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Clinical Trial Results:
UK Multicentre Open-label Randomised Controlled Trial Of IV Iron Therapy In Incident Haemodialysis Patients

Summary
EudraCT number	2013-002267-25
Trial protocol	GB
Global end of trial date	06 Jun 2018

Results information
Results version number	v1(current)
This version publication date	04 Aug 2019
First version publication date	04 Aug 2019
Other versions
Summary report(s)	Final Publication

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

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Trial information

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Sponsor protocol code

PIVOTAL

ISRCTN number

US NCT number

WHO universal trial number (UTN)

Sponsor organisation name

King's College Hospital NHS Foundation Trust

Sponsor organisation address

Denmark Hill, London, United Kingdom, SE5 9RS

Public contact

Professor Iain Macdougall, King's College Hospital NHS Foundation Trust, +44 02032996233, iain.macdougall@nhs.net

Scientific contact

Professor Iain Macdougall, King's College Hospital NHS Foundation Trust, +44 02032996233, iain.macdougall@nhs.net

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

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

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

Analysis stage

Final

Date of interim/final analysis

06 Jun 2018

Is this the analysis of the primary completion data?

Yes

Primary completion date

06 Jun 2018

Global end of trial reached?

Yes

Global end of trial date

06 Jun 2018

Was the trial ended prematurely?

Main objective of the trial

To compare the effect of a proactive high-dose, with a reactive low-dose, IV iron regimen on all-cause mortality and the incidence of non-fatal cardiovascular endpoints in haemodialysis patients.

Protection of trial subjects

During the period between informed consent and randomisation, if there is a strong clinical indication that a patient requires iron, then iron may be administered (this is not considered to be a protocol breach).

Background therapy

Patients established on a chronic haemodialysis programme for end-stage renal failure

Evidence for comparator

To compare the effect of a proactive high-dose, with a reactive low-dose, IV iron regimen on all-cause mortality and the incidence of non-fatal cardiovascular endpoints in haemodialysis patients

Actual start date of recruitment

01 Sep 2013

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

United Kingdom: 2141

Worldwide total number of subjects

2141

EEA total number of subjects

2141

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

865

From 65 to 84 years

1024

85 years and over

252

Subject disposition

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Recruitment details

Participants were recruited from multiple clinical centres across the UK between 2013 and 2018

Screening details

Age >18 years - Patients established on a chronic haemodialysis programme for end-stage renal failure - Clinically stable (Investigator’s judgement) - 0–12 months since commencing haemodialysis

Period 1 title

Overall Trial (overall period)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Not blinded

Blinding implementation details

not applicable

Are arms mutually exclusive

Yes

Proactive IV iron arm

Arm description

IV iron 400mg/month Total study period approximately 4 years (event-driven) – projected treatment duration per patient > 2 years

Arm type

Experimental

Investigational medicinal product name

Venofer

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for solution for injection

Routes of administration

Intravenous use

Dosage and administration details

IV iron 400mg/month by Intravenous Infustion

Reactive IV iron arm

Arm description

IV iron sucrose 100–200mg / month if becomes “iron deficien

Arm type

Active comparator

Investigational medicinal product name

Venofer

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for solution for injection

Routes of administration

Intravenous use

Dosage and administration details

IV iron sucrose 100–200mg / month if becomes “iron deficien

Number of subjects in period 1	Proactive IV iron arm	Reactive IV iron arm
Started	1093	1048
Completed	488	407
Not completed	605	641
Adverse event, serious fatal	246	269
Consent withdrawn by subject	42	44
Moved to peritoneal dialysis	13	17
Home dialysis	45	36
Lost to follow-up	62	78
Transplant	184	187
Protocol deviation	13	10

Baseline characteristics

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End points

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Reporting group title

Proactive IV iron arm

Reporting group description

IV iron 400mg/month Total study period approximately 4 years (event-driven) – projected treatment duration per patient > 2 years

Reporting group title

Reactive IV iron arm

Reporting group description

IV iron sucrose 100–200mg / month if becomes “iron deficien

Primary: Time to first event

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End point title

Time to first event ^[1]

End point description

Time to first event: all-cause death or a composite of non-fatal cardiovascular events (myocardial infarction, stroke, and hospitalisation for heart failure) adjudicated by a blinded Endpoint Adjudication Committee.

End point type

Primary

End point timeframe

not applicable

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: Please see attached publication and appendix

End point values	Proactive IV iron arm	Reactive IV iron arm
Number of subjects analysed	1080	1038
Units: whole	1080	1038

Attachments

Results additional data

No statistical analyses for this end point

Secondary: Secondary Efficacy Endpoints

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End point title

Secondary Efficacy Endpoints

End point description

Incidence of all-cause death and a composite of myocardial infarction, stroke, and hospitalisation for heart failure as recurrent events. - Time to (and incidence of) all-cause death - Time to (and incidence of) first composite cardiovascular event - Time to (and incidence of) first myocardial infarction - Time to (and incidence of) first stroke - Time to (and incidence of) first hospitalisation for heart failure - Transfusion requirements - EQ-5D QOL and KDQOL - ESA dose requirements

End point type

Secondary

End point timeframe

0 to 18 months (event driven)

End point values	Proactive IV iron arm	Reactive IV iron arm
Number of subjects analysed	1080	1038
Units: whole	1080	1038

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

Adverse events were recorded from baseline/randomisation until the end of study for each patient.

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

15.1

Reporting group title

Proactive IV Iron

Reporting group description

Reporting group title

Reactive IV Iron

Reporting group description

Notes
[1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
Justification: Adverse events or reactions listed in the SmPC were not reported, with the exception of immediate hypersensitivity-like reactions to IV iron. Common non-life-threatening symptoms such as constipation, diarrhoea, headache, etc. do not need to be reported. Only serious adverse events and episodes of infection and vascular access thrombosis will be recorded. No other non-serious adverse events will be recorded.

Serious adverse events	Proactive IV Iron	Reactive IV Iron
Total subjects affected by serious adverse events
subjects affected / exposed	709 / 1093 (64.87%)	671 / 1048 (64.03%)
number of deaths (all causes)	246	269
number of deaths resulting from adverse events	246	269
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
ADENOCARCINOMA
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
ADRENAL NEOPLASM
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
BLADDER CANCER
subjects affected / exposed	2 / 1093 (0.18%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 0
BLADDER NEOPLASM
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
BLADDER TRANSITIONAL CELL CARCINOMA
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
BREAST CANCER
subjects affected / exposed	0 / 1093 (0.00%)	2 / 1048 (0.19%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 1
CARDIAC MYXOMA
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
CENTRAL NERVOUS SYSTEM LYMPHOMA
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
CERVIX CANCER METASTATIC
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
COLON CANCER
subjects affected / exposed	2 / 1093 (0.18%)	3 / 1048 (0.29%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 1
GASTRIC CANCER
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
GASTROINTESTINAL CARCINOMA
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
HEPATIC NEOPLASM MALIGNANT
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
LUNG ADENOCARCINOMA
subjects affected / exposed	2 / 1093 (0.18%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
LUNG CANCER METASTATIC
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
LUNG NEOPLASM MALIGNANT
subjects affected / exposed	4 / 1093 (0.37%)	4 / 1048 (0.38%)
occurrences causally related to treatment / all	0 / 4	0 / 4
deaths causally related to treatment / all	0 / 2	0 / 2
LUNG SQUAMOUS CELL CARCINOMA STAGE UNSPECIFIED
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
LYMPHOMA
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
MALIGNANT MELANOMA
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
MEDIASTINUM NEOPLASM
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
MESOTHELIOMA MALIGNANT
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
METASTASES TO CENTRAL NERVOUS SYSTEM
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
METASTASES TO PANCREAS
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
METASTASIS
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
METASTATIC MALIGNANT MELANOMA
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
METASTATIC NEOPLASM
subjects affected / exposed	2 / 1093 (0.18%)	2 / 1048 (0.19%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 1	0 / 1
MULTIPLE MYELOMA
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
NEOPLASM MALIGNANT
subjects affected / exposed	2 / 1093 (0.18%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 0
NEUROENDOCRINE TUMOUR
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
NON-SMALL CELL LUNG CANCER
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
PANCREATIC CARCINOMA
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
PELVIC NEOPLASM
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
PITUITARY TUMOUR BENIGN
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
PLEURAL NEOPLASM
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
PROSTATE CANCER METASTATIC
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
RECTAL CANCER
subjects affected / exposed	0 / 1093 (0.00%)	2 / 1048 (0.19%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
RENAL CANCER RECURRENT
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
RENAL CELL CARCINOMA RECURRENT
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
SALIVARY GLAND CANCER
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
SKIN CANCER
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
SMALL CELL LUNG CANCER STAGE UNSPECIFIED
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
VULVAL CANCER
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
PROGRESSIVE SUPRANUCLEAR PALSY
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Vascular disorders
Stroke
subjects affected / exposed	12 / 1093 (1.10%)	13 / 1048 (1.24%)
occurrences causally related to treatment / all	0 / 12	0 / 13
deaths causally related to treatment / all	0 / 12	0 / 13
AIR EMBOLISM
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
ANEURYSM RUPTURED
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
ANGIOPATHY
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (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	2 / 1093 (0.18%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 0
AORTIC CALCIFICATION
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
AORTIC STENOSIS
subjects affected / exposed	0 / 1093 (0.00%)	6 / 1048 (0.57%)
occurrences causally related to treatment / all	0 / 0	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 1
ARTERIAL DISORDER
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
ARTERIOSCLEROSIS
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
ARTERIOVENOUS FISTULA
subjects affected / exposed	1 / 1093 (0.09%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
BRACHIOCEPHALIC ARTERY OCCLUSION
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
CIRCULATORY COLLAPSE
subjects affected / exposed	17 / 1093 (1.56%)	16 / 1048 (1.53%)
occurrences causally related to treatment / all	0 / 22	0 / 18
deaths causally related to treatment / all	0 / 5	0 / 4
DEEP VEIN THROMBOSIS
subjects affected / exposed	3 / 1093 (0.27%)	4 / 1048 (0.38%)
occurrences causally related to treatment / all	0 / 3	0 / 5
deaths causally related to treatment / all	0 / 1	0 / 0
DIABETIC VASCULAR DISORDER
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
EMBOLISM
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
VENOUS EMBOLISM
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
EXTREMITY NECROSIS
subjects affected / exposed	5 / 1093 (0.46%)	5 / 1048 (0.48%)
occurrences causally related to treatment / all	0 / 5	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 1
HAEMATOMA
subjects affected / exposed	6 / 1093 (0.55%)	5 / 1048 (0.48%)
occurrences causally related to treatment / all	0 / 6	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
HAEMORRHAGE
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
HYPERTENSION
subjects affected / exposed	10 / 1093 (0.91%)	6 / 1048 (0.57%)
occurrences causally related to treatment / all	0 / 12	0 / 7
deaths causally related to treatment / all	0 / 1	0 / 0
HYPERTENSIVE CRISIS
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (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	20 / 1093 (1.83%)	18 / 1048 (1.72%)
occurrences causally related to treatment / all	0 / 22	0 / 20
deaths causally related to treatment / all	0 / 2	0 / 3
HYPOVOLAEMIC SHOCK
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
INTERMITTENT CLAUDICATION
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
MALIGNANT HYPERTENSION
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
MICROSCOPIC POLYANGIITIS
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (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	4 / 1093 (0.37%)	5 / 1048 (0.48%)
occurrences causally related to treatment / all	0 / 4	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
PERIPHERAL ARTERIAL OCCLUSIVE DISEASE
subjects affected / exposed	1 / 1093 (0.09%)	2 / 1048 (0.19%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
PERIPHERAL ARTERY THROMBOSIS
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
PERIPHERAL ISCHAEMIA
subjects affected / exposed	14 / 1093 (1.28%)	22 / 1048 (2.10%)
occurrences causally related to treatment / all	0 / 15	0 / 25
deaths causally related to treatment / all	0 / 4	0 / 7
PERIPHERAL VASCULAR DISORDER
subjects affected / exposed	3 / 1093 (0.27%)	2 / 1048 (0.19%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 1	0 / 0
STEAL SYNDROME
subjects affected / exposed	3 / 1093 (0.27%)	2 / 1048 (0.19%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
SUPERIOR VENA CAVA SYNDROME
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (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 / 1093 (0.18%)	2 / 1048 (0.19%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
VASCULAR STENOSIS
subjects affected / exposed	1 / 1093 (0.09%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
VENOUS OCCLUSION
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
VENOUS STENOSIS
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
VENA CAVA THROMBOSIS
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
TEMPORAL ARTERITIS
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
POOR VENOUS ACCESS
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Surgical and medical procedures
ABSCESS DRAINAGE
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
AMPUTATION OF PENIS
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
ANEURYSM REPAIR
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
ANGIOPLASTY
subjects affected / exposed	1 / 1093 (0.09%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
ANKLE OPERATION
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
AORTIC VALVE REPLACEMENT
subjects affected / exposed	2 / 1093 (0.18%)	3 / 1048 (0.29%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
ARTERIOVENOUS FISTULA OPERATION
subjects affected / exposed	29 / 1093 (2.65%)	18 / 1048 (1.72%)
occurrences causally related to treatment / all	0 / 34	0 / 21
deaths causally related to treatment / all	0 / 0	0 / 0
ARTERIOVENOUS GRAFT
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
BLADDER NECK OPERATION
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
BUNION OPERATION
subjects affected / exposed	1 / 1093 (0.09%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
CARDIAC PACEMAKER INSERTION
subjects affected / exposed	2 / 1093 (0.18%)	3 / 1048 (0.29%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
CARPAL TUNNEL DECOMPRESSION
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
CATHETER PLACEMENT
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
CATHETER REMOVAL
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
CENTRAL VENOUS CATHETERISATION
subjects affected / exposed	3 / 1093 (0.27%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
CHOLECYSTECTOMY
subjects affected / exposed	0 / 1093 (0.00%)	3 / 1048 (0.29%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
CORONARY ANGIOPLASTY
subjects affected / exposed	1 / 1093 (0.09%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
CORONARY ARTERIAL STENT INSERTION
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
CORONARY ARTERY BYPASS
subjects affected / exposed	1 / 1093 (0.09%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
DEBRIDEMENT
subjects affected / exposed	1 / 1093 (0.09%)	3 / 1048 (0.29%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
DIALYSIS
subjects affected / exposed	2 / 1093 (0.18%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
DIALYSIS DEVICE INSERTION
subjects affected / exposed	3 / 1093 (0.27%)	2 / 1048 (0.19%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
DRUG THERAPY
subjects affected / exposed	1 / 1093 (0.09%)	2 / 1048 (0.19%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
EMERGENCY CARE
subjects affected / exposed	2 / 1093 (0.18%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 0
EMPYEMA DRAINAGE
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
ENDOTRACHEAL INTUBATION
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
FINGER AMPUTATION
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
FISTULA REPAIR
subjects affected / exposed	3 / 1093 (0.27%)	2 / 1048 (0.19%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
FOOT AMPUTATION
subjects affected / exposed	2 / 1093 (0.18%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
GASTROINTESTINAL SURGERY
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
GENITOURINARY OPERATION
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
HERNIA REPAIR
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
HIP ARTHROPLASTY
subjects affected / exposed	1 / 1093 (0.09%)	2 / 1048 (0.19%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 1
HOSPITALISATION
subjects affected / exposed	2 / 1093 (0.18%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
HYSTERECTOMY
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
ILEOSTOMY
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
INCISIONAL DRAINAGE
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
INCISIONAL HERNIA REPAIR
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
INTRAVENOUS CATHETER MANAGEMENT
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
KNEE ARTHROPLASTY
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
LEG AMPUTATION
subjects affected / exposed	7 / 1093 (0.64%)	7 / 1048 (0.67%)
occurrences causally related to treatment / all	0 / 7	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
LESION EXCISION
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
LIMB AMPUTATION
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
MALIGNANT TUMOUR EXCISION
subjects affected / exposed	1 / 1093 (0.09%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
MASTECTOMY
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
MENISCUS OPERATION
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
NEPHRECTOMY
subjects affected / exposed	2 / 1093 (0.18%)	3 / 1048 (0.29%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 1	0 / 0
OPEN REDUCTION OF FRACTURE
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
OVARIOCENTESIS
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
PANCREATICODUODENECTOMY
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
PARATHYROIDECTOMY
subjects affected / exposed	9 / 1093 (0.82%)	5 / 1048 (0.48%)
occurrences causally related to treatment / all	0 / 9	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
PARTIAL LUNG RESECTION
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
PERCUTANEOUS CORONARY INTERVENTION
subjects affected / exposed	5 / 1093 (0.46%)	2 / 1048 (0.19%)
occurrences causally related to treatment / all	0 / 5	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
PERIPHERAL ARTERY ANGIOPLASTY
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
PERIPHERAL ARTERY BYPASS
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
PREOPERATIVE CARE
subjects affected / exposed	1 / 1093 (0.09%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
PROLAPSE REPAIR
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
PROPHYLAXIS
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
RENAL TRANSPLANT
subjects affected / exposed	1 / 1093 (0.09%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
SALPINGO-OOPHORECTOMY UNILATERAL
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
SALVAGE THERAPY
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
SKIN GRAFT
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
SKIN NEOPLASM EXCISION
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
SURGERY
subjects affected / exposed	3 / 1093 (0.27%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
THERAPY CESSATION
subjects affected / exposed	7 / 1093 (0.64%)	8 / 1048 (0.76%)
occurrences causally related to treatment / all	0 / 7	0 / 8
deaths causally related to treatment / all	0 / 7	0 / 8
THORACIC CAVITY DRAINAGE
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
THROMBECTOMY
subjects affected / exposed	2 / 1093 (0.18%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
THROMBOEMBOLECTOMY
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
THROMBOLYSIS
subjects affected / exposed	0 / 1093 (0.00%)	2 / 1048 (0.19%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
THROMBOSIS PROPHYLAXIS
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
TOE AMPUTATION
subjects affected / exposed	6 / 1093 (0.55%)	7 / 1048 (0.67%)
occurrences causally related to treatment / all	0 / 6	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
TRANSFUSION
subjects affected / exposed	2 / 1093 (0.18%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
URETERAL STENT INSERTION
subjects affected / exposed	1 / 1093 (0.09%)	2 / 1048 (0.19%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
URINARY TRACT OPERATION
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
UROSTOMY
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
VASCULAR OPERATION
subjects affected / exposed	15 / 1093 (1.37%)	8 / 1048 (0.76%)
occurrences causally related to treatment / all	0 / 15	0 / 8
deaths causally related to treatment / all	0 / 0	0 / 1
General disorders and administration site conditions
Adverse drug reaction
subjects affected / exposed	1 / 1093 (0.09%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	1 / 1	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Asthenia
subjects affected / exposed	6 / 1093 (0.55%)	2 / 1048 (0.19%)
occurrences causally related to treatment / all	0 / 6	0 / 2
deaths causally related to treatment / all	0 / 2	0 / 1
Cardiac death
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Catheter site haemorrhage
subjects affected / exposed	1 / 1093 (0.09%)	12 / 1048 (1.15%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Catheter site pain
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Chest discomfort
subjects affected / exposed	1 / 1093 (0.09%)	2 / 1048 (0.19%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Chest pain
subjects affected / exposed	52 / 1093 (4.76%)	51 / 1048 (4.87%)
occurrences causally related to treatment / all	0 / 72	0 / 67
deaths causally related to treatment / all	0 / 3	0 / 2
Chills
subjects affected / exposed	2 / 1093 (0.18%)	4 / 1048 (0.38%)
occurrences causally related to treatment / all	0 / 2	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Complication of device removal
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Death
subjects affected / exposed	34 / 1093 (3.11%)	28 / 1048 (2.67%)
occurrences causally related to treatment / all	0 / 34	0 / 28
deaths causally related to treatment / all	0 / 34	0 / 28
Device dislocation
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Device occlusion
subjects affected / exposed	7 / 1093 (0.64%)	4 / 1048 (0.38%)
occurrences causally related to treatment / all	0 / 7	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Drug resistance
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Fatigue management
subjects affected / exposed	3 / 1093 (0.27%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gait disturbance
subjects affected / exposed	2 / 1093 (0.18%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
General physical health deterioration
subjects affected / exposed	5 / 1093 (0.46%)	5 / 1048 (0.48%)
occurrences causally related to treatment / all	0 / 5	0 / 5
deaths causally related to treatment / all	0 / 4	0 / 2
Hernia
subjects affected / exposed	2 / 1093 (0.18%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hypothermia
subjects affected / exposed	1 / 1093 (0.09%)	2 / 1048 (0.19%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 1	0 / 0
Injury associated with device
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
ischaemic ulcer
subjects affected / exposed	0 / 1093 (0.00%)	2 / 1048 (0.19%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
local swelling
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Malaise
subjects affected / exposed	18 / 1093 (1.65%)	10 / 1048 (0.95%)
occurrences causally related to treatment / all	0 / 19	0 / 12
deaths causally related to treatment / all	0 / 3	0 / 1
medical device complication
subjects affected / exposed	10 / 1093 (0.91%)	5 / 1048 (0.48%)
occurrences causally related to treatment / all	0 / 11	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Multi-organ failure
subjects affected / exposed	5 / 1093 (0.46%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 5	0 / 1
deaths causally related to treatment / all	0 / 5	0 / 1
Necrosis
subjects affected / exposed	6 / 1093 (0.55%)	2 / 1048 (0.19%)
occurrences causally related to treatment / all	0 / 6	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Non-cardiac chest pain
subjects affected / exposed	0 / 1093 (0.00%)	5 / 1048 (0.48%)
occurrences causally related to treatment / all	0 / 0	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Oedema peripheral
subjects affected / exposed	2 / 1093 (0.18%)	4 / 1048 (0.38%)
occurrences causally related to treatment / all	0 / 2	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 1
Pain
subjects affected / exposed	1 / 1093 (0.09%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pelvic mass
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pyrexia
subjects affected / exposed	17 / 1093 (1.56%)	11 / 1048 (1.05%)
occurrences causally related to treatment / all	0 / 18	0 / 14
deaths causally related to treatment / all	0 / 1	0 / 0
Sudden cardiac death
subjects affected / exposed	3 / 1093 (0.27%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 3	0 / 1
Sudden unexplained death in epilepsy
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Swelling
subjects affected / exposed	1 / 1093 (0.09%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Suprapubic pain
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Treatment failure
subjects affected / exposed	0 / 1093 (0.00%)	2 / 1048 (0.19%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Immune system disorders
DRUG HYPERSENSITIVITY
subjects affected / exposed	13 / 1093 (1.19%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
HEART TRANSPLANT REJECTION
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
CONTRAST MEDIA ALLERGY
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Social circumstances
SOCIAL PROBLEM
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
SOCIAL STAY HOSPITALISATION
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
TREATMENT NONCOMPLIANCE
subjects affected / exposed	1 / 1093 (0.09%)	2 / 1048 (0.19%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Reproductive system and breast disorders
EPIDIDYMITIS
subjects affected / exposed	0 / 1093 (0.00%)	2 / 1048 (0.19%)
occurrences causally related to treatment / all	0 / 0	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
FEMALE GENITAL TRACT FISTULA
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
PELVIC HAEMATOMA
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
PENILE NECROSIS
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
VAGINAL HAEMORRHAGE
subjects affected / exposed	0 / 1093 (0.00%)	2 / 1048 (0.19%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
PLEURAL EFFUSION
subjects affected / exposed	22 / 1093 (2.01%)	19 / 1048 (1.81%)
occurrences causally related to treatment / all	0 / 25	0 / 27
deaths causally related to treatment / all	0 / 2	0 / 4
Respiratory, thoracic and mediastinal disorders
ACUTE PULMONARY OEDEMA
subjects affected / exposed	2 / 1093 (0.18%)	3 / 1048 (0.29%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 2
ACUTE RESPIRATORY FAILURE
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
ALVEOLITIS ALLERGIC
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
ASPIRATION
subjects affected / exposed	0 / 1093 (0.00%)	2 / 1048 (0.19%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 1
ASTHMA
subjects affected / exposed	1 / 1093 (0.09%)	4 / 1048 (0.38%)
occurrences causally related to treatment / all	0 / 1	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 1
BRONCHIECTASIS
subjects affected / exposed	0 / 1093 (0.00%)	3 / 1048 (0.29%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 1
CHOKING
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
subjects affected / exposed	8 / 1093 (0.73%)	14 / 1048 (1.34%)
occurrences causally related to treatment / all	0 / 10	0 / 17
deaths causally related to treatment / all	0 / 0	0 / 3
CHRONIC RESPIRATORY FAILURE
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
COUGH
subjects affected / exposed	3 / 1093 (0.27%)	3 / 1048 (0.29%)
occurrences causally related to treatment / all	0 / 3	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
DYSPNOEA
subjects affected / exposed	42 / 1093 (3.84%)	43 / 1048 (4.10%)
occurrences causally related to treatment / all	0 / 53	0 / 50
deaths causally related to treatment / all	0 / 2	0 / 6
EMPHYSEMA
subjects affected / exposed	1 / 1093 (0.09%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
EPISTAXIS
subjects affected / exposed	5 / 1093 (0.46%)	2 / 1048 (0.19%)
occurrences causally related to treatment / all	0 / 7	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
HAEMOPTYSIS
subjects affected / exposed	1 / 1093 (0.09%)	2 / 1048 (0.19%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
HAEMOTHORAX
subjects affected / exposed	1 / 1093 (0.09%)	2 / 1048 (0.19%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 2
LARYNGEAL DYSPNOEA
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
LARYNGEAL STENOSIS
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
NON-CARDIOGENIC PULMONARY OEDEMA
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
LUNG DISORDER
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
LUNG CONSOLIDATION
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
HYPOXIA
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
DYSPNOEA EXERTIONAL
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
PLEURISY
subjects affected / exposed	1 / 1093 (0.09%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
PLEURITIC PAIN
subjects affected / exposed	2 / 1093 (0.18%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
PNEUMONIA ASPIRATION
subjects affected / exposed	3 / 1093 (0.27%)	3 / 1048 (0.29%)
occurrences causally related to treatment / all	0 / 3	0 / 3
deaths causally related to treatment / all	0 / 2	0 / 0
PNEUMOTHORAX
subjects affected / exposed	0 / 1093 (0.00%)	2 / 1048 (0.19%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 1
PRODUCTIVE COUGH
subjects affected / exposed	3 / 1093 (0.27%)	7 / 1048 (0.67%)
occurrences causally related to treatment / all	0 / 3	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
PULMONARY ARTERY ANEURYSM
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
PULMONARY CONGESTION
subjects affected / exposed	0 / 1093 (0.00%)	2 / 1048 (0.19%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
PULMONARY EMBOLISM
subjects affected / exposed	6 / 1093 (0.55%)	6 / 1048 (0.57%)
occurrences causally related to treatment / all	0 / 7	0 / 6
deaths causally related to treatment / all	0 / 1	0 / 1
PULMONARY FIBROSIS
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
PULMONARY OEDEMA
subjects affected / exposed	25 / 1093 (2.29%)	27 / 1048 (2.58%)
occurrences causally related to treatment / all	0 / 25	0 / 35
deaths causally related to treatment / all	0 / 1	0 / 3
RESPIRATORY ARREST
subjects affected / exposed	3 / 1093 (0.27%)	2 / 1048 (0.19%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 1
RESPIRATORY DISORDER
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
RESPIRATORY DISTRESS
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
RESPIRATORY FAILURE
subjects affected / exposed	2 / 1093 (0.18%)	6 / 1048 (0.57%)
occurrences causally related to treatment / all	0 / 2	0 / 6
deaths causally related to treatment / all	0 / 2	0 / 2
WHEEZING
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Psychiatric disorders
AFFECT LABILITY
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
AGITATION
subjects affected / exposed	2 / 1093 (0.18%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
ANXIETY
subjects affected / exposed	0 / 1093 (0.00%)	2 / 1048 (0.19%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
CONFUSIONAL STATE
subjects affected / exposed	18 / 1093 (1.65%)	18 / 1048 (1.72%)
occurrences causally related to treatment / all	0 / 23	0 / 19
deaths causally related to treatment / all	0 / 3	0 / 4
DELIRIUM
subjects affected / exposed	3 / 1093 (0.27%)	4 / 1048 (0.38%)
occurrences causally related to treatment / all	0 / 3	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
DEPRESSED MOOD
subjects affected / exposed	0 / 1093 (0.00%)	2 / 1048 (0.19%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
IMPAIRED SELF-CARE
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
PSYCHOTIC DISORDER
subjects affected / exposed	0 / 1093 (0.00%)	2 / 1048 (0.19%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatobiliary disorders
Bile duct obstruction
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Bile duct stenosis
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Biliary colic
subjects affected / exposed	1 / 1093 (0.09%)	2 / 1048 (0.19%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Cholangitis
subjects affected / exposed	3 / 1093 (0.27%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cholecystitis
subjects affected / exposed	8 / 1093 (0.73%)	4 / 1048 (0.38%)
occurrences causally related to treatment / all	0 / 10	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Cholecystitis acute
subjects affected / exposed	3 / 1093 (0.27%)	5 / 1048 (0.48%)
occurrences causally related to treatment / all	0 / 3	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Cholelithiasis
subjects affected / exposed	2 / 1093 (0.18%)	3 / 1048 (0.29%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Gallbladder perforation
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatic cirrhosis
subjects affected / exposed	3 / 1093 (0.27%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Hepatitis acute
subjects affected / exposed	0 / 1093 (0.00%)	2 / 1048 (0.19%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 1
Hepatic failure
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Jaundice
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Jaundice cholestatic
subjects affected / exposed	0 / 1093 (0.00%)	2 / 1048 (0.19%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Liver disorder
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Investigations
ANTICOAGULATION DRUG LEVEL ABOVE THERAPEUTIC
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
CORONARY ARTERIOGRAM
subjects affected / exposed	0 / 1093 (0.00%)	4 / 1048 (0.38%)
occurrences causally related to treatment / all	0 / 0	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
BIOPSY LYMPH GLAND
subjects affected / exposed	2 / 1093 (0.18%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
BLOOD CULTURE POSITIVE
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
BLOOD GLUCOSE ABNORMAL
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
BLOOD GLUCOSE FLUCTUATION
subjects affected / exposed	1 / 1093 (0.09%)	2 / 1048 (0.19%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
BLOOD GLUCOSE INCREASED
subjects affected / exposed	3 / 1093 (0.27%)	2 / 1048 (0.19%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
BLOOD PHOSPHORUS DECREASED
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
BLOOD POTASSIUM INCREASED
subjects affected / exposed	4 / 1093 (0.37%)	6 / 1048 (0.57%)
occurrences causally related to treatment / all	0 / 4	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
BLOOD PRESSURE INCREASED
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
CARDIAC OUTPUT DECREASED
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
CARDIAC PACEMAKER EVALUATION
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
CLOSTRIDIUM TEST POSITIVE
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
COLONOSCOPY
subjects affected / exposed	2 / 1093 (0.18%)	2 / 1048 (0.19%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
COMA SCALE ABNORMAL
subjects affected / exposed	2 / 1093 (0.18%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
C-REACTIVE PROTEIN ABNORMAL
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
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	3 / 1093 (0.27%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
DRUG LEVEL ABOVE THERAPEUTIC
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
ECHOCARDIOGRAM ABNORMAL
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
ELECTROCARDIOGRAM ABNORMAL
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
FISTULOGRAM
subjects affected / exposed	1 / 1093 (0.09%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
DECREASED HAEMOGLOBIN
subjects affected / exposed	4 / 1093 (0.37%)	5 / 1048 (0.48%)
occurrences causally related to treatment / all	0 / 4	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
HEART RATE IRREGULAR
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
INFLAMMATORY MARKER INCREASED
subjects affected / exposed	1 / 1093 (0.09%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
INTERNATIONAL NORMALISED RATIO ABNORMAL
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
INTERNATIONAL NORMALISED RATIO INCREASED
subjects affected / exposed	3 / 1093 (0.27%)	2 / 1048 (0.19%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
LISTERIA TEST POSITIVE
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
LIVER FUNCTION TEST ABNORMAL
subjects affected / exposed	1 / 1093 (0.09%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
MEDIASTINOSCOPY
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
PULMONARY FUNCTION TEST DECREASED
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
SIGMOIDOSCOPY
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
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 / 1093 (0.09%)	4 / 1048 (0.38%)
occurrences causally related to treatment / all	0 / 1	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
INCREASED T TROPONIN
subjects affected / exposed	1 / 1093 (0.09%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
URINE OUTPUT DECREASED
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
WEIGHT DECREASED
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Injury, poisoning and procedural complications
ACCIDENTAL OVERDOSE
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
ANKLE FRACTURE
subjects affected / exposed	4 / 1093 (0.37%)	5 / 1048 (0.48%)
occurrences causally related to treatment / all	0 / 4	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
ANEURYSM ARTERIOVENOUS FISTULA
subjects affected / exposed	2 / 1093 (0.18%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
ARTERIOVENOUS FISTULA OCCLUSION
subjects affected / exposed	34 / 1093 (3.11%)	33 / 1048 (3.15%)
occurrences causally related to treatment / all	0 / 38	0 / 36
deaths causally related to treatment / all	0 / 0	0 / 0
ACCIDENT
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
ARTERIOVENOUS FISTULA SITE COMPLICATION
subjects affected / exposed	24 / 1093 (2.20%)	20 / 1048 (1.91%)
occurrences causally related to treatment / all	0 / 24	0 / 20
deaths causally related to treatment / all	0 / 0	0 / 1
ARTERIOVENOUS FISTULA SITE HAEMORRHAGE
subjects affected / exposed	12 / 1093 (1.10%)	12 / 1048 (1.15%)
occurrences causally related to treatment / all	0 / 13	0 / 13
deaths causally related to treatment / all	0 / 0	0 / 1
ARTERIOVENOUS FISTULA THROMBOSIS
subjects affected / exposed	43 / 1093 (3.93%)	27 / 1048 (2.58%)
occurrences causally related to treatment / all	0 / 52	0 / 28
deaths causally related to treatment / all	0 / 1	0 / 0
ARTERIOVENOUS GRAFT SITE HAEMATOMA
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
CERVICAL VERTEBRAL FRACTURE
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
CLAVICLE FRACTURE
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
COMPLICATIONS OF TRANSPLANT SURGERY
subjects affected / exposed	1 / 1093 (0.09%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
CONTUSION
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
DIALYSIS RELATED COMPLICATION
subjects affected / exposed	7 / 1093 (0.64%)	7 / 1048 (0.67%)
occurrences causally related to treatment / all	0 / 7	0 / 7
deaths causally related to treatment / all	0 / 1	0 / 2
FACE INJURY
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
FALL
subjects affected / exposed	33 / 1093 (3.02%)	55 / 1048 (5.25%)
occurrences causally related to treatment / all	0 / 39	0 / 59
deaths causally related to treatment / all	0 / 1	0 / 13
FEMORAL NECK FRACTURE
subjects affected / exposed	13 / 1093 (1.19%)	23 / 1048 (2.19%)
occurrences causally related to treatment / all	0 / 14	0 / 24
deaths causally related to treatment / all	0 / 2	0 / 2
FEMUR FRACTURE
subjects affected / exposed	2 / 1093 (0.18%)	4 / 1048 (0.38%)
occurrences causally related to treatment / all	0 / 2	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 1
FIBULA FRACTURE
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
FOOT FRACTURE
subjects affected / exposed	1 / 1093 (0.09%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
FOREIGN BODY
subjects affected / exposed	0 / 1093 (0.00%)	2 / 1048 (0.19%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
FRACTURE
subjects affected / exposed	1 / 1093 (0.09%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 0
GASTROINTESTINAL STOMA COMPLICATION
subjects affected / exposed	1 / 1093 (0.09%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
GRAFT COMPLICATION
subjects affected / exposed	0 / 1093 (0.00%)	2 / 1048 (0.19%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
GRAFT HAEMORRHAGE
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
GRAFT THROMBOSIS
subjects affected / exposed	3 / 1093 (0.27%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
HAEMATURIA TRAUMATIC
subjects affected / exposed	1 / 1093 (0.09%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
HAEMODIALYSIS COMPLICATION
subjects affected / exposed	2 / 1093 (0.18%)	3 / 1048 (0.29%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 1	0 / 0
HAEMODIALYSIS-INDUCED SYMPTOM
subjects affected / exposed	4 / 1093 (0.37%)	3 / 1048 (0.29%)
occurrences causally related to treatment / all	0 / 4	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
HAND FRACTURE
subjects affected / exposed	3 / 1093 (0.27%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
HEAD INJURY
subjects affected / exposed	3 / 1093 (0.27%)	2 / 1048 (0.19%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
HEPATIC HAEMATOMA
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
HIP FRACTURE
subjects affected / exposed	3 / 1093 (0.27%)	3 / 1048 (0.29%)
occurrences causally related to treatment / all	0 / 3	0 / 3
deaths causally related to treatment / all	0 / 1	0 / 0
HUMERUS FRACTURE
subjects affected / exposed	3 / 1093 (0.27%)	2 / 1048 (0.19%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
IATROGENIC INJURY
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
INCISIONAL HERNIA
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
INCISIONAL HERNIA, OBSTRUCTIVE
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
INJURY
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
JOINT DISLOCATION
subjects affected / exposed	0 / 1093 (0.00%)	4 / 1048 (0.38%)
occurrences causally related to treatment / all	0 / 0	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
JOINT INJURY
subjects affected / exposed	0 / 1093 (0.00%)	2 / 1048 (0.19%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
LACERATION
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
LIMB INJURY
subjects affected / exposed	1 / 1093 (0.09%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
LOWER LIMB FRACTURE
subjects affected / exposed	3 / 1093 (0.27%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
MULTIPLE FRACTURES
subjects affected / exposed	1 / 1093 (0.09%)	3 / 1048 (0.29%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
MUSCLE INJURY
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
OVERDOSE
subjects affected / exposed	1 / 1093 (0.09%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
PATELLA FRACTURE
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
PELVIC FRACTURE
subjects affected / exposed	3 / 1093 (0.27%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
PERIPROSTHETIC FRACTURE
subjects affected / exposed	1 / 1093 (0.09%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
PERITONEAL DIALYSIS COMPLICATION
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
POST GASTRIC SURGERY SYNDROME
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
POST PROCEDURAL COMPLICATION
subjects affected / exposed	2 / 1093 (0.18%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
POST PROCEDURAL DIARRHOEA
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
POST PROCEDURAL HAEMATOMA
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
POST PROCEDURAL MYOCARDIAL INFARCTION
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
POST PROCEDURAL SWELLING
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
POSTOPERATIVE ILEUS
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
POSTOPERATIVE WOUND COMPLICATION
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
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 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
PROCEDURAL HAEMORRHAGE
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
PROCEDURAL HYPERTENSION
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
PROCEDURAL HYPOTENSION
subjects affected / exposed	6 / 1093 (0.55%)	4 / 1048 (0.38%)
occurrences causally related to treatment / all	0 / 6	0 / 4
deaths causally related to treatment / all	0 / 2	0 / 1
PROCEDURAL PAIN
subjects affected / exposed	1 / 1093 (0.09%)	3 / 1048 (0.29%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
PROCEDURAL VOMITING
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
PUBIS FRACTURE
subjects affected / exposed	2 / 1093 (0.18%)	5 / 1048 (0.48%)
occurrences causally related to treatment / all	0 / 2	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
RADIUS FRACTURE
subjects affected / exposed	1 / 1093 (0.09%)	2 / 1048 (0.19%)
occurrences causally related to treatment / all	0 / 1	0 / 22
deaths causally related to treatment / all	0 / 0	0 / 0
RENAL GRAFT LOSS
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
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 / 1093 (0.09%)	2 / 1048 (0.19%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
ROAD TRAFFIC ACCIDENT
subjects affected / exposed	3 / 1093 (0.27%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
SHUNT OCCLUSION
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
SOFT TISSUE INJURY
subjects affected / exposed	0 / 1093 (0.00%)	2 / 1048 (0.19%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
SPINAL FRACTURE
subjects affected / exposed	1 / 1093 (0.09%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
SUBDURAL HAEMATOMA
subjects affected / exposed	4 / 1093 (0.37%)	2 / 1048 (0.19%)
occurrences causally related to treatment / all	0 / 5	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 1
SUBDURAL HAEMORRHAGE
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
TIBIA FRACTURE
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
TOXICITY TO VARIOUS AGENTS
subjects affected / exposed	2 / 1093 (0.18%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
TRAUMATIC HAEMATOMA
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
UPPER LIMB FRACTURE
subjects affected / exposed	2 / 1093 (0.18%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
VASCULAR ACCESS COMPLICATION
subjects affected / exposed	20 / 1093 (1.83%)	13 / 1048 (1.24%)
occurrences causally related to treatment / all	0 / 24	0 / 15
deaths causally related to treatment / all	0 / 0	0 / 1
VASCULAR GRAFT COMPLICATION
subjects affected / exposed	3 / 1093 (0.27%)	3 / 1048 (0.29%)
occurrences causally related to treatment / all	0 / 3	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
VASCULAR GRAFT OCCLUSION
subjects affected / exposed	8 / 1093 (0.73%)	2 / 1048 (0.19%)
occurrences causally related to treatment / all	0 / 11	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
VASCULAR GRAFT THROMBOSIS
subjects affected / exposed	14 / 1093 (1.28%)	13 / 1048 (1.24%)
occurrences causally related to treatment / all	0 / 16	0 / 13
deaths causally related to treatment / all	0 / 0	0 / 0
VASCULAR PSEUDOANEURYSM
subjects affected / exposed	1 / 1093 (0.09%)	3 / 1048 (0.29%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
WOUND
subjects affected / exposed	1 / 1093 (0.09%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
WOUND HAEMATOMA
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
WRIST FRACTURE
subjects affected / exposed	2 / 1093 (0.18%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
VENOUS INJURY
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Congenital, familial and genetic disorders
Tracheo-oesophageal fistula
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac disorders
Myocardial infarction
subjects affected / exposed	16 / 1093 (1.46%)	9 / 1048 (0.86%)
occurrences causally related to treatment / all	0 / 16	0 / 9
deaths causally related to treatment / all	0 / 16	0 / 9
Acute coronary syndrome
subjects affected / exposed	5 / 1093 (0.46%)	13 / 1048 (1.24%)
occurrences causally related to treatment / all	0 / 5	0 / 15
deaths causally related to treatment / all	0 / 0	0 / 0
Acute myocardial infarction
subjects affected / exposed	42 / 1093 (3.84%)	50 / 1048 (4.77%)
occurrences causally related to treatment / all	0 / 46	0 / 59
deaths causally related to treatment / all	0 / 6	0 / 5
Angina pectoris
subjects affected / exposed	9 / 1093 (0.82%)	12 / 1048 (1.15%)
occurrences causally related to treatment / all	0 / 11	0 / 14
deaths causally related to treatment / all	0 / 0	0 / 0
Unstable Angina
subjects affected / exposed	3 / 1093 (0.27%)	9 / 1048 (0.86%)
occurrences causally related to treatment / all	0 / 3	0 / 9
deaths causally related to treatment / all	0 / 0	0 / 0
Arrhythmia
subjects affected / exposed	2 / 1093 (0.18%)	3 / 1048 (0.29%)
occurrences causally related to treatment / all	0 / 3	0 / 3
deaths causally related to treatment / all	0 / 1	0 / 0
Atrial fibrillation
subjects affected / exposed	13 / 1093 (1.19%)	21 / 1048 (2.00%)
occurrences causally related to treatment / all	0 / 19	0 / 26
deaths causally related to treatment / all	0 / 2	0 / 3
Bradycardia
subjects affected / exposed	8 / 1093 (0.73%)	4 / 1048 (0.38%)
occurrences causally related to treatment / all	0 / 9	0 / 4
deaths causally related to treatment / all	0 / 1	0 / 1
Cardiac arrest
subjects affected / exposed	21 / 1093 (1.92%)	26 / 1048 (2.48%)
occurrences causally related to treatment / all	0 / 22	0 / 26
deaths causally related to treatment / all	0 / 17	0 / 19
Cardiac disorder
subjects affected / exposed	6 / 1093 (0.55%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 6	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Cardiac failure
subjects affected / exposed	7 / 1093 (0.64%)	9 / 1048 (0.86%)
occurrences causally related to treatment / all	0 / 7	0 / 9
deaths causally related to treatment / all	0 / 2	0 / 4
Acute Cardiac failure
subjects affected / exposed	1 / 1093 (0.09%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 1
Congestive Cardiac failure
subjects affected / exposed	6 / 1093 (0.55%)	7 / 1048 (0.67%)
occurrences causally related to treatment / all	0 / 6	0 / 7
deaths causally related to treatment / all	0 / 2	0 / 5
Cardio-respiratory arrest
subjects affected / exposed	2 / 1093 (0.18%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 2	0 / 1
Coronary artery disease
subjects affected / exposed	4 / 1093 (0.37%)	6 / 1048 (0.57%)
occurrences causally related to treatment / all	0 / 4	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Coronary artery stenosis
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Arteriosclerosis coronary artery
subjects affected / exposed	0 / 1093 (0.00%)	2 / 1048 (0.19%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 2
Atrial flutter
subjects affected / exposed	2 / 1093 (0.18%)	4 / 1048 (0.38%)
occurrences causally related to treatment / all	0 / 2	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Atrioventricular block
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Complete Atrioventricular block
subjects affected / exposed	6 / 1093 (0.55%)	4 / 1048 (0.38%)
occurrences causally related to treatment / all	0 / 6	0 / 5
deaths causally related to treatment / all	0 / 1	0 / 0
Atrioventricular block second degree
subjects affected / exposed	1 / 1093 (0.09%)	2 / 1048 (0.19%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac failure chronic
subjects affected / exposed	0 / 1093 (0.00%)	2 / 1048 (0.19%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 2
Cardiac tamponade
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (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	6 / 1093 (0.55%)	7 / 1048 (0.67%)
occurrences causally related to treatment / all	0 / 6	0 / 7
deaths causally related to treatment / all	0 / 2	0 / 5
Cardiogenic shock
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Cardiomegaly
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Hypertensive heart disease
subjects affected / exposed	1 / 1093 (0.09%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 0
Intracardiac mass
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Left ventricular dysfunction
subjects affected / exposed	1 / 1093 (0.09%)	3 / 1048 (0.29%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 1	0 / 2
Left ventricular failure
subjects affected / exposed	0 / 1093 (0.00%)	3 / 1048 (0.29%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 3
Left ventricular hypertrophy
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Mitral valve disease
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Myocardial ischaemia
subjects affected / exposed	5 / 1093 (0.46%)	5 / 1048 (0.48%)
occurrences causally related to treatment / all	0 / 5	0 / 5
deaths causally related to treatment / all	0 / 4	0 / 3
Myocarditis
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Palpitations
subjects affected / exposed	5 / 1093 (0.46%)	2 / 1048 (0.19%)
occurrences causally related to treatment / all	0 / 5	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Nodal arrhythmia
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pericardial effusion
subjects affected / exposed	3 / 1093 (0.27%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pericardial haemorrhage
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Pericarditis
subjects affected / exposed	4 / 1093 (0.37%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 4	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 0
Pulseless electrical activity
subjects affected / exposed	1 / 1093 (0.09%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Supraventricular tachycardia
subjects affected / exposed	2 / 1093 (0.18%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Tachycardia
subjects affected / exposed	6 / 1093 (0.55%)	4 / 1048 (0.38%)
occurrences causally related to treatment / all	0 / 7	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Trifascicular block
subjects affected / exposed	1 / 1093 (0.09%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Ventricular tachycardia
subjects affected / exposed	1 / 1093 (0.09%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Ventricular fibrillation
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Nervous system disorders
AMNESIA
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (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	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
BALANCE DISORDER
subjects affected / exposed	2 / 1093 (0.18%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
BALLISMUS
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
BASAL GANGLIA STROKE
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
BRAIN INJURY
subjects affected / exposed	3 / 1093 (0.27%)	3 / 1048 (0.29%)
occurrences causally related to treatment / all	0 / 3	0 / 3
deaths causally related to treatment / all	0 / 3	0 / 3
CAROTID ARTERY STENOSIS
subjects affected / exposed	1 / 1093 (0.09%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
CENTRAL NERVOUS SYSTEM LESION
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
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	1 / 1093 (0.09%)	5 / 1048 (0.48%)
occurrences causally related to treatment / all	0 / 1	0 / 5
deaths causally related to treatment / all	0 / 1	0 / 2
CEREBRAL INFARCTION
subjects affected / exposed	4 / 1093 (0.37%)	4 / 1048 (0.38%)
occurrences causally related to treatment / all	0 / 5	0 / 4
deaths causally related to treatment / all	0 / 2	0 / 1
CEREBRAL ISCHAEMIA
subjects affected / exposed	1 / 1093 (0.09%)	1 / 1048 (0.10%)
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	12 / 1093 (1.10%)	16 / 1048 (1.53%)
occurrences causally related to treatment / all	0 / 45	0 / 18
deaths causally related to treatment / all	0 / 8	0 / 5
CEREBROVASCULAR DISORDER
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
COMA URAEMIC
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
CONSCIOUSNESS FLUCTUATING
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
CONVULSION
subjects affected / exposed	6 / 1093 (0.55%)	4 / 1048 (0.38%)
occurrences causally related to treatment / all	0 / 7	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
DEPRESSED LEVEL OF CONSCIOUSNESS
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
DIZZINESS
subjects affected / exposed	8 / 1093 (0.73%)	4 / 1048 (0.38%)
occurrences causally related to treatment / all	0 / 8	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
DYSARTHRIA
subjects affected / exposed	1 / 1093 (0.09%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
DYSKINESIA
subjects affected / exposed	1 / 1093 (0.09%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
EMBOLIC CEREBRAL INFARCTION
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
ENCEPHALITIS
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
ENCEPHALITIS AUTOIMMUNE
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
ENCEPHALOPATHY
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
EPILEPSY
subjects affected / exposed	2 / 1093 (0.18%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
GRAND MAL CONVULSION
subjects affected / exposed	2 / 1093 (0.18%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
GUILLAIN-BARRE SYNDROME
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
HAEMORRHAGE INTRACRANIAL
subjects affected / exposed	1 / 1093 (0.09%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 1
HAEMORRHAGIC CEREBRAL INFARCTION
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
HAEMORRHAGIC STROKE
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
HEADACHE
subjects affected / exposed	6 / 1093 (0.55%)	5 / 1048 (0.48%)
occurrences causally related to treatment / all	0 / 6	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
HEMIPARESIS
subjects affected / exposed	4 / 1093 (0.37%)	5 / 1048 (0.48%)
occurrences causally related to treatment / all	0 / 4	0 / 5
deaths causally related to treatment / all	0 / 1	0 / 0
HEPATIC ENCEPHALOPATHY
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
HYPERGLYCAEMIC SEIZURE
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
HYPERTENSIVE ENCEPHALOPATHY
subjects affected / exposed	1 / 1093 (0.09%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
HYPOAESTHESIA
subjects affected / exposed	1 / 1093 (0.09%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
HYPOGLYCAEMIC SEIZURE
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
INTRAVENTRICULAR HAEMORRHAGE
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
ISCHAEMIC STROKE
subjects affected / exposed	2 / 1093 (0.18%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
LACUNAR INFARCTION
subjects affected / exposed	2 / 1093 (0.18%)	3 / 1048 (0.29%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
LETHARGY
subjects affected / exposed	5 / 1093 (0.46%)	2 / 1048 (0.19%)
occurrences causally related to treatment / all	0 / 5	0 / 3
deaths causally related to treatment / all	0 / 1	0 / 0
LOSS OF CONSCIOUSNESS
subjects affected / exposed	3 / 1093 (0.27%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
MEMORY IMPAIRMENT
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
MERALGIA PARAESTHETICA
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
MIGRAINE
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (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 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
MYOCLONUS
subjects affected / exposed	2 / 1093 (0.18%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
MYXOEDEMA COMA
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
NERVOUS SYSTEM DISORDER
subjects affected / exposed	1 / 1093 (0.09%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
NEUROLOGICAL SYMPTOM
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
NEUROPATHY PERIPHERAL
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
PERONEAL NERVE PALSY
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
PRESYNCOPE
subjects affected / exposed	7 / 1093 (0.64%)	4 / 1048 (0.38%)
occurrences causally related to treatment / all	0 / 7	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
SEIZURE LIKE PHENOMENA
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
SENSORY LOSS
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
SOMNOLENCE
subjects affected / exposed	0 / 1093 (0.00%)	3 / 1048 (0.29%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
SPEECH DISORDER
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
SPINAL CORD COMPRESSION
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
SYNCOPE
subjects affected / exposed	6 / 1093 (0.55%)	4 / 1048 (0.38%)
occurrences causally related to treatment / all	0 / 6	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
TRANSIENT ISCHAEMIC ATTACK
subjects affected / exposed	11 / 1093 (1.01%)	11 / 1048 (1.05%)
occurrences causally related to treatment / all	0 / 12	0 / 11
deaths causally related to treatment / all	0 / 0	0 / 0
TREMOR
subjects affected / exposed	1 / 1093 (0.09%)	2 / 1048 (0.19%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
UNRESPONSIVE TO STIMULI
subjects affected / exposed	7 / 1093 (0.64%)	4 / 1048 (0.38%)
occurrences causally related to treatment / all	0 / 7	0 / 4
deaths causally related to treatment / all	0 / 1	0 / 0
VASCULAR DEMENTIA
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
VIITH NERVE PARALYSIS
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (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	8 / 1093 (0.73%)	13 / 1048 (1.24%)
occurrences causally related to treatment / all	0 / 8	0 / 15
deaths causally related to treatment / all	0 / 0	0 / 1
Lymphadenectomy
subjects affected / exposed	2 / 1093 (0.18%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Nephrogenic anaemia
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pancytopenia
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (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	2 / 1093 (0.18%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Ear and labyrinth disorders
Vertigo
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Eye disorders
Amaurosis fugax
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cataract
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Eye pain
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hyphaema
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Retinal haemorrhage
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Retinal vascular occlusion
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Retinal artery occlusion
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Visual impairment
subjects affected / exposed	1 / 1093 (0.09%)	11 / 1048 (1.05%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Vitreous haemorrhage
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal disorders
Abdominal adhesions
subjects affected / exposed	0 / 1093 (0.00%)	2 / 1048 (0.19%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 1
Abdominal pain
subjects affected / exposed	23 / 1093 (2.10%)	14 / 1048 (1.34%)
occurrences causally related to treatment / all	0 / 28	0 / 15
deaths causally related to treatment / all	0 / 4	0 / 1
Abdominal distension
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Abdominal hernia
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Abdominal pain lower
subjects affected / exposed	0 / 1093 (0.00%)	4 / 1048 (0.38%)
occurrences causally related to treatment / all	0 / 0	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Abdominal pain upper
subjects affected / exposed	2 / 1093 (0.18%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Abdominal strangulated hernia
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Abdominal wall haematoma
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Anal fissure
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (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	0 / 1093 (0.00%)	2 / 1048 (0.19%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 1
Bowel movement irregularity
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Coeliac disease
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Colitis
subjects affected / exposed	2 / 1093 (0.18%)	3 / 1048 (0.29%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Colitis ischaemic
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Colitis ulcerative
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
colonic stenosis
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Constipation
subjects affected / exposed	6 / 1093 (0.55%)	2 / 1048 (0.19%)
occurrences causally related to treatment / all	0 / 7	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Diabetic gastroparesis
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Diarrhoea
subjects affected / exposed	11 / 1093 (1.01%)	13 / 1048 (1.24%)
occurrences causally related to treatment / all	0 / 12	0 / 13
deaths causally related to treatment / all	0 / 0	0 / 0
Diarrhoea haemorrhagic
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Diverticulum
subjects affected / exposed	2 / 1093 (0.18%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Duodenal ulcer perforation
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Duodenal ulcer haemorrhage
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Duodenitis
subjects affected / exposed	2 / 1093 (0.18%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Dysphagia
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Dyspepsia
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Faeces discoloured
subjects affected / exposed	0 / 1093 (0.00%)	2 / 1048 (0.19%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
faecal incontinence
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastric antral vascular ectasia
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastric haemorrhage
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastric disorder
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gastric ulcer
subjects affected / exposed	1 / 1093 (0.09%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastric perforation
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastritis
subjects affected / exposed	3 / 1093 (0.27%)	4 / 1048 (0.38%)
occurrences causally related to treatment / all	0 / 3	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal haemorrhage
subjects affected / exposed	3 / 1093 (0.27%)	9 / 1048 (0.86%)
occurrences causally related to treatment / all	0 / 3	0 / 9
deaths causally related to treatment / all	0 / 1	0 / 1
Gastrointestinal motility disorder
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal hypermotility
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal angiodysplasia
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal pain
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
gastrooesophagitis
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Gastrooesophageal reflux disease
subjects affected / exposed	2 / 1093 (0.18%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Haematemesis
subjects affected / exposed	5 / 1093 (0.46%)	6 / 1048 (0.57%)
occurrences causally related to treatment / all	0 / 5	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 1
Haemorrhoidal haemorrhage
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Haemorrhoids
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
ileitis
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Impaired gastric emptying
subjects affected / exposed	6 / 1093 (0.55%)	3 / 1048 (0.29%)
occurrences causally related to treatment / all	0 / 6	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Intestinal fistula
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Inguinal hernia
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Intestinal ischaemia
subjects affected / exposed	7 / 1093 (0.64%)	8 / 1048 (0.76%)
occurrences causally related to treatment / all	0 / 7	0 / 8
deaths causally related to treatment / all	0 / 4	0 / 5
Intestinal obstruction
subjects affected / exposed	3 / 1093 (0.27%)	5 / 1048 (0.48%)
occurrences causally related to treatment / all	0 / 3	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 3
Irritable bowel syndrome
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Intestinal perforation
subjects affected / exposed	1 / 1093 (0.09%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 1
Large intestine perforation
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Malabsorption
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (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	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Melaena
subjects affected / exposed	7 / 1093 (0.64%)	7 / 1048 (0.67%)
occurrences causally related to treatment / all	0 / 7	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
Megacolon
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Mouth ulceration
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Nausea
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Oesophageal rupture
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (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 / 1093 (0.09%)	2 / 1048 (0.19%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Pancreatic cyst
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pancreatitis
subjects affected / exposed	3 / 1093 (0.27%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 0
Pancreatic mass
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Pancreatitis chronic
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pancreatitis acute
subjects affected / exposed	1 / 1093 (0.09%)	3 / 1048 (0.29%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 1
Proctitis
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Peptic ulcer
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Rectal haemorrhage
subjects affected / exposed	7 / 1093 (0.64%)	11 / 1048 (1.05%)
occurrences causally related to treatment / all	0 / 7	0 / 11
deaths causally related to treatment / all	0 / 1	0 / 2
Retching
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Retroperitoneal fibrosis
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Small intestinal obstruction
subjects affected / exposed	6 / 1093 (0.55%)	4 / 1048 (0.38%)
occurrences causally related to treatment / all	0 / 6	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 1
Steatorrhoea
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Upper gastrointestinal haemorrhage
subjects affected / exposed	3 / 1093 (0.27%)	10 / 1048 (0.95%)
occurrences causally related to treatment / all	0 / 5	0 / 10
deaths causally related to treatment / all	0 / 0	0 / 1
Umbilical hernia, obstructive
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Varices oesophageal
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Volvulus
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Vomiting
subjects affected / exposed	26 / 1093 (2.38%)	18 / 1048 (1.72%)
occurrences causally related to treatment / all	0 / 30	0 / 20
deaths causally related to treatment / all	0 / 3	0 / 0
Skin and subcutaneous tissue disorders
COLD SWEAT
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
DECUBITUS ULCER
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
DIABETIC FOOT
subjects affected / exposed	7 / 1093 (0.64%)	4 / 1048 (0.38%)
occurrences causally related to treatment / all	0 / 7	0 / 4
deaths causally related to treatment / all	0 / 1	0 / 0
DIABETIC ULCER
subjects affected / exposed	1 / 1093 (0.09%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
DRY GANGRENE
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
HYPERHIDROSIS
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
RASH
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
RASH MACULO-PAPULAR
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (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 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
SKIN REACTION
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
SKIN SWELLING
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
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	11 / 1093 (1.01%)	6 / 1048 (0.57%)
occurrences causally related to treatment / all	0 / 11	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Renal and urinary disorders
AZOTAEMIA
subjects affected / exposed	0 / 1093 (0.00%)	2 / 1048 (0.19%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
BLADDER OUTLET OBSTRUCTION
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
DYSURIA
subjects affected / exposed	2 / 1093 (0.18%)	0 / 1048 (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 / 1093 (0.91%)	10 / 1048 (0.95%)
occurrences causally related to treatment / all	0 / 11	0 / 13
deaths causally related to treatment / all	0 / 0	0 / 0
MICTURITION URGENCY
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
NEPHROLITHIASIS
subjects affected / exposed	3 / 1093 (0.27%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
NEPHROTIC SYNDROME
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
OBSTRUCTIVE UROPATHY
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (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	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
RENAL CYST HAEMORRHAGE
subjects affected / exposed	1 / 1093 (0.09%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
RENAL FAILURE
subjects affected / exposed	3 / 1093 (0.27%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 2	0 / 1
ACUTE RENAL FAILURE
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
CHRONIC RENAL FAILURE
subjects affected / exposed	8 / 1093 (0.73%)	27 / 1048 (2.58%)
occurrences causally related to treatment / all	0 / 8	0 / 27
deaths causally related to treatment / all	0 / 7	0 / 21
RENAL IMPAIRMENT
subjects affected / exposed	1 / 1093 (0.09%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 0
RENAL MASS
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
RENAL PAIN
subjects affected / exposed	1 / 1093 (0.09%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
URINARY RETENTION
subjects affected / exposed	4 / 1093 (0.37%)	3 / 1048 (0.29%)
occurrences causally related to treatment / all	0 / 5	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
URINARY TRACT DISORDER
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
URINARY TRACT OBSTRUCTION
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
PRIAPISM
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
TESTICULAR PAIN
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Endocrine disorders
Hyperparathyroidism tertiary
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (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	1 / 1093 (0.09%)	7 / 1048 (0.67%)
occurrences causally related to treatment / all	0 / 1	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
ARTHRITIS
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
ARTHROPATHY
subjects affected / exposed	1 / 1093 (0.09%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
BACK PAIN
subjects affected / exposed	3 / 1093 (0.27%)	6 / 1048 (0.57%)
occurrences causally related to treatment / all	0 / 4	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
BURSITIS
subjects affected / exposed	0 / 1093 (0.00%)	2 / 1048 (0.19%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 1
COCCYDYNIA
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
COSTOCHONDRITIS
subjects affected / exposed	1 / 1093 (0.09%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
FLANK PAIN
subjects affected / exposed	2 / 1093 (0.18%)	2 / 1048 (0.19%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
FRACTURE NONUNION
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
GROIN PAIN
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
HAEMARTHROSIS
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
JOINT SWELLING
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
MOBILITY DECREASED
subjects affected / exposed	4 / 1093 (0.37%)	4 / 1048 (0.38%)
occurrences causally related to treatment / all	0 / 4	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 1
MUSCLE TWITCHING
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
MUSCULAR WEAKNESS
subjects affected / exposed	0 / 1093 (0.00%)	5 / 1048 (0.48%)
occurrences causally related to treatment / all	0 / 0	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 2
MUSCULOSKELETAL CHEST PAIN
subjects affected / exposed	6 / 1093 (0.55%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 6	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
MUSCULOSKELETAL PAIN
subjects affected / exposed	2 / 1093 (0.18%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
MUSCULOSKELETAL STIFFNESS
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
MYOPATHY
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
NECK PAIN
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
NEUROPATHIC ARTHROPATHY
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
OSTEOARTHRITIS
subjects affected / exposed	1 / 1093 (0.09%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
OSTEONECROSIS
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
PAIN IN EXTREMITY
subjects affected / exposed	4 / 1093 (0.37%)	5 / 1048 (0.48%)
occurrences causally related to treatment / all	0 / 5	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
POLYMYALGIA RHEUMATICA
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
RHEUMATOID ARTHRITIS
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
SPINAL OSTEOARTHRITIS
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
SYSTEMIC LUPUS ERYTHEMATOSUS
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (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 SEPSIS
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
ABSCESS
subjects affected / exposed	3 / 1093 (0.27%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
ABSCESS LIMB
subjects affected / exposed	2 / 1093 (0.18%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
ANAL ABSCESS
subjects affected / exposed	0 / 1093 (0.00%)	4 / 1048 (0.38%)
occurrences causally related to treatment / all	0 / 0	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
APPENDICITIS
subjects affected / exposed	2 / 1093 (0.18%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
APPENDICITIS PERFORATED
subjects affected / exposed	2 / 1093 (0.18%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
ARTERIOVENOUS FISTULA SITE INFECTION
subjects affected / exposed	8 / 1093 (0.73%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 8	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
ARTERIOVENOUS GRAFT SITE INFECTION
subjects affected / exposed	2 / 1093 (0.18%)	3 / 1048 (0.29%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
ARTHRITIS BACTERIAL
subjects affected / exposed	4 / 1093 (0.37%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 4	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
ARTHRITIS INFECTIVE
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
BACTERAEMIA
subjects affected / exposed	4 / 1093 (0.37%)	4 / 1048 (0.38%)
occurrences causally related to treatment / all	0 / 4	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
BACTERIAL INFECTION
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (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	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
BILIARY SEPSIS
subjects affected / exposed	1 / 1093 (0.09%)	6 / 1048 (0.57%)
occurrences causally related to treatment / all	0 / 1	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
BRONCHIOLITIS
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
BRONCHITIS
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
BRONCHOPNEUMONIA
subjects affected / exposed	2 / 1093 (0.18%)	4 / 1048 (0.38%)
occurrences causally related to treatment / all	0 / 2	0 / 4
deaths causally related to treatment / all	0 / 2	0 / 2
CAMPYLOBACTER GASTROENTERITIS
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
CAMPYLOBACTER INFECTION
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
CAMPYLOBACTER SEPSIS
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
CARDIAC VALVE VEGETATION
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
CATHETER SITE INFECTION
subjects affected / exposed	1 / 1093 (0.09%)	3 / 1048 (0.29%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
CELLULITIS
subjects affected / exposed	18 / 1093 (1.65%)	24 / 1048 (2.29%)
occurrences causally related to treatment / all	0 / 18	0 / 32
deaths causally related to treatment / all	0 / 0	0 / 2
CELLULITIS GANGRENOUS
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
CENTRAL NERVOUS SYSTEM INFECTION
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (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	2 / 1093 (0.18%)	2 / 1048 (0.19%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
CLOSTRIDIUM DIFFICILE COLITIS
subjects affected / exposed	1 / 1093 (0.09%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
CYSTITIS
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (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	23 / 1093 (2.10%)	20 / 1048 (1.91%)
occurrences causally related to treatment / all	0 / 25	0 / 23
deaths causally related to treatment / all	0 / 0	0 / 0
DEVICE RELATED SEPSIS
subjects affected / exposed	25 / 1093 (2.29%)	15 / 1048 (1.43%)
occurrences causally related to treatment / all	0 / 27	0 / 18
deaths causally related to treatment / all	0 / 1	0 / 2
DIABETIC FOOT INFECTION
subjects affected / exposed	0 / 1093 (0.00%)	3 / 1048 (0.29%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
DIVERTICULITIS
subjects affected / exposed	3 / 1093 (0.27%)	4 / 1048 (0.38%)
occurrences causally related to treatment / all	0 / 3	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
DIARRHOEA INFECTIOUS
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
EMPHYSEMATOUS PYELONEPHRITIS
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (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 / 1093 (0.09%)	0 / 1048 (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 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
ENDOCARDITIS1
subjects affected / exposed	1 / 1093 (0.09%)	2 / 1048 (0.19%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 1
ENTEROBACTER SEPSIS
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
ENTEROCOCCAL INFECTION
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
ENTEROCOCCAL SEPSIS
subjects affected / exposed	2 / 1093 (0.18%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
ESCHERICHIA BACTERAEMIA
subjects affected / exposed	6 / 1093 (0.55%)	2 / 1048 (0.19%)
occurrences causally related to treatment / all	0 / 6	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
ESCHERICHIA INFECTION
subjects affected / exposed	1 / 1093 (0.09%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
ESCHERICHIA URINARY TRACT INFECTION
subjects affected / exposed	3 / 1093 (0.27%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
GALLBLADDER ABSCESS
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
GANGRENE
subjects affected / exposed	10 / 1093 (0.91%)	3 / 1048 (0.29%)
occurrences causally related to treatment / all	0 / 11	0 / 3
deaths causally related to treatment / all	0 / 3	0 / 0
GASTROENTERITIS
subjects affected / exposed	11 / 1093 (1.01%)	11 / 1048 (1.05%)
occurrences causally related to treatment / all	0 / 11	0 / 11
deaths causally related to treatment / all	0 / 0	0 / 0
GASTROENTERITIS VIRAL
subjects affected / exposed	4 / 1093 (0.37%)	6 / 1048 (0.57%)
occurrences causally related to treatment / all	0 / 4	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
GRAFT INFECTION
subjects affected / exposed	3 / 1093 (0.27%)	2 / 1048 (0.19%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
GROIN ABSCESS
subjects affected / exposed	2 / 1093 (0.18%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
H1N1 INFLUENZA
subjects affected / exposed	0 / 1093 (0.00%)	2 / 1048 (0.19%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
HAEMATOMA INFECTION
subjects affected / exposed	1 / 1093 (0.09%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
INFECTED SKIN ULCER
subjects affected / exposed	6 / 1093 (0.55%)	6 / 1048 (0.57%)
occurrences causally related to treatment / all	0 / 7	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
INFECTION
subjects affected / exposed	11 / 1093 (1.01%)	8 / 1048 (0.76%)
occurrences causally related to treatment / all	1 / 12	0 / 9
deaths causally related to treatment / all	0 / 2	0 / 0
INFECTIVE EXACERBATION OF CHRONIC OBSTRUCTIVE AIRWAYS DISEASE
subjects affected / exposed	4 / 1093 (0.37%)	11 / 1048 (1.05%)
occurrences causally related to treatment / all	0 / 5	0 / 22
deaths causally related to treatment / all	0 / 0	0 / 4
INFLUENZA
subjects affected / exposed	8 / 1093 (0.73%)	5 / 1048 (0.48%)
occurrences causally related to treatment / all	0 / 8	0 / 5
deaths causally related to treatment / all	0 / 2	0 / 0
INTERVERTEBRAL DISCITIS
subjects affected / exposed	4 / 1093 (0.37%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 4	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 1
KLEBSIELLA SEPSIS
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
LIVER ABSCESS
subjects affected / exposed	2 / 1093 (0.18%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
LOBAR PNEUMONIA
subjects affected / exposed	1 / 1093 (0.09%)	5 / 1048 (0.48%)
occurrences causally related to treatment / all	0 / 1	0 / 5
deaths causally related to treatment / all	0 / 1	0 / 1
LOCALISED INFECTION
subjects affected / exposed	10 / 1093 (0.91%)	12 / 1048 (1.15%)
occurrences causally related to treatment / all	0 / 10	0 / 12
deaths causally related to treatment / all	0 / 1	0 / 0
LOWER RESPIRATORY TRACT INFECTION
subjects affected / exposed	77 / 1093 (7.04%)	94 / 1048 (8.97%)
occurrences causally related to treatment / all	0 / 92	0 / 113
deaths causally related to treatment / all	0 / 4	0 / 11
INJECTION SITE INFECTION
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
INFECTIVE EXACERBATION OF BRONCHIECTASIS
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
INFECTIVE ANEURYSM
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
INFECTIOUS PLEURAL EFFUSION
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
INFECTED FISTULA
subjects affected / exposed	4 / 1093 (0.37%)	6 / 1048 (0.57%)
occurrences causally related to treatment / all	0 / 4	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
HERPES ZOSTER
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
LOWER RESPIRATORY TRACT INFECTION VIRAL
subjects affected / exposed	2 / 1093 (0.18%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
LUNG INFECTION
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
LUNG INFECTION PSEUDOMONAL
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
METAPNEUMOVIRUS INFECTION
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
NEUTROPENIC SEPSIS
subjects affected / exposed	2 / 1093 (0.18%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 4	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
OESOPHAGEAL CANDIDIASIS
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
ORAL CANDIDIASIS
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
OSTEOMYELITIS
subjects affected / exposed	8 / 1093 (0.73%)	17 / 1048 (1.62%)
occurrences causally related to treatment / all	0 / 8	0 / 25
deaths causally related to treatment / all	0 / 0	0 / 4
OTITIS EXTERNA
subjects affected / exposed	2 / 1093 (0.18%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 0
PAROTITIS
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
PERIHEPATIC ABSCESS
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
PERITONITIS
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
PILONIDAL CYST
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (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	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
PNEUMOCYSTIS JIROVECI PNEUMONIA
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (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	72 / 1093 (6.59%)	70 / 1048 (6.68%)
occurrences causally related to treatment / all	0 / 83	0 / 85
deaths causally related to treatment / all	0 / 13	0 / 9
PNEUMONIA BACTERIAL
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
PNEUMONIA INFLUENZAL
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
PNEUMONIA KLEBSIELLA
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
PNEUMONIA VIRAL
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
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	3 / 1093 (0.27%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
POST PROCEDURAL PNEUMONIA
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
POST PROCEDURAL SEPSIS
subjects affected / exposed	1 / 1093 (0.09%)	3 / 1048 (0.29%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 2
POSTOPERATIVE WOUND INFECTION
subjects affected / exposed	4 / 1093 (0.37%)	5 / 1048 (0.48%)
occurrences causally related to treatment / all	0 / 4	0 / 6
deaths causally related to treatment / all	0 / 1	0 / 1
PSEUDOMEMBRANOUS COLITIS
subjects affected / exposed	2 / 1093 (0.18%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
PSOAS ABSCESS
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
PULMONARY SEPSIS
subjects affected / exposed	8 / 1093 (0.73%)	10 / 1048 (0.95%)
occurrences causally related to treatment / all	0 / 9	0 / 10
deaths causally related to treatment / all	0 / 3	0 / 1
PULMONARY TUBERCULOSIS
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
PYELONEPHRITIS
subjects affected / exposed	4 / 1093 (0.37%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 5	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
PYONEPHROSIS
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
RENAL ABSCESS
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
RENAL CYST INFECTION
subjects affected / exposed	2 / 1093 (0.18%)	2 / 1048 (0.19%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
RESPIRATORY SYNCYTIAL VIRUS INFECTION
subjects affected / exposed	2 / 1093 (0.18%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
RESPIRATORY TRACT INFECTION VIRAL
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
RESPIRATORY TRACT INFECTION
subjects affected / exposed	4 / 1093 (0.37%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 4	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
RHINOVIRUS INFECTION
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (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	60 / 1093 (5.49%)	57 / 1048 (5.44%)
occurrences causally related to treatment / all	0 / 71	0 / 61
deaths causally related to treatment / all	0 / 16	0 / 13
SEPTIC ARTHRITIS STAPHYLOCOCCAL
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
SEPTIC EMBOLUS
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
SEPTIC ENCEPHALOPATHY
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
SEPTIC NECROSIS
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
SEPTIC SHOCK
subjects affected / exposed	2 / 1093 (0.18%)	5 / 1048 (0.48%)
occurrences causally related to treatment / all	0 / 2	0 / 5
deaths causally related to treatment / all	0 / 1	0 / 3
SOFT TISSUE INFECTION
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
SPLENIC ABSCESS
subjects affected / exposed	0 / 1093 (0.00%)	2 / 1048 (0.19%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 2
STAPHYLOCOCCAL BACTERAEMIA
subjects affected / exposed	8 / 1093 (0.73%)	3 / 1048 (0.29%)
occurrences causally related to treatment / all	0 / 9	0 / 3
deaths causally related to treatment / all	0 / 1	0 / 1
STAPHYLOCOCCAL INFECTION
subjects affected / exposed	2 / 1093 (0.18%)	3 / 1048 (0.29%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
STAPHYLOCOCCAL SEPSIS
subjects affected / exposed	5 / 1093 (0.46%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	2 / 5	0 / 1
deaths causally related to treatment / all	2 / 2	0 / 0
STREPTOCOCCAL SEPSIS
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
SUBCUTANEOUS ABSCESS
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
TONSILLITIS
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
TOOTH ABSCESS
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (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	0 / 1093 (0.00%)	1 / 1048 (0.10%)
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	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
URETHRITIS
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
URINARY TRACT INFECTION
subjects affected / exposed	29 / 1093 (2.65%)	18 / 1048 (1.72%)
occurrences causally related to treatment / all	0 / 29	0 / 18
deaths causally related to treatment / all	0 / 2	0 / 0
UROSEPSIS
subjects affected / exposed	18 / 1093 (1.65%)	11 / 1048 (1.05%)
occurrences causally related to treatment / all	0 / 20	0 / 12
deaths causally related to treatment / all	0 / 2	0 / 1
URINARY TRACT INFECTION PSEUDOMONAL
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
VIRAL INFECTION
subjects affected / exposed	1 / 1093 (0.09%)	2 / 1048 (0.19%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
WOUND INFECTION
subjects affected / exposed	2 / 1093 (0.18%)	2 / 1048 (0.19%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Metabolism and nutrition disorders
FLUID OVERLOAD
subjects affected / exposed	41 / 1093 (3.75%)	63 / 1048 (6.01%)
occurrences causally related to treatment / all	0 / 51	0 / 79
deaths causally related to treatment / all	0 / 2	0 / 4
GOUT
subjects affected / exposed	1 / 1093 (0.09%)	2 / 1048 (0.19%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
HYPERCALCAEMIA
subjects affected / exposed	2 / 1093 (0.18%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
HYPERGLYCAEMIA
subjects affected / exposed	9 / 1093 (0.82%)	9 / 1048 (0.86%)
occurrences causally related to treatment / all	0 / 9	0 / 14
deaths causally related to treatment / all	0 / 0	0 / 0
HYPERKALAEMIA
subjects affected / exposed	29 / 1093 (2.65%)	28 / 1048 (2.67%)
occurrences causally related to treatment / all	0 / 35	0 / 36
deaths causally related to treatment / all	0 / 3	0 / 1
HYPOCALCAEMIA
subjects affected / exposed	1 / 1093 (0.09%)	2 / 1048 (0.19%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
HYPOGLYCAEMIA
subjects affected / exposed	10 / 1093 (0.91%)	20 / 1048 (1.91%)
occurrences causally related to treatment / all	0 / 11	0 / 25
deaths causally related to treatment / all	0 / 0	0 / 0
HYPONATRAEMIA
subjects affected / exposed	1 / 1093 (0.09%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
HYPOVOLAEMIA
subjects affected / exposed	1 / 1093 (0.09%)	2 / 1048 (0.19%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
MALNUTRITION
subjects affected / exposed	1 / 1093 (0.09%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
METABOLIC ACIDOSIS
subjects affected / exposed	1 / 1093 (0.09%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
TYPE 1 DIABETES MELLITUS
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
ACIDOSIS
subjects affected / exposed	1 / 1093 (0.09%)	0 / 1048 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
CACHEXIA
subjects affected / exposed	0 / 1093 (0.00%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
CALCIPHYLAXIS
subjects affected / exposed	3 / 1093 (0.27%)	3 / 1048 (0.29%)
occurrences causally related to treatment / all	0 / 3	0 / 4
deaths causally related to treatment / all	0 / 1	0 / 0
DECREASED APPETITE
subjects affected / exposed	1 / 1093 (0.09%)	2 / 1048 (0.19%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
DEHYDRATION
subjects affected / exposed	2 / 1093 (0.18%)	2 / 1048 (0.19%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
DIABETES MELLITUS
subjects affected / exposed	2 / 1093 (0.18%)	3 / 1048 (0.29%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 2	0 / 2
INADEQUATE CONTROL DIABETES MELLITUS
subjects affected / exposed	1 / 1093 (0.09%)	5 / 1048 (0.48%)
occurrences causally related to treatment / all	0 / 1	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
DIABETIC KETOACIDOSIS
subjects affected / exposed	9 / 1093 (0.82%)	3 / 1048 (0.29%)
occurrences causally related to treatment / all	0 / 13	0 / 8
deaths causally related to treatment / all	0 / 2	0 / 1
ELECTROLYTE IMBALANCE
subjects affected / exposed	1 / 1093 (0.09%)	1 / 1048 (0.10%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 0%

Non-serious adverse events	Proactive IV Iron	Reactive IV Iron
Total subjects affected by non serious adverse events
subjects affected / exposed	0 / 1093 (0.00%)	0 / 1048 (0.00%)

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Were there any global substantial amendments to the protocol? No

Were there any global interruptions to the trial? No

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

None reported

http://www.ncbi.nlm.nih.gov/pubmed/30641026

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UK Multicentre Open-label Randomised Controlled Trial Of IV Iron Therapy In Incident Haemodialysis Patients

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Clinical Trial Results: UK Multicentre Open-label Randomised Controlled Trial Of IV Iron Therapy In Incident Haemodialysis Patients

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Primary: Time to first event

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Substantial protocol amendments (globally)

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Clinical Trial Results:
UK Multicentre Open-label Randomised Controlled Trial Of IV Iron Therapy In Incident Haemodialysis Patients