Flag of the European Union

EU Clinical Trials Register

Help

Clinical trials

The European Union Clinical Trials Register allows you to search for protocol and results information on:

interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC

clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
Clinical Trials Information System (CTIS).

The EU Clinical Trials Register currently displays 43851 clinical trials with a EudraCT protocol, of which 7283 are clinical trials conducted with subjects less than 18 years old. The register also displays information on 18700 older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).

Examples: Cancer AND drug name. Pneumonia AND sponsor name.
How to search [pdf]

Advanced Search:

Select Country:	Select Age Range:
Select Trial Status:	Select Trial Phase:
Select Gender:
Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
Clear advanced search filters

< Back to search results

Clinical Trial Results:
A Randomised, Double-Blind, Placebo-Controlled, International, Multicentre, Phase III Study to Investigate the Efficacy and Safety of Ticagrelor and ASA Compared with ASA in the Prevention of Stroke and Death in Patients with Acute Ischaemic Stroke or Transient Ischaemic Attack

Summary
EudraCT number	2016-004232-37
Trial protocol	SE CZ HU BG FR DE ES BE PL SK IT RO
Global end of trial date	13 Dec 2019

Results information
Results version number	v1(current)
This version publication date	04 Dec 2020
First version publication date	04 Dec 2020
Other versions

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

Collapse all Expand all

Trial information

Top of page

Sponsor protocol code

D5134C00003

ISRCTN number

-

US NCT number

NCT03354429

WHO universal trial number (UTN)

-

Sponsor organisation name

AstraZeneca AB

Sponsor organisation address

Södertälje, Södertälje, Sweden, SE 151 85

Public contact

Information Center, AstraZeneca AB, 1 877-240-9479, Information.Center@astrazeneca.com

Scientific contact

Information Center, AstraZeneca AB, 1 877-240-9479, Information.Center@astrazeneca.com

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

No

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

No

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

No

Analysis stage

Final

Date of interim/final analysis

16 Jan 2020

Is this the analysis of the primary completion data?

Yes

Primary completion date

13 Dec 2019

Global end of trial reached?

Yes

Global end of trial date

13 Dec 2019

Was the trial ended prematurely?

No

Main objective of the trial

To demonstrate superior efficacy of ticagrelor and ASA compared with placebo and ASA in patients with acute ischaemic stroke (AIS) or TIA in the prevention of the composite of stroke and death at 30 days

Protection of trial subjects

Patients treated with aspirin as part of standard of care. An independent data monitoring committee was responsible for safeguarding the interests of the patients by assessing the benefit/risk profile of the intervention during the study, and for reviewing the overall conduct of the study

Background therapy

Aspirin as part of standard of care. Loading dose of 300-325 mg day 1, followed by 75-100 mg once daily

Evidence for comparator

-

Actual start date of recruitment

22 Jan 2018

Long term follow-up planned

No

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

Argentina: 98

Country: Number of subjects enrolled

Australia: 54

Country: Number of subjects enrolled

Belgium: 162

Country: Number of subjects enrolled

Brazil: 143

Country: Number of subjects enrolled

Bulgaria: 401

Country: Number of subjects enrolled

Canada: 23

Country: Number of subjects enrolled

China: 1480

Country: Number of subjects enrolled

Czechia: 147

Country: Number of subjects enrolled

France: 444

Country: Number of subjects enrolled

Germany: 192

Country: Number of subjects enrolled

Hong Kong: 69

Country: Number of subjects enrolled

Hungary: 692

Country: Number of subjects enrolled

India: 329

Country: Number of subjects enrolled

Italy: 154

Country: Number of subjects enrolled

Mexico: 105

Country: Number of subjects enrolled

Peru: 301

Country: Number of subjects enrolled

Poland: 406

Country: Number of subjects enrolled

Romania: 66

Country: Number of subjects enrolled

Russian Federation: 1293

Country: Number of subjects enrolled

Saudi Arabia: 27

Country: Number of subjects enrolled

Slovakia: 269

Country: Number of subjects enrolled

Korea, Republic of: 282

Country: Number of subjects enrolled

Spain: 857

Country: Number of subjects enrolled

Sweden: 157

Country: Number of subjects enrolled

Taiwan: 248

Country: Number of subjects enrolled

Thailand: 968

Country: Number of subjects enrolled

Ukraine: 350

Country: Number of subjects enrolled

Vietnam: 1299

Worldwide total number of subjects

11016

EEA total number of subjects

3947

Number of subjects enrolled per age group

In utero

0

Preterm newborn - gestational age < 37 wk

0

Newborns (0-27 days)

0

Infants and toddlers (28 days-23 months)

0

Children (2-11 years)

0

Adolescents (12-17 years)

0

Adults (18-64 years)

5308

From 65 to 84 years

5312

85 years and over

396

Subject disposition

Top of page

Recruitment details

414 study sites in 28 countries enrolled patients. The first patient was enrolled on 22 January 2018. The last patient visit took place on 13 December 2019.

Screening details

11073 patients enrolled; 11016 patients randomised. 57 patients who were not randomised (patient did not meet inclusion/exclusion criteria n=52, patient decision n=5).

Period 1 title

Overall Study (overall period)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

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

Are arms mutually exclusive

Yes

TICAGRELOR

Arm description

Ticagrelor 180 mg day 1, followed by 90 mg twice daily day 2-30

Arm type

Experimental

Investigational medicinal product name

Ticagrelor

Investigational medicinal product code

Other name

Pharmaceutical forms

Film-coated tablet

Routes of administration

Oral use

Dosage and administration details

180 mg loading dose followed by 90 mg twice daily

PLACEBO

Arm description

Placebo 180 mg day 1, followed by 90 mg twice daily day 2-30

Arm type

Placebo

Investigational medicinal product name

Placebo (matching ticagrelor)

Investigational medicinal product code

Other name

Pharmaceutical forms

Film-coated tablet

Routes of administration

Oral use

Dosage and administration details

Matching 180 mg loading dose followed by 90 mg twice daily

Number of subjects in period 1	TICAGRELOR	PLACEBO
Started	5523	5493
Completed	5514	5486
Not completed	9	7
Consent withdrawn by subject	8	7
Lost to follow-up	1	-

Baseline characteristics

Top of page

Reporting group title

TICAGRELOR

Reporting group description

Ticagrelor 180 mg day 1, followed by 90 mg twice daily day 2-30

Reporting group title

PLACEBO

Reporting group description

Placebo 180 mg day 1, followed by 90 mg twice daily day 2-30

Reporting group values	TICAGRELOR	PLACEBO	Total
Number of subjects	5523	5493	11016
Age categorical
Units: Subjects
In utero	0	0	0
Preterm newborn infants (gestational age < 37 wks)	0	0	0
Newborns (0-27 days)	0	0	0
Infants and toddlers (28 days-23 months)	0	0	0
Children (2-11 years)	0	0	0
Adolescents (12-17 years)	0	0	0
Adults (18-64 years)	2676	2632	5308
From 65-84 years	2642	2670	5312
85 years and over	205	191	396
Age Continuous
Units: Years
arithmetic mean (standard deviation)	65.2 ± 11.0	65.1 ± 11.1	-
Sex: Female, Male
Units: Participants
Female	2108	2171	4279
Male	3415	3322	6737
Race/Ethnicity, Customized
Units: Subjects
White	2973	2948	5921
Black or African American	21	32	53
Asian	2353	2339	4692
Native Hawaiian or other Pacific Islander	1	3	4
American Indian or Alaska Native	173	168	341
Other	2	3	5

End points

Top of page

Reporting group title

TICAGRELOR

Reporting group description

Ticagrelor 180 mg day 1, followed by 90 mg twice daily day 2-30

Reporting group title

PLACEBO

Reporting group description

Placebo 180 mg day 1, followed by 90 mg twice daily day 2-30

Primary: Composite of subsequent stroke or death

Top of page

End point title

Composite of subsequent stroke or death

End point description

Participants with subsequent stroke or death

End point type

Primary

End point timeframe

From randomisation (day 1) to visit 3 (day 30-34)

End point values	TICAGRELOR	PLACEBO
Number of subjects analysed	5523	5493
Units: Number of participants with event	303	362

Prevention of the composite of stroke and death

Statistical analysis description

Time from randomisation to first subsequent stroke or death

Comparison groups

TICAGRELOR v PLACEBO

Number of subjects included in analysis

11016

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.015 ^[1]

Method

Regression, Cox

Parameter type

Hazard ratio (HR)

Point estimate

0.83

Confidence interval

level

95%

sides

2-sided

lower limit

0.71

upper limit

0.96

Notes
[1] - The hypothesis was tested at the 4.996% two-sided significance level to account for the planned interim analysis with the overall type I error preserved at 5%. A hierarchical test sequence was used to address the issue of multiple testing

Secondary: Ischaemic stroke

Top of page

End point title

Ischaemic stroke

End point description

Number of participants with ischaemic stroke

End point type

Secondary

End point timeframe

From randomisation (day 1) to visit 3 (day 30-34)

End point values	TICAGRELOR	PLACEBO
Number of subjects analysed	5523	5493
Units: Participants with event	276	345

Prevention of ischaemic stroke

Statistical analysis description

Time from randomisation to first subsequent ischaemic stroke (including strokes classified as “Undetermined”)

Comparison groups

TICAGRELOR v PLACEBO

Number of subjects included in analysis

11016

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.004 ^[2]

Method

Regression, Cox

Parameter type

Hazard ratio (HR)

Point estimate

0.79

Confidence interval

level

95%

sides

2-sided

lower limit

0.68

upper limit

0.93

Notes
[2] - The hypothesis was tested at the 4.996% two-sided significance level to account for the planned interim analysis with the overall type I error preserved at 5%. A hierarchical test sequence was used to address the issue of multiple testing

Secondary: The modified Rankin Scale (mRS) score >1 at Visit 3

Top of page

End point title

The modified Rankin Scale (mRS) score >1 at Visit 3

End point description

The modified Rankin Scale (mRS) is a scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The scale runs from 0-6, running from perfect health without symptoms to death.0 - No symptoms,1 - No significant disability. Able to carry out all usual activities, despite some symptoms. 2 - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. 3 - Moderate disability. Requires some help, but able to walk unassisted. 4 - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. 5 - Severe disability. Requires constant nursing care and attention, bedridden, incontinent. 6 - Dead.

End point type

Secondary

End point timeframe

Visit 3 (day 30-34)

End point values	TICAGRELOR	PLACEBO
Number of subjects analysed	5386	5333
Units: Participants with mRS score >1	1282	1284

Reduction of overall disability

Statistical analysis description

Modified Rankin Scale (mRS) score >1 at Visit 3

Comparison groups

TICAGRELOR v PLACEBO

Number of subjects included in analysis

10719

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.613 ^[3]

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

0.98

Confidence interval

level

95%

sides

2-sided

lower limit

0.89

upper limit

1.07

Notes
[3] - The hypothesis was tested at the 4.996% two-sided significance level to account for the planned interim analysis with the overall type I error preserved at 5%. A hierarchical test sequence was used to address the issue of multiple testing

Other pre-specified: Bleeding event that fulfils SAE criteria and is categorised as GUSTO Severe

Top of page

End point title

Bleeding event that fulfils SAE criteria and is categorised as GUSTO Severe

End point description

Participants with bleeding event that fulfils SAE criteria and is categorised as GUSTO Severe

End point type

Other pre-specified

End point timeframe

From randomisation (day 1) to visit 3 (day 30-34)

End point values	TICAGRELOR	PLACEBO
Number of subjects analysed	5523	5493
Units: Participants with event	28	7

GUSTO Severe bleeding

Statistical analysis description

Time from randomisation to first bleeding event that fulfils SAE criteria and is categorised as GUSTO Severe

Comparison groups

TICAGRELOR v PLACEBO

Number of subjects included in analysis

11016

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.001

Method

Regression, Cox

Parameter type

Hazard ratio (HR)

Point estimate

3.99

Confidence interval

level

95%

sides

2-sided

lower limit

1.74

upper limit

9.14

Other pre-specified: ICH or fatal bleeding event

Top of page

End point title

ICH or fatal bleeding event

End point description

Participants with ICH or fatal bleeding event

End point type

Other pre-specified

End point timeframe

From randomisation (day 1) to visit 3 (day 30-34)

End point values	TICAGRELOR	PLACEBO
Number of subjects analysed	5523	5493
Units: Participants with event	22	6

ICH or fatal bleeding

Statistical analysis description

Time from randomisation to first intracranial haemorrhage or fatal bleeding event

Comparison groups

TICAGRELOR v PLACEBO

Number of subjects included in analysis

11016

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.005

Method

Regression, Cox

Parameter type

Hazard ratio (HR)

Point estimate

3.66

Confidence interval

level

95%

sides

2-sided

lower limit

1.48

upper limit

9.02

Other pre-specified: Bleeding event that fulfils SAE criteria and is categorised as GUSTO Moderate/Severe

Top of page

End point title

Bleeding event that fulfils SAE criteria and is categorised as GUSTO Moderate/Severe

End point description

Participants with bleeding event that fulfils SAE criteria and is categorised as GUSTO Moderate/Severe

End point type

Other pre-specified

End point timeframe

From randomisation (day 1) to visit 3 (day 30-34)

End point values	TICAGRELOR	PLACEBO
Number of subjects analysed	5523	5493
Units: Participants with event	36	11

GUSTO Moderate/Severe bleeding

Statistical analysis description

Time from randomisation to first bleeding event that fulfils SAE criteria and is categorised as GUSTO Moderate/Severe

Comparison groups

TICAGRELOR v PLACEBO

Number of subjects included in analysis

11016

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

Regression, Cox

Parameter type

Hazard ratio (HR)

Point estimate

3.27

Confidence interval

level

95%

sides

2-sided

lower limit

1.67

upper limit

6.43

Other pre-specified: Premature permanent discontinuation of IP due to bleeding

Top of page

End point title

Premature permanent discontinuation of IP due to bleeding

End point description

Participants with premature permanent discontinuation of IP due to bleeding

End point type

Other pre-specified

End point timeframe

From randomisation (day 1) to visit 3 (day 30-34)

End point values	TICAGRELOR	PLACEBO
Number of subjects analysed	5523	5493
Units: Participants with event	152	32

Permanent discontinuation of IP due to bleeding

Statistical analysis description

Time from randomisation to premature permanent discontinuation of IP due to bleeding

Comparison groups

TICAGRELOR v PLACEBO

Number of subjects included in analysis

11016

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

Regression, Cox

Parameter type

Hazard ratio (HR)

Point estimate

4.8

Confidence interval

level

95%

sides

2-sided

lower limit

3.28

upper limit

7.02

Adverse events

Top of page

Timeframe for reporting adverse events

From randomisation (day 1) up to visit 3 (day 30-34)

Adverse event reporting additional description

Systematic assessment of serious adverse events and adverse events leading to premature permanent discontinuation of study drug. Other non-serious adverse events were not to be reported

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

22.1

Reporting group title

Ticagrelor 90 mg bd

Reporting group description

-

Reporting group title

Placebo

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: Only serious adverse events and adverse events leading to discontinuation of study drug were to be collected. Hence, the number of non-serious events were limited and no preferred term reached the 5% threshold.

Serious adverse events	Ticagrelor 90 mg bd	Placebo
Total subjects affected by serious adverse events
subjects affected / exposed	571 / 5523 (10.34%)	609 / 5493 (11.09%)
number of deaths (all causes)	36	27
number of deaths resulting from adverse events
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute leukaemia
subjects affected / exposed	1 / 5523 (0.02%)	0 / 5493 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Adenocarcinoma
subjects affected / exposed	1 / 5523 (0.02%)	0 / 5493 (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	1 / 5523 (0.02%)	0 / 5493 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Brain neoplasm
subjects affected / exposed	1 / 5523 (0.02%)	0 / 5493 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Brain neoplasm malignant
subjects affected / exposed	1 / 5523 (0.02%)	0 / 5493 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac myxoma
subjects affected / exposed	0 / 5523 (0.00%)	1 / 5493 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Colon cancer
subjects affected / exposed	1 / 5523 (0.02%)	0 / 5493 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Colorectal adenocarcinoma
subjects affected / exposed	1 / 5523 (0.02%)	0 / 5493 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Focal nodular hyperplasia
subjects affected / exposed	0 / 5523 (0.00%)	1 / 5493 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastric cancer
subjects affected / exposed	1 / 5523 (0.02%)	1 / 5493 (0.02%)
occurrences causally related to treatment / all	1 / 1	0 / 1
deaths causally related to treatment / all	1 / 1	0 / 0
Glioma
subjects affected / exposed	0 / 5523 (0.00%)	1 / 5493 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatic cancer
subjects affected / exposed	0 / 5523 (0.00%)	1 / 5493 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Lung adenocarcinoma
subjects affected / exposed	0 / 5523 (0.00%)	1 / 5493 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Lung carcinoma cell type unspecified recurrent
subjects affected / exposed	0 / 5523 (0.00%)	1 / 5493 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Lung neoplasm
subjects affected / exposed	0 / 5523 (0.00%)	1 / 5493 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Lung neoplasm malignant
subjects affected / exposed	2 / 5523 (0.04%)	1 / 5493 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Malignant mediastinal neoplasm
subjects affected / exposed	0 / 5523 (0.00%)	1 / 5493 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Meningioma
subjects affected / exposed	1 / 5523 (0.02%)	0 / 5493 (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 / 5523 (0.00%)	1 / 5493 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Metastatic gastric cancer
subjects affected / exposed	0 / 5523 (0.00%)	1 / 5493 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Myelofibrosis
subjects affected / exposed	1 / 5523 (0.02%)	0 / 5493 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Myeloproliferative neoplasm
subjects affected / exposed	1 / 5523 (0.02%)	0 / 5493 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Ovarian neoplasm
subjects affected / exposed	1 / 5523 (0.02%)	0 / 5493 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Pancreatic carcinoma metastatic
subjects affected / exposed	0 / 5523 (0.00%)	1 / 5493 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Phaeochromocytoma
subjects affected / exposed	0 / 5523 (0.00%)	1 / 5493 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pharyngeal cancer
subjects affected / exposed	1 / 5523 (0.02%)	0 / 5493 (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 / 5523 (0.02%)	0 / 5493 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Prostate cancer
subjects affected / exposed	0 / 5523 (0.00%)	1 / 5493 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Prostate cancer metastatic
subjects affected / exposed	1 / 5523 (0.02%)	0 / 5493 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Rectal adenocarcinoma
subjects affected / exposed	1 / 5523 (0.02%)	0 / 5493 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Rectal cancer
subjects affected / exposed	1 / 5523 (0.02%)	0 / 5493 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Renal cancer
subjects affected / exposed	0 / 5523 (0.00%)	1 / 5493 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Renal neoplasm
subjects affected / exposed	1 / 5523 (0.02%)	0 / 5493 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Uterine cancer
subjects affected / exposed	0 / 5523 (0.00%)	1 / 5493 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Vascular disorders
Aortic dissection
subjects affected / exposed	1 / 5523 (0.02%)	0 / 5493 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Aortic intramural haematoma
subjects affected / exposed	1 / 5523 (0.02%)	0 / 5493 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Aortic stenosis
subjects affected / exposed	0 / 5523 (0.00%)	1 / 5493 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Arterial stenosis
subjects affected / exposed	1 / 5523 (0.02%)	0 / 5493 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Arteritis
subjects affected / exposed	0 / 5523 (0.00%)	1 / 5493 (0.02%)
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	1 / 5523 (0.02%)	0 / 5493 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Deep vein thrombosis
subjects affected / exposed	0 / 5523 (0.00%)	2 / 5493 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Haematoma
subjects affected / exposed	0 / 5523 (0.00%)	1 / 5493 (0.02%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hypertension
subjects affected / exposed	5 / 5523 (0.09%)	5 / 5493 (0.09%)
occurrences causally related to treatment / all	0 / 5	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Hypertensive crisis
subjects affected / exposed	3 / 5523 (0.05%)	4 / 5493 (0.07%)
occurrences causally related to treatment / all	0 / 3	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Hypertensive urgency
subjects affected / exposed	1 / 5523 (0.02%)	1 / 5493 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hypotension
subjects affected / exposed	0 / 5523 (0.00%)	1 / 5493 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Penetrating aortic ulcer
subjects affected / exposed	0 / 5523 (0.00%)	1 / 5493 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Peripheral arterial occlusive disease
subjects affected / exposed	1 / 5523 (0.02%)	2 / 5493 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Peripheral ischaemia
subjects affected / exposed	1 / 5523 (0.02%)	0 / 5493 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Subclavian artery stenosis
subjects affected / exposed	0 / 5523 (0.00%)	1 / 5493 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Vasculitis
subjects affected / exposed	1 / 5523 (0.02%)	0 / 5493 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Vena cava thrombosis
subjects affected / exposed	1 / 5523 (0.02%)	0 / 5493 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
General disorders and administration site conditions
Chest discomfort
subjects affected / exposed	1 / 5523 (0.02%)	0 / 5493 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Chest pain
subjects affected / exposed	1 / 5523 (0.02%)	0 / 5493 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Death
subjects affected / exposed	4 / 5523 (0.07%)	4 / 5493 (0.07%)
occurrences causally related to treatment / all	0 / 4	0 / 4
deaths causally related to treatment / all	0 / 4	0 / 4
Device related thrombosis
subjects affected / exposed	0 / 5523 (0.00%)	1 / 5493 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
General physical health deterioration
subjects affected / exposed	1 / 5523 (0.02%)	0 / 5493 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Necrosis
subjects affected / exposed	1 / 5523 (0.02%)	0 / 5493 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Non-cardiac chest pain
subjects affected / exposed	1 / 5523 (0.02%)	0 / 5493 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pyrexia
subjects affected / exposed	2 / 5523 (0.04%)	1 / 5493 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Sudden cardiac death
subjects affected / exposed	0 / 5523 (0.00%)	1 / 5493 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Immune system disorders
Anaphylactic reaction
subjects affected / exposed	1 / 5523 (0.02%)	2 / 5493 (0.04%)
occurrences causally related to treatment / all	1 / 1	1 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Anaphylactic shock
subjects affected / exposed	0 / 5523 (0.00%)	1 / 5493 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Drug hypersensitivity
subjects affected / exposed	0 / 5523 (0.00%)	1 / 5493 (0.02%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Reproductive system and breast disorders
Endometrial hyperplasia
subjects affected / exposed	1 / 5523 (0.02%)	0 / 5493 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Menorrhagia
subjects affected / exposed	0 / 5523 (0.00%)	1 / 5493 (0.02%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Uterine haemorrhage
subjects affected / exposed	0 / 5523 (0.00%)	1 / 5493 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
subjects affected / exposed	1 / 5523 (0.02%)	0 / 5493 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Acute respiratory failure
subjects affected / exposed	1 / 5523 (0.02%)	1 / 5493 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 1
Bronchitis chronic
subjects affected / exposed	2 / 5523 (0.04%)	0 / 5493 (0.00%)
occurrences causally related to treatment / all	1 / 2	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Chronic obstructive pulmonary disease
subjects affected / exposed	0 / 5523 (0.00%)	1 / 5493 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Dyspnoea
subjects affected / exposed	3 / 5523 (0.05%)	2 / 5493 (0.04%)
occurrences causally related to treatment / all	3 / 3	2 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Epistaxis
subjects affected / exposed	6 / 5523 (0.11%)	0 / 5493 (0.00%)
occurrences causally related to treatment / all	4 / 6	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Haemoptysis
subjects affected / exposed	1 / 5523 (0.02%)	1 / 5493 (0.02%)
occurrences causally related to treatment / all	0 / 1	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pleural effusion
subjects affected / exposed	1 / 5523 (0.02%)	0 / 5493 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumonia aspiration
subjects affected / exposed	0 / 5523 (0.00%)	2 / 5493 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 1
Pneumonitis
subjects affected / exposed	1 / 5523 (0.02%)	0 / 5493 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Pulmonary embolism
subjects affected / exposed	9 / 5523 (0.16%)	5 / 5493 (0.09%)
occurrences causally related to treatment / all	1 / 9	0 / 5
deaths causally related to treatment / all	0 / 1	0 / 1
Pulmonary granuloma
subjects affected / exposed	0 / 5523 (0.00%)	1 / 5493 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Respiratory failure
subjects affected / exposed	1 / 5523 (0.02%)	0 / 5493 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Respiratory tract haemorrhage
subjects affected / exposed	1 / 5523 (0.02%)	0 / 5493 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Psychiatric disorders
Anxiety
subjects affected / exposed	1 / 5523 (0.02%)	1 / 5493 (0.02%)
occurrences causally related to treatment / all	1 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Anxiety disorder
subjects affected / exposed	0 / 5523 (0.00%)	2 / 5493 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Completed suicide
subjects affected / exposed	1 / 5523 (0.02%)	0 / 5493 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Confusional state
subjects affected / exposed	2 / 5523 (0.04%)	0 / 5493 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Conversion disorder
subjects affected / exposed	0 / 5523 (0.00%)	1 / 5493 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Delirium
subjects affected / exposed	1 / 5523 (0.02%)	3 / 5493 (0.05%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Hallucination, visual
subjects affected / exposed	1 / 5523 (0.02%)	0 / 5493 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Neuropsychiatric symptoms
subjects affected / exposed	1 / 5523 (0.02%)	0 / 5493 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Organic brain syndrome
subjects affected / exposed	0 / 5523 (0.00%)	2 / 5493 (0.04%)
occurrences causally related to treatment / all	0 / 0	1 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Panic disorder
subjects affected / exposed	1 / 5523 (0.02%)	0 / 5493 (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	2 / 5523 (0.04%)	0 / 5493 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Sleep disorder
subjects affected / exposed	1 / 5523 (0.02%)	0 / 5493 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Somatic symptom disorder
subjects affected / exposed	1 / 5523 (0.02%)	0 / 5493 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Product issues
Device dislocation
subjects affected / exposed	0 / 5523 (0.00%)	1 / 5493 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Investigations
Blood glucose increased
subjects affected / exposed	0 / 5523 (0.00%)	1 / 5493 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
International normalised ratio increased
subjects affected / exposed	1 / 5523 (0.02%)	0 / 5493 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Occult blood positive
subjects affected / exposed	0 / 5523 (0.00%)	1 / 5493 (0.02%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Injury, poisoning and procedural complications
Arterial bypass occlusion
subjects affected / exposed	0 / 5523 (0.00%)	1 / 5493 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Clavicle fracture
subjects affected / exposed	0 / 5523 (0.00%)	1 / 5493 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Femoral neck fracture
subjects affected / exposed	1 / 5523 (0.02%)	0 / 5493 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Femur fracture
subjects affected / exposed	0 / 5523 (0.00%)	2 / 5493 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Head injury
subjects affected / exposed	0 / 5523 (0.00%)	2 / 5493 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Hip fracture
subjects affected / exposed	0 / 5523 (0.00%)	1 / 5493 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Open globe injury
subjects affected / exposed	0 / 5523 (0.00%)	1 / 5493 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Periprocedural myocardial infarction
subjects affected / exposed	1 / 5523 (0.02%)	0 / 5493 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Post procedural haemorrhage
subjects affected / exposed	1 / 5523 (0.02%)	0 / 5493 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Rib fracture
subjects affected / exposed	1 / 5523 (0.02%)	0 / 5493 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Spinal compression fracture
subjects affected / exposed	0 / 5523 (0.00%)	2 / 5493 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Subdural haematoma
subjects affected / exposed	1 / 5523 (0.02%)	0 / 5493 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Thermal burn
subjects affected / exposed	0 / 5523 (0.00%)	1 / 5493 (0.02%)
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	1 / 5523 (0.02%)	0 / 5493 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Traumatic intracranial haemorrhage
subjects affected / exposed	0 / 5523 (0.00%)	1 / 5493 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Vascular pseudoaneurysm
subjects affected / exposed	0 / 5523 (0.00%)	1 / 5493 (0.02%)
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
Atrial septal defect
subjects affected / exposed	1 / 5523 (0.02%)	4 / 5493 (0.07%)
occurrences causally related to treatment / all	0 / 1	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Vascular malformation
subjects affected / exposed	1 / 5523 (0.02%)	0 / 5493 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac disorders
Acute coronary syndrome
subjects affected / exposed	1 / 5523 (0.02%)	0 / 5493 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Acute left ventricular failure
subjects affected / exposed	1 / 5523 (0.02%)	0 / 5493 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Acute myocardial infarction
subjects affected / exposed	4 / 5523 (0.07%)	5 / 5493 (0.09%)
occurrences causally related to treatment / all	0 / 4	1 / 5
deaths causally related to treatment / all	0 / 2	0 / 0
Angina unstable
subjects affected / exposed	2 / 5523 (0.04%)	0 / 5493 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Aortic valve disease mixed
subjects affected / exposed	1 / 5523 (0.02%)	0 / 5493 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Arrhythmia
subjects affected / exposed	0 / 5523 (0.00%)	1 / 5493 (0.02%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Arteriosclerosis coronary artery
subjects affected / exposed	0 / 5523 (0.00%)	1 / 5493 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Atrial fibrillation
subjects affected / exposed	18 / 5523 (0.33%)	15 / 5493 (0.27%)
occurrences causally related to treatment / all	0 / 18	0 / 17
deaths causally related to treatment / all	0 / 1	0 / 0
Atrial tachycardia
subjects affected / exposed	1 / 5523 (0.02%)	0 / 5493 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Atrial thrombosis
subjects affected / exposed	4 / 5523 (0.07%)	2 / 5493 (0.04%)
occurrences causally related to treatment / all	0 / 4	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Atrioventricular block complete
subjects affected / exposed	1 / 5523 (0.02%)	2 / 5493 (0.04%)
occurrences causally related to treatment / all	0 / 1	1 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Atrioventricular block second degree
subjects affected / exposed	3 / 5523 (0.05%)	0 / 5493 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Bradycardia
subjects affected / exposed	1 / 5523 (0.02%)	2 / 5493 (0.04%)
occurrences causally related to treatment / all	0 / 1	1 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac arrest
subjects affected / exposed	1 / 5523 (0.02%)	0 / 5493 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac asthma
subjects affected / exposed	1 / 5523 (0.02%)	0 / 5493 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac failure
subjects affected / exposed	0 / 5523 (0.00%)	2 / 5493 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 1
Cardiac failure acute
subjects affected / exposed	1 / 5523 (0.02%)	0 / 5493 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac failure chronic
subjects affected / exposed	1 / 5523 (0.02%)	0 / 5493 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Cardiac failure congestive
subjects affected / exposed	3 / 5523 (0.05%)	0 / 5493 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac ventricular thrombosis
subjects affected / exposed	0 / 5523 (0.00%)	1 / 5493 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cardio-respiratory arrest
subjects affected / exposed	0 / 5523 (0.00%)	2 / 5493 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 1
Cardiomyopathy
subjects affected / exposed	1 / 5523 (0.02%)	0 / 5493 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Congestive cardiomyopathy
subjects affected / exposed	1 / 5523 (0.02%)	0 / 5493 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Coronary artery disease
subjects affected / exposed	2 / 5523 (0.04%)	2 / 5493 (0.04%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Coronary artery occlusion
subjects affected / exposed	0 / 5523 (0.00%)	1 / 5493 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Intracardiac thrombus
subjects affected / exposed	2 / 5523 (0.04%)	0 / 5493 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Ischaemic cardiomyopathy
subjects affected / exposed	0 / 5523 (0.00%)	1 / 5493 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Mitral valve disease
subjects affected / exposed	1 / 5523 (0.02%)	0 / 5493 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Mitral valve disease mixed
subjects affected / exposed	0 / 5523 (0.00%)	1 / 5493 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Mitral valve incompetence
subjects affected / exposed	1 / 5523 (0.02%)	0 / 5493 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Myocardial infarction
subjects affected / exposed	2 / 5523 (0.04%)	0 / 5493 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Myocardial ischaemia
subjects affected / exposed	1 / 5523 (0.02%)	1 / 5493 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pericardial effusion
subjects affected / exposed	0 / 5523 (0.00%)	2 / 5493 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Right ventricular failure
subjects affected / exposed	0 / 5523 (0.00%)	1 / 5493 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Sinoatrial block
subjects affected / exposed	1 / 5523 (0.02%)	0 / 5493 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Sinus bradycardia
subjects affected / exposed	1 / 5523 (0.02%)	1 / 5493 (0.02%)
occurrences causally related to treatment / all	1 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Sinus node dysfunction
subjects affected / exposed	1 / 5523 (0.02%)	0 / 5493 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Supraventricular tachycardia
subjects affected / exposed	1 / 5523 (0.02%)	1 / 5493 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Ventricular extrasystoles
subjects affected / exposed	0 / 5523 (0.00%)	1 / 5493 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Ventricular fibrillation
subjects affected / exposed	0 / 5523 (0.00%)	1 / 5493 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Ventricular tachycardia
subjects affected / exposed	1 / 5523 (0.02%)	0 / 5493 (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
Autonomic neuropathy
subjects affected / exposed	0 / 5523 (0.00%)	1 / 5493 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Balance disorder
subjects affected / exposed	2 / 5523 (0.04%)	0 / 5493 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Brain oedema
subjects affected / exposed	3 / 5523 (0.05%)	3 / 5493 (0.05%)
occurrences causally related to treatment / all	0 / 3	0 / 3
deaths causally related to treatment / all	0 / 3	0 / 1
Basal ganglia haemorrhage
subjects affected / exposed	1 / 5523 (0.02%)	0 / 5493 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Brain stem stroke
subjects affected / exposed	1 / 5523 (0.02%)	0 / 5493 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Brain stem syndrome
subjects affected / exposed	0 / 5523 (0.00%)	1 / 5493 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Carotid arteriosclerosis
subjects affected / exposed	0 / 5523 (0.00%)	1 / 5493 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Carotid artery occlusion
subjects affected / exposed	0 / 5523 (0.00%)	2 / 5493 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Carotid artery stenosis
subjects affected / exposed	8 / 5523 (0.14%)	7 / 5493 (0.13%)
occurrences causally related to treatment / all	0 / 8	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
Carpal tunnel syndrome
subjects affected / exposed	0 / 5523 (0.00%)	1 / 5493 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Central pain syndrome
subjects affected / exposed	0 / 5523 (0.00%)	1 / 5493 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cerebellar infarction
subjects affected / exposed	1 / 5523 (0.02%)	0 / 5493 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Cerebral artery stenosis
subjects affected / exposed	2 / 5523 (0.04%)	2 / 5493 (0.04%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Cerebral haemorrhage
subjects affected / exposed	4 / 5523 (0.07%)	3 / 5493 (0.05%)
occurrences causally related to treatment / all	2 / 4	2 / 3
deaths causally related to treatment / all	2 / 4	1 / 2
Cerebral infarction
subjects affected / exposed	6 / 5523 (0.11%)	8 / 5493 (0.15%)
occurrences causally related to treatment / all	3 / 6	0 / 8
deaths causally related to treatment / all	0 / 0	0 / 0
Cerebral ischaemia
subjects affected / exposed	2 / 5523 (0.04%)	0 / 5493 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cerebral venous sinus thrombosis
subjects affected / exposed	0 / 5523 (0.00%)	1 / 5493 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cerebral venous thrombosis
subjects affected / exposed	1 / 5523 (0.02%)	0 / 5493 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cerebrovascular accident
subjects affected / exposed	6 / 5523 (0.11%)	7 / 5493 (0.13%)
occurrences causally related to treatment / all	0 / 6	1 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
Cerebrovascular disorder
subjects affected / exposed	0 / 5523 (0.00%)	1 / 5493 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Cerebrovascular insufficiency
subjects affected / exposed	1 / 5523 (0.02%)	0 / 5493 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Chronic inflammatory demyelinating polyradiculoneuropathy
subjects affected / exposed	0 / 5523 (0.00%)	1 / 5493 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Dizziness
subjects affected / exposed	2 / 5523 (0.04%)	3 / 5493 (0.05%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Dementia Alzheimer's type
subjects affected / exposed	0 / 5523 (0.00%)	1 / 5493 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Dysgraphia
subjects affected / exposed	0 / 5523 (0.00%)	1 / 5493 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Dysmetria
subjects affected / exposed	0 / 5523 (0.00%)	1 / 5493 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Epilepsy
subjects affected / exposed	5 / 5523 (0.09%)	3 / 5493 (0.05%)
occurrences causally related to treatment / all	0 / 5	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Guillain-Barre syndrome
subjects affected / exposed	1 / 5523 (0.02%)	0 / 5493 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Haemorrhage intracranial
subjects affected / exposed	2 / 5523 (0.04%)	0 / 5493 (0.00%)
occurrences causally related to treatment / all	1 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Haemorrhagic stroke
subjects affected / exposed	7 / 5523 (0.13%)	0 / 5493 (0.00%)
occurrences causally related to treatment / all	5 / 7	0 / 0
deaths causally related to treatment / all	4 / 6	0 / 0
Haemorrhagic transformation stroke
subjects affected / exposed	8 / 5523 (0.14%)	6 / 5493 (0.11%)
occurrences causally related to treatment / all	6 / 8	4 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Headache
subjects affected / exposed	0 / 5523 (0.00%)	1 / 5493 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hemianaesthesia
subjects affected / exposed	0 / 5523 (0.00%)	1 / 5493 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hemiparesis
subjects affected / exposed	0 / 5523 (0.00%)	1 / 5493 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatic encephalopathy
subjects affected / exposed	0 / 5523 (0.00%)	1 / 5493 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hydrocephalus
subjects affected / exposed	1 / 5523 (0.02%)	0 / 5493 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hypoaesthesia
subjects affected / exposed	1 / 5523 (0.02%)	1 / 5493 (0.02%)
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 / 5523 (0.00%)	1 / 5493 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Intracranial aneurysm
subjects affected / exposed	1 / 5523 (0.02%)	2 / 5493 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Ischaemic cerebral infarction
subjects affected / exposed	4 / 5523 (0.07%)	6 / 5493 (0.11%)
occurrences causally related to treatment / all	1 / 4	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Ischaemic stroke
subjects affected / exposed	254 / 5523 (4.60%)	324 / 5493 (5.90%)
occurrences causally related to treatment / all	19 / 258	36 / 330
deaths causally related to treatment / all	0 / 8	0 / 7
Lacunar stroke
subjects affected / exposed	0 / 5523 (0.00%)	2 / 5493 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Lacunar infarction
subjects affected / exposed	1 / 5523 (0.02%)	0 / 5493 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Loss of consciousness
subjects affected / exposed	2 / 5523 (0.04%)	0 / 5493 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Memory impairment
subjects affected / exposed	0 / 5523 (0.00%)	1 / 5493 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Migraine
subjects affected / exposed	0 / 5523 (0.00%)	1 / 5493 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Neurological symptom
subjects affected / exposed	1 / 5523 (0.02%)	0 / 5493 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Paraesthesia
subjects affected / exposed	0 / 5523 (0.00%)	1 / 5493 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Paresis
subjects affected / exposed	0 / 5523 (0.00%)	1 / 5493 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Parkinson's disease
subjects affected / exposed	0 / 5523 (0.00%)	1 / 5493 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Partial seizures
subjects affected / exposed	2 / 5523 (0.04%)	0 / 5493 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Post stroke seizure
subjects affected / exposed	0 / 5523 (0.00%)	1 / 5493 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Psychomotor hyperactivity
subjects affected / exposed	1 / 5523 (0.02%)	0 / 5493 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Seizure
subjects affected / exposed	4 / 5523 (0.07%)	3 / 5493 (0.05%)
occurrences causally related to treatment / all	0 / 4	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Somnolence
subjects affected / exposed	0 / 5523 (0.00%)	1 / 5493 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Status epilepticus
subjects affected / exposed	2 / 5523 (0.04%)	0 / 5493 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Spondylitic myelopathy
subjects affected / exposed	1 / 5523 (0.02%)	0 / 5493 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Stroke in evolution
subjects affected / exposed	1 / 5523 (0.02%)	0 / 5493 (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	1 / 5523 (0.02%)	0 / 5493 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Subarachnoid haemorrhage
subjects affected / exposed	2 / 5523 (0.04%)	0 / 5493 (0.00%)
occurrences causally related to treatment / all	2 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Tension headache
subjects affected / exposed	1 / 5523 (0.02%)	0 / 5493 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Thalamic infarction
subjects affected / exposed	1 / 5523 (0.02%)	0 / 5493 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Transient ischaemic attack
subjects affected / exposed	12 / 5523 (0.22%)	30 / 5493 (0.55%)
occurrences causally related to treatment / all	0 / 12	3 / 31
deaths causally related to treatment / all	0 / 0	0 / 0
Vascular dementia
subjects affected / exposed	1 / 5523 (0.02%)	0 / 5493 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Vertebral artery stenosis
subjects affected / exposed	2 / 5523 (0.04%)	0 / 5493 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Blood and lymphatic system disorders
Anaemia
subjects affected / exposed	0 / 5523 (0.00%)	1 / 5493 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Iron deficiency anaemia
subjects affected / exposed	1 / 5523 (0.02%)	1 / 5493 (0.02%)
occurrences causally related to treatment / all	0 / 1	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Lymphadenopathy mediastinal
subjects affected / exposed	1 / 5523 (0.02%)	0 / 5493 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Normochromic normocytic anaemia
subjects affected / exposed	0 / 5523 (0.00%)	1 / 5493 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Normocytic anaemia
subjects affected / exposed	1 / 5523 (0.02%)	0 / 5493 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Polycythaemia
subjects affected / exposed	0 / 5523 (0.00%)	1 / 5493 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Spontaneous haematoma
subjects affected / exposed	1 / 5523 (0.02%)	0 / 5493 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Thrombocytopenia
subjects affected / exposed	1 / 5523 (0.02%)	0 / 5493 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Ear and labyrinth disorders
Vertigo positional
subjects affected / exposed	2 / 5523 (0.04%)	2 / 5493 (0.04%)
occurrences causally related to treatment / all	0 / 2	1 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Vestibular ataxia
subjects affected / exposed	1 / 5523 (0.02%)	0 / 5493 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Eye disorders
Angle closure glaucoma
subjects affected / exposed	0 / 5523 (0.00%)	1 / 5493 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Diabetic retinopathy
subjects affected / exposed	1 / 5523 (0.02%)	0 / 5493 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Idiopathic orbital inflammation
subjects affected / exposed	1 / 5523 (0.02%)	0 / 5493 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Visual impairment
subjects affected / exposed	0 / 5523 (0.00%)	1 / 5493 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal disorders
Abdominal pain
subjects affected / exposed	1 / 5523 (0.02%)	0 / 5493 (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	1 / 5523 (0.02%)	0 / 5493 (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	1 / 5523 (0.02%)	0 / 5493 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Diverticular perforation
subjects affected / exposed	1 / 5523 (0.02%)	0 / 5493 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Duodenal ulcer haemorrhage
subjects affected / exposed	1 / 5523 (0.02%)	0 / 5493 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Dyspepsia
subjects affected / exposed	1 / 5523 (0.02%)	0 / 5493 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Dysphagia
subjects affected / exposed	1 / 5523 (0.02%)	2 / 5493 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Gastric disorder
subjects affected / exposed	1 / 5523 (0.02%)	0 / 5493 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gastritis
subjects affected / exposed	1 / 5523 (0.02%)	0 / 5493 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal haemorrhage
subjects affected / exposed	6 / 5523 (0.11%)	6 / 5493 (0.11%)
occurrences causally related to treatment / all	5 / 6	3 / 6
deaths causally related to treatment / all	0 / 1	0 / 0
Gingival bleeding
subjects affected / exposed	1 / 5523 (0.02%)	0 / 5493 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Haemorrhoidal haemorrhage
subjects affected / exposed	1 / 5523 (0.02%)	1 / 5493 (0.02%)
occurrences causally related to treatment / all	1 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Inguinal hernia
subjects affected / exposed	0 / 5523 (0.00%)	1 / 5493 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Lower gastrointestinal haemorrhage
subjects affected / exposed	3 / 5523 (0.05%)	0 / 5493 (0.00%)
occurrences causally related to treatment / all	1 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Melaena
subjects affected / exposed	2 / 5523 (0.04%)	0 / 5493 (0.00%)
occurrences causally related to treatment / all	2 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Oesophageal haemorrhage
subjects affected / exposed	2 / 5523 (0.04%)	0 / 5493 (0.00%)
occurrences causally related to treatment / all	2 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Oesophageal ulcer haemorrhage
subjects affected / exposed	1 / 5523 (0.02%)	0 / 5493 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pancreatitis chronic
subjects affected / exposed	0 / 5523 (0.00%)	1 / 5493 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Rectal haemorrhage
subjects affected / exposed	3 / 5523 (0.05%)	2 / 5493 (0.04%)
occurrences causally related to treatment / all	3 / 3	2 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Rectal ulcer haemorrhage
subjects affected / exposed	1 / 5523 (0.02%)	0 / 5493 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Small intestinal haemorrhage
subjects affected / exposed	2 / 5523 (0.04%)	0 / 5493 (0.00%)
occurrences causally related to treatment / all	2 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Upper gastrointestinal haemorrhage
subjects affected / exposed	5 / 5523 (0.09%)	1 / 5493 (0.02%)
occurrences causally related to treatment / all	4 / 5	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Vomiting
subjects affected / exposed	0 / 5523 (0.00%)	1 / 5493 (0.02%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatobiliary disorders
Acute hepatic failure
subjects affected / exposed	1 / 5523 (0.02%)	0 / 5493 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Bile duct stone
subjects affected / exposed	0 / 5523 (0.00%)	1 / 5493 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cholangitis
subjects affected / exposed	1 / 5523 (0.02%)	1 / 5493 (0.02%)
occurrences causally related to treatment / all	1 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cholecystitis
subjects affected / exposed	1 / 5523 (0.02%)	2 / 5493 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Cholecystitis acute
subjects affected / exposed	1 / 5523 (0.02%)	2 / 5493 (0.04%)
occurrences causally related to treatment / all	0 / 1	1 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Cholelithiasis
subjects affected / exposed	0 / 5523 (0.00%)	1 / 5493 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatic function abnormal
subjects affected / exposed	1 / 5523 (0.02%)	0 / 5493 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatitis acute
subjects affected / exposed	1 / 5523 (0.02%)	0 / 5493 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatocellular injury
subjects affected / exposed	0 / 5523 (0.00%)	1 / 5493 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Skin and subcutaneous tissue disorders
Angioedema
subjects affected / exposed	0 / 5523 (0.00%)	1 / 5493 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Ecchymosis
subjects affected / exposed	1 / 5523 (0.02%)	0 / 5493 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Rash
subjects affected / exposed	1 / 5523 (0.02%)	0 / 5493 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Urticaria
subjects affected / exposed	0 / 5523 (0.00%)	1 / 5493 (0.02%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Renal and urinary disorders
Acute kidney injury
subjects affected / exposed	4 / 5523 (0.07%)	2 / 5493 (0.04%)
occurrences causally related to treatment / all	0 / 4	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Chronic kidney disease
subjects affected / exposed	2 / 5523 (0.04%)	1 / 5493 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 0
Cystitis haemorrhagic
subjects affected / exposed	1 / 5523 (0.02%)	0 / 5493 (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	0 / 5523 (0.00%)	1 / 5493 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
End stage renal disease
subjects affected / exposed	1 / 5523 (0.02%)	0 / 5493 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Haematuria
subjects affected / exposed	8 / 5523 (0.14%)	1 / 5493 (0.02%)
occurrences causally related to treatment / all	6 / 8	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Nephrolithiasis
subjects affected / exposed	1 / 5523 (0.02%)	0 / 5493 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Nephropathy toxic
subjects affected / exposed	1 / 5523 (0.02%)	1 / 5493 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Prerenal failure
subjects affected / exposed	0 / 5523 (0.00%)	1 / 5493 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Renal colic
subjects affected / exposed	1 / 5523 (0.02%)	1 / 5493 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Renal failure
subjects affected / exposed	1 / 5523 (0.02%)	3 / 5493 (0.05%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Renal injury
subjects affected / exposed	1 / 5523 (0.02%)	0 / 5493 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Urethral stenosis
subjects affected / exposed	0 / 5523 (0.00%)	1 / 5493 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Urinary bladder polyp
subjects affected / exposed	1 / 5523 (0.02%)	0 / 5493 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Urinary retention
subjects affected / exposed	1 / 5523 (0.02%)	1 / 5493 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Endocrine disorders
Hypothyroidism
subjects affected / exposed	1 / 5523 (0.02%)	0 / 5493 (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
Back pain
subjects affected / exposed	0 / 5523 (0.00%)	1 / 5493 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Bursitis
subjects affected / exposed	1 / 5523 (0.02%)	0 / 5493 (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 / 5523 (0.02%)	0 / 5493 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gouty arthritis
subjects affected / exposed	0 / 5523 (0.00%)	1 / 5493 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Intervertebral disc protrusion
subjects affected / exposed	0 / 5523 (0.00%)	2 / 5493 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Limb discomfort
subjects affected / exposed	1 / 5523 (0.02%)	0 / 5493 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Muscular weakness
subjects affected / exposed	1 / 5523 (0.02%)	2 / 5493 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Sympathetic posterior cervical syndrome
subjects affected / exposed	0 / 5523 (0.00%)	1 / 5493 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Infections and infestations
Anal abscess
subjects affected / exposed	1 / 5523 (0.02%)	0 / 5493 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Appendicitis
subjects affected / exposed	1 / 5523 (0.02%)	0 / 5493 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Brain abscess
subjects affected / exposed	0 / 5523 (0.00%)	1 / 5493 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Bronchitis
subjects affected / exposed	0 / 5523 (0.00%)	1 / 5493 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cellulitis
subjects affected / exposed	1 / 5523 (0.02%)	3 / 5493 (0.05%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Clostridium colitis
subjects affected / exposed	0 / 5523 (0.00%)	1 / 5493 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Endocarditis
subjects affected / exposed	2 / 5523 (0.04%)	0 / 5493 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Escherichia sepsis
subjects affected / exposed	1 / 5523 (0.02%)	0 / 5493 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Escherichia urinary tract infection
subjects affected / exposed	0 / 5523 (0.00%)	1 / 5493 (0.02%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastroenteritis
subjects affected / exposed	0 / 5523 (0.00%)	1 / 5493 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Gastrointestinal bacterial infection
subjects affected / exposed	1 / 5523 (0.02%)	2 / 5493 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal infection
subjects affected / exposed	0 / 5523 (0.00%)	1 / 5493 (0.02%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Infectious pleural effusion
subjects affected / exposed	1 / 5523 (0.02%)	0 / 5493 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Intervertebral discitis
subjects affected / exposed	0 / 5523 (0.00%)	1 / 5493 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Klebsiella sepsis
subjects affected / exposed	0 / 5523 (0.00%)	1 / 5493 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Neurosyphilis
subjects affected / exposed	1 / 5523 (0.02%)	1 / 5493 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Peritonitis
subjects affected / exposed	0 / 5523 (0.00%)	1 / 5493 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumonia
subjects affected / exposed	25 / 5523 (0.45%)	28 / 5493 (0.51%)
occurrences causally related to treatment / all	1 / 25	2 / 29
deaths causally related to treatment / all	0 / 2	0 / 4
Pseudomembranous colitis
subjects affected / exposed	0 / 5523 (0.00%)	1 / 5493 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pyelonephritis acute
subjects affected / exposed	1 / 5523 (0.02%)	0 / 5493 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pyelonephritis chronic
subjects affected / exposed	1 / 5523 (0.02%)	0 / 5493 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Respiratory syncytial virus infection
subjects affected / exposed	1 / 5523 (0.02%)	0 / 5493 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Respiratory tract infection
subjects affected / exposed	1 / 5523 (0.02%)	1 / 5493 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Sepsis
subjects affected / exposed	3 / 5523 (0.05%)	5 / 5493 (0.09%)
occurrences causally related to treatment / all	0 / 3	0 / 5
deaths causally related to treatment / all	0 / 2	0 / 1
Septic shock
subjects affected / exposed	2 / 5523 (0.04%)	1 / 5493 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Tonsillitis
subjects affected / exposed	1 / 5523 (0.02%)	0 / 5493 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Tracheobronchitis
subjects affected / exposed	1 / 5523 (0.02%)	0 / 5493 (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	2 / 5523 (0.04%)	0 / 5493 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Upper respiratory tract infection
subjects affected / exposed	0 / 5523 (0.00%)	1 / 5493 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Urinary tract infection
subjects affected / exposed	6 / 5523 (0.11%)	7 / 5493 (0.13%)
occurrences causally related to treatment / all	0 / 6	2 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
Urinary tract infection enterococcal
subjects affected / exposed	1 / 5523 (0.02%)	0 / 5493 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Urosepsis
subjects affected / exposed	1 / 5523 (0.02%)	1 / 5493 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Viral infection
subjects affected / exposed	1 / 5523 (0.02%)	0 / 5493 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Wound infection
subjects affected / exposed	1 / 5523 (0.02%)	1 / 5493 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Metabolism and nutrition disorders
Dehydration
subjects affected / exposed	1 / 5523 (0.02%)	0 / 5493 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Diabetes mellitus inadequate control
subjects affected / exposed	1 / 5523 (0.02%)	0 / 5493 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Diabetic metabolic decompensation
subjects affected / exposed	0 / 5523 (0.00%)	1 / 5493 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Electrolyte imbalance
subjects affected / exposed	1 / 5523 (0.02%)	0 / 5493 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gout
subjects affected / exposed	2 / 5523 (0.04%)	2 / 5493 (0.04%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Hypoglycaemia
subjects affected / exposed	3 / 5523 (0.05%)	1 / 5493 (0.02%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hypokalaemia
subjects affected / exposed	1 / 5523 (0.02%)	0 / 5493 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hyponatraemia
subjects affected / exposed	3 / 5523 (0.05%)	1 / 5493 (0.02%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0

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

Non-serious adverse events	Ticagrelor 90 mg bd	Placebo
Total subjects affected by non serious adverse events
subjects affected / exposed	0 / 5523 (0.00%)	0 / 5493 (0.00%)

More information

Top of page

Were there any global substantial amendments to the protocol? Yes

08 May 2019

Number of randomised subjects reduced from 13000 to 11000

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

http://www.ncbi.nlm.nih.gov/pubmed/32668111

For support, Contact us.

The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

European Medicines Agency © 1995-Sat Apr 20 08:15:23 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands