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Clinical Trial Results:
Dapagliflozin Effect on Cardiovascular Events A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Effect of Dapagliflozin 10 mg Once Daily on the Incidence of Cardiovascular Death, Myocardial Infarction or Ischemic Stroke in Patients with Type 2 Diabetes

Summary
EudraCT number	2013-000239-28
Trial protocol	GB CZ IT SE SK BG NL ES DE PL HU BE
Global end of trial date	16 Sep 2018

Results information
Results version number	v1(current)
This version publication date	25 Sep 2019
First version publication date	25 Sep 2019
Other versions

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

Collapse all Expand all

Trial information

Top of page

Sponsor protocol code

D1693C00001

ISRCTN number

-

US NCT number

NCT01730534

WHO universal trial number (UTN)

-

Sponsor organisation name

AstraZeneca AB

Sponsor organisation address

151 85, Södertälje, Sweden,

Public contact

Information Centre, AstraZeneca AB, +1 800 2369933, information.centre@astrazeneca.com

Scientific contact

Global Study Leader, AstraZeneca, +49 4103 708 3792, Sandra.ranft@astrazeneca.com

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

No

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

No

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

No

Analysis stage

Final

Date of interim/final analysis

11 Sep 2018

Is this the analysis of the primary completion data?

Yes

Primary completion date

11 Sep 2018

Global end of trial reached?

Yes

Global end of trial date

16 Sep 2018

Was the trial ended prematurely?

No

Main objective of the trial

The primary objective is to determine the effect of dapagliflozin relative to placebo on cardiovascular outcome when added to current background therapy in patients with type 2 diabetes mellitus (T2DM) with either established cardiovascular disease or at least two cardiovascular risk factors.

Protection of trial subjects

Not applicable

Background therapy

-

Evidence for comparator

-

Actual start date of recruitment

25 Apr 2013

Long term follow-up planned

No

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

Brazil: 326

Country: Number of subjects enrolled

Mexico: 868

Country: Number of subjects enrolled

Australia: 414

Country: Number of subjects enrolled

China: 215

Country: Number of subjects enrolled

Hong Kong: 50

Country: Number of subjects enrolled

India: 193

Country: Number of subjects enrolled

Japan: 95

Country: Number of subjects enrolled

Philippines: 336

Country: Number of subjects enrolled

Korea, Republic of: 357

Country: Number of subjects enrolled

Taiwan: 110

Country: Number of subjects enrolled

Argentina: 683

Country: Number of subjects enrolled

Thailand: 259

Country: Number of subjects enrolled

Vietnam: 157

Country: Number of subjects enrolled

Belgium: 114

Country: Number of subjects enrolled

Bulgaria: 832

Country: Number of subjects enrolled

Czech Republic: 638

Country: Number of subjects enrolled

France: 187

Country: Number of subjects enrolled

Germany: 215

Country: Number of subjects enrolled

Hungary: 713

Country: Number of subjects enrolled

Israel: 340

Country: Number of subjects enrolled

Italy: 155

Country: Number of subjects enrolled

Netherlands: 401

Country: Number of subjects enrolled

Poland: 931

Country: Number of subjects enrolled

Romania: 483

Country: Number of subjects enrolled

Russian Federation: 395

Country: Number of subjects enrolled

Slovakia: 346

Country: Number of subjects enrolled

South Africa: 456

Country: Number of subjects enrolled

Spain: 195

Country: Number of subjects enrolled

Sweden: 453

Country: Number of subjects enrolled

Turkey: 53

Country: Number of subjects enrolled

Ukraine: 356

Country: Number of subjects enrolled

United Kingdom: 366

Country: Number of subjects enrolled

Canada: 1583

Country: Number of subjects enrolled

United States: 3885

Worldwide total number of subjects

17160

EEA total number of subjects

6029

Number of subjects enrolled per age group

In utero

0

Preterm newborn - gestational age < 37 wk

0

Newborns (0-27 days)

0

Infants and toddlers (28 days-23 months)

0

Children (2-11 years)

0

Adolescents (12-17 years)

0

Adults (18-64 years)

9253

From 65 to 84 years

7890

85 years and over

17

Subject disposition

Top of page

Recruitment details

-

Screening details

In DECLARE at the first visit, i.e. the enrollment visit 1, patients were evaluated regarding the protocol mandated inclusion and exclusion criteria. If eligible, the patient started a single-blind (for the patient) run-in period receiving placebo tablets for 4-8 weeks.

Period 1 title

Overall Study (overall period)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

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

Are arms mutually exclusive

Yes

Dapa 10 mg

Arm description

Dapagliflozin 10 mg tablets administered orally once daily

Arm type

Active comparator

Investigational medicinal product name

Dapagliflozin

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Dapagliflozin 10 mg tablets administered orally once daily

Placebo

Arm description

Matching placebo for dapagliflozin 10 mg administered orally once daily

Arm type

Placebo

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Matching placebo for dapagliflozin 10 mg administered orally once daily

Number of subjects in period 1	Dapa 10 mg	Placebo
Started	8582	8578
Completed	8473	8433
Not completed	109	145
Consent withdrawn by subject	97	127
Lost to follow-up	12	18

Baseline characteristics

Top of page

Reporting group title

Dapa 10 mg

Reporting group description

Dapagliflozin 10 mg tablets administered orally once daily

Reporting group title

Placebo

Reporting group description

Matching placebo for dapagliflozin 10 mg administered orally once daily

Reporting group values	Dapa 10 mg	Placebo	Total
Number of subjects	8582	8578	17160
Age, Customized
Units: Subjects
<65 years	4631	4622	9253
>=65 years	3951	3956	7907
Age Continuous
Units: years
arithmetic mean (standard deviation)	63.9 ( 6.8 )	64.0 ( 6.8 )	-
Sex: Female, Male
Units: Subjects
Male	5411	5327	10738
Female	3171	3251	6422
Race/Ethnicity, Customized
Units: Subjects
White	6843	6810	13653
Black or African American	295	308	603
Asian	1148	1155	2303
American Indian or Alaska Native	52	52	104
Native Hawaiian or other Pacific Islander	9	13	22
Other	235	240	475
Age, Customized
Units: Subjects
<75 years	8044	8020	16064
>=75 years	538	558	1096
Baseline CV risk category
Units: Subjects
Established CV disease	3474	3500	6974
Multiple risk factors for CV events	5108	5078	10186
Ethnicity (NIH/OMB)
Units: Subjects
Hispanic or Latino	1298	1270	2568
Not Hispanic or Latino	7284	7308	14592
Unknown or Not Reported	0	0	0

End points

Top of page

Reporting group title

Dapa 10 mg

Reporting group description

Dapagliflozin 10 mg tablets administered orally once daily

Reporting group title

Placebo

Reporting group description

Matching placebo for dapagliflozin 10 mg administered orally once daily

Primary: Time to first event included in the composite endpoint of CV death, MI or ischemic stroke

Top of page

End point title

Time to first event included in the composite endpoint of CV death, MI or ischemic stroke

End point description

Safety and co-primary efficacy

End point type

Primary

End point timeframe

up to 5.2 years

End point values	Dapa 10 mg	Placebo
Number of subjects analysed	8582	8578
Units: Participants
Number of patients with an event	756	803

Cox regression

Comparison groups

Dapa 10 mg v Placebo

Number of subjects included in analysis

17160

Analysis specification

Pre-specified

Analysis type

P-value

= 0.172

Method

Regression, Cox

Parameter type

Hazard ratio (HR)

Point estimate

0.93

Confidence interval

level

95%

sides

2-sided

lower limit

0.84

upper limit

1.03

Primary: Time to first event included in the composite endpoint of CV death or hospitalization due to heart failure.

Top of page

End point title

Time to first event included in the composite endpoint of CV death or hospitalization due to heart failure.

End point description

Co-primary efficacy

End point type

Primary

End point timeframe

up to 5.2 years

End point values	Dapa 10 mg	Placebo
Number of subjects analysed	8582	8578
Units: Participants
Number of patients with an event	417	496

Cox regression

Comparison groups

Dapa 10 mg v Placebo

Number of subjects included in analysis

17160

Analysis specification

Pre-specified

Analysis type

P-value

= 0.005

Method

Regression, Cox

Parameter type

Hazard ratio (HR)

Point estimate

0.83

Confidence interval

level

95%

sides

2-sided

lower limit

0.73

upper limit

0.95

Secondary: Time to first event of renal composite endpoint: Confirmed sustained ≥40% decrease in eGFR to eGFR <60 ml/min/1.73m2 and/or ESRD and/or renal or CV death.

Top of page

End point title

Time to first event of renal composite endpoint: Confirmed sustained ≥40% decrease in eGFR to eGFR <60 ml/min/1.73m2 and/or ESRD and/or renal or CV death.

End point description

Secondary

End point type

Secondary

End point timeframe

up to 5.2 years

End point values	Dapa 10 mg	Placebo
Number of subjects analysed	8582	8578
Units: Participants
Number of patients with an event	370	480

Cox regression

Comparison groups

Dapa 10 mg v Placebo

Number of subjects included in analysis

17160

Analysis specification

Pre-specified

Analysis type

P-value

< 0.001

Method

Regression, Cox

Parameter type

Hazard ratio (HR)

Point estimate

0.76

Confidence interval

level

95%

sides

2-sided

lower limit

0.67

upper limit

0.87

Secondary: Time to All-cause mortality.

Top of page

End point title

Time to All-cause mortality.

End point description

Secondary

End point type

Secondary

End point timeframe

up to 5.2 years

End point values	Dapa 10 mg	Placebo
Number of subjects analysed	8582	8578
Units: Participants
Number of patients with an event	529	570

Cox regression

Comparison groups

Dapa 10 mg v Placebo

Number of subjects included in analysis

17160

Analysis specification

Pre-specified

Analysis type

P-value

= 0.198

Method

Regression, Cox

Parameter type

Hazard ratio (HR)

Point estimate

0.93

Confidence interval

level

95%

sides

2-sided

lower limit

0.82

upper limit

1.04

Adverse events

Top of page

Timeframe for reporting adverse events

up to 5.2 years

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

21

Reporting group title

Placebo

Reporting group description

Matching placebo for dapagliflozin 10 mg administered orally once daily

Reporting group title

Dapa 10 mg

Reporting group description

Dapagliflozin 10 mg tablets administered orally once daily

Serious adverse events	Placebo	Dapa 10 mg
Total subjects affected by serious adverse events
subjects affected / exposed	3418 / 8569 (39.89%)	3205 / 8574 (37.38%)
number of deaths (all causes)	569	529
number of deaths resulting from adverse events	566	527
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acral lentiginous melanoma
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Acute myeloid leukaemia
subjects affected / exposed	2 / 8569 (0.02%)	4 / 8574 (0.05%)
occurrences causally related to treatment / all	0 / 3	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 2
Acute myelomonocytic leukaemia
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Adenocarcinoma
subjects affected / exposed	3 / 8569 (0.04%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Adenocarcinoma gastric
subjects affected / exposed	3 / 8569 (0.04%)	3 / 8574 (0.03%)
occurrences causally related to treatment / all	0 / 3	0 / 3
deaths causally related to treatment / all	0 / 2	0 / 1
Adenocarcinoma of appendix
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Adenocarcinoma of colon
subjects affected / exposed	18 / 8569 (0.21%)	20 / 8574 (0.23%)
occurrences causally related to treatment / all	0 / 18	0 / 20
deaths causally related to treatment / all	0 / 0	0 / 1
Adenocarcinoma pancreas
subjects affected / exposed	5 / 8569 (0.06%)	4 / 8574 (0.05%)
occurrences causally related to treatment / all	0 / 5	1 / 4
deaths causally related to treatment / all	0 / 5	1 / 1
Adenoid cystic carcinoma
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Adenoma benign
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Adrenal adenoma
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Adrenal neoplasm
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Adrenocortical carcinoma
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Anal squamous cell carcinoma
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Anaplastic astrocytoma
subjects affected / exposed	1 / 8569 (0.01%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 1
Anaplastic large-cell lymphoma
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
B-cell lymphoma
subjects affected / exposed	0 / 8569 (0.00%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Basal cell carcinoma
subjects affected / exposed	27 / 8569 (0.32%)	34 / 8574 (0.40%)
occurrences causally related to treatment / all	0 / 37	0 / 42
deaths causally related to treatment / all	0 / 0	0 / 0
Basosquamous carcinoma
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Benign breast neoplasm
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Benign ear neoplasm
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Benign gastric neoplasm
subjects affected / exposed	1 / 8569 (0.01%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Benign gastrointestinal neoplasm
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Benign hepatic neoplasm
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Benign laryngeal neoplasm
subjects affected / exposed	1 / 8569 (0.01%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Benign lung neoplasm
subjects affected / exposed	3 / 8569 (0.04%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Benign lymph node neoplasm
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Benign neoplasm
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Benign neoplasm of bladder
subjects affected / exposed	1 / 8569 (0.01%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Benign neoplasm of adrenal gland
subjects affected / exposed	1 / 8569 (0.01%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Benign neoplasm of thyroid gland
subjects affected / exposed	4 / 8569 (0.05%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 4	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Benign neoplasm of spinal cord
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Benign ovarian tumour
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Benign pancreatic neoplasm
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Benign renal neoplasm
subjects affected / exposed	1 / 8569 (0.01%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Benign salivary gland neoplasm
subjects affected / exposed	1 / 8569 (0.01%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Benign soft tissue neoplasm
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Bladder cancer
subjects affected / exposed	25 / 8569 (0.29%)	12 / 8574 (0.14%)
occurrences causally related to treatment / all	3 / 25	0 / 12
deaths causally related to treatment / all	0 / 0	0 / 0
Bladder cancer recurrent
subjects affected / exposed	2 / 8569 (0.02%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Bladder cancer stage 0, with cancer in situ
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Bladder neoplasm
subjects affected / exposed	5 / 8569 (0.06%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 5	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Bladder papilloma
subjects affected / exposed	2 / 8569 (0.02%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Bladder transitional cell carcinoma
subjects affected / exposed	8 / 8569 (0.09%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	2 / 8	0 / 1
deaths causally related to treatment / all	0 / 2	0 / 0
Bladder transitional cell carcinoma metastatic
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	1 / 1	0 / 0
Bone cancer
subjects affected / exposed	1 / 8569 (0.01%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Bone cancer metastatic
subjects affected / exposed	0 / 8569 (0.00%)	3 / 8574 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 1
Bone neoplasm
subjects affected / exposed	0 / 8569 (0.00%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 0	1 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Bowen's disease
subjects affected / exposed	3 / 8569 (0.04%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 3	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Brain neoplasm
subjects affected / exposed	2 / 8569 (0.02%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 2	0 / 1
Brain neoplasm benign
subjects affected / exposed	2 / 8569 (0.02%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Brain neoplasm malignant
subjects affected / exposed	3 / 8569 (0.04%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 2	0 / 0
Breast cancer
subjects affected / exposed	2 / 8569 (0.02%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Breast cancer female
subjects affected / exposed	20 / 8569 (0.23%)	19 / 8574 (0.22%)
occurrences causally related to treatment / all	0 / 22	2 / 20
deaths causally related to treatment / all	0 / 1	0 / 0
Breast cancer metastatic
subjects affected / exposed	4 / 8569 (0.05%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 5	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Breast neoplasm
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Bronchial carcinoma
subjects affected / exposed	2 / 8569 (0.02%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 0
Cancer pain
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Carcinoid tumour of the duodenum
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Carcinoid tumour of the small bowel
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Central nervous system lymphoma
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Cervix carcinoma
subjects affected / exposed	2 / 8569 (0.02%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cholangiocarcinoma
subjects affected / exposed	7 / 8569 (0.08%)	5 / 8574 (0.06%)
occurrences causally related to treatment / all	1 / 7	0 / 5
deaths causally related to treatment / all	0 / 3	0 / 5
Chondromatosis
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Chondrosarcoma
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Chronic leukaemia
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Chronic lymphocytic leukaemia
subjects affected / exposed	6 / 8569 (0.07%)	7 / 8574 (0.08%)
occurrences causally related to treatment / all	0 / 6	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
Chronic myeloid leukaemia
subjects affected / exposed	2 / 8569 (0.02%)	3 / 8574 (0.03%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Clear cell renal cell carcinoma
subjects affected / exposed	0 / 8569 (0.00%)	4 / 8574 (0.05%)
occurrences causally related to treatment / all	0 / 0	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 1
Colon adenoma
subjects affected / exposed	7 / 8569 (0.08%)	8 / 8574 (0.09%)
occurrences causally related to treatment / all	0 / 7	0 / 8
deaths causally related to treatment / all	0 / 0	0 / 0
Colon cancer
subjects affected / exposed	16 / 8569 (0.19%)	16 / 8574 (0.19%)
occurrences causally related to treatment / all	0 / 16	0 / 17
deaths causally related to treatment / all	0 / 2	0 / 2
Colon cancer metastatic
subjects affected / exposed	2 / 8569 (0.02%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Colon neoplasm
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Colorectal adenocarcinoma
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Colorectal cancer
subjects affected / exposed	3 / 8569 (0.04%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 0
Colorectal cancer metastatic
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Dermatofibrosarcoma protuberans
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Ductal adenocarcinoma of pancreas
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Endometrial adenocarcinoma
subjects affected / exposed	7 / 8569 (0.08%)	3 / 8574 (0.03%)
occurrences causally related to treatment / all	0 / 8	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 1
Endometrial cancer
subjects affected / exposed	5 / 8569 (0.06%)	4 / 8574 (0.05%)
occurrences causally related to treatment / all	0 / 5	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Endometrial cancer metastatic
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Fallopian tube cancer metastatic
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Follicular thyroid cancer
subjects affected / exposed	1 / 8569 (0.01%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Fibroadenoma of breast
subjects affected / exposed	1 / 8569 (0.01%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gallbladder cancer metastatic
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Gallbladder adenocarcinoma
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gallbladder neoplasm
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Gastric adenoma
subjects affected / exposed	1 / 8569 (0.01%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Gastric cancer
subjects affected / exposed	8 / 8569 (0.09%)	5 / 8574 (0.06%)
occurrences causally related to treatment / all	0 / 8	0 / 5
deaths causally related to treatment / all	0 / 1	0 / 1
Gastric cancer stage 0
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal adenocarcinoma
subjects affected / exposed	2 / 8569 (0.02%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal carcinoma
subjects affected / exposed	2 / 8569 (0.02%)	3 / 8574 (0.03%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal stromal cancer
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal stromal tumour
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal tract adenoma
subjects affected / exposed	2 / 8569 (0.02%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gingival cancer
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 1
Glioblastoma
subjects affected / exposed	2 / 8569 (0.02%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Glioblastoma multiforme
subjects affected / exposed	1 / 8569 (0.01%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 1	0 / 2
Glottis carcinoma
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Haemangioma
subjects affected / exposed	0 / 8569 (0.00%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Haemangiopericytoma
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hairy cell leukaemia
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatic cancer
subjects affected / exposed	5 / 8569 (0.06%)	3 / 8574 (0.03%)
occurrences causally related to treatment / all	0 / 5	0 / 3
deaths causally related to treatment / all	0 / 5	0 / 1
Hepatic cancer metastatic
subjects affected / exposed	1 / 8569 (0.01%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatocellular carcinoma
subjects affected / exposed	4 / 8569 (0.05%)	8 / 8574 (0.09%)
occurrences causally related to treatment / all	0 / 4	0 / 9
deaths causally related to treatment / all	0 / 2	0 / 4
Hodgkin's disease
subjects affected / exposed	1 / 8569 (0.01%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Hypopharyngeal cancer
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Infected neoplasm
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Intestinal adenocarcinoma
subjects affected / exposed	3 / 8569 (0.04%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Intraductal proliferative breast lesion
subjects affected / exposed	2 / 8569 (0.02%)	5 / 8574 (0.06%)
occurrences causally related to treatment / all	0 / 2	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Invasive breast carcinoma
subjects affected / exposed	2 / 8569 (0.02%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Invasive ductal breast carcinoma
subjects affected / exposed	5 / 8569 (0.06%)	9 / 8574 (0.10%)
occurrences causally related to treatment / all	0 / 5	0 / 9
deaths causally related to treatment / all	0 / 0	0 / 0
Invasive lobular breast carcinoma
subjects affected / exposed	2 / 8569 (0.02%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Juvenile melanoma benign
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Keratoacanthoma
subjects affected / exposed	1 / 8569 (0.01%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Large intestine benign neoplasm
subjects affected / exposed	1 / 8569 (0.01%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Laryngeal cancer
subjects affected / exposed	2 / 8569 (0.02%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Laryngeal cancer metastatic
subjects affected / exposed	1 / 8569 (0.01%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Laryngeal squamous cell carcinoma
subjects affected / exposed	3 / 8569 (0.04%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Lentigo maligna
subjects affected / exposed	1 / 8569 (0.01%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Leukaemia
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	1 / 1	0 / 0
Lipoma
subjects affected / exposed	3 / 8569 (0.04%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Liposarcoma
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Lung adenocarcinoma
subjects affected / exposed	6 / 8569 (0.07%)	5 / 8574 (0.06%)
occurrences causally related to treatment / all	1 / 7	0 / 5
deaths causally related to treatment / all	0 / 1	0 / 1
Lung cancer metastatic
subjects affected / exposed	14 / 8569 (0.16%)	11 / 8574 (0.13%)
occurrences causally related to treatment / all	0 / 14	0 / 12
deaths causally related to treatment / all	0 / 13	0 / 6
Lung carcinoma cell type unspecified stage 0
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Lung neoplasm
subjects affected / exposed	3 / 8569 (0.04%)	3 / 8574 (0.03%)
occurrences causally related to treatment / all	0 / 3	0 / 3
deaths causally related to treatment / all	0 / 2	0 / 2
Lung neoplasm malignant
subjects affected / exposed	21 / 8569 (0.25%)	12 / 8574 (0.14%)
occurrences causally related to treatment / all	0 / 21	0 / 13
deaths causally related to treatment / all	0 / 4	0 / 6
Lung squamous cell carcinoma metastatic
subjects affected / exposed	2 / 8569 (0.02%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 2	0 / 0
Lymphocytic leukaemia
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Lymphoma
subjects affected / exposed	1 / 8569 (0.01%)	5 / 8574 (0.06%)
occurrences causally related to treatment / all	1 / 1	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 1
Malignant anorectal neoplasm
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Malignant melanoma
subjects affected / exposed	12 / 8569 (0.14%)	13 / 8574 (0.15%)
occurrences causally related to treatment / all	0 / 12	0 / 17
deaths causally related to treatment / all	0 / 0	0 / 0
Malignant melanoma in situ
subjects affected / exposed	4 / 8569 (0.05%)	6 / 8574 (0.07%)
occurrences causally related to treatment / all	1 / 4	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
Malignant neoplasm of pleura metastatic
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Malignant neoplasm of renal pelvis
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Malignant neoplasm of unknown primary site
subjects affected / exposed	1 / 8569 (0.01%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Malignant peritoneal neoplasm
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
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	2 / 8569 (0.02%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Melanocytic naevus
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Melanoma recurrent
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Meningioma
subjects affected / exposed	1 / 8569 (0.01%)	4 / 8574 (0.05%)
occurrences causally related to treatment / all	0 / 1	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Meningioma benign
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Mesothelioma malignant
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Metastases to adrenals
subjects affected / exposed	2 / 8569 (0.02%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Metastases to bone
subjects affected / exposed	2 / 8569 (0.02%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Metastases to central nervous system
subjects affected / exposed	1 / 8569 (0.01%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Metastases to lymph nodes
subjects affected / exposed	1 / 8569 (0.01%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Metastases to lung
subjects affected / exposed	1 / 8569 (0.01%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Metastases to peritoneum
subjects affected / exposed	1 / 8569 (0.01%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Metastases to rectum
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Metastases to spinal cord
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Metastases to spine
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Metastatic bronchial carcinoma
subjects affected / exposed	2 / 8569 (0.02%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Metastatic carcinoma of the bladder
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Metastatic gastric cancer
subjects affected / exposed	3 / 8569 (0.04%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 2	0 / 1
Metastatic neoplasm
subjects affected / exposed	1 / 8569 (0.01%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 1	0 / 0
Metastatic malignant melanoma
subjects affected / exposed	5 / 8569 (0.06%)	3 / 8574 (0.03%)
occurrences causally related to treatment / all	0 / 7	0 / 5
deaths causally related to treatment / all	0 / 2	0 / 2
Metastatic renal cell carcinoma
subjects affected / exposed	1 / 8569 (0.01%)	4 / 8574 (0.05%)
occurrences causally related to treatment / all	0 / 1	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 1
Metastatic squamous cell carcinoma
subjects affected / exposed	1 / 8569 (0.01%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Monoclonal gammopathy
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Myelodysplastic syndrome
subjects affected / exposed	0 / 8569 (0.00%)	5 / 8574 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 1
Myeloproliferative neoplasm
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Nasopharyngeal cancer
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Neoplasm malignant
subjects affected / exposed	1 / 8569 (0.01%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 1
Neoplasm
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Neoplasm prostate
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Neuroendocrine tumour
subjects affected / exposed	1 / 8569 (0.01%)	1 / 8574 (0.01%)
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 / 8569 (0.01%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Neuroendocrine tumour of the lung
subjects affected / exposed	1 / 8569 (0.01%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 0
Non-small cell lung cancer
subjects affected / exposed	3 / 8569 (0.04%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Neuroendocrine tumour of the lung metastatic
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Non-small cell lung cancer metastatic
subjects affected / exposed	1 / 8569 (0.01%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Ocular neoplasm
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Non-small cell lung cancer recurrent
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Oesophageal adenocarcinoma
subjects affected / exposed	3 / 8569 (0.04%)	4 / 8574 (0.05%)
occurrences causally related to treatment / all	0 / 3	0 / 4
deaths causally related to treatment / all	0 / 2	0 / 1
Oesophageal carcinoma
subjects affected / exposed	4 / 8569 (0.05%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 4	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 0
Oesophageal squamous cell carcinoma
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Oral neoplasm benign
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Oropharyngeal cancer
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Osteoma
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Ovarian adenoma
subjects affected / exposed	2 / 8569 (0.02%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Ovarian cancer
subjects affected / exposed	1 / 8569 (0.01%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 1
Ovarian neoplasm
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Ovarian epithelial cancer
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Ovarian cancer metastatic
subjects affected / exposed	0 / 8569 (0.00%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 1
Pancreatic carcinoma
subjects affected / exposed	8 / 8569 (0.09%)	9 / 8574 (0.10%)
occurrences causally related to treatment / all	0 / 8	0 / 9
deaths causally related to treatment / all	0 / 5	0 / 5
Pancreatic carcinoma metastatic
subjects affected / exposed	9 / 8569 (0.11%)	8 / 8574 (0.09%)
occurrences causally related to treatment / all	0 / 10	0 / 9
deaths causally related to treatment / all	0 / 6	0 / 7
Pancreatic neoplasm
subjects affected / exposed	0 / 8569 (0.00%)	4 / 8574 (0.05%)
occurrences causally related to treatment / all	0 / 0	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 2
Pancreatic neuroendocrine tumour
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pancreatoblastoma
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Papillary cystadenoma lymphomatosum
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Papillary renal cell carcinoma
subjects affected / exposed	1 / 8569 (0.01%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Papillary serous endometrial carcinoma
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Papillary thyroid cancer
subjects affected / exposed	3 / 8569 (0.04%)	3 / 8574 (0.03%)
occurrences causally related to treatment / all	0 / 3	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Papillary tumour of renal pelvis
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Parathyroid tumour benign
subjects affected / exposed	2 / 8569 (0.02%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pelvic neoplasm
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Penile squamous cell carcinoma
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Peritoneal carcinoma metastatic
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Phaeochromocytoma
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pharyngeal cancer
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pituitary tumour
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pituitary tumour benign
subjects affected / exposed	1 / 8569 (0.01%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Plasma cell leukaemia
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Plasma cell myeloma
subjects affected / exposed	6 / 8569 (0.07%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 6	0 / 2
deaths causally related to treatment / all	0 / 1	0 / 0
Pleomorphic adenoma
subjects affected / exposed	0 / 8569 (0.00%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Prostate cancer
subjects affected / exposed	55 / 8569 (0.64%)	69 / 8574 (0.80%)
occurrences causally related to treatment / all	0 / 55	3 / 70
deaths causally related to treatment / all	0 / 2	0 / 0
Prostate cancer metastatic
subjects affected / exposed	7 / 8569 (0.08%)	6 / 8574 (0.07%)
occurrences causally related to treatment / all	0 / 7	0 / 6
deaths causally related to treatment / all	0 / 1	0 / 0
Prostate cancer recurrent
subjects affected / exposed	1 / 8569 (0.01%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Prostatic adenoma
subjects affected / exposed	3 / 8569 (0.04%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Rectal adenocarcinoma
subjects affected / exposed	4 / 8569 (0.05%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 4	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Rectal adenoma
subjects affected / exposed	0 / 8569 (0.00%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Rectal cancer
subjects affected / exposed	4 / 8569 (0.05%)	4 / 8574 (0.05%)
occurrences causally related to treatment / all	0 / 4	0 / 4
deaths causally related to treatment / all	0 / 1	0 / 0
Rectal cancer metastatic
subjects affected / exposed	2 / 8569 (0.02%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 1
Renal cancer
subjects affected / exposed	7 / 8569 (0.08%)	10 / 8574 (0.12%)
occurrences causally related to treatment / all	0 / 8	1 / 10
deaths causally related to treatment / all	0 / 1	0 / 0
Renal cell carcinoma
subjects affected / exposed	8 / 8569 (0.09%)	10 / 8574 (0.12%)
occurrences causally related to treatment / all	0 / 8	1 / 10
deaths causally related to treatment / all	0 / 0	0 / 0
Renal neoplasm
subjects affected / exposed	4 / 8569 (0.05%)	6 / 8574 (0.07%)
occurrences causally related to treatment / all	0 / 4	1 / 6
deaths causally related to treatment / all	0 / 1	0 / 0
Retro-orbital neoplasm
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (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	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Salivary gland neoplasm
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Sebaceous carcinoma
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Seborrhoeic keratosis
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Signet-ring cell carcinoma
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Small cell lung cancer
subjects affected / exposed	3 / 8569 (0.04%)	5 / 8574 (0.06%)
occurrences causally related to treatment / all	0 / 3	0 / 5
deaths causally related to treatment / all	0 / 2	0 / 2
Small cell lung cancer extensive stage
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Small cell lung cancer metastatic
subjects affected / exposed	4 / 8569 (0.05%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 4	0 / 0
deaths causally related to treatment / all	0 / 3	0 / 0
Soft tissue sarcoma
subjects affected / exposed	0 / 8569 (0.00%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Small intestine adenocarcinoma
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Spinal cord neoplasm
subjects affected / exposed	0 / 8569 (0.00%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 0	1 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Squamous cell carcinoma
subjects affected / exposed	10 / 8569 (0.12%)	8 / 8574 (0.09%)
occurrences causally related to treatment / all	0 / 10	0 / 12
deaths causally related to treatment / all	0 / 0	0 / 0
Squamous cell carcinoma of lung
subjects affected / exposed	3 / 8569 (0.04%)	4 / 8574 (0.05%)
occurrences causally related to treatment / all	0 / 3	0 / 4
deaths causally related to treatment / all	0 / 2	0 / 2
Squamous cell carcinoma of skin
subjects affected / exposed	9 / 8569 (0.11%)	4 / 8574 (0.05%)
occurrences causally related to treatment / all	0 / 12	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Squamous cell carcinoma of the oral cavity
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
T-cell lymphoma
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Squamous cell carcinoma of the tongue
subjects affected / exposed	2 / 8569 (0.02%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	1 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Throat cancer
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Thyroid adenoma
subjects affected / exposed	0 / 8569 (0.00%)	2 / 8574 (0.02%)
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 / 8569 (0.01%)	3 / 8574 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Thyroid cancer metastatic
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Thyroid neoplasm
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Tongue neoplasm malignant stage unspecified
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (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	12 / 8569 (0.14%)	11 / 8574 (0.13%)
occurrences causally related to treatment / all	5 / 14	3 / 11
deaths causally related to treatment / all	0 / 1	0 / 0
Tonsil cancer
subjects affected / exposed	2 / 8569 (0.02%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 2	1 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Transitional cell cancer of the renal pelvis and ureter
subjects affected / exposed	1 / 8569 (0.01%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Transitional cell carcinoma recurrent
subjects affected / exposed	2 / 8569 (0.02%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	1 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Tumour obstruction
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (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	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Uterine cancer
subjects affected / exposed	3 / 8569 (0.04%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Uterine leiomyoma
subjects affected / exposed	2 / 8569 (0.02%)	4 / 8574 (0.05%)
occurrences causally related to treatment / all	0 / 2	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Vaginal cancer stage 0
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Vulval cancer
subjects affected / exposed	1 / 8569 (0.01%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 1
Vocal cord neoplasm
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Vulval cancer stage 0
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Bladder cancer stage II
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Diffuse large B-cell lymphoma stage I
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Diffuse large B-cell lymphoma
subjects affected / exposed	2 / 8569 (0.02%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 1
Endometrial cancer stage I
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gastric cancer stage III
subjects affected / exposed	2 / 8569 (0.02%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Lung adenocarcinoma stage III
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
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 IV
subjects affected / exposed	0 / 8569 (0.00%)	3 / 8574 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 2
Malignant neoplasm of ampulla of Vater
subjects affected / exposed	1 / 8569 (0.01%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	1 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Non-Hodgkin's lymphoma
subjects affected / exposed	2 / 8569 (0.02%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Non-Hodgkin's lymphoma stage IV
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Non-small cell lung cancer stage IV
subjects affected / exposed	0 / 8569 (0.00%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 2
Prostate cancer stage IV
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Vascular disorders
Accelerated hypertension
subjects affected / exposed	1 / 8569 (0.01%)	3 / 8574 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Aortic aneurysm
subjects affected / exposed	10 / 8569 (0.12%)	12 / 8574 (0.14%)
occurrences causally related to treatment / all	0 / 11	0 / 12
deaths causally related to treatment / all	0 / 2	0 / 0
Aortic aneurysm rupture
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Angiopathy
subjects affected / exposed	1 / 8569 (0.01%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Aortic stenosis
subjects affected / exposed	17 / 8569 (0.20%)	22 / 8574 (0.26%)
occurrences causally related to treatment / all	0 / 17	0 / 22
deaths causally related to treatment / all	0 / 0	0 / 0
Aortic dilatation
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Aortic dissection
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Arterial occlusive disease
subjects affected / exposed	0 / 8569 (0.00%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Arterial insufficiency
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Arterial disorder
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Arterial thrombosis
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Arterial perforation
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Arteriosclerosis
subjects affected / exposed	5 / 8569 (0.06%)	4 / 8574 (0.05%)
occurrences causally related to treatment / all	0 / 5	0 / 4
deaths causally related to treatment / all	0 / 2	0 / 1
Arteritis
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Arteriovenous fistula
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (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 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Blood pressure fluctuation
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Circulatory collapse
subjects affected / exposed	3 / 8569 (0.04%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 1	0 / 1
Claudication of jaw muscles
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Deep vein thrombosis
subjects affected / exposed	12 / 8569 (0.14%)	17 / 8574 (0.20%)
occurrences causally related to treatment / all	0 / 12	2 / 18
deaths causally related to treatment / all	0 / 0	0 / 0
Dry gangrene
subjects affected / exposed	0 / 8569 (0.00%)	3 / 8574 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Diabetic vascular disorder
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Embolism
subjects affected / exposed	2 / 8569 (0.02%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Essential hypertension
subjects affected / exposed	3 / 8569 (0.04%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Extremity necrosis
subjects affected / exposed	4 / 8569 (0.05%)	7 / 8574 (0.08%)
occurrences causally related to treatment / all	0 / 4	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
Femoral artery aneurysm
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Femoral artery embolism
subjects affected / exposed	2 / 8569 (0.02%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Haematoma
subjects affected / exposed	6 / 8569 (0.07%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 6	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Haemorrhagic vasculitis
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hypertension
subjects affected / exposed	27 / 8569 (0.32%)	27 / 8574 (0.31%)
occurrences causally related to treatment / all	0 / 31	0 / 28
deaths causally related to treatment / all	0 / 0	0 / 1
Hypertensive crisis
subjects affected / exposed	24 / 8569 (0.28%)	14 / 8574 (0.16%)
occurrences causally related to treatment / all	0 / 28	0 / 21
deaths causally related to treatment / all	0 / 0	0 / 0
Hypertensive emergency
subjects affected / exposed	7 / 8569 (0.08%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 7	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Hypotension
subjects affected / exposed	14 / 8569 (0.16%)	28 / 8574 (0.33%)
occurrences causally related to treatment / all	1 / 14	2 / 29
deaths causally related to treatment / all	0 / 1	0 / 0
Hypovolaemic shock
subjects affected / exposed	2 / 8569 (0.02%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 0
Iliac artery disease
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
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	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Iliac artery occlusion
subjects affected / exposed	2 / 8569 (0.02%)	3 / 8574 (0.03%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Intermittent claudication
subjects affected / exposed	3 / 8569 (0.04%)	5 / 8574 (0.06%)
occurrences causally related to treatment / all	0 / 3	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Internal haemorrhage
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Ischaemia
subjects affected / exposed	0 / 8569 (0.00%)	3 / 8574 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 1
Ischaemic limb pain
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Jugular vein thrombosis
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Leriche syndrome
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Lymphatic fistula
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Lymphoedema
subjects affected / exposed	1 / 8569 (0.01%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Malignant hypertension
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Microangiopathy
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Orthostatic hypotension
subjects affected / exposed	12 / 8569 (0.14%)	6 / 8574 (0.07%)
occurrences causally related to treatment / all	0 / 13	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Peripheral arterial occlusive disease
subjects affected / exposed	49 / 8569 (0.57%)	43 / 8574 (0.50%)
occurrences causally related to treatment / all	0 / 53	0 / 56
deaths causally related to treatment / all	0 / 1	0 / 0
Peripheral artery aneurysm
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Peripheral artery dissection
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Peripheral artery haematoma
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Peripheral artery occlusion
subjects affected / exposed	15 / 8569 (0.18%)	14 / 8574 (0.16%)
occurrences causally related to treatment / all	0 / 20	0 / 18
deaths causally related to treatment / all	0 / 0	0 / 0
Peripheral artery stenosis
subjects affected / exposed	20 / 8569 (0.23%)	23 / 8574 (0.27%)
occurrences causally related to treatment / all	0 / 22	0 / 36
deaths causally related to treatment / all	0 / 0	0 / 0
Peripheral artery thrombosis
subjects affected / exposed	4 / 8569 (0.05%)	4 / 8574 (0.05%)
occurrences causally related to treatment / all	0 / 4	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Peripheral embolism
subjects affected / exposed	0 / 8569 (0.00%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Peripheral vascular disorder
subjects affected / exposed	19 / 8569 (0.22%)	34 / 8574 (0.40%)
occurrences causally related to treatment / all	0 / 21	1 / 46
deaths causally related to treatment / all	0 / 0	0 / 0
Peripheral ischaemia
subjects affected / exposed	35 / 8569 (0.41%)	30 / 8574 (0.35%)
occurrences causally related to treatment / all	0 / 41	0 / 32
deaths causally related to treatment / all	0 / 0	0 / 0
Peripheral venous disease
subjects affected / exposed	2 / 8569 (0.02%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Phlebitis
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Raynaud's phenomenon
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (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	2 / 8569 (0.02%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 2	0 / 1
Shock haemorrhagic
subjects affected / exposed	1 / 8569 (0.01%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 1
Subclavian artery occlusion
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Subclavian steal syndrome
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Subclavian artery stenosis
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Superior vena cava stenosis
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Temporal arteritis
subjects affected / exposed	2 / 8569 (0.02%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Thromboangiitis obliterans
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Thrombophlebitis
subjects affected / exposed	1 / 8569 (0.01%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Thrombophlebitis superficial
subjects affected / exposed	0 / 8569 (0.00%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Thrombosis
subjects affected / exposed	1 / 8569 (0.01%)	3 / 8574 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Varicose ulceration
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Varicose vein
subjects affected / exposed	5 / 8569 (0.06%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 6	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Vascular occlusion
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
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 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Vasospasm
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Venous thrombosis
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Venous thrombosis limb
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Surgical and medical procedures
Hospitalisation
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
General disorders and administration site conditions
Adverse drug reaction
subjects affected / exposed	0 / 8569 (0.00%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Asthenia
subjects affected / exposed	10 / 8569 (0.12%)	4 / 8574 (0.05%)
occurrences causally related to treatment / all	0 / 10	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Chest pain
subjects affected / exposed	20 / 8569 (0.23%)	29 / 8574 (0.34%)
occurrences causally related to treatment / all	0 / 20	0 / 34
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac death
subjects affected / exposed	2 / 8569 (0.02%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 2	0 / 1
Complication associated with device
subjects affected / exposed	1 / 8569 (0.01%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Critical illness
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Death
subjects affected / exposed	89 / 8569 (1.04%)	81 / 8574 (0.94%)
occurrences causally related to treatment / all	0 / 89	0 / 81
deaths causally related to treatment / all	0 / 89	0 / 81
Dehiscence
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Drowning
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Drug intolerance
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Exercise tolerance decreased
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Drug withdrawal syndrome
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gait disturbance
subjects affected / exposed	2 / 8569 (0.02%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
General physical health deterioration
subjects affected / exposed	5 / 8569 (0.06%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 5	0 / 2
deaths causally related to treatment / all	0 / 1	0 / 1
Generalised oedema
subjects affected / exposed	0 / 8569 (0.00%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Hernia
subjects affected / exposed	1 / 8569 (0.01%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Granuloma
subjects affected / exposed	1 / 8569 (0.01%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hypothermia
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Impaired healing
subjects affected / exposed	3 / 8569 (0.04%)	5 / 8574 (0.06%)
occurrences causally related to treatment / all	0 / 3	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Implant site inflammation
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Incarcerated hernia
subjects affected / exposed	1 / 8569 (0.01%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Inflammation
subjects affected / exposed	0 / 8569 (0.00%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Medical device pain
subjects affected / exposed	2 / 8569 (0.02%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Malaise
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (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 irritation
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Microlithiasis
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Multiple organ dysfunction syndrome
subjects affected / exposed	8 / 8569 (0.09%)	9 / 8574 (0.10%)
occurrences causally related to treatment / all	1 / 8	0 / 9
deaths causally related to treatment / all	0 / 5	0 / 4
Necrobiosis
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Necrosis
subjects affected / exposed	1 / 8569 (0.01%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Non-cardiac chest pain
subjects affected / exposed	107 / 8569 (1.25%)	93 / 8574 (1.08%)
occurrences causally related to treatment / all	1 / 120	0 / 110
deaths causally related to treatment / all	0 / 0	0 / 0
Oedema
subjects affected / exposed	2 / 8569 (0.02%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Oedema peripheral
subjects affected / exposed	5 / 8569 (0.06%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 5	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Organ failure
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pacemaker syndrome
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pain
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pelvic mass
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Peripheral swelling
subjects affected / exposed	2 / 8569 (0.02%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pyrexia
subjects affected / exposed	13 / 8569 (0.15%)	7 / 8574 (0.08%)
occurrences causally related to treatment / all	0 / 13	1 / 14
deaths causally related to treatment / all	0 / 1	0 / 0
Soft tissue inflammation
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Stent-graft endoleak
subjects affected / exposed	0 / 8569 (0.00%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Submandibular mass
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (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	16 / 8569 (0.19%)	14 / 8574 (0.16%)
occurrences causally related to treatment / all	0 / 16	0 / 14
deaths causally related to treatment / all	0 / 16	0 / 14
Sudden death
subjects affected / exposed	23 / 8569 (0.27%)	21 / 8574 (0.24%)
occurrences causally related to treatment / all	0 / 23	0 / 21
deaths causally related to treatment / all	0 / 23	0 / 21
Systemic inflammatory response syndrome
subjects affected / exposed	2 / 8569 (0.02%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Vascular stent occlusion
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Vascular stent stenosis
subjects affected / exposed	8 / 8569 (0.09%)	7 / 8574 (0.08%)
occurrences causally related to treatment / all	1 / 8	0 / 8
deaths causally related to treatment / all	0 / 0	0 / 0
Vascular stent thrombosis
subjects affected / exposed	1 / 8569 (0.01%)	3 / 8574 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Immune system disorders
Allergy to metals
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Allergy to vaccine
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Anaphylactic reaction
subjects affected / exposed	2 / 8569 (0.02%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 2	1 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Anaphylactic shock
subjects affected / exposed	5 / 8569 (0.06%)	3 / 8574 (0.03%)
occurrences causally related to treatment / all	0 / 5	0 / 3
deaths causally related to treatment / all	0 / 1	0 / 0
Drug hypersensitivity
subjects affected / exposed	3 / 8569 (0.04%)	4 / 8574 (0.05%)
occurrences causally related to treatment / all	0 / 3	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Hashitoxicosis
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hypersensitivity
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (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	1 / 8569 (0.01%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Reproductive system and breast disorders
Acquired hydrocele
subjects affected / exposed	5 / 8569 (0.06%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 5	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Acquired phimosis
subjects affected / exposed	1 / 8569 (0.01%)	11 / 8574 (0.13%)
occurrences causally related to treatment / all	0 / 1	2 / 11
deaths causally related to treatment / all	0 / 0	0 / 0
Balanoposthitis
subjects affected / exposed	2 / 8569 (0.02%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	1 / 2	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Benign prostatic hyperplasia
subjects affected / exposed	31 / 8569 (0.36%)	28 / 8574 (0.33%)
occurrences causally related to treatment / all	0 / 31	0 / 30
deaths causally related to treatment / all	0 / 0	0 / 0
Breast mass
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Breast pain
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cervical dysplasia
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Colpocele
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cystocele
subjects affected / exposed	2 / 8569 (0.02%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Endometrial hyperplasia
subjects affected / exposed	3 / 8569 (0.04%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Endometrial hypertrophy
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Erectile dysfunction
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Female genital tract fistula
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gynaecomastia
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hydrosalpinx
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Ovarian cyst
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pelvic haemorrhage
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pelvic prolapse
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Penile necrosis
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Peyronie's disease
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Postmenopausal haemorrhage
subjects affected / exposed	2 / 8569 (0.02%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Prostatic disorder
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Prostatitis
subjects affected / exposed	8 / 8569 (0.09%)	4 / 8574 (0.05%)
occurrences causally related to treatment / all	2 / 9	1 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Prostatomegaly
subjects affected / exposed	5 / 8569 (0.06%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 5	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Rectocele
subjects affected / exposed	1 / 8569 (0.01%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Testicular cyst
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Uterine polyp
subjects affected / exposed	3 / 8569 (0.04%)	3 / 8574 (0.03%)
occurrences causally related to treatment / all	0 / 3	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Uterine prolapse
subjects affected / exposed	2 / 8569 (0.02%)	6 / 8574 (0.07%)
occurrences causally related to treatment / all	0 / 2	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Uterovaginal prolapse
subjects affected / exposed	2 / 8569 (0.02%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Vaginal dysplasia
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Vaginal prolapse
subjects affected / exposed	0 / 8569 (0.00%)	3 / 8574 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Varicocele
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
subjects affected / exposed	8 / 8569 (0.09%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	1 / 8	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 0
Acute respiratory distress syndrome
subjects affected / exposed	4 / 8569 (0.05%)	3 / 8574 (0.03%)
occurrences causally related to treatment / all	0 / 4	0 / 3
deaths causally related to treatment / all	0 / 2	0 / 0
Acute respiratory failure
subjects affected / exposed	43 / 8569 (0.50%)	37 / 8574 (0.43%)
occurrences causally related to treatment / all	0 / 50	0 / 41
deaths causally related to treatment / all	0 / 12	0 / 5
Alveolitis allergic
subjects affected / exposed	1 / 8569 (0.01%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Apnoea
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Aspiration
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Asthma
subjects affected / exposed	18 / 8569 (0.21%)	6 / 8574 (0.07%)
occurrences causally related to treatment / all	0 / 21	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Asthma-chronic obstructive pulmonary disease overlap syndrome
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Asthmatic crisis
subjects affected / exposed	0 / 8569 (0.00%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Atelectasis
subjects affected / exposed	2 / 8569 (0.02%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Bronchial hyperreactivity
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Bronchitis chronic
subjects affected / exposed	2 / 8569 (0.02%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Bronchiectasis
subjects affected / exposed	1 / 8569 (0.01%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Bronchospasm
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Chronic obstructive pulmonary disease
subjects affected / exposed	54 / 8569 (0.63%)	54 / 8574 (0.63%)
occurrences causally related to treatment / all	0 / 90	1 / 81
deaths causally related to treatment / all	0 / 5	0 / 5
Chronic respiratory failure
subjects affected / exposed	4 / 8569 (0.05%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 4	0 / 2
deaths causally related to treatment / all	0 / 1	0 / 0
Dyspnoea
subjects affected / exposed	21 / 8569 (0.25%)	4 / 8574 (0.05%)
occurrences causally related to treatment / all	0 / 22	0 / 4
deaths causally related to treatment / all	0 / 1	0 / 1
Dyspnoea exertional
subjects affected / exposed	5 / 8569 (0.06%)	4 / 8574 (0.05%)
occurrences causally related to treatment / all	0 / 5	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Epistaxis
subjects affected / exposed	5 / 8569 (0.06%)	4 / 8574 (0.05%)
occurrences causally related to treatment / all	0 / 5	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Emphysema
subjects affected / exposed	2 / 8569 (0.02%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Haemoptysis
subjects affected / exposed	2 / 8569 (0.02%)	5 / 8574 (0.06%)
occurrences causally related to treatment / all	0 / 2	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 1
Haemothorax
subjects affected / exposed	2 / 8569 (0.02%)	3 / 8574 (0.03%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Hydrothorax
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Interstitial lung disease
subjects affected / exposed	5 / 8569 (0.06%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 5	0 / 1
deaths causally related to treatment / all	0 / 2	0 / 0
Hypoxia
subjects affected / exposed	3 / 8569 (0.04%)	3 / 8574 (0.03%)
occurrences causally related to treatment / all	0 / 3	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Idiopathic pulmonary fibrosis
subjects affected / exposed	0 / 8569 (0.00%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Lung disorder
subjects affected / exposed	2 / 8569 (0.02%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Lung infiltration
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Nasal polyps
subjects affected / exposed	0 / 8569 (0.00%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Paraneoplastic pleural effusion
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Obstructive airways disorder
subjects affected / exposed	2 / 8569 (0.02%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Nasal septum deviation
subjects affected / exposed	0 / 8569 (0.00%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Pickwickian syndrome
subjects affected / exposed	1 / 8569 (0.01%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pleural effusion
subjects affected / exposed	13 / 8569 (0.15%)	6 / 8574 (0.07%)
occurrences causally related to treatment / all	0 / 14	0 / 7
deaths causally related to treatment / all	0 / 1	0 / 0
Pleural thickening
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pleurisy
subjects affected / exposed	3 / 8569 (0.04%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Pleuritic pain
subjects affected / exposed	1 / 8569 (0.01%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumonia aspiration
subjects affected / exposed	10 / 8569 (0.12%)	18 / 8574 (0.21%)
occurrences causally related to treatment / all	0 / 10	0 / 19
deaths causally related to treatment / all	0 / 2	0 / 2
Pulmonary amyloidosis
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumonitis
subjects affected / exposed	5 / 8569 (0.06%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	1 / 5	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumothorax
subjects affected / exposed	4 / 8569 (0.05%)	6 / 8574 (0.07%)
occurrences causally related to treatment / all	0 / 4	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Pulmonary arterial hypertension
subjects affected / exposed	2 / 8569 (0.02%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pulmonary congestion
subjects affected / exposed	0 / 8569 (0.00%)	4 / 8574 (0.05%)
occurrences causally related to treatment / all	0 / 0	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Pulmonary embolism
subjects affected / exposed	27 / 8569 (0.32%)	26 / 8574 (0.30%)
occurrences causally related to treatment / all	0 / 27	1 / 26
deaths causally related to treatment / all	0 / 8	0 / 5
Pulmonary hypertension
subjects affected / exposed	4 / 8569 (0.05%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 19	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Pulmonary haemorrhage
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Pulmonary fibrosis
subjects affected / exposed	1 / 8569 (0.01%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Pulmonary infarction
subjects affected / exposed	1 / 8569 (0.01%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 0
Pulmonary mass
subjects affected / exposed	11 / 8569 (0.13%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 11	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Reflux laryngitis
subjects affected / exposed	1 / 8569 (0.01%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pulmonary oedema
subjects affected / exposed	15 / 8569 (0.18%)	4 / 8574 (0.05%)
occurrences causally related to treatment / all	2 / 16	0 / 4
deaths causally related to treatment / all	1 / 4	0 / 0
Pulmonary thrombosis
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Respiratory acidosis
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Respiratory arrest
subjects affected / exposed	1 / 8569 (0.01%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Respiratory distress
subjects affected / exposed	1 / 8569 (0.01%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Respiratory failure
subjects affected / exposed	24 / 8569 (0.28%)	29 / 8574 (0.34%)
occurrences causally related to treatment / all	0 / 28	1 / 30
deaths causally related to treatment / all	0 / 9	0 / 7
Restrictive pulmonary disease
subjects affected / exposed	1 / 8569 (0.01%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Rheumatoid lung
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Rhinitis hypertrophic
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Sleep apnoea syndrome
subjects affected / exposed	1 / 8569 (0.01%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Vocal cord leukoplakia
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Psychiatric disorders
Acute psychosis
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Adjustment disorder
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Agitation
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Alcohol withdrawal syndrome
subjects affected / exposed	1 / 8569 (0.01%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Anxiety
subjects affected / exposed	2 / 8569 (0.02%)	3 / 8574 (0.03%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Anxiety disorder
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Completed suicide
subjects affected / exposed	2 / 8569 (0.02%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 2	0 / 2
Confusional state
subjects affected / exposed	12 / 8569 (0.14%)	4 / 8574 (0.05%)
occurrences causally related to treatment / all	2 / 12	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Conversion disorder
subjects affected / exposed	2 / 8569 (0.02%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Delirium
subjects affected / exposed	4 / 8569 (0.05%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 4	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Depressed mood
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Depression
subjects affected / exposed	13 / 8569 (0.15%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 15	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Drug abuse
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hallucination
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hypomania
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Major depression
subjects affected / exposed	6 / 8569 (0.07%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 6	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Mental status changes
subjects affected / exposed	7 / 8569 (0.08%)	5 / 8574 (0.06%)
occurrences causally related to treatment / all	0 / 7	0 / 5
deaths causally related to treatment / all	0 / 1	0 / 0
Mood disorder due to a general medical condition
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Panic attack
subjects affected / exposed	2 / 8569 (0.02%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Post-traumatic stress disorder
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (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	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Schizoaffective disorder
subjects affected / exposed	1 / 8569 (0.01%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Schizophrenia
subjects affected / exposed	2 / 8569 (0.02%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Schizoaffective disorder depressive type
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (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 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Stress
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Suicidal ideation
subjects affected / exposed	2 / 8569 (0.02%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Suicide attempt
subjects affected / exposed	2 / 8569 (0.02%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Product issues
Device breakage
subjects affected / exposed	0 / 8569 (0.00%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Device dislocation
subjects affected / exposed	1 / 8569 (0.01%)	3 / 8574 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Device failure
subjects affected / exposed	2 / 8569 (0.02%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Device lead damage
subjects affected / exposed	1 / 8569 (0.01%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Device malfunction
subjects affected / exposed	1 / 8569 (0.01%)	3 / 8574 (0.03%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Device occlusion
subjects affected / exposed	0 / 8569 (0.00%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Stent malfunction
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatobiliary disorders
Bile duct obstruction
subjects affected / exposed	2 / 8569 (0.02%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Bile duct stenosis
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Bile duct stone
subjects affected / exposed	8 / 8569 (0.09%)	9 / 8574 (0.10%)
occurrences causally related to treatment / all	0 / 8	1 / 10
deaths causally related to treatment / all	0 / 0	0 / 0
Biliary colic
subjects affected / exposed	2 / 8569 (0.02%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Biliary dyskinesia
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Biliary dyspepsia
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cholangitis
subjects affected / exposed	5 / 8569 (0.06%)	11 / 8574 (0.13%)
occurrences causally related to treatment / all	0 / 6	0 / 12
deaths causally related to treatment / all	0 / 0	0 / 0
Cholangitis acute
subjects affected / exposed	2 / 8569 (0.02%)	4 / 8574 (0.05%)
occurrences causally related to treatment / all	0 / 2	1 / 5
deaths causally related to treatment / all	0 / 1	0 / 0
Cholecystitis
subjects affected / exposed	22 / 8569 (0.26%)	18 / 8574 (0.21%)
occurrences causally related to treatment / all	0 / 23	0 / 18
deaths causally related to treatment / all	0 / 0	0 / 0
Cholecystitis acute
subjects affected / exposed	22 / 8569 (0.26%)	25 / 8574 (0.29%)
occurrences causally related to treatment / all	0 / 22	0 / 25
deaths causally related to treatment / all	0 / 1	0 / 0
Cholecystitis chronic
subjects affected / exposed	6 / 8569 (0.07%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 6	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cholelithiasis
subjects affected / exposed	38 / 8569 (0.44%)	26 / 8574 (0.30%)
occurrences causally related to treatment / all	1 / 40	0 / 26
deaths causally related to treatment / all	0 / 0	0 / 0
Chronic hepatic failure
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Drug-induced liver injury
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gallbladder cholesterolosis
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gallbladder perforation
subjects affected / exposed	0 / 8569 (0.00%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Gallbladder polyp
subjects affected / exposed	2 / 8569 (0.02%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatic cirrhosis
subjects affected / exposed	11 / 8569 (0.13%)	7 / 8574 (0.08%)
occurrences causally related to treatment / all	2 / 13	0 / 8
deaths causally related to treatment / all	0 / 3	0 / 1
Hepatic cyst
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatic failure
subjects affected / exposed	3 / 8569 (0.04%)	4 / 8574 (0.05%)
occurrences causally related to treatment / all	0 / 4	0 / 4
deaths causally related to treatment / all	0 / 1	0 / 0
Hepatic fibrosis
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatic mass
subjects affected / exposed	3 / 8569 (0.04%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatic steatosis
subjects affected / exposed	4 / 8569 (0.05%)	3 / 8574 (0.03%)
occurrences causally related to treatment / all	0 / 4	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatitis
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatitis acute
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatorenal syndrome
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hydrocholecystis
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Ischaemic hepatitis
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Jaundice
subjects affected / exposed	2 / 8569 (0.02%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Liver injury
subjects affected / exposed	0 / 8569 (0.00%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Non-alcoholic steatohepatitis
subjects affected / exposed	2 / 8569 (0.02%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Porcelain gallbladder
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Portal vein thrombosis
subjects affected / exposed	2 / 8569 (0.02%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Investigations
Anticoagulation drug level below therapeutic
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Blood creatine phosphokinase increased
subjects affected / exposed	1 / 8569 (0.01%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Blood creatinine increased
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Blood glucose abnormal
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Blood glucose increased
subjects affected / exposed	4 / 8569 (0.05%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 4	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Blood pressure increased
subjects affected / exposed	0 / 8569 (0.00%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Blood pressure decreased
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Catheterisation cardiac
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Brain natriuretic peptide increased
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
General physical condition abnormal
subjects affected / exposed	1 / 8569 (0.01%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 0
Glomerular filtration rate decreased
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
International normalised ratio increased
subjects affected / exposed	3 / 8569 (0.04%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatic enzyme increased
subjects affected / exposed	0 / 8569 (0.00%)	3 / 8574 (0.03%)
occurrences causally related to treatment / all	0 / 0	1 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Liver function test increased
subjects affected / exposed	2 / 8569 (0.02%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	1 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Transaminases increased
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Troponin increased
subjects affected / exposed	7 / 8569 (0.08%)	11 / 8574 (0.13%)
occurrences causally related to treatment / all	0 / 8	0 / 12
deaths causally related to treatment / all	0 / 0	0 / 0
Urine cytology abnormal
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Weight decreased
subjects affected / exposed	2 / 8569 (0.02%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	2 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Electrocardiogram QT prolonged
subjects affected / exposed	2 / 8569 (0.02%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	1 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Electrocardiogram ST segment elevation
subjects affected / exposed	1 / 8569 (0.01%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatitis C antibody positive
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Troponin I increased
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Troponin T increased
subjects affected / exposed	0 / 8569 (0.00%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Injury, poisoning and procedural complications
Abdominal injury
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Abdominal wall wound
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Abdominal wound dehiscence
subjects affected / exposed	0 / 8569 (0.00%)	3 / 8574 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Accidental overdose
subjects affected / exposed	1 / 8569 (0.01%)	3 / 8574 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Accidental poisoning
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Acetabulum fracture
subjects affected / exposed	1 / 8569 (0.01%)	3 / 8574 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Alcohol poisoning
subjects affected / exposed	3 / 8569 (0.04%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 3	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Allergic transfusion reaction
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Anaemia postoperative
subjects affected / exposed	1 / 8569 (0.01%)	3 / 8574 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Anastomotic leak
subjects affected / exposed	1 / 8569 (0.01%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Anastomotic ulcer
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Ankle fracture
subjects affected / exposed	14 / 8569 (0.16%)	19 / 8574 (0.22%)
occurrences causally related to treatment / all	0 / 14	0 / 19
deaths causally related to treatment / all	0 / 0	0 / 0
Arterial bypass occlusion
subjects affected / exposed	1 / 8569 (0.01%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Arterial injury
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Arterial restenosis
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Back injury
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Avulsion fracture
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Bone contusion
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (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	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Brain contusion
subjects affected / exposed	2 / 8569 (0.02%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac procedure complication
subjects affected / exposed	1 / 8569 (0.01%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 1	1 / 2
deaths causally related to treatment / all	0 / 0	0 / 1
Cardiac valve replacement complication
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Carotid artery restenosis
subjects affected / exposed	2 / 8569 (0.02%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cartilage injury
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cataract operation complication
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Cervical vertebral fracture
subjects affected / exposed	4 / 8569 (0.05%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 4	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 0
Cement embolism
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Chest crushing
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Chest injury
subjects affected / exposed	0 / 8569 (0.00%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Clavicle fracture
subjects affected / exposed	1 / 8569 (0.01%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Complications of transplanted liver
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Compression fracture
subjects affected / exposed	0 / 8569 (0.00%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Concussion
subjects affected / exposed	7 / 8569 (0.08%)	5 / 8574 (0.06%)
occurrences causally related to treatment / all	0 / 7	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Contusion
subjects affected / exposed	4 / 8569 (0.05%)	4 / 8574 (0.05%)
occurrences causally related to treatment / all	0 / 4	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Confusion postoperative
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Coronary artery restenosis
subjects affected / exposed	1 / 8569 (0.01%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Coronary bypass stenosis
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Costal cartilage fracture
subjects affected / exposed	1 / 8569 (0.01%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Craniocerebral injury
subjects affected / exposed	3 / 8569 (0.04%)	5 / 8574 (0.06%)
occurrences causally related to treatment / all	0 / 3	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 3
Cystitis radiation
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Exposure to toxic agent
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Extradural haematoma
subjects affected / exposed	1 / 8569 (0.01%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Eyelid injury
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Facial bones fracture
subjects affected / exposed	4 / 8569 (0.05%)	10 / 8574 (0.12%)
occurrences causally related to treatment / all	0 / 4	0 / 10
deaths causally related to treatment / all	0 / 0	0 / 0
Femoral neck fracture
subjects affected / exposed	9 / 8569 (0.11%)	5 / 8574 (0.06%)
occurrences causally related to treatment / all	0 / 9	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Fall
subjects affected / exposed	20 / 8569 (0.23%)	14 / 8574 (0.16%)
occurrences causally related to treatment / all	1 / 20	0 / 14
deaths causally related to treatment / all	0 / 0	0 / 0
Femur fracture
subjects affected / exposed	18 / 8569 (0.21%)	16 / 8574 (0.19%)
occurrences causally related to treatment / all	1 / 18	0 / 16
deaths causally related to treatment / all	0 / 0	0 / 0
Fibula fracture
subjects affected / exposed	4 / 8569 (0.05%)	5 / 8574 (0.06%)
occurrences causally related to treatment / all	0 / 4	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Foot fracture
subjects affected / exposed	5 / 8569 (0.06%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 5	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Foreign body in gastrointestinal tract
subjects affected / exposed	1 / 8569 (0.01%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Foreign body in respiratory tract
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Fracture displacement
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Fractured sacrum
subjects affected / exposed	0 / 8569 (0.00%)	3 / 8574 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Gun shot wound
subjects affected / exposed	2 / 8569 (0.02%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Haematuria traumatic
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hand fracture
subjects affected / exposed	4 / 8569 (0.05%)	3 / 8574 (0.03%)
occurrences causally related to treatment / all	0 / 4	1 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Heat stroke
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Head injury
subjects affected / exposed	8 / 8569 (0.09%)	4 / 8574 (0.05%)
occurrences causally related to treatment / all	0 / 8	0 / 5
deaths causally related to treatment / all	0 / 2	0 / 0
Hip fracture
subjects affected / exposed	15 / 8569 (0.18%)	13 / 8574 (0.15%)
occurrences causally related to treatment / all	0 / 16	0 / 13
deaths causally related to treatment / all	0 / 0	0 / 0
Ilium fracture
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Humerus fracture
subjects affected / exposed	20 / 8569 (0.23%)	11 / 8574 (0.13%)
occurrences causally related to treatment / all	2 / 20	1 / 12
deaths causally related to treatment / all	0 / 0	0 / 0
Injury
subjects affected / exposed	1 / 8569 (0.01%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Incisional hernia
subjects affected / exposed	2 / 8569 (0.02%)	6 / 8574 (0.07%)
occurrences causally related to treatment / all	0 / 2	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Intentional overdose
subjects affected / exposed	2 / 8569 (0.02%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Jaw fracture
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Joint dislocation
subjects affected / exposed	1 / 8569 (0.01%)	5 / 8574 (0.06%)
occurrences causally related to treatment / all	0 / 1	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Joint injury
subjects affected / exposed	1 / 8569 (0.01%)	3 / 8574 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Laceration
subjects affected / exposed	1 / 8569 (0.01%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Ligament rupture
subjects affected / exposed	0 / 8569 (0.00%)	3 / 8574 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Ligament sprain
subjects affected / exposed	3 / 8569 (0.04%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 3	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Limb crushing injury
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Limb fracture
subjects affected / exposed	1 / 8569 (0.01%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Limb injury
subjects affected / exposed	4 / 8569 (0.05%)	7 / 8574 (0.08%)
occurrences causally related to treatment / all	0 / 4	1 / 8
deaths causally related to treatment / all	0 / 0	0 / 0
Limb traumatic amputation
subjects affected / exposed	0 / 8569 (0.00%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Lisfranc fracture
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Lower limb fracture
subjects affected / exposed	9 / 8569 (0.11%)	5 / 8574 (0.06%)
occurrences causally related to treatment / all	0 / 9	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Lumbar vertebral fracture
subjects affected / exposed	6 / 8569 (0.07%)	5 / 8574 (0.06%)
occurrences causally related to treatment / all	0 / 6	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Meniscus injury
subjects affected / exposed	2 / 8569 (0.02%)	6 / 8574 (0.07%)
occurrences causally related to treatment / all	0 / 2	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Multiple fractures
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Multiple injuries
subjects affected / exposed	3 / 8569 (0.04%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Muscle strain
subjects affected / exposed	0 / 8569 (0.00%)	3 / 8574 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Muscle rupture
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Nerve injury
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Ocular procedural complication
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Overdose
subjects affected / exposed	6 / 8569 (0.07%)	5 / 8574 (0.06%)
occurrences causally related to treatment / all	1 / 6	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Patella fracture
subjects affected / exposed	1 / 8569 (0.01%)	3 / 8574 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Pelvic fracture
subjects affected / exposed	4 / 8569 (0.05%)	3 / 8574 (0.03%)
occurrences causally related to treatment / all	0 / 4	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Periorbital haematoma
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Periprocedural myocardial infarction
subjects affected / exposed	2 / 8569 (0.02%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Peripheral artery restenosis
subjects affected / exposed	3 / 8569 (0.04%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 5	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Periprosthetic fracture
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumothorax traumatic
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumoconiosis
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Post concussion syndrome
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Post procedural complication
subjects affected / exposed	14 / 8569 (0.16%)	8 / 8574 (0.09%)
occurrences causally related to treatment / all	0 / 14	0 / 8
deaths causally related to treatment / all	0 / 1	0 / 0
Post laminectomy syndrome
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
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	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Post procedural discharge
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Post procedural haematoma
subjects affected / exposed	1 / 8569 (0.01%)	4 / 8574 (0.05%)
occurrences causally related to treatment / all	0 / 1	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Post procedural haematuria
subjects affected / exposed	1 / 8569 (0.01%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Post procedural haemorrhage
subjects affected / exposed	4 / 8569 (0.05%)	11 / 8574 (0.13%)
occurrences causally related to treatment / all	0 / 5	0 / 12
deaths causally related to treatment / all	0 / 0	0 / 1
Post procedural inflammation
subjects affected / exposed	1 / 8569 (0.01%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Post procedural myocardial infarction
subjects affected / exposed	1 / 8569 (0.01%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Postoperative ileus
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Postoperative delirium
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Postoperative respiratory failure
subjects affected / exposed	1 / 8569 (0.01%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Postoperative thoracic procedure complication
subjects affected / exposed	1 / 8569 (0.01%)	3 / 8574 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Postoperative thrombosis
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Postoperative wound complication
subjects affected / exposed	2 / 8569 (0.02%)	4 / 8574 (0.05%)
occurrences causally related to treatment / all	0 / 2	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Procedural complication
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
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	2 / 8569 (0.02%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Procedural pain
subjects affected / exposed	1 / 8569 (0.01%)	3 / 8574 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Procedural pneumothorax
subjects affected / exposed	0 / 8569 (0.00%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Procedural shock
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Pubis fracture
subjects affected / exposed	2 / 8569 (0.02%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	1 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Radiation oesophagitis
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Rectal laceration postoperative
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Radius fracture
subjects affected / exposed	10 / 8569 (0.12%)	7 / 8574 (0.08%)
occurrences causally related to treatment / all	0 / 10	1 / 8
deaths causally related to treatment / all	0 / 0	0 / 0
Rib fracture
subjects affected / exposed	15 / 8569 (0.18%)	12 / 8574 (0.14%)
occurrences causally related to treatment / all	0 / 17	0 / 13
deaths causally related to treatment / all	0 / 0	0 / 0
Road traffic accident
subjects affected / exposed	7 / 8569 (0.08%)	8 / 8574 (0.09%)
occurrences causally related to treatment / all	0 / 7	0 / 8
deaths causally related to treatment / all	0 / 3	0 / 2
Sedation complication
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Seroma
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Skin abrasion
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Skin injury
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Skin wound
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
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	6 / 8569 (0.07%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 6	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Skull fractured base
subjects affected / exposed	1 / 8569 (0.01%)	1 / 8574 (0.01%)
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	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Spinal column injury
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Spinal compression fracture
subjects affected / exposed	4 / 8569 (0.05%)	12 / 8574 (0.14%)
occurrences causally related to treatment / all	0 / 4	0 / 12
deaths causally related to treatment / all	0 / 0	0 / 0
Spinal fracture
subjects affected / exposed	4 / 8569 (0.05%)	4 / 8574 (0.05%)
occurrences causally related to treatment / all	0 / 4	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Splenic injury
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Splenic rupture
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Stab wound
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Sternal fracture
subjects affected / exposed	4 / 8569 (0.05%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 4	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Stoma site haemorrhage
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Subarachnoid haemorrhage
subjects affected / exposed	9 / 8569 (0.11%)	6 / 8574 (0.07%)
occurrences causally related to treatment / all	0 / 9	1 / 6
deaths causally related to treatment / all	0 / 1	0 / 1
Subcutaneous haematoma
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Subdural haematoma
subjects affected / exposed	11 / 8569 (0.13%)	8 / 8574 (0.09%)
occurrences causally related to treatment / all	0 / 13	0 / 9
deaths causally related to treatment / all	0 / 0	0 / 1
Subdural haemorrhage
subjects affected / exposed	1 / 8569 (0.01%)	3 / 8574 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 1
Tendon injury
subjects affected / exposed	2 / 8569 (0.02%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Tendon rupture
subjects affected / exposed	8 / 8569 (0.09%)	5 / 8574 (0.06%)
occurrences causally related to treatment / all	0 / 8	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Thermal burn
subjects affected / exposed	3 / 8569 (0.04%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Thoracic vertebral fracture
subjects affected / exposed	6 / 8569 (0.07%)	3 / 8574 (0.03%)
occurrences causally related to treatment / all	0 / 6	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Tibia fracture
subjects affected / exposed	5 / 8569 (0.06%)	12 / 8574 (0.14%)
occurrences causally related to treatment / all	0 / 5	0 / 12
deaths causally related to treatment / all	0 / 0	0 / 0
Tongue injury
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Toxicity to various agents
subjects affected / exposed	4 / 8569 (0.05%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 4	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Transfusion reaction
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Transplant dysfunction
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Traumatic arthritis
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Traumatic fracture
subjects affected / exposed	1 / 8569 (0.01%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Traumatic haemothorax
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Traumatic intracranial haemorrhage
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Ulna fracture
subjects affected / exposed	3 / 8569 (0.04%)	3 / 8574 (0.03%)
occurrences causally related to treatment / all	0 / 3	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Upper limb fracture
subjects affected / exposed	4 / 8569 (0.05%)	8 / 8574 (0.09%)
occurrences causally related to treatment / all	0 / 4	0 / 8
deaths causally related to treatment / all	0 / 0	0 / 0
Vascular graft occlusion
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Vascular graft restenosis
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Vascular graft thrombosis
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Vascular pseudoaneurysm
subjects affected / exposed	5 / 8569 (0.06%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 5	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Wound
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Wound dehiscence
subjects affected / exposed	3 / 8569 (0.04%)	3 / 8574 (0.03%)
occurrences causally related to treatment / all	0 / 3	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Wound haematoma
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Wound necrosis
subjects affected / exposed	2 / 8569 (0.02%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Wrist fracture
subjects affected / exposed	5 / 8569 (0.06%)	6 / 8574 (0.07%)
occurrences causally related to treatment / all	0 / 5	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Congenital, familial and genetic disorders
Adenomatous polyposis coli
subjects affected / exposed	1 / 8569 (0.01%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Congenital hepatobiliary anomaly
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
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 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hydrocele
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hypertrophic cardiomyopathy
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Vitello-intestinal duct remnant
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Diverticulitis Meckel's
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac disorders
Acute cardiac event
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Acute coronary syndrome
subjects affected / exposed	31 / 8569 (0.36%)	17 / 8574 (0.20%)
occurrences causally related to treatment / all	0 / 33	0 / 22
deaths causally related to treatment / all	0 / 4	0 / 1
Acute left ventricular failure
subjects affected / exposed	17 / 8569 (0.20%)	16 / 8574 (0.19%)
occurrences causally related to treatment / all	0 / 23	0 / 22
deaths causally related to treatment / all	0 / 1	0 / 1
Acute myocardial infarction
subjects affected / exposed	233 / 8569 (2.72%)	265 / 8574 (3.09%)
occurrences causally related to treatment / all	7 / 264	3 / 293
deaths causally related to treatment / all	0 / 18	0 / 24
Angina pectoris
subjects affected / exposed	159 / 8569 (1.86%)	154 / 8574 (1.80%)
occurrences causally related to treatment / all	1 / 175	0 / 178
deaths causally related to treatment / all	0 / 1	0 / 0
Angina unstable
subjects affected / exposed	269 / 8569 (3.14%)	271 / 8574 (3.16%)
occurrences causally related to treatment / all	4 / 332	2 / 349
deaths causally related to treatment / all	0 / 0	0 / 0
Aortic valve calcification
subjects affected / exposed	0 / 8569 (0.00%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Aortic valve disease
subjects affected / exposed	2 / 8569 (0.02%)	3 / 8574 (0.03%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Aortic valve disease mixed
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Aortic valve incompetence
subjects affected / exposed	1 / 8569 (0.01%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Aortic valve stenosis
subjects affected / exposed	2 / 8569 (0.02%)	10 / 8574 (0.12%)
occurrences causally related to treatment / all	0 / 2	0 / 10
deaths causally related to treatment / all	0 / 0	0 / 0
Arrhythmia
subjects affected / exposed	6 / 8569 (0.07%)	5 / 8574 (0.06%)
occurrences causally related to treatment / all	0 / 6	0 / 5
deaths causally related to treatment / all	0 / 3	0 / 1
Arteriosclerosis coronary artery
subjects affected / exposed	16 / 8569 (0.19%)	3 / 8574 (0.03%)
occurrences causally related to treatment / all	1 / 21	0 / 3
deaths causally related to treatment / all	0 / 1	0 / 0
Atrial fibrillation
subjects affected / exposed	139 / 8569 (1.62%)	117 / 8574 (1.36%)
occurrences causally related to treatment / all	3 / 177	1 / 138
deaths causally related to treatment / all	0 / 1	0 / 2
Atrial flutter
subjects affected / exposed	34 / 8569 (0.40%)	21 / 8574 (0.24%)
occurrences causally related to treatment / all	0 / 44	1 / 25
deaths causally related to treatment / all	0 / 0	0 / 0
Atrial tachycardia
subjects affected / exposed	2 / 8569 (0.02%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Atrial thrombosis
subjects affected / exposed	2 / 8569 (0.02%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Atrioventricular block
subjects affected / exposed	7 / 8569 (0.08%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	1 / 7	1 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Atrioventricular block complete
subjects affected / exposed	14 / 8569 (0.16%)	19 / 8574 (0.22%)
occurrences causally related to treatment / all	0 / 14	0 / 19
deaths causally related to treatment / all	0 / 1	0 / 0
Atrioventricular block second degree
subjects affected / exposed	7 / 8569 (0.08%)	10 / 8574 (0.12%)
occurrences causally related to treatment / all	0 / 7	0 / 10
deaths causally related to treatment / all	0 / 0	0 / 0
Bradyarrhythmia
subjects affected / exposed	0 / 8569 (0.00%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Bradycardia
subjects affected / exposed	21 / 8569 (0.25%)	16 / 8574 (0.19%)
occurrences causally related to treatment / all	0 / 22	1 / 17
deaths causally related to treatment / all	0 / 0	0 / 1
Bifascicular block
subjects affected / exposed	1 / 8569 (0.01%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Bundle branch block left
subjects affected / exposed	2 / 8569 (0.02%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Bundle branch block right
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac arrest
subjects affected / exposed	31 / 8569 (0.36%)	33 / 8574 (0.38%)
occurrences causally related to treatment / all	1 / 32	1 / 34
deaths causally related to treatment / all	0 / 19	1 / 28
Cardiac asthma
subjects affected / exposed	5 / 8569 (0.06%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 8	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac disorder
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac failure
subjects affected / exposed	188 / 8569 (2.19%)	147 / 8574 (1.71%)
occurrences causally related to treatment / all	4 / 252	2 / 199
deaths causally related to treatment / all	0 / 12	0 / 24
Cardiac failure acute
subjects affected / exposed	31 / 8569 (0.36%)	22 / 8574 (0.26%)
occurrences causally related to treatment / all	0 / 39	0 / 25
deaths causally related to treatment / all	0 / 7	0 / 6
Cardiac failure congestive
subjects affected / exposed	147 / 8569 (1.72%)	121 / 8574 (1.41%)
occurrences causally related to treatment / all	4 / 205	0 / 177
deaths causally related to treatment / all	0 / 9	0 / 12
Cardiac failure chronic
subjects affected / exposed	20 / 8569 (0.23%)	12 / 8574 (0.14%)
occurrences causally related to treatment / all	0 / 23	1 / 14
deaths causally related to treatment / all	0 / 2	0 / 0
Cardiac ventricular thrombosis
subjects affected / exposed	5 / 8569 (0.06%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 5	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac tamponade
subjects affected / exposed	2 / 8569 (0.02%)	3 / 8574 (0.03%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Cardio-respiratory arrest
subjects affected / exposed	11 / 8569 (0.13%)	12 / 8574 (0.14%)
occurrences causally related to treatment / all	1 / 11	0 / 12
deaths causally related to treatment / all	0 / 8	0 / 12
Cardiogenic shock
subjects affected / exposed	13 / 8569 (0.15%)	19 / 8574 (0.22%)
occurrences causally related to treatment / all	0 / 16	0 / 19
deaths causally related to treatment / all	0 / 6	0 / 14
Cardiomegaly
subjects affected / exposed	1 / 8569 (0.01%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiomyopathy
subjects affected / exposed	8 / 8569 (0.09%)	7 / 8574 (0.08%)
occurrences causally related to treatment / all	0 / 8	0 / 8
deaths causally related to treatment / all	0 / 1	0 / 0
Cardiomyopathy acute
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiopulmonary failure
subjects affected / exposed	7 / 8569 (0.08%)	3 / 8574 (0.03%)
occurrences causally related to treatment / all	0 / 7	0 / 3
deaths causally related to treatment / all	0 / 6	0 / 2
Cardiovascular insufficiency
subjects affected / exposed	1 / 8569 (0.01%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 1
Cardiovascular disorder
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Chronotropic incompetence
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Chronic left ventricular failure
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Congestive cardiomyopathy
subjects affected / exposed	3 / 8569 (0.04%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 0
Conduction disorder
subjects affected / exposed	1 / 8569 (0.01%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cor pulmonale
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Coronary artery aneurysm
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Coronary artery occlusion
subjects affected / exposed	5 / 8569 (0.06%)	9 / 8574 (0.10%)
occurrences causally related to treatment / all	0 / 5	0 / 9
deaths causally related to treatment / all	0 / 0	0 / 0
Coronary artery disease
subjects affected / exposed	84 / 8569 (0.98%)	106 / 8574 (1.24%)
occurrences causally related to treatment / all	1 / 87	5 / 113
deaths causally related to treatment / all	1 / 3	0 / 5
Coronary artery stenosis
subjects affected / exposed	22 / 8569 (0.26%)	12 / 8574 (0.14%)
occurrences causally related to treatment / all	0 / 23	0 / 13
deaths causally related to treatment / all	0 / 0	0 / 0
Coronary artery thrombosis
subjects affected / exposed	1 / 8569 (0.01%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Coronary ostial stenosis
subjects affected / exposed	1 / 8569 (0.01%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Dressler's syndrome
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Diastolic dysfunction
subjects affected / exposed	2 / 8569 (0.02%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Extrasystoles
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Heart valve incompetence
subjects affected / exposed	1 / 8569 (0.01%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Heart valve stenosis
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (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	2 / 8569 (0.02%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 0
Left ventricular dysfunction
subjects affected / exposed	2 / 8569 (0.02%)	3 / 8574 (0.03%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Ischaemic cardiomyopathy
subjects affected / exposed	18 / 8569 (0.21%)	10 / 8574 (0.12%)
occurrences causally related to treatment / all	0 / 18	0 / 10
deaths causally related to treatment / all	0 / 0	0 / 1
Left ventricular failure
subjects affected / exposed	13 / 8569 (0.15%)	11 / 8574 (0.13%)
occurrences causally related to treatment / all	0 / 13	0 / 15
deaths causally related to treatment / all	0 / 0	0 / 0
Mitral valve incompetence
subjects affected / exposed	6 / 8569 (0.07%)	7 / 8574 (0.08%)
occurrences causally related to treatment / all	0 / 6	0 / 8
deaths causally related to treatment / all	0 / 0	0 / 0
Mitral valve stenosis
subjects affected / exposed	0 / 8569 (0.00%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Myocardial infarction
subjects affected / exposed	108 / 8569 (1.26%)	96 / 8574 (1.12%)
occurrences causally related to treatment / all	2 / 111	1 / 104
deaths causally related to treatment / all	0 / 24	0 / 19
Myocarditis
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Myocardial ischaemia
subjects affected / exposed	54 / 8569 (0.63%)	47 / 8574 (0.55%)
occurrences causally related to treatment / all	0 / 61	0 / 49
deaths causally related to treatment / all	0 / 3	0 / 4
Nodal arrhythmia
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Palpitations
subjects affected / exposed	3 / 8569 (0.04%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Pericardial effusion
subjects affected / exposed	3 / 8569 (0.04%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pericarditis
subjects affected / exposed	4 / 8569 (0.05%)	8 / 8574 (0.09%)
occurrences causally related to treatment / all	0 / 5	0 / 12
deaths causally related to treatment / all	0 / 0	0 / 0
Postinfarction angina
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Prinzmetal angina
subjects affected / exposed	0 / 8569 (0.00%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Pulseless electrical activity
subjects affected / exposed	2 / 8569 (0.02%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Rheumatic heart disease
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Right ventricular failure
subjects affected / exposed	4 / 8569 (0.05%)	4 / 8574 (0.05%)
occurrences causally related to treatment / all	1 / 4	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 1
Sinus arrest
subjects affected / exposed	0 / 8569 (0.00%)	3 / 8574 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Sinus bradycardia
subjects affected / exposed	5 / 8569 (0.06%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 5	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Sinus node dysfunction
subjects affected / exposed	13 / 8569 (0.15%)	14 / 8574 (0.16%)
occurrences causally related to treatment / all	0 / 14	0 / 14
deaths causally related to treatment / all	0 / 0	0 / 0
Sinus tachycardia
subjects affected / exposed	2 / 8569 (0.02%)	3 / 8574 (0.03%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Supraventricular tachycardia
subjects affected / exposed	6 / 8569 (0.07%)	12 / 8574 (0.14%)
occurrences causally related to treatment / all	0 / 7	0 / 12
deaths causally related to treatment / all	0 / 0	0 / 0
Tachyarrhythmia
subjects affected / exposed	2 / 8569 (0.02%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Tachycardia
subjects affected / exposed	5 / 8569 (0.06%)	5 / 8574 (0.06%)
occurrences causally related to treatment / all	0 / 6	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Torsade de pointes
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Tricuspid valve incompetence
subjects affected / exposed	1 / 8569 (0.01%)	3 / 8574 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Trifascicular block
subjects affected / exposed	1 / 8569 (0.01%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Ventricular arrhythmia
subjects affected / exposed	2 / 8569 (0.02%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 4	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 0
Ventricular extrasystoles
subjects affected / exposed	2 / 8569 (0.02%)	4 / 8574 (0.05%)
occurrences causally related to treatment / all	0 / 2	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Ventricular failure
subjects affected / exposed	0 / 8569 (0.00%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Ventricular fibrillation
subjects affected / exposed	9 / 8569 (0.11%)	8 / 8574 (0.09%)
occurrences causally related to treatment / all	0 / 11	0 / 8
deaths causally related to treatment / all	0 / 1	0 / 4
Ventricular tachycardia
subjects affected / exposed	15 / 8569 (0.18%)	19 / 8574 (0.22%)
occurrences causally related to treatment / all	1 / 21	0 / 23
deaths causally related to treatment / all	0 / 0	0 / 1
Adams-Stokes syndrome
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Nervous system disorders
Amnesia
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Amyotrophic lateral sclerosis
subjects affected / exposed	1 / 8569 (0.01%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Aphasia
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Arachnoid cyst
subjects affected / exposed	1 / 8569 (0.01%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Ataxia
subjects affected / exposed	1 / 8569 (0.01%)	3 / 8574 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Autonomic failure syndrome
subjects affected / exposed	2 / 8569 (0.02%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Balance disorder
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Basal ganglia infarction
subjects affected / exposed	1 / 8569 (0.01%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Basilar artery perforation
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Brain injury
subjects affected / exposed	6 / 8569 (0.07%)	3 / 8574 (0.03%)
occurrences causally related to treatment / all	0 / 6	0 / 3
deaths causally related to treatment / all	0 / 2	0 / 0
Brain oedema
subjects affected / exposed	0 / 8569 (0.00%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 1
Brain stem infarction
subjects affected / exposed	3 / 8569 (0.04%)	6 / 8574 (0.07%)
occurrences causally related to treatment / all	0 / 3	0 / 8
deaths causally related to treatment / all	0 / 0	0 / 0
Brain stem haemorrhage
subjects affected / exposed	0 / 8569 (0.00%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Brain stem stroke
subjects affected / exposed	2 / 8569 (0.02%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Carotid arteriosclerosis
subjects affected / exposed	0 / 8569 (0.00%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Burning sensation
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Carotid artery occlusion
subjects affected / exposed	1 / 8569 (0.01%)	5 / 8574 (0.06%)
occurrences causally related to treatment / all	0 / 1	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Carotid artery stenosis
subjects affected / exposed	21 / 8569 (0.25%)	27 / 8574 (0.31%)
occurrences causally related to treatment / all	0 / 22	0 / 27
deaths causally related to treatment / all	0 / 0	0 / 0
Carotid artery insufficiency
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Carotid sinus syndrome
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Carpal tunnel syndrome
subjects affected / exposed	3 / 8569 (0.04%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cerebellar ataxia
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
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	2 / 8569 (0.02%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cerebellar infarction
subjects affected / exposed	2 / 8569 (0.02%)	5 / 8574 (0.06%)
occurrences causally related to treatment / all	0 / 2	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 1
Cerebellar stroke
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cerebral artery embolism
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cerebral artery occlusion
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cerebral atrophy
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cerebral haematoma
subjects affected / exposed	1 / 8569 (0.01%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cerebral haemorrhage
subjects affected / exposed	6 / 8569 (0.07%)	7 / 8574 (0.08%)
occurrences causally related to treatment / all	0 / 6	0 / 7
deaths causally related to treatment / all	0 / 1	0 / 2
Cerebral infarction
subjects affected / exposed	32 / 8569 (0.37%)	24 / 8574 (0.28%)
occurrences causally related to treatment / all	2 / 33	1 / 27
deaths causally related to treatment / all	0 / 3	0 / 4
Cerebral ischaemia
subjects affected / exposed	9 / 8569 (0.11%)	6 / 8574 (0.07%)
occurrences causally related to treatment / all	0 / 10	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Cerebrovascular accident
subjects affected / exposed	88 / 8569 (1.03%)	102 / 8574 (1.19%)
occurrences causally related to treatment / all	3 / 94	2 / 112
deaths causally related to treatment / all	0 / 11	0 / 10
Cerebrovascular disorder
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cerebrovascular insufficiency
subjects affected / exposed	0 / 8569 (0.00%)	3 / 8574 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Cervical cord compression
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cervical radiculopathy
subjects affected / exposed	2 / 8569 (0.02%)	3 / 8574 (0.03%)
occurrences causally related to treatment / all	0 / 2	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Cervicobrachial syndrome
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cluster headache
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cognitive disorder
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (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 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cranial nerve palsies multiple
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Dementia
subjects affected / exposed	1 / 8569 (0.01%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Demyelinating polyneuropathy
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Diabetic autonomic neuropathy
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Diabetic hyperosmolar coma
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Diabetic coma
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Diabetic neuropathy
subjects affected / exposed	4 / 8569 (0.05%)	5 / 8574 (0.06%)
occurrences causally related to treatment / all	0 / 5	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Dizziness
subjects affected / exposed	9 / 8569 (0.11%)	14 / 8574 (0.16%)
occurrences causally related to treatment / all	1 / 9	0 / 14
deaths causally related to treatment / all	0 / 0	0 / 0
Dizziness postural
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Dysarthria
subjects affected / exposed	3 / 8569 (0.04%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Dystonic tremor
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
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	4 / 8569 (0.05%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 4	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Encephalopathy
subjects affected / exposed	8 / 8569 (0.09%)	3 / 8574 (0.03%)
occurrences causally related to treatment / all	0 / 8	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Epilepsy
subjects affected / exposed	5 / 8569 (0.06%)	3 / 8574 (0.03%)
occurrences causally related to treatment / all	0 / 5	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Essential tremor
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Facial paralysis
subjects affected / exposed	8 / 8569 (0.09%)	3 / 8574 (0.03%)
occurrences causally related to treatment / all	0 / 8	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Facial paresis
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Focal dyscognitive seizures
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Generalised tonic-clonic seizure
subjects affected / exposed	2 / 8569 (0.02%)	0 / 8574 (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	3 / 8569 (0.04%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Haemorrhagic cerebral infarction
subjects affected / exposed	1 / 8569 (0.01%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Haemorrhagic stroke
subjects affected / exposed	11 / 8569 (0.13%)	5 / 8574 (0.06%)
occurrences causally related to treatment / all	0 / 11	0 / 5
deaths causally related to treatment / all	0 / 2	0 / 3
Haemorrhagic transformation stroke
subjects affected / exposed	4 / 8569 (0.05%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 4	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Headache
subjects affected / exposed	3 / 8569 (0.04%)	3 / 8574 (0.03%)
occurrences causally related to treatment / all	0 / 3	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Hemianopia homonymous
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hemiparesis
subjects affected / exposed	1 / 8569 (0.01%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hydrocephalus
subjects affected / exposed	4 / 8569 (0.05%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 4	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatic encephalopathy
subjects affected / exposed	4 / 8569 (0.05%)	3 / 8574 (0.03%)
occurrences causally related to treatment / all	0 / 5	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 1
Hypoaesthesia
subjects affected / exposed	2 / 8569 (0.02%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Hypertensive encephalopathy
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hypoglycaemic coma
subjects affected / exposed	2 / 8569 (0.02%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	1 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hypoglycaemic unconsciousness
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hypoglycaemic encephalopathy
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hypokinesia
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
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	2 / 8569 (0.02%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Intensive care unit acquired weakness
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
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	2 / 8569 (0.02%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Intraventricular haemorrhage
subjects affected / exposed	1 / 8569 (0.01%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 1	0 / 2
Ischaemic cerebral infarction
subjects affected / exposed	1 / 8569 (0.01%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Ischaemic neuropathy
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Ischaemic stroke
subjects affected / exposed	90 / 8569 (1.05%)	97 / 8574 (1.13%)
occurrences causally related to treatment / all	0 / 99	2 / 105
deaths causally related to treatment / all	0 / 7	0 / 6
Lacunar infarction
subjects affected / exposed	14 / 8569 (0.16%)	8 / 8574 (0.09%)
occurrences causally related to treatment / all	0 / 14	0 / 9
deaths causally related to treatment / all	0 / 0	0 / 0
Lateral medullary syndrome
subjects affected / exposed	2 / 8569 (0.02%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Lacunar stroke
subjects affected / exposed	0 / 8569 (0.00%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Lumbar radiculopathy
subjects affected / exposed	6 / 8569 (0.07%)	4 / 8574 (0.05%)
occurrences causally related to treatment / all	0 / 6	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Loss of consciousness
subjects affected / exposed	6 / 8569 (0.07%)	4 / 8574 (0.05%)
occurrences causally related to treatment / all	0 / 6	0 / 4
deaths causally related to treatment / all	0 / 1	0 / 0
Lumbosacral radiculopathy
subjects affected / exposed	0 / 8569 (0.00%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Medication overuse headache
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Memory impairment
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Metabolic encephalopathy
subjects affected / exposed	3 / 8569 (0.04%)	4 / 8574 (0.05%)
occurrences causally related to treatment / all	0 / 3	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Migraine
subjects affected / exposed	2 / 8569 (0.02%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Multiple system atrophy
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
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	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Muscle contractions involuntary
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Myelopathy
subjects affected / exposed	1 / 8569 (0.01%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Nerve compression
subjects affected / exposed	1 / 8569 (0.01%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Nervous system disorder
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Neuralgia
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Neurological symptom
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Neurodegenerative disorder
subjects affected / exposed	0 / 8569 (0.00%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Neuropathy peripheral
subjects affected / exposed	1 / 8569 (0.01%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Normal pressure hydrocephalus
subjects affected / exposed	1 / 8569 (0.01%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Occipital neuralgia
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Paraparesis
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Paraesthesia
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Parkinson's disease
subjects affected / exposed	3 / 8569 (0.04%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 6	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Partial seizures
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Peroneal nerve palsy
subjects affected / exposed	1 / 8569 (0.01%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Polyneuropathy
subjects affected / exposed	2 / 8569 (0.02%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Post herpetic neuralgia
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Presyncope
subjects affected / exposed	3 / 8569 (0.04%)	3 / 8574 (0.03%)
occurrences causally related to treatment / all	0 / 3	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Postictal paralysis
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Quadriplegia
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Radicular pain
subjects affected / exposed	2 / 8569 (0.02%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Radicular syndrome
subjects affected / exposed	2 / 8569 (0.02%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Radiculopathy
subjects affected / exposed	1 / 8569 (0.01%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Ruptured cerebral aneurysm
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Sciatica
subjects affected / exposed	7 / 8569 (0.08%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 7	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Seizure
subjects affected / exposed	10 / 8569 (0.12%)	5 / 8574 (0.06%)
occurrences causally related to treatment / all	1 / 10	1 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Simple partial seizures
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Somnolence
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (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 / 8569 (0.01%)	0 / 8574 (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 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Stiff person syndrome
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Status epilepticus
subjects affected / exposed	1 / 8569 (0.01%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Subdural hygroma
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Stroke in evolution
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Syncope
subjects affected / exposed	41 / 8569 (0.48%)	37 / 8574 (0.43%)
occurrences causally related to treatment / all	2 / 44	3 / 38
deaths causally related to treatment / all	0 / 0	0 / 0
Thalamic infarction
subjects affected / exposed	2 / 8569 (0.02%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Thoracic outlet syndrome
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Tension headache
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Toxic encephalopathy
subjects affected / exposed	0 / 8569 (0.00%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Thrombotic stroke
subjects affected / exposed	3 / 8569 (0.04%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	1 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 1
Thrombotic cerebral infarction
subjects affected / exposed	0 / 8569 (0.00%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Toxic neuropathy
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Tremor
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Transient ischaemic attack
subjects affected / exposed	54 / 8569 (0.63%)	68 / 8574 (0.79%)
occurrences causally related to treatment / all	1 / 59	1 / 76
deaths causally related to treatment / all	0 / 1	0 / 0
Vascular encephalopathy
subjects affected / exposed	2 / 8569 (0.02%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Vascular dementia
subjects affected / exposed	2 / 8569 (0.02%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Vertebral artery stenosis
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Vocal cord paralysis
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Vertebrobasilar insufficiency
subjects affected / exposed	5 / 8569 (0.06%)	4 / 8574 (0.05%)
occurrences causally related to treatment / all	0 / 5	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Dementia Alzheimer's type
subjects affected / exposed	0 / 8569 (0.00%)	3 / 8574 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Dementia with Lewy bodies
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Guillain-Barre syndrome
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
IIIrd nerve paralysis
subjects affected / exposed	1 / 8569 (0.01%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
VIth nerve paralysis
subjects affected / exposed	1 / 8569 (0.01%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
VIth nerve paresis
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (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	2 / 8569 (0.02%)	3 / 8574 (0.03%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Wernicke-Korsakoff syndrome
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (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
Agranulocytosis
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Anaemia
subjects affected / exposed	28 / 8569 (0.33%)	20 / 8574 (0.23%)
occurrences causally related to treatment / all	0 / 30	0 / 20
deaths causally related to treatment / all	0 / 0	0 / 0
Anaemia of chronic disease
subjects affected / exposed	3 / 8569 (0.04%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Coagulopathy
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Disseminated intravascular coagulation
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Elephantiasis
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hilar lymphadenopathy
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Haemorrhagic anaemia
subjects affected / exposed	4 / 8569 (0.05%)	3 / 8574 (0.03%)
occurrences causally related to treatment / all	0 / 4	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Febrile neutropenia
subjects affected / exposed	4 / 8569 (0.05%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 4	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Immune thrombocytopenic purpura
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Iron deficiency anaemia
subjects affected / exposed	18 / 8569 (0.21%)	12 / 8574 (0.14%)
occurrences causally related to treatment / all	0 / 18	0 / 14
deaths causally related to treatment / all	0 / 0	0 / 0
Lymphadenopathy
subjects affected / exposed	1 / 8569 (0.01%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Lymphadenopathy mediastinal
subjects affected / exposed	0 / 8569 (0.00%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Leukocytosis
subjects affected / exposed	1 / 8569 (0.01%)	4 / 8574 (0.05%)
occurrences causally related to treatment / all	0 / 1	1 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Neutropenia
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Normocytic anaemia
subjects affected / exposed	1 / 8569 (0.01%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Microcytic anaemia
subjects affected / exposed	3 / 8569 (0.04%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Plasmacytosis
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pancytopenia
subjects affected / exposed	1 / 8569 (0.01%)	3 / 8574 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Splenic cyst
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Splenic infarction
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Thrombocytopenic purpura
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Thrombocytopenia
subjects affected / exposed	3 / 8569 (0.04%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 4	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Anaemia vitamin B12 deficiency
subjects affected / exposed	2 / 8569 (0.02%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Ear and labyrinth disorders
Acute vestibular syndrome
subjects affected / exposed	3 / 8569 (0.04%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Deafness neurosensory
subjects affected / exposed	1 / 8569 (0.01%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Hypoacusis
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Sudden hearing loss
subjects affected / exposed	1 / 8569 (0.01%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Tinnitus
subjects affected / exposed	1 / 8569 (0.01%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Vertigo
subjects affected / exposed	12 / 8569 (0.14%)	11 / 8574 (0.13%)
occurrences causally related to treatment / all	0 / 13	0 / 11
deaths causally related to treatment / all	0 / 0	0 / 0
Vertigo labyrinthine
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Vertigo positional
subjects affected / exposed	8 / 8569 (0.09%)	5 / 8574 (0.06%)
occurrences causally related to treatment / all	1 / 8	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Vestibular ataxia
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Vestibular disorder
subjects affected / exposed	3 / 8569 (0.04%)	3 / 8574 (0.03%)
occurrences causally related to treatment / all	0 / 3	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Eye disorders
Amaurosis
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Amblyopia
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Amaurosis fugax
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Blindness transient
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Astigmatism
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cataract
subjects affected / exposed	26 / 8569 (0.30%)	28 / 8574 (0.33%)
occurrences causally related to treatment / all	0 / 32	0 / 31
deaths causally related to treatment / all	0 / 0	0 / 0
Cataract nuclear
subjects affected / exposed	2 / 8569 (0.02%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cataract subcapsular
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Corneal deposits
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Dacryostenosis acquired
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Diabetic retinal oedema
subjects affected / exposed	1 / 8569 (0.01%)	3 / 8574 (0.03%)
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	2 / 8569 (0.02%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Diplopia
subjects affected / exposed	3 / 8569 (0.04%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Endocrine ophthalmopathy
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Exophthalmos
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Glaucoma
subjects affected / exposed	2 / 8569 (0.02%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Eye haemorrhage
subjects affected / exposed	1 / 8569 (0.01%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Iridocyclitis
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Iritis
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Lagophthalmos
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Macular fibrosis
subjects affected / exposed	1 / 8569 (0.01%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Macular degeneration
subjects affected / exposed	0 / 8569 (0.00%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Macular oedema
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Maculopathy
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Retinal artery occlusion
subjects affected / exposed	0 / 8569 (0.00%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Retinal detachment
subjects affected / exposed	4 / 8569 (0.05%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 6	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Retinal haemorrhage
subjects affected / exposed	1 / 8569 (0.01%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	1 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Retinal tear
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Retinal vascular occlusion
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Tractional retinal detachment
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Retinal vein occlusion
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Ulcerative keratitis
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Vision blurred
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Visual impairment
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Vitreous haemorrhage
subjects affected / exposed	6 / 8569 (0.07%)	4 / 8574 (0.05%)
occurrences causally related to treatment / all	0 / 7	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Tolosa-Hunt syndrome
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal disorders
Abdominal discomfort
subjects affected / exposed	2 / 8569 (0.02%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Abdominal adhesions
subjects affected / exposed	2 / 8569 (0.02%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Abdominal incarcerated hernia
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Abdominal hernia
subjects affected / exposed	7 / 8569 (0.08%)	4 / 8574 (0.05%)
occurrences causally related to treatment / all	0 / 7	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Abdominal hernia obstructive
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Abdominal pain lower
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Abdominal pain
subjects affected / exposed	9 / 8569 (0.11%)	13 / 8574 (0.15%)
occurrences causally related to treatment / all	0 / 9	0 / 13
deaths causally related to treatment / all	0 / 0	0 / 0
Abdominal pain upper
subjects affected / exposed	5 / 8569 (0.06%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 7	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Acute haemorrhagic ulcerative colitis
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Alcoholic pancreatitis
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Anal fissure
subjects affected / exposed	0 / 8569 (0.00%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Ascites
subjects affected / exposed	1 / 8569 (0.01%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Anal fistula
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Barrett's oesophagus
subjects affected / exposed	0 / 8569 (0.00%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Colitis
subjects affected / exposed	11 / 8569 (0.13%)	5 / 8574 (0.06%)
occurrences causally related to treatment / all	0 / 11	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Colitis microscopic
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Colitis ischaemic
subjects affected / exposed	2 / 8569 (0.02%)	7 / 8574 (0.08%)
occurrences causally related to treatment / all	0 / 2	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
Constipation
subjects affected / exposed	3 / 8569 (0.04%)	13 / 8574 (0.15%)
occurrences causally related to treatment / all	0 / 3	0 / 14
deaths causally related to treatment / all	0 / 0	0 / 0
Colitis ulcerative
subjects affected / exposed	2 / 8569 (0.02%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Diabetic gastroenteropathy
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Diabetic gastroparesis
subjects affected / exposed	2 / 8569 (0.02%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Dieulafoy's vascular malformation
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Diarrhoea
subjects affected / exposed	11 / 8569 (0.13%)	10 / 8574 (0.12%)
occurrences causally related to treatment / all	1 / 11	0 / 11
deaths causally related to treatment / all	0 / 0	0 / 0
Diverticulum intestinal haemorrhagic
subjects affected / exposed	1 / 8569 (0.01%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Diverticulum
subjects affected / exposed	2 / 8569 (0.02%)	5 / 8574 (0.06%)
occurrences causally related to treatment / all	0 / 2	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Duodenal ulcer haemorrhage
subjects affected / exposed	2 / 8569 (0.02%)	4 / 8574 (0.05%)
occurrences causally related to treatment / all	0 / 2	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Duodenal ulcer
subjects affected / exposed	3 / 8569 (0.04%)	3 / 8574 (0.03%)
occurrences causally related to treatment / all	0 / 3	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Duodenal ulcer perforation
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Duodenitis
subjects affected / exposed	1 / 8569 (0.01%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Dyspepsia
subjects affected / exposed	1 / 8569 (0.01%)	3 / 8574 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Dysphagia
subjects affected / exposed	2 / 8569 (0.02%)	5 / 8574 (0.06%)
occurrences causally related to treatment / all	0 / 2	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Enteritis
subjects affected / exposed	2 / 8569 (0.02%)	3 / 8574 (0.03%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Enterocolitis
subjects affected / exposed	1 / 8569 (0.01%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Enterocutaneous fistula
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Enterovesical fistula
subjects affected / exposed	1 / 8569 (0.01%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Epigastric discomfort
subjects affected / exposed	1 / 8569 (0.01%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Epiploic appendagitis
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Faecaloma
subjects affected / exposed	0 / 8569 (0.00%)	4 / 8574 (0.05%)
occurrences causally related to treatment / all	0 / 0	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Faeces discoloured
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Food poisoning
subjects affected / exposed	3 / 8569 (0.04%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Gastric haemorrhage
subjects affected / exposed	2 / 8569 (0.02%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 1	0 / 0
Gastric perforation
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastric polyps
subjects affected / exposed	2 / 8569 (0.02%)	3 / 8574 (0.03%)
occurrences causally related to treatment / all	0 / 2	1 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Gastric stenosis
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastric ulcer
subjects affected / exposed	11 / 8569 (0.13%)	9 / 8574 (0.10%)
occurrences causally related to treatment / all	0 / 11	0 / 9
deaths causally related to treatment / all	0 / 0	0 / 0
Gastric ulcer haemorrhage
subjects affected / exposed	2 / 8569 (0.02%)	4 / 8574 (0.05%)
occurrences causally related to treatment / all	0 / 2	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Gastritis
subjects affected / exposed	20 / 8569 (0.23%)	13 / 8574 (0.15%)
occurrences causally related to treatment / all	1 / 20	0 / 15
deaths causally related to treatment / all	0 / 0	0 / 0
Gastritis erosive
subjects affected / exposed	1 / 8569 (0.01%)	3 / 8574 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Gastroduodenitis
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal angiodysplasia
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal haemorrhage
subjects affected / exposed	18 / 8569 (0.21%)	17 / 8574 (0.20%)
occurrences causally related to treatment / all	0 / 18	0 / 18
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal inflammation
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal necrosis
subjects affected / exposed	0 / 8569 (0.00%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal obstruction
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal perforation
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal ulcer haemorrhage
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrooesophageal reflux disease
subjects affected / exposed	10 / 8569 (0.12%)	3 / 8574 (0.03%)
occurrences causally related to treatment / all	0 / 10	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Gingival bleeding
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Haematemesis
subjects affected / exposed	3 / 8569 (0.04%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Haematochezia
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Haemorrhoidal haemorrhage
subjects affected / exposed	2 / 8569 (0.02%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Haemorrhoids
subjects affected / exposed	3 / 8569 (0.04%)	4 / 8574 (0.05%)
occurrences causally related to treatment / all	0 / 3	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Hernial eventration
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hiatus hernia
subjects affected / exposed	3 / 8569 (0.04%)	4 / 8574 (0.05%)
occurrences causally related to treatment / all	0 / 3	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Ileus
subjects affected / exposed	4 / 8569 (0.05%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 4	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Ileus paralytic
subjects affected / exposed	1 / 8569 (0.01%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Impaired gastric emptying
subjects affected / exposed	2 / 8569 (0.02%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Incarcerated umbilical hernia
subjects affected / exposed	1 / 8569 (0.01%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Inguinal hernia
subjects affected / exposed	13 / 8569 (0.15%)	10 / 8574 (0.12%)
occurrences causally related to treatment / all	0 / 13	0 / 11
deaths causally related to treatment / all	0 / 0	0 / 0
Intestinal fibrosis
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Intestinal haemorrhage
subjects affected / exposed	2 / 8569 (0.02%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Intestinal infarction
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Intestinal ischaemia
subjects affected / exposed	1 / 8569 (0.01%)	4 / 8574 (0.05%)
occurrences causally related to treatment / all	0 / 1	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Intestinal perforation
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Intestinal obstruction
subjects affected / exposed	4 / 8569 (0.05%)	3 / 8574 (0.03%)
occurrences causally related to treatment / all	0 / 4	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Intestinal polyp
subjects affected / exposed	0 / 8569 (0.00%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Intestinal pseudo-obstruction
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Intra-abdominal fluid collection
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Jejunal perforation
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Intra-abdominal haemorrhage
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Intussusception
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Large intestinal ulcer
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Large intestinal ulcer haemorrhage
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Large intestine perforation
subjects affected / exposed	2 / 8569 (0.02%)	3 / 8574 (0.03%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Large intestine polyp
subjects affected / exposed	9 / 8569 (0.11%)	12 / 8574 (0.14%)
occurrences causally related to treatment / all	0 / 9	0 / 12
deaths causally related to treatment / all	0 / 0	0 / 0
Lower gastrointestinal haemorrhage
subjects affected / exposed	2 / 8569 (0.02%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 1	0 / 0
Lumbar hernia
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Melaena
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Mesenteric artery embolism
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Mesenteric artery stenosis
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Nausea
subjects affected / exposed	2 / 8569 (0.02%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Mesenteric panniculitis
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Mesenteric vascular insufficiency
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Obstruction gastric
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Obstructive pancreatitis
subjects affected / exposed	2 / 8569 (0.02%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Odynophagia
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Oesophageal food impaction
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Oesophageal obstruction
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Oesophageal perforation
subjects affected / exposed	0 / 8569 (0.00%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Oesophageal ulcer
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Oesophageal varices haemorrhage
subjects affected / exposed	2 / 8569 (0.02%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Oesophagitis
subjects affected / exposed	1 / 8569 (0.01%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Pancreatic cyst
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Oesophagitis ulcerative
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Palatal oedema
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pancreatic duct obstruction
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pancreatic pseudocyst
subjects affected / exposed	1 / 8569 (0.01%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	1 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Pancreatic necrosis
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pancreatitis
subjects affected / exposed	12 / 8569 (0.14%)	12 / 8574 (0.14%)
occurrences causally related to treatment / all	1 / 12	1 / 12
deaths causally related to treatment / all	0 / 1	0 / 0
Pancreatitis acute
subjects affected / exposed	15 / 8569 (0.18%)	13 / 8574 (0.15%)
occurrences causally related to treatment / all	1 / 17	0 / 13
deaths causally related to treatment / all	0 / 0	0 / 1
Pancreatitis relapsing
subjects affected / exposed	2 / 8569 (0.02%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pancreatitis chronic
subjects affected / exposed	1 / 8569 (0.01%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Pancreatitis necrotising
subjects affected / exposed	0 / 8569 (0.00%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Peptic ulcer haemorrhage
subjects affected / exposed	2 / 8569 (0.02%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Peptic ulcer
subjects affected / exposed	2 / 8569 (0.02%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	1 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Pancreatolithiasis
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Periodontal disease
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Peritoneal adhesions
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Proctitis
subjects affected / exposed	1 / 8569 (0.01%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumoperitoneum
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Portal hypertensive gastropathy
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Rectal haemorrhage
subjects affected / exposed	2 / 8569 (0.02%)	5 / 8574 (0.06%)
occurrences causally related to treatment / all	0 / 2	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Retroperitoneal haematoma
subjects affected / exposed	2 / 8569 (0.02%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 0
Retroperitoneal haemorrhage
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Salivary gland cyst
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Small intestinal obstruction
subjects affected / exposed	9 / 8569 (0.11%)	10 / 8574 (0.12%)
occurrences causally related to treatment / all	0 / 9	0 / 10
deaths causally related to treatment / all	0 / 0	0 / 0
Small intestinal haemorrhage
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Small intestine ulcer
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Small intestinal perforation
subjects affected / exposed	0 / 8569 (0.00%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Steatorrhoea
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Thrombosis mesenteric vessel
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Umbilical hernia
subjects affected / exposed	9 / 8569 (0.11%)	5 / 8574 (0.06%)
occurrences causally related to treatment / all	0 / 10	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Vomiting
subjects affected / exposed	9 / 8569 (0.11%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 9	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Varices oesophageal
subjects affected / exposed	2 / 8569 (0.02%)	3 / 8574 (0.03%)
occurrences causally related to treatment / all	0 / 3	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 1
Upper gastrointestinal haemorrhage
subjects affected / exposed	8 / 8569 (0.09%)	3 / 8574 (0.03%)
occurrences causally related to treatment / all	0 / 8	0 / 3
deaths causally related to treatment / all	0 / 1	0 / 0
Mallory-Weiss syndrome
subjects affected / exposed	0 / 8569 (0.00%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Skin and subcutaneous tissue disorders
Actinic keratosis
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Angioedema
subjects affected / exposed	2 / 8569 (0.02%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Decubitus ulcer
subjects affected / exposed	3 / 8569 (0.04%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 3	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Dermal cyst
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Dermatitis contact
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Diabetic bullosis
subjects affected / exposed	0 / 8569 (0.00%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Diabetic foot
subjects affected / exposed	29 / 8569 (0.34%)	37 / 8574 (0.43%)
occurrences causally related to treatment / all	0 / 34	0 / 45
deaths causally related to treatment / all	0 / 0	0 / 0
Diabetic ulcer
subjects affected / exposed	0 / 8569 (0.00%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Eczema
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Erythema multiforme
subjects affected / exposed	0 / 8569 (0.00%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Fixed eruption
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hidradenitis
subjects affected / exposed	1 / 8569 (0.01%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hypersensitivity vasculitis
subjects affected / exposed	2 / 8569 (0.02%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Ischaemic skin ulcer
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Keloid scar
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Lichen planus
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Lichen sclerosus
subjects affected / exposed	2 / 8569 (0.02%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Melanocytic hyperplasia
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Neuropathic ulcer
subjects affected / exposed	1 / 8569 (0.01%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Purpura
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pyoderma gangrenosum
subjects affected / exposed	0 / 8569 (0.00%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Skin swelling
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Skin ulcer
subjects affected / exposed	23 / 8569 (0.27%)	24 / 8574 (0.28%)
occurrences causally related to treatment / all	0 / 26	1 / 28
deaths causally related to treatment / all	0 / 0	0 / 0
Stasis dermatitis
subjects affected / exposed	3 / 8569 (0.04%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Toxic skin eruption
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Urticaria
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Henoch-Schonlein purpura
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Renal and urinary disorders
Acute kidney injury
subjects affected / exposed	127 / 8569 (1.48%)	94 / 8574 (1.10%)
occurrences causally related to treatment / all	21 / 152	10 / 96
deaths causally related to treatment / all	1 / 6	1 / 4
Azotaemia
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Bladder disorder
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Bladder outlet obstruction
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Bladder perforation
subjects affected / exposed	2 / 8569 (0.02%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Bladder mass
subjects affected / exposed	1 / 8569 (0.01%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Bladder prolapse
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Calculus urethral
subjects affected / exposed	2 / 8569 (0.02%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Calculus bladder
subjects affected / exposed	6 / 8569 (0.07%)	5 / 8574 (0.06%)
occurrences causally related to treatment / all	0 / 6	0 / 5
deaths causally related to treatment / all	0 / 1	0 / 0
Calculus urinary
subjects affected / exposed	4 / 8569 (0.05%)	4 / 8574 (0.05%)
occurrences causally related to treatment / all	1 / 4	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Chronic kidney disease
subjects affected / exposed	13 / 8569 (0.15%)	9 / 8574 (0.10%)
occurrences causally related to treatment / all	1 / 17	1 / 10
deaths causally related to treatment / all	0 / 2	0 / 0
Cystitis glandularis
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cystitis noninfective
subjects affected / exposed	0 / 8569 (0.00%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Cystitis haemorrhagic
subjects affected / exposed	1 / 8569 (0.01%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Cystitis ulcerative
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
End stage renal disease
subjects affected / exposed	7 / 8569 (0.08%)	3 / 8574 (0.03%)
occurrences causally related to treatment / all	1 / 8	0 / 3
deaths causally related to treatment / all	1 / 3	0 / 0
Dysuria
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Diabetic nephropathy
subjects affected / exposed	2 / 8569 (0.02%)	3 / 8574 (0.03%)
occurrences causally related to treatment / all	0 / 3	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 1
Glomerulonephritis
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Haematuria
subjects affected / exposed	16 / 8569 (0.19%)	4 / 8574 (0.05%)
occurrences causally related to treatment / all	0 / 19	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Hydronephrosis
subjects affected / exposed	6 / 8569 (0.07%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 6	1 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Lower urinary tract symptoms
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Myeloma cast nephropathy
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Ketonuria
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Nephrolithiasis
subjects affected / exposed	18 / 8569 (0.21%)	14 / 8574 (0.16%)
occurrences causally related to treatment / all	0 / 18	0 / 16
deaths causally related to treatment / all	0 / 0	0 / 0
Oedematous kidney
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Nephrotic syndrome
subjects affected / exposed	3 / 8569 (0.04%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pelvi-ureteric obstruction
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Proteinuria
subjects affected / exposed	1 / 8569 (0.01%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 1	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pollakiuria
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Renal artery stenosis
subjects affected / exposed	1 / 8569 (0.01%)	3 / 8574 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Renal colic
subjects affected / exposed	5 / 8569 (0.06%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	1 / 5	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Renal cyst
subjects affected / exposed	2 / 8569 (0.02%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Renal cyst ruptured
subjects affected / exposed	1 / 8569 (0.01%)	1 / 8574 (0.01%)
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	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Renal failure
subjects affected / exposed	17 / 8569 (0.20%)	10 / 8574 (0.12%)
occurrences causally related to treatment / all	1 / 17	2 / 11
deaths causally related to treatment / all	0 / 2	0 / 1
Renal haematoma
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Renal impairment
subjects affected / exposed	12 / 8569 (0.14%)	3 / 8574 (0.03%)
occurrences causally related to treatment / all	2 / 12	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Renal infarct
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Renal injury
subjects affected / exposed	1 / 8569 (0.01%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Renal tubular acidosis
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Renal tubular necrosis
subjects affected / exposed	3 / 8569 (0.04%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	1 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Stress urinary incontinence
subjects affected / exposed	2 / 8569 (0.02%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Ureteric stenosis
subjects affected / exposed	0 / 8569 (0.00%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Ureterolithiasis
subjects affected / exposed	17 / 8569 (0.20%)	5 / 8574 (0.06%)
occurrences causally related to treatment / all	1 / 21	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
Urethral meatus stenosis
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Urethral obstruction
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Urethral stenosis
subjects affected / exposed	5 / 8569 (0.06%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 6	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Urinary bladder haemorrhage
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Urinary bladder polyp
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Urinary incontinence
subjects affected / exposed	1 / 8569 (0.01%)	3 / 8574 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Urinary retention
subjects affected / exposed	10 / 8569 (0.12%)	8 / 8574 (0.09%)
occurrences causally related to treatment / all	1 / 10	1 / 8
deaths causally related to treatment / all	0 / 0	0 / 0
Urinary tract obstruction
subjects affected / exposed	0 / 8569 (0.00%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Endocrine disorders
Adrenal insufficiency
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Adrenal mass
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Adrenomegaly
subjects affected / exposed	2 / 8569 (0.02%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Basedow's disease
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Goitre
subjects affected / exposed	8 / 8569 (0.09%)	7 / 8574 (0.08%)
occurrences causally related to treatment / all	0 / 8	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
Hyperadrenalism
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hyperparathyroidism
subjects affected / exposed	1 / 8569 (0.01%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Hypopituitarism
subjects affected / exposed	1 / 8569 (0.01%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hyperparathyroidism primary
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Thyroid mass
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Toxic nodular goitre
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Musculoskeletal and connective tissue disorders
Arthritis
subjects affected / exposed	9 / 8569 (0.11%)	14 / 8574 (0.16%)
occurrences causally related to treatment / all	0 / 9	0 / 14
deaths causally related to treatment / all	0 / 0	0 / 0
Arthralgia
subjects affected / exposed	2 / 8569 (0.02%)	7 / 8574 (0.08%)
occurrences causally related to treatment / all	0 / 2	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
Articular calcification
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Arthropathy
subjects affected / exposed	1 / 8569 (0.01%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Arthritis reactive
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cervical spinal stenosis
subjects affected / exposed	6 / 8569 (0.07%)	6 / 8574 (0.07%)
occurrences causally related to treatment / all	0 / 6	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Bursitis
subjects affected / exposed	3 / 8569 (0.04%)	5 / 8574 (0.06%)
occurrences causally related to treatment / all	0 / 3	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Back pain
subjects affected / exposed	9 / 8569 (0.11%)	5 / 8574 (0.06%)
occurrences causally related to treatment / all	0 / 9	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Chondromalacia
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Chondropathy
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Compartment syndrome
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Diastasis recti abdominis
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Costochondritis
subjects affected / exposed	0 / 8569 (0.00%)	3 / 8574 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Dupuytren's contracture
subjects affected / exposed	0 / 8569 (0.00%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Extraskeletal ossification
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Flank pain
subjects affected / exposed	1 / 8569 (0.01%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Facet joint syndrome
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Fasciitis
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Foot deformity
subjects affected / exposed	1 / 8569 (0.01%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Fracture malunion
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Fracture nonunion
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gouty arthritis
subjects affected / exposed	4 / 8569 (0.05%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 4	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Haemarthrosis
subjects affected / exposed	0 / 8569 (0.00%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Intervertebral disc compression
subjects affected / exposed	1 / 8569 (0.01%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Intervertebral disc degeneration
subjects affected / exposed	6 / 8569 (0.07%)	3 / 8574 (0.03%)
occurrences causally related to treatment / all	0 / 6	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Intervertebral disc disorder
subjects affected / exposed	3 / 8569 (0.04%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Intervertebral disc displacement
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
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	17 / 8569 (0.20%)	24 / 8574 (0.28%)
occurrences causally related to treatment / all	0 / 18	0 / 25
deaths causally related to treatment / all	0 / 0	0 / 0
Jaw cyst
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Ligament calcification
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Joint ankylosis
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Joint contracture
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Meniscal degeneration
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Lumbar spinal stenosis
subjects affected / exposed	18 / 8569 (0.21%)	14 / 8574 (0.16%)
occurrences causally related to treatment / all	0 / 18	0 / 15
deaths causally related to treatment / all	0 / 0	0 / 0
Muscle fibrosis
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Mobility decreased
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Muscle spasms
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Muscle haemorrhage
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Muscular weakness
subjects affected / exposed	6 / 8569 (0.07%)	5 / 8574 (0.06%)
occurrences causally related to treatment / all	0 / 6	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Musculoskeletal chest pain
subjects affected / exposed	24 / 8569 (0.28%)	12 / 8574 (0.14%)
occurrences causally related to treatment / all	0 / 25	0 / 12
deaths causally related to treatment / all	0 / 0	0 / 0
Myalgia
subjects affected / exposed	0 / 8569 (0.00%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Musculoskeletal pain
subjects affected / exposed	3 / 8569 (0.04%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Neuropathic arthropathy
subjects affected / exposed	1 / 8569 (0.01%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Myositis
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Neck pain
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Osteochondrosis
subjects affected / exposed	2 / 8569 (0.02%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Osteitis
subjects affected / exposed	4 / 8569 (0.05%)	3 / 8574 (0.03%)
occurrences causally related to treatment / all	0 / 4	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Osteoarthritis
subjects affected / exposed	92 / 8569 (1.07%)	103 / 8574 (1.20%)
occurrences causally related to treatment / all	0 / 102	1 / 114
deaths causally related to treatment / all	0 / 0	0 / 0
Osteonecrosis
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Osteoporosis
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Osteolysis
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Osteoporotic fracture
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pain in jaw
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pain in extremity
subjects affected / exposed	2 / 8569 (0.02%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Periarthritis
subjects affected / exposed	1 / 8569 (0.01%)	3 / 8574 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Pathological fracture
subjects affected / exposed	1 / 8569 (0.01%)	3 / 8574 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Patellofemoral pain syndrome
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Polyarthritis
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Polymyalgia rheumatica
subjects affected / exposed	3 / 8569 (0.04%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pseudarthrosis
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Rheumatoid arthritis
subjects affected / exposed	4 / 8569 (0.05%)	7 / 8574 (0.08%)
occurrences causally related to treatment / all	0 / 4	0 / 8
deaths causally related to treatment / all	0 / 0	0 / 1
Rhabdomyolysis
subjects affected / exposed	7 / 8569 (0.08%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 7	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Psoriatic arthropathy
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Sjogren's syndrome
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Spinal column stenosis
subjects affected / exposed	12 / 8569 (0.14%)	11 / 8574 (0.13%)
occurrences causally related to treatment / all	0 / 13	0 / 11
deaths causally related to treatment / all	0 / 0	0 / 0
Rotator cuff syndrome
subjects affected / exposed	16 / 8569 (0.19%)	4 / 8574 (0.05%)
occurrences causally related to treatment / all	0 / 16	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Spinal ligament ossification
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Spinal osteoarthritis
subjects affected / exposed	3 / 8569 (0.04%)	9 / 8574 (0.10%)
occurrences causally related to treatment / all	0 / 3	0 / 9
deaths causally related to treatment / all	0 / 0	0 / 0
Spondylolisthesis
subjects affected / exposed	5 / 8569 (0.06%)	3 / 8574 (0.03%)
occurrences causally related to treatment / all	0 / 6	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Spondylitis
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Spinal pain
subjects affected / exposed	2 / 8569 (0.02%)	4 / 8574 (0.05%)
occurrences causally related to treatment / all	0 / 2	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Tendonitis
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Synovial cyst
subjects affected / exposed	3 / 8569 (0.04%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Tenosynovitis
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Trigger finger
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Tenosynovitis stenosans
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Vertebral foraminal stenosis
subjects affected / exposed	0 / 8569 (0.00%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Vertebral lesion
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Immunoglobulin G4 related disease
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Infections and infestations
Abdominal abscess
subjects affected / exposed	2 / 8569 (0.02%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Abdominal sepsis
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Abdominal wall abscess
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Abscess
subjects affected / exposed	1 / 8569 (0.01%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Abscess limb
subjects affected / exposed	9 / 8569 (0.11%)	8 / 8574 (0.09%)
occurrences causally related to treatment / all	1 / 10	0 / 8
deaths causally related to treatment / all	0 / 0	0 / 0
Acquired immunodeficiency syndrome
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Acute endocarditis
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Acute sinusitis
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Amoebiasis
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Anal abscess
subjects affected / exposed	5 / 8569 (0.06%)	5 / 8574 (0.06%)
occurrences causally related to treatment / all	0 / 5	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Appendiceal abscess
subjects affected / exposed	1 / 8569 (0.01%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Appendicitis
subjects affected / exposed	12 / 8569 (0.14%)	12 / 8574 (0.14%)
occurrences causally related to treatment / all	0 / 12	0 / 12
deaths causally related to treatment / all	0 / 0	0 / 0
Appendicitis perforated
subjects affected / exposed	1 / 8569 (0.01%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Arthritis bacterial
subjects affected / exposed	11 / 8569 (0.13%)	6 / 8574 (0.07%)
occurrences causally related to treatment / all	0 / 13	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Arthritis infective
subjects affected / exposed	1 / 8569 (0.01%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Aspergilloma
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Atypical pneumonia
subjects affected / exposed	1 / 8569 (0.01%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Bacteraemia
subjects affected / exposed	3 / 8569 (0.04%)	6 / 8574 (0.07%)
occurrences causally related to treatment / all	0 / 3	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Bacterascites
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Bacterial colitis
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Bacterial sepsis
subjects affected / exposed	1 / 8569 (0.01%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Bacterial tracheitis
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Bacteriuria
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Beta haemolytic streptococcal infection
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Biliary sepsis
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Bone abscess
subjects affected / exposed	1 / 8569 (0.01%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Brain abscess
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Breast abscess
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Bronchitis
subjects affected / exposed	35 / 8569 (0.41%)	15 / 8574 (0.17%)
occurrences causally related to treatment / all	0 / 35	0 / 16
deaths causally related to treatment / all	0 / 0	0 / 0
Bronchitis bacterial
subjects affected / exposed	0 / 8569 (0.00%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Bronchitis viral
subjects affected / exposed	2 / 8569 (0.02%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Burn infection
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Bursitis infective
subjects affected / exposed	2 / 8569 (0.02%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Campylobacter gastroenteritis
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cellulitis
subjects affected / exposed	93 / 8569 (1.09%)	84 / 8574 (0.98%)
occurrences causally related to treatment / all	2 / 117	0 / 100
deaths causally related to treatment / all	0 / 0	0 / 0
Cellulitis gangrenous
subjects affected / exposed	1 / 8569 (0.01%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cellulitis of male external genital organ
subjects affected / exposed	1 / 8569 (0.01%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cellulitis orbital
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cellulitis staphylococcal
subjects affected / exposed	1 / 8569 (0.01%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Central nervous system infection
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Chest wall abscess
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cholecystitis infective
subjects affected / exposed	3 / 8569 (0.04%)	6 / 8574 (0.07%)
occurrences causally related to treatment / all	0 / 3	0 / 6
deaths causally related to treatment / all	0 / 1	0 / 0
Chronic sinusitis
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Clostridial sepsis
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Clostridium difficile colitis
subjects affected / exposed	2 / 8569 (0.02%)	7 / 8574 (0.08%)
occurrences causally related to treatment / all	0 / 2	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
Clostridium difficile infection
subjects affected / exposed	1 / 8569 (0.01%)	4 / 8574 (0.05%)
occurrences causally related to treatment / all	0 / 1	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 1
Cystitis
subjects affected / exposed	3 / 8569 (0.04%)	9 / 8574 (0.10%)
occurrences causally related to treatment / all	0 / 3	1 / 9
deaths causally related to treatment / all	0 / 0	0 / 0
Cytomegalovirus viraemia
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Dengue fever
subjects affected / exposed	3 / 8569 (0.04%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Diabetic foot infection
subjects affected / exposed	13 / 8569 (0.15%)	10 / 8574 (0.12%)
occurrences causally related to treatment / all	0 / 13	1 / 11
deaths causally related to treatment / all	0 / 1	0 / 0
Device related infection
subjects affected / exposed	2 / 8569 (0.02%)	4 / 8574 (0.05%)
occurrences causally related to treatment / all	0 / 2	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Diabetic gangrene
subjects affected / exposed	11 / 8569 (0.13%)	7 / 8574 (0.08%)
occurrences causally related to treatment / all	0 / 11	0 / 9
deaths causally related to treatment / all	0 / 0	0 / 0
Diarrhoea infectious
subjects affected / exposed	1 / 8569 (0.01%)	3 / 8574 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Diverticulitis
subjects affected / exposed	20 / 8569 (0.23%)	20 / 8574 (0.23%)
occurrences causally related to treatment / all	0 / 22	1 / 24
deaths causally related to treatment / all	0 / 0	0 / 0
Diverticulitis intestinal haemorrhagic
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Empyema
subjects affected / exposed	2 / 8569 (0.02%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Encephalitis
subjects affected / exposed	4 / 8569 (0.05%)	3 / 8574 (0.03%)
occurrences causally related to treatment / all	0 / 4	0 / 3
deaths causally related to treatment / all	0 / 3	0 / 0
Encephalomyelitis
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Endocarditis
subjects affected / exposed	2 / 8569 (0.02%)	4 / 8574 (0.05%)
occurrences causally related to treatment / all	0 / 2	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 1
Endocarditis bacterial
subjects affected / exposed	1 / 8569 (0.01%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Endocarditis enterococcal
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Endocarditis staphylococcal
subjects affected / exposed	1 / 8569 (0.01%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Endometritis
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Enteritis infectious
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Enterococcal bacteraemia
subjects affected / exposed	1 / 8569 (0.01%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Enterococcal sepsis
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Epididymitis
subjects affected / exposed	2 / 8569 (0.02%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	1 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Epiglottitis
subjects affected / exposed	2 / 8569 (0.02%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Escherichia bacteraemia
subjects affected / exposed	2 / 8569 (0.02%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	1 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Erysipelas
subjects affected / exposed	13 / 8569 (0.15%)	11 / 8574 (0.13%)
occurrences causally related to treatment / all	0 / 13	1 / 12
deaths causally related to treatment / all	0 / 0	0 / 0
Escherichia sepsis
subjects affected / exposed	0 / 8569 (0.00%)	4 / 8574 (0.05%)
occurrences causally related to treatment / all	0 / 0	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Escherichia urinary tract infection
subjects affected / exposed	3 / 8569 (0.04%)	3 / 8574 (0.03%)
occurrences causally related to treatment / all	1 / 3	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
External ear cellulitis
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Extradural abscess
subjects affected / exposed	3 / 8569 (0.04%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 4	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Fungal infection
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gangrene
subjects affected / exposed	30 / 8569 (0.35%)	22 / 8574 (0.26%)
occurrences causally related to treatment / all	0 / 40	0 / 23
deaths causally related to treatment / all	0 / 0	0 / 0
Gas gangrene
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastric infection
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastroenteritis
subjects affected / exposed	27 / 8569 (0.32%)	26 / 8574 (0.30%)
occurrences causally related to treatment / all	0 / 27	2 / 27
deaths causally related to treatment / all	0 / 0	0 / 0
Gastroenteritis norovirus
subjects affected / exposed	1 / 8569 (0.01%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastroenteritis rotavirus
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastroenteritis salmonella
subjects affected / exposed	1 / 8569 (0.01%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastroenteritis viral
subjects affected / exposed	5 / 8569 (0.06%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 5	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Groin abscess
subjects affected / exposed	2 / 8569 (0.02%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Giardiasis
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Helicobacter infection
subjects affected / exposed	2 / 8569 (0.02%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Haematoma infection
subjects affected / exposed	2 / 8569 (0.02%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatitis viral
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Herpes zoster
subjects affected / exposed	3 / 8569 (0.04%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Human anaplasmosis
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Implant site infection
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Infected skin ulcer
subjects affected / exposed	3 / 8569 (0.04%)	4 / 8574 (0.05%)
occurrences causally related to treatment / all	0 / 3	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Infection
subjects affected / exposed	6 / 8569 (0.07%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 6	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Infectious colitis
subjects affected / exposed	2 / 8569 (0.02%)	3 / 8574 (0.03%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Infective exacerbation of chronic obstructive airways disease
subjects affected / exposed	1 / 8569 (0.01%)	3 / 8574 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Infective gastroduodenitis
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Influenza
subjects affected / exposed	15 / 8569 (0.18%)	17 / 8574 (0.20%)
occurrences causally related to treatment / all	0 / 15	0 / 17
deaths causally related to treatment / all	0 / 0	0 / 0
Intervertebral discitis
subjects affected / exposed	4 / 8569 (0.05%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 4	0 / 2
deaths causally related to treatment / all	0 / 1	0 / 0
Klebsiella bacteraemia
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (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 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Legionella infection
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Liver abscess
subjects affected / exposed	4 / 8569 (0.05%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 4	0 / 2
deaths causally related to treatment / all	0 / 1	0 / 2
Localised infection
subjects affected / exposed	10 / 8569 (0.12%)	16 / 8574 (0.19%)
occurrences causally related to treatment / all	0 / 11	0 / 16
deaths causally related to treatment / all	0 / 1	0 / 0
Lower respiratory tract infection
subjects affected / exposed	10 / 8569 (0.12%)	9 / 8574 (0.10%)
occurrences causally related to treatment / all	0 / 10	0 / 11
deaths causally related to treatment / all	0 / 0	0 / 0
Lung abscess
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Lung infection
subjects affected / exposed	2 / 8569 (0.02%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Lyme disease
subjects affected / exposed	2 / 8569 (0.02%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Mastitis
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Malaria
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Mastoiditis
subjects affected / exposed	1 / 8569 (0.01%)	3 / 8574 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Mediastinitis
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (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 abscess
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (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 / 8569 (0.01%)	0 / 8574 (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	2 / 8569 (0.02%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Meningitis
subjects affected / exposed	1 / 8569 (0.01%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Meningitis aseptic
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Meningitis pneumococcal
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Meningitis viral
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Mucormycosis
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Muscle abscess
subjects affected / exposed	0 / 8569 (0.00%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Necrotising fasciitis
subjects affected / exposed	5 / 8569 (0.06%)	4 / 8574 (0.05%)
occurrences causally related to treatment / all	1 / 5	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Neurosyphilis
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Neutropenic sepsis
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Oesophageal candidiasis
subjects affected / exposed	0 / 8569 (0.00%)	3 / 8574 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Onychomycosis
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Oral candidiasis
subjects affected / exposed	0 / 8569 (0.00%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Orchitis
subjects affected / exposed	3 / 8569 (0.04%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Oropharyngeal candidiasis
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Osteomyelitis
subjects affected / exposed	39 / 8569 (0.46%)	26 / 8574 (0.30%)
occurrences causally related to treatment / all	1 / 46	0 / 35
deaths causally related to treatment / all	0 / 0	0 / 0
Osteomyelitis acute
subjects affected / exposed	3 / 8569 (0.04%)	3 / 8574 (0.03%)
occurrences causally related to treatment / all	0 / 3	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Osteomyelitis chronic
subjects affected / exposed	3 / 8569 (0.04%)	4 / 8574 (0.05%)
occurrences causally related to treatment / all	0 / 3	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Otitis externa
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Otitis media
subjects affected / exposed	0 / 8569 (0.00%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Otitis media chronic
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pancreatic abscess
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Parainfluenzae virus infection
subjects affected / exposed	0 / 8569 (0.00%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Parotitis
subjects affected / exposed	3 / 8569 (0.04%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pelvic abscess
subjects affected / exposed	0 / 8569 (0.00%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Pelvic inflammatory disease
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Perineal abscess
subjects affected / exposed	1 / 8569 (0.01%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Perinephric abscess
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Periodontitis
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Peritonitis
subjects affected / exposed	5 / 8569 (0.06%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 5	0 / 2
deaths causally related to treatment / all	0 / 2	0 / 2
Peritonitis bacterial
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Peritonsillar abscess
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pharyngitis
subjects affected / exposed	2 / 8569 (0.02%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pleurisy viral
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumococcal infection
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Pneumococcal sepsis
subjects affected / exposed	0 / 8569 (0.00%)	4 / 8574 (0.05%)
occurrences causally related to treatment / all	0 / 0	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumonia
subjects affected / exposed	219 / 8569 (2.56%)	194 / 8574 (2.26%)
occurrences causally related to treatment / all	3 / 246	2 / 212
deaths causally related to treatment / all	1 / 21	0 / 10
Pneumonia bacterial
subjects affected / exposed	5 / 8569 (0.06%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 5	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Pneumonia pneumococcal
subjects affected / exposed	1 / 8569 (0.01%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumonia respiratory syncytial viral
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumonia staphylococcal
subjects affected / exposed	0 / 8569 (0.00%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumonia streptococcal
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumonia viral
subjects affected / exposed	4 / 8569 (0.05%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 4	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Post procedural cellulitis
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Post procedural infection
subjects affected / exposed	5 / 8569 (0.06%)	9 / 8574 (0.10%)
occurrences causally related to treatment / all	0 / 5	0 / 9
deaths causally related to treatment / all	0 / 0	0 / 0
Postoperative abscess
subjects affected / exposed	1 / 8569 (0.01%)	3 / 8574 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Postoperative wound infection
subjects affected / exposed	13 / 8569 (0.15%)	11 / 8574 (0.13%)
occurrences causally related to treatment / all	0 / 13	0 / 11
deaths causally related to treatment / all	0 / 0	0 / 0
Prostatic abscess
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pulmonary sepsis
subjects affected / exposed	1 / 8569 (0.01%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Pulmonary tuberculosis
subjects affected / exposed	3 / 8569 (0.04%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pyelitis
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pyelonephritis
subjects affected / exposed	14 / 8569 (0.16%)	14 / 8574 (0.16%)
occurrences causally related to treatment / all	9 / 15	0 / 14
deaths causally related to treatment / all	0 / 0	0 / 0
Pyelonephritis acute
subjects affected / exposed	15 / 8569 (0.18%)	10 / 8574 (0.12%)
occurrences causally related to treatment / all	5 / 15	3 / 10
deaths causally related to treatment / all	0 / 0	0 / 0
Pyelonephritis chronic
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Rectal abscess
subjects affected / exposed	3 / 8569 (0.04%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Renal abscess
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (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	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Respiratory syncytial virus bronchitis
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Respiratory syncytial virus infection
subjects affected / exposed	1 / 8569 (0.01%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Respiratory tract infection
subjects affected / exposed	5 / 8569 (0.06%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 7	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 0
Retroperitoneal abscess
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Rhinitis
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Rickettsiosis
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Rotavirus infection
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Salmonella bacteraemia
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Scrotal abscess
subjects affected / exposed	4 / 8569 (0.05%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 4	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Scrub typhus
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Sepsis
subjects affected / exposed	70 / 8569 (0.82%)	77 / 8574 (0.90%)
occurrences causally related to treatment / all	2 / 71	3 / 84
deaths causally related to treatment / all	0 / 10	0 / 14
Sepsis syndrome
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Septic arthritis staphylococcal
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Septic shock
subjects affected / exposed	24 / 8569 (0.28%)	21 / 8574 (0.24%)
occurrences causally related to treatment / all	1 / 27	0 / 22
deaths causally related to treatment / all	0 / 9	0 / 7
Sinusitis
subjects affected / exposed	2 / 8569 (0.02%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Sinusitis fungal
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Skin bacterial infection
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Skin infection
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Soft tissue infection
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Splenic abscess
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Staphylococcal abscess
subjects affected / exposed	1 / 8569 (0.01%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Staphylococcal bacteraemia
subjects affected / exposed	3 / 8569 (0.04%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	1 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Staphylococcal infection
subjects affected / exposed	3 / 8569 (0.04%)	4 / 8574 (0.05%)
occurrences causally related to treatment / all	0 / 3	1 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Staphylococcal sepsis
subjects affected / exposed	5 / 8569 (0.06%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 5	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Streptococcal abscess
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Streptococcal sepsis
subjects affected / exposed	1 / 8569 (0.01%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 0
Streptococcal bacteraemia
subjects affected / exposed	2 / 8569 (0.02%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Tick-borne fever
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Tonsillitis
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (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	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Tooth infection
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Tracheitis
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Tracheobronchitis
subjects affected / exposed	2 / 8569 (0.02%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Tuberculosis
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Upper respiratory tract infection
subjects affected / exposed	5 / 8569 (0.06%)	5 / 8574 (0.06%)
occurrences causally related to treatment / all	0 / 5	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Urinary tract infection
subjects affected / exposed	67 / 8569 (0.78%)	49 / 8574 (0.57%)
occurrences causally related to treatment / all	20 / 71	15 / 53
deaths causally related to treatment / all	0 / 0	0 / 0
Urinary tract infection bacterial
subjects affected / exposed	1 / 8569 (0.01%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Urinary tract infection enterococcal
subjects affected / exposed	2 / 8569 (0.02%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Urosepsis
subjects affected / exposed	25 / 8569 (0.29%)	22 / 8574 (0.26%)
occurrences causally related to treatment / all	9 / 26	9 / 23
deaths causally related to treatment / all	0 / 0	1 / 1
Vestibular neuronitis
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Viraemia
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Viral infection
subjects affected / exposed	7 / 8569 (0.08%)	5 / 8574 (0.06%)
occurrences causally related to treatment / all	0 / 8	1 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Viral sinusitis
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Viral myocarditis
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Viral upper respiratory tract infection
subjects affected / exposed	1 / 8569 (0.01%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Wound abscess
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Wound infection pseudomonas
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Wound infection
subjects affected / exposed	10 / 8569 (0.12%)	11 / 8574 (0.13%)
occurrences causally related to treatment / all	0 / 11	0 / 12
deaths causally related to treatment / all	0 / 0	0 / 1
Acute hepatitis B
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Chronic hepatitis C
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
H1N1 influenza
subjects affected / exposed	1 / 8569 (0.01%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
HIV infection
subjects affected / exposed	1 / 8569 (0.01%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
HIV-associated neurocognitive disorder
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatitis A
subjects affected / exposed	1 / 8569 (0.01%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatitis B
subjects affected / exposed	0 / 8569 (0.00%)	2 / 8574 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatitis E
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
West Nile viral infection
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Metabolism and nutrition disorders
Adult failure to thrive
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Alcoholic ketoacidosis
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Dehydration
subjects affected / exposed	19 / 8569 (0.22%)	20 / 8574 (0.23%)
occurrences causally related to treatment / all	1 / 19	1 / 21
deaths causally related to treatment / all	0 / 0	0 / 0
Decreased appetite
subjects affected / exposed	2 / 8569 (0.02%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Diabetes mellitus
subjects affected / exposed	13 / 8569 (0.15%)	5 / 8574 (0.06%)
occurrences causally related to treatment / all	1 / 13	1 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Diabetes mellitus inadequate control
subjects affected / exposed	29 / 8569 (0.34%)	14 / 8574 (0.16%)
occurrences causally related to treatment / all	2 / 34	0 / 14
deaths causally related to treatment / all	0 / 0	0 / 0
Diabetes with hyperosmolarity
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Diabetic complication
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Diabetic ketoacidosis
subjects affected / exposed	23 / 8569 (0.27%)	27 / 8574 (0.31%)
occurrences causally related to treatment / all	2 / 27	2 / 29
deaths causally related to treatment / all	1 / 2	0 / 0
Diabetic ketosis
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Diabetic metabolic decompensation
subjects affected / exposed	27 / 8569 (0.32%)	17 / 8574 (0.20%)
occurrences causally related to treatment / all	0 / 35	0 / 23
deaths causally related to treatment / all	0 / 0	0 / 0
Electrolyte imbalance
subjects affected / exposed	4 / 8569 (0.05%)	3 / 8574 (0.03%)
occurrences causally related to treatment / all	0 / 4	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Euglycaemic diabetic ketoacidosis
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Failure to thrive
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gout
subjects affected / exposed	6 / 8569 (0.07%)	3 / 8574 (0.03%)
occurrences causally related to treatment / all	0 / 7	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Fluid retention
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Fluid overload
subjects affected / exposed	1 / 8569 (0.01%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hypercalcaemia
subjects affected / exposed	1 / 8569 (0.01%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hyperglycaemia
subjects affected / exposed	55 / 8569 (0.64%)	37 / 8574 (0.43%)
occurrences causally related to treatment / all	1 / 56	0 / 49
deaths causally related to treatment / all	0 / 0	0 / 0
Hyperglycaemic hyperosmolar nonketotic syndrome
subjects affected / exposed	5 / 8569 (0.06%)	4 / 8574 (0.05%)
occurrences causally related to treatment / all	0 / 5	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Hyperkalaemia
subjects affected / exposed	6 / 8569 (0.07%)	6 / 8574 (0.07%)
occurrences causally related to treatment / all	0 / 7	2 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Hyperlipidaemia
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hypernatraemia
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hypertriglyceridaemia
subjects affected / exposed	1 / 8569 (0.01%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hyperuricaemia
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hypocalcaemia
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hypoglycaemia
subjects affected / exposed	86 / 8569 (1.00%)	69 / 8574 (0.80%)
occurrences causally related to treatment / all	19 / 101	23 / 86
deaths causally related to treatment / all	0 / 0	0 / 1
Hypokalaemia
subjects affected / exposed	4 / 8569 (0.05%)	5 / 8574 (0.06%)
occurrences causally related to treatment / all	0 / 4	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Hypomagnesaemia
subjects affected / exposed	1 / 8569 (0.01%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	1 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hypovolaemia
subjects affected / exposed	4 / 8569 (0.05%)	14 / 8574 (0.16%)
occurrences causally related to treatment / all	1 / 4	0 / 14
deaths causally related to treatment / all	0 / 0	0 / 0
Hyponatraemia
subjects affected / exposed	9 / 8569 (0.11%)	9 / 8574 (0.10%)
occurrences causally related to treatment / all	0 / 9	1 / 10
deaths causally related to treatment / all	0 / 0	0 / 0
Ketoacidosis
subjects affected / exposed	2 / 8569 (0.02%)	7 / 8574 (0.08%)
occurrences causally related to treatment / all	0 / 2	2 / 8
deaths causally related to treatment / all	0 / 0	0 / 0
Ketosis
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Lactic acidosis
subjects affected / exposed	3 / 8569 (0.04%)	4 / 8574 (0.05%)
occurrences causally related to treatment / all	0 / 3	1 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Latent autoimmune diabetes in adults
subjects affected / exposed	1 / 8569 (0.01%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Malnutrition
subjects affected / exposed	2 / 8569 (0.02%)	0 / 8574 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Lipomatosis
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Obesity
subjects affected / exposed	8 / 8569 (0.09%)	3 / 8574 (0.03%)
occurrences causally related to treatment / all	0 / 8	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Metabolic acidosis
subjects affected / exposed	3 / 8569 (0.04%)	3 / 8574 (0.03%)
occurrences causally related to treatment / all	1 / 3	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Type 1 diabetes mellitus
subjects affected / exposed	2 / 8569 (0.02%)	4 / 8574 (0.05%)
occurrences causally related to treatment / all	0 / 2	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Type 2 diabetes mellitus
subjects affected / exposed	7 / 8569 (0.08%)	7 / 8574 (0.08%)
occurrences causally related to treatment / all	0 / 7	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
Vitamin D deficiency
subjects affected / exposed	0 / 8569 (0.00%)	1 / 8574 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 1%

Non-serious adverse events	Placebo	Dapa 10 mg
Total subjects affected by non serious adverse events
subjects affected / exposed	342 / 8569 (3.99%)	268 / 8574 (3.13%)
Renal and urinary disorders
Acute kidney injury
subjects affected / exposed	112 / 8569 (1.31%)	82 / 8574 (0.96%)
occurrences all number	129	91
Renal impairment
subjects affected / exposed	146 / 8569 (1.70%)	121 / 8574 (1.41%)
occurrences all number	159	126
Chronic kidney disease
subjects affected / exposed	104 / 8569 (1.21%)	77 / 8574 (0.90%)
occurrences all number	108	78

More information

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Were there any global substantial amendments to the protocol? Yes

19 Dec 2013

Amendment #2 included implementation of a request from regulatory authorities to include further measurements and action to allow patients to continue study drug if creatinine clearance was found to be <60 ml/min during the study. With these measures added, patients could stay on study drug until creatinine clearance <30 ml/min as planned.

28 Apr 2014

Amendment #3 included implementation as per regulatory authorities’ requirement to add hypersensitivity reactions (SAE/DAE), urinary tract infections (SAE/DAE), genital infections (SAE/DAE) and fractures to be recorded as AE of special interest.

25 Sep 2016

Amendment #5 included implementation as per regulatory authorities’ requirements to add to adjudicate possible cases of diabetes ketoacidosis and collect additional information on cases of amputations.

Were there any global interruptions to the trial? No

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

None reported

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