjects affected / exposed	32 / 7890 (0.41%)	29 / 7912 (0.37%)
occurrences causally related to treatment / all	3 / 34	0 / 33
deaths causally related to treatment / all	0 / 0	0 / 0
Hypertensive crisis
subjects affected / exposed	16 / 7890 (0.20%)	15 / 7912 (0.19%)
occurrences causally related to treatment / all	1 / 16	0 / 15
deaths causally related to treatment / all	0 / 0	0 / 0
Hypertensive emergency
subjects affected / exposed	1 / 7890 (0.01%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hypoperfusion
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hypotension
subjects affected / exposed	39 / 7890 (0.49%)	27 / 7912 (0.34%)
occurrences causally related to treatment / all	0 / 41	0 / 28
deaths causally related to treatment / all	0 / 0	0 / 2
Hypovolaemic shock
subjects affected / exposed	2 / 7890 (0.03%)	6 / 7912 (0.08%)
occurrences causally related to treatment / all	0 / 2	0 / 6
deaths causally related to treatment / all	0 / 1	0 / 5
Iliac artery occlusion
subjects affected / exposed	7 / 7890 (0.09%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 9	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Iliac artery rupture
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Infarction
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Intermittent claudication
subjects affected / exposed	28 / 7890 (0.35%)	21 / 7912 (0.27%)
occurrences causally related to treatment / all	0 / 35	0 / 24
deaths causally related to treatment / all	0 / 0	0 / 0
Intra-abdominal haematoma
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Ischaemia
subjects affected / exposed	2 / 7890 (0.03%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Ischaemic limb pain
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Lymphocele
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Orthostatic hypertension
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
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	8 / 7890 (0.10%)	7 / 7912 (0.09%)
occurrences causally related to treatment / all	0 / 9	0 / 8
deaths causally related to treatment / all	0 / 0	0 / 0
Pelvic venous thrombosis
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (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	55 / 7890 (0.70%)	46 / 7912 (0.58%)
occurrences causally related to treatment / all	1 / 68	0 / 54
deaths causally related to treatment / all	0 / 0	0 / 0
Peripheral artery aneurysm
subjects affected / exposed	2 / 7890 (0.03%)	6 / 7912 (0.08%)
occurrences causally related to treatment / all	0 / 3	0 / 8
deaths causally related to treatment / all	0 / 0	0 / 0
Peripheral artery stenosis
subjects affected / exposed	21 / 7890 (0.27%)	23 / 7912 (0.29%)
occurrences causally related to treatment / all	0 / 34	0 / 27
deaths causally related to treatment / all	0 / 0	0 / 0
Peripheral artery thrombosis
subjects affected / exposed	5 / 7890 (0.06%)	3 / 7912 (0.04%)
occurrences causally related to treatment / all	0 / 5	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 1
Peripheral embolism
subjects affected / exposed	1 / 7890 (0.01%)	2 / 7912 (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	20 / 7890 (0.25%)	19 / 7912 (0.24%)
occurrences causally related to treatment / all	0 / 26	0 / 22
deaths causally related to treatment / all	0 / 0	0 / 1
Peripheral vascular disorder
subjects affected / exposed	27 / 7890 (0.34%)	24 / 7912 (0.30%)
occurrences causally related to treatment / all	0 / 29	0 / 32
deaths causally related to treatment / all	0 / 0	0 / 1
Phlebitis
subjects affected / exposed	2 / 7890 (0.03%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Phlebitis superficial
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Poor peripheral circulation
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Raynaud’s phenomenon
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Renovascular hypertension
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Shock
subjects affected / exposed	1 / 7890 (0.01%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Shock haemorrhagic
subjects affected / exposed	1 / 7890 (0.01%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 1
Subclavian artery aneurysm
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Subclavian artery occlusion
subjects affected / exposed	2 / 7890 (0.03%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Subclavian artery stenosis
subjects affected / exposed	4 / 7890 (0.05%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 4	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Subclavian steal syndrome
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Temporal arteritis
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Thromboangiitis obliterans
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Thrombophlebitis
subjects affected / exposed	2 / 7890 (0.03%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Thrombophlebitis superficial
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Thrombosis
subjects affected / exposed	3 / 7890 (0.04%)	7 / 7912 (0.09%)
occurrences causally related to treatment / all	0 / 3	1 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
Varicose ulceration
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Varicose vein
subjects affected / exposed	3 / 7890 (0.04%)	5 / 7912 (0.06%)
occurrences causally related to treatment / all	0 / 4	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Varicose vein ruptured
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Vascular insufficiency
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Venous insufficiency
subjects affected / exposed	2 / 7890 (0.03%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Venous stenosis
subjects affected / exposed	2 / 7890 (0.03%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Venous thrombosis
subjects affected / exposed	1 / 7890 (0.01%)	4 / 7912 (0.05%)
occurrences causally related to treatment / all	0 / 1	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Venous thrombosis limb
subjects affected / exposed	1 / 7890 (0.01%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Surgical and medical procedures
Coronary revascularisation
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
General disorders and administration site conditions
Adverse drug reaction
subjects affected / exposed	2 / 7890 (0.03%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Asthenia
subjects affected / exposed	15 / 7890 (0.19%)	11 / 7912 (0.14%)
occurrences causally related to treatment / all	0 / 17	0 / 11
deaths causally related to treatment / all	0 / 0	0 / 2
Axillary pain
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac complication associated with device
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Chest discomfort
subjects affected / exposed	7 / 7890 (0.09%)	9 / 7912 (0.11%)
occurrences causally related to treatment / all	0 / 8	0 / 9
deaths causally related to treatment / all	0 / 0	0 / 0
Chest pain
subjects affected / exposed	18 / 7890 (0.23%)	11 / 7912 (0.14%)
occurrences causally related to treatment / all	0 / 18	0 / 11
deaths causally related to treatment / all	0 / 0	0 / 2
Chills
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Death
subjects affected / exposed	73 / 7890 (0.93%)	56 / 7912 (0.71%)
occurrences causally related to treatment / all	1 / 73	0 / 56
deaths causally related to treatment / all	1 / 73	0 / 56
Device battery issue
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Device dislocation
subjects affected / exposed	1 / 7890 (0.01%)	3 / 7912 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Device lead damage
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Device lead issue
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Device malfunction
subjects affected / exposed	5 / 7890 (0.06%)	4 / 7912 (0.05%)
occurrences causally related to treatment / all	0 / 6	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Device occlusion
subjects affected / exposed	11 / 7890 (0.14%)	12 / 7912 (0.15%)
occurrences causally related to treatment / all	1 / 11	0 / 13
deaths causally related to treatment / all	0 / 0	0 / 0
Device power source issue
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Drowning
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Drug intolerance
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Exercise tolerance decreased
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Face oedema
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Fat necrosis
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Fatigue
subjects affected / exposed	9 / 7890 (0.11%)	8 / 7912 (0.10%)
occurrences causally related to treatment / all	1 / 10	0 / 9
deaths causally related to treatment / all	0 / 0	0 / 0
Gait disturbance
subjects affected / exposed	0 / 7890 (0.00%)	3 / 7912 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
General physical health deterioration
subjects affected / exposed	2 / 7890 (0.03%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Generalised oedema
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hernia
subjects affected / exposed	5 / 7890 (0.06%)	3 / 7912 (0.04%)
occurrences causally related to treatment / all	0 / 6	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Hypothermia
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Ill-defined disorder
subjects affected / exposed	1 / 7890 (0.01%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Impaired healing
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Implant site thrombosis
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Inflammation
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Influenza like illness
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Ischaemic ulcer
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Lipogranuloma
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Malaise
subjects affected / exposed	2 / 7890 (0.03%)	3 / 7912 (0.04%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Medical device complication
subjects affected / exposed	4 / 7890 (0.05%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 5	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Medical device pain
subjects affected / exposed	2 / 7890 (0.03%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Medical device site reaction
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Multi-organ disorder
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Multi-organ failure
subjects affected / exposed	6 / 7890 (0.08%)	6 / 7912 (0.08%)
occurrences causally related to treatment / all	0 / 6	0 / 6
deaths causally related to treatment / all	0 / 6	0 / 6
Nodule
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Non-cardiac chest pain
subjects affected / exposed	196 / 7890 (2.48%)	191 / 7912 (2.41%)
occurrences causally related to treatment / all	0 / 235	1 / 238
deaths causally related to treatment / all	0 / 0	0 / 0
Oedema peripheral
subjects affected / exposed	6 / 7890 (0.08%)	8 / 7912 (0.10%)
occurrences causally related to treatment / all	0 / 6	0 / 8
deaths causally related to treatment / all	0 / 0	0 / 0
Pain
subjects affected / exposed	1 / 7890 (0.01%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Polyp
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Puncture site haemorrhage
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pyrexia
subjects affected / exposed	12 / 7890 (0.15%)	12 / 7912 (0.15%)
occurrences causally related to treatment / all	0 / 14	1 / 17
deaths causally related to treatment / all	0 / 0	0 / 1
Spinal pain
subjects affected / exposed	1 / 7890 (0.01%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Stent embolisation
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Sudden cardiac death
subjects affected / exposed	22 / 7890 (0.28%)	24 / 7912 (0.30%)
occurrences causally related to treatment / all	0 / 22	0 / 24
deaths causally related to treatment / all	0 / 22	0 / 24
Sudden death
subjects affected / exposed	56 / 7890 (0.71%)	57 / 7912 (0.72%)
occurrences causally related to treatment / all	0 / 56	1 / 57
deaths causally related to treatment / all	0 / 56	1 / 57
Systemic inflammatory response syndrome
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Thrombosis in device
subjects affected / exposed	1 / 7890 (0.01%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Ulcer haemorrhage
subjects affected / exposed	2 / 7890 (0.03%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Vestibulitis
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Immune system disorders
Allergic oedema
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Allergy to arthropod bite
subjects affected / exposed	1 / 7890 (0.01%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Allergy to arthropod sting
subjects affected / exposed	3 / 7890 (0.04%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 0
Anaphylactic reaction
subjects affected / exposed	1 / 7890 (0.01%)	4 / 7912 (0.05%)
occurrences causally related to treatment / all	0 / 2	1 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Food allergy
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hypersensitivity
subjects affected / exposed	2 / 7890 (0.03%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Social circumstances
Disability
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Reproductive system and breast disorders
Acquired hydrocele
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Acquired phimosis
subjects affected / exposed	2 / 7890 (0.03%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Benign prostatic hyperplasia
subjects affected / exposed	28 / 7890 (0.35%)	31 / 7912 (0.39%)
occurrences causally related to treatment / all	0 / 28	0 / 33
deaths causally related to treatment / all	0 / 0	0 / 0
Breast enlargement
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cervical dysplasia
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Endometrial hyperplasia
subjects affected / exposed	1 / 7890 (0.01%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Epididymal cyst
subjects affected / exposed	2 / 7890 (0.03%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Epididymitis
subjects affected / exposed	1 / 7890 (0.01%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Genital pain
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gynaecomastia
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Ovarian cyst
subjects affected / exposed	2 / 7890 (0.03%)	3 / 7912 (0.04%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Ovarian mass
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pelvic fluid collection
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Penile swelling
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Peyronie’s disease
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Prostatic disorder
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Prostatic obstruction
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Prostatism
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Prostatitis
subjects affected / exposed	4 / 7890 (0.05%)	9 / 7912 (0.11%)
occurrences causally related to treatment / all	0 / 5	0 / 9
deaths causally related to treatment / all	0 / 0	0 / 0
Prostatomegaly
subjects affected / exposed	8 / 7890 (0.10%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 8	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Scrotal oedema
subjects affected / exposed	2 / 7890 (0.03%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Scrotal swelling
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Uterine polyp
subjects affected / exposed	2 / 7890 (0.03%)	3 / 7912 (0.04%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Uterine prolapse
subjects affected / exposed	2 / 7890 (0.03%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Uterovaginal prolapse
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Vaginal polyp
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Vaginal prolapse
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
Acute lung injury
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Acute pulmonary oedema
subjects affected / exposed	14 / 7890 (0.18%)	12 / 7912 (0.15%)
occurrences causally related to treatment / all	0 / 15	0 / 13
deaths causally related to treatment / all	0 / 4	0 / 0
Acute respiratory distress syndrome
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Acute respiratory failure
subjects affected / exposed	18 / 7890 (0.23%)	10 / 7912 (0.13%)
occurrences causally related to treatment / all	0 / 18	0 / 12
deaths causally related to treatment / all	0 / 4	0 / 2
Apnoea
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Asphyxia
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Aspiration
subjects affected / exposed	2 / 7890 (0.03%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 2	0 / 0
Asthma
subjects affected / exposed	8 / 7890 (0.10%)	6 / 7912 (0.08%)
occurrences causally related to treatment / all	0 / 8	0 / 7
deaths causally related to treatment / all	0 / 2	0 / 0
Atelectasis
subjects affected / exposed	1 / 7890 (0.01%)	4 / 7912 (0.05%)
occurrences causally related to treatment / all	0 / 1	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Bronchial hyperreactivity
subjects affected / exposed	0 / 7890 (0.00%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Bronchiectasis
subjects affected / exposed	2 / 7890 (0.03%)	3 / 7912 (0.04%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 1
Bronchitis chronic
subjects affected / exposed	4 / 7890 (0.05%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 4	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Bronchopleural fistula
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Bronchopulmonary disease
subjects affected / exposed	1 / 7890 (0.01%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Bronchospasm
subjects affected / exposed	0 / 7890 (0.00%)	4 / 7912 (0.05%)
occurrences causally related to treatment / all	0 / 0	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 2
Chronic obstructive pulmonary disease
subjects affected / exposed	52 / 7890 (0.66%)	50 / 7912 (0.63%)
occurrences causally related to treatment / all	0 / 74	0 / 75
deaths causally related to treatment / all	0 / 3	0 / 3
Chronic respiratory failure
subjects affected / exposed	2 / 7890 (0.03%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 1	0 / 0
Cough
subjects affected / exposed	2 / 7890 (0.03%)	3 / 7912 (0.04%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Diaphragmatic disorder
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Diaphragmatic paralysis
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Dysphonia
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Dyspnoea
subjects affected / exposed	39 / 7890 (0.49%)	52 / 7912 (0.66%)
occurrences causally related to treatment / all	0 / 42	0 / 55
deaths causally related to treatment / all	0 / 0	0 / 2
Dyspnoea exertional
subjects affected / exposed	7 / 7890 (0.09%)	10 / 7912 (0.13%)
occurrences causally related to treatment / all	1 / 7	0 / 10
deaths causally related to treatment / all	0 / 0	0 / 0
Emphysema
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (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	6 / 7890 (0.08%)	10 / 7912 (0.13%)
occurrences causally related to treatment / all	0 / 6	0 / 11
deaths causally related to treatment / all	0 / 0	0 / 0
Haemoptysis
subjects affected / exposed	6 / 7890 (0.08%)	7 / 7912 (0.09%)
occurrences causally related to treatment / all	0 / 6	0 / 7
deaths causally related to treatment / all	0 / 1	0 / 0
Haemothorax
subjects affected / exposed	2 / 7890 (0.03%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hydropneumothorax
subjects affected / exposed	2 / 7890 (0.03%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hydrothorax
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hypoxia
subjects affected / exposed	5 / 7890 (0.06%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 6	0 / 3
deaths causally related to treatment / all	0 / 2	0 / 0
Idiopathic pulmonary fibrosis
subjects affected / exposed	1 / 7890 (0.01%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Increased upper airway secretion
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Interstitial lung disease
subjects affected / exposed	2 / 7890 (0.03%)	3 / 7912 (0.04%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 1	0 / 2
Laryngeal cyst
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Laryngeal oedema
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Laryngospasm
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Lung consolidation
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Lung cyst
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (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	2 / 7890 (0.03%)	4 / 7912 (0.05%)
occurrences causally related to treatment / all	0 / 2	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 3
Lung infiltration
subjects affected / exposed	3 / 7890 (0.04%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	1 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Mediastinal haematoma
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Mediastinal haemorrhage
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Nasal cyst
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Nasal mucosal hypertrophy
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Nasal polyps
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Nasal septum deviation
subjects affected / exposed	0 / 7890 (0.00%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Nasal turbinate hypertrophy
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Obstructive airways disorder
subjects affected / exposed	3 / 7890 (0.04%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Organising pneumonia
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Oropharyngeal pain
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Orthopnoea
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Painful respiration
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pharyngeal oedema
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pleural effusion
subjects affected / exposed	20 / 7890 (0.25%)	12 / 7912 (0.15%)
occurrences causally related to treatment / all	0 / 22	0 / 13
deaths causally related to treatment / all	0 / 0	0 / 1
Pleuritic pain
subjects affected / exposed	1 / 7890 (0.01%)	4 / 7912 (0.05%)
occurrences causally related to treatment / all	0 / 1	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumonia aspiration
subjects affected / exposed	4 / 7890 (0.05%)	3 / 7912 (0.04%)
occurrences causally related to treatment / all	0 / 4	0 / 3
deaths causally related to treatment / all	0 / 4	0 / 0
Pneumonitis
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (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	6 / 7890 (0.08%)	6 / 7912 (0.08%)
occurrences causally related to treatment / all	0 / 7	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Productive cough
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pulmonary arterial hypertension
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pulmonary congestion
subjects affected / exposed	2 / 7890 (0.03%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pulmonary embolism
subjects affected / exposed	26 / 7890 (0.33%)	35 / 7912 (0.44%)
occurrences causally related to treatment / all	1 / 29	1 / 35
deaths causally related to treatment / all	0 / 3	0 / 7
Pulmonary fibrosis
subjects affected / exposed	2 / 7890 (0.03%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 1
Pulmonary haemorrhage
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
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	0 / 7890 (0.00%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 1
Pulmonary mass
subjects affected / exposed	0 / 7890 (0.00%)	4 / 7912 (0.05%)
occurrences causally related to treatment / all	0 / 0	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 1
Pulmonary oedema
subjects affected / exposed	15 / 7890 (0.19%)	17 / 7912 (0.21%)
occurrences causally related to treatment / all	0 / 15	1 / 17
deaths causally related to treatment / all	0 / 1	0 / 4
Respiratory arrest
subjects affected / exposed	1 / 7890 (0.01%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Respiratory disorder
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Respiratory distress
subjects affected / exposed	2 / 7890 (0.03%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 1	0 / 1
Respiratory failure
subjects affected / exposed	24 / 7890 (0.30%)	18 / 7912 (0.23%)
occurrences causally related to treatment / all	0 / 25	0 / 18
deaths causally related to treatment / all	0 / 10	0 / 3
Restrictive pulmonary disease
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Sleep apnoea syndrome
subjects affected / exposed	6 / 7890 (0.08%)	4 / 7912 (0.05%)
occurrences causally related to treatment / all	0 / 8	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Snoring
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Status asthmaticus
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Vocal cord thickening
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Wheezing
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Psychiatric disorders
Aggression
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Agitation
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Alcohol abuse
subjects affected / exposed	2 / 7890 (0.03%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Alcohol withdrawal syndrome
subjects affected / exposed	2 / 7890 (0.03%)	3 / 7912 (0.04%)
occurrences causally related to treatment / all	0 / 3	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Alcoholism
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Anxiety
subjects affected / exposed	4 / 7890 (0.05%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 4	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Anxiety disorder
subjects affected / exposed	2 / 7890 (0.03%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Completed suicide
subjects affected / exposed	3 / 7890 (0.04%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 3	0 / 2
Confusional state
subjects affected / exposed	12 / 7890 (0.15%)	8 / 7912 (0.10%)
occurrences causally related to treatment / all	0 / 12	0 / 9
deaths causally related to treatment / all	0 / 1	0 / 0
Conversion disorder
subjects affected / exposed	1 / 7890 (0.01%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Delirium
subjects affected / exposed	4 / 7890 (0.05%)	7 / 7912 (0.09%)
occurrences causally related to treatment / all	0 / 4	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
Depression
subjects affected / exposed	7 / 7890 (0.09%)	8 / 7912 (0.10%)
occurrences causally related to treatment / all	0 / 8	1 / 9
deaths causally related to treatment / all	0 / 0	0 / 0
Depression suicidal
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Disorientation
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Dysthymic disorder
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Emotional distress
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hallucination
subjects affected / exposed	0 / 7890 (0.00%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Hallucination, auditory
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Impulse-control disorder
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Insomnia
subjects affected / exposed	1 / 7890 (0.01%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Major depression
subjects affected / exposed	2 / 7890 (0.03%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Mania
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Mental disorder
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Mental status changes
subjects affected / exposed	6 / 7890 (0.08%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 6	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Panic attack
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Psychogenic seizure
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Psychotic disorder
subjects affected / exposed	1 / 7890 (0.01%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Sleep disorder
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Somatoform disorder cardiovascular
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Suicidal behaviour
subjects affected / exposed	1 / 7890 (0.01%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Suicidal ideation
subjects affected / exposed	2 / 7890 (0.03%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Suicide attempt
subjects affected / exposed	1 / 7890 (0.01%)	5 / 7912 (0.06%)
occurrences causally related to treatment / all	0 / 1	0 / 5
deaths causally related to treatment / all	0 / 1	0 / 0
Hepatobiliary disorders
Acute hepatic failure
subjects affected / exposed	1 / 7890 (0.01%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Alcoholic liver disease
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Bile duct obstruction
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Bile duct stenosis
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Bile duct stone
subjects affected / exposed	3 / 7890 (0.04%)	6 / 7912 (0.08%)
occurrences causally related to treatment / all	0 / 3	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
Biliary colic
subjects affected / exposed	1 / 7890 (0.01%)	3 / 7912 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Biliary fistula
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cholangitis
subjects affected / exposed	3 / 7890 (0.04%)	3 / 7912 (0.04%)
occurrences causally related to treatment / all	0 / 3	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Cholangitis acute
subjects affected / exposed	2 / 7890 (0.03%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cholecystitis
subjects affected / exposed	24 / 7890 (0.30%)	21 / 7912 (0.27%)
occurrences causally related to treatment / all	0 / 25	0 / 22
deaths causally related to treatment / all	0 / 0	0 / 0
Cholecystitis acute
subjects affected / exposed	24 / 7890 (0.30%)	19 / 7912 (0.24%)
occurrences causally related to treatment / all	0 / 24	0 / 20
deaths causally related to treatment / all	0 / 0	0 / 1
Cholecystitis chronic
subjects affected / exposed	7 / 7890 (0.09%)	5 / 7912 (0.06%)
occurrences causally related to treatment / all	0 / 7	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Cholelithiasis
subjects affected / exposed	28 / 7890 (0.35%)	30 / 7912 (0.38%)
occurrences causally related to treatment / all	0 / 29	0 / 31
deaths causally related to treatment / all	0 / 0	0 / 0
Cholelithiasis obstructive
subjects affected / exposed	2 / 7890 (0.03%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cholestasis
subjects affected / exposed	1 / 7890 (0.01%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Drug-induced liver injury
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gallbladder disorder
subjects affected / exposed	1 / 7890 (0.01%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gallbladder pain
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gallbladder perforation
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatic cirrhosis
subjects affected / exposed	0 / 7890 (0.00%)	3 / 7912 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 1
Hepatic cyst
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatic failure
subjects affected / exposed	1 / 7890 (0.01%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 1	0 / 2
Hepatic function abnormal
subjects affected / exposed	2 / 7890 (0.03%)	5 / 7912 (0.06%)
occurrences causally related to treatment / all	1 / 2	2 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatic haemorrhage
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatic mass
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatic steatosis
subjects affected / exposed	3 / 7890 (0.04%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 4	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatitis
subjects affected / exposed	0 / 7890 (0.00%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 0	1 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatitis acute
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Hepatitis alcoholic
subjects affected / exposed	2 / 7890 (0.03%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatitis toxic
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatocellular injury
subjects affected / exposed	2 / 7890 (0.03%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatorenal failure
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Hepatotoxicity
subjects affected / exposed	2 / 7890 (0.03%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	1 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hydrocholecystis
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hyperbilirubinaemia
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Ischaemic hepatitis
subjects affected / exposed	2 / 7890 (0.03%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 2	0 / 0
Jaundice
subjects affected / exposed	1 / 7890 (0.01%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 1	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Jaundice cholestatic
subjects affected / exposed	3 / 7890 (0.04%)	3 / 7912 (0.04%)
occurrences causally related to treatment / all	0 / 3	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Liver injury
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumobilia
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Portal hypertension
subjects affected / exposed	2 / 7890 (0.03%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Abdominal infection
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Investigations
Activated partial thromboplastin time prolonged
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Alanine aminotransferase abnormal
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Alanine aminotransferase increased
subjects affected / exposed	11 / 7890 (0.14%)	4 / 7912 (0.05%)
occurrences causally related to treatment / all	1 / 11	2 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Aspartate aminotransferase abnormal
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Aspartate aminotransferase increased
subjects affected / exposed	6 / 7890 (0.08%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	1 / 6	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Bile output abnormal
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Blood alkaline phosphatase increased
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Blood bilirubin increased
subjects affected / exposed	2 / 7890 (0.03%)	4 / 7912 (0.05%)
occurrences causally related to treatment / all	0 / 2	1 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Blood creatine phosphokinase increased
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Blood creatinine increased
subjects affected / exposed	4 / 7890 (0.05%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 4	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Blood glucose decreased
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Blood glucose increased
subjects affected / exposed	3 / 7890 (0.04%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Blood potassium decreased
subjects affected / exposed	2 / 7890 (0.03%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Blood pressure decreased
subjects affected / exposed	0 / 7890 (0.00%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Blood pressure increased
subjects affected / exposed	1 / 7890 (0.01%)	3 / 7912 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Blood urea increased
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Blood urine present
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
C-reactive protein increased
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac murmur
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac stress test abnormal
subjects affected / exposed	0 / 7890 (0.00%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Carotid bruit
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
ECG signs of myocardial ischaemia
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Ejection fraction decreased
subjects affected / exposed	4 / 7890 (0.05%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 4	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Electrocardiogram ST segment depression
subjects affected / exposed	3 / 7890 (0.04%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gamma-glutamyltransferase increased
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Haemoglobin decreased
subjects affected / exposed	1 / 7890 (0.01%)	4 / 7912 (0.05%)
occurrences causally related to treatment / all	0 / 1	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Heart rate decreased
subjects affected / exposed	1 / 7890 (0.01%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Heart rate increased
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Heart rate irregular
subjects affected / exposed	2 / 7890 (0.03%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatic enzyme abnormal
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatic enzyme increased
subjects affected / exposed	5 / 7890 (0.06%)	8 / 7912 (0.10%)
occurrences causally related to treatment / all	1 / 5	2 / 8
deaths causally related to treatment / all	0 / 0	0 / 0
International normalised ratio increased5
subjects affected / exposed	5 / 7890 (0.06%)	3 / 7912 (0.04%)
occurrences causally related to treatment / all	2 / 5	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Intraocular pressure increased
subjects affected / exposed	1 / 7890 (0.01%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Liver function test abnormal
subjects affected / exposed	2 / 7890 (0.03%)	5 / 7912 (0.06%)
occurrences causally related to treatment / all	1 / 2	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 2
Occult blood positive
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Oxygen saturation decreased
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Prostatic specific antigen increased
subjects affected / exposed	1 / 7890 (0.01%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Red blood cell sedimentation rate increased
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Scan myocardial perfusion abnormal
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Streptococcus test positive
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Stroke volume decreased
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Transaminases increased
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Troponin I increased
subjects affected / exposed	1 / 7890 (0.01%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Troponin increased
subjects affected / exposed	3 / 7890 (0.04%)	3 / 7912 (0.04%)
occurrences causally related to treatment / all	0 / 3	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Weight decreased
subjects affected / exposed	5 / 7890 (0.06%)	3 / 7912 (0.04%)
occurrences causally related to treatment / all	0 / 5	0 / 3
deaths causally related to treatment / all	0 / 1	0 / 0
White blood cell count increased
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Bilirubin conjugated increased
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
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 home
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Accidental overdose
subjects affected / exposed	2 / 7890 (0.03%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Acetabulum fracture
subjects affected / exposed	3 / 7890 (0.04%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Anaemia postoperative
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Animal bite
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Ankle fracture
subjects affected / exposed	7 / 7890 (0.09%)	4 / 7912 (0.05%)
occurrences causally related to treatment / all	0 / 7	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Arterial injury
subjects affected / exposed	2 / 7890 (0.03%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Arterial restenosis
subjects affected / exposed	4 / 7890 (0.05%)	3 / 7912 (0.04%)
occurrences causally related to treatment / all	0 / 5	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Arteriovenous fistula thrombosis
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Arthropod sting
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Back injury
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Bone contusion
subjects affected / exposed	2 / 7890 (0.03%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Brain contusion
subjects affected / exposed	0 / 7890 (0.00%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Burns first degree
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Burns second degree
subjects affected / exposed	2 / 7890 (0.03%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac function disturbance postoperative
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Cardiac procedure complication
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Carotid artery restenosis
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Chest injury
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
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 / 7890 (0.01%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Comminuted fracture
subjects affected / exposed	1 / 7890 (0.01%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Concussion
subjects affected / exposed	4 / 7890 (0.05%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 4	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Contusion
subjects affected / exposed	6 / 7890 (0.08%)	5 / 7912 (0.06%)
occurrences causally related to treatment / all	0 / 6	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Coronary artery restenosis
subjects affected / exposed	28 / 7890 (0.35%)	19 / 7912 (0.24%)
occurrences causally related to treatment / all	0 / 31	0 / 21
deaths causally related to treatment / all	0 / 0	0 / 0
Craniocerebral injury
subjects affected / exposed	3 / 7890 (0.04%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 2
Eschar
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Excoriation
subjects affected / exposed	3 / 7890 (0.04%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 4	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Extradural haematoma
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Eye injury
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Eye penetration
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Face injury
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Fall
subjects affected / exposed	17 / 7890 (0.22%)	11 / 7912 (0.14%)
occurrences causally related to treatment / all	0 / 17	0 / 11
deaths causally related to treatment / all	0 / 2	0 / 1
Femoral neck fracture
subjects affected / exposed	12 / 7890 (0.15%)	6 / 7912 (0.08%)
occurrences causally related to treatment / all	0 / 12	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Femur fracture
subjects affected / exposed	11 / 7890 (0.14%)	12 / 7912 (0.15%)
occurrences causally related to treatment / all	0 / 11	0 / 12
deaths causally related to treatment / all	0 / 2	0 / 1
Fibula fracture
subjects affected / exposed	4 / 7890 (0.05%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 4	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Foot fracture
subjects affected / exposed	4 / 7890 (0.05%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 4	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Forearm fracture
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Foreign body
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Fracture
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Fractured sacrum
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal disorder postoperative
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal stoma complication
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Graft thrombosis
subjects affected / exposed	3 / 7890 (0.04%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Gun shot wound
subjects affected / exposed	2 / 7890 (0.03%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hand fracture
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Head injury
subjects affected / exposed	11 / 7890 (0.14%)	7 / 7912 (0.09%)
occurrences causally related to treatment / all	0 / 11	0 / 7
deaths causally related to treatment / all	0 / 2	0 / 0
Heart injury
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hip fracture
subjects affected / exposed	10 / 7890 (0.13%)	13 / 7912 (0.16%)
occurrences causally related to treatment / all	0 / 10	0 / 13
deaths causally related to treatment / all	0 / 0	0 / 1
Humerus fracture
subjects affected / exposed	5 / 7890 (0.06%)	5 / 7912 (0.06%)
occurrences causally related to treatment / all	0 / 6	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Incision site haematoma
subjects affected / exposed	1 / 7890 (0.01%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Incision site haemorrhage
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (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	4 / 7890 (0.05%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 4	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Incisional hernia, obstructive
subjects affected / exposed	3 / 7890 (0.04%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Inflammation of wound
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Injury
subjects affected / exposed	3 / 7890 (0.04%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 1
Internal injury
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Intervertebral disc injury
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Jaw fracture
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Joint dislocation
subjects affected / exposed	5 / 7890 (0.06%)	4 / 7912 (0.05%)
occurrences causally related to treatment / all	0 / 6	0 / 8
deaths causally related to treatment / all	0 / 0	0 / 0
Joint injury
subjects affected / exposed	3 / 7890 (0.04%)	4 / 7912 (0.05%)
occurrences causally related to treatment / all	0 / 3	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Kidney contusion
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Laceration
subjects affected / exposed	9 / 7890 (0.11%)	4 / 7912 (0.05%)
occurrences causally related to treatment / all	0 / 10	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Ligament injury
subjects affected / exposed	1 / 7890 (0.01%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Ligament rupture
subjects affected / exposed	2 / 7890 (0.03%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Ligament sprain
subjects affected / exposed	1 / 7890 (0.01%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Limb crushing injury
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (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	3 / 7890 (0.04%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Limb traumatic amputation
subjects affected / exposed	1 / 7890 (0.01%)	3 / 7912 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Liver contusion
subjects affected / exposed	2 / 7890 (0.03%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Lower limb fracture
subjects affected / exposed	4 / 7890 (0.05%)	3 / 7912 (0.04%)
occurrences causally related to treatment / all	0 / 4	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Lumbar vertebral fracture
subjects affected / exposed	2 / 7890 (0.03%)	4 / 7912 (0.05%)
occurrences causally related to treatment / all	0 / 2	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Meniscus injury
subjects affected / exposed	8 / 7890 (0.10%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 8	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Mental status changes postoperative
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Multiple fractures
subjects affected / exposed	1 / 7890 (0.01%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Multiple injuries
subjects affected / exposed	5 / 7890 (0.06%)	3 / 7912 (0.04%)
occurrences causally related to treatment / all	0 / 5	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Muscle rupture
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Muscle strain
subjects affected / exposed	1 / 7890 (0.01%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Overdose
subjects affected / exposed	5 / 7890 (0.06%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 6	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 0
Patella fracture
subjects affected / exposed	4 / 7890 (0.05%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 5	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Pelvic fracture
subjects affected / exposed	5 / 7890 (0.06%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 5	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 1
Periprosthetic fracture
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Perirenal haematoma
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Poisoning
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Post laminectomy syndrome
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Post procedural complication
subjects affected / exposed	5 / 7890 (0.06%)	5 / 7912 (0.06%)
occurrences causally related to treatment / all	0 / 5	0 / 5
deaths causally related to treatment / all	0 / 1	0 / 0
Post procedural fistula
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Post procedural haematoma
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
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	4 / 7890 (0.05%)	6 / 7912 (0.08%)
occurrences causally related to treatment / all	0 / 4	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Post procedural myocardial infarction
subjects affected / exposed	3 / 7890 (0.04%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Post procedural stroke
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Post procedural swelling
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Postoperative hernia
subjects affected / exposed	1 / 7890 (0.01%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Postoperative ileus
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Postoperative respiratory failure
subjects affected / exposed	1 / 7890 (0.01%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 1
Postoperative thoracic procedure complication
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Postoperative thrombosis
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Procedural complication
subjects affected / exposed	2 / 7890 (0.03%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Procedural haemorrhage
subjects affected / exposed	2 / 7890 (0.03%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Procedural headache
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Procedural hypotension
subjects affected / exposed	0 / 7890 (0.00%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Procedural nausea
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Procedural pain
subjects affected / exposed	3 / 7890 (0.04%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Procedural vomiting
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pubis fracture
subjects affected / exposed	1 / 7890 (0.01%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pulmonary contusion
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Radius fracture
subjects affected / exposed	5 / 7890 (0.06%)	6 / 7912 (0.08%)
occurrences causally related to treatment / all	0 / 5	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Renal haematoma
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Rib fracture
subjects affected / exposed	9 / 7890 (0.11%)	6 / 7912 (0.08%)
occurrences causally related to treatment / all	0 / 9	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Road traffic accident
subjects affected / exposed	6 / 7890 (0.08%)	3 / 7912 (0.04%)
occurrences causally related to treatment / all	0 / 6	0 / 3
deaths causally related to treatment / all	0 / 1	0 / 1
Shunt stenosis
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Skull fracture
subjects affected / exposed	0 / 7890 (0.00%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Skull fractured base
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Soft tissue injury
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Spinal column injury
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Spinal compression fracture
subjects affected / exposed	5 / 7890 (0.06%)	5 / 7912 (0.06%)
occurrences causally related to treatment / all	0 / 5	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Spinal fracture
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Splenic rupture
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Splinter
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Subcutaneous haematoma
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Subdural haematoma
subjects affected / exposed	8 / 7890 (0.10%)	15 / 7912 (0.19%)
occurrences causally related to treatment / all	0 / 10	1 / 16
deaths causally related to treatment / all	0 / 2	0 / 5
Subdural haemorrhage
subjects affected / exposed	2 / 7890 (0.03%)	3 / 7912 (0.04%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 1	0 / 0
Suture related complication
subjects affected / exposed	1 / 7890 (0.01%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Synovial rupture
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Tendon injury
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (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	8 / 7890 (0.10%)	8 / 7912 (0.10%)
occurrences causally related to treatment / all	0 / 8	0 / 8
deaths causally related to treatment / all	0 / 0	0 / 0
Testicular injury
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Thermal burn
subjects affected / exposed	4 / 7890 (0.05%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 4	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Thoracic vertebral fracture
subjects affected / exposed	2 / 7890 (0.03%)	4 / 7912 (0.05%)
occurrences causally related to treatment / all	0 / 2	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Tibia fracture
subjects affected / exposed	5 / 7890 (0.06%)	5 / 7912 (0.06%)
occurrences causally related to treatment / all	0 / 5	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Toxicity to various agents
subjects affected / exposed	6 / 7890 (0.08%)	4 / 7912 (0.05%)
occurrences causally related to treatment / all	0 / 6	0 / 5
deaths causally related to treatment / all	0 / 2	0 / 0
Transfusion reaction
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Transplant failure
subjects affected / exposed	2 / 7890 (0.03%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Traumatic haematoma
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Traumatic intracranial haemorrhage
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Traumatic renal injury
subjects affected / exposed	1 / 7890 (0.01%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Ulna fracture
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Upper limb fracture
subjects affected / exposed	1 / 7890 (0.01%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Urinary bladder rupture
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Vascular bypass dysfunction
subjects affected / exposed	2 / 7890 (0.03%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Vascular graft complication
subjects affected / exposed	6 / 7890 (0.08%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 7	1 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Vascular graft occlusion
subjects affected / exposed	8 / 7890 (0.10%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 11	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Vascular graft thrombosis
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Vascular procedure complication
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Venomous sting
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Wound
subjects affected / exposed	2 / 7890 (0.03%)	4 / 7912 (0.05%)
occurrences causally related to treatment / all	0 / 2	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Wound dehiscence
subjects affected / exposed	2 / 7890 (0.03%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Wound evisceration
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Wound haematoma
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Wound necrosis
subjects affected / exposed	0 / 7890 (0.00%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Wrist fracture
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Congenital, familial and genetic disorders
Arteriovenous malformation
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Atrial septal defect
subjects affected / exposed	0 / 7890 (0.00%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Hypertrophic cardiomyopathy
subjects affected / exposed	0 / 7890 (0.00%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Spinal vessel congenital anomaly
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Syringomyelia
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (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	17 / 7890 (0.22%)	17 / 7912 (0.21%)
occurrences causally related to treatment / all	0 / 19	0 / 17
deaths causally related to treatment / all	0 / 0	0 / 2
Acute left ventricular failure
subjects affected / exposed	3 / 7890 (0.04%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Acute myocardial infarction
subjects affected / exposed	359 / 7890 (4.55%)	303 / 7912 (3.83%)
occurrences causally related to treatment / all	7 / 425	9 / 357
deaths causally related to treatment / all	1 / 44	1 / 35
Angina pectoris
subjects affected / exposed	271 / 7890 (3.43%)	248 / 7912 (3.13%)
occurrences causally related to treatment / all	0 / 309	0 / 282
deaths causally related to treatment / all	0 / 3	0 / 0
Angina unstable
subjects affected / exposed	489 / 7890 (6.20%)	472 / 7912 (5.97%)
occurrences causally related to treatment / all	8 / 618	2 / 569
deaths causally related to treatment / all	0 / 6	0 / 4
Aortic valve disease
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Aortic valve disease mixed
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Aortic valve incompetence
subjects affected / exposed	1 / 7890 (0.01%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Aortic valve stenosis
subjects affected / exposed	10 / 7890 (0.13%)	7 / 7912 (0.09%)
occurrences causally related to treatment / all	0 / 11	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 1
Arrhythmia
subjects affected / exposed	8 / 7890 (0.10%)	7 / 7912 (0.09%)
occurrences causally related to treatment / all	0 / 8	0 / 7
deaths causally related to treatment / all	0 / 3	0 / 2
Arrhythmia supraventricular
subjects affected / exposed	4 / 7890 (0.05%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 4	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Arteriosclerosis coronary artery
subjects affected / exposed	15 / 7890 (0.19%)	5 / 7912 (0.06%)
occurrences causally related to treatment / all	0 / 15	0 / 5
deaths causally related to treatment / all	0 / 2	0 / 1
Arteriospasm coronary
subjects affected / exposed	2 / 7890 (0.03%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Atrial fibrillation
subjects affected / exposed	135 / 7890 (1.71%)	123 / 7912 (1.55%)
occurrences causally related to treatment / all	2 / 164	0 / 153
deaths causally related to treatment / all	0 / 2	0 / 0
Atrial flutter
subjects affected / exposed	27 / 7890 (0.34%)	27 / 7912 (0.34%)
occurrences causally related to treatment / all	0 / 36	0 / 31
deaths causally related to treatment / all	0 / 0	0 / 0
Atrial tachycardia
subjects affected / exposed	1 / 7890 (0.01%)	56 / 7912 (0.71%)
occurrences causally related to treatment / all	0 / 1	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Atrial thrombosis
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Atrioventricular block
subjects affected / exposed	9 / 7890 (0.11%)	5 / 7912 (0.06%)
occurrences causally related to treatment / all	0 / 9	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Atrioventricular block complete
subjects affected / exposed	12 / 7890 (0.15%)	5 / 7912 (0.06%)
occurrences causally related to treatment / all	0 / 12	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Atrioventricular block first degree
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
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	7 / 7890 (0.09%)	8 / 7912 (0.10%)
occurrences causally related to treatment / all	0 / 7	0 / 8
deaths causally related to treatment / all	0 / 0	0 / 0
Atrioventricular dissociation
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Bifascicular block
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Bradyarrhythmia
subjects affected / exposed	2 / 7890 (0.03%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Bradycardia
subjects affected / exposed	19 / 7890 (0.24%)	24 / 7912 (0.30%)
occurrences causally related to treatment / all	0 / 19	1 / 25
deaths causally related to treatment / all	0 / 1	0 / 1
Bundle branch block left
subjects affected / exposed	2 / 7890 (0.03%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Bundle branch block right
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac aneurysm
subjects affected / exposed	1 / 7890 (0.01%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac arrest
subjects affected / exposed	26 / 7890 (0.33%)	28 / 7912 (0.35%)
occurrences causally related to treatment / all	0 / 26	0 / 28
deaths causally related to treatment / all	0 / 20	0 / 22
Cardiac asthma
subjects affected / exposed	1 / 7890 (0.01%)	3 / 7912 (0.04%)
occurrences causally related to treatment / all	0 / 1	1 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac discomfort
subjects affected / exposed	6 / 7890 (0.08%)	5 / 7912 (0.06%)
occurrences causally related to treatment / all	1 / 6	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac disorder
subjects affected / exposed	3 / 7890 (0.04%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 3	1 / 2
deaths causally related to treatment / all	0 / 1	0 / 0
Cardiac failure
subjects affected / exposed	178 / 7890 (2.26%)	155 / 7912 (1.96%)
occurrences causally related to treatment / all	2 / 244	3 / 225
deaths causally related to treatment / all	1 / 36	0 / 26
Cardiac failure acute
subjects affected / exposed	16 / 7890 (0.20%)	10 / 7912 (0.13%)
occurrences causally related to treatment / all	1 / 16	0 / 12
deaths causally related to treatment / all	1 / 8	0 / 2
Cardiac failure chronic
subjects affected / exposed	19 / 7890 (0.24%)	17 / 7912 (0.21%)
occurrences causally related to treatment / all	1 / 21	0 / 21
deaths causally related to treatment / all	0 / 5	0 / 2
Cardiac failure congestive
subjects affected / exposed	135 / 7890 (1.71%)	125 / 7912 (1.58%)
occurrences causally related to treatment / all	2 / 196	1 / 168
deaths causally related to treatment / all	0 / 13	0 / 9
Cardiac tamponade
subjects affected / exposed	2 / 7890 (0.03%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac valve disease
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cardio-respiratory arrest
subjects affected / exposed	15 / 7890 (0.19%)	15 / 7912 (0.19%)
occurrences causally related to treatment / all	1 / 15	1 / 15
deaths causally related to treatment / all	1 / 14	1 / 15
Cardiogenic shock
subjects affected / exposed	11 / 7890 (0.14%)	16 / 7912 (0.20%)
occurrences causally related to treatment / all	0 / 11	0 / 16
deaths causally related to treatment / all	0 / 3	0 / 10
Cardiomyopathy
subjects affected / exposed	4 / 7890 (0.05%)	3 / 7912 (0.04%)
occurrences causally related to treatment / all	0 / 4	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 1
Cardiopulmonary failure
subjects affected / exposed	2 / 7890 (0.03%)	6 / 7912 (0.08%)
occurrences causally related to treatment / all	0 / 2	0 / 6
deaths causally related to treatment / all	0 / 1	0 / 5
Cardiovascular deconditioning
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiovascular disorder
subjects affected / exposed	6 / 7890 (0.08%)	4 / 7912 (0.05%)
occurrences causally related to treatment / all	0 / 6	0 / 4
deaths causally related to treatment / all	0 / 3	0 / 3
Cardiovascular insufficiency
subjects affected / exposed	4 / 7890 (0.05%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 4	0 / 1
deaths causally related to treatment / all	0 / 3	0 / 1
Chronic left ventricular failure
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Chronotropic incompetence
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Conduction disorder
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Congestive cardiomyopathy
subjects affected / exposed	4 / 7890 (0.05%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 4	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 0
Cor pulmonale chronic
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Coronary artery disease
subjects affected / exposed	177 / 7890 (2.24%)	168 / 7912 (2.12%)
occurrences causally related to treatment / all	0 / 190	0 / 185
deaths causally related to treatment / all	0 / 6	0 / 2
Coronary artery insufficiency
subjects affected / exposed	1 / 7890 (0.01%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 1	0 / 1
Coronary artery occlusion
subjects affected / exposed	17 / 7890 (0.22%)	19 / 7912 (0.24%)
occurrences causally related to treatment / all	1 / 17	0 / 19
deaths causally related to treatment / all	0 / 0	0 / 0
Coronary artery stenosis
subjects affected / exposed	59 / 7890 (0.75%)	56 / 7912 (0.71%)
occurrences causally related to treatment / all	3 / 64	0 / 59
deaths causally related to treatment / all	0 / 0	0 / 0
Diastolic dysfunction
subjects affected / exposed	1 / 7890 (0.01%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Extrasystoles
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hypertensive cardiomyopathy
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hypertensive heart disease
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Intracardiac thrombus
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Ischaemic cardiomyopathy
subjects affected / exposed	14 / 7890 (0.18%)	11 / 7912 (0.14%)
occurrences causally related to treatment / all	0 / 14	0 / 11
deaths causally related to treatment / all	0 / 1	0 / 1
Left ventricular dysfunction
subjects affected / exposed	8 / 7890 (0.10%)	13 / 7912 (0.16%)
occurrences causally related to treatment / all	0 / 8	0 / 13
deaths causally related to treatment / all	0 / 0	0 / 1
Left ventricular failure
subjects affected / exposed	6 / 7890 (0.08%)	12 / 7912 (0.15%)
occurrences causally related to treatment / all	0 / 6	0 / 14
deaths causally related to treatment / all	0 / 2	0 / 2
Left ventricular hypertrophy
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Mitral valve disease
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Mitral valve incompetence
subjects affected / exposed	9 / 7890 (0.11%)	10 / 7912 (0.13%)
occurrences causally related to treatment / all	0 / 9	0 / 12
deaths causally related to treatment / all	0 / 0	0 / 0
Mitral valve stenosis
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Myocardial fibrosis
subjects affected / exposed	2 / 7890 (0.03%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 2	0 / 1
Myocardial infarction
subjects affected / exposed	54 / 7890 (0.68%)	56 / 7912 (0.71%)
occurrences causally related to treatment / all	1 / 55	1 / 56
deaths causally related to treatment / all	0 / 21	1 / 34
Myocardial ischaemia
subjects affected / exposed	41 / 7890 (0.52%)	47 / 7912 (0.59%)
occurrences causally related to treatment / all	0 / 45	0 / 49
deaths causally related to treatment / all	0 / 2	0 / 2
Myocarditis
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Nodal arrhythmia
subjects affected / exposed	1 / 7890 (0.01%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Palpitations
subjects affected / exposed	9 / 7890 (0.11%)	5 / 7912 (0.06%)
occurrences causally related to treatment / all	0 / 9	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Pericardial effusion
subjects affected / exposed	6 / 7890 (0.08%)	5 / 7912 (0.06%)
occurrences causally related to treatment / all	0 / 7	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
Pericardial haemorrhage
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pericarditis
subjects affected / exposed	1 / 7890 (0.01%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pericarditis constrictive
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Postinfarction angina
subjects affected / exposed	2 / 7890 (0.03%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Prinzmetal angina
subjects affected / exposed	1 / 7890 (0.01%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pulseless electrical activity
subjects affected / exposed	2 / 7890 (0.03%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Right ventricular failure
subjects affected / exposed	3 / 7890 (0.04%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	1 / 4	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 0
Sick sinus syndrome
subjects affected / exposed	24 / 7890 (0.30%)	15 / 7912 (0.19%)
occurrences causally related to treatment / all	0 / 24	0 / 15
deaths causally related to treatment / all	0 / 0	0 / 0
Silent myocardial infarction
subjects affected / exposed	0 / 7890 (0.00%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Sinoatrial block
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Sinus arrest
subjects affected / exposed	1 / 7890 (0.01%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Sinus arrhythmia
subjects affected / exposed	0 / 7890 (0.00%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Sinus bradycardia
subjects affected / exposed	1 / 7890 (0.01%)	4 / 7912 (0.05%)
occurrences causally related to treatment / all	0 / 1	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Sinus tachycardia
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Stress cardiomyopathy
subjects affected / exposed	1 / 7890 (0.01%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Supraventricular extrasystoles
subjects affected / exposed	2 / 7890 (0.03%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Supraventricular tachyarrhythmia
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (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	8 / 7890 (0.10%)	14 / 7912 (0.18%)
occurrences causally related to treatment / all	0 / 11	3 / 16
deaths causally related to treatment / all	0 / 0	0 / 1
Systolic dysfunction
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Tachycardia
subjects affected / exposed	4 / 7890 (0.05%)	3 / 7912 (0.04%)
occurrences causally related to treatment / all	0 / 5	1 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Torsade de pointes
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Tricuspid valve disease
subjects affected / exposed	0 / 7890 (0.00%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Trifascicular block
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Ventricular arrhythmia
subjects affected / exposed	1 / 7890 (0.01%)	4 / 7912 (0.05%)
occurrences causally related to treatment / all	0 / 1	1 / 4
deaths causally related to treatment / all	0 / 1	0 / 0
Ventricular dyssynchrony
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Ventricular extrasystoles
subjects affected / exposed	9 / 7890 (0.11%)	8 / 7912 (0.10%)
occurrences causally related to treatment / all	0 / 11	0 / 8
deaths causally related to treatment / all	0 / 0	0 / 0
Ventricular fibrillation
subjects affected / exposed	19 / 7890 (0.24%)	22 / 7912 (0.28%)
occurrences causally related to treatment / all	0 / 23	0 / 23
deaths causally related to treatment / all	0 / 7	0 / 5
Ventricular tachyarrhythmia
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Ventricular tachycardia
subjects affected / exposed	42 / 7890 (0.53%)	37 / 7912 (0.47%)
occurrences causally related to treatment / all	1 / 56	1 / 41
deaths causally related to treatment / all	0 / 2	1 / 3
Congenital coronary artery malformation
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hydrocele
subjects affected / exposed	5 / 7890 (0.06%)	6 / 7912 (0.08%)
occurrences causally related to treatment / all	0 / 5	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Nervous system disorders
Alcoholic seizure
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Altered state of consciousness
subjects affected / exposed	0 / 7890 (0.00%)	3 / 7912 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Amyotrophic lateral sclerosis
subjects affected / exposed	0 / 7890 (0.00%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 2
Aphasia
subjects affected / exposed	1 / 7890 (0.01%)	4 / 7912 (0.05%)
occurrences causally related to treatment / all	0 / 1	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Ataxia
subjects affected / exposed	3 / 7890 (0.04%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Balance disorder
subjects affected / exposed	0 / 7890 (0.00%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Basal ganglia infarction
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Brain injury
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Brain midline shift
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Brain oedema
subjects affected / exposed	1 / 7890 (0.01%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Brain stem haemorrhage
subjects affected / exposed	1 / 7890 (0.01%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 1
Brain stem infarction
subjects affected / exposed	4 / 7890 (0.05%)	5 / 7912 (0.06%)
occurrences causally related to treatment / all	0 / 4	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 1
Brain stem ischaemia
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Brain stem stroke
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Carotid arteriosclerosis
subjects affected / exposed	1 / 7890 (0.01%)	3 / 7912 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Carotid artery disease
subjects affected / exposed	4 / 7890 (0.05%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 4	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Carotid artery occlusion
subjects affected / exposed	7 / 7890 (0.09%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 7	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Carotid artery stenosis
subjects affected / exposed	47 / 7890 (0.60%)	48 / 7912 (0.61%)
occurrences causally related to treatment / all	0 / 51	0 / 54
deaths causally related to treatment / all	0 / 0	0 / 0
Carpal tunnel syndrome
subjects affected / exposed	4 / 7890 (0.05%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 4	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Cauda equina syndrome
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Central nervous system lesion
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cerebellar haemorrhage
subjects affected / exposed	1 / 7890 (0.01%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cerebellar infarction
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Diabetic mononeuropathy
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Diabetic neuropathy
subjects affected / exposed	4 / 7890 (0.05%)	4 / 7912 (0.05%)
occurrences causally related to treatment / all	0 / 4	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Disturbance in attention
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Dizziness
subjects affected / exposed	18 / 7890 (0.23%)	18 / 7912 (0.23%)
occurrences causally related to treatment / all	1 / 18	0 / 20
deaths causally related to treatment / all	0 / 0	0 / 1
Dizziness exertional
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Dizziness postural
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Dysaesthesia
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Dysarthria
subjects affected / exposed	2 / 7890 (0.03%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Dyslalia
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Dystonia
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Embolic cerebral infarction
subjects affected / exposed	3 / 7890 (0.04%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Embolic stroke
subjects affected / exposed	4 / 7890 (0.05%)	5 / 7912 (0.06%)
occurrences causally related to treatment / all	0 / 4	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Encephalitis
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Encephalomalacia
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Encephalopathy
subjects affected / exposed	2 / 7890 (0.03%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Epilepsy
subjects affected / exposed	5 / 7890 (0.06%)	7 / 7912 (0.09%)
occurrences causally related to treatment / all	1 / 5	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
Facial paresis
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Grand mal convulsion
subjects affected / exposed	0 / 7890 (0.00%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 0	1 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Guillain-Barre syndrome
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Haemorrhage intracranial
subjects affected / exposed	3 / 7890 (0.04%)	3 / 7912 (0.04%)
occurrences causally related to treatment / all	0 / 3	0 / 3
deaths causally related to treatment / all	0 / 1	0 / 1
Haemorrhagic cerebral infarction
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Haemorrhagic stroke
subjects affected / exposed	19 / 7890 (0.24%)	15 / 7912 (0.19%)
occurrences causally related to treatment / all	0 / 19	2 / 15
deaths causally related to treatment / all	0 / 8	0 / 5
Haemorrhagic transformation stroke
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Headache
subjects affected / exposed	7 / 7890 (0.09%)	5 / 7912 (0.06%)
occurrences causally related to treatment / all	1 / 8	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 1
Hemianopia
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hemiparesis
subjects affected / exposed	4 / 7890 (0.05%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 4	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hemiplegic migraine
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hydrocephalus
subjects affected / exposed	1 / 7890 (0.01%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 0
Hypertensive encephalopathy
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hypoaesthesia
subjects affected / exposed	1 / 7890 (0.01%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hypoglycaemic coma
subjects affected / exposed	2 / 7890 (0.03%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hypoglycaemic unconsciousness
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hypotonia
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hypoxic-ischaemic encephalopathy
subjects affected / exposed	0 / 7890 (0.00%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Intercostal neuralgia
subjects affected / exposed	0 / 7890 (0.00%)	3 / 7912 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Intracranial aneurysm
subjects affected / exposed	0 / 7890 (0.00%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Intraventricular haemorrhage
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Ischaemic cerebral infarction
subjects affected / exposed	20 / 7890 (0.25%)	13 / 7912 (0.16%)
occurrences causally related to treatment / all	0 / 22	1 / 14
deaths causally related to treatment / all	0 / 1	0 / 0
Ischaemic neuropathy
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Ischaemic stroke
subjects affected / exposed	97 / 7890 (1.23%)	94 / 7912 (1.19%)
occurrences causally related to treatment / all	1 / 107	1 / 99
deaths causally related to treatment / all	0 / 4	0 / 15
Lacunar infarction
subjects affected / exposed	6 / 7890 (0.08%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 6	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Lethargy
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Loss of consciousness
subjects affected / exposed	4 / 7890 (0.05%)	5 / 7912 (0.06%)
occurrences causally related to treatment / all	0 / 4	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Memory impairment
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Meningoradiculitis
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Metabolic encephalopathy
subjects affected / exposed	1 / 7890 (0.01%)	3 / 7912 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Migraine
subjects affected / exposed	1 / 7890 (0.01%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Mononeuritis
subjects affected / exposed	1 / 7890 (0.01%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Monoparesis
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Movement disorder
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Nerve compression
subjects affected / exposed	2 / 7890 (0.03%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Nerve root compression
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Nervous system disorder
subjects affected / exposed	1 / 7890 (0.01%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 0
Neuralgia
subjects affected / exposed	2 / 7890 (0.03%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Neuritis
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Neuritis cranial
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Neurological symptom
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Neuropathy peripheral
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Normal pressure hydrocephalus
subjects affected / exposed	1 / 7890 (0.01%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Orthostatic intolerance
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Paraesthesia
subjects affected / exposed	1 / 7890 (0.01%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Paraplegia
subjects affected / exposed	0 / 7890 (0.00%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Paresis
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Parkinson’s disease
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Peripheral nerve paresis
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Polyneuropathy
subjects affected / exposed	2 / 7890 (0.03%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Polyneuropathy chronic
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Post herpetic neuralgia
subjects affected / exposed	1 / 7890 (0.01%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Presyncope
subjects affected / exposed	16 / 7890 (0.20%)	16 / 7912 (0.20%)
occurrences causally related to treatment / all	0 / 16	0 / 17
deaths causally related to treatment / all	0 / 0	0 / 0
Pseudoradicular syndrome
subjects affected / exposed	0 / 7890 (0.00%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Radicular syndrome
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Radiculitis lumbosacral
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Radiculopathy
subjects affected / exposed	2 / 7890 (0.03%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Restless legs syndrome
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Retrograde amnesia
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Reversible ischaemic neurological deficit
subjects affected / exposed	2 / 7890 (0.03%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Ruptured cerebral aneurysm
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Sciatica
subjects affected / exposed	6 / 7890 (0.08%)	6 / 7912 (0.08%)
occurrences causally related to treatment / all	0 / 6	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Senile dementia
subjects affected / exposed	1 / 7890 (0.01%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Sensory disturbance
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Sensory loss
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Simple partial seizures
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Somnolence
subjects affected / exposed	2 / 7890 (0.03%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Spinal claudication
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Spinal cord compression
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Spinal cord disorder
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Spinal haematoma
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Spondylitic myelopathy
subjects affected / exposed	2 / 7890 (0.03%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Status epilepticus
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Stupor
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Subarachnoid haemorrhage
subjects affected / exposed	7 / 7890 (0.09%)	3 / 7912 (0.04%)
occurrences causally related to treatment / all	0 / 7	0 / 3
deaths causally related to treatment / all	0 / 1	0 / 1
Syncope
subjects affected / exposed	79 / 7890 (1.00%)	72 / 7912 (0.91%)
occurrences causally related to treatment / all	0 / 81	0 / 77
deaths causally related to treatment / all	0 / 1	0 / 1
Thalamic infarction
subjects affected / exposed	1 / 7890 (0.01%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Thrombotic cerebral infarction
subjects affected / exposed	2 / 7890 (0.03%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Thrombotic stroke
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Transient global amnesia
subjects affected / exposed	2 / 7890 (0.03%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Transient ischaemic attack
subjects affected / exposed	87 / 7890 (1.10%)	67 / 7912 (0.85%)
occurrences causally related to treatment / all	4 / 98	0 / 75
deaths causally related to treatment / all	0 / 0	0 / 0
Tremor
subjects affected / exposed	0 / 7890 (0.00%)	5 / 7912 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Trigeminal neuralgia
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
VIIth nerve paralysis
subjects affected / exposed	3 / 7890 (0.04%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
VIth nerve paralysis
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Vascular dementia
subjects affected / exposed	2 / 7890 (0.03%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Vascular encephalopathy
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Vascular parkinsonism
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Vertebral artery stenosis
subjects affected / exposed	1 / 7890 (0.01%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Vertebrobasilar insufficiency
subjects affected / exposed	4 / 7890 (0.05%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 5	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Vertigo CNS origin
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Vocal cord paralysis
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
White matter lesion
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cerebral arteriosclerosis
subjects affected / exposed	1 / 7890 (0.01%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cerebral artery embolism
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cerebral artery occlusion
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cerebral artery stenosis
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (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	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cerebral haematoma
subjects affected / exposed	1 / 7890 (0.01%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cerebral haemorrhage
subjects affected / exposed	2 / 7890 (0.03%)	5 / 7912 (0.06%)
occurrences causally related to treatment / all	0 / 2	0 / 5
deaths causally related to treatment / all	0 / 2	0 / 2
Cerebral infarction
subjects affected / exposed	7 / 7890 (0.09%)	15 / 7912 (0.19%)
occurrences causally related to treatment / all	0 / 7	1 / 16
deaths causally related to treatment / all	0 / 1	0 / 0
Cerebral ischaemia
subjects affected / exposed	2 / 7890 (0.03%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cerebrovascular accident
subjects affected / exposed	28 / 7890 (0.35%)	33 / 7912 (0.42%)
occurrences causally related to treatment / all	0 / 28	0 / 33
deaths causally related to treatment / all	0 / 3	0 / 10
Cerebrovascular disorder
subjects affected / exposed	2 / 7890 (0.03%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Cervical myelopathy
subjects affected / exposed	1 / 7890 (0.01%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cervicobrachial syndrome
subjects affected / exposed	4 / 7890 (0.05%)	4 / 7912 (0.05%)
occurrences causally related to treatment / all	0 / 4	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Cognitive disorder
subjects affected / exposed	1 / 7890 (0.01%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Coma
subjects affected / exposed	1 / 7890 (0.01%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 0
Complex partial seizures
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Complex regional pain syndrome
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Convulsion
subjects affected / exposed	8 / 7890 (0.10%)	5 / 7912 (0.06%)
occurrences causally related to treatment / all	0 / 10	0 / 5
deaths causally related to treatment / all	0 / 1	0 / 0
Critical illness polyneuropathy
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Dementia
subjects affected / exposed	4 / 7890 (0.05%)	4 / 7912 (0.05%)
occurrences causally related to treatment / all	0 / 4	0 / 4
deaths causally related to treatment / all	0 / 1	0 / 0
Dementia Alzheimer’s type
subjects affected / exposed	1 / 7890 (0.01%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Dementia with Lewy bodies
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Depressed level of consciousness
subjects affected / exposed	1 / 7890 (0.01%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Diabetic hyperosmolar coma
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
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
Anaemia
subjects affected / exposed	52 / 7890 (0.66%)	42 / 7912 (0.53%)
occurrences causally related to treatment / all	2 / 54	0 / 43
deaths causally related to treatment / all	1 / 3	0 / 1
Anaemia macrocytic
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Anaemia megaloblastic
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Anaemia of chronic disease
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Bone marrow failure
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Bone marrow ischaemia
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Coagulopathy
subjects affected / exposed	3 / 7890 (0.04%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Disseminated intravascular coagulation
subjects affected / exposed	3 / 7890 (0.04%)	3 / 7912 (0.04%)
occurrences causally related to treatment / all	0 / 3	0 / 3
deaths causally related to treatment / all	0 / 2	0 / 3
Febrile neutropenia
subjects affected / exposed	2 / 7890 (0.03%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 0
Haemolytic anaemia
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Haemorrhagic anaemia
subjects affected / exposed	1 / 7890 (0.01%)	5 / 7912 (0.06%)
occurrences causally related to treatment / all	0 / 1	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 1
Hyperprothrombinaemia
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (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	3 / 7890 (0.04%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Idiopathic thrombocytopenic purpura
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Iron deficiency anaemia
subjects affected / exposed	8 / 7890 (0.10%)	6 / 7912 (0.08%)
occurrences causally related to treatment / all	0 / 8	0 / 7
deaths causally related to treatment / all	0 / 1	0 / 0
Jaundice acholuric
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Leukocytosis
subjects affected / exposed	2 / 7890 (0.03%)	5 / 7912 (0.06%)
occurrences causally related to treatment / all	0 / 2	1 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Lymphadenopathy
subjects affected / exposed	1 / 7890 (0.01%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Microcytic anaemia
subjects affected / exposed	2 / 7890 (0.03%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pancytopenia
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Polycythaemia
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Spontaneous haematoma
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Thrombocytopenia
subjects affected / exposed	7 / 7890 (0.09%)	5 / 7912 (0.06%)
occurrences causally related to treatment / all	1 / 7	0 / 6
deaths causally related to treatment / all	0 / 1	0 / 0
Ear and labyrinth disorders
Deafness
subjects affected / exposed	0 / 7890 (0.00%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Otosclerosis
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Ototoxicity
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Sudden hearing loss
subjects affected / exposed	1 / 7890 (0.01%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Tinnitus
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Vertigo
subjects affected / exposed	6 / 7890 (0.08%)	14 / 7912 (0.18%)
occurrences causally related to treatment / all	0 / 6	0 / 16
deaths causally related to treatment / all	0 / 0	0 / 0
Vertigo labyrinthine
subjects affected / exposed	1 / 7890 (0.01%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Vertigo positional
subjects affected / exposed	3 / 7890 (0.04%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Vestibular disorder
subjects affected / exposed	4 / 7890 (0.05%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 4	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Eye disorders
Amaurosis fugax
subjects affected / exposed	3 / 7890 (0.04%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Blindness
subjects affected / exposed	1 / 7890 (0.01%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Blindness unilateral
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cataract
subjects affected / exposed	16 / 7890 (0.20%)	16 / 7912 (0.20%)
occurrences causally related to treatment / all	0 / 20	0 / 17
deaths causally related to treatment / all	0 / 0	0 / 0
Conjunctivitis
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Dacryostenosis acquired
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Diabetic eye disease
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Diabetic retinopathy
subjects affected / exposed	0 / 7890 (0.00%)	3 / 7912 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Diplopia
subjects affected / exposed	1 / 7890 (0.01%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Eye disorder
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Eye haemorrhage
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Eye pain
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Eyelid ptosis
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Glaucoma
subjects affected / exposed	1 / 7890 (0.01%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Macular fibrosis
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Ocular retrobulbar haemorrhage
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Ocular vascular disorder
subjects affected / exposed	1 / 7890 (0.01%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Ophthalmoplegia
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (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 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pterygium
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Retinal artery occlusion
subjects affected / exposed	0 / 7890 (0.00%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Retinal artery thrombosis
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Retinal degeneration
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Retinal detachment
subjects affected / exposed	3 / 7890 (0.04%)	3 / 7912 (0.04%)
occurrences causally related to treatment / all	0 / 3	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Retinal haemorrhage
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Retinal ischaemia
subjects affected / exposed	0 / 7890 (0.00%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Retinal tear
subjects affected / exposed	2 / 7890 (0.03%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Retinal vascular thrombosis
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (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 / 7890 (0.01%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Retinopathy
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Ulcerative keratitis
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Vision blurred
subjects affected / exposed	1 / 7890 (0.01%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Visual acuity reduced
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Vitreous haemorrhage
subjects affected / exposed	2 / 7890 (0.03%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal disorders
Abdominal adhesions
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Abdominal distension
subjects affected / exposed	0 / 7890 (0.00%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Abdominal hernia
subjects affected / exposed	5 / 7890 (0.06%)	6 / 7912 (0.08%)
occurrences causally related to treatment / all	0 / 5	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Abdominal hernia obstructive
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Abdominal pain
subjects affected / exposed	25 / 7890 (0.32%)	12 / 7912 (0.15%)
occurrences causally related to treatment / all	1 / 25	0 / 13
deaths causally related to treatment / all	0 / 0	0 / 0
Abdominal pain upper
subjects affected / exposed	7 / 7890 (0.09%)	11 / 7912 (0.14%)
occurrences causally related to treatment / all	1 / 7	0 / 13
deaths causally related to treatment / all	0 / 0	0 / 0
Abdominal strangulated hernia
subjects affected / exposed	2 / 7890 (0.03%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Abdominal wall haematoma
subjects affected / exposed	0 / 7890 (0.00%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Abdominal wall mass
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Acute abdomen
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Alcoholic pancreatitis
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Anal fissure
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Anal fistula
subjects affected / exposed	3 / 7890 (0.04%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Anorectal disorder
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Appendix disorder
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Ascites
subjects affected / exposed	5 / 7890 (0.06%)	3 / 7912 (0.04%)
occurrences causally related to treatment / all	0 / 7	0 / 4
deaths causally related to treatment / all	0 / 1	0 / 1
Buccal polyp
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Colitis
subjects affected / exposed	12 / 7890 (0.15%)	7 / 7912 (0.09%)
occurrences causally related to treatment / all	0 / 12	0 / 8
deaths causally related to treatment / all	0 / 0	0 / 0
Colitis ischaemic
subjects affected / exposed	5 / 7890 (0.06%)	6 / 7912 (0.08%)
occurrences causally related to treatment / all	0 / 7	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 1
Colitis ulcerative
subjects affected / exposed	1 / 7890 (0.01%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	1 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Colonic stenosis
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Constipation
subjects affected / exposed	5 / 7890 (0.06%)	11 / 7912 (0.14%)
occurrences causally related to treatment / all	0 / 5	0 / 11
deaths causally related to treatment / all	0 / 0	0 / 0
Crohn’s disease
subjects affected / exposed	1 / 7890 (0.01%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Dental caries
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Diabetic gastroparesis
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Diaphragmatic hernia
subjects affected / exposed	0 / 7890 (0.00%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Diarrhoea
subjects affected / exposed	21 / 7890 (0.27%)	23 / 7912 (0.29%)
occurrences causally related to treatment / all	3 / 21	3 / 25
deaths causally related to treatment / all	0 / 0	0 / 0
Diarrhoea haemorrhagic
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Dieulafoy’s vascular malformation
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Diverticular perforation
subjects affected / exposed	0 / 7890 (0.00%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Diverticulitis intestinal haemorrhagic
subjects affected / exposed	1 / 7890 (0.01%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Diverticulum
subjects affected / exposed	3 / 7890 (0.04%)	3 / 7912 (0.04%)
occurrences causally related to treatment / all	0 / 3	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Diverticulum intestinal
subjects affected / exposed	5 / 7890 (0.06%)	7 / 7912 (0.09%)
occurrences causally related to treatment / all	0 / 7	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
Diverticulum intestinal haemorrhagic
subjects affected / exposed	4 / 7890 (0.05%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 4	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Duodenal polyp
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Duodenal ulcer
subjects affected / exposed	6 / 7890 (0.08%)	5 / 7912 (0.06%)
occurrences causally related to treatment / all	0 / 6	2 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Duodenal ulcer haemorrhage
subjects affected / exposed	7 / 7890 (0.09%)	5 / 7912 (0.06%)
occurrences causally related to treatment / all	2 / 8	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Duodenal ulcer perforation
subjects affected / exposed	2 / 7890 (0.03%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Duodenal vascular ectasia
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Duodenitis
subjects affected / exposed	1 / 7890 (0.01%)	4 / 7912 (0.05%)
occurrences causally related to treatment / all	0 / 1	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Dyspepsia
subjects affected / exposed	4 / 7890 (0.05%)	4 / 7912 (0.05%)
occurrences causally related to treatment / all	0 / 4	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Dysphagia
subjects affected / exposed	4 / 7890 (0.05%)	4 / 7912 (0.05%)
occurrences causally related to treatment / all	0 / 4	0 / 4
deaths causally related to treatment / all	0 / 1	0 / 0
Enteritis
subjects affected / exposed	1 / 7890 (0.01%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Enterocolitis
subjects affected / exposed	1 / 7890 (0.01%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Enterovesical fistula
subjects affected / exposed	2 / 7890 (0.03%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Epigastric discomfort
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Erosive duodenitis
subjects affected / exposed	1 / 7890 (0.01%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Erosive oesophagitis
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Faecal incontinence
subjects affected / exposed	1 / 7890 (0.01%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Faeces discoloured
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Femoral hernia, obstructive
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Frequent bowel movements
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gallstone ileus
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastric dysplasia
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastric haemorrhage
subjects affected / exposed	3 / 7890 (0.04%)	6 / 7912 (0.08%)
occurrences causally related to treatment / all	0 / 3	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 1
Gastric polyps
subjects affected / exposed	2 / 7890 (0.03%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastric ulcer
subjects affected / exposed	7 / 7890 (0.09%)	17 / 7912 (0.21%)
occurrences causally related to treatment / all	0 / 7	0 / 17
deaths causally related to treatment / all	0 / 1	0 / 0
Gastric ulcer haemorrhage
subjects affected / exposed	6 / 7890 (0.08%)	5 / 7912 (0.06%)
occurrences causally related to treatment / all	1 / 7	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 1
Gastritis
subjects affected / exposed	18 / 7890 (0.23%)	12 / 7912 (0.15%)
occurrences causally related to treatment / all	2 / 18	0 / 12
deaths causally related to treatment / all	0 / 0	0 / 0
Gastritis atrophic
subjects affected / exposed	1 / 7890 (0.01%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastritis erosive
subjects affected / exposed	7 / 7890 (0.09%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 8	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Gastritis haemorrhagic
subjects affected / exposed	3 / 7890 (0.04%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Gastroduodenal ulcer
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gastroduodenitis
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal angiodysplasia
subjects affected / exposed	2 / 7890 (0.03%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal angiodysplasia haemorrhagic
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal erosion
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal haemorrhage
subjects affected / exposed	26 / 7890 (0.33%)	30 / 7912 (0.38%)
occurrences causally related to treatment / all	0 / 27	0 / 31
deaths causally related to treatment / all	0 / 2	0 / 2
Gastrointestinal ischaemia
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Gastrointestinal motility disorder
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal necrosis
subjects affected / exposed	1 / 7890 (0.01%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal pain
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal ulcer haemorrhage
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (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	18 / 7890 (0.23%)	14 / 7912 (0.18%)
occurrences causally related to treatment / all	0 / 18	0 / 14
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrooesophagitis
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Haematemesis
subjects affected / exposed	2 / 7890 (0.03%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Haematochezia
subjects affected / exposed	1 / 7890 (0.01%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Haemorrhagic erosive gastritis
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (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	0 / 7890 (0.00%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Haemorrhoids
subjects affected / exposed	8 / 7890 (0.10%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 8	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Hiatus hernia
subjects affected / exposed	1 / 7890 (0.01%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Hypoaesthesia oral
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Ileal ulcer
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Ileitis
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (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	7 / 7890 (0.09%)	6 / 7912 (0.08%)
occurrences causally related to treatment / all	1 / 7	1 / 6
deaths causally related to treatment / all	0 / 1	0 / 1
Ileus paralytic
subjects affected / exposed	0 / 7890 (0.00%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Inguinal hernia
subjects affected / exposed	48 / 7890 (0.61%)	31 / 7912 (0.39%)
occurrences causally related to treatment / all	0 / 50	0 / 33
deaths causally related to treatment / all	0 / 0	0 / 0
Inguinal hernia, obstructive
subjects affected / exposed	2 / 7890 (0.03%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Internal hernia
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Intestinal haemorrhage
subjects affected / exposed	1 / 7890 (0.01%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Intestinal infarction
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Intestinal ischaemia
subjects affected / exposed	5 / 7890 (0.06%)	4 / 7912 (0.05%)
occurrences causally related to treatment / all	0 / 7	0 / 5
deaths causally related to treatment / all	0 / 2	0 / 1
Intestinal obstruction
subjects affected / exposed	7 / 7890 (0.09%)	9 / 7912 (0.11%)
occurrences causally related to treatment / all	0 / 7	0 / 9
deaths causally related to treatment / all	0 / 3	0 / 0
Intestinal perforation
subjects affected / exposed	1 / 7890 (0.01%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Intestinal polyp
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Large intestinal ulcer
subjects affected / exposed	0 / 7890 (0.00%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Large intestine perforation
subjects affected / exposed	2 / 7890 (0.03%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Large intestine polyp
subjects affected / exposed	16 / 7890 (0.20%)	21 / 7912 (0.27%)
occurrences causally related to treatment / all	0 / 16	0 / 23
deaths causally related to treatment / all	0 / 1	0 / 0
Lip haematoma
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Lower gastrointestinal haemorrhage
subjects affected / exposed	10 / 7890 (0.13%)	4 / 7912 (0.05%)
occurrences causally related to treatment / all	0 / 11	0 / 5
deaths causally related to treatment / all	0 / 1	0 / 0
Lumbar hernia
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Mallory-Weiss syndrome
subjects affected / exposed	4 / 7890 (0.05%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 5	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Melaena
subjects affected / exposed	3 / 7890 (0.04%)	5 / 7912 (0.06%)
occurrences causally related to treatment / all	0 / 3	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Mesenteric artery stenosis
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Mesenteric occlusion
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Mesenteric panniculitis
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Mouth cyst
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Nausea
subjects affected / exposed	12 / 7890 (0.15%)	11 / 7912 (0.14%)
occurrences causally related to treatment / all	0 / 13	0 / 12
deaths causally related to treatment / all	0 / 0	0 / 0
Oedema mouth
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Oedematous pancreatitis
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Oesophageal dysplasia
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Oesophageal perforation
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (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 / 7890 (0.01%)	3 / 7912 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Oesophageal ulcer haemorrhage
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (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 / 7890 (0.01%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Oesophagitis
subjects affected / exposed	1 / 7890 (0.01%)	5 / 7912 (0.06%)
occurrences causally related to treatment / all	0 / 1	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Oral pain
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pancreatic calcification
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pancreatic disorder
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (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	15 / 7890 (0.19%)	15 / 7912 (0.19%)
occurrences causally related to treatment / all	2 / 20	2 / 15
deaths causally related to treatment / all	0 / 0	0 / 0
Pancreatitis acute
subjects affected / exposed	12 / 7890 (0.15%)	7 / 7912 (0.09%)
occurrences causally related to treatment / all	1 / 13	1 / 7
deaths causally related to treatment / all	0 / 2	0 / 0
Pancreatitis chronic
subjects affected / exposed	4 / 7890 (0.05%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 4	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Pancreatitis haemorrhagic
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pancreatitis necrotising
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Papilla of Vater stenosis
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Paraesthesia oral
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Peptic ulcer
subjects affected / exposed	1 / 7890 (0.01%)	3 / 7912 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Peptic ulcer haemorrhage
subjects affected / exposed	2 / 7890 (0.03%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Peptic ulcer perforation
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Pneumatosis intestinalis
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Poor dental condition
subjects affected / exposed	0 / 7890 (0.00%)	11 / 7912 (0.14%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Proctalgia
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Proctitis
subjects affected / exposed	1 / 7890 (0.01%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Proctitis ulcerative
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Rectal haemorrhage
subjects affected / exposed	9 / 7890 (0.11%)	13 / 7912 (0.16%)
occurrences causally related to treatment / all	0 / 9	0 / 15
deaths causally related to treatment / all	0 / 0	0 / 0
Rectal polyp
subjects affected / exposed	1 / 7890 (0.01%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Rectal prolapse
subjects affected / exposed	2 / 7890 (0.03%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Reflux gastritis
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Retroperitoneal haematoma
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Retroperitoneal haemorrhage
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Small intestinal obstruction
subjects affected / exposed	9 / 7890 (0.11%)	11 / 7912 (0.14%)
occurrences causally related to treatment / all	0 / 11	0 / 11
deaths causally related to treatment / all	0 / 0	0 / 0
Small intestinal perforation
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Spigelian hernia
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Stomach mass
subjects affected / exposed	1 / 7890 (0.01%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Subileus
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Tooth disorder
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Toothache
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Umbilical hernia
subjects affected / exposed	7 / 7890 (0.09%)	6 / 7912 (0.08%)
occurrences causally related to treatment / all	0 / 7	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Umbilical hernia, obstructive
subjects affected / exposed	2 / 7890 (0.03%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Upper gastrointestinal haemorrhage
subjects affected / exposed	16 / 7890 (0.20%)	18 / 7912 (0.23%)
occurrences causally related to treatment / all	0 / 17	1 / 18
deaths causally related to treatment / all	0 / 2	0 / 0
Volvulus
subjects affected / exposed	0 / 7890 (0.00%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Vomiting
subjects affected / exposed	12 / 7890 (0.15%)	7 / 7912 (0.09%)
occurrences causally related to treatment / all	0 / 14	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
Skin and subcutaneous tissue disorders
Actinic keratosis
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Angioedema
subjects affected / exposed	2 / 7890 (0.03%)	3 / 7912 (0.04%)
occurrences causally related to treatment / all	0 / 2	2 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Blister
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cold sweat
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Decubitus ulcer
subjects affected / exposed	1 / 7890 (0.01%)	3 / 7912 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 1	0 / 1
Dermatitis allergic
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Diabetic foot
subjects affected / exposed	14 / 7890 (0.18%)	5 / 7912 (0.06%)
occurrences causally related to treatment / all	0 / 20	0 / 5
deaths causally related to treatment / all	0 / 1	0 / 0
Drug eruption
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Ecchymosis
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Eczema
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Eczema asteatotic
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Erythema multiforme
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Erythema nodosum
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Hyperhidrosis
subjects affected / exposed	4 / 7890 (0.05%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 4	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Keloid scar
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Leukocytoclastic vasculitis
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Neuropathic ulcer
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pemphigoid
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pruritus
subjects affected / exposed	0 / 7890 (0.00%)	3 / 7912 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Psoriasis
subjects affected / exposed	1 / 7890 (0.01%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	1 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pyoderma gangrenosum
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Rash
subjects affected / exposed	2 / 7890 (0.03%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Rash generalised
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Skin disorder
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Skin necrosis
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (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	8 / 7890 (0.10%)	5 / 7912 (0.06%)
occurrences causally related to treatment / all	0 / 9	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Stasis dermatitis
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Swelling face
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (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 / 7890 (0.00%)	1 / 7912 (0.01%)
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 prerenal failure
subjects affected / exposed	3 / 7890 (0.04%)	3 / 7912 (0.04%)
occurrences causally related to treatment / all	0 / 3	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 1
Bladder dilatation
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Bladder discomfort
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Bladder dysfunction
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Bladder hypertrophy
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
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	2 / 7890 (0.03%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Calculus ureteric
subjects affected / exposed	9 / 7890 (0.11%)	6 / 7912 (0.08%)
occurrences causally related to treatment / all	0 / 9	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Calculus urinary
subjects affected / exposed	5 / 7890 (0.06%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 6	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cystitis glandularis
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cystitis haemorrhagic
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cystitis noninfective
subjects affected / exposed	2 / 7890 (0.03%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cystitis ulcerative
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Diabetic nephropathy
subjects affected / exposed	1 / 7890 (0.01%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Dysuria
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Glomerulonephritis
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Glomerulonephritis chronic
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Haematuria
subjects affected / exposed	15 / 7890 (0.19%)	12 / 7912 (0.15%)
occurrences causally related to treatment / all	0 / 18	0 / 22
deaths causally related to treatment / all	0 / 1	0 / 0
Hydronephrosis
subjects affected / exposed	7 / 7890 (0.09%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 7	0 / 0
deaths causally related to treatment / all	0 / 2	0 / 0
Incontinence
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Lower urinary tract symptoms
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Micturition disorder
subjects affected / exposed	2 / 7890 (0.03%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Nephritic syndrome
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Nephrolithiasis
subjects affected / exposed	10 / 7890 (0.13%)	11 / 7912 (0.14%)
occurrences causally related to treatment / all	0 / 12	0 / 11
deaths causally related to treatment / all	0 / 0	0 / 0
Nephrotic syndrome
subjects affected / exposed	0 / 7890 (0.00%)	3 / 7912 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Neurogenic bladder
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pollakiuria
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Renal artery arteriosclerosis
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Renal artery dissection
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Renal artery stenosis
subjects affected / exposed	4 / 7890 (0.05%)	5 / 7912 (0.06%)
occurrences causally related to treatment / all	0 / 4	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Renal colic
subjects affected / exposed	8 / 7890 (0.10%)	6 / 7912 (0.08%)
occurrences causally related to treatment / all	0 / 8	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Renal cyst
subjects affected / exposed	3 / 7890 (0.04%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Renal cyst haemorrhage
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Renal failure
subjects affected / exposed	17 / 7890 (0.22%)	31 / 7912 (0.39%)
occurrences causally related to treatment / all	0 / 17	1 / 34
deaths causally related to treatment / all	0 / 8	0 / 5
Renal failure acute
subjects affected / exposed	61 / 7890 (0.77%)	83 / 7912 (1.05%)
occurrences causally related to treatment / all	2 / 79	0 / 91
deaths causally related to treatment / all	1 / 10	0 / 11
Renal failure chronic
subjects affected / exposed	13 / 7890 (0.16%)	10 / 7912 (0.13%)
occurrences causally related to treatment / all	0 / 15	0 / 10
deaths causally related to treatment / all	0 / 5	0 / 0
Renal haemorrhage
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Renal impairment
subjects affected / exposed	8 / 7890 (0.10%)	9 / 7912 (0.11%)
occurrences causally related to treatment / all	1 / 8	0 / 9
deaths causally related to treatment / all	0 / 0	0 / 1
Renal infarct
subjects affected / exposed	1 / 7890 (0.01%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Renal mass
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Renal pain
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Renal tubular necrosis
subjects affected / exposed	2 / 7890 (0.03%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Stress urinary incontinence
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Tubulointerstitial nephritis
subjects affected / exposed	0 / 7890 (0.00%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Ureteric obstruction
subjects affected / exposed	2 / 7890 (0.03%)	0 / 7912 (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	1 / 7890 (0.01%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Urethral disorder
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Urethral stenosis
subjects affected / exposed	5 / 7890 (0.06%)	5 / 7912 (0.06%)
occurrences causally related to treatment / all	0 / 5	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Urinary bladder haemorrhage
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Urinary bladder polyp
subjects affected / exposed	1 / 7890 (0.01%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 2	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Urinary incontinence
subjects affected / exposed	0 / 7890 (0.00%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Urinary retention
subjects affected / exposed	19 / 7890 (0.24%)	7 / 7912 (0.09%)
occurrences causally related to treatment / all	0 / 20	0 / 8
deaths causally related to treatment / all	0 / 0	0 / 0
Urinary tract obstruction
subjects affected / exposed	1 / 7890 (0.01%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Endocrine disorders
Adrenal disorder
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Adrenal insufficiency
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Goitre
subjects affected / exposed	2 / 7890 (0.03%)	3 / 7912 (0.04%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Hyperparathyroidism
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hyperparathyroidism primary
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hyperthyroidism
subjects affected / exposed	4 / 7890 (0.05%)	4 / 7912 (0.05%)
occurrences causally related to treatment / all	0 / 4	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Hypothyroidism
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Thyroid cyst
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Thyroid disorder
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Toxic nodular goitre
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Musculoskeletal and connective tissue disorders
Arthralgia
subjects affected / exposed	19 / 7890 (0.24%)	13 / 7912 (0.16%)
occurrences causally related to treatment / all	0 / 19	0 / 13
deaths causally related to treatment / all	0 / 1	0 / 0
Arthritis
subjects affected / exposed	7 / 7890 (0.09%)	13 / 7912 (0.16%)
occurrences causally related to treatment / all	0 / 7	0 / 14
deaths causally related to treatment / all	0 / 0	0 / 0
Arthritis reactive
subjects affected / exposed	1 / 7890 (0.01%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Arthropathy
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Articular calcification
subjects affected / exposed	1 / 7890 (0.01%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Back disorder
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Back pain
subjects affected / exposed	27 / 7890 (0.34%)	20 / 7912 (0.25%)
occurrences causally related to treatment / all	0 / 31	0 / 22
deaths causally related to treatment / all	0 / 0	0 / 0
Bone erosion
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Bone fistula
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Bone lesion
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Bone pain
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Bursitis
subjects affected / exposed	1 / 7890 (0.01%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Cervical spinal stenosis
subjects affected / exposed	9 / 7890 (0.11%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 9	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Chondromalacia
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Chondropathy
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Costochondritis
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Dupuytren’s contracture
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Exostosis
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Fistula
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Flank pain
subjects affected / exposed	1 / 7890 (0.01%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Foot deformity
subjects affected / exposed	2 / 7890 (0.03%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gouty arthritis
subjects affected / exposed	3 / 7890 (0.04%)	3 / 7912 (0.04%)
occurrences causally related to treatment / all	0 / 3	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Haemarthrosis
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Inclusion body myositis
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Inguinal mass
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
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	2 / 7890 (0.03%)	3 / 7912 (0.04%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Intervertebral disc disorder
subjects affected / exposed	3 / 7890 (0.04%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Intervertebral disc displacement
subjects affected / exposed	0 / 7890 (0.00%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Intervertebral disc protrusion
subjects affected / exposed	24 / 7890 (0.30%)	16 / 7912 (0.20%)
occurrences causally related to treatment / all	0 / 25	0 / 17
deaths causally related to treatment / all	0 / 0	0 / 0
Joint effusion
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Joint swelling
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Limb discomfort
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Lumbar spinal stenosis
subjects affected / exposed	9 / 7890 (0.11%)	13 / 7912 (0.16%)
occurrences causally related to treatment / all	0 / 9	0 / 13
deaths causally related to treatment / all	0 / 0	0 / 0
Metatarsalgia
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Monarthritis
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Muscle haemorrhage
subjects affected / exposed	2 / 7890 (0.03%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Muscle spasms
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Muscular weakness
subjects affected / exposed	6 / 7890 (0.08%)	3 / 7912 (0.04%)
occurrences causally related to treatment / all	0 / 6	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Musculoskeletal chest pain
subjects affected / exposed	9 / 7890 (0.11%)	11 / 7912 (0.14%)
occurrences causally related to treatment / all	0 / 10	0 / 11
deaths causally related to treatment / all	0 / 0	0 / 0
Musculoskeletal discomfort
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Musculoskeletal pain
subjects affected / exposed	6 / 7890 (0.08%)	8 / 7912 (0.10%)
occurrences causally related to treatment / all	0 / 6	0 / 8
deaths causally related to treatment / all	0 / 0	0 / 0
Myalgia
subjects affected / exposed	6 / 7890 (0.08%)	9 / 7912 (0.11%)
occurrences causally related to treatment / all	0 / 6	2 / 9
deaths causally related to treatment / all	0 / 0	0 / 0
Myofascial pain syndrome
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Myositis
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
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 / 7890 (0.00%)	4 / 7912 (0.05%)
occurrences causally related to treatment / all	0 / 0	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Osteitis
subjects affected / exposed	2 / 7890 (0.03%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Osteoarthritis
subjects affected / exposed	78 / 7890 (0.99%)	73 / 7912 (0.92%)
occurrences causally related to treatment / all	0 / 86	0 / 81
deaths causally related to treatment / all	0 / 0	0 / 0
Osteochondrosis
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Osteonecrosis
subjects affected / exposed	5 / 7890 (0.06%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 6	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Osteoporosis
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Osteoporotic fracture
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pain in extremity
subjects affected / exposed	2 / 7890 (0.03%)	3 / 7912 (0.04%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Pathological fracture
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Periarthritis
subjects affected / exposed	1 / 7890 (0.01%)	3 / 7912 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Polyarthritis
subjects affected / exposed	2 / 7890 (0.03%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Polymyalgia rheumatica
subjects affected / exposed	4 / 7890 (0.05%)	3 / 7912 (0.04%)
occurrences causally related to treatment / all	0 / 4	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Rhabdomyolysis
subjects affected / exposed	4 / 7890 (0.05%)	7 / 7912 (0.09%)
occurrences causally related to treatment / all	1 / 4	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 2
Rheumatoid arthritis
subjects affected / exposed	2 / 7890 (0.03%)	3 / 7912 (0.04%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Rotator cuff syndrome
subjects affected / exposed	9 / 7890 (0.11%)	7 / 7912 (0.09%)
occurrences causally related to treatment / all	0 / 9	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
Scoliosis
subjects affected / exposed	2 / 7890 (0.03%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Spinal column stenosis
subjects affected / exposed	16 / 7890 (0.20%)	13 / 7912 (0.16%)
occurrences causally related to treatment / all	0 / 16	0 / 14
deaths causally related to treatment / all	0 / 0	0 / 0
Spinal deformity
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Spinal osteoarthritis
subjects affected / exposed	12 / 7890 (0.15%)	5 / 7912 (0.06%)
occurrences causally related to treatment / all	0 / 13	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Spondylitis
subjects affected / exposed	2 / 7890 (0.03%)	0 / 7912 (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	3 / 7890 (0.04%)	5 / 7912 (0.06%)
occurrences causally related to treatment / all	0 / 3	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Spondylolysis
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Synovitis
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Tendon disorder
subjects affected / exposed	0 / 7890 (0.00%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Tendonitis
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Tenosynovitis
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Tenosynovitis stenosans
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Vertebral foraminal stenosis
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Infections and infestations
Abdominal abscess
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Abdominal sepsis
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Abdominal wall abscess
subjects affected / exposed	0 / 7890 (0.00%)	3 / 7912 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Abdominal wall infection
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Abscess
subjects affected / exposed	5 / 7890 (0.06%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 5	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Abscess jaw
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Abscess limb
subjects affected / exposed	2 / 7890 (0.03%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Acute hepatitis B
subjects affected / exposed	1 / 7890 (0.01%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Acute pulmonary histoplasmosis
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Amoebiasis
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Anal abscess
subjects affected / exposed	1 / 7890 (0.01%)	3 / 7912 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Appendiceal abscess
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (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	19 / 7890 (0.24%)	15 / 7912 (0.19%)
occurrences causally related to treatment / all	0 / 19	0 / 15
deaths causally related to treatment / all	0 / 0	0 / 0
Appendicitis perforated
subjects affected / exposed	3 / 7890 (0.04%)	3 / 7912 (0.04%)
occurrences causally related to treatment / all	0 / 3	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Arteriosclerotic gangrene
subjects affected / exposed	1 / 7890 (0.01%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 0
Arthritis bacterial
subjects affected / exposed	1 / 7890 (0.01%)	3 / 7912 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Arthritis infective
subjects affected / exposed	2 / 7890 (0.03%)	3 / 7912 (0.04%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Bacteraemia
subjects affected / exposed	1 / 7890 (0.01%)	5 / 7912 (0.06%)
occurrences causally related to treatment / all	0 / 1	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Bacterial pyelonephritis
subjects affected / exposed	2 / 7890 (0.03%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Bacterial sepsis
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Biliary sepsis
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Bone abscess
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Borrelia infection
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (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	18 / 7890 (0.23%)	24 / 7912 (0.30%)
occurrences causally related to treatment / all	0 / 18	0 / 27
deaths causally related to treatment / all	0 / 2	0 / 0
Bronchopneumonia
subjects affected / exposed	7 / 7890 (0.09%)	12 / 7912 (0.15%)
occurrences causally related to treatment / all	0 / 7	0 / 12
deaths causally related to treatment / all	0 / 2	0 / 4
Bursitis infective
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Campylobacter gastroenteritis
subjects affected / exposed	1 / 7890 (0.01%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Carbuncle
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Catheter site infection
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (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	46 / 7890 (0.58%)	38 / 7912 (0.48%)
occurrences causally related to treatment / all	0 / 53	0 / 44
deaths causally related to treatment / all	0 / 0	0 / 0
Cellulitis gangrenous
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Cellulitis staphylococcal
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cholangitis suppurative
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Cholecystitis infective
subjects affected / exposed	1 / 7890 (0.01%)	4 / 7912 (0.05%)
occurrences causally related to treatment / all	0 / 1	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 1
Chronic sinusitis
subjects affected / exposed	2 / 7890 (0.03%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Clostridium difficile colitis
subjects affected / exposed	2 / 7890 (0.03%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Clostridium difficile infection
subjects affected / exposed	3 / 7890 (0.04%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Cystitis
subjects affected / exposed	2 / 7890 (0.03%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Dengue fever
subjects affected / exposed	1 / 7890 (0.01%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Device related infection
subjects affected / exposed	8 / 7890 (0.10%)	6 / 7912 (0.08%)
occurrences causally related to treatment / all	0 / 9	0 / 10
deaths causally related to treatment / all	0 / 1	0 / 0
Device related sepsis
subjects affected / exposed	1 / 7890 (0.01%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Diabetic foot infection
subjects affected / exposed	2 / 7890 (0.03%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Diabetic gangrene
subjects affected / exposed	2 / 7890 (0.03%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Diarrhoea infectious
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Disseminated tuberculosis
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Diverticulitis
subjects affected / exposed	11 / 7890 (0.14%)	15 / 7912 (0.19%)
occurrences causally related to treatment / all	0 / 11	0 / 16
deaths causally related to treatment / all	0 / 0	0 / 1
Dysentery
subjects affected / exposed	1 / 7890 (0.01%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Ear infection
subjects affected / exposed	1 / 7890 (0.01%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Echinococciasis
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Empyema
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Endocarditis
subjects affected / exposed	0 / 7890 (0.00%)	4 / 7912 (0.05%)
occurrences causally related to treatment / all	0 / 0	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Endocarditis bacterial
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Endocarditis enterococcal
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Endocarditis staphylococcal
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Endometritis
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Endophthalmitis
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Enteritis infectious
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Enterobacter infection
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Enterococcal bacteraemia
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Enterococcal infection
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Enterococcal sepsis
subjects affected / exposed	2 / 7890 (0.03%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 0
Enterocolitis infectious
subjects affected / exposed	1 / 7890 (0.01%)	3 / 7912 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Epiglottitis
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Erysipelas
subjects affected / exposed	14 / 7890 (0.18%)	8 / 7912 (0.10%)
occurrences causally related to treatment / all	0 / 14	0 / 8
deaths causally related to treatment / all	0 / 0	0 / 0
Escherichia bacteraemia
subjects affected / exposed	3 / 7890 (0.04%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Escherichia infection
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Escherichia sepsis
subjects affected / exposed	0 / 7890 (0.00%)	4 / 7912 (0.05%)
occurrences causally related to treatment / all	0 / 0	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Escherichia urinary tract infection
subjects affected / exposed	0 / 7890 (0.00%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
External ear cellulitis
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Extradural abscess
subjects affected / exposed	1 / 7890 (0.01%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Febrile infection
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Fungal oesophagitis
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gallbladder empyema
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (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	4 / 7890 (0.05%)	3 / 7912 (0.04%)
occurrences causally related to treatment / all	0 / 4	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Gastritis viral
subjects affected / exposed	1 / 7890 (0.01%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastroenteritis
subjects affected / exposed	29 / 7890 (0.37%)	31 / 7912 (0.39%)
occurrences causally related to treatment / all	0 / 32	0 / 34
deaths causally related to treatment / all	0 / 0	0 / 0
Gastroenteritis rotavirus
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastroenteritis salmonella
subjects affected / exposed	1 / 7890 (0.01%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastroenteritis viral
subjects affected / exposed	5 / 7890 (0.06%)	5 / 7912 (0.06%)
occurrences causally related to treatment / all	0 / 5	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal viral infection
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Genital infection fungal
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Giardiasis
subjects affected / exposed	2 / 7890 (0.03%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Graft infection
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Groin abscess
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
H1N1 influenza
subjects affected / exposed	2 / 7890 (0.03%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
HIV infection
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Haematoma infection
subjects affected / exposed	2 / 7890 (0.03%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Helicobacter gastritis
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Helicobacter infection
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatitis A
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatitis B
subjects affected / exposed	2 / 7890 (0.03%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatitis C
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatitis E
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatitis viral
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Herpes zoster
subjects affected / exposed	5 / 7890 (0.06%)	5 / 7912 (0.06%)
occurrences causally related to treatment / all	0 / 5	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Herpes zoster ophthalmic
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Histoplasmosis
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Implant site infection
subjects affected / exposed	2 / 7890 (0.03%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Infected bites
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Infected skin ulcer
subjects affected / exposed	1 / 7890 (0.01%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Infection
subjects affected / exposed	4 / 7890 (0.05%)	4 / 7912 (0.05%)
occurrences causally related to treatment / all	0 / 4	0 / 4
deaths causally related to treatment / all	0 / 2	0 / 0
Infectious pleural effusion
subjects affected / exposed	1 / 7890 (0.01%)	1 / 7912 (0.01%)
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	3 / 7890 (0.04%)	3 / 7912 (0.04%)
occurrences causally related to treatment / all	0 / 3	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Infective myositis
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Influenza
subjects affected / exposed	7 / 7890 (0.09%)	7 / 7912 (0.09%)
occurrences causally related to treatment / all	0 / 7	0 / 7
deaths causally related to treatment / all	0 / 2	0 / 0
Intertrigo candida
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Intervertebral discitis
subjects affected / exposed	2 / 7890 (0.03%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Keratitis herpetic
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Kidney infection
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Klebsiella bacteraemia
subjects affected / exposed	1 / 7890 (0.01%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Klebsiella sepsis
subjects affected / exposed	1 / 7890 (0.01%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Laryngitis
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Leptospirosis
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Liver abscess
subjects affected / exposed	1 / 7890 (0.01%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Lobar pneumonia
subjects affected / exposed	17 / 7890 (0.22%)	9 / 7912 (0.11%)
occurrences causally related to treatment / all	0 / 17	0 / 10
deaths causally related to treatment / all	0 / 0	0 / 1
Localised infection
subjects affected / exposed	9 / 7890 (0.11%)	9 / 7912 (0.11%)
occurrences causally related to treatment / all	0 / 9	0 / 9
deaths causally related to treatment / all	0 / 0	0 / 1
Lower respiratory tract infection
subjects affected / exposed	10 / 7890 (0.13%)	8 / 7912 (0.10%)
occurrences causally related to treatment / all	0 / 11	0 / 10
deaths causally related to treatment / all	0 / 0	0 / 0
Lung abscess
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Lung infection
subjects affected / exposed	8 / 7890 (0.10%)	5 / 7912 (0.06%)
occurrences causally related to treatment / all	0 / 8	0 / 5
deaths causally related to treatment / all	0 / 1	0 / 0
Lyme disease
subjects affected / exposed	2 / 7890 (0.03%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Lymphangitis
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Mastoiditis
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Mediastinitis
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Meningitis
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Meningitis bacterial
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Meningitis cryptococcal
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Mycoplasma infection
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Mycotoxicosis
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Nasopharyngitis
subjects affected / exposed	1 / 7890 (0.01%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Necrotising fasciitis
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Oesophageal candidiasis
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Oral candidiasis
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Orchitis
subjects affected / exposed	2 / 7890 (0.03%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Osteomyelitis
subjects affected / exposed	7 / 7890 (0.09%)	10 / 7912 (0.13%)
occurrences causally related to treatment / all	0 / 7	0 / 10
deaths causally related to treatment / all	0 / 0	0 / 0
Osteomyelitis chronic
subjects affected / exposed	0 / 7890 (0.00%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Otitis media
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Otitis media chronic
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Paronychia
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Parotitis
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (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 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Periorbital cellulitis
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Peritoneal abscess
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (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	7 / 7890 (0.09%)	3 / 7912 (0.04%)
occurrences causally related to treatment / all	0 / 7	0 / 3
deaths causally related to treatment / all	0 / 2	0 / 1
Peritonsillar abscess
subjects affected / exposed	2 / 7890 (0.03%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Peritonsillitis
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pharyngitis
subjects affected / exposed	0 / 7890 (0.00%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Plasmodium vivax infection
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumococcal sepsis
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumonia
subjects affected / exposed	160 / 7890 (2.03%)	139 / 7912 (1.76%)
occurrences causally related to treatment / all	0 / 176	0 / 157
deaths causally related to treatment / all	0 / 20	0 / 18
Pneumonia bacterial
subjects affected / exposed	0 / 7890 (0.00%)	4 / 7912 (0.05%)
occurrences causally related to treatment / all	0 / 0	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 2
Pneumonia chlamydial
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	1 / 1	0 / 0
Pneumonia klebsiella
subjects affected / exposed	1 / 7890 (0.01%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumonia necrotising
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumonia streptococcal
subjects affected / exposed	2 / 7890 (0.03%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumonia viral
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Post procedural infection
subjects affected / exposed	1 / 7890 (0.01%)	6 / 7912 (0.08%)
occurrences causally related to treatment / all	0 / 1	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Postoperative abscess
subjects affected / exposed	0 / 7890 (0.00%)	4 / 7912 (0.05%)
occurrences causally related to treatment / all	0 / 0	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Postoperative wound infection
subjects affected / exposed	3 / 7890 (0.04%)	5 / 7912 (0.06%)
occurrences causally related to treatment / all	0 / 3	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Prostatic abscess
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pseudomembranous colitis
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pseudomonal bacteraemia
subjects affected / exposed	0 / 7890 (0.00%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Pseudomonas infection
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Psoas abscess
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
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 / 7890 (0.01%)	0 / 7912 (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	3 / 7890 (0.04%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 1	0 / 0
Pyelonephritis
subjects affected / exposed	6 / 7890 (0.08%)	12 / 7912 (0.15%)
occurrences causally related to treatment / all	0 / 8	0 / 12
deaths causally related to treatment / all	0 / 0	0 / 0
Pyelonephritis acute
subjects affected / exposed	1 / 7890 (0.01%)	4 / 7912 (0.05%)
occurrences causally related to treatment / all	0 / 1	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Pyelonephritis chronic
subjects affected / exposed	2 / 7890 (0.03%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pyopneumothorax
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Respiratory tract infection
subjects affected / exposed	7 / 7890 (0.09%)	8 / 7912 (0.10%)
occurrences causally related to treatment / all	0 / 8	0 / 8
deaths causally related to treatment / all	0 / 1	0 / 0
Respiratory tract infection viral
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Retroperitoneal abscess
subjects affected / exposed	2 / 7890 (0.03%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Retroperitoneal infection
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Salmonella sepsis
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Salmonellosis
subjects affected / exposed	1 / 7890 (0.01%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Scrotal abscess
subjects affected / exposed	1 / 7890 (0.01%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Scrub typhus
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Sepsis
subjects affected / exposed	23 / 7890 (0.29%)	35 / 7912 (0.44%)
occurrences causally related to treatment / all	0 / 25	0 / 37
deaths causally related to treatment / all	0 / 8	0 / 15
Sepsis syndrome
subjects affected / exposed	1 / 7890 (0.01%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Septic embolus
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Septic shock
subjects affected / exposed	25 / 7890 (0.32%)	9 / 7912 (0.11%)
occurrences causally related to treatment / all	0 / 26	1 / 10
deaths causally related to treatment / all	0 / 17	0 / 3
Sialoadenitis
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Sinobronchitis
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Sinusitis
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Skin infection
subjects affected / exposed	2 / 7890 (0.03%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 1
Soft tissue infection
subjects affected / exposed	0 / 7890 (0.00%)	3 / 7912 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Staphylococcal bacteraemia
subjects affected / exposed	1 / 7890 (0.01%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Staphylococcal infection
subjects affected / exposed	6 / 7890 (0.08%)	6 / 7912 (0.08%)
occurrences causally related to treatment / all	0 / 7	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Staphylococcal osteomyelitis
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Staphylococcal sepsis
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Streptococcal bacteraemia
subjects affected / exposed	1 / 7890 (0.01%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Streptococcal infection
subjects affected / exposed	2 / 7890 (0.03%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Streptococcal sepsis
subjects affected / exposed	1 / 7890 (0.01%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Subacute endocarditis
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
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 / 7890 (0.01%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Superinfection
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Suspected transmission of an infectious agent via product
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Tinea pedis
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Tongue abscess
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Tonsillitis
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Tooth abscess
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Tracheitis
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Tracheobronchitis
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Tracheobronchitis viral
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Tuberculosis
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Upper respiratory tract infection
subjects affected / exposed	3 / 7890 (0.04%)	4 / 7912 (0.05%)
occurrences causally related to treatment / all	0 / 3	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 1
Urethritis
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Urinary tract infection
subjects affected / exposed	36 / 7890 (0.46%)	43 / 7912 (0.54%)
occurrences causally related to treatment / all	0 / 49	0 / 44
deaths causally related to treatment / all	0 / 1	0 / 2
Urinary tract infection bacterial
subjects affected / exposed	0 / 7890 (0.00%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 1
Urinary tract infection pseudomonal
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Urosepsis
subjects affected / exposed	15 / 7890 (0.19%)	14 / 7912 (0.18%)
occurrences causally related to treatment / all	0 / 20	0 / 14
deaths causally related to treatment / all	0 / 1	0 / 3
Vaginal abscess
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Varicella
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Wound sepsis
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Alcohol poisoning
subjects affected / exposed	4 / 7890 (0.05%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 4	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Vascular pseudoaneurysm
subjects affected / exposed	5 / 7890 (0.06%)	3 / 7912 (0.04%)
occurrences causally related to treatment / all	0 / 5	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Bronchitis bacterial
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Vestibular neuronitis
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Viral infection
subjects affected / exposed	2 / 7890 (0.03%)	4 / 7912 (0.05%)
occurrences causally related to treatment / all	0 / 2	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 1
Viral tracheitis
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Viral upper respiratory tract infection
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Wound infection
subjects affected / exposed	6 / 7890 (0.08%)	3 / 7912 (0.04%)
occurrences causally related to treatment / all	0 / 7	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Wound infection staphylococcal
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Metabolism and nutrition disorders
Acidosis
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Cachexia
subjects affected / exposed	1 / 7890 (0.01%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 0
Decreased appetite
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Dehydration
subjects affected / exposed	24 / 7890 (0.30%)	33 / 7912 (0.42%)
occurrences causally related to treatment / all	0 / 27	0 / 33
deaths causally related to treatment / all	0 / 1	0 / 1
Diabetes mellitus
subjects affected / exposed	0 / 7890 (0.00%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Diabetes mellitus inadequate control
subjects affected / exposed	8 / 7890 (0.10%)	26 / 7912 (0.33%)
occurrences causally related to treatment / all	0 / 9	0 / 29
deaths causally related to treatment / all	0 / 0	0 / 0
Diabetic complication
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Diabetic ketoacidosis
subjects affected / exposed	5 / 7890 (0.06%)	3 / 7912 (0.04%)
occurrences causally related to treatment / all	0 / 5	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Electrolyte imbalance
subjects affected / exposed	1 / 7890 (0.01%)	3 / 7912 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 1
Failure to thrive
subjects affected / exposed	1 / 7890 (0.01%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Fluid overload
subjects affected / exposed	2 / 7890 (0.03%)	2 / 7912 (0.03%)
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 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Fructose intolerance
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gout
subjects affected / exposed	5 / 7890 (0.06%)	5 / 7912 (0.06%)
occurrences causally related to treatment / all	0 / 5	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Hypercalcaemia
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hyperglycaemia
subjects affected / exposed	5 / 7890 (0.06%)	4 / 7912 (0.05%)
occurrences causally related to treatment / all	0 / 8	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Hyperkalaemia
subjects affected / exposed	9 / 7890 (0.11%)	11 / 7912 (0.14%)
occurrences causally related to treatment / all	0 / 10	0 / 13
deaths causally related to treatment / all	0 / 1	0 / 1
Hyperlipidaemia
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hyperosmolar state
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hypertriglyceridaemia
subjects affected / exposed	1 / 7890 (0.01%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 1	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hypoalbuminaemia
subjects affected / exposed	0 / 7890 (0.00%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Hypocalcaemia
subjects affected / exposed	0 / 7890 (0.00%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Hypoglycaemia
subjects affected / exposed	26 / 7890 (0.33%)	24 / 7912 (0.30%)
occurrences causally related to treatment / all	0 / 28	0 / 26
deaths causally related to treatment / all	0 / 1	0 / 0
Hypokalaemia
subjects affected / exposed	7 / 7890 (0.09%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 7	0 / 3
deaths causally related to treatment / all	0 / 2	0 / 0
Hypomagnesaemia
subjects affected / exposed	1 / 7890 (0.01%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hyponatraemia
subjects affected / exposed	8 / 7890 (0.10%)	10 / 7912 (0.13%)
occurrences causally related to treatment / all	0 / 9	0 / 11
deaths causally related to treatment / all	0 / 1	0 / 0
Hypophosphataemia
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hypovolaemia
subjects affected / exposed	4 / 7890 (0.05%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 4	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Insulin-requiring type 2 diabetes mellitus
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Ketoacidosis
subjects affected / exposed	1 / 7890 (0.01%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 1	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Malnutrition
subjects affected / exposed	1 / 7890 (0.01%)	3 / 7912 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 1
Metabolic acidosis
subjects affected / exposed	2 / 7890 (0.03%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 1	0 / 1
Metabolic syndrome
subjects affected / exposed	0 / 7890 (0.00%)	1 / 7912 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Obesity
subjects affected / exposed	2 / 7890 (0.03%)	4 / 7912 (0.05%)
occurrences causally related to treatment / all	0 / 2	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Type 1 diabetes mellitus
subjects affected / exposed	2 / 7890 (0.03%)	2 / 7912 (0.03%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Type 2 diabetes mellitus
subjects affected / exposed	37 / 7890 (0.47%)	27 / 7912 (0.34%)
occurrences causally related to treatment / all	0 / 38	0 / 28
deaths causally related to treatment / all	0 / 1	0 / 1
Vitamin B12 deficiency
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Vitamin D deficiency
subjects affected / exposed	1 / 7890 (0.01%)	0 / 7912 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 2%

Non-serious adverse events	Placebo	Darapladib
Total subjects affected by non serious adverse events
subjects affected / exposed	4885 / 7890 (61.91%)	5171 / 7912 (65.36%)
Vascular disorders
Hypertension
subjects affected / exposed	660 / 7890 (8.37%)	643 / 7912 (8.13%)
occurrences all number	751	749
Hypotension
subjects affected / exposed	181 / 7890 (2.29%)	184 / 7912 (2.33%)
occurrences all number	198	201
General disorders and administration site conditions
Fatigue
subjects affected / exposed	357 / 7890 (4.52%)	354 / 7912 (4.47%)
occurrences all number	384	377
Non-cardiac chest pain
subjects affected / exposed	376 / 7890 (4.77%)	366 / 7912 (4.63%)
occurrences all number	458	425
Oedema peripheral
subjects affected / exposed	419 / 7890 (5.31%)	431 / 7912 (5.45%)
occurrences all number	468	497
Respiratory, thoracic and mediastinal disorders
Cough
subjects affected / exposed	404 / 7890 (5.12%)	401 / 7912 (5.07%)
occurrences all number	471	464
Dyspnoea
subjects affected / exposed	346 / 7890 (4.39%)	324 / 7912 (4.10%)
occurrences all number	395	354
Psychiatric disorders
Insomnia
subjects affected / exposed	164 / 7890 (2.08%)	126 / 7912 (1.59%)
occurrences all number	170	135
Investigations
Blood glucose increased
subjects affected / exposed	181 / 7890 (2.29%)	171 / 7912 (2.16%)
occurrences all number	208	183
Blood pressure increased
subjects affected / exposed	197 / 7890 (2.50%)	173 / 7912 (2.19%)
occurrences all number	236	193
Cardiac disorders
Angina pectoris
subjects affected / exposed	528 / 7890 (6.69%)	457 / 7912 (5.78%)
occurrences all number	645	563
Atrial fibrillation
subjects affected / exposed	245 / 7890 (3.11%)	257 / 7912 (3.25%)
occurrences all number	274	292
Nervous system disorders
Headache
subjects affected / exposed	357 / 7890 (4.52%)	296 / 7912 (3.74%)
occurrences all number	410	340
Dizziness
subjects affected / exposed	491 / 7890 (6.22%)	456 / 7912 (5.76%)
occurrences all number	556	533
Blood and lymphatic system disorders
Anaemia
subjects affected / exposed	208 / 7890 (2.64%)	191 / 7912 (2.41%)
occurrences all number	220	204
Eye disorders
Cataract
subjects affected / exposed	198 / 7890 (2.51%)	203 / 7912 (2.57%)
occurrences all number	254	259
Gastrointestinal disorders
Abdominal pain
subjects affected / exposed	188 / 7890 (2.38%)	163 / 7912 (2.06%)
occurrences all number	213	183
Abdominal pain upper
subjects affected / exposed	152 / 7890 (1.93%)	180 / 7912 (2.28%)
occurrences all number	167	194
Abnormal faeces
subjects affected / exposed	63 / 7890 (0.80%)	728 / 7912 (9.20%)
occurrences all number	66	762
Constipation
subjects affected / exposed	255 / 7890 (3.23%)	247 / 7912 (3.12%)
occurrences all number	271	260
Diarrhoea
subjects affected / exposed	479 / 7890 (6.07%)	949 / 7912 (11.99%)
occurrences all number	566	1185
Dyspepsia
subjects affected / exposed	182 / 7890 (2.31%)	177 / 7912 (2.24%)
occurrences all number	197	197
Flatulence
subjects affected / exposed	92 / 7890 (1.17%)	189 / 7912 (2.39%)
occurrences all number	96	211
Gastritis
subjects affected / exposed	192 / 7890 (2.43%)	159 / 7912 (2.01%)
occurrences all number	204	166
Gastrooesophageal reflux disease
subjects affected / exposed	160 / 7890 (2.03%)	144 / 7912 (1.82%)
occurrences all number	169	160
Large intestine polyp
subjects affected / exposed	265 / 7890 (3.36%)	259 / 7912 (3.27%)
occurrences all number	328	285
Nausea
subjects affected / exposed	222 / 7890 (2.81%)	228 / 7912 (2.88%)
occurrences all number	250	253
Skin and subcutaneous tissue disorders
Skin odour abnormal
subjects affected / exposed	34 / 7890 (0.43%)	383 / 7912 (4.84%)
occurrences all number	38	425
Renal and urinary disorders
Urine odour abnormal
subjects affected / exposed	81 / 7890 (1.03%)	473 / 7912 (5.98%)
occurrences all number	83	491
Musculoskeletal and connective tissue disorders
Arthralgia
subjects affected / exposed	401 / 7890 (5.08%)	385 / 7912 (4.87%)
occurrences all number	468	449
Back pain
subjects affected / exposed	466 / 7890 (5.91%)	421 / 7912 (5.32%)
occurrences all number	514	457
Muscle spasms
subjects affected / exposed	168 / 7890 (2.13%)	164 / 7912 (2.07%)
occurrences all number	184	185
Musculoskeletal pain
subjects affected / exposed	219 / 7890 (2.78%)	180 / 7912 (2.28%)
occurrences all number	239	190
Myalgia
subjects affected / exposed	244 / 7890 (3.09%)	207 / 7912 (2.62%)
occurrences all number	290	221
Osteoarthritis
subjects affected / exposed	176 / 7890 (2.23%)	167 / 7912 (2.11%)
occurrences all number	198	183
Pain in extremity
subjects affected / exposed	354 / 7890 (4.49%)	315 / 7912 (3.98%)
occurrences all number	399	357
Infections and infestations
Bronchitis
subjects affected / exposed	416 / 7890 (5.27%)	389 / 7912 (4.92%)
occurrences all number	523	489
Influenza
subjects affected / exposed	253 / 7890 (3.21%)	223 / 7912 (2.82%)
occurrences all number	305	263
Nasopharyngitis
subjects affected / exposed	588 / 7890 (7.45%)	548 / 7912 (6.93%)
occurrences all number	754	825
Sinusitis
subjects affected / exposed	189 / 7890 (2.40%)	157 / 7912 (1.98%)
occurrences all number	231	195
Upper respiratory tract infection
subjects affected / exposed	425 / 7890 (5.39%)	367 / 7912 (4.64%)
occurrences all number	534	492
Urinary tract infection
subjects affected / exposed	296 / 7890 (3.75%)	260 / 7912 (3.29%)
occurrences all number	375	331
Metabolism and nutrition disorders
Type 2 diabetes mellitus
subjects affected / exposed	608 / 7890 (7.71%)	566 / 7912 (7.15%)
occurrences all number	633	592

More information

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Were there any global substantial amendments to the protocol? Yes

24 Aug 2009

Clarification and correction of different items in protocol. RATIONALE: Following initial investigator meetings and discussions of the original protocol, it became apparent that changes were needed to improve understanding of the protocol.

11 Feb 2010

The primary intent of this amendment was to add a single cognitive function assessment (Montreal Cognitive Assessment) for all participants (if an approved translation was available) prior to the end of the study. RATIONALE: This change added an exploratory assessment that was of scientific interest and may be relevant to planning future clinical trials among this patient population.

29 Jul 2010

The primary intent of this amendment was to revise the threshold for excluding participants of Japanese, Chinese, or Korean ancestry with plasma levels of Lp-PLA2 activity from <=10 to <=20.0 nanomoles (nmol)/minute (min)/milliliter (mL). RATIONALE: The original text excluded Japanese, Chinese, and Korean participants with plasma Lp-PLA2 activity <=10 nmol/min/mL prior to randomization. This threshold was intended to be a surrogate measure for being homozygous for the 279F null variant allele, predominantly found in East Asians, and was listed as an exclusion criterion to avoid randomizing participants who would not be expected to produce circulating levels of the Lp-PLA2 enzyme. As participants who were homozygous for the 279F null allele would have no Lp-PLA2 enzyme to inhibit, it was important to identify these participants since there would be no clear rationale for exposing such participants to the investigational Lp-PLA2 inhibitor darapladib. Data from participants with chronic coronary heart disease in this study determined that Japanese, Chinese, and Korean participants who were homozygous for the 279F variant had reported baseline plasma Lp-PLA2 activity levels approaching 20.0 nmol/min/mL when measured by the assay used in this study. The text for the exclusion criterion pertaining to Japanese, Chinese, and Korean participants revised the threshold for the plasma Lp-PLA2 activity to <=20.0 nmol/min/mL prior to randomization, which was expected to help ensure that Japanese, Chinese, and Korean particiapants who were homozygous for the 279F variant were not enrolled.

29 Mar 2012

The primary intent of this amendment was to allow the Follow-up visit to be conducted by telephone in particiapnts who met pre-defined criteria. RATIONALE: This change allowed collection of study endpoints/safety data in participants unable to attend a Follow-up clinic visit.

10 Oct 2012

The primary intent was to allow increased collection of data on new cancer, recurrence of cancer, or progression of cancer; and adjudication of all GI neoplasms (malignant and benign) and all GI polyps (malignant, and benign, and non-neoplastic). RATIONALE: Darapladib was given by oral gavage to male and female rodents starting from before sexual maturation and continuing every day throughout their lifetime for up to 2 years. Data from these studies became available prior to the end of the study. Overall, the data suggested drug-related increases in the incidence of adenomas and/or adenocarcinomas of the jejunum in male mice and male rats given higher doses of darapladib. The Independent Data Monitoring Committee for both this study and the other Phase III study (Study SB480848/033) reviewed these data and re-reviewed the safety data, including reports of tumors in study participants. Following this review, the IDMC recommended that the trials continue without any changes. However, this protocol change was proposed and incorporated by the sponsor to allow a more thorough review of neoplasms reported in this study.

29 Nov 2012

This country-specific amendment for France was required by the French regulatory authority (ANSM). Participants diagnosed with inflammatory bowel disease (Crohn’s disease or ulcerative colitis) must immediately discontinue investigational product (IP).

Were there any global interruptions to the trial? No

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

None reported

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