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Clinical Trial Results:
Allopurinol and cardiovascular outcomes in patients with ischaemic heart disease (ALL-HEART)

Summary
EudraCT number	2013-003559-39
Trial protocol	GB
Global end of trial date	31 Mar 2022

Results information
Results version number	v1(current)
This version publication date	16 Apr 2023
First version publication date	16 Apr 2023
Other versions

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

2011PP02

ISRCTN number

ISRCTN32017426

US NCT number

WHO universal trial number (UTN)

Sponsor organisation name

University of Dundee and NHS Tayside

Sponsor organisation address

Ninewells Hospital and Medical School, Dundee, UK, Dundee, United Kingdom, DD1 9SY

Public contact

Isla Mackenzie, MEMO Research and Hypertension Research Centre, University of Dundee, +44 01382383119, i.s.mackenzie@dundee.ac.uk

Scientific contact

Isla Mackenzie, MEMO Research and Hypertension Research Centre, University of Dundee, +44 01382383119, i.s.mackenzie@dundee.ac.uk

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

01 Jul 2022

Is this the analysis of the primary completion data?

Yes

Primary completion date

30 Oct 2021

Global end of trial reached?

Yes

Global end of trial date

31 Mar 2022

Was the trial ended prematurely?

Main objective of the trial

The primary aim is to determine whether the addition of allopurinol up to 600mg daily to usual therapy in patients with ischaemic heart disease (IHD) improves cardiovascular outcomes ie reduces the risk of heart attack, stroke or death from cardiovascular disease.

Protection of trial subjects

To minimise the chance of pain or discomfort whilst blood samples were taken, samples were taken by appropriately experienced nurses/doctors, following standard local blood sampling guidance. There was a potential risk that a small number of subjects randomised to the 'allopurinol' arm might develop skin reactions to allopurinol. Most of these were likely to be mild rashes, but occasionally serious rashes could occur. Any patient developing a rash on allopurinol was advised to stop treatment immediately and seek medical advice. Safety blood tests were checked at 6 weeks (+/-1 week) for patients randomised to allopurinol. The IDMC met regularly throughout the trial and reviewed pharmacovigilance data, protecting the safety of trial subjects.

Background therapy

Participants in both arms of the trial received usual care from their own healthcare providers as background therapy.

Evidence for comparator

Previous studies suggested a potential beneficial role of allopurinol in patients with ischaemic heart disease. Usual care, rather than placebo, was chosen as the comparator as this was a pragmatic clinical trial.

Actual start date of recruitment

07 Feb 2014

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: 6134

Worldwide total number of subjects

6134

EEA total number of subjects

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)

948

From 65 to 84 years

4946

85 years and over

240

Subject disposition

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Recruitment details

Screening period was from 7 February 2014 to 29 September 2017. A total of 6134 patients from England and Scotland (UK) consented to be enrolled in the trial and were assessed for eligibility. Eligible patients were aged over 60 years, with ischaemic heart disease but no history of gout.

Screening details

Of the 6134 patients who were consented and assessed for eligibility, 5937 were randomised. Of the 5937 patients randomised, 216 were excluded post-randomisation (184 did not meet eGFR entry criteria on screening bloods and 32 did not meet other inclusion/exclusion criteria), leaving 5721 validly randomised participants for the efficacy analyses.

Period 1 title

overall trial (overall period)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Not blinded

Blinding implementation details

The primary and secondary clinical endpoints adjudication was carried out by an independent adjudication committee blinded to randomisation/treatment group. Recruitment and blinded accumulation of study endpoints were reviewed by the trial steering committee on an ongoing basis. The pharmacovigilance group reviewed blinded SAEs.

Are arms mutually exclusive

Yes

Allopurinol

Arm description

Patients randomised to the allopurinol treatment arm with screening visit eGFR blood result greater than 60mL/min/1.73m2 received 100mg allopurinol daily for two weeks, then 300mg daily for two weeks then 600mg daily thereafter (given as 300mg twice daily). Participants with screening visit eGFR blood result 30-59mL/min/1.73m2 received 100mg allopurinol daily for two weeks, then 300mg daily thereafter. The daily dose of allopurinol could be reduced to lower than the maximum listed above if necessary by a physician during the study. Allopurinol could be stopped if necessary during the study.

Arm type

Experimental

Investigational medicinal product name

Allopurinol

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Up to 600mg daily given as 300mg twice daily if screening visit eGFR result greater than 60mL/min or up to 300mg daily if screening visit eGFR result 30-59mL/min/1.73m2

Usual care

Arm description

Subjects randomised to the usual care arm continued their usual care

Arm type

No intervention

Investigational medicinal product name

No investigational medicinal product assigned in this arm

Number of subjects in period 1 ^[1]	Allopurinol	Usual care
Started	2853	2868
Completed	2307	2489
Not completed	546	379
Adverse event, serious fatal	288	303
Consent withdrawn by subject	258	76

Notes
[1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
Justification: The worldwide no. of participants enrolled (consented and assessed for eligibility) was 6134. 197 were excluded and not randomised (167 ineligible pre-randomisation, 30 not randomised (screening visit not completed or participant withdrew consent before randomisation)). Age data was not available for 148 enrolled participants (these have been added into the most frequent 65-84yrs category). The no. of participants validly randomised and included in the mITT efficacy analysis population is 5721.

Baseline characteristics

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Reporting group title

Allopurinol

Reporting group description

Reporting group title

Usual care

Reporting group description

Subjects randomised to the usual care arm continued their usual care

Reporting group values	Allopurinol	Usual care	Total
Number of subjects	2853	2868	5721
Age categorical
Units: Subjects
In utero			0
Preterm newborn infants (gestational age < 37 wks)			0
Newborns (0-27 days)			0
Infants and toddlers (28 days-23 months)			0
Children (2-11 years)			0
Adolescents (12-17 years)			0
Adults (18-64 years)			0
From 65-84 years			0
85 years and over			0
Age continuous
Age at study entry
Units: years
arithmetic mean (standard deviation)	71.9 ± 6.7	72.0 ± 6.8	-
Gender categorical
Gender at study entry
Units: Subjects
Female	685	713	1398
Male	2168	2153	4321
Transgender	0	2	2

Subject analysis set title

Efficacy analysis set

Subject analysis set type

Modified intention-to-treat

Subject analysis set description

All validly randomised participants

Subject analysis set title

Safety analysis set

Subject analysis set type

Safety analysis

Subject analysis set description

All validly randomised participants in the allopurinol arm who started randomised medication plus all validly randomised participants in the usual care arm.

Subject analysis sets values	Efficacy analysis set	Safety analysis set
Number of subjects	5721	5673
Age categorical
Units: Subjects
In utero
Preterm newborn infants (gestational age < 37 wks)
Newborns (0-27 days)
Infants and toddlers (28 days-23 months)
Children (2-11 years)
Adolescents (12-17 years)
Adults (18-64 years)
From 65-84 years
85 years and over
Age continuous
Age at study entry
Units: years
arithmetic mean (standard deviation)	72.0 ± 6.8	71.9 ± 6.7
Gender categorical
Gender at study entry
Units: Subjects
Female	1398	1383
Male	4321	4288
Transgender	2	2

End points

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Reporting group title

Allopurinol

Reporting group description

Reporting group title

Usual care

Reporting group description

Subjects randomised to the usual care arm continued their usual care

Subject analysis set title

Efficacy analysis set

Subject analysis set type

Modified intention-to-treat

Subject analysis set description

All validly randomised participants

Subject analysis set title

Safety analysis set

Subject analysis set type

Safety analysis

Subject analysis set description

All validly randomised participants in the allopurinol arm who started randomised medication plus all validly randomised participants in the usual care arm.

Primary: Primary outcome (modified ITT)

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End point title

Primary outcome (modified ITT)

End point description

Composite endpoint: non-fatal myocardial infarction, non-fatal stroke or cardiovascular death

End point type

Primary

End point timeframe

Time from randomisation to first occurrence of a primary endpoint event.

End point values	Allopurinol	Usual care	Efficacy analysis set
Number of subjects analysed	2853	2868	5721
Units: Participants with a first event	314	325	639

Attachments

Primary outcome mITT

Modified intention-to-treat analysis

Statistical analysis description

The mITT analysis censored follow-up after death from any cause not included in the endpoint being considered, date of withdrawal of all consent to participate further in the study, or the end of the study, whichever occurred first.

Comparison groups

Usual care v Allopurinol

Number of subjects included in analysis

5721

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.65 ^[1]

Method

Regression, Cox

Parameter type

Hazard ratio (HR)

Point estimate

1.04

Confidence interval

level

95%

sides

2-sided

lower limit

0.89

upper limit

1.21

Notes
[1] - P-value was calculated with the Wald test

Secondary: Secondary - non-fatal myocardial infarction

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End point title

Secondary - non-fatal myocardial infarction

End point description

Non-fatal myocardial infarction

End point type

Secondary

End point timeframe

From randomisation to first occurrence of event in participant

End point values	Allopurinol	Usual care	Efficacy analysis set
Number of subjects analysed	2853	2868	5721
Units: Participants with a first event	156	172	328

Attachments

Secondary outcome: non-fatal myocardial infarction

Modified intention-to-treat analysis

Statistical analysis description

Comparison groups

Allopurinol v Usual care

Number of subjects included in analysis

5721

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.81 ^[2]

Method

Regression, Cox

Parameter type

Hazard ratio (HR)

Point estimate

0.97

Confidence interval

level

95%

sides

2-sided

lower limit

0.78

upper limit

1.21

Notes
[2] - P-value was calculated with the Wald test

Secondary: Secondary - non-fatal stroke

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End point title

Secondary - non-fatal stroke

End point description

Non-fatal stroke

End point type

Secondary

End point timeframe

From randomisation to first occurrence of event in participant

End point values	Allopurinol	Usual care	Efficacy analysis set
Number of subjects analysed	2853	2868	5721
Units: Participants with a first event	96	86	182

Attachments

Secondary outcome: non-fatal stroke

Modified intention-to-treat analysis

Statistical analysis description

Comparison groups

Usual care v Allopurinol

Number of subjects included in analysis

5721

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.23 ^[3]

Method

Regression, Cox

Parameter type

Hazard ratio (HR)

Point estimate

1.2

Confidence interval

level

95%

sides

2-sided

lower limit

0.89

upper limit

1.6

Notes
[3] - P-value was calculated with the Wald test

Secondary: Secondary - cardiovascular death

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End point title

Secondary - cardiovascular death

End point description

Cardiovascular death

End point type

Secondary

End point timeframe

From randomisation to first occurrence of event in participant

End point values	Allopurinol	Usual care	Efficacy analysis set
Number of subjects analysed	2853	2868	5721
Units: Participants with a first event	112	109	221

Attachments

Secondary outcome: cardiovascular death

Modified intention-to-treat analysis

Statistical analysis description

Comparison groups

Allopurinol v Usual care

Number of subjects included in analysis

5721

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.48 ^[4]

Method

Regression, Cox

Parameter type

Hazard ratio (HR)

Point estimate

1.1

Confidence interval

level

95%

sides

2-sided

lower limit

0.85

upper limit

1.43

Notes
[4] - P-value was calculated with the Wald test

Secondary: Secondary - all-cause mortality

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End point title

Secondary - all-cause mortality

End point description

All-cause mortality

End point type

Secondary

End point timeframe

From randomisation to first occurrence of event in participant

End point values	Allopurinol	Usual care	Efficacy analysis set
Number of subjects analysed	2853	2868	5721
Units: Participants with a first event	288	303	591

Attachments

Secondary outcome: all-cause mortality

Modified intention-to-treat analysis

Statistical analysis description

Comparison groups

Allopurinol v Usual care

Number of subjects included in analysis

5721

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.77 ^[5]

Method

Regression, Cox

Parameter type

Hazard ratio (HR)

Point estimate

1.02

Confidence interval

level

95%

sides

2-sided

lower limit

0.87

upper limit

1.2

Notes
[5] - P-value was calculated with the Wald test

Adverse events

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Timeframe for reporting adverse events

Summaries of AEs are presented from randomisation to the end of the study treatment period, withdrawal of consent or death (whichever came first).

Adverse event reporting additional description

SAEs (related or unrelated to study treatment) and AEs only considered related to treatment were recorded during the study and collected separately. Related SAE data do not overlap with related AE data. SAEs were followed up for 30 days after the end of the study unless participants had withdrawn consent.

Assessment type

Non-systematic

Dictionary name

MedDRA

Dictionary version

15.1

Reporting group title

Safety analysis set - allopurinol arm

Reporting group description

All validly randomised participants allocated to the allopurinol arm who took at least one dose of randomised medication. Non-serious AE above threshold of 5% are reported here.

Reporting group title

Safety analysis set - usual care arm

Reporting group description

All validly randomised participants allocated to the usual care arm.

Serious adverse events	Safety analysis set - allopurinol arm	Safety analysis set - usual care arm
Total subjects affected by serious adverse events
subjects affected / exposed	2036 / 2805 (72.58%)	2194 / 2868 (76.50%)
number of deaths (all causes)	288	303
number of deaths resulting from adverse events	288	303
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin cancer
subjects affected / exposed	104 / 2805 (3.71%)	129 / 2868 (4.50%)
occurrences causally related to treatment / all	0 / 124	0 / 175
deaths causally related to treatment / all	0 / 0	0 / 0
Prostate cancer
subjects affected / exposed	78 / 2805 (2.78%)	71 / 2868 (2.48%)
occurrences causally related to treatment / all	0 / 100	0 / 89
deaths causally related to treatment / all	0 / 2	0 / 1
Large intestine benign neoplasm
subjects affected / exposed	35 / 2805 (1.25%)	58 / 2868 (2.02%)
occurrences causally related to treatment / all	0 / 36	0 / 60
deaths causally related to treatment / all	0 / 0	0 / 0
Lung neoplasm malignant
subjects affected / exposed	23 / 2805 (0.82%)	35 / 2868 (1.22%)
occurrences causally related to treatment / all	0 / 29	0 / 48
deaths causally related to treatment / all	0 / 10	0 / 14
Benign colonic neoplasm
subjects affected / exposed	16 / 2805 (0.57%)	31 / 2868 (1.08%)
occurrences causally related to treatment / all	0 / 17	0 / 32
deaths causally related to treatment / all	0 / 0	0 / 0
Bladder cancer
subjects affected / exposed	23 / 2805 (0.82%)	19 / 2868 (0.66%)
occurrences causally related to treatment / all	0 / 29	0 / 31
deaths causally related to treatment / all	0 / 2	0 / 3
External ear neoplasm malignant
subjects affected / exposed	13 / 2805 (0.46%)	19 / 2868 (0.66%)
occurrences causally related to treatment / all	0 / 15	0 / 23
deaths causally related to treatment / all	0 / 0	0 / 0
Lung carcinoma cell type unspecified stage 0
subjects affected / exposed	15 / 2805 (0.53%)	17 / 2868 (0.59%)
occurrences causally related to treatment / all	0 / 17	0 / 22
deaths causally related to treatment / all	0 / 0	0 / 2
Colon cancer
subjects affected / exposed	15 / 2805 (0.53%)	15 / 2868 (0.52%)
occurrences causally related to treatment / all	0 / 20	0 / 24
deaths causally related to treatment / all	0 / 0	0 / 0
Neoplasm malignant
subjects affected / exposed	11 / 2805 (0.39%)	13 / 2868 (0.45%)
occurrences causally related to treatment / all	0 / 12	0 / 18
deaths causally related to treatment / all	0 / 0	0 / 2
Carcinoma in situ of skin
subjects affected / exposed	10 / 2805 (0.36%)	13 / 2868 (0.45%)
occurrences causally related to treatment / all	0 / 10	0 / 14
deaths causally related to treatment / all	0 / 0	0 / 0
Benign anorectal neoplasm
subjects affected / exposed	7 / 2805 (0.25%)	13 / 2868 (0.45%)
occurrences causally related to treatment / all	0 / 8	0 / 13
deaths causally related to treatment / all	0 / 0	0 / 0
Breast cancer
subjects affected / exposed	8 / 2805 (0.29%)	11 / 2868 (0.38%)
occurrences causally related to treatment / all	0 / 10	0 / 11
deaths causally related to treatment / all	0 / 0	0 / 0
Malignant neoplasm of eyelid
subjects affected / exposed	8 / 2805 (0.29%)	10 / 2868 (0.35%)
occurrences causally related to treatment / all	0 / 11	0 / 12
deaths causally related to treatment / all	0 / 0	0 / 0
Lung cancer metastatic
subjects affected / exposed	9 / 2805 (0.32%)	8 / 2868 (0.28%)
occurrences causally related to treatment / all	0 / 9	0 / 8
deaths causally related to treatment / all	0 / 7	0 / 6
Malignant melanoma
subjects affected / exposed	9 / 2805 (0.32%)	8 / 2868 (0.28%)
occurrences causally related to treatment / all	0 / 11	0 / 9
deaths causally related to treatment / all	0 / 1	0 / 0
Oesophageal carcinoma
subjects affected / exposed	9 / 2805 (0.32%)	7 / 2868 (0.24%)
occurrences causally related to treatment / all	0 / 14	0 / 16
deaths causally related to treatment / all	0 / 2	0 / 2
Bladder neoplasm
subjects affected / exposed	9 / 2805 (0.32%)	6 / 2868 (0.21%)
occurrences causally related to treatment / all	0 / 12	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
Gastric cancer
subjects affected / exposed	5 / 2805 (0.18%)	10 / 2868 (0.35%)
occurrences causally related to treatment / all	0 / 6	0 / 16
deaths causally related to treatment / all	0 / 2	0 / 1
Rectal cancer
subjects affected / exposed	5 / 2805 (0.18%)	10 / 2868 (0.35%)
occurrences causally related to treatment / all	0 / 5	0 / 14
deaths causally related to treatment / all	0 / 0	0 / 2
Pancreatic carcinoma
subjects affected / exposed	6 / 2805 (0.21%)	8 / 2868 (0.28%)
occurrences causally related to treatment / all	0 / 10	0 / 14
deaths causally related to treatment / all	0 / 4	0 / 5
Metastatic neoplasm
subjects affected / exposed	5 / 2805 (0.18%)	8 / 2868 (0.28%)
occurrences causally related to treatment / all	0 / 5	0 / 8
deaths causally related to treatment / all	0 / 4	0 / 7
Chronic lymphocytic leukaemia
subjects affected / exposed	7 / 2805 (0.25%)	5 / 2868 (0.17%)
occurrences causally related to treatment / all	0 / 8	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Malignant melanoma in situ
subjects affected / exposed	8 / 2805 (0.29%)	4 / 2868 (0.14%)
occurrences causally related to treatment / all	0 / 9	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Non-Hodgkin's lymphoma
subjects affected / exposed	3 / 2805 (0.11%)	9 / 2868 (0.31%)
occurrences causally related to treatment / all	0 / 3	0 / 16
deaths causally related to treatment / all	0 / 2	0 / 0
Prostate cancer metastatic
subjects affected / exposed	5 / 2805 (0.18%)	6 / 2868 (0.21%)
occurrences causally related to treatment / all	0 / 5	0 / 6
deaths causally related to treatment / all	0 / 2	0 / 4
Renal cancer
subjects affected / exposed	6 / 2805 (0.21%)	5 / 2868 (0.17%)
occurrences causally related to treatment / all	0 / 6	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Seborrhoeic keratosis
subjects affected / exposed	6 / 2805 (0.21%)	5 / 2868 (0.17%)
occurrences causally related to treatment / all	0 / 6	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Bladder cancer stage 0, with cancer in situ
subjects affected / exposed	5 / 2805 (0.18%)	5 / 2868 (0.17%)
occurrences causally related to treatment / all	0 / 7	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Melanocytic naevus
subjects affected / exposed	6 / 2805 (0.21%)	4 / 2868 (0.14%)
occurrences causally related to treatment / all	0 / 6	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Plasma cell myeloma
subjects affected / exposed	3 / 2805 (0.11%)	7 / 2868 (0.24%)
occurrences causally related to treatment / all	0 / 4	0 / 13
deaths causally related to treatment / all	0 / 0	0 / 1
Gastrointestinal carcinoma
subjects affected / exposed	4 / 2805 (0.14%)	5 / 2868 (0.17%)
occurrences causally related to treatment / all	0 / 4	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 1
Metastases to bone
subjects affected / exposed	3 / 2805 (0.11%)	6 / 2868 (0.21%)
occurrences causally related to treatment / all	0 / 5	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Breast cancer female
subjects affected / exposed	5 / 2805 (0.18%)	3 / 2868 (0.10%)
occurrences causally related to treatment / all	0 / 6	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Malignant neoplasm of unknown primary site
subjects affected / exposed	4 / 2805 (0.14%)	4 / 2868 (0.14%)
occurrences causally related to treatment / all	0 / 7	0 / 5
deaths causally related to treatment / all	0 / 3	0 / 1
Myelodysplastic syndrome
subjects affected / exposed	6 / 2805 (0.21%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 14	0 / 2
deaths causally related to treatment / all	0 / 1	0 / 0
Bronchial carcinoma
subjects affected / exposed	5 / 2805 (0.18%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 5	0 / 2
deaths causally related to treatment / all	0 / 1	0 / 0
Multiple myeloma
subjects affected / exposed	1 / 2805 (0.04%)	6 / 2868 (0.21%)
occurrences causally related to treatment / all	0 / 1	0 / 8
deaths causally related to treatment / all	0 / 0	0 / 2
Ovarian cancer
subjects affected / exposed	5 / 2805 (0.18%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 10	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 1
Brain neoplasm malignant
subjects affected / exposed	3 / 2805 (0.11%)	3 / 2868 (0.10%)
occurrences causally related to treatment / all	0 / 5	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 1
Metastases to central nervous system
subjects affected / exposed	2 / 2805 (0.07%)	4 / 2868 (0.14%)
occurrences causally related to treatment / all	0 / 2	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Tongue neoplasm malignant stage unspecified
subjects affected / exposed	4 / 2805 (0.14%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 5	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Basal cell carcinoma
subjects affected / exposed	1 / 2805 (0.04%)	4 / 2868 (0.14%)
occurrences causally related to treatment / all	0 / 1	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Benign neoplasm of skin
subjects affected / exposed	2 / 2805 (0.07%)	3 / 2868 (0.10%)
occurrences causally related to treatment / all	0 / 3	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Endometrial cancer
subjects affected / exposed	2 / 2805 (0.07%)	3 / 2868 (0.10%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Metastases to liver
subjects affected / exposed	3 / 2805 (0.11%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 4	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Pancreatic carcinoma metastatic
subjects affected / exposed	3 / 2805 (0.11%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 3	0 / 2
Benign laryngeal neoplasm
subjects affected / exposed	3 / 2805 (0.11%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 5	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Colorectal cancer
subjects affected / exposed	2 / 2805 (0.07%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Colorectal cancer metastatic
subjects affected / exposed	1 / 2805 (0.04%)	3 / 2868 (0.10%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 1	0 / 0
Hepatic neoplasm malignant
subjects affected / exposed	3 / 2805 (0.11%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 5	0 / 4
deaths causally related to treatment / all	0 / 2	0 / 0
Lip and/or oral cavity cancer
subjects affected / exposed	1 / 2805 (0.04%)	3 / 2868 (0.10%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Mesothelioma
subjects affected / exposed	3 / 2805 (0.11%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 8	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Metastases to pleura
subjects affected / exposed	1 / 2805 (0.04%)	3 / 2868 (0.10%)
occurrences causally related to treatment / all	0 / 1	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Monoclonal gammopathy
subjects affected / exposed	2 / 2805 (0.07%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Non-small cell lung cancer
subjects affected / exposed	1 / 2805 (0.04%)	3 / 2868 (0.10%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 1
Squamous cell carcinoma
subjects affected / exposed	3 / 2805 (0.11%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Uterine cancer
subjects affected / exposed	2 / 2805 (0.07%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Acute myeloid leukaemia
subjects affected / exposed	2 / 2805 (0.07%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 5	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 0
Benign salivary gland neoplasm
subjects affected / exposed	1 / 2805 (0.04%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Cholangiocarcinoma
subjects affected / exposed	1 / 2805 (0.04%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 1	0 / 2
Colon cancer metastatic
subjects affected / exposed	1 / 2805 (0.04%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 1	0 / 2
Connective tissue neoplasm
subjects affected / exposed	1 / 2805 (0.04%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Diffuse large B-cell lymphoma
subjects affected / exposed	2 / 2805 (0.07%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 1
Glioblastoma
subjects affected / exposed	2 / 2805 (0.07%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 2	0 / 1
Haemangioma
subjects affected / exposed	3 / 2805 (0.11%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Laryngeal cancer
subjects affected / exposed	1 / 2805 (0.04%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Lipoma
subjects affected / exposed	1 / 2805 (0.04%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Lung adenocarcinoma
subjects affected / exposed	1 / 2805 (0.04%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 1	0 / 0
Metastases to lymph nodes
subjects affected / exposed	1 / 2805 (0.04%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Oral neoplasm benign
subjects affected / exposed	2 / 2805 (0.07%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Ovarian cancer metastatic
subjects affected / exposed	2 / 2805 (0.07%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 2	0 / 0
Pleural mesothelioma
subjects affected / exposed	2 / 2805 (0.07%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Prostate cancer stage 0
subjects affected / exposed	2 / 2805 (0.07%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pyogenic granuloma
subjects affected / exposed	1 / 2805 (0.04%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Renal neoplasm
subjects affected / exposed	2 / 2805 (0.07%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Small cell lung cancer stage unspecified
subjects affected / exposed	1 / 2805 (0.04%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 2
Tonsil cancer
subjects affected / exposed	1 / 2805 (0.04%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Waldenstrom's macroglobulinaemia
subjects affected / exposed	0 / 2805 (0.00%)	3 / 2868 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
B-cell lymphoma
subjects affected / exposed	0 / 2805 (0.00%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 1
Benign gastric neoplasm
subjects affected / exposed	0 / 2805 (0.00%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Benign ovarian tumour
subjects affected / exposed	2 / 2805 (0.07%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Benign renal neoplasm
subjects affected / exposed	1 / 2805 (0.04%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Bile duct cancer
subjects affected / exposed	1 / 2805 (0.04%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Breast cancer metastatic
subjects affected / exposed	1 / 2805 (0.04%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Breast cancer recurrent
subjects affected / exposed	1 / 2805 (0.04%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Colon cancer stage 0
subjects affected / exposed	0 / 2805 (0.00%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Essential thrombocythaemia
subjects affected / exposed	0 / 2805 (0.00%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Gallbladder cancer
subjects affected / exposed	1 / 2805 (0.04%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 1
Gastrointestinal neoplasm
subjects affected / exposed	0 / 2805 (0.00%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatic cancer metastatic
subjects affected / exposed	1 / 2805 (0.04%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 1
Hepatocellular carcinoma
subjects affected / exposed	1 / 2805 (0.04%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 1
Hodgkin's disease
subjects affected / exposed	1 / 2805 (0.04%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 0
Hodgkin's disease mixed cellularity stage unspecified
subjects affected / exposed	1 / 2805 (0.04%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 5	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Hypopharyngeal cancer
subjects affected / exposed	1 / 2805 (0.04%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 0
Lip and/or oral cavity cancer stage 0
subjects affected / exposed	0 / 2805 (0.00%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Lymphoma
subjects affected / exposed	2 / 2805 (0.07%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Malignant peritoneal neoplasm
subjects affected / exposed	1 / 2805 (0.04%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 5	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Meningioma benign
subjects affected / exposed	2 / 2805 (0.07%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Metastases to abdominal cavity
subjects affected / exposed	1 / 2805 (0.04%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Metastatic renal cell carcinoma
subjects affected / exposed	1 / 2805 (0.04%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 0
Myeloproliferative neoplasm
subjects affected / exposed	1 / 2805 (0.04%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Neoplasm skin
subjects affected / exposed	1 / 2805 (0.04%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Non-small cell lung cancer metastatic
subjects affected / exposed	0 / 2805 (0.00%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 2
Oesophageal adenocarcinoma
subjects affected / exposed	1 / 2805 (0.04%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 1	0 / 1
Pancreatic neoplasm
subjects affected / exposed	2 / 2805 (0.07%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Parathyroid tumour benign
subjects affected / exposed	1 / 2805 (0.04%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Prostate cancer recurrent
subjects affected / exposed	2 / 2805 (0.07%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Renal cancer metastatic
subjects affected / exposed	0 / 2805 (0.00%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Small intestine carcinoma
subjects affected / exposed	1 / 2805 (0.04%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 2	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 1
Superficial spreading melanoma stage unspecified
subjects affected / exposed	0 / 2805 (0.00%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Thyroid cancer
subjects affected / exposed	1 / 2805 (0.04%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Vulval cancer
subjects affected / exposed	1 / 2805 (0.04%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 1
Acoustic neuroma
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Acute myelomonocytic leukaemia
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Adenocarcinoma
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Adenoid cystic carcinoma
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Adenoma benign
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Adenosquamous cell lung cancer
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Adrenal gland cancer
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Anaplastic large-cell lymphoma
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Benign duodenal neoplasm
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Benign neoplasm
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Benign neoplasm of adrenal gland
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Benign neoplasm of bladder
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Benign neoplasm of spinal cord
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Benign neoplasm of thymus
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Benign pancreatic neoplasm
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Bladder transitional cell carcinoma
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Bladder transitional cell carcinoma stage II
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Bone neoplasm malignant
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 1
Bowen's disease
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Brain neoplasm
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Carcinoma in situ of penis
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cervix carcinoma
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cervix carcinoma stage I
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Chronic myeloid leukaemia
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Colon cancer stage I
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Colon neoplasm
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Diffuse large B-cell lymphoma recurrent
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 1
Fallopian tube cancer
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gammopathy
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastric cancer stage 0
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gastric neoplasm
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal cancer metastatic
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Gastrointestinal stromal tumour
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Genital neoplasm malignant female
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Glioma
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Glottis carcinoma
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Haematological malignancy
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatic cancer
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatobiliary cancer
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Hodgkin's disease lymphocyte predominance type stage unspecified
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Intraductal proliferative breast lesion
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Invasive lobular breast carcinoma
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Large intestine carcinoma
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Laryngeal cancer stage 0
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Laryngeal neoplasm
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Light chain disease
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Lip neoplasm malignant stage unspecified
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Lung adenocarcinoma metastatic
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Lung carcinoma cell type unspecified stage I
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
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 stage II
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Lung squamous cell carcinoma recurrent
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Lung squamous cell carcinoma stage unspecified
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Malignant melanoma of eyelid
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Malignant melanoma stage I
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Malignant neoplasm progression
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Malignant pleural effusion
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Malignant urinary tract neoplasm
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Meningioma
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Mesothelioma malignant advanced
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Metastases to lung
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Metastases to spine
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Metastasis
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Metastatic carcinoma of the bladder
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Metastatic gastric cancer
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Metastatic lymphoma
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
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	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Myelofibrosis
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Myeloid leukaemia
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Myeloproliferative disorder
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Nasal neoplasm
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Neoplasm
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Nervous system neoplasm benign
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Neuroendocrine carcinoma metastatic
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Neuroendocrine carcinoma of the skin
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 1
Non-small cell lung cancer stage I
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Ocular neoplasm
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Oesophageal cancer metastatic
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Oesophageal carcinoma stage 0
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Oesophageal neoplasm
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Ovarian cancer stage III
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Penile malignant neoplasm
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Penis carcinoma
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Peritoneal neoplasm
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Plasmacytoma
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Polycythaemia vera
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Primary mediastinal large B-cell lymphoma
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Prostate cancer stage IV
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pseudomyxoma peritonei
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Rectal cancer metastatic
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Rectal cancer stage 0
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Rectal neoplasm
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Rectal polyp
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Renal cell carcinoma
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Renal oncocytoma
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Salivary gland cancer
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Salivary gland neoplasm
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Skin papilloma
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Small cell lung cancer
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Small cell lung cancer metastatic
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Small intestine adenocarcinoma
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Soft tissue sarcoma
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Spinal meningioma benign
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Squamous cell carcinoma of lung
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
T-cell lymphoma
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Teratoma
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Thymoma malignant
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Transitional cell carcinoma
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Transitional cell carcinoma metastatic
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Tumour haemorrhage
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Uterine leiomyoma
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Vulval cancer metastatic
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Non-Hodgkin's lymphoma stage IV
subjects affected / exposed	2 / 2805 (0.07%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Vascular disorders
Arteriosclerosis
subjects affected / exposed	101 / 2805 (3.60%)	96 / 2868 (3.35%)
occurrences causally related to treatment / all	0 / 117	0 / 109
deaths causally related to treatment / all	0 / 5	0 / 2
Circulatory collapse
subjects affected / exposed	67 / 2805 (2.39%)	75 / 2868 (2.62%)
occurrences causally related to treatment / all	0 / 78	0 / 81
deaths causally related to treatment / all	0 / 0	0 / 0
Aortic stenosis
subjects affected / exposed	18 / 2805 (0.64%)	21 / 2868 (0.73%)
occurrences causally related to treatment / all	0 / 21	0 / 22
deaths causally related to treatment / all	0 / 1	0 / 1
Aortic aneurysm
subjects affected / exposed	22 / 2805 (0.78%)	15 / 2868 (0.52%)
occurrences causally related to treatment / all	0 / 26	0 / 16
deaths causally related to treatment / all	0 / 0	0 / 0
Orthostatic hypotension
subjects affected / exposed	19 / 2805 (0.68%)	15 / 2868 (0.52%)
occurrences causally related to treatment / all	0 / 20	0 / 16
deaths causally related to treatment / all	0 / 0	0 / 0
Peripheral vascular disorder
subjects affected / exposed	9 / 2805 (0.32%)	12 / 2868 (0.42%)
occurrences causally related to treatment / all	0 / 11	0 / 14
deaths causally related to treatment / all	0 / 0	0 / 0
Deep vein thrombosis
subjects affected / exposed	11 / 2805 (0.39%)	7 / 2868 (0.24%)
occurrences causally related to treatment / all	0 / 11	0 / 9
deaths causally related to treatment / all	0 / 0	0 / 0
Peripheral arterial occlusive disease
subjects affected / exposed	4 / 2805 (0.14%)	12 / 2868 (0.42%)
occurrences causally related to treatment / all	0 / 4	0 / 20
deaths causally related to treatment / all	0 / 0	0 / 1
Arterial stenosis
subjects affected / exposed	4 / 2805 (0.14%)	11 / 2868 (0.38%)
occurrences causally related to treatment / all	0 / 4	0 / 13
deaths causally related to treatment / all	0 / 0	0 / 0
Peripheral ischaemia
subjects affected / exposed	4 / 2805 (0.14%)	11 / 2868 (0.38%)
occurrences causally related to treatment / all	0 / 4	0 / 14
deaths causally related to treatment / all	0 / 0	0 / 0
Hypotension
subjects affected / exposed	5 / 2805 (0.18%)	7 / 2868 (0.24%)
occurrences causally related to treatment / all	0 / 5	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
Varicose vein
subjects affected / exposed	4 / 2805 (0.14%)	8 / 2868 (0.28%)
occurrences causally related to treatment / all	0 / 5	0 / 8
deaths causally related to treatment / all	0 / 0	0 / 0
Aortic aneurysm rupture
subjects affected / exposed	6 / 2805 (0.21%)	5 / 2868 (0.17%)
occurrences causally related to treatment / all	0 / 6	0 / 5
deaths causally related to treatment / all	0 / 4	0 / 4
Temporal arteritis
subjects affected / exposed	4 / 2805 (0.14%)	7 / 2868 (0.24%)
occurrences causally related to treatment / all	0 / 4	0 / 8
deaths causally related to treatment / all	0 / 0	0 / 0
Essential hypertension
subjects affected / exposed	2 / 2805 (0.07%)	7 / 2868 (0.24%)
occurrences causally related to treatment / all	0 / 2	0 / 9
deaths causally related to treatment / all	0 / 0	0 / 0
Hypertension
subjects affected / exposed	3 / 2805 (0.11%)	5 / 2868 (0.17%)
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	3 / 2805 (0.11%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 4	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Intermittent claudication
subjects affected / exposed	3 / 2805 (0.11%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Peripheral artery aneurysm
subjects affected / exposed	2 / 2805 (0.07%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Peripheral embolism
subjects affected / exposed	1 / 2805 (0.04%)	3 / 2868 (0.10%)
occurrences causally related to treatment / all	0 / 2	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Varicophlebitis
subjects affected / exposed	3 / 2805 (0.11%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Varicose ulceration
subjects affected / exposed	3 / 2805 (0.11%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Lymphoedema
subjects affected / exposed	2 / 2805 (0.07%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Peripheral venous disease
subjects affected / exposed	1 / 2805 (0.04%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Extremity necrosis
subjects affected / exposed	1 / 2805 (0.04%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Peripheral artery stenosis
subjects affected / exposed	1 / 2805 (0.04%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Thrombophlebitis superficial
subjects affected / exposed	0 / 2805 (0.00%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Aneurysm
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Aortic dissection
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Aortic embolus
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Arterial disorder
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Bleeding varicose vein
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Embolism venous
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Haematoma
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Haemorrhage
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Haemorrhagic infarction
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Iliac artery embolism
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Intra-abdominal haematoma
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Ischaemia
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Microscopic polyangiitis
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Phlebitis
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Post thrombotic syndrome
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Shock
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Vascular compression
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Vasculitis
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Vein disorder
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Venous insufficiency
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Surgical and medical procedures
Percutaneous coronary intervention
subjects affected / exposed	36 / 2805 (1.28%)	52 / 2868 (1.81%)
occurrences causally related to treatment / all	0 / 39	0 / 54
deaths causally related to treatment / all	0 / 0	0 / 1
Hip arthroplasty
subjects affected / exposed	30 / 2805 (1.07%)	34 / 2868 (1.19%)
occurrences causally related to treatment / all	0 / 32	0 / 36
deaths causally related to treatment / all	0 / 0	0 / 0
Knee arthroplasty
subjects affected / exposed	26 / 2805 (0.93%)	32 / 2868 (1.12%)
occurrences causally related to treatment / all	0 / 28	0 / 37
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac pacemaker insertion
subjects affected / exposed	26 / 2805 (0.93%)	23 / 2868 (0.80%)
occurrences causally related to treatment / all	0 / 27	0 / 23
deaths causally related to treatment / all	0 / 0	0 / 0
Coronary artery bypass
subjects affected / exposed	22 / 2805 (0.78%)	24 / 2868 (0.84%)
occurrences causally related to treatment / all	0 / 22	0 / 26
deaths causally related to treatment / all	0 / 1	0 / 0
Coronary arterial stent insertion
subjects affected / exposed	22 / 2805 (0.78%)	17 / 2868 (0.59%)
occurrences causally related to treatment / all	0 / 23	0 / 18
deaths causally related to treatment / all	0 / 0	0 / 0
Postoperative care
subjects affected / exposed	16 / 2805 (0.57%)	22 / 2868 (0.77%)
occurrences causally related to treatment / all	0 / 18	0 / 27
deaths causally related to treatment / all	0 / 0	0 / 0
Aortic valve replacement
subjects affected / exposed	17 / 2805 (0.61%)	10 / 2868 (0.35%)
occurrences causally related to treatment / all	0 / 18	0 / 10
deaths causally related to treatment / all	0 / 0	0 / 0
Medical device implantation
subjects affected / exposed	13 / 2805 (0.46%)	13 / 2868 (0.45%)
occurrences causally related to treatment / all	0 / 17	0 / 15
deaths causally related to treatment / all	0 / 0	0 / 0
Angioplasty
subjects affected / exposed	9 / 2805 (0.32%)	15 / 2868 (0.52%)
occurrences causally related to treatment / all	0 / 9	0 / 15
deaths causally related to treatment / all	0 / 0	0 / 0
Cataract operation
subjects affected / exposed	8 / 2805 (0.29%)	14 / 2868 (0.49%)
occurrences causally related to treatment / all	0 / 12	0 / 14
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac pacemaker adjustment
subjects affected / exposed	11 / 2805 (0.39%)	7 / 2868 (0.24%)
occurrences causally related to treatment / all	0 / 11	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
Cholecystectomy
subjects affected / exposed	8 / 2805 (0.29%)	8 / 2868 (0.28%)
occurrences causally related to treatment / all	0 / 8	0 / 8
deaths causally related to treatment / all	0 / 0	0 / 0
Stent placement
subjects affected / exposed	8 / 2805 (0.29%)	8 / 2868 (0.28%)
occurrences causally related to treatment / all	0 / 8	0 / 8
deaths causally related to treatment / all	0 / 0	0 / 0
Inguinal hernia repair
subjects affected / exposed	4 / 2805 (0.14%)	10 / 2868 (0.35%)
occurrences causally related to treatment / all	0 / 4	0 / 10
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac ablation
subjects affected / exposed	6 / 2805 (0.21%)	6 / 2868 (0.21%)
occurrences causally related to treatment / all	0 / 6	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Implantable defibrillator insertion
subjects affected / exposed	4 / 2805 (0.14%)	8 / 2868 (0.28%)
occurrences causally related to treatment / all	0 / 4	0 / 8
deaths causally related to treatment / all	0 / 0	0 / 0
Aortic aneurysm repair
subjects affected / exposed	3 / 2805 (0.11%)	7 / 2868 (0.24%)
occurrences causally related to treatment / all	0 / 3	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
Cardioversion
subjects affected / exposed	4 / 2805 (0.14%)	6 / 2868 (0.21%)
occurrences causally related to treatment / all	0 / 4	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Transurethral prostatectomy
subjects affected / exposed	5 / 2805 (0.18%)	5 / 2868 (0.17%)
occurrences causally related to treatment / all	0 / 5	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Spinal decompression
subjects affected / exposed	3 / 2805 (0.11%)	6 / 2868 (0.21%)
occurrences causally related to treatment / all	0 / 3	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac resynchronisation therapy
subjects affected / exposed	5 / 2805 (0.18%)	3 / 2868 (0.10%)
occurrences causally related to treatment / all	0 / 5	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Colectomy
subjects affected / exposed	4 / 2805 (0.14%)	4 / 2868 (0.14%)
occurrences causally related to treatment / all	0 / 4	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 1
Hospitalisation
subjects affected / exposed	6 / 2805 (0.21%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 6	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Coronary angioplasty
subjects affected / exposed	1 / 2805 (0.04%)	6 / 2868 (0.21%)
occurrences causally related to treatment / all	0 / 1	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Leg amputation
subjects affected / exposed	1 / 2805 (0.04%)	6 / 2868 (0.21%)
occurrences causally related to treatment / all	0 / 1	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
Peripheral artery angioplasty
subjects affected / exposed	4 / 2805 (0.14%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 5	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Hysterectomy
subjects affected / exposed	1 / 2805 (0.04%)	4 / 2868 (0.14%)
occurrences causally related to treatment / all	0 / 1	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Mitral valve replacement
subjects affected / exposed	3 / 2805 (0.11%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Shoulder arthroplasty
subjects affected / exposed	2 / 2805 (0.07%)	3 / 2868 (0.10%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Vascular graft
subjects affected / exposed	1 / 2805 (0.04%)	4 / 2868 (0.14%)
occurrences causally related to treatment / all	0 / 1	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Aortic valve repair
subjects affected / exposed	3 / 2805 (0.11%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac pacemaker replacement
subjects affected / exposed	2 / 2805 (0.07%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Hernia repair
subjects affected / exposed	2 / 2805 (0.07%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Peripheral artery bypass
subjects affected / exposed	0 / 2805 (0.00%)	4 / 2868 (0.14%)
occurrences causally related to treatment / all	0 / 0	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Prostatectomy
subjects affected / exposed	0 / 2805 (0.00%)	4 / 2868 (0.14%)
occurrences causally related to treatment / all	0 / 0	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Renal stone removal
subjects affected / exposed	2 / 2805 (0.07%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Skin neoplasm excision
subjects affected / exposed	2 / 2805 (0.07%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Stoma care
subjects affected / exposed	2 / 2805 (0.07%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
cardiac pacemaker revision
subjects affected / exposed	2 / 2805 (0.07%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Carotid endarterectomy
subjects affected / exposed	0 / 2805 (0.00%)	3 / 2868 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Colostomy
subjects affected / exposed	0 / 2805 (0.00%)	3 / 2868 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Coronary revascularisation
subjects affected / exposed	1 / 2805 (0.04%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Elective procedure
subjects affected / exposed	1 / 2805 (0.04%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Intervertebral disc operation
subjects affected / exposed	1 / 2805 (0.04%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Lymphadenectomy
subjects affected / exposed	2 / 2805 (0.07%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Peripheral endarterectomy
subjects affected / exposed	0 / 2805 (0.00%)	3 / 2868 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Spinal operation
subjects affected / exposed	2 / 2805 (0.07%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Transurethral bladder resection
subjects affected / exposed	1 / 2805 (0.04%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Urethrotomy
subjects affected / exposed	1 / 2805 (0.04%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Aortic bypass
subjects affected / exposed	1 / 2805 (0.04%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Arthrodesis
subjects affected / exposed	0 / 2805 (0.00%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Bladder neoplasm surgery
subjects affected / exposed	1 / 2805 (0.04%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac operation
subjects affected / exposed	0 / 2805 (0.00%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac pacemaker removal
subjects affected / exposed	1 / 2805 (0.04%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cautery to nose
subjects affected / exposed	2 / 2805 (0.07%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cystoprostatectomy
subjects affected / exposed	1 / 2805 (0.04%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Elective surgery
subjects affected / exposed	1 / 2805 (0.04%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Endarterectomy
subjects affected / exposed	1 / 2805 (0.04%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Foot amputation
subjects affected / exposed	1 / 2805 (0.04%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrectomy
subjects affected / exposed	0 / 2805 (0.00%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Heart valve replacement
subjects affected / exposed	1 / 2805 (0.04%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hepaticojejunostomy
subjects affected / exposed	1 / 2805 (0.04%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hip surgery
subjects affected / exposed	0 / 2805 (0.00%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Implantable cardiac monitor insertion
subjects affected / exposed	1 / 2805 (0.04%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Intraocular lens implant
subjects affected / exposed	1 / 2805 (0.04%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Keratoplasty
subjects affected / exposed	2 / 2805 (0.07%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Mastectomy
subjects affected / exposed	1 / 2805 (0.04%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Nephrectomy
subjects affected / exposed	1 / 2805 (0.04%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Open reduction of fracture
subjects affected / exposed	1 / 2805 (0.04%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Polypectomy
subjects affected / exposed	1 / 2805 (0.04%)	1 / 2868 (0.03%)
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 / 2805 (0.04%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Prophylactic chemotherapy
subjects affected / exposed	2 / 2805 (0.07%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Prostatic operation
subjects affected / exposed	0 / 2805 (0.00%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Resection of rectum
subjects affected / exposed	0 / 2805 (0.00%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Salpingo-oophorectomy bilateral
subjects affected / exposed	0 / 2805 (0.00%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Shoulder operation
subjects affected / exposed	1 / 2805 (0.04%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Spinal fusion surgery
subjects affected / exposed	0 / 2805 (0.00%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Therapeutic procedure
subjects affected / exposed	1 / 2805 (0.04%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Thyroidectomy
subjects affected / exposed	1 / 2805 (0.04%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Toe amputation
subjects affected / exposed	1 / 2805 (0.04%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Abdominal hernia repair
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Abdominal operation
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Abscess drainage
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Adhesiolysis
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Alcohol detoxification
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Amputation of penis
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Aneurysm repair
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Ankle arthroplasty
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Arterial stent insertion
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Atherectomy
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Balloon atrial septostomy
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Breast lump removal
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Bunion operation
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Carotid artery stent insertion
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Carpal tunnel decompression
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Choledocholithotomy
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cholelithotomy
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Circumcision
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Colon polypectomy
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Corneal transplant
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cyst removal
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Debridement
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Drain placement
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Drug therapy changed
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Endotracheal intubation
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Enterostomy
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Epidural injection
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Eye laser surgery
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Eye operation
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Fasciectomy
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Glaucoma surgery
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Heart valve operation
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Incisional hernia repair
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Internal fixation of fracture
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Intestinal adhesion lysis
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Intestinal operation
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Intestinal stent insertion
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Joint manipulation
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Knee operation
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Laparotomy
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Laryngectomy
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Lesion excision
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Lithotripsy
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Lung operation
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
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 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Medical device change
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Meniscus removal
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Mitral valve repair
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Nasal cavity packing
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Omentectomy
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Orthopaedic procedure
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pain management
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Peripheral artery stent insertion
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pharyngeal operation
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
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	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pulmonary bullectomy
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pyloromyotomy
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Radical cystectomy
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Radical prostatectomy
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Radioactive iodine therapy
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Radiotherapy
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Radiotherapy to skin
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Rehabilitation therapy
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Removal of internal fixation
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Resuscitation
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Rotator cuff repair
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Salivary gland operation
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Small intestinal resection
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Small intestine operation
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Spinal laminectomy
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Surgery
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Tendon operation
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Therapy cessation
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Tonsillectomy
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Tracheostomy
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Tumour excision
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Ureteral stent insertion
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Urethral operation
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Urethral stent insertion
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (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 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Uterine polypectomy
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Varicose vein operation
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Vascular operation
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Vascular stent insertion
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Venous stent insertion
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Wrist surgery
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
General disorders and administration site conditions
Chest pain
subjects affected / exposed	188 / 2805 (6.70%)	184 / 2868 (6.42%)
occurrences causally related to treatment / all	1 / 241	0 / 247
deaths causally related to treatment / all	0 / 0	0 / 0
Complication associated with device
subjects affected / exposed	24 / 2805 (0.86%)	33 / 2868 (1.15%)
occurrences causally related to treatment / all	0 / 28	0 / 36
deaths causally related to treatment / all	0 / 0	0 / 0
Non-cardiac chest pain
subjects affected / exposed	26 / 2805 (0.93%)	18 / 2868 (0.63%)
occurrences causally related to treatment / all	2 / 26	0 / 20
deaths causally related to treatment / all	0 / 0	0 / 0
Ill-defined disorder
subjects affected / exposed	15 / 2805 (0.53%)	15 / 2868 (0.52%)
occurrences causally related to treatment / all	0 / 16	0 / 19
deaths causally related to treatment / all	0 / 0	0 / 0
Asthenia
subjects affected / exposed	5 / 2805 (0.18%)	4 / 2868 (0.14%)
occurrences causally related to treatment / all	0 / 5	0 / 4
deaths causally related to treatment / all	0 / 2	0 / 2
Death
subjects affected / exposed	4 / 2805 (0.14%)	5 / 2868 (0.17%)
occurrences causally related to treatment / all	0 / 4	0 / 5
deaths causally related to treatment / all	0 / 4	0 / 5
Gait disturbance
subjects affected / exposed	7 / 2805 (0.25%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 7	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
General physical health deterioration
subjects affected / exposed	4 / 2805 (0.14%)	5 / 2868 (0.17%)
occurrences causally related to treatment / all	0 / 4	0 / 5
deaths causally related to treatment / all	0 / 2	0 / 4
Malaise
subjects affected / exposed	7 / 2805 (0.25%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	2 / 7	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Multiple organ dysfunction syndrome
subjects affected / exposed	4 / 2805 (0.14%)	4 / 2868 (0.14%)
occurrences causally related to treatment / all	0 / 4	0 / 4
deaths causally related to treatment / all	0 / 4	0 / 3
Oedema peripheral
subjects affected / exposed	6 / 2805 (0.21%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 6	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Localised oedema
subjects affected / exposed	3 / 2805 (0.11%)	4 / 2868 (0.14%)
occurrences causally related to treatment / all	0 / 3	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Medical device complication
subjects affected / exposed	6 / 2805 (0.21%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 6	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pyrexia
subjects affected / exposed	5 / 2805 (0.18%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 7	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Chest discomfort
subjects affected / exposed	3 / 2805 (0.11%)	3 / 2868 (0.10%)
occurrences causally related to treatment / all	0 / 3	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Eye complication associated with device
subjects affected / exposed	2 / 2805 (0.07%)	3 / 2868 (0.10%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Multi-organ failure
subjects affected / exposed	2 / 2805 (0.07%)	3 / 2868 (0.10%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 2	0 / 2
Fatigue
subjects affected / exposed	1 / 2805 (0.04%)	3 / 2868 (0.10%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Pain
subjects affected / exposed	3 / 2805 (0.11%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 4	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Adverse drug reaction
subjects affected / exposed	1 / 2805 (0.04%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Exercise tolerance decreased
subjects affected / exposed	0 / 2805 (0.00%)	3 / 2868 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Hypothermia
subjects affected / exposed	2 / 2805 (0.07%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Abasia
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Adverse food reaction
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Chills
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Condition aggravated
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Device failure
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Device issue
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Device lead issue
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Device occlusion
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Disease progression
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Effusion
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hanging
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Hernia
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Implant site haematoma
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Mass
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Perforated ulcer
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Sudden cardiac death
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Thrombosis in device
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Vascular stent stenosis
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Immune system disorders
Amyloidosis
subjects affected / exposed	0 / 2805 (0.00%)	3 / 2868 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 2
Hypersensitivity
subjects affected / exposed	2 / 2805 (0.07%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	2 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Anaphylactic shock
subjects affected / exposed	1 / 2805 (0.04%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Amyloidosis senile
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Anaphylactic reaction
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Anti-neutrophil cytoplasmic antibody positive vasculitis
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Drug hypersensitivity
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hypogammaglobulinaemia
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Sarcoidosis
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Social circumstances
Contraindication to medical treatment
subjects affected / exposed	2 / 2805 (0.07%)	4 / 2868 (0.14%)
occurrences causally related to treatment / all	0 / 2	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Bereavement
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac assistance device user
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Social problem
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Tobacco user
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Reproductive system and breast disorders
Benign prostatic hyperplasia
subjects affected / exposed	25 / 2805 (0.89%)	36 / 2868 (1.26%)
occurrences causally related to treatment / all	0 / 29	0 / 40
deaths causally related to treatment / all	0 / 1	0 / 0
Uterovaginal prolapse
subjects affected / exposed	5 / 2805 (0.18%)	6 / 2868 (0.21%)
occurrences causally related to treatment / all	0 / 7	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Leukoplakia of penis
subjects affected / exposed	1 / 2805 (0.04%)	3 / 2868 (0.10%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Prostatitis
subjects affected / exposed	3 / 2805 (0.11%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Uterine polyp
subjects affected / exposed	2 / 2805 (0.07%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Cystocele
subjects affected / exposed	2 / 2805 (0.07%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Male reproductive tract disorder
subjects affected / exposed	1 / 2805 (0.04%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Prostatic disorder
subjects affected / exposed	0 / 2805 (0.00%)	3 / 2868 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Balanoposthitis
subjects affected / exposed	1 / 2805 (0.04%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Genital disorder male
subjects affected / exposed	1 / 2805 (0.04%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Ovarian cyst
subjects affected / exposed	1 / 2805 (0.04%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pelvic pain
subjects affected / exposed	2 / 2805 (0.07%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Postmenopausal haemorrhage
subjects affected / exposed	1 / 2805 (0.04%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Prostatic haemorrhage
subjects affected / exposed	1 / 2805 (0.04%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Rectocele
subjects affected / exposed	1 / 2805 (0.04%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Breast necrosis
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pelvic prolapse
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Penile haemorrhage
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Penis disorder
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Polycystic ovaries
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Prostatomegaly
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Uterine disorder
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Vulval disorder
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Vulval leukoplakia
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Vulvovaginal inflammation
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
subjects affected / exposed	51 / 2805 (1.82%)	65 / 2868 (2.27%)
occurrences causally related to treatment / all	0 / 57	0 / 90
deaths causally related to treatment / all	0 / 1	0 / 3
Dyspnoea
subjects affected / exposed	39 / 2805 (1.39%)	44 / 2868 (1.53%)
occurrences causally related to treatment / all	0 / 41	0 / 47
deaths causally related to treatment / all	0 / 1	0 / 1
Epistaxis
subjects affected / exposed	26 / 2805 (0.93%)	27 / 2868 (0.94%)
occurrences causally related to treatment / all	1 / 39	0 / 38
deaths causally related to treatment / all	0 / 0	0 / 0
Pulmonary embolism
subjects affected / exposed	19 / 2805 (0.68%)	30 / 2868 (1.05%)
occurrences causally related to treatment / all	0 / 23	0 / 36
deaths causally related to treatment / all	0 / 4	0 / 3
Pleural effusion
subjects affected / exposed	10 / 2805 (0.36%)	17 / 2868 (0.59%)
occurrences causally related to treatment / all	0 / 11	0 / 23
deaths causally related to treatment / all	0 / 0	0 / 0
Asthma
subjects affected / exposed	10 / 2805 (0.36%)	7 / 2868 (0.24%)
occurrences causally related to treatment / all	0 / 11	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
Interstitial lung disease
subjects affected / exposed	9 / 2805 (0.32%)	8 / 2868 (0.28%)
occurrences causally related to treatment / all	0 / 9	0 / 11
deaths causally related to treatment / all	0 / 1	0 / 1
Pulmonary fibrosis
subjects affected / exposed	9 / 2805 (0.32%)	8 / 2868 (0.28%)
occurrences causally related to treatment / all	0 / 11	0 / 8
deaths causally related to treatment / all	0 / 2	0 / 2
Pulmonary oedema
subjects affected / exposed	12 / 2805 (0.43%)	5 / 2868 (0.17%)
occurrences causally related to treatment / all	0 / 12	0 / 5
deaths causally related to treatment / all	0 / 6	0 / 2
Sleep apnoea syndrome
subjects affected / exposed	6 / 2805 (0.21%)	10 / 2868 (0.35%)
occurrences causally related to treatment / all	0 / 8	0 / 14
deaths causally related to treatment / all	0 / 0	0 / 0
Bronchiectasis
subjects affected / exposed	9 / 2805 (0.32%)	6 / 2868 (0.21%)
occurrences causally related to treatment / all	0 / 11	0 / 21
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumonia aspiration
subjects affected / exposed	4 / 2805 (0.14%)	11 / 2868 (0.38%)
occurrences causally related to treatment / all	0 / 4	0 / 15
deaths causally related to treatment / all	0 / 3	0 / 5
Haemoptysis
subjects affected / exposed	7 / 2805 (0.25%)	7 / 2868 (0.24%)
occurrences causally related to treatment / all	0 / 7	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
Lung disorder
subjects affected / exposed	7 / 2805 (0.25%)	7 / 2868 (0.24%)
occurrences causally related to treatment / all	0 / 8	0 / 8
deaths causally related to treatment / all	0 / 1	0 / 1
Emphysema
subjects affected / exposed	7 / 2805 (0.25%)	6 / 2868 (0.21%)
occurrences causally related to treatment / all	0 / 9	0 / 6
deaths causally related to treatment / all	0 / 2	0 / 1
Cough
subjects affected / exposed	6 / 2805 (0.21%)	4 / 2868 (0.14%)
occurrences causally related to treatment / all	0 / 6	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Idiopathic pulmonary fibrosis
subjects affected / exposed	6 / 2805 (0.21%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 7	0 / 5
deaths causally related to treatment / all	0 / 3	0 / 2
Respiratory failure
subjects affected / exposed	3 / 2805 (0.11%)	5 / 2868 (0.17%)
occurrences causally related to treatment / all	0 / 3	0 / 5
deaths causally related to treatment / all	0 / 1	0 / 2
Respiration abnormal
subjects affected / exposed	3 / 2805 (0.11%)	4 / 2868 (0.14%)
occurrences causally related to treatment / all	0 / 3	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Haemothorax
subjects affected / exposed	4 / 2805 (0.14%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 4	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumothorax
subjects affected / exposed	3 / 2805 (0.11%)	3 / 2868 (0.10%)
occurrences causally related to treatment / all	0 / 3	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Pulmonary hypertension
subjects affected / exposed	2 / 2805 (0.07%)	4 / 2868 (0.14%)
occurrences causally related to treatment / all	0 / 3	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Acute pulmonary oedema
subjects affected / exposed	2 / 2805 (0.07%)	3 / 2868 (0.10%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 1	0 / 1
Dyspnoea exertional
subjects affected / exposed	1 / 2805 (0.04%)	4 / 2868 (0.14%)
occurrences causally related to treatment / all	0 / 2	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Pleurisy
subjects affected / exposed	2 / 2805 (0.07%)	3 / 2868 (0.10%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Chronic respiratory failure
subjects affected / exposed	2 / 2805 (0.07%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 2	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Laryngeal disorder
subjects affected / exposed	1 / 2805 (0.04%)	3 / 2868 (0.10%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Nasal polyps
subjects affected / exposed	1 / 2805 (0.04%)	3 / 2868 (0.10%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Vocal cord disorder
subjects affected / exposed	0 / 2805 (0.00%)	4 / 2868 (0.14%)
occurrences causally related to treatment / all	0 / 0	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Nasal disorder
subjects affected / exposed	2 / 2805 (0.07%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pharyngeal disorder
subjects affected / exposed	2 / 2805 (0.07%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pleural fibrosis
subjects affected / exposed	2 / 2805 (0.07%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hiccups
subjects affected / exposed	1 / 2805 (0.04%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hypoxia
subjects affected / exposed	1 / 2805 (0.04%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Pneumonitis
subjects affected / exposed	1 / 2805 (0.04%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Productive cough
subjects affected / exposed	2 / 2805 (0.07%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Wheezing
subjects affected / exposed	2 / 2805 (0.07%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Acute respiratory failure
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Asphyxia
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Bronchial disorder
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Bronchial polyp
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Choking
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Dysphonia
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Dyspnoea paroxysmal nocturnal
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hydropneumothorax
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hypersensitivity pneumonitis
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hyperventilation
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hypoventilation
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Mediastinal disorder
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Mouth breathing
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Oropharyngeal pain
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Orthopnoea
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pharyngeal pouch
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pleural disorder
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pleuritic pain
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumothorax spontaneous
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumothorax spontaneous tension
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
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	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pulmonary eosinophilia
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pulmonary mass
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pulmonary sarcoidosis
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Respiratory disorder
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Sinus polyp
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Thoracic haemorrhage
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Psychiatric disorders
Delirium
subjects affected / exposed	12 / 2805 (0.43%)	12 / 2868 (0.42%)
occurrences causally related to treatment / all	0 / 13	0 / 15
deaths causally related to treatment / all	0 / 0	0 / 2
Confusional state
subjects affected / exposed	9 / 2805 (0.32%)	6 / 2868 (0.21%)
occurrences causally related to treatment / all	0 / 11	0 / 6
deaths causally related to treatment / all	0 / 1	0 / 0
Disorientation
subjects affected / exposed	4 / 2805 (0.14%)	5 / 2868 (0.17%)
occurrences causally related to treatment / all	0 / 4	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Depression
subjects affected / exposed	5 / 2805 (0.18%)	3 / 2868 (0.10%)
occurrences causally related to treatment / all	0 / 8	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Anxiety disorder
subjects affected / exposed	3 / 2805 (0.11%)	4 / 2868 (0.14%)
occurrences causally related to treatment / all	0 / 3	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Anxiety
subjects affected / exposed	2 / 2805 (0.07%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Hallucination, Visual
subjects affected / exposed	1 / 2805 (0.04%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Alcohol withdrawal syndrome
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Alcoholism
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Asperger's disorder
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Behaviour disorder
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Delirium tremens
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Delusional disorder, unspecified type
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Depressed mood
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Dissociative disorder
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hallucination
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (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 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Restlessness
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Sleep disorder
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Somatic symptom disorder
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Suicidal ideation
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Suicide attempt
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Product issues
Device dislocation
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Product size issue
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatobiliary disorders
Cholecystitis acute
subjects affected / exposed	22 / 2805 (0.78%)	15 / 2868 (0.52%)
occurrences causally related to treatment / all	0 / 22	0 / 15
deaths causally related to treatment / all	0 / 1	0 / 1
Cholecystitis
subjects affected / exposed	20 / 2805 (0.71%)	16 / 2868 (0.56%)
occurrences causally related to treatment / all	0 / 21	0 / 16
deaths causally related to treatment / all	0 / 0	0 / 1
Cholelithiasis
subjects affected / exposed	20 / 2805 (0.71%)	15 / 2868 (0.52%)
occurrences causally related to treatment / all	0 / 22	0 / 15
deaths causally related to treatment / all	0 / 0	0 / 0
Bile duct stone
subjects affected / exposed	8 / 2805 (0.29%)	11 / 2868 (0.38%)
occurrences causally related to treatment / all	0 / 11	0 / 16
deaths causally related to treatment / all	0 / 0	0 / 0
Cholangitis
subjects affected / exposed	6 / 2805 (0.21%)	7 / 2868 (0.24%)
occurrences causally related to treatment / all	0 / 7	0 / 8
deaths causally related to treatment / all	0 / 0	0 / 0
Cholecystitis chronic
subjects affected / exposed	3 / 2805 (0.11%)	4 / 2868 (0.14%)
occurrences causally related to treatment / all	0 / 3	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Bile duct obstruction
subjects affected / exposed	4 / 2805 (0.14%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 4	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 1
Hepatic cirrhosis
subjects affected / exposed	3 / 2805 (0.11%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 5	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Liver disorder
subjects affected / exposed	4 / 2805 (0.14%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 5	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatic steatosis
subjects affected / exposed	3 / 2805 (0.11%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Biliary tract disorder
subjects affected / exposed	2 / 2805 (0.07%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gallbladder perforation
subjects affected / exposed	0 / 2805 (0.00%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatic failure
subjects affected / exposed	1 / 2805 (0.04%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 0
Hepatic fibrosis
subjects affected / exposed	1 / 2805 (0.04%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatic lesion
subjects affected / exposed	2 / 2805 (0.07%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatitis
subjects affected / exposed	1 / 2805 (0.04%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Non-alcoholic steatohepatitis
subjects affected / exposed	0 / 2805 (0.00%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Portal hypertension
subjects affected / exposed	1 / 2805 (0.04%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Bile duct stenosis
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Biliary colic
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cholangitis sclerosing
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cirrhosis alcoholic
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatic cyst
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Nonalcoholic fatty liver disease
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Investigations
Angiogram
subjects affected / exposed	32 / 2805 (1.14%)	38 / 2868 (1.32%)
occurrences causally related to treatment / all	0 / 33	0 / 38
deaths causally related to treatment / all	0 / 0	0 / 0
Angiocardiogram
subjects affected / exposed	24 / 2805 (0.86%)	36 / 2868 (1.26%)
occurrences causally related to treatment / all	0 / 24	0 / 36
deaths causally related to treatment / all	0 / 0	0 / 0
Physical examination
subjects affected / exposed	11 / 2805 (0.39%)	14 / 2868 (0.49%)
occurrences causally related to treatment / all	0 / 14	0 / 14
deaths causally related to treatment / all	0 / 0	0 / 0
Arteriogram coronary
subjects affected / exposed	9 / 2805 (0.32%)	9 / 2868 (0.31%)
occurrences causally related to treatment / all	0 / 9	0 / 9
deaths causally related to treatment / all	0 / 0	0 / 0
Blood test abnormal
subjects affected / exposed	9 / 2805 (0.32%)	8 / 2868 (0.28%)
occurrences causally related to treatment / all	0 / 9	0 / 9
deaths causally related to treatment / all	0 / 0	0 / 0
Medical observation
subjects affected / exposed	7 / 2805 (0.25%)	8 / 2868 (0.28%)
occurrences causally related to treatment / all	0 / 8	0 / 8
deaths causally related to treatment / all	0 / 0	0 / 0
Investigation
subjects affected / exposed	5 / 2805 (0.18%)	8 / 2868 (0.28%)
occurrences causally related to treatment / all	0 / 5	0 / 8
deaths causally related to treatment / all	0 / 0	0 / 0
Blood osmolarity decreased
subjects affected / exposed	4 / 2805 (0.14%)	6 / 2868 (0.21%)
occurrences causally related to treatment / all	0 / 4	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Liver function test abnormal
subjects affected / exposed	4 / 2805 (0.14%)	6 / 2868 (0.21%)
occurrences causally related to treatment / all	0 / 4	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Cystoscopy
subjects affected / exposed	1 / 2805 (0.04%)	3 / 2868 (0.10%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Arteriogram coronary abnormal
subjects affected / exposed	2 / 2805 (0.07%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Diagnostic procedure
subjects affected / exposed	2 / 2805 (0.07%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Haemoglobin decreased
subjects affected / exposed	3 / 2805 (0.11%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Arthroscopy
subjects affected / exposed	0 / 2805 (0.00%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiovascular function test abnormal
subjects affected / exposed	0 / 2805 (0.00%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Catheterisation cardiac
subjects affected / exposed	0 / 2805 (0.00%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Endoscopy upper gastrointestinal tract
subjects affected / exposed	0 / 2805 (0.00%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Heart rate irregular
subjects affected / exposed	1 / 2805 (0.04%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Scan myocardial perfusion
subjects affected / exposed	2 / 2805 (0.07%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Stress echocardiogram
subjects affected / exposed	0 / 2805 (0.00%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Weight decreased
subjects affected / exposed	0 / 2805 (0.00%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
X-ray abnormal
subjects affected / exposed	0 / 2805 (0.00%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Anticoagulation drug level below therapeutic
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Arteriogram coronary normal
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Biopsy adrenal gland
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Biopsy bladder
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Blood culture positive
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Blood electrolytes abnormal
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Blood folate decreased
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Blood osmolarity increased
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Blood potassium decreased
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
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	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Blood sodium decreased
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Bronchoscopy
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac monitoring
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Colonoscopy
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Computerised tomogram thorax
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Device function test
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Ejection fraction
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Ejection fraction normal
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Electrocardiogram ST segment elevation
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (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 / 2805 (0.00%)	1 / 2868 (0.03%)
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	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Heart rate abnormal
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Heart rate decreased
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Heart rate increased
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatic enzyme increased
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Influenza A virus test positive
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Laparoscopy abnormal
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Magnetic resonance imaging brain
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Mediastinoscopy
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Oxygen consumption increased
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
SARS-CoV-2 test positive
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Troponin normal
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Urological examination
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Injury, poisoning and procedural complications
Fall
subjects affected / exposed	44 / 2805 (1.57%)	40 / 2868 (1.39%)
occurrences causally related to treatment / all	0 / 53	0 / 46
deaths causally related to treatment / all	0 / 0	0 / 0
Head injury
subjects affected / exposed	18 / 2805 (0.64%)	27 / 2868 (0.94%)
occurrences causally related to treatment / all	0 / 18	0 / 29
deaths causally related to treatment / all	0 / 0	0 / 0
Femoral neck fracture
subjects affected / exposed	19 / 2805 (0.68%)	14 / 2868 (0.49%)
occurrences causally related to treatment / all	0 / 20	0 / 17
deaths causally related to treatment / all	0 / 1	0 / 0
Post procedural haemorrhage
subjects affected / exposed	14 / 2805 (0.50%)	16 / 2868 (0.56%)
occurrences causally related to treatment / all	0 / 14	0 / 21
deaths causally related to treatment / all	0 / 0	0 / 0
Femur fracture
subjects affected / exposed	7 / 2805 (0.25%)	12 / 2868 (0.42%)
occurrences causally related to treatment / all	0 / 7	0 / 13
deaths causally related to treatment / all	0 / 0	0 / 0
Skin injury
subjects affected / exposed	10 / 2805 (0.36%)	9 / 2868 (0.31%)
occurrences causally related to treatment / all	0 / 10	0 / 10
deaths causally related to treatment / all	0 / 0	0 / 0
Post procedural complication
subjects affected / exposed	7 / 2805 (0.25%)	10 / 2868 (0.35%)
occurrences causally related to treatment / all	0 / 8	0 / 11
deaths causally related to treatment / all	0 / 0	0 / 0
Humerus fracture
subjects affected / exposed	7 / 2805 (0.25%)	9 / 2868 (0.31%)
occurrences causally related to treatment / all	0 / 7	0 / 9
deaths causally related to treatment / all	0 / 0	0 / 0
Rib fracture
subjects affected / exposed	9 / 2805 (0.32%)	6 / 2868 (0.21%)
occurrences causally related to treatment / all	0 / 9	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
Meniscus injury
subjects affected / exposed	8 / 2805 (0.29%)	4 / 2868 (0.14%)
occurrences causally related to treatment / all	0 / 8	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Subdural haemorrhage
subjects affected / exposed	4 / 2805 (0.14%)	8 / 2868 (0.28%)
occurrences causally related to treatment / all	0 / 4	0 / 10
deaths causally related to treatment / all	0 / 0	0 / 0
Toxicity to various agents
subjects affected / exposed	8 / 2805 (0.29%)	4 / 2868 (0.14%)
occurrences causally related to treatment / all	0 / 9	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Hip fracture
subjects affected / exposed	7 / 2805 (0.25%)	4 / 2868 (0.14%)
occurrences causally related to treatment / all	0 / 7	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Ankle fracture
subjects affected / exposed	3 / 2805 (0.11%)	7 / 2868 (0.24%)
occurrences causally related to treatment / all	0 / 3	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
Joint dislocation
subjects affected / exposed	1 / 2805 (0.04%)	9 / 2868 (0.31%)
occurrences causally related to treatment / all	0 / 1	0 / 18
deaths causally related to treatment / all	0 / 0	0 / 0
Lower limb fracture
subjects affected / exposed	3 / 2805 (0.11%)	7 / 2868 (0.24%)
occurrences causally related to treatment / all	0 / 3	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
Open wound
subjects affected / exposed	5 / 2805 (0.18%)	5 / 2868 (0.17%)
occurrences causally related to treatment / all	0 / 5	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Pubis fracture
subjects affected / exposed	6 / 2805 (0.21%)	4 / 2868 (0.14%)
occurrences causally related to treatment / all	0 / 6	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Radius fracture
subjects affected / exposed	3 / 2805 (0.11%)	7 / 2868 (0.24%)
occurrences causally related to treatment / all	0 / 3	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
Asbestosis
subjects affected / exposed	2 / 2805 (0.07%)	7 / 2868 (0.24%)
occurrences causally related to treatment / all	0 / 2	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 3
Incisional hernia
subjects affected / exposed	6 / 2805 (0.21%)	3 / 2868 (0.10%)
occurrences causally related to treatment / all	0 / 6	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Limb injury
subjects affected / exposed	6 / 2805 (0.21%)	3 / 2868 (0.10%)
occurrences causally related to treatment / all	0 / 6	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Chest injury
subjects affected / exposed	4 / 2805 (0.14%)	3 / 2868 (0.10%)
occurrences causally related to treatment / all	0 / 4	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Pelvic fracture
subjects affected / exposed	4 / 2805 (0.14%)	3 / 2868 (0.10%)
occurrences causally related to treatment / all	0 / 4	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Subdural haematoma
subjects affected / exposed	2 / 2805 (0.07%)	5 / 2868 (0.17%)
occurrences causally related to treatment / all	0 / 2	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 1
Facial bones fracture
subjects affected / exposed	3 / 2805 (0.11%)	3 / 2868 (0.10%)
occurrences causally related to treatment / all	0 / 3	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Foreign body
subjects affected / exposed	4 / 2805 (0.14%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 5	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Joint injury
subjects affected / exposed	1 / 2805 (0.04%)	5 / 2868 (0.17%)
occurrences causally related to treatment / all	0 / 1	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Thoracic vertebral fracture
subjects affected / exposed	3 / 2805 (0.11%)	3 / 2868 (0.10%)
occurrences causally related to treatment / all	0 / 3	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Tibia fracture
subjects affected / exposed	2 / 2805 (0.07%)	4 / 2868 (0.14%)
occurrences causally related to treatment / all	0 / 2	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Upper limb fracture
subjects affected / exposed	4 / 2805 (0.14%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 4	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 1
Contusion
subjects affected / exposed	4 / 2805 (0.14%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 4	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastroenteritis radiation
subjects affected / exposed	2 / 2805 (0.07%)	3 / 2868 (0.10%)
occurrences causally related to treatment / all	0 / 3	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Multiple fractures
subjects affected / exposed	3 / 2805 (0.11%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Road traffic accident
subjects affected / exposed	2 / 2805 (0.07%)	3 / 2868 (0.10%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Spinal fracture
subjects affected / exposed	3 / 2805 (0.11%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Tendon rupture
subjects affected / exposed	2 / 2805 (0.07%)	3 / 2868 (0.10%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Alcohol poisoning
subjects affected / exposed	3 / 2805 (0.11%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Craniocerebral injury
subjects affected / exposed	1 / 2805 (0.04%)	3 / 2868 (0.10%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 1	0 / 1
Foot fracture
subjects affected / exposed	2 / 2805 (0.07%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal stoma complication
subjects affected / exposed	2 / 2805 (0.07%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 3	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Injury
subjects affected / exposed	3 / 2805 (0.11%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Lumbar vertebral fracture
subjects affected / exposed	3 / 2805 (0.11%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Ulna fracture
subjects affected / exposed	3 / 2805 (0.11%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Acetabulum fracture
subjects affected / exposed	3 / 2805 (0.11%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Back injury
subjects affected / exposed	1 / 2805 (0.04%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Concussion
subjects affected / exposed	3 / 2805 (0.11%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Forearm fracture
subjects affected / exposed	2 / 2805 (0.07%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hand fracture
subjects affected / exposed	1 / 2805 (0.04%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Laceration
subjects affected / exposed	2 / 2805 (0.07%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Ligament sprain
subjects affected / exposed	1 / 2805 (0.04%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Muscle injury
subjects affected / exposed	1 / 2805 (0.04%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Venom poisoning
subjects affected / exposed	0 / 2805 (0.00%)	3 / 2868 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Wrist fracture
subjects affected / exposed	1 / 2805 (0.04%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Cervical vertebral fracture
subjects affected / exposed	1 / 2805 (0.04%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Excoriation
subjects affected / exposed	2 / 2805 (0.07%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Glaucoma traumatic
subjects affected / exposed	1 / 2805 (0.04%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Ilium fracture
subjects affected / exposed	0 / 2805 (0.00%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Meniscus lesion
subjects affected / exposed	1 / 2805 (0.04%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Neck injury
subjects affected / exposed	1 / 2805 (0.04%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 0
Patella fracture
subjects affected / exposed	2 / 2805 (0.07%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Periprosthetic fracture
subjects affected / exposed	2 / 2805 (0.07%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumothorax traumatic
subjects affected / exposed	2 / 2805 (0.07%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Postoperative wound complication
subjects affected / exposed	2 / 2805 (0.07%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Procedural complication
subjects affected / exposed	0 / 2805 (0.00%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Radiation proctitis
subjects affected / exposed	1 / 2805 (0.04%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Soft tissue injury
subjects affected / exposed	0 / 2805 (0.00%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Splenic injury
subjects affected / exposed	1 / 2805 (0.04%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Synovial rupture
subjects affected / exposed	0 / 2805 (0.00%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Thermal burn
subjects affected / exposed	2 / 2805 (0.07%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Traumatic haemothorax
subjects affected / exposed	1 / 2805 (0.04%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Vascular pseudoaneurysm
subjects affected / exposed	1 / 2805 (0.04%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Accident
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Accident at home
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Airway burns
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Arteriovenous fistula occlusion
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Burns second degree
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Burns third degree
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac valve replacement complication
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Chemical poisoning
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Clavicle fracture
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Closed globe injury
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Exposure to chemical pollution
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Eye injury
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Eyelid contusion
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Eyelid injury
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Fibula fracture
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Foreign body in gastrointestinal tract
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Genital injury
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Incarcerated parastomal hernia
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Intestinal anastomosis complication
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Ligament injury
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Peripheral nerve injury
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumoconiosis
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Post concussion syndrome
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Post procedural constipation
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Post procedural discharge
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Post procedural haematoma
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Post procedural haematuria
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
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 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Post procedural pulmonary embolism
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Post procedural stroke
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Post procedural swelling
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Procedural haemorrhage
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Procedural pain
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Radiation skin injury
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Respiratory fume inhalation disorder
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Scapula fracture
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Scar
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Seroma
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Skull fracture
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Skull fractured base
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Spinal compression fracture
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Spinal cord injury
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Sternal fracture
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Stomal hernia
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Superficial injury of eye
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Tooth fracture
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Traumatic anuria
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Urinary tract stoma complication
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Urostomy complication
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Vascular graft complication
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Vulvovaginal injury
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Wound dehiscence
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
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
Phimosis
subjects affected / exposed	10 / 2805 (0.36%)	8 / 2868 (0.28%)
occurrences causally related to treatment / all	0 / 10	0 / 8
deaths causally related to treatment / all	0 / 0	0 / 0
Corneal dystrophy
subjects affected / exposed	4 / 2805 (0.14%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 5	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hydrocele
subjects affected / exposed	4 / 2805 (0.14%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 4	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Birth mark
subjects affected / exposed	1 / 2805 (0.04%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Arteriovenous malformation
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Atrial septal defect
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Congenital aortic valve stenosis
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Congenital cystic kidney disease
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Congenital endocrine anomaly
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Congenital foot malformation
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cystic lymphangioma
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Heart disease congenital
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hereditary sideroblastic anaemia
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hypertrophic cardiomyopathy
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Melkersson-Rosenthal syndrome
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Syndactyly
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac disorders
Angina pectoris
subjects affected / exposed	152 / 2805 (5.42%)	162 / 2868 (5.65%)
occurrences causally related to treatment / all	4 / 198	0 / 229
deaths causally related to treatment / all	0 / 0	0 / 0
Atrial fibrillation
subjects affected / exposed	132 / 2805 (4.71%)	169 / 2868 (5.89%)
occurrences causally related to treatment / all	0 / 184	0 / 275
deaths causally related to treatment / all	0 / 0	0 / 1
Acute myocardial infarction
subjects affected / exposed	125 / 2805 (4.46%)	121 / 2868 (4.22%)
occurrences causally related to treatment / all	0 / 145	0 / 141
deaths causally related to treatment / all	0 / 13	0 / 16
Cardiac failure
subjects affected / exposed	47 / 2805 (1.68%)	54 / 2868 (1.88%)
occurrences causally related to treatment / all	0 / 55	0 / 64
deaths causally related to treatment / all	0 / 4	0 / 9
Myocardial infarction
subjects affected / exposed	48 / 2805 (1.71%)	47 / 2868 (1.64%)
occurrences causally related to treatment / all	0 / 49	0 / 48
deaths causally related to treatment / all	0 / 19	0 / 17
Angina unstable
subjects affected / exposed	36 / 2805 (1.28%)	50 / 2868 (1.74%)
occurrences causally related to treatment / all	0 / 45	0 / 65
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac failure congestive
subjects affected / exposed	39 / 2805 (1.39%)	42 / 2868 (1.46%)
occurrences causally related to treatment / all	0 / 45	0 / 48
deaths causally related to treatment / all	0 / 3	0 / 11
Myocardial ischaemia
subjects affected / exposed	32 / 2805 (1.14%)	41 / 2868 (1.43%)
occurrences causally related to treatment / all	0 / 32	0 / 44
deaths causally related to treatment / all	0 / 15	0 / 18
Aortic valve stenosis
subjects affected / exposed	14 / 2805 (0.50%)	21 / 2868 (0.73%)
occurrences causally related to treatment / all	0 / 18	0 / 25
deaths causally related to treatment / all	0 / 0	0 / 1
Left ventricular failure
subjects affected / exposed	14 / 2805 (0.50%)	19 / 2868 (0.66%)
occurrences causally related to treatment / all	0 / 16	0 / 19
deaths causally related to treatment / all	0 / 2	0 / 7
Bradycardia
subjects affected / exposed	11 / 2805 (0.39%)	19 / 2868 (0.66%)
occurrences causally related to treatment / all	0 / 11	0 / 20
deaths causally related to treatment / all	0 / 0	0 / 0
Left ventricular dysfunction
subjects affected / exposed	11 / 2805 (0.39%)	15 / 2868 (0.52%)
occurrences causally related to treatment / all	0 / 11	0 / 17
deaths causally related to treatment / all	0 / 0	0 / 0
Ventricular tachycardia
subjects affected / exposed	13 / 2805 (0.46%)	13 / 2868 (0.45%)
occurrences causally related to treatment / all	0 / 16	0 / 18
deaths causally related to treatment / all	0 / 0	0 / 0
Acute coronary syndrome
subjects affected / exposed	11 / 2805 (0.39%)	11 / 2868 (0.38%)
occurrences causally related to treatment / all	0 / 11	0 / 11
deaths causally related to treatment / all	0 / 0	0 / 0
Atrioventricular block complete
subjects affected / exposed	6 / 2805 (0.21%)	16 / 2868 (0.56%)
occurrences causally related to treatment / all	0 / 6	0 / 16
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac arrest
subjects affected / exposed	11 / 2805 (0.39%)	8 / 2868 (0.28%)
occurrences causally related to treatment / all	0 / 11	0 / 8
deaths causally related to treatment / all	0 / 3	0 / 6
Palpitations
subjects affected / exposed	6 / 2805 (0.21%)	11 / 2868 (0.38%)
occurrences causally related to treatment / all	0 / 6	0 / 14
deaths causally related to treatment / all	0 / 0	0 / 0
Arrhythmia
subjects affected / exposed	5 / 2805 (0.18%)	9 / 2868 (0.31%)
occurrences causally related to treatment / all	0 / 5	0 / 10
deaths causally related to treatment / all	0 / 0	0 / 0
Atrial flutter
subjects affected / exposed	9 / 2805 (0.32%)	5 / 2868 (0.17%)
occurrences causally related to treatment / all	0 / 9	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Atrioventricular block second degree
subjects affected / exposed	8 / 2805 (0.29%)	6 / 2868 (0.21%)
occurrences causally related to treatment / all	0 / 9	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Coronary artery disease
subjects affected / exposed	4 / 2805 (0.14%)	10 / 2868 (0.35%)
occurrences causally related to treatment / all	0 / 4	0 / 10
deaths causally related to treatment / all	0 / 0	0 / 0
Atrioventricular block first degree
subjects affected / exposed	5 / 2805 (0.18%)	7 / 2868 (0.24%)
occurrences causally related to treatment / all	0 / 5	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
Supraventricular tachycardia
subjects affected / exposed	6 / 2805 (0.21%)	6 / 2868 (0.21%)
occurrences causally related to treatment / all	0 / 7	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac valve disease
subjects affected / exposed	8 / 2805 (0.29%)	3 / 2868 (0.10%)
occurrences causally related to treatment / all	0 / 8	0 / 3
deaths causally related to treatment / all	0 / 1	0 / 0
Ischaemic cardiomyopathy
subjects affected / exposed	5 / 2805 (0.18%)	5 / 2868 (0.17%)
occurrences causally related to treatment / all	0 / 5	0 / 6
deaths causally related to treatment / all	0 / 1	0 / 0
Cardiac disorder
subjects affected / exposed	5 / 2805 (0.18%)	3 / 2868 (0.10%)
occurrences causally related to treatment / all	0 / 5	0 / 3
deaths causally related to treatment / all	0 / 4	0 / 1
Mitral valve incompetence
subjects affected / exposed	1 / 2805 (0.04%)	7 / 2868 (0.24%)
occurrences causally related to treatment / all	0 / 1	0 / 8
deaths causally related to treatment / all	0 / 0	0 / 0
Aortic valve disease mixed
subjects affected / exposed	0 / 2805 (0.00%)	6 / 2868 (0.21%)
occurrences causally related to treatment / all	0 / 0	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Atrioventricular block
subjects affected / exposed	4 / 2805 (0.14%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 4	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Bundle branch block left
subjects affected / exposed	3 / 2805 (0.11%)	3 / 2868 (0.10%)
occurrences causally related to treatment / all	0 / 3	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Sick sinus syndrome
subjects affected / exposed	2 / 2805 (0.07%)	4 / 2868 (0.14%)
occurrences causally related to treatment / all	0 / 2	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Trifascicular block
subjects affected / exposed	3 / 2805 (0.11%)	3 / 2868 (0.10%)
occurrences causally related to treatment / all	0 / 4	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Ventricular extrasystoles
subjects affected / exposed	2 / 2805 (0.07%)	4 / 2868 (0.14%)
occurrences causally related to treatment / all	0 / 2	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Aortic valve disease
subjects affected / exposed	2 / 2805 (0.07%)	3 / 2868 (0.10%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Pericarditis
subjects affected / exposed	4 / 2805 (0.14%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 8	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Sinus node dysfunction
subjects affected / exposed	1 / 2805 (0.04%)	4 / 2868 (0.14%)
occurrences causally related to treatment / all	0 / 1	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Acute left ventricular failure
subjects affected / exposed	3 / 2805 (0.11%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 2	0 / 1
Aortic valve incompetence
subjects affected / exposed	1 / 2805 (0.04%)	3 / 2868 (0.10%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac failure acute
subjects affected / exposed	0 / 2805 (0.00%)	4 / 2868 (0.14%)
occurrences causally related to treatment / all	0 / 0	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Ventricular fibrillation
subjects affected / exposed	3 / 2805 (0.11%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 2	0 / 0
Arteriosclerosis coronary artery
subjects affected / exposed	2 / 2805 (0.07%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 0
Cardiogenic shock
subjects affected / exposed	3 / 2805 (0.11%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 3	0 / 0
Cardiomegaly
subjects affected / exposed	2 / 2805 (0.07%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cor pulmonale
subjects affected / exposed	0 / 2805 (0.00%)	3 / 2868 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 1
Mitral valve prolapse
subjects affected / exposed	1 / 2805 (0.04%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Right ventricular failure
subjects affected / exposed	1 / 2805 (0.04%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 1	0 / 0
Bifascicular block
subjects affected / exposed	2 / 2805 (0.07%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac failure chronic
subjects affected / exposed	0 / 2805 (0.00%)	2 / 2868 (0.07%)
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 / 2805 (0.04%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Conduction disorder
subjects affected / exposed	0 / 2805 (0.00%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Coronary artery occlusion
subjects affected / exposed	1 / 2805 (0.04%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Coronary artery stenosis
subjects affected / exposed	2 / 2805 (0.07%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Intracardiac thrombus
subjects affected / exposed	1 / 2805 (0.04%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Left ventricular hypertrophy
subjects affected / exposed	0 / 2805 (0.00%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Pericardial effusion
subjects affected / exposed	1 / 2805 (0.04%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Sinus bradycardia
subjects affected / exposed	1 / 2805 (0.04%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Tachycardia
subjects affected / exposed	2 / 2805 (0.07%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Tachycardia paroxysmal
subjects affected / exposed	1 / 2805 (0.04%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Acute cardiac event
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Arteriospasm coronary
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Atrial tachycardia
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Bradyarrhythmia
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Bundle branch block right
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac amyloidosis
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac aneurysm
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cardio-respiratory arrest
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Cardiomyopathy alcoholic
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiorenal syndrome
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Congestive cardiomyopathy
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cor pulmonale acute
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Coronary artery thrombosis
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Diastolic dysfunction
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hypertensive heart disease
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Hypertrophic cardiomyopathy
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Metabolic cardiomyopathy
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Microvascular coronary artery disease
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
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	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Mitral valve stenosis
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Myocardial fibrosis
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Myocardial rupture
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Pulseless electrical activity
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Right ventricular dysfunction
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Nervous system disorders
Transient ischaemic attack
subjects affected / exposed	47 / 2805 (1.68%)	38 / 2868 (1.32%)
occurrences causally related to treatment / all	0 / 52	0 / 43
deaths causally related to treatment / all	0 / 0	0 / 0
Cerebrovascular accident
subjects affected / exposed	37 / 2805 (1.32%)	39 / 2868 (1.36%)
occurrences causally related to treatment / all	0 / 39	0 / 41
deaths causally related to treatment / all	0 / 2	0 / 2
Cerebral infarction
subjects affected / exposed	27 / 2805 (0.96%)	22 / 2868 (0.77%)
occurrences causally related to treatment / all	0 / 30	0 / 24
deaths causally related to treatment / all	0 / 1	0 / 1
Carpal tunnel syndrome
subjects affected / exposed	16 / 2805 (0.57%)	27 / 2868 (0.94%)
occurrences causally related to treatment / all	0 / 20	0 / 31
deaths causally related to treatment / all	0 / 0	0 / 0
Dementia
subjects affected / exposed	14 / 2805 (0.50%)	29 / 2868 (1.01%)
occurrences causally related to treatment / all	0 / 14	0 / 29
deaths causally related to treatment / all	0 / 1	0 / 2
Parkinson's disease
subjects affected / exposed	14 / 2805 (0.50%)	16 / 2868 (0.56%)
occurrences causally related to treatment / all	0 / 17	0 / 17
deaths causally related to treatment / all	0 / 0	0 / 1
Dementia Alzheimer's type
subjects affected / exposed	15 / 2805 (0.53%)	14 / 2868 (0.49%)
occurrences causally related to treatment / all	0 / 15	0 / 14
deaths causally related to treatment / all	0 / 1	0 / 1
Dizziness
subjects affected / exposed	17 / 2805 (0.61%)	11 / 2868 (0.38%)
occurrences causally related to treatment / all	0 / 18	0 / 11
deaths causally related to treatment / all	0 / 0	0 / 0
Syncope
subjects affected / exposed	12 / 2805 (0.43%)	16 / 2868 (0.56%)
occurrences causally related to treatment / all	0 / 12	0 / 19
deaths causally related to treatment / all	0 / 0	0 / 0
Radiculopathy
subjects affected / exposed	11 / 2805 (0.39%)	16 / 2868 (0.56%)
occurrences causally related to treatment / all	0 / 17	0 / 21
deaths causally related to treatment / all	0 / 0	0 / 0
Vascular dementia
subjects affected / exposed	8 / 2805 (0.29%)	17 / 2868 (0.59%)
occurrences causally related to treatment / all	0 / 10	0 / 18
deaths causally related to treatment / all	0 / 1	0 / 0
Headache
subjects affected / exposed	8 / 2805 (0.29%)	7 / 2868 (0.24%)
occurrences causally related to treatment / all	1 / 1	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
Ischaemic stroke
subjects affected / exposed	7 / 2805 (0.25%)	6 / 2868 (0.21%)
occurrences causally related to treatment / all	0 / 7	0 / 8
deaths causally related to treatment / all	0 / 0	0 / 1
Cerebral haemorrhage
subjects affected / exposed	10 / 2805 (0.36%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 12	0 / 2
deaths causally related to treatment / all	0 / 6	0 / 1
Lacunar infarction
subjects affected / exposed	7 / 2805 (0.25%)	5 / 2868 (0.17%)
occurrences causally related to treatment / all	0 / 7	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Seizure
subjects affected / exposed	5 / 2805 (0.18%)	7 / 2868 (0.24%)
occurrences causally related to treatment / all	0 / 7	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
Subarachnoid haemorrhage
subjects affected / exposed	7 / 2805 (0.25%)	5 / 2868 (0.17%)
occurrences causally related to treatment / all	0 / 7	0 / 5
deaths causally related to treatment / all	0 / 3	0 / 0
Migraine
subjects affected / exposed	5 / 2805 (0.18%)	5 / 2868 (0.17%)
occurrences causally related to treatment / all	0 / 5	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Peripheral nerve lesion
subjects affected / exposed	5 / 2805 (0.18%)	5 / 2868 (0.17%)
occurrences causally related to treatment / all	0 / 5	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Cognitive disorder
subjects affected / exposed	4 / 2805 (0.14%)	5 / 2868 (0.17%)
occurrences causally related to treatment / all	0 / 4	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Convulsion
subjects affected / exposed	1 / 2805 (0.04%)	7 / 2868 (0.24%)
occurrences causally related to treatment / all	0 / 1	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
Neuropathy peripheral
subjects affected / exposed	4 / 2805 (0.14%)	3 / 2868 (0.10%)
occurrences causally related to treatment / all	0 / 4	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Epilepsy
subjects affected / exposed	3 / 2805 (0.11%)	3 / 2868 (0.10%)
occurrences causally related to treatment / all	0 / 3	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Mixed dementia
subjects affected / exposed	5 / 2805 (0.18%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 5	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Neurological symptom
subjects affected / exposed	2 / 2805 (0.07%)	4 / 2868 (0.14%)
occurrences causally related to treatment / all	0 / 2	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Presyncope
subjects affected / exposed	2 / 2805 (0.07%)	4 / 2868 (0.14%)
occurrences causally related to treatment / all	0 / 2	0 / 5
deaths causally related to treatment / all	0 / 1	0 / 0
Sciatica
subjects affected / exposed	3 / 2805 (0.11%)	3 / 2868 (0.10%)
occurrences causally related to treatment / all	0 / 3	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Brain injury
subjects affected / exposed	2 / 2805 (0.07%)	3 / 2868 (0.10%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 1	0 / 2
Loss of consciousness
subjects affected / exposed	1 / 2805 (0.04%)	4 / 2868 (0.14%)
occurrences causally related to treatment / all	0 / 1	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Paraesthesia
subjects affected / exposed	1 / 2805 (0.04%)	4 / 2868 (0.14%)
occurrences causally related to treatment / all	0 / 1	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Cerebellar infarction
subjects affected / exposed	2 / 2805 (0.07%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Dementia of the Alzheimer's type, with delirium
subjects affected / exposed	3 / 2805 (0.11%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 0
Hemiparesis
subjects affected / exposed	4 / 2805 (0.14%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 4	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Myelopathy
subjects affected / exposed	0 / 2805 (0.00%)	4 / 2868 (0.14%)
occurrences causally related to treatment / all	0 / 0	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Polyneuropathy
subjects affected / exposed	2 / 2805 (0.07%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Carotid artery stenosis
subjects affected / exposed	1 / 2805 (0.04%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Cerebrovascular disorder
subjects affected / exposed	2 / 2805 (0.07%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 0
Embolic cerebral infarction
subjects affected / exposed	3 / 2805 (0.11%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Haemorrhage intracranial
subjects affected / exposed	1 / 2805 (0.04%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 1
Nerve root compression
subjects affected / exposed	3 / 2805 (0.11%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 4	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Tension headache
subjects affected / exposed	1 / 2805 (0.04%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Basal ganglia infarction
subjects affected / exposed	1 / 2805 (0.04%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cauda equina syndrome
subjects affected / exposed	1 / 2805 (0.04%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Cervical myelopathy
subjects affected / exposed	0 / 2805 (0.00%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Dementia with Lewy bodies
subjects affected / exposed	1 / 2805 (0.04%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Diabetic neuropathy
subjects affected / exposed	1 / 2805 (0.04%)	1 / 2868 (0.03%)
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 / 2805 (0.04%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Grand mal convulsion
subjects affected / exposed	2 / 2805 (0.07%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hypoaesthesia
subjects affected / exposed	1 / 2805 (0.04%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
IIIrd nerve paralysis
subjects affected / exposed	1 / 2805 (0.04%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
IVth nerve paralysis
subjects affected / exposed	1 / 2805 (0.04%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Motor neurone disease
subjects affected / exposed	0 / 2805 (0.00%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 1
Partial seizures
subjects affected / exposed	1 / 2805 (0.04%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Thrombotic cerebral infarction
subjects affected / exposed	0 / 2805 (0.00%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Amnesia
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Aphasia
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Arachnoid cyst
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Ataxia
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Autonomic neuropathy
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (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	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Brain stem haemorrhage
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Brain stem infarction
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Carotid artery disease
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cerebellar haemorrhage
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cerebellar stroke
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cerebellar syndrome
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cerebral amyloid angiopathy
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cerebral artery occlusion
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Cerebral disorder
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cerebral ischaemia
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cerebral small vessel ischaemic disease
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Coma
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Complex partial seizures
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Embolic stroke
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Facial paralysis
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Frontotemporal dementia
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Haemorrhagic stroke
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hemianopia homonymous
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hydrocephalus
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hypoxic-ischaemic encephalopathy
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Idiopathic generalised epilepsy
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
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 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Lacunar stroke
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Lethargy
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Migraine with aura
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Mononeuropathy
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Motor dysfunction
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Myasthenia gravis
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Neurodegenerative disorder
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Post herpetic neuralgia
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Quadriplegia
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Radial nerve palsy
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Simple partial seizures
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Slow response to stimuli
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Spinal claudication
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (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	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Spinal cord disorder
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Spinal cord ischaemia
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Spondylitic myelopathy
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Stupor
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Temporal lobe epilepsy
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Thalamus haemorrhage
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Transient global amnesia
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Tremor
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Trigeminal neuralgia
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Unresponsive to stimuli
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
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 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
VIth nerve paralysis
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Vertebral artery thrombosis
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Vertigo CNS origin
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (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
Iron deficiency anaemia
subjects affected / exposed	43 / 2805 (1.53%)	43 / 2868 (1.50%)
occurrences causally related to treatment / all	0 / 53	0 / 50
deaths causally related to treatment / all	0 / 0	0 / 0
Anaemia
subjects affected / exposed	49 / 2805 (1.75%)	36 / 2868 (1.26%)
occurrences causally related to treatment / all	0 / 58	0 / 41
deaths causally related to treatment / all	0 / 0	0 / 0
Lymphadenopathy
subjects affected / exposed	4 / 2805 (0.14%)	3 / 2868 (0.10%)
occurrences causally related to treatment / all	0 / 4	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Agranulocytosis
subjects affected / exposed	3 / 2805 (0.11%)	3 / 2868 (0.10%)
occurrences causally related to treatment / all	0 / 3	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Anaemia folate deficiency
subjects affected / exposed	1 / 2805 (0.04%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Autoimmune haemolytic anaemia
subjects affected / exposed	1 / 2805 (0.04%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 1	0 / 15
deaths causally related to treatment / all	0 / 0	0 / 0
Thrombocytopenia
subjects affected / exposed	2 / 2805 (0.07%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hypergammaglobulinaemia
subjects affected / exposed	0 / 2805 (0.00%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Idiopathic thrombocytopenic purpura
subjects affected / exposed	1 / 2805 (0.04%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Microcytic anaemia
subjects affected / exposed	0 / 2805 (0.00%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Anaemia haemolytic autoimmune
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Anaemia of malignant disease
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Bone marrow disorder
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Bone marrow oedema syndrome
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Haemolytic anaemia
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Haemorrhagic disorder
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hypereosinophilic syndrome
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Neutropenia
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (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 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Paratracheal lymphadenopathy
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pernicious anaemia
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Polycythaemia
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Purpura non-thrombocytopenic
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Splenomegaly
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
White blood cell disorder
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Ear and labyrinth disorders
Vertigo positional
subjects affected / exposed	7 / 2805 (0.25%)	8 / 2868 (0.28%)
occurrences causally related to treatment / all	0 / 9	0 / 8
deaths causally related to treatment / all	0 / 0	0 / 0
Vertigo
subjects affected / exposed	2 / 2805 (0.07%)	4 / 2868 (0.14%)
occurrences causally related to treatment / all	0 / 2	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Vestibular disorder
subjects affected / exposed	0 / 2805 (0.00%)	3 / 2868 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Meniere's disease
subjects affected / exposed	0 / 2805 (0.00%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Tinnitus
subjects affected / exposed	1 / 2805 (0.04%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Deafness
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Inner ear disorder
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Tympanic membrane perforation
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Tympanosclerosis
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Eye disorders
Cataract
subjects affected / exposed	301 / 2805 (10.73%)	301 / 2868 (10.50%)
occurrences causally related to treatment / all	1 / 451	0 / 437
deaths causally related to treatment / all	0 / 0	0 / 0
Posterior capsule opacification
subjects affected / exposed	16 / 2805 (0.57%)	15 / 2868 (0.52%)
occurrences causally related to treatment / all	0 / 18	0 / 16
deaths causally related to treatment / all	0 / 0	0 / 0
Macular degeneration
subjects affected / exposed	12 / 2805 (0.43%)	12 / 2868 (0.42%)
occurrences causally related to treatment / all	0 / 19	0 / 17
deaths causally related to treatment / all	0 / 0	0 / 0
Glaucoma
subjects affected / exposed	9 / 2805 (0.32%)	12 / 2868 (0.42%)
occurrences causally related to treatment / all	0 / 10	0 / 14
deaths causally related to treatment / all	0 / 0	0 / 0
Ectropion
subjects affected / exposed	5 / 2805 (0.18%)	9 / 2868 (0.31%)
occurrences causally related to treatment / all	0 / 6	0 / 10
deaths causally related to treatment / all	0 / 0	0 / 0
Open angle glaucoma
subjects affected / exposed	5 / 2805 (0.18%)	9 / 2868 (0.31%)
occurrences causally related to treatment / all	0 / 5	0 / 9
deaths causally related to treatment / all	0 / 0	0 / 0
Entropion
subjects affected / exposed	4 / 2805 (0.14%)	6 / 2868 (0.21%)
occurrences causally related to treatment / all	0 / 4	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
Retinal artery occlusion
subjects affected / exposed	5 / 2805 (0.18%)	3 / 2868 (0.10%)
occurrences causally related to treatment / all	0 / 6	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Eyelid disorder
subjects affected / exposed	3 / 2805 (0.11%)	4 / 2868 (0.14%)
occurrences causally related to treatment / all	0 / 3	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Lacrimation increased
subjects affected / exposed	2 / 2805 (0.07%)	5 / 2868 (0.17%)
occurrences causally related to treatment / all	0 / 2	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Retinal detachment
subjects affected / exposed	5 / 2805 (0.18%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 5	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Eyelid ptosis
subjects affected / exposed	1 / 2805 (0.04%)	5 / 2868 (0.17%)
occurrences causally related to treatment / all	0 / 1	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Diplopia
subjects affected / exposed	2 / 2805 (0.07%)	3 / 2868 (0.10%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Retinal disorder
subjects affected / exposed	2 / 2805 (0.07%)	3 / 2868 (0.10%)
occurrences causally related to treatment / all	0 / 2	0 / 17
deaths causally related to treatment / all	0 / 0	0 / 0
Vitreous haemorrhage
subjects affected / exposed	4 / 2805 (0.14%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 4	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Amaurosis fugax
subjects affected / exposed	1 / 2805 (0.04%)	3 / 2868 (0.10%)
occurrences causally related to treatment / all	1 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Dacryostenosis acquired
subjects affected / exposed	1 / 2805 (0.04%)	3 / 2868 (0.10%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Diabetic retinopathy
subjects affected / exposed	3 / 2805 (0.11%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Eye disorder
subjects affected / exposed	1 / 2805 (0.04%)	3 / 2868 (0.10%)
occurrences causally related to treatment / all	0 / 1	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Corneal degeneration
subjects affected / exposed	2 / 2805 (0.07%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Diabetic eye disease
subjects affected / exposed	2 / 2805 (0.07%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Inflammation of lacrimal passage
subjects affected / exposed	2 / 2805 (0.07%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Retinal vein occlusion
subjects affected / exposed	2 / 2805 (0.07%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Vitreous disorder
subjects affected / exposed	1 / 2805 (0.04%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Blepharospasm
subjects affected / exposed	1 / 2805 (0.04%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Blindness unilateral
subjects affected / exposed	1 / 2805 (0.04%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Chalazion
subjects affected / exposed	2 / 2805 (0.07%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Corneal disorder
subjects affected / exposed	1 / 2805 (0.04%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Ocular myasthenia
subjects affected / exposed	2 / 2805 (0.07%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Parophthalmia
subjects affected / exposed	1 / 2805 (0.04%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Retinal haemorrhage
subjects affected / exposed	1 / 2805 (0.04%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Retinal tear
subjects affected / exposed	0 / 2805 (0.00%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Serous retinal detachment
subjects affected / exposed	2 / 2805 (0.07%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Tractional retinal detachment
subjects affected / exposed	1 / 2805 (0.04%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Visual acuity reduced
subjects affected / exposed	0 / 2805 (0.00%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Aphakia
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Binocular eye movement disorder
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Blindness
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cataract diabetic
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cataract nuclear
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Conjunctival deposit
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Corneal decompensation
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Corneal oedema
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Iridocyclitis
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Keratitis
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Lens dislocation
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Lens disorder
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Neovascular age-related macular degeneration
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Retinal artery embolism
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Retinal vascular disorder
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal disorders
Diverticulum
subjects affected / exposed	70 / 2805 (2.50%)	83 / 2868 (2.89%)
occurrences causally related to treatment / all	0 / 74	0 / 92
deaths causally related to treatment / all	0 / 0	0 / 0
Gastritis
subjects affected / exposed	50 / 2805 (1.78%)	57 / 2868 (1.99%)
occurrences causally related to treatment / all	0 / 53	0 / 61
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrooesophageal reflux disease
subjects affected / exposed	49 / 2805 (1.75%)	44 / 2868 (1.53%)
occurrences causally related to treatment / all	1 / 52	0 / 48
deaths causally related to treatment / all	0 / 0	0 / 0
Inguinal hernia
subjects affected / exposed	43 / 2805 (1.53%)	43 / 2868 (1.50%)
occurrences causally related to treatment / all	0 / 51	0 / 51
deaths causally related to treatment / all	0 / 0	0 / 0
Abdominal pain upper
subjects affected / exposed	28 / 2805 (1.00%)	39 / 2868 (1.36%)
occurrences causally related to treatment / all	0 / 28	0 / 41
deaths causally related to treatment / all	0 / 0	0 / 0
Large intestine polyp
subjects affected / exposed	20 / 2805 (0.71%)	40 / 2868 (1.39%)
occurrences causally related to treatment / all	0 / 21	0 / 41
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal haemorrhage
subjects affected / exposed	28 / 2805 (1.00%)	29 / 2868 (1.01%)
occurrences causally related to treatment / all	0 / 31	0 / 31
deaths causally related to treatment / all	0 / 0	0 / 1
Abdominal pain
subjects affected / exposed	23 / 2805 (0.82%)	29 / 2868 (1.01%)
occurrences causally related to treatment / all	2 / 26	0 / 30
deaths causally related to treatment / all	0 / 0	0 / 0
Barrett's oesophagus
subjects affected / exposed	30 / 2805 (1.07%)	21 / 2868 (0.73%)
occurrences causally related to treatment / all	0 / 43	0 / 24
deaths causally related to treatment / all	0 / 0	0 / 0
Dysphagia
subjects affected / exposed	25 / 2805 (0.89%)	20 / 2868 (0.70%)
occurrences causally related to treatment / all	0 / 27	0 / 20
deaths causally related to treatment / all	0 / 1	0 / 0
Constipation
subjects affected / exposed	18 / 2805 (0.64%)	20 / 2868 (0.70%)
occurrences causally related to treatment / all	0 / 19	0 / 21
deaths causally related to treatment / all	0 / 0	0 / 0
Change of bowel habit
subjects affected / exposed	11 / 2805 (0.39%)	25 / 2868 (0.87%)
occurrences causally related to treatment / all	0 / 11	0 / 25
deaths causally related to treatment / all	0 / 0	0 / 0
Diaphragmatic hernia
subjects affected / exposed	16 / 2805 (0.57%)	18 / 2868 (0.63%)
occurrences causally related to treatment / all	0 / 18	0 / 18
deaths causally related to treatment / all	0 / 0	0 / 0
Haemorrhoids
subjects affected / exposed	16 / 2805 (0.57%)	15 / 2868 (0.52%)
occurrences causally related to treatment / all	0 / 19	0 / 18
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal polyp
subjects affected / exposed	12 / 2805 (0.43%)	14 / 2868 (0.49%)
occurrences causally related to treatment / all	0 / 14	0 / 15
deaths causally related to treatment / all	0 / 0	0 / 0
Intestinal obstruction
subjects affected / exposed	12 / 2805 (0.43%)	14 / 2868 (0.49%)
occurrences causally related to treatment / all	0 / 15	0 / 17
deaths causally related to treatment / all	0 / 0	0 / 1
Colonic polyp
subjects affected / exposed	9 / 2805 (0.32%)	16 / 2868 (0.56%)
occurrences causally related to treatment / all	0 / 9	0 / 22
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal inflammation
subjects affected / exposed	12 / 2805 (0.43%)	13 / 2868 (0.45%)
occurrences causally related to treatment / all	0 / 13	0 / 16
deaths causally related to treatment / all	0 / 0	0 / 0
Oesophagitis
subjects affected / exposed	13 / 2805 (0.46%)	12 / 2868 (0.42%)
occurrences causally related to treatment / all	0 / 13	0 / 12
deaths causally related to treatment / all	0 / 0	0 / 0
Rectal haemorrhage
subjects affected / exposed	12 / 2805 (0.43%)	12 / 2868 (0.42%)
occurrences causally related to treatment / all	0 / 12	0 / 12
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal disorder
subjects affected / exposed	12 / 2805 (0.43%)	11 / 2868 (0.38%)
occurrences causally related to treatment / all	0 / 12	0 / 11
deaths causally related to treatment / all	0 / 0	0 / 0
Rectal polyp
subjects affected / exposed	8 / 2805 (0.29%)	11 / 2868 (0.38%)
occurrences causally related to treatment / all	0 / 9	0 / 11
deaths causally related to treatment / all	0 / 0	0 / 0
Vomiting
subjects affected / exposed	9 / 2805 (0.32%)	10 / 2868 (0.35%)
occurrences causally related to treatment / all	0 / 9	0 / 10
deaths causally related to treatment / all	0 / 0	0 / 0
Abdominal pain lower
subjects affected / exposed	5 / 2805 (0.18%)	10 / 2868 (0.35%)
occurrences causally related to treatment / all	0 / 5	0 / 11
deaths causally related to treatment / all	0 / 0	0 / 0
Melaena
subjects affected / exposed	4 / 2805 (0.14%)	10 / 2868 (0.35%)
occurrences causally related to treatment / all	0 / 4	0 / 10
deaths causally related to treatment / all	0 / 0	0 / 0
Umbilical hernia
subjects affected / exposed	9 / 2805 (0.32%)	5 / 2868 (0.17%)
occurrences causally related to treatment / all	0 / 9	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Crohn's disease
subjects affected / exposed	5 / 2805 (0.18%)	8 / 2868 (0.28%)
occurrences causally related to treatment / all	0 / 5	0 / 14
deaths causally related to treatment / all	0 / 0	0 / 0
Duodenitis
subjects affected / exposed	9 / 2805 (0.32%)	4 / 2868 (0.14%)
occurrences causally related to treatment / all	0 / 9	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Dyspepsia
subjects affected / exposed	5 / 2805 (0.18%)	7 / 2868 (0.24%)
occurrences causally related to treatment / all	0 / 5	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
Oesophageal ulcer
subjects affected / exposed	8 / 2805 (0.29%)	4 / 2868 (0.14%)
occurrences causally related to treatment / all	0 / 9	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Pancreatitis
subjects affected / exposed	5 / 2805 (0.18%)	7 / 2868 (0.24%)
occurrences causally related to treatment / all	0 / 6	0 / 10
deaths causally related to treatment / all	0 / 0	0 / 0
Dyskinesia oesophageal
subjects affected / exposed	6 / 2805 (0.21%)	5 / 2868 (0.17%)
occurrences causally related to treatment / all	0 / 6	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Colitis ulcerative
subjects affected / exposed	6 / 2805 (0.21%)	4 / 2868 (0.14%)
occurrences causally related to treatment / all	0 / 11	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Diarrhoea
subjects affected / exposed	5 / 2805 (0.18%)	5 / 2868 (0.17%)
occurrences causally related to treatment / all	0 / 5	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Oesophageal obstruction
subjects affected / exposed	4 / 2805 (0.14%)	6 / 2868 (0.21%)
occurrences causally related to treatment / all	0 / 7	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Anal fistula
subjects affected / exposed	4 / 2805 (0.14%)	5 / 2868 (0.17%)
occurrences causally related to treatment / all	0 / 6	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Tooth disorder
subjects affected / exposed	6 / 2805 (0.21%)	3 / 2868 (0.10%)
occurrences causally related to treatment / all	0 / 6	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal toxicity
subjects affected / exposed	3 / 2805 (0.11%)	5 / 2868 (0.17%)
occurrences causally related to treatment / all	0 / 4	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Haematemesis
subjects affected / exposed	4 / 2805 (0.14%)	4 / 2868 (0.14%)
occurrences causally related to treatment / all	0 / 4	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Obstructive pancreatitis
subjects affected / exposed	5 / 2805 (0.18%)	3 / 2868 (0.10%)
occurrences causally related to treatment / all	0 / 7	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Pancreatitis acute
subjects affected / exposed	3 / 2805 (0.11%)	5 / 2868 (0.17%)
occurrences causally related to treatment / all	0 / 3	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Abnormal faeces
subjects affected / exposed	2 / 2805 (0.07%)	5 / 2868 (0.17%)
occurrences causally related to treatment / all	0 / 2	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Colitis ischaemic
subjects affected / exposed	3 / 2805 (0.11%)	4 / 2868 (0.14%)
occurrences causally related to treatment / all	0 / 3	0 / 4
deaths causally related to treatment / all	0 / 2	0 / 1
Dental caries
subjects affected / exposed	4 / 2805 (0.14%)	3 / 2868 (0.10%)
occurrences causally related to treatment / all	0 / 5	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Inguinal hernia, Obstructive
subjects affected / exposed	2 / 2805 (0.07%)	5 / 2868 (0.17%)
occurrences causally related to treatment / all	0 / 2	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Intestinal ischaemia
subjects affected / exposed	1 / 2805 (0.04%)	6 / 2868 (0.21%)
occurrences causally related to treatment / all	0 / 1	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 5
Oral disorder
subjects affected / exposed	3 / 2805 (0.11%)	4 / 2868 (0.14%)
occurrences causally related to treatment / all	0 / 4	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Small intestinal obstruction
subjects affected / exposed	3 / 2805 (0.11%)	4 / 2868 (0.14%)
occurrences causally related to treatment / all	0 / 4	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Anal incontinence
subjects affected / exposed	4 / 2805 (0.14%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 5	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Upper gastrointestinal haemorrhage
subjects affected / exposed	3 / 2805 (0.11%)	3 / 2868 (0.10%)
occurrences causally related to treatment / all	0 / 3	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Chronic gastritis
subjects affected / exposed	2 / 2805 (0.07%)	3 / 2868 (0.10%)
occurrences causally related to treatment / all	0 / 3	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Abdominal hernia
subjects affected / exposed	1 / 2805 (0.04%)	3 / 2868 (0.10%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Colitis microscopic
subjects affected / exposed	2 / 2805 (0.07%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Diverticulum intestinal
subjects affected / exposed	2 / 2805 (0.07%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Rectal prolapse
subjects affected / exposed	3 / 2805 (0.11%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 7	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Abdominal discomfort
subjects affected / exposed	1 / 2805 (0.04%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Ascites
subjects affected / exposed	2 / 2805 (0.07%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 4	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Duodenal ulcer
subjects affected / exposed	1 / 2805 (0.04%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Gastritis haemorrhagic
subjects affected / exposed	2 / 2805 (0.07%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Intestinal perforation
subjects affected / exposed	2 / 2805 (0.07%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 0
Lower gastrointestinal haemorrhage
subjects affected / exposed	3 / 2805 (0.11%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Mesenteric vascular insufficiency
subjects affected / exposed	2 / 2805 (0.07%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pancreatic cyst
subjects affected / exposed	2 / 2805 (0.07%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Pancreatitis chronic
subjects affected / exposed	1 / 2805 (0.04%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Salivary gland disorder
subjects affected / exposed	2 / 2805 (0.07%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Tongue disorder
subjects affected / exposed	1 / 2805 (0.04%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Varices oesophageal
subjects affected / exposed	3 / 2805 (0.11%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Abdominal hernia obstructive
subjects affected / exposed	1 / 2805 (0.04%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Alcoholic pancreatitis
subjects affected / exposed	1 / 2805 (0.04%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Anorectal disorder
subjects affected / exposed	2 / 2805 (0.07%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Coeliac disease
subjects affected / exposed	1 / 2805 (0.04%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Colitis
subjects affected / exposed	1 / 2805 (0.04%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Diverticular perforation
subjects affected / exposed	1 / 2805 (0.04%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Femoral hernia
subjects affected / exposed	1 / 2805 (0.04%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastric haemorrhage
subjects affected / exposed	2 / 2805 (0.07%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gastric ulcer
subjects affected / exposed	2 / 2805 (0.07%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gastric ulcer haemorrhage
subjects affected / exposed	1 / 2805 (0.04%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastritis atrophic
subjects affected / exposed	0 / 2805 (0.00%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal angiodysplasia
subjects affected / exposed	2 / 2805 (0.07%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gingival disorder
subjects affected / exposed	1 / 2805 (0.04%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Haemorrhoidal haemorrhage
subjects affected / exposed	2 / 2805 (0.07%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hiatus hernia
subjects affected / exposed	2 / 2805 (0.07%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Intestinal ulcer
subjects affected / exposed	0 / 2805 (0.00%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Irritable bowel syndrome
subjects affected / exposed	2 / 2805 (0.07%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Mallory-Weiss syndrome
subjects affected / exposed	0 / 2805 (0.00%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Nausea
subjects affected / exposed	0 / 2805 (0.00%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Obstruction gastric
subjects affected / exposed	1 / 2805 (0.04%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Oesophageal disorder
subjects affected / exposed	2 / 2805 (0.07%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pancreatic disorder
subjects affected / exposed	1 / 2805 (0.04%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Proctitis ulcerative
subjects affected / exposed	1 / 2805 (0.04%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pseudopolyposis
subjects affected / exposed	1 / 2805 (0.04%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Tooth development disorder
subjects affected / exposed	2 / 2805 (0.07%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Volvulus
subjects affected / exposed	1 / 2805 (0.04%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Abdominal adhesions
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Abdominal mass
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Abdominal strangulated hernia
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Anal polyp
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Coeliac artery stenosis
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Colonic fistula
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Diarrhoea haemorrhagic
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Diverticulum gastric
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Diverticulum intestinal haemorrhagic
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Duodenal obstruction
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Duodenal ulcer haemorrhage
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Enteritis
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Enterovesical fistula
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Functional gastrointestinal disorder
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gallstone ileus
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastritis alcoholic
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gastroduodenitis
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Glossitis
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Haemoperitoneum
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Ileus paralytic
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Intestinal fistula
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Intestinal haemorrhage
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Intestinal polyp
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Large intestinal haemorrhage
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Leukoplakia oral
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Malabsorption
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Oesophageal achalasia
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Oesophageal dilatation
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Oesophageal spasm
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Oesophageal varices haemorrhage
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pancreatic calcification
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pancreatic failure
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pancreatitis necrotising
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Peptic ulcer haemorrhage
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Peptic ulcer perforation
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Peritoneal adhesions
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Proctitis
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Radicular cyst
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Rectal ulcer
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Retroperitoneal haemorrhage
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Salivary gland mucocoele
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Tooth socket haemorrhage
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Umbilical hernia, Obstructive airways disorder
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Skin and subcutaneous tissue disorders
Skin disorder
subjects affected / exposed	8 / 2805 (0.29%)	15 / 2868 (0.52%)
occurrences causally related to treatment / all	0 / 8	0 / 16
deaths causally related to treatment / all	0 / 0	0 / 0
Actinic keratosis
subjects affected / exposed	4 / 2805 (0.14%)	12 / 2868 (0.42%)
occurrences causally related to treatment / all	0 / 4	0 / 15
deaths causally related to treatment / all	0 / 0	0 / 0
Dermal cyst
subjects affected / exposed	5 / 2805 (0.18%)	6 / 2868 (0.21%)
occurrences causally related to treatment / all	0 / 5	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
Skin ulcer
subjects affected / exposed	4 / 2805 (0.14%)	5 / 2868 (0.17%)
occurrences causally related to treatment / all	0 / 4	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Angioedema
subjects affected / exposed	3 / 2805 (0.11%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Scar
subjects affected / exposed	3 / 2805 (0.11%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Psoriasis
subjects affected / exposed	1 / 2805 (0.04%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Rash
subjects affected / exposed	3 / 2805 (0.11%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	1 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Rosacea
subjects affected / exposed	1 / 2805 (0.04%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Lichen planus
subjects affected / exposed	0 / 2805 (0.00%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Pemphigoid
subjects affected / exposed	1 / 2805 (0.04%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cold sweat
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Dermatitis
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Diabetic foot
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Diabetic ulcer
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Dry gangrene
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Ecchymosis
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Eczema
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Idiopathic angioedema
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Keloid scar
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Lichen sclerosus
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Neurodermatitis
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Precancerous skin lesion
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Rash generalised
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Skin hyperpigmentation
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Skin hypertrophy
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Renal and urinary disorders
Haematuria
subjects affected / exposed	38 / 2805 (1.35%)	32 / 2868 (1.12%)
occurrences causally related to treatment / all	0 / 45	0 / 39
deaths causally related to treatment / all	0 / 0	0 / 0
Urinary retention
subjects affected / exposed	24 / 2805 (0.86%)	41 / 2868 (1.43%)
occurrences causally related to treatment / all	0 / 27	0 / 48
deaths causally related to treatment / all	0 / 0	0 / 0
Acute kidney injury
subjects affected / exposed	16 / 2805 (0.57%)	28 / 2868 (0.98%)
occurrences causally related to treatment / all	0 / 17	0 / 35
deaths causally related to treatment / all	0 / 0	0 / 1
Nephrolithiasis
subjects affected / exposed	17 / 2805 (0.61%)	16 / 2868 (0.56%)
occurrences causally related to treatment / all	0 / 24	0 / 19
deaths causally related to treatment / all	0 / 0	0 / 0
Bladder disorder
subjects affected / exposed	10 / 2805 (0.36%)	7 / 2868 (0.24%)
occurrences causally related to treatment / all	0 / 11	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
Hydronephrosis
subjects affected / exposed	10 / 2805 (0.36%)	7 / 2868 (0.24%)
occurrences causally related to treatment / all	0 / 12	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
Urethral stenosis
subjects affected / exposed	10 / 2805 (0.36%)	6 / 2868 (0.21%)
occurrences causally related to treatment / all	0 / 11	0 / 10
deaths causally related to treatment / all	0 / 0	0 / 0
Renal failure acute
subjects affected / exposed	7 / 2805 (0.25%)	6 / 2868 (0.21%)
occurrences causally related to treatment / all	0 / 7	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
Tubulointerstitial nephritis
subjects affected / exposed	5 / 2805 (0.18%)	8 / 2868 (0.28%)
occurrences causally related to treatment / all	0 / 5	0 / 8
deaths causally related to treatment / all	0 / 0	0 / 0
Calculus ureteric
subjects affected / exposed	7 / 2805 (0.25%)	5 / 2868 (0.17%)
occurrences causally related to treatment / all	0 / 8	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Urinary tract disorder
subjects affected / exposed	3 / 2805 (0.11%)	9 / 2868 (0.31%)
occurrences causally related to treatment / all	0 / 3	0 / 9
deaths causally related to treatment / all	0 / 0	0 / 0
Bladder neck obstruction
subjects affected / exposed	2 / 2805 (0.07%)	5 / 2868 (0.17%)
occurrences causally related to treatment / all	0 / 2	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Urinary incontinence
subjects affected / exposed	6 / 2805 (0.21%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 6	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Renal failure chronic
subjects affected / exposed	1 / 2805 (0.04%)	4 / 2868 (0.14%)
occurrences causally related to treatment / all	0 / 1	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 1
Calculus bladder
subjects affected / exposed	2 / 2805 (0.07%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Renal failure
subjects affected / exposed	2 / 2805 (0.07%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 2
Renal impairment
subjects affected / exposed	2 / 2805 (0.07%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 1
Calculus urinary
subjects affected / exposed	1 / 2805 (0.04%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Chronic kidney disease
subjects affected / exposed	2 / 2805 (0.07%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cystitis interstitial
subjects affected / exposed	2 / 2805 (0.07%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 4	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Dysuria
subjects affected / exposed	1 / 2805 (0.04%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
End stage renal disease
subjects affected / exposed	2 / 2805 (0.07%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Renal colic
subjects affected / exposed	2 / 2805 (0.07%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Bladder dysfunction
subjects affected / exposed	1 / 2805 (0.04%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Lower urinary tract symptoms
subjects affected / exposed	1 / 2805 (0.04%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Nephrotic syndrome
subjects affected / exposed	1 / 2805 (0.04%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Polyuria
subjects affected / exposed	1 / 2805 (0.04%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Renal disorder
subjects affected / exposed	1 / 2805 (0.04%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Stress urinary incontinence
subjects affected / exposed	0 / 2805 (0.00%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Urinary tract obstruction
subjects affected / exposed	2 / 2805 (0.07%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Anuria
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Bladder diverticulum
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Diabetic nephropathy
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Focal segmental glomerulosclerosis
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Glomerulonephritis
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hydroureter
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pelvi-ureteric obstruction
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Renal atrophy
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Renal cyst
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Renal mass
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Ureteral spasm
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Ureteric stenosis
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Endocrine disorders
Hyperthyroidism
subjects affected / exposed	0 / 2805 (0.00%)	3 / 2868 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Goitre
subjects affected / exposed	0 / 2805 (0.00%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Hypothyroidism
subjects affected / exposed	0 / 2805 (0.00%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Acromegaly
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Addison's disease
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Adrenal disorder
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Adrenocortical insufficiency acute
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Diabetes insipidus
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hyperparathyroidism
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hyperparathyroidism primary
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hypopituitarism
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hypothalamo-pituitary disorder
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Musculoskeletal and connective tissue disorders
Osteoarthritis
subjects affected / exposed	103 / 2805 (3.67%)	122 / 2868 (4.25%)
occurrences causally related to treatment / all	0 / 125	0 / 146
deaths causally related to treatment / all	0 / 0	0 / 0
Back pain
subjects affected / exposed	19 / 2805 (0.68%)	31 / 2868 (1.08%)
occurrences causally related to treatment / all	0 / 24	0 / 44
deaths causally related to treatment / all	0 / 0	0 / 0
Arthralgia
subjects affected / exposed	24 / 2805 (0.86%)	24 / 2868 (0.84%)
occurrences causally related to treatment / all	1 / 28	0 / 27
deaths causally related to treatment / all	0 / 0	0 / 0
Spinal stenosis
subjects affected / exposed	20 / 2805 (0.71%)	17 / 2868 (0.59%)
occurrences causally related to treatment / all	0 / 21	0 / 24
deaths causally related to treatment / all	0 / 0	0 / 0
Musculoskeletal chest pain
subjects affected / exposed	15 / 2805 (0.53%)	20 / 2868 (0.70%)
occurrences causally related to treatment / all	0 / 17	0 / 21
deaths causally related to treatment / all	0 / 0	0 / 0
Soft tissue disorder
subjects affected / exposed	15 / 2805 (0.53%)	19 / 2868 (0.66%)
occurrences causally related to treatment / all	0 / 17	0 / 21
deaths causally related to treatment / all	0 / 0	0 / 0
Polymyalgia rheumatica
subjects affected / exposed	10 / 2805 (0.36%)	17 / 2868 (0.59%)
occurrences causally related to treatment / all	0 / 10	0 / 18
deaths causally related to treatment / all	0 / 0	0 / 0
Dupuytren's contracture
subjects affected / exposed	11 / 2805 (0.39%)	13 / 2868 (0.45%)
occurrences causally related to treatment / all	0 / 11	0 / 14
deaths causally related to treatment / all	0 / 0	0 / 0
Rotator cuff syndrome
subjects affected / exposed	10 / 2805 (0.36%)	13 / 2868 (0.45%)
occurrences causally related to treatment / all	0 / 10	0 / 20
deaths causally related to treatment / all	0 / 0	0 / 0
Pain in extremity
subjects affected / exposed	8 / 2805 (0.29%)	13 / 2868 (0.45%)
occurrences causally related to treatment / all	0 / 9	0 / 13
deaths causally related to treatment / all	0 / 0	0 / 0
Spinal osteoarthritis
subjects affected / exposed	14 / 2805 (0.50%)	7 / 2868 (0.24%)
occurrences causally related to treatment / all	0 / 17	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
Polyarthritis
subjects affected / exposed	8 / 2805 (0.29%)	10 / 2868 (0.35%)
occurrences causally related to treatment / all	0 / 8	0 / 13
deaths causally related to treatment / all	0 / 0	0 / 0
Arthritis
subjects affected / exposed	14 / 2805 (0.50%)	3 / 2868 (0.10%)
occurrences causally related to treatment / all	0 / 14	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Osteoporosis
subjects affected / exposed	10 / 2805 (0.36%)	7 / 2868 (0.24%)
occurrences causally related to treatment / all	0 / 12	0 / 8
deaths causally related to treatment / all	0 / 0	0 / 0
Rheumatoid arthritis
subjects affected / exposed	7 / 2805 (0.25%)	10 / 2868 (0.35%)
occurrences causally related to treatment / all	0 / 7	0 / 22
deaths causally related to treatment / all	0 / 0	0 / 0
Foot deformity
subjects affected / exposed	6 / 2805 (0.21%)	8 / 2868 (0.28%)
occurrences causally related to treatment / all	0 / 6	0 / 9
deaths causally related to treatment / all	0 / 0	0 / 0
Osteoporotic fracture
subjects affected / exposed	5 / 2805 (0.18%)	9 / 2868 (0.31%)
occurrences causally related to treatment / all	0 / 7	0 / 11
deaths causally related to treatment / all	0 / 0	0 / 0
Trigger finger
subjects affected / exposed	5 / 2805 (0.18%)	7 / 2868 (0.24%)
occurrences causally related to treatment / all	0 / 5	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
Myalgia
subjects affected / exposed	2 / 2805 (0.07%)	9 / 2868 (0.31%)
occurrences causally related to treatment / all	0 / 2	0 / 9
deaths causally related to treatment / all	0 / 0	0 / 0
Musculoskeletal pain
subjects affected / exposed	8 / 2805 (0.29%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 9	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Bursitis
subjects affected / exposed	8 / 2805 (0.29%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 8	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Joint effusion
subjects affected / exposed	3 / 2805 (0.11%)	5 / 2868 (0.17%)
occurrences causally related to treatment / all	0 / 3	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Neck pain
subjects affected / exposed	6 / 2805 (0.21%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 6	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Intervertebral disc disorder
subjects affected / exposed	1 / 2805 (0.04%)	5 / 2868 (0.17%)
occurrences causally related to treatment / all	0 / 1	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Synovial cyst
subjects affected / exposed	4 / 2805 (0.14%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 4	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Costochondritis
subjects affected / exposed	1 / 2805 (0.04%)	4 / 2868 (0.14%)
occurrences causally related to treatment / all	0 / 1	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Fibromyalgia
subjects affected / exposed	1 / 2805 (0.04%)	3 / 2868 (0.10%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Intervertebral disc displacement
subjects affected / exposed	3 / 2805 (0.11%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 4	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Mobility decreased
subjects affected / exposed	1 / 2805 (0.04%)	3 / 2868 (0.10%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Muscle disorder
subjects affected / exposed	1 / 2805 (0.04%)	3 / 2868 (0.10%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Pathological fracture
subjects affected / exposed	2 / 2805 (0.07%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 3	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Spondylolisthesis
subjects affected / exposed	3 / 2805 (0.11%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Tendonitis
subjects affected / exposed	1 / 2805 (0.04%)	3 / 2868 (0.10%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Bone disorder
subjects affected / exposed	2 / 2805 (0.07%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Lumbar spinal stenosis
subjects affected / exposed	2 / 2805 (0.07%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Periarthritis
subjects affected / exposed	3 / 2805 (0.11%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Spondyloarthropathy
subjects affected / exposed	2 / 2805 (0.07%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 5	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Arthropathy
subjects affected / exposed	1 / 2805 (0.04%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cervical spinal stenosis
subjects affected / exposed	1 / 2805 (0.04%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Groin pain
subjects affected / exposed	2 / 2805 (0.07%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Haemarthrosis
subjects affected / exposed	1 / 2805 (0.04%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Intervertebral disc degeneration
subjects affected / exposed	0 / 2805 (0.00%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Jaw disorder
subjects affected / exposed	1 / 2805 (0.04%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Joint stiffness
subjects affected / exposed	1 / 2805 (0.04%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Joint swelling
subjects affected / exposed	1 / 2805 (0.04%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Monarthritis
subjects affected / exposed	2 / 2805 (0.07%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Muscle spasms
subjects affected / exposed	1 / 2805 (0.04%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Muscular weakness
subjects affected / exposed	1 / 2805 (0.04%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pseudarthrosis
subjects affected / exposed	1 / 2805 (0.04%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Psoriatic arthropathy
subjects affected / exposed	1 / 2805 (0.04%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Rheumatoid nodule
subjects affected / exposed	2 / 2805 (0.07%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Scoliosis
subjects affected / exposed	0 / 2805 (0.00%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Spinal column stenosis
subjects affected / exposed	0 / 2805 (0.00%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Tenosynovitis
subjects affected / exposed	2 / 2805 (0.07%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Bone cyst
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Bursa disorder
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
CREST syndrome
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Chondrocalcinosis pyrophosphate
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Fracture nonunion
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gouty tophus
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
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 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Limb deformity
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Loose body in joint
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Muscle haemorrhage
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
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	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Nodal osteoarthritis
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Osteolysis
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Osteopenia
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Plantar fascial fibromatosis
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Plantar fasciitis
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Polymyositis
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Rhabdomyolysis
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Spinal pain
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Systemic sclerosis
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 5	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Temporomandibular joint syndrome
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Vertebral wedging
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Infections and infestations
Pneumonia
subjects affected / exposed	106 / 2805 (3.78%)	111 / 2868 (3.87%)
occurrences causally related to treatment / all	0 / 124	0 / 133
deaths causally related to treatment / all	0 / 23	0 / 21
Urinary tract infection
subjects affected / exposed	66 / 2805 (2.35%)	73 / 2868 (2.55%)
occurrences causally related to treatment / all	0 / 76	0 / 88
deaths causally related to treatment / all	0 / 0	0 / 1
Lower respiratory tract infection
subjects affected / exposed	51 / 2805 (1.82%)	81 / 2868 (2.82%)
occurrences causally related to treatment / all	0 / 58	0 / 93
deaths causally related to treatment / all	0 / 3	0 / 3
Sepsis
subjects affected / exposed	44 / 2805 (1.57%)	51 / 2868 (1.78%)
occurrences causally related to treatment / all	0 / 45	0 / 54
deaths causally related to treatment / all	0 / 9	0 / 5
Cellulitis
subjects affected / exposed	29 / 2805 (1.03%)	36 / 2868 (1.26%)
occurrences causally related to treatment / all	0 / 31	0 / 41
deaths causally related to treatment / all	0 / 0	0 / 0
COVID-19
subjects affected / exposed	30 / 2805 (1.07%)	31 / 2868 (1.08%)
occurrences causally related to treatment / all	0 / 30	0 / 34
deaths causally related to treatment / all	0 / 10	0 / 10
Gastroenteritis
subjects affected / exposed	22 / 2805 (0.78%)	39 / 2868 (1.36%)
occurrences causally related to treatment / all	0 / 22	0 / 43
deaths causally related to treatment / all	0 / 0	0 / 0
Infective exacerbation of chronic obstructive airways disease
subjects affected / exposed	18 / 2805 (0.64%)	23 / 2868 (0.80%)
occurrences causally related to treatment / all	0 / 20	0 / 26
deaths causally related to treatment / all	0 / 1	0 / 3
Lobar pneumonia
subjects affected / exposed	15 / 2805 (0.53%)	17 / 2868 (0.59%)
occurrences causally related to treatment / all	0 / 15	0 / 17
deaths causally related to treatment / all	0 / 2	0 / 1
Urosepsis
subjects affected / exposed	12 / 2805 (0.43%)	13 / 2868 (0.45%)
occurrences causally related to treatment / all	0 / 12	0 / 14
deaths causally related to treatment / all	0 / 0	0 / 3
Device related infection
subjects affected / exposed	9 / 2805 (0.32%)	13 / 2868 (0.45%)
occurrences causally related to treatment / all	0 / 11	0 / 15
deaths causally related to treatment / all	0 / 0	0 / 0
Post procedural infection
subjects affected / exposed	9 / 2805 (0.32%)	12 / 2868 (0.42%)
occurrences causally related to treatment / all	0 / 9	0 / 13
deaths causally related to treatment / all	0 / 0	0 / 0
Viral infection
subjects affected / exposed	5 / 2805 (0.18%)	13 / 2868 (0.45%)
occurrences causally related to treatment / all	0 / 5	0 / 13
deaths causally related to treatment / all	0 / 0	0 / 0
COVID-19 pneumonia
subjects affected / exposed	9 / 2805 (0.32%)	8 / 2868 (0.28%)
occurrences causally related to treatment / all	0 / 9	0 / 8
deaths causally related to treatment / all	0 / 7	0 / 7
Cystitis
subjects affected / exposed	9 / 2805 (0.32%)	6 / 2868 (0.21%)
occurrences causally related to treatment / all	0 / 9	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Appendicitis
subjects affected / exposed	5 / 2805 (0.18%)	9 / 2868 (0.31%)
occurrences causally related to treatment / all	0 / 5	0 / 11
deaths causally related to treatment / all	0 / 0	0 / 0
Carbuncle
subjects affected / exposed	7 / 2805 (0.25%)	6 / 2868 (0.21%)
occurrences causally related to treatment / all	0 / 7	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
Bacterial sepsis
subjects affected / exposed	8 / 2805 (0.29%)	3 / 2868 (0.10%)
occurrences causally related to treatment / all	0 / 8	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Labyrinthitis
subjects affected / exposed	3 / 2805 (0.11%)	8 / 2868 (0.28%)
occurrences causally related to treatment / all	0 / 3	0 / 8
deaths causally related to treatment / all	0 / 0	0 / 0
Diverticulitis
subjects affected / exposed	3 / 2805 (0.11%)	7 / 2868 (0.24%)
occurrences causally related to treatment / all	0 / 3	0 / 7
deaths causally related to treatment / all	0 / 1	0 / 0
Influenza
subjects affected / exposed	4 / 2805 (0.14%)	6 / 2868 (0.21%)
occurrences causally related to treatment / all	0 / 6	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 1
Enterocolitis infectious
subjects affected / exposed	4 / 2805 (0.14%)	5 / 2868 (0.17%)
occurrences causally related to treatment / all	0 / 4	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal viral infection
subjects affected / exposed	4 / 2805 (0.14%)	4 / 2868 (0.14%)
occurrences causally related to treatment / all	0 / 4	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Bronchopneumonia
subjects affected / exposed	5 / 2805 (0.18%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 5	0 / 2
deaths causally related to treatment / all	0 / 3	0 / 2
Campylobacter gastroenteritis
subjects affected / exposed	2 / 2805 (0.07%)	5 / 2868 (0.17%)
occurrences causally related to treatment / all	0 / 2	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Clostridium difficile colitis
subjects affected / exposed	1 / 2805 (0.04%)	5 / 2868 (0.17%)
occurrences causally related to treatment / all	0 / 1	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Orchitis
subjects affected / exposed	4 / 2805 (0.14%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 4	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumonia influenzal
subjects affected / exposed	3 / 2805 (0.11%)	3 / 2868 (0.10%)
occurrences causally related to treatment / all	0 / 3	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Neutropenic sepsis
subjects affected / exposed	1 / 2805 (0.04%)	4 / 2868 (0.14%)
occurrences causally related to treatment / all	0 / 1	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 1
Osteomyelitis
subjects affected / exposed	1 / 2805 (0.04%)	4 / 2868 (0.14%)
occurrences causally related to treatment / all	0 / 1	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Periodontitis
subjects affected / exposed	4 / 2805 (0.14%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 5	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Staphylococcal sepsis
subjects affected / exposed	2 / 2805 (0.07%)	3 / 2868 (0.10%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 2
Bacterial infection
subjects affected / exposed	1 / 2805 (0.04%)	3 / 2868 (0.10%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Biliary sepsis
subjects affected / exposed	2 / 2805 (0.07%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Escherichia bacteraemia
subjects affected / exposed	1 / 2805 (0.04%)	3 / 2868 (0.10%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Herpes zoster
subjects affected / exposed	4 / 2805 (0.14%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 4	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Intervertebral discitis
subjects affected / exposed	3 / 2805 (0.11%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Upper respiratory tract infection
subjects affected / exposed	2 / 2805 (0.07%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Anal abscess
subjects affected / exposed	1 / 2805 (0.04%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Endocarditis
subjects affected / exposed	0 / 2805 (0.00%)	3 / 2868 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Gangrene
subjects affected / exposed	0 / 2805 (0.00%)	3 / 2868 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Gastroenteritis viral
subjects affected / exposed	1 / 2805 (0.04%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Oral candidiasis
subjects affected / exposed	3 / 2805 (0.11%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Otitis media
subjects affected / exposed	1 / 2805 (0.04%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Peritonitis
subjects affected / exposed	1 / 2805 (0.04%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 1
Pilonidal cyst
subjects affected / exposed	2 / 2805 (0.07%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Post procedural sepsis
subjects affected / exposed	2 / 2805 (0.07%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Postoperative wound infection
subjects affected / exposed	0 / 2805 (0.00%)	3 / 2868 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Sialoadenitis
subjects affected / exposed	1 / 2805 (0.04%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Subcutaneous abscess
subjects affected / exposed	1 / 2805 (0.04%)	2 / 2868 (0.07%)
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	1 / 2805 (0.04%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Abdominal sepsis
subjects affected / exposed	2 / 2805 (0.07%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Appendicitis perforated
subjects affected / exposed	1 / 2805 (0.04%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Candida infection
subjects affected / exposed	1 / 2805 (0.04%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cholecystitis infective
subjects affected / exposed	1 / 2805 (0.04%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Chronic sinusitis
subjects affected / exposed	2 / 2805 (0.07%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Clostridium difficile infection
subjects affected / exposed	0 / 2805 (0.00%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Diarrhoea infectious
subjects affected / exposed	0 / 2805 (0.00%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Gastroenteritis bacterial
subjects affected / exposed	1 / 2805 (0.04%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal bacterial infection
subjects affected / exposed	1 / 2805 (0.04%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal infection
subjects affected / exposed	0 / 2805 (0.00%)	2 / 2868 (0.07%)
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	0 / 2805 (0.00%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatitis viral
subjects affected / exposed	0 / 2805 (0.00%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Infective exacerbation of bronchiectasis
subjects affected / exposed	0 / 2805 (0.00%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 1
Lyme disease
subjects affected / exposed	1 / 2805 (0.04%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Mycobacterial infection
subjects affected / exposed	0 / 2805 (0.00%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Otitis externa
subjects affected / exposed	1 / 2805 (0.04%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Perichondritis
subjects affected / exposed	0 / 2805 (0.00%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumonia respiratory syncytial viral
subjects affected / exposed	1 / 2805 (0.04%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pulmonary sepsis
subjects affected / exposed	1 / 2805 (0.04%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 0
Pyelonephritis acute
subjects affected / exposed	1 / 2805 (0.04%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pyonephrosis
subjects affected / exposed	2 / 2805 (0.07%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Septic shock
subjects affected / exposed	0 / 2805 (0.00%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 2
Streptococcal infection
subjects affected / exposed	1 / 2805 (0.04%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Abdominal infection
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Acute endocarditis
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Acute sinusitis
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Arthritis bacterial
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Arthritis infective
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Bacteraemia
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Bronchiolitis
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (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 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Bronchopulmonary aspergillosis
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Candidiasis
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cholangitis infective
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (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	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Creutzfeldt-Jakob disease
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Device related sepsis
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Diabetic foot infection
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Disseminated tuberculosis
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Empyema
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Encephalitis viral
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Endophthalmitis
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Epiglottitis
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Escherichia infection
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
External ear cellulitis
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gastritis viral
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Haemophilus infection
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatitis E
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Herpes simplex encephalitis
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Herpes virus infection
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Herpes zoster infection neurological
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hordeolum
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Klebsiella infection
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Klebsiella sepsis
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Liver abscess
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Localised infection
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
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	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Lung infection pseudomonal
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Medical device site infection
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Medical device site joint infection
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Meningitis
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Meningitis streptococcal
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (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	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Oropharyngitis fungal
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Otitis media chronic
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Parotitis
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pelvic abscess
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Perineal abscess
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Perinephric abscess
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Periorbital infection
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pharyngitis
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pleural infection
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (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 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumocystis jirovecii pneumonia
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Pneumonia bacterial
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumonia escherichia
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
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	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumonia necrotising
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Pneumonia parainfluenzae viral
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumonia viral
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Prostatic abscess
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pseudomembranous colitis
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pseudomonas infection
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pyelonephritis
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Rectal abscess
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (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 bronchiolitis
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (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 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Rhinitis
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Sinusitis
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Suspected COVID-19
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (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 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Tracheobronchitis
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Tuberculosis
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Vestibular neuronitis
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Metabolism and nutrition disorders
Type 2 diabetes mellitus
subjects affected / exposed	58 / 2805 (2.07%)	56 / 2868 (1.95%)
occurrences causally related to treatment / all	0 / 58	0 / 59
deaths causally related to treatment / all	0 / 0	0 / 0
Hyperkalaemia
subjects affected / exposed	8 / 2805 (0.29%)	12 / 2868 (0.42%)
occurrences causally related to treatment / all	0 / 8	0 / 12
deaths causally related to treatment / all	0 / 0	0 / 1
Gout
subjects affected / exposed	4 / 2805 (0.14%)	5 / 2868 (0.17%)
occurrences causally related to treatment / all	0 / 4	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Diabetic ketoacidosis
subjects affected / exposed	5 / 2805 (0.18%)	3 / 2868 (0.10%)
occurrences causally related to treatment / all	0 / 5	0 / 3
deaths causally related to treatment / all	0 / 1	0 / 1
Hypoglycaemia
subjects affected / exposed	4 / 2805 (0.14%)	4 / 2868 (0.14%)
occurrences causally related to treatment / all	0 / 4	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Hyponatraemia
subjects affected / exposed	2 / 2805 (0.07%)	6 / 2868 (0.21%)
occurrences causally related to treatment / all	0 / 2	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Magnesium metabolism disorder
subjects affected / exposed	2 / 2805 (0.07%)	5 / 2868 (0.17%)
occurrences causally related to treatment / all	0 / 2	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Abnormal loss of weight
subjects affected / exposed	3 / 2805 (0.11%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Dehydration
subjects affected / exposed	2 / 2805 (0.07%)	3 / 2868 (0.10%)
occurrences causally related to treatment / all	0 / 3	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Fluid overload
subjects affected / exposed	4 / 2805 (0.14%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 4	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Iron metabolism disorder
subjects affected / exposed	4 / 2805 (0.14%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 7	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Hyperglycaemia
subjects affected / exposed	2 / 2805 (0.07%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 1	0 / 0
Electrolyte imbalance
subjects affected / exposed	1 / 2805 (0.04%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Haemochromatosis
subjects affected / exposed	1 / 2805 (0.04%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Hypovolaemia
subjects affected / exposed	2 / 2805 (0.07%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Iron deficiency
subjects affected / exposed	2 / 2805 (0.07%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Diabetes mellitus inadequate control
subjects affected / exposed	2 / 2805 (0.07%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hypokalaemia
subjects affected / exposed	0 / 2805 (0.00%)	2 / 2868 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Obesity
subjects affected / exposed	1 / 2805 (0.04%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Calcium metabolism disorder
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Decreased appetite
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Diabetes mellitus
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Folate deficiency
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hyperglycaemic hyperosmolar nonketotic syndrome
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hyperlipidaemia
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Hyperosmolar state
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hypocalcaemia
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hypomagnesaemia
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Lactic acidosis
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pseudohyperkalaemia
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Starvation
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Type 1 diabetes mellitus
subjects affected / exposed	0 / 2805 (0.00%)	1 / 2868 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Vitamin B complex deficiency
subjects affected / exposed	1 / 2805 (0.04%)	0 / 2868 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0

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

Non-serious adverse events	Safety analysis set - allopurinol arm	Safety analysis set - usual care arm
Total subjects affected by non serious adverse events
subjects affected / exposed	210 / 2805 (7.49%)	0 / 2868 (0.00%)
Skin and subcutaneous tissue disorders
Rash
Additional description: Only potentially treatment-related non-serious adverse events were reported in this trial. Therefore, non-serious adverse events were only reported in the allopurinol group (not the usual care group).
subjects affected / exposed	210 / 2805 (7.49%)	0 / 2868 (0.00%)
occurrences all number	216	0

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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.

n/a

http://www.ncbi.nlm.nih.gov/pubmed/36216006

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Clinical Trial Results:
Allopurinol and cardiovascular outcomes in patients with ischaemic heart disease (ALL-HEART)

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Clinical Trial Results: Allopurinol and cardiovascular outcomes in patients with ischaemic heart disease (ALL-HEART)

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Primary outcome (modified ITT)

Primary: Primary outcome (modified ITT)

Secondary: Secondary - non-fatal myocardial infarction

Secondary: Secondary - non-fatal myocardial infarction

Secondary: Secondary - non-fatal stroke

Secondary: Secondary - non-fatal stroke

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Secondary: Secondary - cardiovascular death

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Secondary: Secondary - all-cause mortality

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Substantial protocol amendments (globally)

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Clinical Trial Results:
Allopurinol and cardiovascular outcomes in patients with ischaemic heart disease (ALL-HEART)