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Clinical Trial Results:
A multicenter, randomized, double-blind, parallel group,active-controlled study to evaluate the efficacy and safety of LCZ696 compared to enalapril on morbidity and mortality in patients with chronic heart failure and reduced ejection fraction

Summary
EudraCT number	2009-015834-31
Trial protocol	PT IS GB ES DE HU NL SE IT RO SK FI FR DK BE CZ LT EE LV BG
Global end of trial date	21 May 2014

Results information
Results version number	v1(current)
This version publication date	15 Jul 2016
First version publication date	15 Jul 2016
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

CLCZ696B2314

ISRCTN number

-

US NCT number

NCT01035255

WHO universal trial number (UTN)

-

Sponsor organisation name

Novartis Pharma AG

Sponsor organisation address

CH-4002, Basel, Switzerland,

Public contact

Clinical Disclosure Office, Novartis Pharma AG, 41 613241111,

Scientific contact

Clinical Disclosure Office, Novartis Pharma AG, 41 613241111,

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

21 May 2014

Is this the analysis of the primary completion data?

No

Global end of trial reached?

Yes

Global end of trial date

21 May 2014

Was the trial ended prematurely?

Yes

Main objective of the trial

The primary objective of this study was to test if LCZ696 is superior to enalapril in delaying time to first occurrence of the composite endpoint, which was defined as either CV death or HF hospitalization, in patients with HF (NYHA class II – IV) and reduced left ventricular EF (≤ 40%, changed to ≤ 35% by Protocol Amendment 1).

Protection of trial subjects

The study was in compliance with the ethical principles derived from the Declaration of Helsinki and the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines. All the local regulatory requirements pertinent to safety of trial subjects were also followed during the conduct of the trial.

Background therapy

-

Evidence for comparator

-

Actual start date of recruitment

08 Dec 2009

Long term follow-up planned

No

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

Slovakia: 349

Country: Number of subjects enrolled

South Africa: 259

Country: Number of subjects enrolled

Spain: 196

Country: Number of subjects enrolled

Sweden: 29

Country: Number of subjects enrolled

Taiwan: 86

Country: Number of subjects enrolled

Thailand: 39

Country: Number of subjects enrolled

Turkey: 64

Country: Number of subjects enrolled

United Kingdom: 242

Country: Number of subjects enrolled

United States: 434

Country: Number of subjects enrolled

Venezuela, Bolivarian Republic of: 20

Country: Number of subjects enrolled

Argentina: 349

Country: Number of subjects enrolled

Belgium: 71

Country: Number of subjects enrolled

Brazil: 316

Country: Number of subjects enrolled

Bulgaria: 510

Country: Number of subjects enrolled

Canada: 168

Country: Number of subjects enrolled

Chile: 43

Country: Number of subjects enrolled

China: 353

Country: Number of subjects enrolled

Colombia: 164

Country: Number of subjects enrolled

Czech Republic: 212

Country: Number of subjects enrolled

Denmark: 106

Country: Number of subjects enrolled

Dominican Republic: 16

Country: Number of subjects enrolled

Ecuador: 103

Country: Number of subjects enrolled

Estonia: 29

Country: Number of subjects enrolled

Finland: 35

Country: Number of subjects enrolled

France: 69

Country: Number of subjects enrolled

Germany: 480

Country: Number of subjects enrolled

Guatemala: 138

Country: Number of subjects enrolled

Hong Kong: 23

Country: Number of subjects enrolled

Hungary: 444

Country: Number of subjects enrolled

Iceland: 18

Country: Number of subjects enrolled

India: 637

Country: Number of subjects enrolled

Israel: 112

Country: Number of subjects enrolled

Italy: 222

Country: Number of subjects enrolled

Korea, Democratic People's Republic of: 82

Country: Number of subjects enrolled

Latvia: 19

Country: Number of subjects enrolled

Lithuania: 22

Country: Number of subjects enrolled

Malaysia: 13

Country: Number of subjects enrolled

Mexico: 137

Country: Number of subjects enrolled

Netherlands: 169

Country: Number of subjects enrolled

Panama: 30

Country: Number of subjects enrolled

Peru: 142

Country: Number of subjects enrolled

Philippines: 223

Country: Number of subjects enrolled

Poland: 197

Country: Number of subjects enrolled

Portugal: 49

Country: Number of subjects enrolled

Romania: 135

Country: Number of subjects enrolled

Russian Federation: 856

Country: Number of subjects enrolled

Singapore: 32

Worldwide total number of subjects

8442

EEA total number of subjects

3603

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)

4299

From 65 to 84 years

4143

85 years and over

0

Subject disposition

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Recruitment details

-

Screening details

The FAS included all randomized patients with the following exclusions: 6 patients were excluded who did not qualify for randomization but were inadvertently randomized into the study and did not receive double-blind study medication; 37 patients were excluded because they were randomized at sites that were closed due to serious GCP violations

Period 1 title

Overall Study (overall period)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

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

Are arms mutually exclusive

Yes

LCZ696

Arm description

Single-blind active run-in period consisted of treatment with enalapril 10 mg bid, followed by LCZ696 100 mg bid, and then LCZ696 200 mg bid over a total duration of 5 to 10 weeks. Temporary down-titration from LCZ696 200 mg bid to LCZ696 100 mg bid was allowed provided the patient was up-titrated back to LCZ696 200 mg bid and tolerated this dose for at least two weeks before being eligible for randomization. LCZ696 200 mg BID during double blind treatment period. Target doses: LCZ696 200 mg bid and enalapril 10 mg bid.

Arm type

Experimental

Investigational medicinal product name

sacubitril/valsartan

Investigational medicinal product code

LCZ696

Other name

sacubitril/valsartan

Pharmaceutical forms

Film-coated tablet

Routes of administration

Oral use

Dosage and administration details

LCZ696 200 mg film-coated tablets orally bid

Enalapril

Arm description

Single-blind active run-in period consisted of treatment with enalapril 10 mg bid, followed by LCZ696 100 mg bid, and then LCZ696 200 mg bid over a total duration of 5 to 10 weeks. Temporary down-titration from LCZ696 200 mg bid to LCZ696 100 mg bid was allowed provided the patient was up-titrated back to LCZ696 200 mg bid and tolerated this dose for at least two weeks before being eligible for randomization. Enalapril 10 mg BID during double blind treatment period. Target doses: LCZ696 200 mg bid and enalapril 10 mg bid.

Arm type

Active comparator

Investigational medicinal product name

enalapril

Investigational medicinal product code

Other name

Vasotec

Pharmaceutical forms

Film-coated tablet

Routes of administration

Oral use

Dosage and administration details

Enalapril 10 mg film-coated tablet bid

Number of subjects in period 1	LCZ696	Enalapril
Started	4209	4233
Completed	3468	3371
Not completed	741	862
patient's request	15	13
Death	724	844
Lost to follow-up	2	5

Baseline characteristics

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Reporting group title

LCZ696

Reporting group description

Single-blind active run-in period consisted of treatment with enalapril 10 mg bid, followed by LCZ696 100 mg bid, and then LCZ696 200 mg bid over a total duration of 5 to 10 weeks. Temporary down-titration from LCZ696 200 mg bid to LCZ696 100 mg bid was allowed provided the patient was up-titrated back to LCZ696 200 mg bid and tolerated this dose for at least two weeks before being eligible for randomization. LCZ696 200 mg BID during double blind treatment period. Target doses: LCZ696 200 mg bid and enalapril 10 mg bid.

Reporting group title

Enalapril

Reporting group description

Single-blind active run-in period consisted of treatment with enalapril 10 mg bid, followed by LCZ696 100 mg bid, and then LCZ696 200 mg bid over a total duration of 5 to 10 weeks. Temporary down-titration from LCZ696 200 mg bid to LCZ696 100 mg bid was allowed provided the patient was up-titrated back to LCZ696 200 mg bid and tolerated this dose for at least two weeks before being eligible for randomization. Enalapril 10 mg BID during double blind treatment period. Target doses: LCZ696 200 mg bid and enalapril 10 mg bid.

Reporting group values	LCZ696	Enalapril	Total
Number of subjects	4209	4233	8442
Age categorical
Units: Subjects
In utero	0	0	0
Preterm newborn infants (gestational age < 37 wks)	0	0	0
Newborns (0-27 days)	0	0	0
Infants and toddlers (28 days-23 months)	0	0	0
Children (2-11 years)	0	0	0
Adolescents (12-17 years)	0	0	0
Adults (18-64 years)	2122	2177	4299
From 65-84 years	2087	2056	4143
85 years and over	0	0	0
Age Continuous \|
Units: years
arithmetic mean (standard deviation)	63.78 ( 11.52 )	63.82 ( 11.25 )	-
Gender, Male/Female
Units: participants
Male	3321	3274	6595
Female	888	959	1847

End points

Top of page

Reporting group title

LCZ696

Reporting group description

Single-blind active run-in period consisted of treatment with enalapril 10 mg bid, followed by LCZ696 100 mg bid, and then LCZ696 200 mg bid over a total duration of 5 to 10 weeks. Temporary down-titration from LCZ696 200 mg bid to LCZ696 100 mg bid was allowed provided the patient was up-titrated back to LCZ696 200 mg bid and tolerated this dose for at least two weeks before being eligible for randomization. LCZ696 200 mg BID during double blind treatment period. Target doses: LCZ696 200 mg bid and enalapril 10 mg bid.

Reporting group title

Enalapril

Reporting group description

Single-blind active run-in period consisted of treatment with enalapril 10 mg bid, followed by LCZ696 100 mg bid, and then LCZ696 200 mg bid over a total duration of 5 to 10 weeks. Temporary down-titration from LCZ696 200 mg bid to LCZ696 100 mg bid was allowed provided the patient was up-titrated back to LCZ696 200 mg bid and tolerated this dose for at least two weeks before being eligible for randomization. Enalapril 10 mg BID during double blind treatment period. Target doses: LCZ696 200 mg bid and enalapril 10 mg bid.

Primary: Number of participants that had first occurrence of the composite endpoint, which is defined as either CV death or HF hospitalization

Top of page

End point title

Number of participants that had first occurrence of the composite endpoint, which is defined as either CV death or HF hospitalization ^[1]

End point description

Number of participants that had first occurrence of the composite endpoint, which is defined as either CV death or HF hospitalization. The data is on the FAS population. Full Analysis Set (FAS) included all randomized patients but the following two exclusions: 6 patients who did not qualify for randomization but were inadvertently randomized into the study and did not receive double-blind study medication; 37 patients because they were randomized at sites that were closed due to serious GCP violations

End point type

Primary

End point timeframe

up to 51 months

Notes
[1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No statistical analysis was planned for this primary outcome

End point values	LCZ696	Enalapril
Number of subjects analysed	4187	4212
Units: participants
Primary Composite	914	1117
CV death	558	693
1st HF Hospitalization	537	658

No statistical analyses for this end point

Secondary: Number of patients reported with all-cause mortality

Top of page

End point title

Number of patients reported with all-cause mortality

End point description

This endpoint measures the number of participants that died from any cause. The data is on the FAS population up to March 31, 2014. Full Analysis Set (FAS) included all randomized patients but the following two exclusions: 6 patients who did not qualify for randomization but were inadvertently randomized into the study and did not receive double-blind study medication; 37 patients because they were randomized at sites that were closed due to serious GCP violations

End point type

Secondary

End point timeframe

up to 51 months

End point values	LCZ696	Enalapril
Number of subjects analysed	4187	4212
Units: participants	711	835

No statistical analyses for this end point

Secondary: Change from baseline to Month 8 for the Kansas City Cardiomyopathy Questionnaire (KCCQ) clinical summary score

Top of page

End point title

Change from baseline to Month 8 for the Kansas City Cardiomyopathy Questionnaire (KCCQ) clinical summary score

End point description

Change from baseline to Month 8 for the Kansas City Cardiomyopathy Questionnaire (KCCQ) clinical summary score. KCCQ is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. KCCQ clinical summary score is a composite assessment of physical limitations and total symptom scores. Scores are transformed to a range of 0-100, in which higher scores reflect better health status. The data is on the FAS population. Full Analysis Set (FAS) included all randomized patients but the following two exclusions: 6 patients who did not qualify for randomization but were inadvertently randomized into the study and did not receive double-blind study medication; 37 patients because they were randomized at sites that were closed due to serious GCP violations. The analysis included all FAS patients with at least one KCCQ data up-to Month 8.

End point type

Secondary

End point timeframe

Baseline, Month 8

End point values	LCZ696	Enalapril
Number of subjects analysed	3643	3638
Units: KCCQ Score
least squares mean (standard error)	-2.99 ( 0.364 )	-4.63 ( 0.364 )

No statistical analyses for this end point

Secondary: Number of patients with first confirmed renal dysfunction

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End point title

Number of patients with first confirmed renal dysfunction

End point description

Number of patients with first confirmed renal dysfunction. The data is on FAS population. Full Analysis Set (FAS) included all randomized patients but the following two exclusions: 6 patients who did not qualify for randomization but were inadvertently randomized into the study and did not receive double-blind study medication; 37 patients because they were randomized at sites that were closed due to serious GCP violations

End point type

Secondary

End point timeframe

up to 51 months

End point values	LCZ696	Enalapril
Number of subjects analysed	4187	4212
Units: participants	94	108

No statistical analyses for this end point

Secondary: Percentage of participants with New Onset of Atrial Fibrillation

Top of page

End point title

Percentage of participants with New Onset of Atrial Fibrillation

End point description

Percentage of participants with New Onset of Atrial Fibrillation. The new onset atrial fibrillation (AF) analysis was based on a subset of FAS: i.e., for patients without a history of AF at baseline (patients with a history of AF were excluded from this analysis).

End point type

Secondary

End point timeframe

up to 51 months

End point values	LCZ696	Enalapril
Number of subjects analysed	2670	2638
Units: Percentage of participants
number (not applicable)	3.15	3.15

No statistical analyses for this end point

Secondary: Number of Patients Reported With Adjudicated Primary Causes of Death

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End point title

Number of Patients Reported With Adjudicated Primary Causes of Death

End point description

Number of patients reported with adjudicated primary causes of death. The data is on Randomization population up to March 31, 2014. Randomized set (RAN): Consisted of all patients who received a randomization number, regardless of receiving trial medication.

End point type

Secondary

End point timeframe

Up to 51 month

End point values	LCZ696	Enalapril
Number of subjects analysed	4209	4233
Units: Participants
Number of patients who died	714	837
CV Death - Fatal MI	25	33
CV Death - Pump Failure	147	185
CV Death - Sudden Death	251	311
CV Death - Presumed Sudden Death	26	23
CV Death - Presumed CV Death	67	95
CV Death - Fatal Stroke	30	34
CV Death - Pulmonary Embolism	4	3
CV Death - CV procedural	3	4
Other CV Death	7	6
Non-CV death - Infection	36	34
Non-CV death - Malignancy	41	41
Non-CV death - Renal	1	1
Non-CV death - Accidental	13	6
Non-CV death - Pulmonary	7	13
Non-CV death - Suicide	4	1
Non-CV death - GI	16	10
Other Non-CV death	2	4
Unknown Death	34	33

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit.

Adverse event reporting additional description

Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field “number of deaths resulting from adverse events” all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

17.0

Reporting group title

Enalapril

Reporting group description

Single-blind active run-in period consisted of treatment with enalapril 10 mg bid, followed by LCZ696 100 mg bid, and then LCZ696 200 mg bid over a total duration of 5 to 10 weeks. Temporary down-titration from LCZ696 200 mg bid to LCZ696 100 mg bid was allowed provided the patient was up-titrated back to LCZ696 200 mg bid and tolerated this dose for at least two weeks before being eligible for randomization. Enalapril 10 mg BID during double blind treatment period

Reporting group title

LCZ696

Reporting group description

Single-blind active run-in period consisted of treatment with enalapril 10 mg bid, followed by LCZ696 100 mg bid, and then LCZ696 200 mg bid over a total duration of 5 to 10 weeks. Temporary down-titration from LCZ696 200 mg bid to LCZ696 100 mg bid was allowed provided the patient was up-titrated back to LCZ696 200 mg bid and tolerated this dose for at least two weeks before being eligible for randomization. LCZ696 200mg BID during double blind treatment period

Serious adverse events	Enalapril	LCZ696
Total subjects affected by serious adverse events
subjects affected / exposed	2142 / 4229 (50.65%)	1937 / 4203 (46.09%)
number of deaths (all causes)	848	729
number of deaths resulting from adverse events	0	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma gastric
subjects affected / exposed	1 / 4229 (0.02%)	2 / 4203 (0.05%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Adenosquamous cell lung cancer
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Adenocarcinoma of colon
subjects affected / exposed	8 / 4229 (0.19%)	3 / 4203 (0.07%)
occurrences causally related to treatment / all	0 / 8	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Basal cell carcinoma
subjects affected / exposed	7 / 4229 (0.17%)	2 / 4203 (0.05%)
occurrences causally related to treatment / all	0 / 7	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
B-cell lymphoma
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (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	2 / 4229 (0.05%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Benign neoplasm of adrenal gland
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Benign neoplasm
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
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	1 / 4229 (0.02%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Benign neoplasm of bladder
subjects affected / exposed	2 / 4229 (0.05%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Bladder adenocarcinoma stage unspecified
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Biliary neoplasm
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Bladder cancer
subjects affected / exposed	5 / 4229 (0.12%)	11 / 4203 (0.26%)
occurrences causally related to treatment / all	0 / 7	0 / 13
deaths causally related to treatment / all	0 / 0	0 / 0
Bladder cancer recurrent
subjects affected / exposed	1 / 4229 (0.02%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Bladder transitional cell carcinoma
subjects affected / exposed	1 / 4229 (0.02%)	2 / 4203 (0.05%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Bone cancer
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Brain neoplasm
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Brain neoplasm malignant
subjects affected / exposed	2 / 4229 (0.05%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Breast cancer
subjects affected / exposed	3 / 4229 (0.07%)	6 / 4203 (0.14%)
occurrences causally related to treatment / all	0 / 3	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Breast cancer recurrent
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Breast neoplasm
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Bronchial carcinoma
subjects affected / exposed	4 / 4229 (0.09%)	2 / 4203 (0.05%)
occurrences causally related to treatment / all	0 / 9	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Bronchioloalveolar carcinoma
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cerebral haemangioma
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cervix carcinoma
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cholangiocarcinoma
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Chronic lymphocytic leukaemia
subjects affected / exposed	1 / 4229 (0.02%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Chronic myeloid leukaemia
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Chronic myelomonocytic leukaemia
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Clear cell renal cell carcinoma
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (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	1 / 4229 (0.02%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Colon cancer
subjects affected / exposed	11 / 4229 (0.26%)	8 / 4203 (0.19%)
occurrences causally related to treatment / all	0 / 11	0 / 8
deaths causally related to treatment / all	0 / 0	0 / 0
Colon cancer metastatic
subjects affected / exposed	0 / 4229 (0.00%)	2 / 4203 (0.05%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Colon neoplasm
subjects affected / exposed	0 / 4229 (0.00%)	2 / 4203 (0.05%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Colorectal adenocarcinoma
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Diffuse large B-cell lymphoma
subjects affected / exposed	1 / 4229 (0.02%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Colorectal cancer
subjects affected / exposed	1 / 4229 (0.02%)	2 / 4203 (0.05%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Gastric cancer
subjects affected / exposed	3 / 4229 (0.07%)	2 / 4203 (0.05%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal cancer metastatic
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal carcinoma
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Glioblastoma
subjects affected / exposed	1 / 4229 (0.02%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Glioblastoma multiforme
subjects affected / exposed	1 / 4229 (0.02%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatic cancer metastatic
subjects affected / exposed	1 / 4229 (0.02%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatic cancer
subjects affected / exposed	2 / 4229 (0.05%)	2 / 4203 (0.05%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Hodgkin's disease
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hypergammaglobulinaemia benign monoclonal
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hypopharyngeal neoplasm benign
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Inflammatory carcinoma of the breast
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Intestinal adenocarcinoma
subjects affected / exposed	1 / 4229 (0.02%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Invasive ductal breast carcinoma
subjects affected / exposed	2 / 4229 (0.05%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Laryngeal cancer
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Large intestine benign neoplasm
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Laryngeal cancer metastatic
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Laryngeal neoplasm
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Lip and/or oral cavity cancer
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (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 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Liposarcoma
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Lipoma
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Liposarcoma recurrent
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Lung adenocarcinoma
subjects affected / exposed	1 / 4229 (0.02%)	5 / 4203 (0.12%)
occurrences causally related to treatment / all	0 / 1	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Lung cancer metastatic
subjects affected / exposed	0 / 4229 (0.00%)	2 / 4203 (0.05%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Lung carcinoma cell type unspecified stage IV
subjects affected / exposed	2 / 4229 (0.05%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Lung neoplasm
subjects affected / exposed	2 / 4229 (0.05%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Lung neoplasm malignant
subjects affected / exposed	13 / 4229 (0.31%)	11 / 4203 (0.26%)
occurrences causally related to treatment / all	0 / 14	0 / 12
deaths causally related to treatment / all	0 / 0	0 / 0
Malignant mediastinal neoplasm
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Lymphoma
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Malignant melanoma
subjects affected / exposed	1 / 4229 (0.02%)	2 / 4203 (0.05%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Malignant neoplasm of pleura
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Malignant neoplasm progression
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Meningioma
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Metastases to bone
subjects affected / exposed	0 / 4229 (0.00%)	3 / 4203 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Meningioma benign
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Metastases to central nervous system
subjects affected / exposed	1 / 4229 (0.02%)	3 / 4203 (0.07%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Metastases to liver
subjects affected / exposed	6 / 4229 (0.14%)	6 / 4203 (0.14%)
occurrences causally related to treatment / all	0 / 8	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Metastases to lung
subjects affected / exposed	1 / 4229 (0.02%)	4 / 4203 (0.10%)
occurrences causally related to treatment / all	0 / 1	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Metastases to lymph nodes
subjects affected / exposed	2 / 4229 (0.05%)	3 / 4203 (0.07%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Metastases to spine
subjects affected / exposed	2 / 4229 (0.05%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Metastases to spleen
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Metastatic malignant melanoma
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Metastatic neoplasm
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Myelodysplastic syndrome
subjects affected / exposed	3 / 4229 (0.07%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 4	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Nasal neoplasm benign
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Nasopharyngeal cancer
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Neoplasm malignant
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Neurilemmoma benign
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Neuroma
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Neuroendocrine tumour
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Non-small cell lung cancer
subjects affected / exposed	0 / 4229 (0.00%)	3 / 4203 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Oesophageal adenocarcinoma
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Oesophageal carcinoma
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (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 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pancreatic neoplasm
subjects affected / exposed	1 / 4229 (0.02%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pancreatic carcinoma
subjects affected / exposed	2 / 4229 (0.05%)	4 / 4203 (0.10%)
occurrences causally related to treatment / all	0 / 2	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Parathyroid tumour benign
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Prostate cancer
subjects affected / exposed	14 / 4229 (0.33%)	8 / 4203 (0.19%)
occurrences causally related to treatment / all	0 / 14	0 / 8
deaths causally related to treatment / all	0 / 0	0 / 0
Plasma cell myeloma
subjects affected / exposed	1 / 4229 (0.02%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Prostate cancer metastatic
subjects affected / exposed	1 / 4229 (0.02%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Prostatic adenoma
subjects affected / exposed	2 / 4229 (0.05%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Rectal adenocarcinoma
subjects affected / exposed	0 / 4229 (0.00%)	3 / 4203 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Rectal cancer
subjects affected / exposed	6 / 4229 (0.14%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 7	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Rectosigmoid cancer
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Refractory cytopenia with unilineage dysplasia
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Renal cancer
subjects affected / exposed	4 / 4229 (0.09%)	3 / 4203 (0.07%)
occurrences causally related to treatment / all	0 / 4	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Renal cancer stage III
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Renal cell carcinoma
subjects affected / exposed	2 / 4229 (0.05%)	3 / 4203 (0.07%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Renal neoplasm
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Salivary gland adenoma
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Seborrhoeic keratosis
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (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	2 / 4229 (0.05%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Small cell lung cancer
subjects affected / exposed	2 / 4229 (0.05%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 4	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Soft tissue cancer
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Small intestine carcinoma
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Spermatocytic seminoma
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Squamous cell carcinoma
subjects affected / exposed	3 / 4229 (0.07%)	3 / 4203 (0.07%)
occurrences causally related to treatment / all	0 / 3	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Squamous cell carcinoma of lung
subjects affected / exposed	0 / 4229 (0.00%)	2 / 4203 (0.05%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Squamous cell carcinoma of the tongue
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Thyroid cancer
subjects affected / exposed	1 / 4229 (0.02%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Tonsil cancer
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Transitional cell carcinoma
subjects affected / exposed	1 / 4229 (0.02%)	2 / 4203 (0.05%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Tumour ulceration
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Uterine cancer
subjects affected / exposed	0 / 4229 (0.00%)	2 / 4203 (0.05%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Uterine leiomyoma
subjects affected / exposed	2 / 4229 (0.05%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Vascular disorders
Accelerated hypertension
subjects affected / exposed	2 / 4229 (0.05%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Aneurysm
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Angiodysplasia
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (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	11 / 4229 (0.26%)	8 / 4203 (0.19%)
occurrences causally related to treatment / all	0 / 11	0 / 9
deaths causally related to treatment / all	0 / 0	0 / 0
Aortic dilatation
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Aortic occlusion
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Aortic stenosis
subjects affected / exposed	2 / 4229 (0.05%)	6 / 4203 (0.14%)
occurrences causally related to treatment / all	0 / 2	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Arterial occlusive disease
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Arterial thrombosis
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Arteriosclerosis
subjects affected / exposed	1 / 4229 (0.02%)	3 / 4203 (0.07%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Arteriovenous fistula
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Bleeding varicose vein
subjects affected / exposed	2 / 4229 (0.05%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Blood pressure inadequately controlled
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Circulatory collapse
subjects affected / exposed	8 / 4229 (0.19%)	5 / 4203 (0.12%)
occurrences causally related to treatment / all	0 / 8	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Deep vein thrombosis
subjects affected / exposed	5 / 4229 (0.12%)	5 / 4203 (0.12%)
occurrences causally related to treatment / all	0 / 5	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Diabetic vascular disorder
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Extremity necrosis
subjects affected / exposed	0 / 4229 (0.00%)	2 / 4203 (0.05%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Femoral artery embolism
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (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	6 / 4229 (0.14%)	3 / 4203 (0.07%)
occurrences causally related to treatment / all	0 / 6	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Haematoma
subjects affected / exposed	1 / 4229 (0.02%)	2 / 4203 (0.05%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Haemorrhage
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hypertension
subjects affected / exposed	12 / 4229 (0.28%)	13 / 4203 (0.31%)
occurrences causally related to treatment / all	0 / 15	0 / 15
deaths causally related to treatment / all	0 / 0	0 / 0
Hypertensive crisis
subjects affected / exposed	2 / 4229 (0.05%)	7 / 4203 (0.17%)
occurrences causally related to treatment / all	0 / 2	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
Hypertensive emergency
subjects affected / exposed	2 / 4229 (0.05%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hypoperfusion
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hypotension
subjects affected / exposed	68 / 4229 (1.61%)	59 / 4203 (1.40%)
occurrences causally related to treatment / all	34 / 73	23 / 61
deaths causally related to treatment / all	0 / 0	0 / 0
Iliac artery occlusion
subjects affected / exposed	3 / 4229 (0.07%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hypovolaemic shock
subjects affected / exposed	2 / 4229 (0.05%)	5 / 4203 (0.12%)
occurrences causally related to treatment / all	0 / 2	1 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Ischaemia
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Intermittent claudication
subjects affected / exposed	3 / 4229 (0.07%)	2 / 4203 (0.05%)
occurrences causally related to treatment / all	0 / 4	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Jugular vein thrombosis
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Lymphatic fistula
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (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	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Lymphoedema
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Orthostatic hypotension
subjects affected / exposed	3 / 4229 (0.07%)	5 / 4203 (0.12%)
occurrences causally related to treatment / all	1 / 3	5 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
Peripheral arterial occlusive disease
subjects affected / exposed	13 / 4229 (0.31%)	22 / 4203 (0.52%)
occurrences causally related to treatment / all	0 / 13	0 / 28
deaths causally related to treatment / all	0 / 0	0 / 0
Peripheral artery aneurysm
subjects affected / exposed	1 / 4229 (0.02%)	3 / 4203 (0.07%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Peripheral artery stenosis
subjects affected / exposed	2 / 4229 (0.05%)	4 / 4203 (0.10%)
occurrences causally related to treatment / all	0 / 2	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Peripheral circulatory failure
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Peripheral artery thrombosis
subjects affected / exposed	3 / 4229 (0.07%)	4 / 4203 (0.10%)
occurrences causally related to treatment / all	0 / 3	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Peripheral ischaemia
subjects affected / exposed	8 / 4229 (0.19%)	18 / 4203 (0.43%)
occurrences causally related to treatment / all	0 / 9	0 / 22
deaths causally related to treatment / all	0 / 0	0 / 0
Peripheral embolism
subjects affected / exposed	2 / 4229 (0.05%)	4 / 4203 (0.10%)
occurrences causally related to treatment / all	0 / 2	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Peripheral vascular disorder
subjects affected / exposed	5 / 4229 (0.12%)	7 / 4203 (0.17%)
occurrences causally related to treatment / all	0 / 7	0 / 9
deaths causally related to treatment / all	0 / 0	0 / 0
Phlebitis
subjects affected / exposed	0 / 4229 (0.00%)	2 / 4203 (0.05%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Polyarteritis nodosa
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Shock
subjects affected / exposed	5 / 4229 (0.12%)	4 / 4203 (0.10%)
occurrences causally related to treatment / all	0 / 5	1 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Shock haemorrhagic
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Subgaleal haematoma
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Superior vena cava syndrome
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Thrombophlebitis
subjects affected / exposed	3 / 4229 (0.07%)	3 / 4203 (0.07%)
occurrences causally related to treatment / all	0 / 3	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Thrombophlebitis superficial
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (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	2 / 4229 (0.05%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	1 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Varicose vein
subjects affected / exposed	2 / 4229 (0.05%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Vascular compression
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Vasculitis
subjects affected / exposed	0 / 4229 (0.00%)	2 / 4203 (0.05%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Venous haemorrhage
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Vein collapse
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Venous thrombosis
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Venous insufficiency
subjects affected / exposed	3 / 4229 (0.07%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Venous thrombosis limb
subjects affected / exposed	2 / 4229 (0.05%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Surgical and medical procedures
Cardiac pacemaker insertion
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Endotracheal intubation
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Implantable defibrillator insertion
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Lymphadenectomy
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Resuscitation
subjects affected / exposed	1 / 4229 (0.02%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Thyroidectomy
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pregnancy, puerperium and perinatal conditions
Pregnancy
subjects affected / exposed	0 / 4229 (0.00%)	2 / 4203 (0.05%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
General disorders and administration site conditions
Accidental death
subjects affected / exposed	0 / 4229 (0.00%)	2 / 4203 (0.05%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Asthenia
subjects affected / exposed	9 / 4229 (0.21%)	9 / 4203 (0.21%)
occurrences causally related to treatment / all	2 / 9	0 / 9
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac death
subjects affected / exposed	114 / 4229 (2.70%)	85 / 4203 (2.02%)
occurrences causally related to treatment / all	1 / 115	1 / 85
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac complication associated with device
subjects affected / exposed	1 / 4229 (0.02%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Chest discomfort
subjects affected / exposed	1 / 4229 (0.02%)	3 / 4203 (0.07%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Chest pain
subjects affected / exposed	3 / 4229 (0.07%)	3 / 4203 (0.07%)
occurrences causally related to treatment / all	0 / 3	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Chills
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Concomitant disease aggravated
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Death
subjects affected / exposed	78 / 4229 (1.84%)	56 / 4203 (1.33%)
occurrences causally related to treatment / all	2 / 78	2 / 56
deaths causally related to treatment / all	0 / 0	0 / 0
Device battery issue
subjects affected / exposed	8 / 4229 (0.19%)	11 / 4203 (0.26%)
occurrences causally related to treatment / all	0 / 8	0 / 11
deaths causally related to treatment / all	0 / 0	0 / 0
Device dislocation
subjects affected / exposed	3 / 4229 (0.07%)	3 / 4203 (0.07%)
occurrences causally related to treatment / all	0 / 3	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Device breakage
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Device failure
subjects affected / exposed	5 / 4229 (0.12%)	6 / 4203 (0.14%)
occurrences causally related to treatment / all	0 / 5	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Device issue
subjects affected / exposed	2 / 4229 (0.05%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Device leakage
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Device lead damage
subjects affected / exposed	1 / 4229 (0.02%)	2 / 4203 (0.05%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Device malfunction
subjects affected / exposed	11 / 4229 (0.26%)	15 / 4203 (0.36%)
occurrences causally related to treatment / all	0 / 11	0 / 15
deaths causally related to treatment / all	0 / 0	0 / 0
Device occlusion
subjects affected / exposed	2 / 4229 (0.05%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Device stimulation issue
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Disease progression
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Drowning
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (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	1 / 4229 (0.02%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Euthanasia
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Fatigue
subjects affected / exposed	10 / 4229 (0.24%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 12	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gait disturbance
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
General physical health deterioration
subjects affected / exposed	3 / 4229 (0.07%)	2 / 4203 (0.05%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Generalised oedema
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hernia
subjects affected / exposed	1 / 4229 (0.02%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hernia obstructive
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Impaired healing
subjects affected / exposed	1 / 4229 (0.02%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hyperthermia
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Implant site haematoma
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Implant site inflammation
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Implant site reaction
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Implant site ulcer
subjects affected / exposed	1 / 4229 (0.02%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Inflammation
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Local swelling
subjects affected / exposed	3 / 4229 (0.07%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Malaise
subjects affected / exposed	2 / 4229 (0.05%)	4 / 4203 (0.10%)
occurrences causally related to treatment / all	0 / 2	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Medical device complication
subjects affected / exposed	1 / 4229 (0.02%)	5 / 4203 (0.12%)
occurrences causally related to treatment / all	0 / 1	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Medical device pain
subjects affected / exposed	3 / 4229 (0.07%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Medical device site reaction
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (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	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Multi-organ failure
subjects affected / exposed	15 / 4229 (0.35%)	14 / 4203 (0.33%)
occurrences causally related to treatment / all	0 / 15	0 / 14
deaths causally related to treatment / all	0 / 0	0 / 0
Necrosis
subjects affected / exposed	1 / 4229 (0.02%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Non-cardiac chest pain
subjects affected / exposed	36 / 4229 (0.85%)	33 / 4203 (0.79%)
occurrences causally related to treatment / all	0 / 51	0 / 39
deaths causally related to treatment / all	0 / 0	0 / 0
Oedema
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Oedema due to cardiac disease
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Oedema peripheral
subjects affected / exposed	15 / 4229 (0.35%)	10 / 4203 (0.24%)
occurrences causally related to treatment / all	0 / 22	0 / 12
deaths causally related to treatment / all	0 / 0	0 / 0
Pacemaker generated arrhythmia
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Perforated ulcer
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (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	69 / 4229 (1.63%)	67 / 4203 (1.59%)
occurrences causally related to treatment / all	3 / 69	2 / 67
deaths causally related to treatment / all	0 / 0	0 / 0
Pyrexia
subjects affected / exposed	12 / 4229 (0.28%)	9 / 4203 (0.21%)
occurrences causally related to treatment / all	0 / 12	0 / 9
deaths causally related to treatment / all	0 / 0	0 / 0
Sudden death
subjects affected / exposed	78 / 4229 (1.84%)	66 / 4203 (1.57%)
occurrences causally related to treatment / all	1 / 79	2 / 66
deaths causally related to treatment / all	0 / 0	0 / 0
Temperature regulation disorder
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Vessel puncture site haemorrhage
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Vessel puncture site haematoma
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Immune system disorders
Allergy to arthropod sting
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Anaphylactic reaction
subjects affected / exposed	0 / 4229 (0.00%)	2 / 4203 (0.05%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Anaphylactic shock
subjects affected / exposed	1 / 4229 (0.02%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Drug hypersensitivity
subjects affected / exposed	5 / 4229 (0.12%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	1 / 5	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Sarcoidosis
subjects affected / exposed	0 / 4229 (0.00%)	2 / 4203 (0.05%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Hypersensitivity
subjects affected / exposed	0 / 4229 (0.00%)	2 / 4203 (0.05%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Reproductive system and breast disorders
Benign prostatic hyperplasia
subjects affected / exposed	9 / 4229 (0.21%)	8 / 4203 (0.19%)
occurrences causally related to treatment / all	0 / 10	0 / 8
deaths causally related to treatment / all	0 / 0	0 / 0
Acquired phimosis
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (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	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Breast pain
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cervical polyp
subjects affected / exposed	1 / 4229 (0.02%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Menorrhagia
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Erectile dysfunction
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Ovarian cyst
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Perineal pain
subjects affected / exposed	1 / 4229 (0.02%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Postmenopausal haemorrhage
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Prostatic obstruction
subjects affected / exposed	1 / 4229 (0.02%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Prostatitis
subjects affected / exposed	3 / 4229 (0.07%)	3 / 4203 (0.07%)
occurrences causally related to treatment / all	0 / 4	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Uterine haemorrhage
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Vaginal haemorrhage
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Uterine polyp
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Vaginal relaxation
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
subjects affected / exposed	19 / 4229 (0.45%)	20 / 4203 (0.48%)
occurrences causally related to treatment / all	0 / 22	0 / 23
deaths causally related to treatment / all	0 / 0	0 / 0
Acute respiratory distress syndrome
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Acute respiratory failure
subjects affected / exposed	11 / 4229 (0.26%)	11 / 4203 (0.26%)
occurrences causally related to treatment / all	0 / 12	0 / 11
deaths causally related to treatment / all	0 / 0	0 / 0
Asphyxia
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Atelectasis
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Asthma
subjects affected / exposed	6 / 4229 (0.14%)	4 / 4203 (0.10%)
occurrences causally related to treatment / all	0 / 11	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Bronchiectasis
subjects affected / exposed	1 / 4229 (0.02%)	3 / 4203 (0.07%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Bronchospasm
subjects affected / exposed	1 / 4229 (0.02%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Bronchitis chronic
subjects affected / exposed	6 / 4229 (0.14%)	3 / 4203 (0.07%)
occurrences causally related to treatment / all	0 / 6	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Chronic respiratory failure
subjects affected / exposed	0 / 4229 (0.00%)	2 / 4203 (0.05%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Chronic obstructive pulmonary disease
subjects affected / exposed	46 / 4229 (1.09%)	40 / 4203 (0.95%)
occurrences causally related to treatment / all	0 / 61	0 / 63
deaths causally related to treatment / all	0 / 0	0 / 0
Cough
subjects affected / exposed	9 / 4229 (0.21%)	3 / 4203 (0.07%)
occurrences causally related to treatment / all	6 / 10	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Dysphonia
subjects affected / exposed	1 / 4229 (0.02%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Dyspnoea
subjects affected / exposed	57 / 4229 (1.35%)	51 / 4203 (1.21%)
occurrences causally related to treatment / all	1 / 71	4 / 58
deaths causally related to treatment / all	0 / 0	0 / 0
Dyspnoea exertional
subjects affected / exposed	4 / 4229 (0.09%)	5 / 4203 (0.12%)
occurrences causally related to treatment / all	0 / 4	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Dyspnoea paroxysmal nocturnal
subjects affected / exposed	2 / 4229 (0.05%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Emphysema
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Haemoptysis
subjects affected / exposed	11 / 4229 (0.26%)	4 / 4203 (0.10%)
occurrences causally related to treatment / all	0 / 11	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Epistaxis
subjects affected / exposed	7 / 4229 (0.17%)	7 / 4203 (0.17%)
occurrences causally related to treatment / all	0 / 7	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
Hiccups
subjects affected / exposed	1 / 4229 (0.02%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Haemothorax
subjects affected / exposed	0 / 4229 (0.00%)	2 / 4203 (0.05%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Hydrothorax
subjects affected / exposed	2 / 4229 (0.05%)	3 / 4203 (0.07%)
occurrences causally related to treatment / all	0 / 2	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Hypoxia
subjects affected / exposed	7 / 4229 (0.17%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 7	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Interstitial lung disease
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Laryngeal oedema
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Lung infiltration
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (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	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Nasal polyps
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Nocturnal dyspnoea
subjects affected / exposed	1 / 4229 (0.02%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Obstructive airways disorder
subjects affected / exposed	0 / 4229 (0.00%)	2 / 4203 (0.05%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Orthopnoea
subjects affected / exposed	3 / 4229 (0.07%)	4 / 4203 (0.10%)
occurrences causally related to treatment / all	0 / 6	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Pleural effusion
subjects affected / exposed	19 / 4229 (0.45%)	16 / 4203 (0.38%)
occurrences causally related to treatment / all	0 / 21	0 / 18
deaths causally related to treatment / all	0 / 0	0 / 0
Pleurisy
subjects affected / exposed	1 / 4229 (0.02%)	2 / 4203 (0.05%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumonia aspiration
subjects affected / exposed	8 / 4229 (0.19%)	5 / 4203 (0.12%)
occurrences causally related to treatment / all	0 / 8	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumothorax
subjects affected / exposed	3 / 4229 (0.07%)	6 / 4203 (0.14%)
occurrences causally related to treatment / all	0 / 3	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumonitis
subjects affected / exposed	3 / 4229 (0.07%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumothorax spontaneous
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pulmonary congestion
subjects affected / exposed	6 / 4229 (0.14%)	2 / 4203 (0.05%)
occurrences causally related to treatment / all	0 / 6	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Productive cough
subjects affected / exposed	2 / 4229 (0.05%)	3 / 4203 (0.07%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Pulmonary fibrosis
subjects affected / exposed	2 / 4229 (0.05%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pulmonary embolism
subjects affected / exposed	23 / 4229 (0.54%)	22 / 4203 (0.52%)
occurrences causally related to treatment / all	1 / 24	0 / 22
deaths causally related to treatment / all	0 / 0	0 / 0
Pulmonary infarction
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pulmonary haemorrhage
subjects affected / exposed	2 / 4229 (0.05%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Pulmonary hypertension
subjects affected / exposed	5 / 4229 (0.12%)	3 / 4203 (0.07%)
occurrences causally related to treatment / all	0 / 5	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Pulmonary microemboli
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pulmonary mass
subjects affected / exposed	2 / 4229 (0.05%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Rales
subjects affected / exposed	4 / 4229 (0.09%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 4	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pulmonary oedema
subjects affected / exposed	21 / 4229 (0.50%)	21 / 4203 (0.50%)
occurrences causally related to treatment / all	0 / 23	0 / 26
deaths causally related to treatment / all	0 / 0	0 / 0
Respiratory arrest
subjects affected / exposed	2 / 4229 (0.05%)	2 / 4203 (0.05%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Respiratory distress
subjects affected / exposed	1 / 4229 (0.02%)	5 / 4203 (0.12%)
occurrences causally related to treatment / all	0 / 1	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Respiratory acidosis
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Respiratory failure
subjects affected / exposed	26 / 4229 (0.61%)	25 / 4203 (0.59%)
occurrences causally related to treatment / all	1 / 26	0 / 25
deaths causally related to treatment / all	0 / 0	0 / 0
Respiratory fatigue
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Tachypnoea
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Sleep apnoea syndrome
subjects affected / exposed	2 / 4229 (0.05%)	3 / 4203 (0.07%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Vocal cord leukoplakia
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Tracheal stenosis
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Psychiatric disorders
Alcohol abuse
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Alcohol withdrawal syndrome
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Anxiety
subjects affected / exposed	2 / 4229 (0.05%)	3 / 4203 (0.07%)
occurrences causally related to treatment / all	0 / 2	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Alcoholism
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Completed suicide
subjects affected / exposed	1 / 4229 (0.02%)	2 / 4203 (0.05%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Confusional state
subjects affected / exposed	8 / 4229 (0.19%)	6 / 4203 (0.14%)
occurrences causally related to treatment / all	0 / 8	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Delirium
subjects affected / exposed	4 / 4229 (0.09%)	2 / 4203 (0.05%)
occurrences causally related to treatment / all	0 / 4	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Delirium tremens
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Depression
subjects affected / exposed	0 / 4229 (0.00%)	5 / 4203 (0.12%)
occurrences causally related to treatment / all	0 / 0	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Disorientation
subjects affected / exposed	2 / 4229 (0.05%)	0 / 4203 (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	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Generalised anxiety disorder
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Hypochondriasis
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 4	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hallucination
subjects affected / exposed	2 / 4229 (0.05%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Insomnia
subjects affected / exposed	2 / 4229 (0.05%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Major depression
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Mental status changes
subjects affected / exposed	0 / 4229 (0.00%)	4 / 4203 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Mental disorder
subjects affected / exposed	1 / 4229 (0.02%)	2 / 4203 (0.05%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Mental disorder due to a general medical condition
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Panic disorder
subjects affected / exposed	1 / 4229 (0.02%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Mood disorder due to a general medical condition
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Psychotic disorder
subjects affected / exposed	2 / 4229 (0.05%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Psychiatric symptom
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Psychotic disorder due to a general medical condition
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Schizophrenia
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Somatisation disorder
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
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	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Somatoform disorder gastrointestinal
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Suicide attempt
subjects affected / exposed	1 / 4229 (0.02%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatobiliary disorders
Acute hepatic failure
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Bile duct stone
subjects affected / exposed	3 / 4229 (0.07%)	4 / 4203 (0.10%)
occurrences causally related to treatment / all	0 / 3	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Biliary colic
subjects affected / exposed	2 / 4229 (0.05%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Biliary dilatation
subjects affected / exposed	0 / 4229 (0.00%)	2 / 4203 (0.05%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac cirrhosis
subjects affected / exposed	1 / 4229 (0.02%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cholangitis acute
subjects affected / exposed	0 / 4229 (0.00%)	4 / 4203 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Cholangitis
subjects affected / exposed	1 / 4229 (0.02%)	2 / 4203 (0.05%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Cholecystitis
subjects affected / exposed	8 / 4229 (0.19%)	5 / 4203 (0.12%)
occurrences causally related to treatment / all	0 / 8	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Cholecystitis acute
subjects affected / exposed	12 / 4229 (0.28%)	12 / 4203 (0.29%)
occurrences causally related to treatment / all	0 / 12	0 / 13
deaths causally related to treatment / all	0 / 0	0 / 0
Cholecystitis chronic
subjects affected / exposed	1 / 4229 (0.02%)	3 / 4203 (0.07%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Cholelithiasis
subjects affected / exposed	17 / 4229 (0.40%)	10 / 4203 (0.24%)
occurrences causally related to treatment / all	0 / 17	0 / 10
deaths causally related to treatment / all	0 / 0	0 / 0
Cholestasis
subjects affected / exposed	2 / 4229 (0.05%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	1 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gallbladder perforation
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatic congestion
subjects affected / exposed	3 / 4229 (0.07%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatic cirrhosis
subjects affected / exposed	5 / 4229 (0.12%)	3 / 4203 (0.07%)
occurrences causally related to treatment / all	0 / 6	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatic failure
subjects affected / exposed	4 / 4229 (0.09%)	5 / 4203 (0.12%)
occurrences causally related to treatment / all	0 / 4	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatic function abnormal
subjects affected / exposed	2 / 4229 (0.05%)	3 / 4203 (0.07%)
occurrences causally related to treatment / all	1 / 2	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatic ischaemia
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
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	1 / 4229 (0.02%)	3 / 4203 (0.07%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatitis
subjects affected / exposed	1 / 4229 (0.02%)	2 / 4203 (0.05%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatitis acute
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatitis toxic
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatocellular injury
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatomegaly
subjects affected / exposed	2 / 4229 (0.05%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatorenal syndrome
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hydrocholecystis
subjects affected / exposed	1 / 4229 (0.02%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatotoxicity
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hyperbilirubinaemia
subjects affected / exposed	2 / 4229 (0.05%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Ischaemic hepatitis
subjects affected / exposed	2 / 4229 (0.05%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Jaundice
subjects affected / exposed	0 / 4229 (0.00%)	5 / 4203 (0.12%)
occurrences causally related to treatment / all	0 / 0	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Jaundice cholestatic
subjects affected / exposed	1 / 4229 (0.02%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Liver disorder
subjects affected / exposed	2 / 4229 (0.05%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Liver injury
subjects affected / exposed	2 / 4229 (0.05%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Portal hypertension
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Portal vein thrombosis
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Investigations
Acid base balance abnormal
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Alanine aminotransferase increased
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
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	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Blood creatinine increased
subjects affected / exposed	2 / 4229 (0.05%)	4 / 4203 (0.10%)
occurrences causally related to treatment / all	1 / 2	1 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Blood albumin decreased
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Blood potassium decreased
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Blood glucose increased
subjects affected / exposed	0 / 4229 (0.00%)	2 / 4203 (0.05%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Blood pressure systolic decreased
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Blood pressure decreased
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac function test abnormal
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Blood sodium decreased
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
C-reactive protein increased
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Coagulation factor increased
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Coagulation time prolonged
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Creatinine renal clearance decreased
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Ejection fraction
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Ejection fraction decreased
subjects affected / exposed	2 / 4229 (0.05%)	2 / 4203 (0.05%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Electrocardiogram QRS complex abnormal
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Escherichia test positive
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Glomerular filtration rate decreased
subjects affected / exposed	1 / 4229 (0.02%)	2 / 4203 (0.05%)
occurrences causally related to treatment / all	0 / 1	2 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Gastric pH decreased
subjects affected / exposed	2 / 4229 (0.05%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Heart rate decreased
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
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	0 / 4229 (0.00%)	2 / 4203 (0.05%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Haemoglobin decreased
subjects affected / exposed	2 / 4229 (0.05%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
International normalised ratio abnormal
subjects affected / exposed	2 / 4229 (0.05%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
International normalised ratio increased
subjects affected / exposed	8 / 4229 (0.19%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	1 / 9	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Oxygen saturation decreased
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Liver function test abnormal
subjects affected / exposed	3 / 4229 (0.07%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	2 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Prothrombin time prolonged
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Respiratory rate increased
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Prothrombin time abnormal
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Troponin increased
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Urine output decreased
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Weight decreased
subjects affected / exposed	5 / 4229 (0.12%)	5 / 4203 (0.12%)
occurrences causally related to treatment / all	0 / 5	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Venous pressure jugular increased
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Weight increased
subjects affected / exposed	2 / 4229 (0.05%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Injury, poisoning and procedural complications
Abdominal injury
subjects affected / exposed	1 / 4229 (0.02%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Accident
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (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	2 / 4229 (0.05%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Animal bite
subjects affected / exposed	1 / 4229 (0.02%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Ankle fracture
subjects affected / exposed	2 / 4229 (0.05%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Arterial restenosis
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Bone contusion
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Brain contusion
subjects affected / exposed	2 / 4229 (0.05%)	1 / 4203 (0.02%)
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	3 / 4229 (0.07%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac contusion
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac valve replacement complication
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac valve rupture
subjects affected / exposed	1 / 4229 (0.02%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Chemical peritonitis
subjects affected / exposed	1 / 4229 (0.02%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Chest injury
subjects affected / exposed	1 / 4229 (0.02%)	2 / 4203 (0.05%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Clavicle fracture
subjects affected / exposed	1 / 4229 (0.02%)	2 / 4203 (0.05%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Concussion
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Compression fracture
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Contusion
subjects affected / exposed	4 / 4229 (0.09%)	2 / 4203 (0.05%)
occurrences causally related to treatment / all	1 / 4	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Coronary artery restenosis
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Craniocerebral injury
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cystitis radiation
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Excoriation
subjects affected / exposed	1 / 4229 (0.02%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Extradural haematoma
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Face injury
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Eyeball rupture
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Facial bones fracture
subjects affected / exposed	1 / 4229 (0.02%)	2 / 4203 (0.05%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Fall
subjects affected / exposed	10 / 4229 (0.24%)	6 / 4203 (0.14%)
occurrences causally related to treatment / all	1 / 10	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
Femoral neck fracture
subjects affected / exposed	7 / 4229 (0.17%)	5 / 4203 (0.12%)
occurrences causally related to treatment / all	0 / 9	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Femur fracture
subjects affected / exposed	7 / 4229 (0.17%)	6 / 4203 (0.14%)
occurrences causally related to treatment / all	0 / 7	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Fibula fracture
subjects affected / exposed	2 / 4229 (0.05%)	2 / 4203 (0.05%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Foot fracture
subjects affected / exposed	2 / 4229 (0.05%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Forearm fracture
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
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 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Graft complication
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hand fracture
subjects affected / exposed	1 / 4229 (0.02%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Head injury
subjects affected / exposed	5 / 4229 (0.12%)	6 / 4203 (0.14%)
occurrences causally related to treatment / all	0 / 5	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Hip fracture
subjects affected / exposed	12 / 4229 (0.28%)	6 / 4203 (0.14%)
occurrences causally related to treatment / all	0 / 12	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Humerus fracture
subjects affected / exposed	3 / 4229 (0.07%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Incisional hernia
subjects affected / exposed	1 / 4229 (0.02%)	3 / 4203 (0.07%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Jaw fracture
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
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	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Joint injury
subjects affected / exposed	0 / 4229 (0.00%)	4 / 4203 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Laceration
subjects affected / exposed	1 / 4229 (0.02%)	5 / 4203 (0.12%)
occurrences causally related to treatment / all	0 / 1	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Limb traumatic amputation
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Lower limb fracture
subjects affected / exposed	2 / 4229 (0.05%)	2 / 4203 (0.05%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Lumbar vertebral fracture
subjects affected / exposed	1 / 4229 (0.02%)	2 / 4203 (0.05%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Median nerve injury
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Medication error
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Meniscus injury
subjects affected / exposed	2 / 4229 (0.05%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Multiple fractures
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Multiple injuries
subjects affected / exposed	1 / 4229 (0.02%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Muscle rupture
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Overdose
subjects affected / exposed	5 / 4229 (0.12%)	3 / 4203 (0.07%)
occurrences causally related to treatment / all	0 / 5	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Patella fracture
subjects affected / exposed	3 / 4229 (0.07%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 4	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pelvic fracture
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Post concussion syndrome
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Post procedural complication
subjects affected / exposed	2 / 4229 (0.05%)	2 / 4203 (0.05%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Post procedural discharge
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Post procedural fistula
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
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	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Post procedural haemorrhage
subjects affected / exposed	2 / 4229 (0.05%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Post procedural myocardial infarction
subjects affected / exposed	1 / 4229 (0.02%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Postoperative renal failure
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Postoperative thoracic procedure complication
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Postoperative wound complication
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Procedural complication
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Procedural haemorrhage
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (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 / 4229 (0.02%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Radiation proctitis
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Road traffic accident
subjects affected / exposed	3 / 4229 (0.07%)	7 / 4203 (0.17%)
occurrences causally related to treatment / all	0 / 3	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
Sacroiliac fracture
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
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	1 / 4229 (0.02%)	4 / 4203 (0.10%)
occurrences causally related to treatment / all	0 / 1	1 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Seroma
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Scapula fracture
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Skull fracture
subjects affected / exposed	2 / 4229 (0.05%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Soft tissue injury
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Spinal cord injury lumbar
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Spinal fracture
subjects affected / exposed	3 / 4229 (0.07%)	2 / 4203 (0.05%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Spinal compression fracture
subjects affected / exposed	4 / 4229 (0.09%)	3 / 4203 (0.07%)
occurrences causally related to treatment / all	0 / 4	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Subdural haematoma
subjects affected / exposed	5 / 4229 (0.12%)	11 / 4203 (0.26%)
occurrences causally related to treatment / all	0 / 5	1 / 12
deaths causally related to treatment / all	0 / 0	0 / 0
Subcutaneous haematoma
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Thermal burn
subjects affected / exposed	1 / 4229 (0.02%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Subdural haemorrhage
subjects affected / exposed	2 / 4229 (0.05%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Tendon rupture
subjects affected / exposed	0 / 4229 (0.00%)	3 / 4203 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Thoracic vertebral fracture
subjects affected / exposed	3 / 4229 (0.07%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Tibia fracture
subjects affected / exposed	2 / 4229 (0.05%)	2 / 4203 (0.05%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Toxicity to various agents
subjects affected / exposed	9 / 4229 (0.21%)	8 / 4203 (0.19%)
occurrences causally related to treatment / all	0 / 14	0 / 8
deaths causally related to treatment / all	0 / 0	0 / 0
Traumatic haematoma
subjects affected / exposed	2 / 4229 (0.05%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Ulna fracture
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Vascular graft complication
subjects affected / exposed	0 / 4229 (0.00%)	2 / 4203 (0.05%)
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	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Vascular graft occlusion
subjects affected / exposed	0 / 4229 (0.00%)	2 / 4203 (0.05%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Vascular graft thrombosis
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Vascular pseudoaneurysm
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Vascular procedure complication
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Wound
subjects affected / exposed	1 / 4229 (0.02%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Wound necrosis
subjects affected / exposed	1 / 4229 (0.02%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Wound dehiscence
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Congenital, familial and genetic disorders
Cryptorchism
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Exomphalos
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal arteriovenous malformation
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Homocystinaemia
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hydrocele
subjects affected / exposed	0 / 4229 (0.00%)	2 / 4203 (0.05%)
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	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Sickle cell anaemia with crisis
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 4	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac disorders
Acute coronary syndrome
subjects affected / exposed	18 / 4229 (0.43%)	18 / 4203 (0.43%)
occurrences causally related to treatment / all	0 / 18	0 / 18
deaths causally related to treatment / all	0 / 0	0 / 0
Acute myocardial infarction
subjects affected / exposed	68 / 4229 (1.61%)	69 / 4203 (1.64%)
occurrences causally related to treatment / all	2 / 73	0 / 74
deaths causally related to treatment / all	0 / 0	0 / 0
Acute left ventricular failure
subjects affected / exposed	5 / 4229 (0.12%)	4 / 4203 (0.10%)
occurrences causally related to treatment / all	1 / 6	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Angina pectoris
subjects affected / exposed	62 / 4229 (1.47%)	55 / 4203 (1.31%)
occurrences causally related to treatment / all	0 / 69	1 / 61
deaths causally related to treatment / all	0 / 0	0 / 0
Adams-Stokes syndrome
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Angina unstable
subjects affected / exposed	51 / 4229 (1.21%)	53 / 4203 (1.26%)
occurrences causally related to treatment / all	1 / 60	0 / 62
deaths causally related to treatment / all	0 / 0	0 / 0
Aortic valve incompetence
subjects affected / exposed	4 / 4229 (0.09%)	3 / 4203 (0.07%)
occurrences causally related to treatment / all	0 / 4	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Aortic valve stenosis
subjects affected / exposed	4 / 4229 (0.09%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 4	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Arrhythmia
subjects affected / exposed	21 / 4229 (0.50%)	23 / 4203 (0.55%)
occurrences causally related to treatment / all	3 / 21	0 / 23
deaths causally related to treatment / all	0 / 0	0 / 0
Arrhythmia supraventricular
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Arteriosclerosis coronary artery
subjects affected / exposed	4 / 4229 (0.09%)	4 / 4203 (0.10%)
occurrences causally related to treatment / all	0 / 4	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Atrial fibrillation
subjects affected / exposed	113 / 4229 (2.67%)	108 / 4203 (2.57%)
occurrences causally related to treatment / all	1 / 128	5 / 127
deaths causally related to treatment / all	0 / 0	0 / 0
Arteriospasm coronary
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Atrial flutter
subjects affected / exposed	18 / 4229 (0.43%)	11 / 4203 (0.26%)
occurrences causally related to treatment / all	0 / 19	0 / 11
deaths causally related to treatment / all	0 / 0	0 / 0
Atrial tachycardia
subjects affected / exposed	1 / 4229 (0.02%)	7 / 4203 (0.17%)
occurrences causally related to treatment / all	0 / 1	0 / 8
deaths causally related to treatment / all	0 / 0	0 / 0
Atrioventricular block
subjects affected / exposed	5 / 4229 (0.12%)	2 / 4203 (0.05%)
occurrences causally related to treatment / all	0 / 5	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Atrioventricular block complete
subjects affected / exposed	10 / 4229 (0.24%)	13 / 4203 (0.31%)
occurrences causally related to treatment / all	0 / 10	1 / 13
deaths causally related to treatment / all	0 / 0	0 / 0
Atrioventricular block first degree
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Atrioventricular block second degree
subjects affected / exposed	5 / 4229 (0.12%)	6 / 4203 (0.14%)
occurrences causally related to treatment / all	0 / 5	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Atrioventricular dissociation
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Bradycardia
subjects affected / exposed	13 / 4229 (0.31%)	11 / 4203 (0.26%)
occurrences causally related to treatment / all	1 / 13	0 / 11
deaths causally related to treatment / all	0 / 0	0 / 0
Bradyarrhythmia
subjects affected / exposed	4 / 4229 (0.09%)	3 / 4203 (0.07%)
occurrences causally related to treatment / all	0 / 4	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac aneurysm
subjects affected / exposed	1 / 4229 (0.02%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Bundle branch block left
subjects affected / exposed	3 / 4229 (0.07%)	2 / 4203 (0.05%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Bundle branch block right
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac arrest
subjects affected / exposed	56 / 4229 (1.32%)	30 / 4203 (0.71%)
occurrences causally related to treatment / all	2 / 58	2 / 30
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac asthma
subjects affected / exposed	3 / 4229 (0.07%)	2 / 4203 (0.05%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac disorder
subjects affected / exposed	1 / 4229 (0.02%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac discomfort
subjects affected / exposed	3 / 4229 (0.07%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac failure chronic
subjects affected / exposed	135 / 4229 (3.19%)	112 / 4203 (2.66%)
occurrences causally related to treatment / all	11 / 191	4 / 152
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac failure
subjects affected / exposed	649 / 4229 (15.35%)	588 / 4203 (13.99%)
occurrences causally related to treatment / all	30 / 1042	20 / 876
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac failure acute
subjects affected / exposed	93 / 4229 (2.20%)	67 / 4203 (1.59%)
occurrences causally related to treatment / all	1 / 131	3 / 81
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac fibrillation
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac failure congestive
subjects affected / exposed	140 / 4229 (3.31%)	112 / 4203 (2.66%)
occurrences causally related to treatment / all	10 / 221	3 / 184
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac hypertrophy
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac perforation
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac tamponade
subjects affected / exposed	2 / 4229 (0.05%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac valve disease
subjects affected / exposed	2 / 4229 (0.05%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac ventricular thrombosis
subjects affected / exposed	3 / 4229 (0.07%)	3 / 4203 (0.07%)
occurrences causally related to treatment / all	0 / 3	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Cardio-respiratory arrest
subjects affected / exposed	27 / 4229 (0.64%)	25 / 4203 (0.59%)
occurrences causally related to treatment / all	0 / 27	0 / 25
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiogenic shock
subjects affected / exposed	38 / 4229 (0.90%)	19 / 4203 (0.45%)
occurrences causally related to treatment / all	1 / 39	1 / 19
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiopulmonary failure
subjects affected / exposed	13 / 4229 (0.31%)	7 / 4203 (0.17%)
occurrences causally related to treatment / all	0 / 13	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiomyopathy
subjects affected / exposed	10 / 4229 (0.24%)	6 / 4203 (0.14%)
occurrences causally related to treatment / all	0 / 12	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiomegaly
subjects affected / exposed	5 / 4229 (0.12%)	2 / 4203 (0.05%)
occurrences causally related to treatment / all	0 / 5	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiorenal syndrome
subjects affected / exposed	2 / 4229 (0.05%)	2 / 4203 (0.05%)
occurrences causally related to treatment / all	1 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiovascular disorder
subjects affected / exposed	1 / 4229 (0.02%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiovascular insufficiency
subjects affected / exposed	1 / 4229 (0.02%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Chordae tendinae rupture
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (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	29 / 4229 (0.69%)	13 / 4203 (0.31%)
occurrences causally related to treatment / all	0 / 30	0 / 17
deaths causally related to treatment / all	0 / 0	0 / 0
Coronary artery disease
subjects affected / exposed	38 / 4229 (0.90%)	35 / 4203 (0.83%)
occurrences causally related to treatment / all	1 / 39	0 / 36
deaths causally related to treatment / all	0 / 0	0 / 0
Cor pulmonale
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Coronary artery stenosis
subjects affected / exposed	7 / 4229 (0.17%)	5 / 4203 (0.12%)
occurrences causally related to treatment / all	0 / 7	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Coronary artery occlusion
subjects affected / exposed	1 / 4229 (0.02%)	2 / 4203 (0.05%)
occurrences causally related to treatment / all	1 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Defect conduction intraventricular
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Dilatation atrial
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Coronary artery thrombosis
subjects affected / exposed	1 / 4229 (0.02%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Dilatation ventricular
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrocardiac syndrome
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (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	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hypertensive heart disease
subjects affected / exposed	2 / 4229 (0.05%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Left ventricular dysfunction
subjects affected / exposed	6 / 4229 (0.14%)	6 / 4203 (0.14%)
occurrences causally related to treatment / all	0 / 6	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Ischaemic cardiomyopathy
subjects affected / exposed	14 / 4229 (0.33%)	5 / 4203 (0.12%)
occurrences causally related to treatment / all	0 / 16	3 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Left ventricular failure
subjects affected / exposed	2 / 4229 (0.05%)	9 / 4203 (0.21%)
occurrences causally related to treatment / all	0 / 2	1 / 9
deaths causally related to treatment / all	0 / 0	0 / 0
Low cardiac output syndrome
subjects affected / exposed	2 / 4229 (0.05%)	2 / 4203 (0.05%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Mitral valve disease
subjects affected / exposed	2 / 4229 (0.05%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Mitral valve disease mixed
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (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	13 / 4229 (0.31%)	10 / 4203 (0.24%)
occurrences causally related to treatment / all	0 / 14	0 / 11
deaths causally related to treatment / all	0 / 0	0 / 0
Myocardial ischaemia
subjects affected / exposed	29 / 4229 (0.69%)	20 / 4203 (0.48%)
occurrences causally related to treatment / all	3 / 29	0 / 20
deaths causally related to treatment / all	0 / 0	0 / 0
Myocardial infarction
subjects affected / exposed	72 / 4229 (1.70%)	65 / 4203 (1.55%)
occurrences causally related to treatment / all	1 / 79	0 / 70
deaths causally related to treatment / all	0 / 0	0 / 0
Myocarditis
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (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 / 4229 (0.02%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Nodal rhythm
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Palpitations
subjects affected / exposed	8 / 4229 (0.19%)	3 / 4203 (0.07%)
occurrences causally related to treatment / all	0 / 8	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Pericardial effusion
subjects affected / exposed	1 / 4229 (0.02%)	1 / 4203 (0.02%)
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	1 / 4229 (0.02%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Right ventricular failure
subjects affected / exposed	4 / 4229 (0.09%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 5	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Right ventricular dysfunction
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Sick sinus syndrome
subjects affected / exposed	9 / 4229 (0.21%)	10 / 4203 (0.24%)
occurrences causally related to treatment / all	0 / 9	0 / 10
deaths causally related to treatment / all	0 / 0	0 / 0
Silent myocardial infarction
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Sinus bradycardia
subjects affected / exposed	3 / 4229 (0.07%)	2 / 4203 (0.05%)
occurrences causally related to treatment / all	0 / 3	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Sinus tachycardia
subjects affected / exposed	2 / 4229 (0.05%)	2 / 4203 (0.05%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Systolic dysfunction
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (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	9 / 4229 (0.21%)	9 / 4203 (0.21%)
occurrences causally related to treatment / all	0 / 9	0 / 9
deaths causally related to treatment / all	0 / 0	0 / 0
Tachyarrhythmia
subjects affected / exposed	3 / 4229 (0.07%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 4	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Tachycardia
subjects affected / exposed	5 / 4229 (0.12%)	2 / 4203 (0.05%)
occurrences causally related to treatment / all	0 / 5	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Torsade de pointes
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Tricuspid valve incompetence
subjects affected / exposed	2 / 4229 (0.05%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Trifascicular block
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Ventricular dysfunction
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Ventricular arrhythmia
subjects affected / exposed	11 / 4229 (0.26%)	5 / 4203 (0.12%)
occurrences causally related to treatment / all	0 / 12	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Ventricular dyssynchrony
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Ventricular extrasystoles
subjects affected / exposed	4 / 4229 (0.09%)	6 / 4203 (0.14%)
occurrences causally related to treatment / all	0 / 5	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Ventricular fibrillation
subjects affected / exposed	28 / 4229 (0.66%)	22 / 4203 (0.52%)
occurrences causally related to treatment / all	2 / 28	0 / 22
deaths causally related to treatment / all	0 / 0	0 / 0
Ventricular flutter
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Ventricular hypokinesia
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Ventricular tachyarrhythmia
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Ventricular tachycardia
subjects affected / exposed	85 / 4229 (2.01%)	66 / 4203 (1.57%)
occurrences causally related to treatment / all	8 / 114	1 / 90
deaths causally related to treatment / all	0 / 0	0 / 0
Nervous system disorders
Amnesia
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Aphasia
subjects affected / exposed	0 / 4229 (0.00%)	2 / 4203 (0.05%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Ataxia
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Basilar artery thrombosis
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Brain hypoxia
subjects affected / exposed	1 / 4229 (0.02%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Brain injury
subjects affected / exposed	1 / 4229 (0.02%)	2 / 4203 (0.05%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Brain mass
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Brain oedema
subjects affected / exposed	4 / 4229 (0.09%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 4	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Brain stem infarction
subjects affected / exposed	1 / 4229 (0.02%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Carotid artery disease
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Carotid artery stenosis
subjects affected / exposed	2 / 4229 (0.05%)	4 / 4203 (0.10%)
occurrences causally related to treatment / all	0 / 2	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Carpal tunnel syndrome
subjects affected / exposed	1 / 4229 (0.02%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cerebellar atrophy
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cerebellar infarction
subjects affected / exposed	1 / 4229 (0.02%)	2 / 4203 (0.05%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Cerebral atrophy
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cerebral haemorrhage
subjects affected / exposed	6 / 4229 (0.14%)	5 / 4203 (0.12%)
occurrences causally related to treatment / all	0 / 6	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Cerebral haematoma
subjects affected / exposed	3 / 4229 (0.07%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cerebral ischaemia
subjects affected / exposed	2 / 4229 (0.05%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cerebral venous thrombosis
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cerebral infarction
subjects affected / exposed	13 / 4229 (0.31%)	8 / 4203 (0.19%)
occurrences causally related to treatment / all	0 / 13	0 / 11
deaths causally related to treatment / all	0 / 0	0 / 0
Cerebrovascular disorder
subjects affected / exposed	1 / 4229 (0.02%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cerebrovascular accident
subjects affected / exposed	72 / 4229 (1.70%)	71 / 4203 (1.69%)
occurrences causally related to treatment / all	1 / 75	1 / 76
deaths causally related to treatment / all	0 / 0	0 / 0
Cerebrovascular insufficiency
subjects affected / exposed	1 / 4229 (0.02%)	2 / 4203 (0.05%)
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 / 4229 (0.02%)	0 / 4203 (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	7 / 4229 (0.17%)	5 / 4203 (0.12%)
occurrences causally related to treatment / all	0 / 7	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Convulsions local
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Dementia
subjects affected / exposed	2 / 4229 (0.05%)	2 / 4203 (0.05%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Dementia Alzheimer's type
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Depressed level of consciousness
subjects affected / exposed	2 / 4229 (0.05%)	0 / 4203 (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	5 / 4229 (0.12%)	10 / 4203 (0.24%)
occurrences causally related to treatment / all	1 / 5	2 / 10
deaths causally related to treatment / all	0 / 0	0 / 0
Diabetic coma
subjects affected / exposed	0 / 4229 (0.00%)	2 / 4203 (0.05%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Diabetic neuropathy
subjects affected / exposed	2 / 4229 (0.05%)	2 / 4203 (0.05%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Dysarthria
subjects affected / exposed	3 / 4229 (0.07%)	2 / 4203 (0.05%)
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	6 / 4229 (0.14%)	3 / 4203 (0.07%)
occurrences causally related to treatment / all	0 / 6	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Epilepsy
subjects affected / exposed	1 / 4229 (0.02%)	3 / 4203 (0.07%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Encephalomalacia
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Guillain-Barre syndrome
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Haemorrhage intracranial
subjects affected / exposed	0 / 4229 (0.00%)	4 / 4203 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Haemorrhagic stroke
subjects affected / exposed	5 / 4229 (0.12%)	5 / 4203 (0.12%)
occurrences causally related to treatment / all	0 / 5	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Headache
subjects affected / exposed	0 / 4229 (0.00%)	3 / 4203 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Haemorrhagic transformation stroke
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hemiparesis
subjects affected / exposed	1 / 4229 (0.02%)	3 / 4203 (0.07%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Hemiplegia
subjects affected / exposed	3 / 4229 (0.07%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hemisensory neglect
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatic encephalopathy
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (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	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hypercapnic coma
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hyperaesthesia
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hypoglycaemic coma
subjects affected / exposed	1 / 4229 (0.02%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hypoaesthesia
subjects affected / exposed	2 / 4229 (0.05%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hypoglycaemic seizure
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (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	2 / 4229 (0.05%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Intercostal neuralgia
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Ischaemic neuropathy
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Lacunar infarction
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Ischaemic stroke
subjects affected / exposed	37 / 4229 (0.87%)	40 / 4203 (0.95%)
occurrences causally related to treatment / all	2 / 38	0 / 42
deaths causally related to treatment / all	0 / 0	0 / 0
Lethargy
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Mental retardation
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Loss of consciousness
subjects affected / exposed	4 / 4229 (0.09%)	2 / 4203 (0.05%)
occurrences causally related to treatment / all	2 / 4	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Motor dysfunction
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
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 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Movement disorder
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Multiple system atrophy
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Neuralgia
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (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	3 / 4229 (0.07%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Paraparesis
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Parkinson's disease
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Partial seizures
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Peripheral sensory neuropathy
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Polyneuropathy
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Presenile dementia
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Presyncope
subjects affected / exposed	7 / 4229 (0.17%)	5 / 4203 (0.12%)
occurrences causally related to treatment / all	1 / 8	1 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Radiculopathy
subjects affected / exposed	0 / 4229 (0.00%)	2 / 4203 (0.05%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Reversible ischaemic neurological deficit
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Sciatica
subjects affected / exposed	1 / 4229 (0.02%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Subarachnoid haemorrhage
subjects affected / exposed	5 / 4229 (0.12%)	3 / 4203 (0.07%)
occurrences causally related to treatment / all	0 / 5	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Syncope
subjects affected / exposed	68 / 4229 (1.61%)	43 / 4203 (1.02%)
occurrences causally related to treatment / all	11 / 75	5 / 47
deaths causally related to treatment / all	0 / 0	0 / 0
Tension headache
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Toxic encephalopathy
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Transient ischaemic attack
subjects affected / exposed	22 / 4229 (0.52%)	18 / 4203 (0.43%)
occurrences causally related to treatment / all	0 / 23	0 / 20
deaths causally related to treatment / all	0 / 0	0 / 0
VIIth nerve paralysis
subjects affected / exposed	2 / 4229 (0.05%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Vertebral artery stenosis
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Vertebrobasilar insufficiency
subjects affected / exposed	1 / 4229 (0.02%)	4 / 4203 (0.10%)
occurrences causally related to treatment / all	0 / 1	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Vocal cord paralysis
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Blood and lymphatic system disorders
Anaemia
subjects affected / exposed	47 / 4229 (1.11%)	31 / 4203 (0.74%)
occurrences causally related to treatment / all	0 / 54	0 / 37
deaths causally related to treatment / all	0 / 0	0 / 0
Anaemia of malignant disease
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Autoimmune haemolytic anaemia
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Anaemia macrocytic
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Coagulopathy
subjects affected / exposed	2 / 4229 (0.05%)	3 / 4203 (0.07%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Disseminated intravascular coagulation
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Haemorrhagic anaemia
subjects affected / exposed	3 / 4229 (0.07%)	2 / 4203 (0.05%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Haemorrhagic disorder
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (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	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Immune thrombocytopenic purpura
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Iron deficiency anaemia
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (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	1 / 4229 (0.02%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Leukopenia
subjects affected / exposed	1 / 4229 (0.02%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	1 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Lymphadenopathy
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Microcytic anaemia
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Nephrogenic anaemia
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Neutropenia
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Normochromic normocytic anaemia
subjects affected / exposed	2 / 4229 (0.05%)	2 / 4203 (0.05%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Pancytopenia
subjects affected / exposed	1 / 4229 (0.02%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pernicious anaemia
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (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 / 4229 (0.02%)	0 / 4203 (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	4 / 4229 (0.09%)	4 / 4203 (0.10%)
occurrences causally related to treatment / all	0 / 4	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Ear and labyrinth disorders
Acute vestibular syndrome
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Deafness neurosensory
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Deafness unilateral
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Ear haemorrhage
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Mastoid disorder
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Tinnitus
subjects affected / exposed	0 / 4229 (0.00%)	2 / 4203 (0.05%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Vertigo
subjects affected / exposed	9 / 4229 (0.21%)	5 / 4203 (0.12%)
occurrences causally related to treatment / all	0 / 10	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Vertigo positional
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Eye disorders
Amaurosis fugax
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Blindness unilateral
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cataract
subjects affected / exposed	8 / 4229 (0.19%)	12 / 4203 (0.29%)
occurrences causally related to treatment / all	0 / 9	0 / 12
deaths causally related to treatment / all	0 / 0	0 / 0
Cataract diabetic
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Conjunctival haemorrhage
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (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	1 / 4229 (0.02%)	2 / 4203 (0.05%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Diplopia
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Glaucoma
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Macular oedema
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Retinal artery embolism
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Retinal detachment
subjects affected / exposed	2 / 4229 (0.05%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Retinal haemorrhage
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Trichiasis
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (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 / 4229 (0.05%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Vision blurred
subjects affected / exposed	0 / 4229 (0.00%)	2 / 4203 (0.05%)
occurrences causally related to treatment / all	0 / 0	1 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal disorders
Abdominal compartment syndrome
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Abdominal adhesions
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Abdominal discomfort
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Abdominal distension
subjects affected / exposed	3 / 4229 (0.07%)	4 / 4203 (0.10%)
occurrences causally related to treatment / all	0 / 3	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Abdominal hernia
subjects affected / exposed	1 / 4229 (0.02%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Abdominal pain
subjects affected / exposed	23 / 4229 (0.54%)	15 / 4203 (0.36%)
occurrences causally related to treatment / all	1 / 26	0 / 15
deaths causally related to treatment / all	0 / 0	0 / 0
Abdominal pain upper
subjects affected / exposed	7 / 4229 (0.17%)	6 / 4203 (0.14%)
occurrences causally related to treatment / all	0 / 7	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Abdominal wall haematoma
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (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	3 / 4229 (0.07%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Anal fissure
subjects affected / exposed	1 / 4229 (0.02%)	2 / 4203 (0.05%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Anal fistula
subjects affected / exposed	0 / 4229 (0.00%)	2 / 4203 (0.05%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Anal haemorrhage
subjects affected / exposed	2 / 4229 (0.05%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Anorectal discomfort
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Ascites
subjects affected / exposed	6 / 4229 (0.14%)	5 / 4203 (0.12%)
occurrences causally related to treatment / all	0 / 6	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Colitis
subjects affected / exposed	3 / 4229 (0.07%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Colitis ischaemic
subjects affected / exposed	4 / 4229 (0.09%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 4	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Colitis ulcerative
subjects affected / exposed	1 / 4229 (0.02%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Constipation
subjects affected / exposed	5 / 4229 (0.12%)	3 / 4203 (0.07%)
occurrences causally related to treatment / all	1 / 7	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Crohn's disease
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Dental caries
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Diarrhoea
subjects affected / exposed	15 / 4229 (0.35%)	22 / 4203 (0.52%)
occurrences causally related to treatment / all	2 / 15	1 / 22
deaths causally related to treatment / all	0 / 0	0 / 0
Diverticulum
subjects affected / exposed	0 / 4229 (0.00%)	3 / 4203 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Diverticulum intestinal
subjects affected / exposed	2 / 4229 (0.05%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Duodenal stenosis
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Duodenal ulcer
subjects affected / exposed	9 / 4229 (0.21%)	2 / 4203 (0.05%)
occurrences causally related to treatment / all	0 / 9	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Duodenal ulcer haemorrhage
subjects affected / exposed	3 / 4229 (0.07%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Duodenitis
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Duodenal ulcer perforation
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Dyspepsia
subjects affected / exposed	4 / 4229 (0.09%)	3 / 4203 (0.07%)
occurrences causally related to treatment / all	0 / 4	1 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Dysphagia
subjects affected / exposed	1 / 4229 (0.02%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Enteritis
subjects affected / exposed	2 / 4229 (0.05%)	3 / 4203 (0.07%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Enterovesical fistula
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Erosive duodenitis
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
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 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Erosive oesophagitis
subjects affected / exposed	3 / 4229 (0.07%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Faecaloma
subjects affected / exposed	0 / 4229 (0.00%)	2 / 4203 (0.05%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Femoral hernia
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastric haemorrhage
subjects affected / exposed	3 / 4229 (0.07%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gastric hypomotility
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gastric perforation
subjects affected / exposed	2 / 4229 (0.05%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastric polyps
subjects affected / exposed	3 / 4229 (0.07%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gastric ulcer haemorrhage
subjects affected / exposed	2 / 4229 (0.05%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gastric ulcer
subjects affected / exposed	3 / 4229 (0.07%)	3 / 4203 (0.07%)
occurrences causally related to treatment / all	0 / 3	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Gastritis
subjects affected / exposed	10 / 4229 (0.24%)	7 / 4203 (0.17%)
occurrences causally related to treatment / all	0 / 10	0 / 8
deaths causally related to treatment / all	0 / 0	0 / 0
Gastritis erosive
subjects affected / exposed	4 / 4229 (0.09%)	3 / 4203 (0.07%)
occurrences causally related to treatment / all	0 / 4	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Gastroduodenal haemorrhage
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastritis haemorrhagic
subjects affected / exposed	1 / 4229 (0.02%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal disorder
subjects affected / exposed	1 / 4229 (0.02%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastroduodenitis
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (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	22 / 4229 (0.52%)	22 / 4203 (0.52%)
occurrences causally related to treatment / all	0 / 22	1 / 26
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal necrosis
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal obstruction
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal ulcer
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrooesophageal reflux disease
subjects affected / exposed	6 / 4229 (0.14%)	4 / 4203 (0.10%)
occurrences causally related to treatment / all	0 / 6	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Haematemesis
subjects affected / exposed	3 / 4229 (0.07%)	2 / 4203 (0.05%)
occurrences causally related to treatment / all	0 / 4	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Haemorrhagic erosive gastritis
subjects affected / exposed	2 / 4229 (0.05%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	2 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Haematochezia
subjects affected / exposed	1 / 4229 (0.02%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Haemorrhoidal haemorrhage
subjects affected / exposed	1 / 4229 (0.02%)	2 / 4203 (0.05%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Haemorrhoids
subjects affected / exposed	2 / 4229 (0.05%)	4 / 4203 (0.10%)
occurrences causally related to treatment / all	0 / 2	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Hiatus hernia
subjects affected / exposed	3 / 4229 (0.07%)	2 / 4203 (0.05%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Hyperchlorhydria
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Ileus paralytic
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (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	2 / 4229 (0.05%)	5 / 4203 (0.12%)
occurrences causally related to treatment / all	0 / 2	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Impaired gastric emptying
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Inguinal hernia
subjects affected / exposed	17 / 4229 (0.40%)	11 / 4203 (0.26%)
occurrences causally related to treatment / all	0 / 17	0 / 11
deaths causally related to treatment / all	0 / 0	0 / 0
Inguinal hernia strangulated
subjects affected / exposed	2 / 4229 (0.05%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Intestinal haemorrhage
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Inguinal hernia, obstructive
subjects affected / exposed	3 / 4229 (0.07%)	2 / 4203 (0.05%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Intestinal obstruction
subjects affected / exposed	5 / 4229 (0.12%)	4 / 4203 (0.10%)
occurrences causally related to treatment / all	0 / 8	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Intestinal ischaemia
subjects affected / exposed	1 / 4229 (0.02%)	5 / 4203 (0.12%)
occurrences causally related to treatment / all	0 / 1	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Intestinal perforation
subjects affected / exposed	2 / 4229 (0.05%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Intestinal polyp
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Intra-abdominal haemorrhage
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Large intestinal haemorrhage
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Large intestine perforation
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Large intestine polyp
subjects affected / exposed	2 / 4229 (0.05%)	5 / 4203 (0.12%)
occurrences causally related to treatment / all	0 / 2	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Lip oedema
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Lower gastrointestinal haemorrhage
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Mallory-Weiss syndrome
subjects affected / exposed	2 / 4229 (0.05%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Melaena
subjects affected / exposed	5 / 4229 (0.12%)	3 / 4203 (0.07%)
occurrences causally related to treatment / all	1 / 5	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Mouth haemorrhage
subjects affected / exposed	2 / 4229 (0.05%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Nausea
subjects affected / exposed	6 / 4229 (0.14%)	6 / 4203 (0.14%)
occurrences causally related to treatment / all	2 / 6	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Obstruction gastric
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Oesophageal achalasia
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Oesophageal ulcer
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Oesophageal ulcer haemorrhage
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Oesophagitis
subjects affected / exposed	1 / 4229 (0.02%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pancreatitis
subjects affected / exposed	8 / 4229 (0.19%)	2 / 4203 (0.05%)
occurrences causally related to treatment / all	0 / 8	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Pancreatitis acute
subjects affected / exposed	4 / 4229 (0.09%)	7 / 4203 (0.17%)
occurrences causally related to treatment / all	2 / 6	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
Pancreatitis chronic
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Parotid gland enlargement
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Parotid duct obstruction
subjects affected / exposed	2 / 4229 (0.05%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Peptic ulcer
subjects affected / exposed	1 / 4229 (0.02%)	2 / 4203 (0.05%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Peptic ulcer perforation
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Portal hypertensive gastropathy
subjects affected / exposed	2 / 4229 (0.05%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Rectal haemorrhage
subjects affected / exposed	3 / 4229 (0.07%)	8 / 4203 (0.19%)
occurrences causally related to treatment / all	1 / 3	0 / 9
deaths causally related to treatment / all	0 / 0	0 / 0
Proctalgia
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Rectal polyp
subjects affected / exposed	1 / 4229 (0.02%)	2 / 4203 (0.05%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Rectal prolapse
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Rectal stenosis
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Retroperitoneal haematoma
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Small intestinal obstruction
subjects affected / exposed	3 / 4229 (0.07%)	3 / 4203 (0.07%)
occurrences causally related to treatment / all	0 / 3	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Retroperitoneal haemorrhage
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Stomatitis
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Subileus
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Toothache
subjects affected / exposed	1 / 4229 (0.02%)	2 / 4203 (0.05%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Umbilical hernia, obstructive
subjects affected / exposed	1 / 4229 (0.02%)	2 / 4203 (0.05%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Umbilical hernia
subjects affected / exposed	6 / 4229 (0.14%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 6	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Upper gastrointestinal haemorrhage
subjects affected / exposed	6 / 4229 (0.14%)	9 / 4203 (0.21%)
occurrences causally related to treatment / all	0 / 7	0 / 9
deaths causally related to treatment / all	0 / 0	0 / 0
Varices oesophageal
subjects affected / exposed	1 / 4229 (0.02%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Vomiting
subjects affected / exposed	14 / 4229 (0.33%)	10 / 4203 (0.24%)
occurrences causally related to treatment / all	1 / 15	0 / 10
deaths causally related to treatment / all	0 / 0	0 / 0
Skin and subcutaneous tissue disorders
Angioedema
subjects affected / exposed	4 / 4229 (0.09%)	3 / 4203 (0.07%)
occurrences causally related to treatment / all	3 / 4	1 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Angiokeratoma
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cutaneous vasculitis
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Decubitus ulcer
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Dermatitis
subjects affected / exposed	1 / 4229 (0.02%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Dermatitis allergic
subjects affected / exposed	0 / 4229 (0.00%)	2 / 4203 (0.05%)
occurrences causally related to treatment / all	0 / 0	1 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Dermatitis contact
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
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	7 / 4229 (0.17%)	7 / 4203 (0.17%)
occurrences causally related to treatment / all	0 / 11	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
Hypersensitivity vasculitis
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hyperhidrosis
subjects affected / exposed	2 / 4229 (0.05%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Lichen planus
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pemphigoid
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pemphigus
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Penile ulceration
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Psoriasis
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Rash
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Skin burning sensation
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Skin erosion
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Skin necrosis
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Skin ulcer
subjects affected / exposed	6 / 4229 (0.14%)	3 / 4203 (0.07%)
occurrences causally related to treatment / all	0 / 6	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Skin ulcer haemorrhage
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Stasis dermatitis
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Urticaria
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Renal and urinary disorders
Acute prerenal failure
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Azotaemia
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Calculus ureteric
subjects affected / exposed	0 / 4229 (0.00%)	2 / 4203 (0.05%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Bladder diverticulum
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Crush syndrome
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cystitis erosive
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Diabetic nephropathy
subjects affected / exposed	2 / 4229 (0.05%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 4	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cystitis haemorrhagic
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cystitis noninfective
subjects affected / exposed	2 / 4229 (0.05%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Haematuria
subjects affected / exposed	10 / 4229 (0.24%)	14 / 4203 (0.33%)
occurrences causally related to treatment / all	0 / 11	0 / 16
deaths causally related to treatment / all	0 / 0	0 / 0
Dysuria
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Incontinence
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hydronephrosis
subjects affected / exposed	3 / 4229 (0.07%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Kidney fibrosis
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Lower urinary tract symptoms
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Nephrolithiasis
subjects affected / exposed	4 / 4229 (0.09%)	2 / 4203 (0.05%)
occurrences causally related to treatment / all	0 / 5	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Nephropathy
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Nephropathy toxic
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Nephrotic syndrome
subjects affected / exposed	2 / 4229 (0.05%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Nephrosclerosis
subjects affected / exposed	0 / 4229 (0.00%)	2 / 4203 (0.05%)
occurrences causally related to treatment / all	0 / 0	1 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Oliguria
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Prerenal failure
subjects affected / exposed	3 / 4229 (0.07%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pelvi-ureteric obstruction
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Proteinuria
subjects affected / exposed	0 / 4229 (0.00%)	2 / 4203 (0.05%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Renal aneurysm
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Renal colic
subjects affected / exposed	1 / 4229 (0.02%)	2 / 4203 (0.05%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Renal cyst
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
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	54 / 4229 (1.28%)	43 / 4203 (1.02%)
occurrences causally related to treatment / all	13 / 62	10 / 44
deaths causally related to treatment / all	0 / 0	0 / 0
Renal failure acute
subjects affected / exposed	79 / 4229 (1.87%)	74 / 4203 (1.76%)
occurrences causally related to treatment / all	11 / 89	17 / 80
deaths causally related to treatment / all	0 / 0	0 / 0
Renal failure chronic
subjects affected / exposed	13 / 4229 (0.31%)	9 / 4203 (0.21%)
occurrences causally related to treatment / all	1 / 14	0 / 9
deaths causally related to treatment / all	0 / 0	0 / 0
Renal injury
subjects affected / exposed	0 / 4229 (0.00%)	2 / 4203 (0.05%)
occurrences causally related to treatment / all	0 / 0	1 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Renal impairment
subjects affected / exposed	57 / 4229 (1.35%)	46 / 4203 (1.09%)
occurrences causally related to treatment / all	17 / 59	14 / 49
deaths causally related to treatment / all	0 / 0	0 / 0
Renal tubular acidosis
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Renal tubular necrosis
subjects affected / exposed	1 / 4229 (0.02%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Tubulointerstitial nephritis
subjects affected / exposed	3 / 4229 (0.07%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Urethral stenosis
subjects affected / exposed	1 / 4229 (0.02%)	2 / 4203 (0.05%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Urinary incontinence
subjects affected / exposed	2 / 4229 (0.05%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Urine flow decreased
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Urinary retention
subjects affected / exposed	8 / 4229 (0.19%)	10 / 4203 (0.24%)
occurrences causally related to treatment / all	0 / 9	0 / 11
deaths causally related to treatment / all	0 / 0	0 / 0
Endocrine disorders
Autoimmune thyroiditis
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Goitre
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hyperthyroidism
subjects affected / exposed	3 / 4229 (0.07%)	3 / 4203 (0.07%)
occurrences causally related to treatment / all	0 / 3	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Hypothyroidism
subjects affected / exposed	4 / 4229 (0.09%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 4	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Thyroiditis subacute
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (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	2 / 4229 (0.05%)	3 / 4203 (0.07%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Arthritis
subjects affected / exposed	2 / 4229 (0.05%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Back pain
subjects affected / exposed	1 / 4229 (0.02%)	7 / 4203 (0.17%)
occurrences causally related to treatment / all	0 / 1	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
Compartment syndrome
subjects affected / exposed	1 / 4229 (0.02%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Dupuytren's contracture
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Costochondritis
subjects affected / exposed	2 / 4229 (0.05%)	3 / 4203 (0.07%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Flank pain
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Foot deformity
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gouty arthritis
subjects affected / exposed	2 / 4229 (0.05%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Haemarthrosis
subjects affected / exposed	1 / 4229 (0.02%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Intervertebral disc degeneration
subjects affected / exposed	1 / 4229 (0.02%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Intervertebral disc displacement
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Intervertebral disc disorder
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Joint laxity
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Intervertebral disc protrusion
subjects affected / exposed	2 / 4229 (0.05%)	2 / 4203 (0.05%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Joint effusion
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Lumbar spinal stenosis
subjects affected / exposed	1 / 4229 (0.02%)	3 / 4203 (0.07%)
occurrences causally related to treatment / all	0 / 1	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Joint swelling
subjects affected / exposed	1 / 4229 (0.02%)	3 / 4203 (0.07%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Mobility decreased
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Muscle fatigue
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Muscle necrosis
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Muscle swelling
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Muscular weakness
subjects affected / exposed	4 / 4229 (0.09%)	3 / 4203 (0.07%)
occurrences causally related to treatment / all	1 / 4	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Musculoskeletal chest pain
subjects affected / exposed	5 / 4229 (0.12%)	4 / 4203 (0.10%)
occurrences causally related to treatment / all	0 / 7	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Musculoskeletal pain
subjects affected / exposed	1 / 4229 (0.02%)	2 / 4203 (0.05%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Myalgia
subjects affected / exposed	1 / 4229 (0.02%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Myalgia intercostal
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Osteitis
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Osteochondrosis
subjects affected / exposed	2 / 4229 (0.05%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Osteoarthritis
subjects affected / exposed	15 / 4229 (0.35%)	16 / 4203 (0.38%)
occurrences causally related to treatment / all	0 / 16	0 / 17
deaths causally related to treatment / all	0 / 0	0 / 0
Osteonecrosis
subjects affected / exposed	2 / 4229 (0.05%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Osteoporotic fracture
subjects affected / exposed	1 / 4229 (0.02%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pathological fracture
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Periarthritis
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (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	3 / 4229 (0.07%)	2 / 4203 (0.05%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Rheumatoid arthritis
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Rhabdomyolysis
subjects affected / exposed	2 / 4229 (0.05%)	4 / 4203 (0.10%)
occurrences causally related to treatment / all	1 / 2	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Rotator cuff syndrome
subjects affected / exposed	3 / 4229 (0.07%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Spinal column stenosis
subjects affected / exposed	3 / 4229 (0.07%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 4	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Spinal osteoarthritis
subjects affected / exposed	0 / 4229 (0.00%)	2 / 4203 (0.05%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Spinal pain
subjects affected / exposed	1 / 4229 (0.02%)	3 / 4203 (0.07%)
occurrences causally related to treatment / all	0 / 1	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Synovitis
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Tendonitis
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Synovial cyst
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Trigger finger
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (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	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Abdominal wall abscess
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Abdominal wall infection
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Abscess limb
subjects affected / exposed	1 / 4229 (0.02%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Abscess neck
subjects affected / exposed	2 / 4229 (0.05%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Abscess oral
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Acinetobacter bacteraemia
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Acinetobacter infection
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Acute endocarditis
subjects affected / exposed	2 / 4229 (0.05%)	2 / 4203 (0.05%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Acute tonsillitis
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
American trypanosomiasis
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (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	3 / 4229 (0.07%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Appendicitis
subjects affected / exposed	6 / 4229 (0.14%)	5 / 4203 (0.12%)
occurrences causally related to treatment / all	0 / 6	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Appendicitis perforated
subjects affected / exposed	1 / 4229 (0.02%)	2 / 4203 (0.05%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Arthritis infective
subjects affected / exposed	2 / 4229 (0.05%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Arthritis bacterial
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Atypical pneumonia
subjects affected / exposed	1 / 4229 (0.02%)	2 / 4203 (0.05%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Bacterial diarrhoea
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Bacteraemia
subjects affected / exposed	0 / 4229 (0.00%)	2 / 4203 (0.05%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Bacterial prostatitis
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Bacterial infection
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Bacterial sepsis
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Bacterial tracheitis
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Bacteriuria
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Biliary sepsis
subjects affected / exposed	1 / 4229 (0.02%)	2 / 4203 (0.05%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Breast cellulitis
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Bronchiolitis
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Bronchitis bacterial
subjects affected / exposed	1 / 4229 (0.02%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Bronchitis
subjects affected / exposed	26 / 4229 (0.61%)	20 / 4203 (0.48%)
occurrences causally related to treatment / all	0 / 27	0 / 23
deaths causally related to treatment / all	0 / 0	0 / 0
Bronchitis fungal
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Bronchitis viral
subjects affected / exposed	1 / 4229 (0.02%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Bronchopneumonia
subjects affected / exposed	14 / 4229 (0.33%)	21 / 4203 (0.50%)
occurrences causally related to treatment / all	0 / 15	0 / 22
deaths causally related to treatment / all	0 / 0	0 / 0
Campylobacter gastroenteritis
subjects affected / exposed	1 / 4229 (0.02%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cellulitis
subjects affected / exposed	23 / 4229 (0.54%)	19 / 4203 (0.45%)
occurrences causally related to treatment / all	0 / 24	0 / 20
deaths causally related to treatment / all	0 / 0	0 / 0
Carbuncle
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cellulitis staphylococcal
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cholecystitis infective
subjects affected / exposed	0 / 4229 (0.00%)	2 / 4203 (0.05%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Chronic hepatitis B
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Clostridial infection
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Clostridium difficile colitis
subjects affected / exposed	2 / 4229 (0.05%)	3 / 4203 (0.07%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Clostridium difficile infection
subjects affected / exposed	3 / 4229 (0.07%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cytomegalovirus infection
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cystitis
subjects affected / exposed	5 / 4229 (0.12%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 6	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Dacryocanaliculitis
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Dermatophytosis
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Device related infection
subjects affected / exposed	11 / 4229 (0.26%)	10 / 4203 (0.24%)
occurrences causally related to treatment / all	0 / 11	0 / 10
deaths causally related to treatment / all	0 / 0	0 / 0
Diabetic foot infection
subjects affected / exposed	1 / 4229 (0.02%)	2 / 4203 (0.05%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Device related sepsis
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Diabetic gangrene
subjects affected / exposed	0 / 4229 (0.00%)	2 / 4203 (0.05%)
occurrences causally related to treatment / all	0 / 0	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Diarrhoea infectious
subjects affected / exposed	1 / 4229 (0.02%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Disseminated tuberculosis
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Diverticulitis
subjects affected / exposed	3 / 4229 (0.07%)	2 / 4203 (0.05%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Encephalitis
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (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 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Encephalitis viral
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Endocarditis
subjects affected / exposed	8 / 4229 (0.19%)	4 / 4203 (0.10%)
occurrences causally related to treatment / all	0 / 8	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Endocarditis bacterial
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Epididymitis
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Erysipelas
subjects affected / exposed	11 / 4229 (0.26%)	10 / 4203 (0.24%)
occurrences causally related to treatment / all	0 / 12	0 / 12
deaths causally related to treatment / all	0 / 0	0 / 0
Escherichia sepsis
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Escherichia urinary tract infection
subjects affected / exposed	2 / 4229 (0.05%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gallbladder abscess
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (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	12 / 4229 (0.28%)	8 / 4203 (0.19%)
occurrences causally related to treatment / all	0 / 12	0 / 9
deaths causally related to treatment / all	0 / 0	0 / 0
Gastroenteritis
subjects affected / exposed	22 / 4229 (0.52%)	22 / 4203 (0.52%)
occurrences causally related to treatment / all	1 / 23	1 / 23
deaths causally related to treatment / all	0 / 0	0 / 0
Gastroenteritis clostridial
subjects affected / exposed	0 / 4229 (0.00%)	2 / 4203 (0.05%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Gastroenteritis norovirus
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastroenteritis viral
subjects affected / exposed	1 / 4229 (0.02%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal bacterial infection
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal infection
subjects affected / exposed	2 / 4229 (0.05%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal viral infection
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Groin abscess
subjects affected / exposed	0 / 4229 (0.00%)	2 / 4203 (0.05%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
H1N1 influenza
subjects affected / exposed	2 / 4229 (0.05%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Haematoma infection
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Haemorrhagic fever
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatitis A
subjects affected / exposed	2 / 4229 (0.05%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Herpes simplex meningoencephalitis
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatitis B
subjects affected / exposed	1 / 4229 (0.02%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Herpes zoster
subjects affected / exposed	3 / 4229 (0.07%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Implant site infection
subjects affected / exposed	1 / 4229 (0.02%)	3 / 4203 (0.07%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Infected cyst
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Infected dermal cyst
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Infected skin ulcer
subjects affected / exposed	3 / 4229 (0.07%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Infective exacerbation of bronchiectasis
subjects affected / exposed	2 / 4229 (0.05%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Infectious pleural effusion
subjects affected / exposed	1 / 4229 (0.02%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Infective exacerbation of chronic obstructive airways disease
subjects affected / exposed	3 / 4229 (0.07%)	5 / 4203 (0.12%)
occurrences causally related to treatment / all	0 / 3	0 / 10
deaths causally related to treatment / all	0 / 0	0 / 0
Intervertebral discitis
subjects affected / exposed	0 / 4229 (0.00%)	2 / 4203 (0.05%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Influenza
subjects affected / exposed	5 / 4229 (0.12%)	5 / 4203 (0.12%)
occurrences causally related to treatment / all	0 / 5	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Kidney infection
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Joint abscess
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Labyrinthitis
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Laryngitis
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Liver abscess
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Lobar pneumonia
subjects affected / exposed	6 / 4229 (0.14%)	5 / 4203 (0.12%)
occurrences causally related to treatment / all	0 / 6	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Localised infection
subjects affected / exposed	2 / 4229 (0.05%)	4 / 4203 (0.10%)
occurrences causally related to treatment / all	0 / 2	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Lower respiratory tract infection
subjects affected / exposed	21 / 4229 (0.50%)	13 / 4203 (0.31%)
occurrences causally related to treatment / all	0 / 22	0 / 13
deaths causally related to treatment / all	0 / 0	0 / 0
Lower respiratory tract infection bacterial
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (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	12 / 4229 (0.28%)	6 / 4203 (0.14%)
occurrences causally related to treatment / all	0 / 13	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
Lower respiratory tract infection viral
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Meningitis
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Morganella infection
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Myocarditis infectious
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Nasopharyngitis
subjects affected / exposed	2 / 4229 (0.05%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Necrotising fasciitis
subjects affected / exposed	0 / 4229 (0.00%)	3 / 4203 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Osteomyelitis
subjects affected / exposed	2 / 4229 (0.05%)	7 / 4203 (0.17%)
occurrences causally related to treatment / all	0 / 2	0 / 8
deaths causally related to treatment / all	0 / 0	0 / 0
Orchitis
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Otitis media
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (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 / 4229 (0.02%)	0 / 4203 (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	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Peritoneal abscess
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Peritonitis
subjects affected / exposed	2 / 4229 (0.05%)	6 / 4203 (0.14%)
occurrences causally related to treatment / all	0 / 2	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Pharyngitis
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumococcal sepsis
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (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	181 / 4229 (4.28%)	155 / 4203 (3.69%)
occurrences causally related to treatment / all	3 / 224	0 / 185
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumonia bacterial
subjects affected / exposed	1 / 4229 (0.02%)	3 / 4203 (0.07%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumonia haemophilus
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumonia klebsiella
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumonia influenzal
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumonia pneumococcal
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumonia legionella
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumonia staphylococcal
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumonia viral
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Post procedural infection
subjects affected / exposed	0 / 4229 (0.00%)	2 / 4203 (0.05%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Post procedural pneumonia
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Postoperative wound infection
subjects affected / exposed	3 / 4229 (0.07%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pseudomembranous colitis
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pulmonary tuberculosis
subjects affected / exposed	2 / 4229 (0.05%)	5 / 4203 (0.12%)
occurrences causally related to treatment / all	0 / 2	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Pulmonary sepsis
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pyelonephritis
subjects affected / exposed	2 / 4229 (0.05%)	3 / 4203 (0.07%)
occurrences causally related to treatment / all	0 / 4	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Pyelonephritis acute
subjects affected / exposed	3 / 4229 (0.07%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pyelonephritis chronic
subjects affected / exposed	1 / 4229 (0.02%)	2 / 4203 (0.05%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Rabies
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Respiratory syncytial virus infection
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Rectal abscess
subjects affected / exposed	2 / 4229 (0.05%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Respiratory tract infection
subjects affected / exposed	8 / 4229 (0.19%)	15 / 4203 (0.36%)
occurrences causally related to treatment / all	0 / 8	0 / 18
deaths causally related to treatment / all	0 / 0	0 / 0
Respiratory tract infection bacterial
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (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	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Scrotal infection
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Scrotal gangrene
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (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	37 / 4229 (0.87%)	24 / 4203 (0.57%)
occurrences causally related to treatment / all	1 / 38	0 / 26
deaths causally related to treatment / all	0 / 0	0 / 0
Septic shock
subjects affected / exposed	23 / 4229 (0.54%)	17 / 4203 (0.40%)
occurrences causally related to treatment / all	0 / 23	0 / 17
deaths causally related to treatment / all	0 / 0	0 / 0
Sinusitis
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Skin bacterial infection
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Soft tissue infection
subjects affected / exposed	2 / 4229 (0.05%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Staphylococcal bacteraemia
subjects affected / exposed	2 / 4229 (0.05%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Staphylococcal abscess
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Staphylococcal infection
subjects affected / exposed	4 / 4229 (0.09%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 5	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Staphylococcal sepsis
subjects affected / exposed	0 / 4229 (0.00%)	4 / 4203 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Stoma site infection
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Streptococcal bacteraemia
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Subcutaneous abscess
subjects affected / exposed	2 / 4229 (0.05%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Tooth abscess
subjects affected / exposed	1 / 4229 (0.02%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Tracheobronchitis
subjects affected / exposed	3 / 4229 (0.07%)	2 / 4203 (0.05%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Tooth infection
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Tuberculosis
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Tuberculous pleurisy
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Upper respiratory tract infection
subjects affected / exposed	11 / 4229 (0.26%)	6 / 4203 (0.14%)
occurrences causally related to treatment / all	0 / 12	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Urinary tract infection
subjects affected / exposed	34 / 4229 (0.80%)	41 / 4203 (0.98%)
occurrences causally related to treatment / all	0 / 37	0 / 46
deaths causally related to treatment / all	0 / 0	0 / 0
Urinary tract infection bacterial
subjects affected / exposed	2 / 4229 (0.05%)	2 / 4203 (0.05%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Urosepsis
subjects affected / exposed	9 / 4229 (0.21%)	8 / 4203 (0.19%)
occurrences causally related to treatment / all	0 / 9	0 / 8
deaths causally related to treatment / all	0 / 0	0 / 0
Vestibular neuronitis
subjects affected / exposed	1 / 4229 (0.02%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Viraemia
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Viral infection
subjects affected / exposed	4 / 4229 (0.09%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 4	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Viral myocarditis
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (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	2 / 4229 (0.05%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Wound abscess
subjects affected / exposed	1 / 4229 (0.02%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Wound sepsis
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Metabolism and nutrition disorders
Cachexia
subjects affected / exposed	1 / 4229 (0.02%)	3 / 4203 (0.07%)
occurrences causally related to treatment / all	0 / 1	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Diabetes mellitus
subjects affected / exposed	23 / 4229 (0.54%)	24 / 4203 (0.57%)
occurrences causally related to treatment / all	0 / 23	0 / 24
deaths causally related to treatment / all	0 / 0	0 / 0
Dehydration
subjects affected / exposed	29 / 4229 (0.69%)	22 / 4203 (0.52%)
occurrences causally related to treatment / all	1 / 30	0 / 22
deaths causally related to treatment / all	0 / 0	0 / 0
Decreased appetite
subjects affected / exposed	5 / 4229 (0.12%)	4 / 4203 (0.10%)
occurrences causally related to treatment / all	0 / 5	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Diabetic ketoacidosis
subjects affected / exposed	4 / 4229 (0.09%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 4	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Diabetes mellitus inadequate control
subjects affected / exposed	8 / 4229 (0.19%)	7 / 4203 (0.17%)
occurrences causally related to treatment / all	0 / 9	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
Electrolyte imbalance
subjects affected / exposed	2 / 4229 (0.05%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	1 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Fluid overload
subjects affected / exposed	2 / 4229 (0.05%)	2 / 4203 (0.05%)
occurrences causally related to treatment / all	0 / 2	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Failure to thrive
subjects affected / exposed	0 / 4229 (0.00%)	2 / 4203 (0.05%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Hyperglycaemia
subjects affected / exposed	4 / 4229 (0.09%)	6 / 4203 (0.14%)
occurrences causally related to treatment / all	0 / 4	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Gout
subjects affected / exposed	10 / 4229 (0.24%)	7 / 4203 (0.17%)
occurrences causally related to treatment / all	1 / 11	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
Hyperglycaemic hyperosmolar nonketotic syndrome
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hyperkalaemia
subjects affected / exposed	42 / 4229 (0.99%)	17 / 4203 (0.40%)
occurrences causally related to treatment / all	17 / 46	13 / 18
deaths causally related to treatment / all	0 / 0	0 / 0
Hyperuricaemia
subjects affected / exposed	2 / 4229 (0.05%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hypocalcaemia
subjects affected / exposed	1 / 4229 (0.02%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Hypervolaemia
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hypochloraemia
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hypoglycaemia
subjects affected / exposed	14 / 4229 (0.33%)	15 / 4203 (0.36%)
occurrences causally related to treatment / all	0 / 14	0 / 15
deaths causally related to treatment / all	0 / 0	0 / 0
Hypokalaemia
subjects affected / exposed	9 / 4229 (0.21%)	12 / 4203 (0.29%)
occurrences causally related to treatment / all	2 / 10	0 / 15
deaths causally related to treatment / all	0 / 0	0 / 0
Hypomagnesaemia
subjects affected / exposed	2 / 4229 (0.05%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hyponatraemia
subjects affected / exposed	12 / 4229 (0.28%)	6 / 4203 (0.14%)
occurrences causally related to treatment / all	2 / 13	1 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
Hypovolaemia
subjects affected / exposed	2 / 4229 (0.05%)	3 / 4203 (0.07%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Hypoproteinaemia
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Iron deficiency
subjects affected / exposed	1 / 4229 (0.02%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Insulin resistance
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Metabolic acidosis
subjects affected / exposed	3 / 4229 (0.07%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Iron overload
subjects affected / exposed	1 / 4229 (0.02%)	0 / 4203 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Malnutrition
subjects affected / exposed	1 / 4229 (0.02%)	2 / 4203 (0.05%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Mineral deficiency
subjects affected / exposed	0 / 4229 (0.00%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Metabolic disorder
subjects affected / exposed	1 / 4229 (0.02%)	1 / 4203 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Type 2 diabetes mellitus
subjects affected / exposed	7 / 4229 (0.17%)	2 / 4203 (0.05%)
occurrences causally related to treatment / all	0 / 7	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0

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

Non-serious adverse events	Enalapril	LCZ696
Total subjects affected by non serious adverse events
subjects affected / exposed	1805 / 4229 (42.68%)	1716 / 4203 (40.83%)
Vascular disorders
Hypotension
subjects affected / exposed	454 / 4229 (10.74%)	700 / 4203 (16.65%)
occurrences all number	557	890
Cardiac disorders
Cardiac failure
subjects affected / exposed	274 / 4229 (6.48%)	214 / 4203 (5.09%)
occurrences all number	359	248
Nervous system disorders
Dizziness
subjects affected / exposed	202 / 4229 (4.78%)	259 / 4203 (6.16%)
occurrences all number	232	320
Respiratory, thoracic and mediastinal disorders
Cough
subjects affected / exposed	528 / 4229 (12.49%)	367 / 4203 (8.73%)
occurrences all number	695	488
Dyspnoea
subjects affected / exposed	263 / 4229 (6.22%)	173 / 4203 (4.12%)
occurrences all number	310	221
Renal and urinary disorders
Renal impairment
subjects affected / exposed	449 / 4229 (10.62%)	393 / 4203 (9.35%)
occurrences all number	570	489
Metabolism and nutrition disorders
Hyperkalaemia
subjects affected / exposed	569 / 4229 (13.45%)	477 / 4203 (11.35%)
occurrences all number	837	686

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Were there any global substantial amendments to the protocol? Yes

15 Dec 2010

Amendment 1: The purpose is to modify the left ventricular ejection fraction (LVEF)inclusion criterion to ≤ 35% from ≤ 40%. This modification is essential to ensure an adequate event rate in the study population where use of evidence-based, disease-modifying agents is increasing. Modify the estimated glomerular filtration rate (eGFR)reduction criterion for continuation in the run-in period to ≤ 35% from ≤ 25%. This modification will provide the investigator with greater discretion in deciding whether to continue the patient in the study, now that greater safety experience with LCZ696 has been gained from ongoing clinical trials in heart failure. Consider use of aldosterone antagonists for all patients with heart failure (HF) rather than advanced HF only. Incorporate input from health authorities on the unblinding of suspected unexpected serious adverse events (SUSARs) to avoid the unblinding of SAEs which are also efficacy endpoints in the trial and, hence, the potential unblinding of investigators and patients to randomized treatment allocation). Exclusion of patient with bilateral renal artery stenosis since renin-angiotensin antagonists, such as the study meds, can cause significant renal dysfunction in patients with this condition. Insertion of cautionary statements about the concomitant administration of PDE-5 inhibitors, neseritide, and intravenous nitrates since the interaction between these blood pressure lowering agents and LCZ696 has not been studied. Inclusion of fasting plasma glucose measurement at Visits 1, 5, and annually thereafter to assess the prevalence of diabetes mellitus at screening and to more routinely check for its incidence. Additional BNP and NT-proBNP measurements at Visit 3 in the biomarker substudy patients to assess the levels of these biomarkers before start of LCZ696 therapy. Addition of pharmacogenetic substudy. Addition of one more futility analysis; added a more conservative approach for stopping the study early for efficacy.

14 Jun 2011

Amendment 2: The purpose of the current amendment is to Add more details on the pharmacogenetic substudy assessments, quality control, and data analysis. Clarify that study bioanalytical monitor and the bioanalyst at the bioanalytical site will be unblinded to facilitate timely pharmacokinetic analysis of LCZ696 samples. Change abbreviated chemistry panel at Visit 3 (end of enalapril run-in /before LCZ696 run-in) and at Visits 8 and 9 (2 and 4 months after start of randomized, double-blind treatment period, respectively) to complete serum chemistry assessments. This will be implemented to assess the safety profile of enalapril during the run-in period before patients start the LCZ696 run-in period and to more comprehensively assess the safety profile shortly (2 and 4 months) after initiation of double-blind treatment. Add more instructions on appropriate follow-up of adverse events and clinically relevant laboratory abnormalities. Clarify long-term follow-up procedures during the double-blind period in this outcome trial to reduce loss to follow-up. Add guidance on frequency of re-screening.

07 Mar 2013

Amendment 3: The purpose of the current amendment is to elevate a pre-specified exploratory objective, i.e., comparing the effects of LCZ696 and enalapril on delaying time to new onset atrial fibrillation, to a secondary objective. The rationale for this change is based on the Recent published data from Study CLCZ696B2214, also known as PARAMOUNT, which demonstrated that LCZ696 treatment in heart failure with preserved ejection fraction results in significant reductions in left atrial volume and left atrial dimension. In addition, safety analysis of this study showed that fewer patients treated with LCZ696 experienced atrial fibrillation as an adverse event than those treated with the comparator (data on file). Therefore, it is hypothesized that LCZ696 may reduce new onset atrial fibrillation to a greater extent than enalapril in patients with heart failure.

26 Mar 2014

Amendment 4: The purpose of the current amendment is to include procedures requested by the Czech Republic health authority (SUKL). Czech Republic patients will be required to undergo an evaluation of cognitive function by a specialist (e.g., a neurologist or a psychiatrist) every six months for the remaining duration of the study and for one year after dis-continuation of study medication.

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.

DMC conducted the final interim analysis 28-Mar-14 and recommended early termination due to compelling efficacy of LCZ696 in HF patients and reduced EF. The PARADIGM-HF Executive Committee accepted the recommendation after consultation with Novartis.

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