Clinical Trial Results:
Effect of ivabradine in patients with stable coronary artery disease without clinical heart failure. A randomised double-blind placebo-controlled international multicentre study. Study assessInG the morbi-mortality beNefits of the If inhibitor ivabradine in patients with coronary arterY disease (SIGNIFY).

Trial information Top of page
Trial identification
Sponsor protocol code	CL3-16257-083
Additional study identifiers
ISRCTN number	ISRCTN61576291
US NCT number	-
WHO universal trial number (UTN)	-
Sponsors
Sponsor organisation name	Institut de Recherches Internationales Servier
Sponsor organisation address	50 rue Carnot, Suresnes Cedex, France, 92284
Public contact	Therapeutic Innovation Pole, Institut de Recherches Internationales Servier 50 rue Carnot 92284 Suresnes Cedex, +33 155724366, clinicaltrials@servier.com
Scientific contact	Therapeutic Innovation Pole, Institut de Recherches Internationales Servier 50 rue Carnot 92284 Suresnes Cedex, +33 155724366, clinicaltrials@servier.com
Paediatric regulatory details
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
Results analysis stage
Analysis stage	Final
Date of interim/final analysis	24 Jan 2014
Is this the analysis of the primary completion data?	Yes
Primary completion date	24 Jan 2014
Global end of trial reached?	Yes
Global end of trial date	24 Jan 2014
Was the trial ended prematurely?	No
General information about the trial
Main objective of the trial	To demonstrate the superiority of ivabradine over placebo in the reduction of CV mortality or non-fatal myocardial infarction.
Protection of trial subjects	Reason to discontinue the study treatment: study drug not tolerated, no longer appropriate or considered as contra-indicated. The measurement of drug concentrations in blood was planned in the case of suspected overdose.
Background therapy	-
Evidence for comparator	-
Actual start date of recruitment	25 Sep 2009
Long term follow-up planned	No
Independent data monitoring committee (IDMC) involvement?	Yes
Population of trial subjects
Number of subjects enrolled per country
Country: Number of subjects enrolled	Korea, Republic of: 446
Country: Number of subjects enrolled	Kazakhstan: 141
Country: Number of subjects enrolled	Latvia: 440
Country: Number of subjects enrolled	Lithuania: 302
Country: Number of subjects enrolled	Macedonia, the former Yugoslav Republic of: 224
Country: Number of subjects enrolled	Malaysia: 74
Country: Number of subjects enrolled	Mexico: 559
Country: Number of subjects enrolled	Netherlands: 555
Country: Number of subjects enrolled	Norway: 56
Country: Number of subjects enrolled	Philippines: 30
Country: Number of subjects enrolled	Poland: 1157
Country: Number of subjects enrolled	Portugal: 27
Country: Number of subjects enrolled	Romania: 892
Country: Number of subjects enrolled	Russian Federation: 2119
Country: Number of subjects enrolled	Serbia: 210
Country: Number of subjects enrolled	Singapore: 21
Country: Number of subjects enrolled	Slovenia: 68
Country: Number of subjects enrolled	South Africa: 374
Country: Number of subjects enrolled	Spain: 235
Country: Number of subjects enrolled	Sweden: 57
Country: Number of subjects enrolled	Switzerland: 50
Country: Number of subjects enrolled	Taiwan: 198
Country: Number of subjects enrolled	Thailand: 96
Country: Number of subjects enrolled	Turkey: 96
Country: Number of subjects enrolled	Ukraine: 1894
Country: Number of subjects enrolled	United Kingdom: 118
Country: Number of subjects enrolled	Uruguay: 29
Country: Number of subjects enrolled	Vietnam: 171
Country: Number of subjects enrolled	Argentina: 954
Country: Number of subjects enrolled	Armenia: 239
Country: Number of subjects enrolled	Australia: 116
Country: Number of subjects enrolled	Austria: 19
Country: Number of subjects enrolled	Belgium: 52
Country: Number of subjects enrolled	Brazil: 853
Country: Number of subjects enrolled	Bulgaria: 1121
Country: Number of subjects enrolled	Canada: 254
Country: Number of subjects enrolled	China: 975
Country: Number of subjects enrolled	Croatia: 197
Country: Number of subjects enrolled	Czech Republic: 539
Country: Number of subjects enrolled	Denmark: 76
Country: Number of subjects enrolled	Estonia: 387
Country: Number of subjects enrolled	Finland: 8
Country: Number of subjects enrolled	France: 99
Country: Number of subjects enrolled	Georgia: 102
Country: Number of subjects enrolled	Germany: 309
Country: Number of subjects enrolled	Greece: 77
Country: Number of subjects enrolled	Hungary: 981
Country: Number of subjects enrolled	Slovakia: 379
Country: Number of subjects enrolled	India: 295
Country: Number of subjects enrolled	Ireland: 47
Country: Number of subjects enrolled	Italy: 384
Worldwide total number of subjects	19102
EEA total number of subjects	8582
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)	10205
From 65 to 84 years	8789
85 years and over	108

Trial information Top of page

Subject disposition Top of page
Recruitment
Recruitment details	A total of 1181 centres in 51 countries screened at least one patient and 1139 centres included at least one patient.
Pre-assignment
Screening details	A total of 23 164 patients were screened, 21 862 were selected and 19 107 were included. The Randomised Set comprised 19 102 patients: 9550 patients in the ivabradine group and 9552 in the placebo group. Of the 19 102 patients in the Randomised Set, 17 724 completed the study: 8830 patients in the ivabradine group and 8894 in the placebo group.
Period 1
Period 1 title	Post-randomisation period (overall period)
Is this the baseline period?	Yes
Allocation method	Randomised - controlled
Blinding used	Double blind
Roles blinded	Subject, Investigator
Arms
Are arms mutually exclusive	Yes
Arm title	Ivabradine
Arm description	Patients taking Ivabradine
Arm type	Study drug
Investigational medicinal product name	Ivabradine
Investigational medicinal product code
Other name
Pharmaceutical forms	Tablet
Routes of administration	Oral use
Dosage and administration details	5 mg, 7.5 mg or 10 mg tablets to be taken orally twice daily at 12-hours intervals, in the morning and in the evening during meals.
Arm title	Placebo
Arm description	Patients taking placebo
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	5 mg, 7.5 mg or 10 mg matching tablets to be taken orally twice daily at 12-hours intervals, in the morning and in the evening during meals.
Number of subjects in period 1 Ivabradine Placebo Started 9550 9552 Completed 8830 8894 Not completed 720 658      Adverse event, serious fatal 485 458      Consent withdrawn by subject 231 199      Physician decision 1 -      Lost to follow-up 3 1

Subject disposition Top of page

Baseline characteristics Top of page
Baseline characteristics reporting groups
Reporting group title	Ivabradine
Reporting group description	Patients taking Ivabradine
Reporting group title	Placebo
Reporting group description	Patients taking placebo
Reporting group values Ivabradine Placebo Total Number of subjects 9550 9552 19102 Age categorical Units: Subjects     In utero 0 0 0     Preterm newborn infants (gestational age < 37 wks) 0 0 0     Newborns (0-27 days) 0 0 0     Infants and toddlers (28 days-23 months) 0 0 0     Children (2-11 years) 0 0 0     Adolescents (12-17 years) 0 0 0     Adults (18-64 years) 5109 5096 10205     From 65-84 years 4387 4402 8789     85 years and over 54 54 108 Age continuous Units: years     arithmetic mean (standard deviation) 65 ( 7.2 ) 65 ( 7.3 ) - Gender categorical Units: Subjects     Female 2601 2662 5263     Male 6949 6890 13839
Subject analysis sets
Subject analysis set title	Randomised set
Subject analysis set type	Intention-to-treat
Subject analysis set description	All included patients with a randomisation number allocated by the IRS.
Subject analysis set title	Safety set
Subject analysis set type	Safety analysis
Subject analysis set description	All patients having received at least one dose of study drug.
Subject analysis set title	Randomised set angina
Subject analysis set type	Intention-to-treat
Subject analysis set description	All symptomatic angina patients of the RS having a CCS class ≥ II at baseline (defined as CCS class ≥ II at selection and inclusion).
Subject analysis set title	Safety set angina
Subject analysis set type	Safety analysis
Subject analysis set description	All symptomatic angina patients of the SS having a CCS class ≥ II at baseline (defined as CCS class ≥ II at selection and inclusion).
Subject analysis sets values Randomised set Safety set Randomised set angina Safety set angina Number of subjects 19102 19083 1204 1203 Age categorical Units: Subjects     In utero 0     Preterm newborn infants (gestational age < 37 wks) 0     Newborns (0-27 days) 0     Infants and toddlers (28 days-23 months) 0     Children (2-11 years) 0     Adolescents (12-17 years) 0     Adults (18-64 years) 5109     From 65-84 years 4387     85 years and over 54 Age continuous Units: years     arithmetic mean (standard deviation) 65 ( 7.2 ) ( ) ( ) ( ) Gender categorical Units: Subjects     Female 5263     Male 13839

Baseline characteristics Top of page

End points Top of page
End points reporting groups
Reporting group title	Ivabradine
Reporting group description	Patients taking Ivabradine
Reporting group title	Placebo
Reporting group description	Patients taking placebo
Subject analysis set title	Randomised set
Subject analysis set type	Intention-to-treat
Subject analysis set description	All included patients with a randomisation number allocated by the IRS.
Subject analysis set title	Safety set
Subject analysis set type	Safety analysis
Subject analysis set description	All patients having received at least one dose of study drug.
Subject analysis set title	Randomised set angina
Subject analysis set type	Intention-to-treat
Subject analysis set description	All symptomatic angina patients of the RS having a CCS class ≥ II at baseline (defined as CCS class ≥ II at selection and inclusion).
Subject analysis set title	Safety set angina
Subject analysis set type	Safety analysis
Subject analysis set description	All symptomatic angina patients of the SS having a CCS class ≥ II at baseline (defined as CCS class ≥ II at selection and inclusion).

End points Top of page

Primary: Primary composite endpoint Top of page
End point title	Primary composite endpoint
End point description	First event among cardiovascular death or non-fatal MI
End point type	Primary
End point timeframe	All criteria are expressed as the time to first event, defined as the duration between the date of randomisation and the date of first occurrence of this event.
End point values Ivabradine Placebo Number of subjects analysed 9550 9552 Units: number of events 654 611
Statistical analysis title	Superiority of Ivabradine versus Placebo
Comparison groups	Ivabradine v Placebo
Number of subjects included in analysis	19102
Analysis specification	Pre-specified
Analysis type	superiority
P-value	= 0.1969
Method	Regression, Cox
Parameter type	Cox proportional hazard
Point estimate	1.08
Confidence interval
level	95%
sides	2-sided
lower limit	0.96
upper limit	1.2
Variability estimate	Standard error of the mean
Dispersion value	0.06

Primary: Primary composite endpoint Top of page

Adverse events Top of page
Adverse events information
Timeframe for reporting adverse events	On treatment
Assessment type	Systematic
Dictionary used for adverse event reporting
Dictionary name	MedDRA
Dictionary version	16.0
Reporting groups
Reporting group title	Ivabradine
Reporting group description	-
Reporting group title	Placebo
Reporting group description	-
Serious adverse events Ivabradine Placebo Total subjects affected by serious adverse events      subjects affected / exposed 3379 / 9539 (35.42%) 3263 / 9544 (34.19%)      number of deaths (all causes) 363 356      number of deaths resulting from adverse events 1 0 Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute leukaemia      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 1 0 / 0 Acute myeloid leukaemia      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Adenocarcinoma gastric      subjects affected / exposed 6 / 9539 (0.06%) 4 / 9544 (0.04%)      occurrences causally related to treatment / all 0 / 6 0 / 4      deaths causally related to treatment / all 0 / 1 0 / 2 Adenocarcinoma of colon      subjects affected / exposed 8 / 9539 (0.08%) 7 / 9544 (0.07%)      occurrences causally related to treatment / all 0 / 8 0 / 7      deaths causally related to treatment / all 0 / 0 0 / 0 Adenocarcinoma pancreas      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Adenolymphoma      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Adrenal adenoma      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Adenosquamous cell lung cancer      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 1 Anal squamous cell carcinoma      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Angiofibroma      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Astrocytoma, low grade      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 B precursor type acute leukaemia      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 B-cell lymphoma      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 1 Basal cell carcinoma      subjects affected / exposed 24 / 9539 (0.25%) 21 / 9544 (0.22%)      occurrences causally related to treatment / all 0 / 25 0 / 23      deaths causally related to treatment / all 0 / 0 0 / 0 Basosquamous carcinoma      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Basosquamous carcinoma of skin      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Benign breast neoplasm      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 Benign neoplasm of prostate      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (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 thyroid gland      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Benign pleural neoplasm      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Benign renal neoplasm      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Bile duct cancer      subjects affected / exposed 2 / 9539 (0.02%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 2 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Bladder cancer      subjects affected / exposed 6 / 9539 (0.06%) 9 / 9544 (0.09%)      occurrences causally related to treatment / all 0 / 6 0 / 9      deaths causally related to treatment / all 0 / 0 0 / 0 Bladder cancer recurrent      subjects affected / exposed 0 / 9539 (0.00%) 3 / 9544 (0.03%)      occurrences causally related to treatment / all 0 / 0 0 / 3      deaths causally related to treatment / all 0 / 0 0 / 0 Bladder cancer stage I, with cancer in situ      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Bladder cancer stage II      subjects affected / exposed 1 / 9539 (0.01%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 1 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Bladder neoplasm      subjects affected / exposed 1 / 9539 (0.01%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 1 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Bladder papilloma      subjects affected / exposed 1 / 9539 (0.01%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 1 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 Bladder transitional cell carcinoma      subjects affected / exposed 5 / 9539 (0.05%) 3 / 9544 (0.03%)      occurrences causally related to treatment / all 0 / 5 0 / 3      deaths causally related to treatment / all 0 / 0 0 / 0 Bladder transitional cell carcinoma recurrent      subjects affected / exposed 2 / 9539 (0.02%) 0 / 9544 (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 stage II      subjects affected / exposed 1 / 9539 (0.01%) 3 / 9544 (0.03%)      occurrences causally related to treatment / all 0 / 1 0 / 3      deaths causally related to treatment / all 0 / 0 0 / 0 Bladder transitional cell carcinoma stage III      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Bowen's disease      subjects affected / exposed 3 / 9539 (0.03%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 3 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Brain cancer metastatic      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Brain neoplasm      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 1 0 / 0 Brain neoplasm malignant      subjects affected / exposed 1 / 9539 (0.01%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 1 0 / 1      deaths causally related to treatment / all 0 / 1 0 / 1 Brain stem glioma      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 1 Breast cancer      subjects affected / exposed 0 / 9539 (0.00%) 5 / 9544 (0.05%)      occurrences causally related to treatment / all 0 / 0 0 / 5      deaths causally related to treatment / all 0 / 0 0 / 0 Breast cancer metastatic      subjects affected / exposed 2 / 9539 (0.02%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 2 0 / 2      deaths causally related to treatment / all 0 / 1 0 / 1 Breast cancer recurrent      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Breast cancer stage I      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Breast cancer stage II      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (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 5 / 9539 (0.05%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 5 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Bronchioloalveolar carcinoma      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Cancer pain      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (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 stomach      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Carotid body tumour      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Castleman's disease      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Cerebral hygroma      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Cervix carcinoma      subjects affected / exposed 0 / 9539 (0.00%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 0 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 1 Cervix carcinoma stage III      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Cholangiocarcinoma      subjects affected / exposed 0 / 9539 (0.00%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 0 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 1 Cholesteatoma      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Chronic lymphocytic leukaemia      subjects affected / exposed 3 / 9539 (0.03%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 3 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Chronic lymphocytic leukaemia stage 2      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Clear cell renal cell carcinoma      subjects affected / exposed 1 / 9539 (0.01%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 1 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Clear cell sarcoma of soft tissue      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Colon adenoma      subjects affected / exposed 4 / 9539 (0.04%) 3 / 9544 (0.03%)      occurrences causally related to treatment / all 0 / 4 0 / 3      deaths causally related to treatment / all 0 / 0 0 / 0 Colon cancer      subjects affected / exposed 6 / 9539 (0.06%) 5 / 9544 (0.05%)      occurrences causally related to treatment / all 0 / 6 0 / 5      deaths causally related to treatment / all 0 / 0 0 / 0 Colon cancer metastatic      subjects affected / exposed 6 / 9539 (0.06%) 7 / 9544 (0.07%)      occurrences causally related to treatment / all 0 / 6 0 / 7      deaths causally related to treatment / all 0 / 3 0 / 1 Colon cancer stage 0      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (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 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Colorectal cancer metastatic      subjects affected / exposed 2 / 9539 (0.02%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 2 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Diffuse large B-cell lymphoma      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (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 III      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Diffuse large B-cell lymphoma stage IV      subjects affected / exposed 1 / 9539 (0.01%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 1 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Ear neoplasm malignant      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (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 2 / 9539 (0.02%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 2 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Ependymoma      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Extranodal marginal zone B-cell lymphoma (MALT type)      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Gallbladder cancer      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Gallbladder neoplasm      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Gastric adenoma      subjects affected / exposed 1 / 9539 (0.01%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 1 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Gastric cancer      subjects affected / exposed 3 / 9539 (0.03%) 8 / 9544 (0.08%)      occurrences causally related to treatment / all 0 / 3 0 / 8      deaths causally related to treatment / all 0 / 1 0 / 2 Gastric cancer stage IV      subjects affected / exposed 3 / 9539 (0.03%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 3 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Gastrointestinal carcinoma      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Gastrointestinal stromal tumour      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Gastrointestinal tract adenoma      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Gastrooesophageal cancer      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Glioblastoma      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 1 0 / 0 Haemangioma of bone      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 Hepatic cancer      subjects affected / exposed 3 / 9539 (0.03%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 3 0 / 0      deaths causally related to treatment / all 0 / 3 0 / 0 Hepatic cancer metastatic      subjects affected / exposed 2 / 9539 (0.02%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 2 0 / 2      deaths causally related to treatment / all 0 / 2 0 / 2 Hepatocellular carcinoma      subjects affected / exposed 2 / 9539 (0.02%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 2 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Hodgkin's disease      subjects affected / exposed 2 / 9539 (0.02%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 2 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Intestinal adenocarcinoma      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Invasive ductal breast carcinoma      subjects affected / exposed 4 / 9539 (0.04%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 4 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 Large cell lung cancer      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Large cell lung cancer metastatic      subjects affected / exposed 2 / 9539 (0.02%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 2 0 / 0      deaths causally related to treatment / all 0 / 2 0 / 0 Large cell lung cancer stage II      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Large intestine benign neoplasm      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Laryngeal cancer      subjects affected / exposed 2 / 9539 (0.02%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 2 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Laryngeal cancer metastatic      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 1 0 / 0 Laryngeal cancer recurrent      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 1 0 / 0 Laryngeal squamous cell carcinoma      subjects affected / exposed 1 / 9539 (0.01%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 1 0 / 2      deaths causally related to treatment / all 0 / 1 0 / 1 Lentigo maligna      subjects affected / exposed 1 / 9539 (0.01%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 1 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Lip and/or oral cavity cancer      subjects affected / exposed 2 / 9539 (0.02%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 2 0 / 2      deaths causally related to treatment / all 0 / 2 0 / 0 Lip and/or oral cavity cancer stage IV      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Lipoma      subjects affected / exposed 2 / 9539 (0.02%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 2 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Lung adenocarcinoma      subjects affected / exposed 4 / 9539 (0.04%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 4 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 Lung adenocarcinoma metastatic      subjects affected / exposed 5 / 9539 (0.05%) 8 / 9544 (0.08%)      occurrences causally related to treatment / all 0 / 5 0 / 9      deaths causally related to treatment / all 0 / 2 0 / 6 Lung adenocarcinoma stage IV      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Lung cancer metastatic      subjects affected / exposed 5 / 9539 (0.05%) 10 / 9544 (0.10%)      occurrences causally related to treatment / all 0 / 5 0 / 10      deaths causally related to treatment / all 0 / 2 0 / 6 Lung carcinoma cell type unspecified stage II      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 1 Lung carcinoma cell type unspecified stage IV      subjects affected / exposed 3 / 9539 (0.03%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 3 0 / 0      deaths causally related to treatment / all 0 / 1 0 / 0 Lung neoplasm      subjects affected / exposed 1 / 9539 (0.01%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 1 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 2 Lung neoplasm malignant      subjects affected / exposed 7 / 9539 (0.07%) 12 / 9544 (0.13%)      occurrences causally related to treatment / all 0 / 7 0 / 12      deaths causally related to treatment / all 0 / 3 0 / 5 Lung squamous cell carcinoma metastatic      subjects affected / exposed 0 / 9539 (0.00%) 3 / 9544 (0.03%)      occurrences causally related to treatment / all 0 / 0 0 / 3      deaths causally related to treatment / all 0 / 0 0 / 2 Lung squamous cell carcinoma stage III      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Lymphangiosis carcinomatosa      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 1 0 / 0 Malignant ascites      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Malignant glioma      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 1 Malignant melanoma      subjects affected / exposed 2 / 9539 (0.02%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 2 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 Malignant neoplasm of ampulla of Vater      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (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 choroid      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (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 eyelid      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Malignant oligodendroglioma      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (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 3 / 9539 (0.03%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 3 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Meningioma      subjects affected / exposed 1 / 9539 (0.01%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 1 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 Mesothelioma      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Metastases to abdominal cavity      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 1 0 / 0 Metastases to adrenals      subjects affected / exposed 2 / 9539 (0.02%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 2 0 / 1      deaths causally related to treatment / all 0 / 1 0 / 0 Metastases to bone      subjects affected / exposed 3 / 9539 (0.03%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 3 0 / 1      deaths causally related to treatment / all 0 / 2 0 / 0 Metastases to bone marrow      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 1 0 / 0 Metastases to central nervous system      subjects affected / exposed 3 / 9539 (0.03%) 4 / 9544 (0.04%)      occurrences causally related to treatment / all 0 / 3 0 / 4      deaths causally related to treatment / all 0 / 2 0 / 0 Metastases to eye      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Metastases to liver      subjects affected / exposed 3 / 9539 (0.03%) 4 / 9544 (0.04%)      occurrences causally related to treatment / all 0 / 3 0 / 4      deaths causally related to treatment / all 0 / 1 0 / 1 Metastases to lung      subjects affected / exposed 2 / 9539 (0.02%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 2 0 / 1      deaths causally related to treatment / all 0 / 1 0 / 0 Metastases to lymph nodes      subjects affected / exposed 0 / 9539 (0.00%) 3 / 9544 (0.03%)      occurrences causally related to treatment / all 0 / 0 0 / 3      deaths causally related to treatment / all 0 / 0 0 / 1 Metastases to peritoneum      subjects affected / exposed 0 / 9539 (0.00%) 4 / 9544 (0.04%)      occurrences causally related to treatment / all 0 / 0 0 / 4      deaths causally related to treatment / all 0 / 0 0 / 1 Metastases to the mediastinum      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Metastases to spine      subjects affected / exposed 1 / 9539 (0.01%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 1 0 / 1      deaths causally related to treatment / all 0 / 1 0 / 0 Metastatic bronchial carcinoma      subjects affected / exposed 1 / 9539 (0.01%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 1 0 / 1      deaths causally related to treatment / all 0 / 1 0 / 1 Metastatic carcinoma of the bladder      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 1 Metastatic gastric cancer      subjects affected / exposed 3 / 9539 (0.03%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 3 0 / 2      deaths causally related to treatment / all 0 / 2 0 / 2 Metastatic malignant melanoma      subjects affected / exposed 0 / 9539 (0.00%) 3 / 9544 (0.03%)      occurrences causally related to treatment / all 0 / 0 0 / 4      deaths causally related to treatment / all 0 / 0 0 / 1 Metastatic neoplasm      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Metastatic renal cell carcinoma      subjects affected / exposed 2 / 9539 (0.02%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 2 0 / 0      deaths causally related to treatment / all 0 / 2 0 / 0 Metastatic pain      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Metastatic squamous cell carcinoma      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 1 Metastatic uterine cancer      subjects affected / exposed 1 / 9539 (0.01%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 1 0 / 1      deaths causally related to treatment / all 0 / 1 0 / 1 Myelodysplastic syndrome      subjects affected / exposed 2 / 9539 (0.02%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 2 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Myelofibrosis      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Myeloproliferative disorder      subjects affected / exposed 4 / 9539 (0.04%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 4 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Nasopharyngeal cancer      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 1 Neoplasm      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Neoplasm skin      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Neuroendocrine carcinoma metastatic      subjects affected / exposed 0 / 9539 (0.00%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 0 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 Neuroendocrine tumour      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Neuroma      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Nodular melanoma      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Non-Hodgkin's lymphoma      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 1 Non-small cell lung cancer      subjects affected / exposed 3 / 9539 (0.03%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 3 0 / 1      deaths causally related to treatment / all 0 / 1 0 / 0 Non-small cell lung cancer metastatic      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Non-small cell lung cancer stage IIIA      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Oesophageal adenocarcinoma      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Oesophageal adenocarcinoma metastatic      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Oesophageal carcinoma      subjects affected / exposed 2 / 9539 (0.02%) 3 / 9544 (0.03%)      occurrences causally related to treatment / all 0 / 2 0 / 3      deaths causally related to treatment / all 0 / 0 0 / 1 Oesophageal squamous cell carcinoma      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 1 0 / 0 Oropharyngeal cancer      subjects affected / exposed 1 / 9539 (0.01%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 1 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Ovarian adenoma      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Ovarian cancer      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 1 Ovarian cancer metastatic      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (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 metastatic      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Ovarian germ cell teratoma benign      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Pancreatic carcinoma      subjects affected / exposed 2 / 9539 (0.02%) 4 / 9544 (0.04%)      occurrences causally related to treatment / all 0 / 2 0 / 4      deaths causally related to treatment / all 0 / 0 0 / 1 Pancreatic carcinoma metastatic      subjects affected / exposed 7 / 9539 (0.07%) 8 / 9544 (0.08%)      occurrences causally related to treatment / all 0 / 7 0 / 8      deaths causally related to treatment / all 0 / 4 0 / 3 Pancreatic neoplasm      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 1 Papillary tumour of renal pelvis      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Parathyroid tumour benign      subjects affected / exposed 1 / 9539 (0.01%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 1 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 Penis carcinoma stage II      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 1 Pharyngeal cancer recurrent      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 1 0 / 0 Pineal parenchymal neoplasm malignant      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 1 0 / 0 Pituitary tumour benign      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Pituitary tumour recurrent      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Plasma cell leukaemia      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 1 0 / 0 Plasma cell myeloma      subjects affected / exposed 2 / 9539 (0.02%) 4 / 9544 (0.04%)      occurrences causally related to treatment / all 0 / 2 0 / 4      deaths causally related to treatment / all 0 / 1 0 / 2 Pleural mesothelioma      subjects affected / exposed 2 / 9539 (0.02%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 2 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Pleural neoplasm      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Polycythaemia vera      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Prostate cancer      subjects affected / exposed 38 / 9539 (0.40%) 18 / 9544 (0.19%)      occurrences causally related to treatment / all 0 / 38 0 / 18      deaths causally related to treatment / all 0 / 0 0 / 0 Prostate cancer metastatic      subjects affected / exposed 4 / 9539 (0.04%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 4 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 1 Prostate cancer recurrent      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Prostate cancer stage I      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Prostate cancer stage II      subjects affected / exposed 0 / 9539 (0.00%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 0 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 Prostate cancer stage III      subjects affected / exposed 1 / 9539 (0.01%) 3 / 9544 (0.03%)      occurrences causally related to treatment / all 0 / 1 0 / 3      deaths causally related to treatment / all 0 / 0 0 / 0 Prostate cancer stage IV      subjects affected / exposed 1 / 9539 (0.01%) 3 / 9544 (0.03%)      occurrences causally related to treatment / all 0 / 1 0 / 3      deaths causally related to treatment / all 0 / 0 0 / 0 Prostatic adenoma      subjects affected / exposed 4 / 9539 (0.04%) 5 / 9544 (0.05%)      occurrences causally related to treatment / all 0 / 4 0 / 5      deaths causally related to treatment / all 0 / 0 0 / 0 Rectal adenocarcinoma      subjects affected / exposed 1 / 9539 (0.01%) 3 / 9544 (0.03%)      occurrences causally related to treatment / all 0 / 1 0 / 3      deaths causally related to treatment / all 0 / 0 0 / 0 Rectal cancer      subjects affected / exposed 5 / 9539 (0.05%) 3 / 9544 (0.03%)      occurrences causally related to treatment / all 0 / 5 0 / 3      deaths causally related to treatment / all 0 / 1 0 / 0 Rectal cancer metastatic      subjects affected / exposed 1 / 9539 (0.01%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 1 0 / 1      deaths causally related to treatment / all 0 / 1 0 / 0 Rectal cancer recurrent      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Rectal cancer stage 0      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Rectal cancer stage IV      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 1 Rectosigmoid cancer      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Rectal neoplasm      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Renal cancer      subjects affected / exposed 6 / 9539 (0.06%) 5 / 9544 (0.05%)      occurrences causally related to treatment / all 0 / 6 0 / 5      deaths causally related to treatment / all 0 / 1 0 / 0 Renal cancer metastatic      subjects affected / exposed 4 / 9539 (0.04%) 3 / 9544 (0.03%)      occurrences causally related to treatment / all 0 / 4 0 / 3      deaths causally related to treatment / all 0 / 0 0 / 0 Renal cancer stage I      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Renal oncocytoma      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Renal cell carcinoma      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Rhabdomyosarcoma      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Salivary gland adenoma      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (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 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Skin cancer metastatic      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Skin cancer      subjects affected / exposed 4 / 9539 (0.04%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 4 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 Small cell lung cancer      subjects affected / exposed 1 / 9539 (0.01%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 1 0 / 2      deaths causally related to treatment / all 0 / 1 0 / 0 Small cell lung cancer metastatic      subjects affected / exposed 1 / 9539 (0.01%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 1 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 1 Small intestine carcinoma      subjects affected / exposed 2 / 9539 (0.02%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 2 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Spinal meningioma benign      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 1 0 / 0 Squamous cell carcinoma      subjects affected / exposed 3 / 9539 (0.03%) 4 / 9544 (0.04%)      occurrences causally related to treatment / all 0 / 3 0 / 4      deaths causally related to treatment / all 0 / 1 0 / 0 Squamous cell carcinoma of head and neck      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (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 lung      subjects affected / exposed 4 / 9539 (0.04%) 5 / 9544 (0.05%)      occurrences causally related to treatment / all 0 / 4 0 / 5      deaths causally related to treatment / all 0 / 2 0 / 2 Squamous cell carcinoma of pharynx      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (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 skin      subjects affected / exposed 2 / 9539 (0.02%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 2 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 Squamous cell carcinoma of the cervix      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 1 0 / 0 Squamous cell carcinoma of the hypopharynx      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (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 oral cavity      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 1 Testicular cancer metastatic      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Throat cancer      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Thyroid cancer metastatic      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Thyroid neoplasm      subjects affected / exposed 1 / 9539 (0.01%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 1 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Tongue neoplasm malignant stage unspecified      subjects affected / exposed 2 / 9539 (0.02%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 2 0 / 1      deaths causally related to treatment / all 0 / 2 0 / 0 Tonsil cancer      subjects affected / exposed 1 / 9539 (0.01%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 1 0 / 1      deaths causally related to treatment / all 0 / 1 0 / 0 Transitional cell carcinoma      subjects affected / exposed 1 / 9539 (0.01%) 3 / 9544 (0.03%)      occurrences causally related to treatment / all 0 / 1 0 / 3      deaths causally related to treatment / all 0 / 0 0 / 0 Urethral cancer metastatic      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Uterine leiomyoma      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Vulval cancer      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Vascular disorders Aortic aneurysm      subjects affected / exposed 4 / 9539 (0.04%) 7 / 9544 (0.07%)      occurrences causally related to treatment / all 0 / 4 0 / 7      deaths causally related to treatment / all 0 / 0 0 / 0 Aortic aneurysm rupture      subjects affected / exposed 2 / 9539 (0.02%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 2 0 / 1      deaths causally related to treatment / all 0 / 2 0 / 0 Aortic arteriosclerosis      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Aortic dilatation      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (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 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Aortic occlusion      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Aortic thrombosis      subjects affected / exposed 5 / 9539 (0.05%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 5 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 Arterial rupture      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Arterial stenosis      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Arteriosclerosis      subjects affected / exposed 1 / 9539 (0.01%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 1 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Blood pressure fluctuation      subjects affected / exposed 2 / 9539 (0.02%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 2 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Blood pressure inadequately controlled      subjects affected / exposed 7 / 9539 (0.07%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 1 / 8 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 Circulatory collapse      subjects affected / exposed 2 / 9539 (0.02%) 7 / 9544 (0.07%)      occurrences causally related to treatment / all 0 / 2 0 / 8      deaths causally related to treatment / all 0 / 0 0 / 0 Deep vein thrombosis      subjects affected / exposed 19 / 9539 (0.20%) 17 / 9544 (0.18%)      occurrences causally related to treatment / all 0 / 19 1 / 17      deaths causally related to treatment / all 0 / 0 0 / 1 Diabetic macroangiopathy      subjects affected / exposed 1 / 9539 (0.01%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 1 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Diabetic microangiopathy      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Diabetic vascular disorder      subjects affected / exposed 3 / 9539 (0.03%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 3 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Embolism      subjects affected / exposed 1 / 9539 (0.01%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 1 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 1 Essential hypertension      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Extremity necrosis      subjects affected / exposed 5 / 9539 (0.05%) 7 / 9544 (0.07%)      occurrences causally related to treatment / all 0 / 6 0 / 7      deaths causally related to treatment / all 0 / 0 0 / 0 Femoral artery aneurysm      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Femoral artery dissection      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (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 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Femoral artery occlusion      subjects affected / exposed 10 / 9539 (0.10%) 14 / 9544 (0.15%)      occurrences causally related to treatment / all 0 / 11 0 / 15      deaths causally related to treatment / all 0 / 0 0 / 0 Haemorrhage      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (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 204 / 9539 (2.14%) 144 / 9544 (1.51%)      occurrences causally related to treatment / all 2 / 220 0 / 152      deaths causally related to treatment / all 0 / 0 0 / 0 Hypertensive crisis      subjects affected / exposed 104 / 9539 (1.09%) 105 / 9544 (1.10%)      occurrences causally related to treatment / all 1 / 117 0 / 119      deaths causally related to treatment / all 0 / 0 0 / 0 Hypertensive emergency      subjects affected / exposed 13 / 9539 (0.14%) 8 / 9544 (0.08%)      occurrences causally related to treatment / all 1 / 15 0 / 8      deaths causally related to treatment / all 0 / 0 0 / 0 Hypotension      subjects affected / exposed 25 / 9539 (0.26%) 36 / 9544 (0.38%)      occurrences causally related to treatment / all 5 / 26 0 / 37      deaths causally related to treatment / all 0 / 0 0 / 0 Hypovolaemic shock      subjects affected / exposed 1 / 9539 (0.01%) 4 / 9544 (0.04%)      occurrences causally related to treatment / all 0 / 1 0 / 4      deaths causally related to treatment / all 0 / 0 0 / 1 Iliac artery occlusion      subjects affected / exposed 1 / 9539 (0.01%) 4 / 9544 (0.04%)      occurrences causally related to treatment / all 0 / 1 0 / 4      deaths causally related to treatment / all 0 / 0 0 / 0 Iliac artery rupture      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Intermittent claudication      subjects affected / exposed 5 / 9539 (0.05%) 8 / 9544 (0.08%)      occurrences causally related to treatment / all 0 / 5 0 / 9      deaths causally related to treatment / all 0 / 0 0 / 0 Jugular vein thrombosis      subjects affected / exposed 2 / 9539 (0.02%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 2 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Labile blood pressure      subjects affected / exposed 1 / 9539 (0.01%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 1 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Labile hypertension      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (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 / 9539 (0.01%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 1 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Lymphoedema      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Lymphostasis      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Malignant hypertension      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (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 / 9539 (0.13%) 6 / 9544 (0.06%)      occurrences causally related to treatment / all 2 / 12 0 / 6      deaths causally related to treatment / all 0 / 0 0 / 0 Pallor      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Peripheral arterial occlusive disease      subjects affected / exposed 52 / 9539 (0.55%) 67 / 9544 (0.70%)      occurrences causally related to treatment / all 0 / 58 0 / 70      deaths causally related to treatment / all 0 / 0 0 / 0 Peripheral artery aneurysm      subjects affected / exposed 3 / 9539 (0.03%) 3 / 9544 (0.03%)      occurrences causally related to treatment / all 0 / 3 0 / 3      deaths causally related to treatment / all 0 / 0 0 / 0 Peripheral artery dissection      subjects affected / exposed 0 / 9539 (0.00%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 0 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 Peripheral artery stenosis      subjects affected / exposed 13 / 9539 (0.14%) 12 / 9544 (0.13%)      occurrences causally related to treatment / all 0 / 16 0 / 12      deaths causally related to treatment / all 0 / 0 0 / 0 Peripheral artery thrombosis      subjects affected / exposed 6 / 9539 (0.06%) 6 / 9544 (0.06%)      occurrences causally related to treatment / all 0 / 6 0 / 6      deaths causally related to treatment / all 0 / 0 0 / 0 Peripheral embolism      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Peripheral ischaemia      subjects affected / exposed 5 / 9539 (0.05%) 8 / 9544 (0.08%)      occurrences causally related to treatment / all 0 / 5 0 / 8      deaths causally related to treatment / all 0 / 0 0 / 1 Peripheral vascular disorder      subjects affected / exposed 1 / 9539 (0.01%) 5 / 9544 (0.05%)      occurrences causally related to treatment / all 0 / 1 0 / 5      deaths causally related to treatment / all 0 / 0 0 / 0 Phlebitis      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Phlebitis superficial      subjects affected / exposed 1 / 9539 (0.01%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 1 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Shock haemorrhagic      subjects affected / exposed 3 / 9539 (0.03%) 5 / 9544 (0.05%)      occurrences causally related to treatment / all 0 / 3 0 / 6      deaths causally related to treatment / all 0 / 1 0 / 1 Subclavian artery occlusion      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (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 2 / 9539 (0.02%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 2 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Subclavian steal syndrome      subjects affected / exposed 1 / 9539 (0.01%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 1 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Subgaleal haematoma      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Systolic hypertension      subjects affected / exposed 1 / 9539 (0.01%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 1 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Thrombophlebitis      subjects affected / exposed 5 / 9539 (0.05%) 6 / 9544 (0.06%)      occurrences causally related to treatment / all 0 / 5 0 / 6      deaths causally related to treatment / all 0 / 0 0 / 0 Thrombophlebitis superficial      subjects affected / exposed 2 / 9539 (0.02%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 2 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 Thrombosis      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Varicose ulceration      subjects affected / exposed 1 / 9539 (0.01%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 1 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Varicose vein      subjects affected / exposed 1 / 9539 (0.01%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 1 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Vasculitis      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Vasculitis necrotising      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Vena cava thrombosis      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Venous insufficiency      subjects affected / exposed 3 / 9539 (0.03%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 3 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 Venous thrombosis      subjects affected / exposed 1 / 9539 (0.01%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 1 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Venous thrombosis limb      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Withdrawal hypertension      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Surgical and medical procedures Abdominal hernia repair      subjects affected / exposed 1 / 9539 (0.01%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 1 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Alcohol detoxification      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Aortic aneurysm repair      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Aortic bypass      subjects affected / exposed 2 / 9539 (0.02%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 2 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Aortic valve repair      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Aortic valve replacement      subjects affected / exposed 0 / 9539 (0.00%) 3 / 9544 (0.03%)      occurrences causally related to treatment / all 0 / 0 0 / 3      deaths causally related to treatment / all 0 / 0 0 / 0 Arterial bypass operation      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Arterial stent insertion      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Arteriovenous fistula operation      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Bladder neoplasm surgery      subjects affected / exposed 1 / 9539 (0.01%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 1 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Blepharoplasty      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Bunion operation      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Cardiac ablation      subjects affected / exposed 0 / 9539 (0.00%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 0 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 Cardiac aneurysm repair      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Cardiac rehabilitation therapy      subjects affected / exposed 23 / 9539 (0.24%) 19 / 9544 (0.20%)      occurrences causally related to treatment / all 0 / 30 0 / 27      deaths causally related to treatment / all 0 / 0 0 / 0 Carotid angioplasty      subjects affected / exposed 2 / 9539 (0.02%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 2 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Carotid artery bypass      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Carotid artery stent insertion      subjects affected / exposed 2 / 9539 (0.02%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 2 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Carotid endarterectomy      subjects affected / exposed 2 / 9539 (0.02%) 3 / 9544 (0.03%)      occurrences causally related to treatment / all 0 / 2 0 / 3      deaths causally related to treatment / all 0 / 0 0 / 0 Cataract operation      subjects affected / exposed 9 / 9539 (0.09%) 9 / 9544 (0.09%)      occurrences causally related to treatment / all 0 / 9 0 / 10      deaths causally related to treatment / all 0 / 0 0 / 0 Chemotherapy      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 Cholecystectomy      subjects affected / exposed 6 / 9539 (0.06%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 6 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 Cholesteatoma removal      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 2 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Circumcision      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Coronary angioplasty      subjects affected / exposed 1 / 9539 (0.01%) 5 / 9544 (0.05%)      occurrences causally related to treatment / all 0 / 1 0 / 5      deaths causally related to treatment / all 0 / 0 0 / 0 Coronary arterial stent insertion      subjects affected / exposed 5 / 9539 (0.05%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 5 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 Coronary artery bypass      subjects affected / exposed 10 / 9539 (0.10%) 18 / 9544 (0.19%)      occurrences causally related to treatment / all 0 / 10 0 / 18      deaths causally related to treatment / all 0 / 0 0 / 0 Coronary revascularisation      subjects affected / exposed 8 / 9539 (0.08%) 5 / 9544 (0.05%)      occurrences causally related to treatment / all 0 / 8 0 / 5      deaths causally related to treatment / all 0 / 0 0 / 0 Diabetes mellitus management      subjects affected / exposed 4 / 9539 (0.04%) 8 / 9544 (0.08%)      occurrences causally related to treatment / all 0 / 5 0 / 12      deaths causally related to treatment / all 0 / 0 0 / 0 Dupuytren's contracture operation      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Fasciectomy      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Femoral hernia repair      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Finger amputation      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Gastrectomy      subjects affected / exposed 1 / 9539 (0.01%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 1 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Gastric banding      subjects affected / exposed 1 / 9539 (0.01%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 1 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Gastric bypass      subjects affected / exposed 0 / 9539 (0.00%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 0 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 Glaucoma surgery      subjects affected / exposed 0 / 9539 (0.00%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 0 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 Hip arthroplasty      subjects affected / exposed 9 / 9539 (0.09%) 9 / 9544 (0.09%)      occurrences causally related to treatment / all 0 / 10 0 / 9      deaths causally related to treatment / all 0 / 0 0 / 0 Hospitalisation      subjects affected / exposed 8 / 9539 (0.08%) 10 / 9544 (0.10%)      occurrences causally related to treatment / all 0 / 13 0 / 11      deaths causally related to treatment / all 0 / 0 0 / 0 Hydrocele operation      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Ileostomy closure      subjects affected / exposed 0 / 9539 (0.00%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 0 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 Implantable defibrillator insertion      subjects affected / exposed 2 / 9539 (0.02%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 2 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Incisional hernia repair      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Infusion      subjects affected / exposed 0 / 9539 (0.00%) 3 / 9544 (0.03%)      occurrences causally related to treatment / all 0 / 0 0 / 7      deaths causally related to treatment / all 0 / 0 0 / 0 Inguinal hernia repair      subjects affected / exposed 3 / 9539 (0.03%) 9 / 9544 (0.09%)      occurrences causally related to treatment / all 0 / 3 0 / 9      deaths causally related to treatment / all 0 / 0 0 / 0 Internal fixation of fracture      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Intraocular lens extraction      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Keratoplasty      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Knee arthroplasty      subjects affected / exposed 4 / 9539 (0.04%) 12 / 9544 (0.13%)      occurrences causally related to treatment / all 0 / 4 0 / 13      deaths causally related to treatment / all 0 / 0 0 / 0 Knee operation      subjects affected / exposed 1 / 9539 (0.01%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 1 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 Leg amputation      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Lens extraction      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Medical device removal      subjects affected / exposed 2 / 9539 (0.02%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 2 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Liver operation      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Meniscus removal      subjects affected / exposed 2 / 9539 (0.02%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 2 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Metatarsal excision      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 Mitral valve repair      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Nasal polypectomy      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Obesity surgery      subjects affected / exposed 2 / 9539 (0.02%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 2 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Nasal septal operation      subjects affected / exposed 1 / 9539 (0.01%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 1 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Oophorectomy bilateral      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Percutaneous coronary intervention      subjects affected / exposed 15 / 9539 (0.16%) 16 / 9544 (0.17%)      occurrences causally related to treatment / all 0 / 15 0 / 16      deaths causally related to treatment / all 0 / 1 0 / 0 Peripheral artery angioplasty      subjects affected / exposed 0 / 9539 (0.00%) 4 / 9544 (0.04%)      occurrences causally related to treatment / all 0 / 0 0 / 4      deaths causally related to treatment / all 0 / 0 0 / 0 Peripheral artery bypass      subjects affected / exposed 2 / 9539 (0.02%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 2 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Peripheral artery stent insertion      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Physiotherapy      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Radical hysterectomy      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Radiotherapy      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Rehabilitation therapy      subjects affected / exposed 8 / 9539 (0.08%) 10 / 9544 (0.10%)      occurrences causally related to treatment / all 0 / 12 0 / 14      deaths causally related to treatment / all 0 / 0 0 / 0 Removal of internal fixation      subjects affected / exposed 4 / 9539 (0.04%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 4 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Renal artery ablation      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Renal stone removal      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Retinal laser coagulation      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Rotator cuff repair      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Shoulder arthroplasty      subjects affected / exposed 1 / 9539 (0.01%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 1 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Sinus operation      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Skin neoplasm excision      subjects affected / exposed 2 / 9539 (0.02%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 2 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Spinal operation      subjects affected / exposed 0 / 9539 (0.00%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 0 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 Suture insertion      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Thyroidectomy      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Toe amputation      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Transurethral prostatectomy      subjects affected / exposed 3 / 9539 (0.03%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 3 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 Umbilical hernia repair      subjects affected / exposed 1 / 9539 (0.01%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 1 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 Urethral dilation procedure      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Urinary calculus removal      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Uterine polypectomy      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Vaginal prolapse repair      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 General disorders and administration site conditions Apparent death      subjects affected / exposed 1 / 9539 (0.01%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 1 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Asthenia      subjects affected / exposed 3 / 9539 (0.03%) 6 / 9544 (0.06%)      occurrences causally related to treatment / all 0 / 3 2 / 6      deaths causally related to treatment / all 0 / 0 0 / 0 Cardiac death      subjects affected / exposed 0 / 9539 (0.00%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 0 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 2 Chest discomfort      subjects affected / exposed 3 / 9539 (0.03%) 4 / 9544 (0.04%)      occurrences causally related to treatment / all 1 / 3 0 / 4      deaths causally related to treatment / all 0 / 0 0 / 0 Chest pain      subjects affected / exposed 32 / 9539 (0.34%) 36 / 9544 (0.38%)      occurrences causally related to treatment / all 0 / 35 0 / 50      deaths causally related to treatment / all 0 / 0 0 / 0 Chills      subjects affected / exposed 0 / 9539 (0.00%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 0 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 Death      subjects affected / exposed 10 / 9539 (0.10%) 7 / 9544 (0.07%)      occurrences causally related to treatment / all 0 / 10 0 / 7      deaths causally related to treatment / all 0 / 10 0 / 7 Device breakage      subjects affected / exposed 1 / 9539 (0.01%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 1 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Device dislocation      subjects affected / exposed 3 / 9539 (0.03%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 3 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 Device extrusion      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Device failure      subjects affected / exposed 2 / 9539 (0.02%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 2 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Device malfunction      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Device occlusion      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Discomfort      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (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 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 1 Drug interaction      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Exercise tolerance decreased      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 1 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Face oedema      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Fatigue      subjects affected / exposed 7 / 9539 (0.07%) 4 / 9544 (0.04%)      occurrences causally related to treatment / all 2 / 7 0 / 4      deaths causally related to treatment / all 0 / 0 0 / 0 Feeling abnormal      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Feeling cold      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Foreign body reaction      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (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 1 / 9539 (0.01%) 3 / 9544 (0.03%)      occurrences causally related to treatment / all 1 / 1 1 / 3      deaths causally related to treatment / all 0 / 0 0 / 0 General physical health deterioration      subjects affected / exposed 3 / 9539 (0.03%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 3 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 Generalised oedema      subjects affected / exposed 3 / 9539 (0.03%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 5 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 Hernia obstructive      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Impaired healing      subjects affected / exposed 1 / 9539 (0.01%) 1 / 9544 (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 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Irritability      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Malaise      subjects affected / exposed 2 / 9539 (0.02%) 3 / 9544 (0.03%)      occurrences causally related to treatment / all 0 / 2 0 / 3      deaths causally related to treatment / all 0 / 0 0 / 0 Medical device complication      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Multi-organ failure      subjects affected / exposed 5 / 9539 (0.05%) 8 / 9544 (0.08%)      occurrences causally related to treatment / all 0 / 5 0 / 8      deaths causally related to treatment / all 0 / 3 0 / 3 Non-cardiac chest pain      subjects affected / exposed 38 / 9539 (0.40%) 29 / 9544 (0.30%)      occurrences causally related to treatment / all 0 / 43 1 / 31      deaths causally related to treatment / all 0 / 0 0 / 0 Oedema peripheral      subjects affected / exposed 9 / 9539 (0.09%) 6 / 9544 (0.06%)      occurrences causally related to treatment / all 0 / 9 0 / 6      deaths causally related to treatment / all 0 / 0 0 / 0 Pacemaker generated arrhythmia      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Pain      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Puncture site haemorrhage      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Pyrexia      subjects affected / exposed 5 / 9539 (0.05%) 4 / 9544 (0.04%)      occurrences causally related to treatment / all 0 / 5 0 / 4      deaths causally related to treatment / all 0 / 0 0 / 0 Spinal pain      subjects affected / exposed 3 / 9539 (0.03%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 4 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Stent-graft endoleak      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Sudden cardiac death      subjects affected / exposed 43 / 9539 (0.45%) 46 / 9544 (0.48%)      occurrences causally related to treatment / all 0 / 43 0 / 46      deaths causally related to treatment / all 0 / 43 0 / 46 Sudden death      subjects affected / exposed 75 / 9539 (0.79%) 74 / 9544 (0.78%)      occurrences causally related to treatment / all 0 / 75 0 / 74      deaths causally related to treatment / all 0 / 75 0 / 74 Systemic inflammatory response syndrome      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Thrombosis in device      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 1 0 / 0 Immune system disorders Allergy to arthropod sting      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Amyloidosis      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Anaphylactic reaction      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Anaphylactic shock      subjects affected / exposed 0 / 9539 (0.00%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 0 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 1 Drug hypersensitivity      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Food allergy      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (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 / 9539 (0.01%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 1 1 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Social circumstances Activities of daily living impaired      subjects affected / exposed 11 / 9539 (0.12%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 11 / 11 1 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Alcohol use      subjects affected / exposed 2 / 9539 (0.02%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 2 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Immobile      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Impaired driving ability      subjects affected / exposed 15 / 9539 (0.16%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 15 / 15 1 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Reproductive system and breast disorders Acquired hydrocele      subjects affected / exposed 0 / 9539 (0.00%) 4 / 9544 (0.04%)      occurrences causally related to treatment / all 0 / 0 0 / 4      deaths causally related to treatment / all 0 / 0 0 / 0 Acquired phimosis      subjects affected / exposed 3 / 9539 (0.03%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 3 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Benign prostatic hyperplasia      subjects affected / exposed 23 / 9539 (0.24%) 28 / 9544 (0.29%)      occurrences causally related to treatment / all 0 / 23 0 / 28      deaths causally related to treatment / all 0 / 0 0 / 0 Breast disorder      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (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 / 9539 (0.02%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 2 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Epididymitis      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (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 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Genital prolapse      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Gynaecomastia      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Pelvic adhesions      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (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 0 / 9539 (0.00%) 3 / 9544 (0.03%)      occurrences causally related to treatment / all 0 / 0 0 / 3      deaths causally related to treatment / all 0 / 0 0 / 0 Prostatomegaly      subjects affected / exposed 2 / 9539 (0.02%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 2 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 Uterine prolapse      subjects affected / exposed 0 / 9539 (0.00%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 0 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 Uterovaginal prolapse      subjects affected / exposed 1 / 9539 (0.01%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 1 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Vaginal haemorrhage      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Varicocele      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Vulval disorder      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (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 Acquired tracheo-oesophageal fistula      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Acute pulmonary oedema      subjects affected / exposed 31 / 9539 (0.32%) 30 / 9544 (0.31%)      occurrences causally related to treatment / all 0 / 33 0 / 32      deaths causally related to treatment / all 0 / 4 0 / 4 Acute respiratory distress syndrome      subjects affected / exposed 1 / 9539 (0.01%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 1 0 / 2      deaths causally related to treatment / all 0 / 1 0 / 0 Acute respiratory failure      subjects affected / exposed 13 / 9539 (0.14%) 12 / 9544 (0.13%)      occurrences causally related to treatment / all 1 / 13 0 / 13      deaths causally related to treatment / all 0 / 3 0 / 1 Alveolitis allergic      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Asphyxia      subjects affected / exposed 1 / 9539 (0.01%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 1 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 1 Asthma      subjects affected / exposed 21 / 9539 (0.22%) 16 / 9544 (0.17%)      occurrences causally related to treatment / all 0 / 22 0 / 21      deaths causally related to treatment / all 0 / 0 0 / 0 Aspiration      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 1 0 / 0 Asthmatic crisis      subjects affected / exposed 1 / 9539 (0.01%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 1 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Atelectasis      subjects affected / exposed 0 / 9539 (0.00%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 0 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 Bronchiectasis      subjects affected / exposed 5 / 9539 (0.05%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 5 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Bronchitis chronic      subjects affected / exposed 5 / 9539 (0.05%) 3 / 9544 (0.03%)      occurrences causally related to treatment / all 0 / 6 0 / 5      deaths causally related to treatment / all 0 / 0 0 / 0 Bronchopneumopathy      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Bronchospasm      subjects affected / exposed 5 / 9539 (0.05%) 3 / 9544 (0.03%)      occurrences causally related to treatment / all 0 / 5 1 / 3      deaths causally related to treatment / all 0 / 0 0 / 0 Choking      subjects affected / exposed 1 / 9539 (0.01%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 1 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Chronic obstructive pulmonary disease      subjects affected / exposed 64 / 9539 (0.67%) 52 / 9544 (0.54%)      occurrences causally related to treatment / all 0 / 84 0 / 62      deaths causally related to treatment / all 0 / 1 0 / 1 Chronic respiratory failure      subjects affected / exposed 4 / 9539 (0.04%) 3 / 9544 (0.03%)      occurrences causally related to treatment / all 0 / 4 0 / 3      deaths causally related to treatment / all 0 / 1 0 / 0 Cough      subjects affected / exposed 7 / 9539 (0.07%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 7 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 Cyanosis central      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Diaphragmatic paralysis      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Dyspnoea      subjects affected / exposed 23 / 9539 (0.24%) 23 / 9544 (0.24%)      occurrences causally related to treatment / all 0 / 25 2 / 26      deaths causally related to treatment / all 0 / 0 0 / 1 Dyspnoea at rest      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Dyspnoea exertional      subjects affected / exposed 1 / 9539 (0.01%) 6 / 9544 (0.06%)      occurrences causally related to treatment / all 1 / 1 0 / 6      deaths causally related to treatment / all 0 / 0 0 / 0 Emphysema      subjects affected / exposed 1 / 9539 (0.01%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 1 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 Epistaxis      subjects affected / exposed 4 / 9539 (0.04%) 6 / 9544 (0.06%)      occurrences causally related to treatment / all 0 / 4 0 / 7      deaths causally related to treatment / all 0 / 0 0 / 0 Granulomatous pneumonitis      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Haemoptysis      subjects affected / exposed 4 / 9539 (0.04%) 3 / 9544 (0.03%)      occurrences causally related to treatment / all 0 / 4 0 / 3      deaths causally related to treatment / all 0 / 0 0 / 0 Haemothorax      subjects affected / exposed 0 / 9539 (0.00%) 6 / 9544 (0.06%)      occurrences causally related to treatment / all 0 / 0 0 / 6      deaths causally related to treatment / all 0 / 0 0 / 0 Hydropneumothorax      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 1 Hydrothorax      subjects affected / exposed 6 / 9539 (0.06%) 8 / 9544 (0.08%)      occurrences causally related to treatment / all 0 / 6 0 / 8      deaths causally related to treatment / all 0 / 0 0 / 0 Hypoxia      subjects affected / exposed 1 / 9539 (0.01%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 1 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Idiopathic pulmonary fibrosis      subjects affected / exposed 2 / 9539 (0.02%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 2 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Interstitial lung disease      subjects affected / exposed 6 / 9539 (0.06%) 3 / 9544 (0.03%)      occurrences causally related to treatment / all 0 / 6 0 / 3      deaths causally related to treatment / all 0 / 1 0 / 0 Laryngeal stenosis      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Lung consolidation      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Lung cyst      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Lung disorder      subjects affected / exposed 1 / 9539 (0.01%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 1 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Lung infiltration      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Nasal polyps      subjects affected / exposed 2 / 9539 (0.02%) 4 / 9544 (0.04%)      occurrences causally related to treatment / all 0 / 2 0 / 4      deaths causally related to treatment / all 0 / 0 0 / 0 Nasal septum deviation      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Obstructive airways disorder      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Organising pneumonia      subjects affected / exposed 1 / 9539 (0.01%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 1 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Pharyngeal oedema      subjects affected / exposed 0 / 9539 (0.00%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 0 1 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 Pickwickian syndrome      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Pleural effusion      subjects affected / exposed 8 / 9539 (0.08%) 7 / 9544 (0.07%)      occurrences causally related to treatment / all 0 / 8 0 / 7      deaths causally related to treatment / all 0 / 0 0 / 0 Pleural fibrosis      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Pleural haemorrhage      subjects affected / exposed 0 / 9539 (0.00%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 0 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 1 Pleurisy      subjects affected / exposed 2 / 9539 (0.02%) 7 / 9544 (0.07%)      occurrences causally related to treatment / all 0 / 2 0 / 7      deaths causally related to treatment / all 0 / 0 0 / 0 Pneumonia aspiration      subjects affected / exposed 7 / 9539 (0.07%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 7 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 1 Pneumonitis      subjects affected / exposed 2 / 9539 (0.02%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 2 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Pneumothorax      subjects affected / exposed 2 / 9539 (0.02%) 6 / 9544 (0.06%)      occurrences causally related to treatment / all 0 / 2 0 / 6      deaths causally related to treatment / all 0 / 0 0 / 0 Pulmonary arterial hypertension      subjects affected / exposed 0 / 9539 (0.00%) 3 / 9544 (0.03%)      occurrences causally related to treatment / all 0 / 0 0 / 3      deaths causally related to treatment / all 0 / 0 0 / 0 Pulmonary artery thrombosis      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Pulmonary congestion      subjects affected / exposed 0 / 9539 (0.00%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 0 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 Pulmonary embolism      subjects affected / exposed 15 / 9539 (0.16%) 24 / 9544 (0.25%)      occurrences causally related to treatment / all 0 / 15 0 / 24      deaths causally related to treatment / all 0 / 5 0 / 8 Pulmonary fibrosis      subjects affected / exposed 4 / 9539 (0.04%) 5 / 9544 (0.05%)      occurrences causally related to treatment / all 0 / 5 0 / 5      deaths causally related to treatment / all 0 / 1 0 / 0 Pulmonary granuloma      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Pulmonary hypertension      subjects affected / exposed 19 / 9539 (0.20%) 10 / 9544 (0.10%)      occurrences causally related to treatment / all 0 / 19 0 / 10      deaths causally related to treatment / all 0 / 2 0 / 0 Pulmonary mass      subjects affected / exposed 1 / 9539 (0.01%) 4 / 9544 (0.04%)      occurrences causally related to treatment / all 0 / 1 0 / 4      deaths causally related to treatment / all 0 / 0 0 / 0 Pulmonary microemboli      subjects affected / exposed 2 / 9539 (0.02%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 2 0 / 0      deaths causally related to treatment / all 0 / 1 0 / 0 Pulmonary oedema      subjects affected / exposed 15 / 9539 (0.16%) 12 / 9544 (0.13%)      occurrences causally related to treatment / all 0 / 16 0 / 12      deaths causally related to treatment / all 0 / 1 0 / 0 Pulmonary thrombosis      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 1 Reflux laryngitis      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Respiration abnormal      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Respiratory acidosis      subjects affected / exposed 1 / 9539 (0.01%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 1 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Respiratory arrest      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 1 Respiratory disorder      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Respiratory distress      subjects affected / exposed 0 / 9539 (0.00%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 0 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 Respiratory failure      subjects affected / exposed 21 / 9539 (0.22%) 27 / 9544 (0.28%)      occurrences causally related to treatment / all 0 / 21 0 / 28      deaths causally related to treatment / all 0 / 5 0 / 6 Sinus polyp      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Sleep apnoea syndrome      subjects affected / exposed 7 / 9539 (0.07%) 5 / 9544 (0.05%)      occurrences causally related to treatment / all 0 / 7 0 / 5      deaths causally related to treatment / all 0 / 0 0 / 0 Snoring      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Status asthmaticus      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Tachypnoea      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Vocal cord polyp      subjects affected / exposed 1 / 9539 (0.01%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 1 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Wheezing      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Psychiatric disorders Acute psychosis      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 1 Aggression      subjects affected / exposed 3 / 9539 (0.03%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 3 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 Agitated depression      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (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 2 / 9539 (0.02%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 2 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Alcohol abuse      subjects affected / exposed 2 / 9539 (0.02%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 2 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Alcohol withdrawal syndrome      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Alcoholism      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Anxiety      subjects affected / exposed 4 / 9539 (0.04%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 4 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 Bipolar I disorder      subjects affected / exposed 0 / 9539 (0.00%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 0 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 Bipolar disorder      subjects affected / exposed 1 / 9539 (0.01%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 1 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Completed suicide      subjects affected / exposed 0 / 9539 (0.00%) 4 / 9544 (0.04%)      occurrences causally related to treatment / all 0 / 0 0 / 4      deaths causally related to treatment / all 0 / 0 0 / 4 Confusional state      subjects affected / exposed 7 / 9539 (0.07%) 10 / 9544 (0.10%)      occurrences causally related to treatment / all 1 / 7 0 / 10      deaths causally related to treatment / all 0 / 0 0 / 0 Delirium      subjects affected / exposed 8 / 9539 (0.08%) 7 / 9544 (0.07%)      occurrences causally related to treatment / all 0 / 9 0 / 7      deaths causally related to treatment / all 0 / 0 0 / 0 Delirium tremens      subjects affected / exposed 1 / 9539 (0.01%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 1 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Delusional disorder, unspecified type      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Depressed mood      subjects affected / exposed 3 / 9539 (0.03%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 1 / 3 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 Depression      subjects affected / exposed 57 / 9539 (0.60%) 54 / 9544 (0.57%)      occurrences causally related to treatment / all 0 / 59 0 / 54      deaths causally related to treatment / all 0 / 0 0 / 0 Depression suicidal      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Depressive symptom      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Disorientation      subjects affected / exposed 1 / 9539 (0.01%) 3 / 9544 (0.03%)      occurrences causally related to treatment / all 0 / 1 0 / 3      deaths causally related to treatment / all 0 / 0 0 / 0 Dysthymic disorder      subjects affected / exposed 1 / 9539 (0.01%) 3 / 9544 (0.03%)      occurrences causally related to treatment / all 0 / 1 0 / 3      deaths causally related to treatment / all 0 / 0 0 / 0 Hallucination      subjects affected / exposed 2 / 9539 (0.02%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 2 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Hallucination, auditory      subjects affected / exposed 0 / 9539 (0.00%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 0 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 Hallucination, visual      subjects affected / exposed 1 / 9539 (0.01%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 1 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Hallucinations, mixed      subjects affected / exposed 1 / 9539 (0.01%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 1 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Impulsive behaviour      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Insomnia      subjects affected / exposed 2 / 9539 (0.02%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 2 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Intentional drug misuse      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (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 1 / 9539 (0.01%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 1 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 Mood disorder due to a general medical condition      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Nervousness      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Obsessive thoughts      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Panic attack      subjects affected / exposed 1 / 9539 (0.01%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 1 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Paranoia      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Persecutory delusion      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Psychomotor retardation      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Psychosomatic disease      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Psychotic disorder due to a general medical condition      subjects affected / exposed 1 / 9539 (0.01%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 1 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Psychotic disorder      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 1 Sleep disorder      subjects affected / exposed 2 / 9539 (0.02%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 2 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Sleep terror      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (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 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Suicidal ideation      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Suicide attempt      subjects affected / exposed 1 / 9539 (0.01%) 3 / 9544 (0.03%)      occurrences causally related to treatment / all 0 / 1 0 / 4      deaths causally related to treatment / all 0 / 0 0 / 0 Hepatobiliary disorders Acute hepatic failure      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 1 0 / 0 Alcoholic liver disease      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Bile duct stone      subjects affected / exposed 4 / 9539 (0.04%) 4 / 9544 (0.04%)      occurrences causally related to treatment / all 0 / 4 0 / 4      deaths causally related to treatment / all 0 / 0 0 / 1 Biliary cirrhosis primary      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Biliary colic      subjects affected / exposed 1 / 9539 (0.01%) 3 / 9544 (0.03%)      occurrences causally related to treatment / all 0 / 1 0 / 3      deaths causally related to treatment / all 0 / 0 0 / 0 Biliary tract disorder      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (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 2 / 9539 (0.02%) 6 / 9544 (0.06%)      occurrences causally related to treatment / all 0 / 2 0 / 6      deaths causally related to treatment / all 0 / 0 0 / 0 Cholecystitis      subjects affected / exposed 9 / 9539 (0.09%) 10 / 9544 (0.10%)      occurrences causally related to treatment / all 0 / 10 0 / 10      deaths causally related to treatment / all 0 / 0 0 / 0 Cholangitis acute      subjects affected / exposed 0 / 9539 (0.00%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 0 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 Cholecystitis acute      subjects affected / exposed 19 / 9539 (0.20%) 17 / 9544 (0.18%)      occurrences causally related to treatment / all 0 / 19 0 / 17      deaths causally related to treatment / all 0 / 0 0 / 0 Cholecystitis chronic      subjects affected / exposed 7 / 9539 (0.07%) 4 / 9544 (0.04%)      occurrences causally related to treatment / all 0 / 7 0 / 4      deaths causally related to treatment / all 0 / 0 0 / 0 Cholelithiasis      subjects affected / exposed 12 / 9539 (0.13%) 20 / 9544 (0.21%)      occurrences causally related to treatment / all 0 / 12 0 / 20      deaths causally related to treatment / all 0 / 0 0 / 1 Cholestasis      subjects affected / exposed 0 / 9539 (0.00%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 0 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 Chronic hepatitis      subjects affected / exposed 2 / 9539 (0.02%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 2 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Cirrhosis alcoholic      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (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 / 9539 (0.01%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 1 1 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Gallbladder perforation      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Gallbladder polyp      subjects affected / exposed 0 / 9539 (0.00%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 0 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 Hepatic cirrhosis      subjects affected / exposed 7 / 9539 (0.07%) 4 / 9544 (0.04%)      occurrences causally related to treatment / all 0 / 8 0 / 4      deaths causally related to treatment / all 0 / 0 0 / 1 Hepatic congestion      subjects affected / exposed 1 / 9539 (0.01%) 4 / 9544 (0.04%)      occurrences causally related to treatment / all 0 / 1 0 / 4      deaths causally related to treatment / all 0 / 0 0 / 0 Hepatic cyst      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Hepatic failure      subjects affected / exposed 0 / 9539 (0.00%) 3 / 9544 (0.03%)      occurrences causally related to treatment / all 0 / 0 0 / 3      deaths causally related to treatment / all 0 / 0 0 / 1 Hepatic mass      subjects affected / exposed 0 / 9539 (0.00%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 0 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 Hepatic steatosis      subjects affected / exposed 1 / 9539 (0.01%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 1 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 Hepatitis acute      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Hepatitis alcoholic      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Hepatitis cholestatic      subjects affected / exposed 1 / 9539 (0.01%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 1 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Hepatomegaly      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Hyperbilirubinaemia      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (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 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Jaundice      subjects affected / exposed 1 / 9539 (0.01%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 1 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Jaundice cholestatic      subjects affected / exposed 2 / 9539 (0.02%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 2 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Liver disorder      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Liver injury      subjects affected / exposed 3 / 9539 (0.03%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 3 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Portal vein thrombosis      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Sphincter of Oddi dysfunction      subjects affected / exposed 1 / 9539 (0.01%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 1 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Post cholecystectomy syndrome      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Investigations Alanine aminotransferase increased      subjects affected / exposed 11 / 9539 (0.12%) 11 / 9544 (0.12%)      occurrences causally related to treatment / all 0 / 11 1 / 11      deaths causally related to treatment / all 0 / 0 0 / 1 Amylase increased      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Arteriogram carotid      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Arteriogram coronary      subjects affected / exposed 43 / 9539 (0.45%) 53 / 9544 (0.56%)      occurrences causally related to treatment / all 0 / 45 0 / 58      deaths causally related to treatment / all 0 / 0 0 / 0 Arthroscopy      subjects affected / exposed 1 / 9539 (0.01%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 1 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Aspartate aminotransferase increased      subjects affected / exposed 12 / 9539 (0.13%) 10 / 9544 (0.10%)      occurrences causally related to treatment / all 0 / 12 1 / 10      deaths causally related to treatment / all 0 / 0 0 / 1 Biopsy prostate      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Blood alkaline phosphatase increased      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Blood creatine phosphokinase increased      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Blood creatinine increased      subjects affected / exposed 3 / 9539 (0.03%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 3 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Blood glucose decreased      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Blood glucose increased      subjects affected / exposed 2 / 9539 (0.02%) 6 / 9544 (0.06%)      occurrences causally related to treatment / all 0 / 2 0 / 6      deaths causally related to treatment / all 0 / 0 0 / 0 Blood iron decreased      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Blood lactate dehydrogenase increased      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Blood parathyroid hormone decreased      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Blood potassium decreased      subjects affected / exposed 0 / 9539 (0.00%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 0 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 Blood potassium increased      subjects affected / exposed 4 / 9539 (0.04%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 4 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Blood pressure decreased      subjects affected / exposed 2 / 9539 (0.02%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 2 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Blood pressure increased      subjects affected / exposed 24 / 9539 (0.25%) 13 / 9544 (0.14%)      occurrences causally related to treatment / all 0 / 26 0 / 14      deaths causally related to treatment / all 0 / 0 0 / 0 Blood pressure systolic decreased      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Blood pressure systolic increased      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Blood triglycerides increased      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Body temperature increased      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 C-reactive protein increased      subjects affected / exposed 1 / 9539 (0.01%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 1 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Cardiac enzymes increased      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Carbohydrate antigen 19-9 increased      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Cardiac stress test abnormal      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Cardiovascular evaluation      subjects affected / exposed 78 / 9539 (0.82%) 84 / 9544 (0.88%)      occurrences causally related to treatment / all 0 / 98 0 / 100      deaths causally related to treatment / all 0 / 0 0 / 0 Catheterisation cardiac      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Cystoscopy normal      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Chest X-ray abnormal      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 ECG signs of myocardial ischaemia      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Ejection fraction decreased      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Electrocardiogram QT prolonged      subjects affected / exposed 57 / 9539 (0.60%) 18 / 9544 (0.19%)      occurrences causally related to treatment / all 42 / 60 6 / 18      deaths causally related to treatment / all 0 / 0 0 / 0 Electrocardiogram ST segment depression      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Electrocardiogram ST segment elevation      subjects affected / exposed 1 / 9539 (0.01%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 1 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Electrocardiogram T wave inversion      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Electrocardiogram ambulatory      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Electrocardiogram change      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Electrocardiogram repolarisation abnormality      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Fibrin D dimer increased      subjects affected / exposed 0 / 9539 (0.00%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 0 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 Gamma-glutamyltransferase increased      subjects affected / exposed 2 / 9539 (0.02%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 2 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Gastrointestinal examination      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Haemoglobin decreased      subjects affected / exposed 2 / 9539 (0.02%) 6 / 9544 (0.06%)      occurrences causally related to treatment / all 0 / 2 0 / 6      deaths causally related to treatment / all 0 / 0 0 / 0 Heart rate decreased      subjects affected / exposed 55 / 9539 (0.58%) 7 / 9544 (0.07%)      occurrences causally related to treatment / all 40 / 55 4 / 7      deaths causally related to treatment / all 0 / 0 0 / 0 Hepatic enzyme increased      subjects affected / exposed 2 / 9539 (0.02%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 2 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 International normalised ratio increased      subjects affected / exposed 1 / 9539 (0.01%) 3 / 9544 (0.03%)      occurrences causally related to treatment / all 0 / 1 0 / 3      deaths causally related to treatment / all 0 / 0 0 / 0 Intraocular pressure increased      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Investigation      subjects affected / exposed 7 / 9539 (0.07%) 6 / 9544 (0.06%)      occurrences causally related to treatment / all 0 / 7 0 / 7      deaths causally related to treatment / all 0 / 0 0 / 0 Oxygen saturation decreased      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Platelet count decreased      subjects affected / exposed 2 / 9539 (0.02%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 2 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Pulmonary arterial pressure increased      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Red blood cell sedimentation rate increased      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Romberg test positive      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Sleep study      subjects affected / exposed 3 / 9539 (0.03%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 3 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Streptococcus test positive      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Stress echocardiogram abnormal      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Thyroid function test abnormal      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Treponema test positive      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (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 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Weight decreased      subjects affected / exposed 5 / 9539 (0.05%) 11 / 9544 (0.12%)      occurrences causally related to treatment / all 0 / 5 0 / 11      deaths causally related to treatment / all 0 / 0 0 / 0 White blood cell count increased      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Injury, poisoning and procedural complications Abdominal injury      subjects affected / exposed 1 / 9539 (0.01%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 1 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Abdominal wound dehiscence      subjects affected / exposed 1 / 9539 (0.01%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 1 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Accident      subjects affected / exposed 0 / 9539 (0.00%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 0 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 Accident at home      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Accidental overdose      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Agitation postoperative      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Alcohol poisoning      subjects affected / exposed 0 / 9539 (0.00%) 3 / 9544 (0.03%)      occurrences causally related to treatment / all 0 / 0 0 / 3      deaths causally related to treatment / all 0 / 0 0 / 0 Anaemia postoperative      subjects affected / exposed 2 / 9539 (0.02%) 4 / 9544 (0.04%)      occurrences causally related to treatment / all 0 / 2 0 / 4      deaths causally related to treatment / all 0 / 0 0 / 0 Ankle fracture      subjects affected / exposed 6 / 9539 (0.06%) 8 / 9544 (0.08%)      occurrences causally related to treatment / all 0 / 6 0 / 8      deaths causally related to treatment / all 0 / 0 0 / 0 Aortic injury      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (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 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Arthropod sting      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Asbestosis      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Back injury      subjects affected / exposed 1 / 9539 (0.01%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 1 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Blindness traumatic      subjects affected / exposed 2 / 9539 (0.02%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 2 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Bone fissure      subjects affected / exposed 1 / 9539 (0.01%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 1 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 Brain contusion      subjects affected / exposed 4 / 9539 (0.04%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 4 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 1 Burns second degree      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Carbon monoxide poisoning      subjects affected / exposed 0 / 9539 (0.00%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 0 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 1 Cardiac contusion      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Cardiac procedure complication      subjects affected / exposed 0 / 9539 (0.00%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 0 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 Cardiac valve replacement complication      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Cardiac valve rupture      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Carotid artery restenosis      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Cervical vertebral fracture      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Chest injury      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Clavicle fracture      subjects affected / exposed 1 / 9539 (0.01%) 4 / 9544 (0.04%)      occurrences causally related to treatment / all 0 / 1 0 / 4      deaths causally related to treatment / all 0 / 0 0 / 0 Concussion      subjects affected / exposed 6 / 9539 (0.06%) 3 / 9544 (0.03%)      occurrences causally related to treatment / all 0 / 6 0 / 3      deaths causally related to treatment / all 0 / 0 0 / 0 Contusion      subjects affected / exposed 9 / 9539 (0.09%) 8 / 9544 (0.08%)      occurrences causally related to treatment / all 0 / 9 0 / 8      deaths causally related to treatment / all 0 / 0 0 / 0 Coronary artery restenosis      subjects affected / exposed 9 / 9539 (0.09%) 12 / 9544 (0.13%)      occurrences causally related to treatment / all 0 / 9 0 / 12      deaths causally related to treatment / all 0 / 0 0 / 0 Corrosive gastritis      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Craniocerebral injury      subjects affected / exposed 2 / 9539 (0.02%) 5 / 9544 (0.05%)      occurrences causally related to treatment / all 0 / 2 0 / 6      deaths causally related to treatment / all 0 / 0 0 / 0 Crushing injury of trunk      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Extradural haematoma      subjects affected / exposed 0 / 9539 (0.00%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 0 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 Eye contusion      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Eye injury      subjects affected / exposed 3 / 9539 (0.03%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 3 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Face injury      subjects affected / exposed 2 / 9539 (0.02%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 2 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Facial bones fracture      subjects affected / exposed 1 / 9539 (0.01%) 4 / 9544 (0.04%)      occurrences causally related to treatment / all 0 / 1 0 / 4      deaths causally related to treatment / all 0 / 0 0 / 0 Febrile nonhaemolytic transfusion reaction      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Fall      subjects affected / exposed 95 / 9539 (1.00%) 109 / 9544 (1.14%)      occurrences causally related to treatment / all 4 / 96 2 / 109      deaths causally related to treatment / all 0 / 0 0 / 0 Femoral neck fracture      subjects affected / exposed 13 / 9539 (0.14%) 12 / 9544 (0.13%)      occurrences causally related to treatment / all 0 / 13 0 / 12      deaths causally related to treatment / all 0 / 0 0 / 0 Femur fracture      subjects affected / exposed 15 / 9539 (0.16%) 10 / 9544 (0.10%)      occurrences causally related to treatment / all 0 / 15 0 / 10      deaths causally related to treatment / all 0 / 0 0 / 0 Fibula fracture      subjects affected / exposed 4 / 9539 (0.04%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 4 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 Foot fracture      subjects affected / exposed 5 / 9539 (0.05%) 3 / 9544 (0.03%)      occurrences causally related to treatment / all 0 / 5 0 / 3      deaths causally related to treatment / all 0 / 0 0 / 0 Foreign body      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Forearm fracture      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Foreign body in eye      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (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 3 / 9539 (0.03%) 4 / 9544 (0.04%)      occurrences causally related to treatment / all 0 / 3 0 / 4      deaths causally related to treatment / all 0 / 0 0 / 0 Head injury      subjects affected / exposed 4 / 9539 (0.04%) 10 / 9544 (0.10%)      occurrences causally related to treatment / all 1 / 4 2 / 11      deaths causally related to treatment / all 0 / 0 0 / 0 Heat stroke      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Hip fracture      subjects affected / exposed 6 / 9539 (0.06%) 6 / 9544 (0.06%)      occurrences causally related to treatment / all 0 / 6 0 / 6      deaths causally related to treatment / all 0 / 0 0 / 0 Humerus fracture      subjects affected / exposed 4 / 9539 (0.04%) 5 / 9544 (0.05%)      occurrences causally related to treatment / all 0 / 4 0 / 5      deaths causally related to treatment / all 0 / 0 0 / 0 Ilium fracture      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Incisional hernia      subjects affected / exposed 0 / 9539 (0.00%) 4 / 9544 (0.04%)      occurrences causally related to treatment / all 0 / 0 0 / 4      deaths causally related to treatment / all 0 / 0 0 / 0 Intentional overdose      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Injury      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Intervertebral disc injury      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Intestinal anastomosis complication      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Jaw fracture      subjects affected / exposed 1 / 9539 (0.01%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 1 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Joint dislocation      subjects affected / exposed 4 / 9539 (0.04%) 3 / 9544 (0.03%)      occurrences causally related to treatment / all 0 / 4 0 / 3      deaths causally related to treatment / all 0 / 0 0 / 0 Joint dislocation postoperative      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Joint injury      subjects affected / exposed 1 / 9539 (0.01%) 4 / 9544 (0.04%)      occurrences causally related to treatment / all 0 / 1 0 / 4      deaths causally related to treatment / all 0 / 0 0 / 0 Kidney rupture      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Laceration      subjects affected / exposed 2 / 9539 (0.02%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 2 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Ligament rupture      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Ligament sprain      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Limb crushing injury      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Limb injury      subjects affected / exposed 1 / 9539 (0.01%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 1 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Limb traumatic amputation      subjects affected / exposed 2 / 9539 (0.02%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 2 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Lip injury      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (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 4 / 9539 (0.04%) 3 / 9544 (0.03%)      occurrences causally related to treatment / all 0 / 4 0 / 3      deaths causally related to treatment / all 0 / 0 0 / 0 Lumbar vertebral fracture      subjects affected / exposed 4 / 9539 (0.04%) 6 / 9544 (0.06%)      occurrences causally related to treatment / all 0 / 4 0 / 6      deaths causally related to treatment / all 0 / 0 0 / 1 Meniscus injury      subjects affected / exposed 2 / 9539 (0.02%) 6 / 9544 (0.06%)      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 1 / 9539 (0.01%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 1 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Multiple injuries      subjects affected / exposed 2 / 9539 (0.02%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 2 0 / 2      deaths causally related to treatment / all 0 / 2 0 / 1 Muscle rupture      subjects affected / exposed 0 / 9539 (0.00%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 0 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 Neck injury      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Osteoradionecrosis      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Pancreatic injury      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Pelvic fracture      subjects affected / exposed 1 / 9539 (0.01%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 1 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 Penetrating abdominal trauma      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Periorbital haematoma      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Peripheral artery restenosis      subjects affected / exposed 1 / 9539 (0.01%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 1 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Pneumoconiosis      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Pneumothorax traumatic      subjects affected / exposed 2 / 9539 (0.02%) 5 / 9544 (0.05%)      occurrences causally related to treatment / all 0 / 2 0 / 5      deaths causally related to treatment / all 0 / 0 0 / 0 Post procedural contusion      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Post procedural complication      subjects affected / exposed 2 / 9539 (0.02%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 2 0 / 2      deaths causally related to treatment / all 0 / 1 0 / 0 Post procedural fistula      subjects affected / exposed 0 / 9539 (0.00%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 0 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 Post procedural haematoma      subjects affected / exposed 3 / 9539 (0.03%) 3 / 9544 (0.03%)      occurrences causally related to treatment / all 0 / 3 0 / 3      deaths causally related to treatment / all 0 / 0 0 / 0 Post procedural haematuria      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Post procedural hypothyroidism      subjects affected / exposed 0 / 9539 (0.00%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 0 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 Post procedural haemorrhage      subjects affected / exposed 3 / 9539 (0.03%) 4 / 9544 (0.04%)      occurrences causally related to treatment / all 0 / 3 0 / 4      deaths causally related to treatment / all 0 / 0 0 / 1 Post procedural myocardial infarction      subjects affected / exposed 14 / 9539 (0.15%) 13 / 9544 (0.14%)      occurrences causally related to treatment / all 0 / 14 0 / 14      deaths causally related to treatment / all 0 / 0 0 / 1 Post procedural pulmonary embolism      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Post-thoracotomy pain syndrome      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Post-traumatic pain      subjects affected / exposed 1 / 9539 (0.01%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 1 / 1 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 Postoperative thoracic procedure complication      subjects affected / exposed 1 / 9539 (0.01%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 1 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 Postoperative ileus      subjects affected / exposed 1 / 9539 (0.01%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 1 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 Postoperative wound complication      subjects affected / exposed 2 / 9539 (0.02%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 2 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 Procedural haemorrhage      subjects affected / exposed 1 / 9539 (0.01%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 1 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Procedural hypertension      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Procedural hypotension      subjects affected / exposed 2 / 9539 (0.02%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 2 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Procedural pain      subjects affected / exposed 2 / 9539 (0.02%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 3 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Procedural site reaction      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Pubis fracture      subjects affected / exposed 1 / 9539 (0.01%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 1 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 Radiation oesophagitis      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Radius fracture      subjects affected / exposed 8 / 9539 (0.08%) 15 / 9544 (0.16%)      occurrences causally related to treatment / all 0 / 8 0 / 15      deaths causally related to treatment / all 0 / 0 0 / 0 Renal haematoma      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Road traffic accident      subjects affected / exposed 23 / 9539 (0.24%) 26 / 9544 (0.27%)      occurrences causally related to treatment / all 0 / 23 0 / 26      deaths causally related to treatment / all 0 / 2 0 / 1 Rib fracture      subjects affected / exposed 8 / 9539 (0.08%) 15 / 9544 (0.16%)      occurrences causally related to treatment / all 0 / 8 0 / 15      deaths causally related to treatment / all 0 / 0 0 / 0 Seroma      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Shunt thrombosis      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Silicosis      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (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 2 / 9539 (0.02%) 3 / 9544 (0.03%)      occurrences causally related to treatment / all 0 / 2 0 / 3      deaths causally related to treatment / all 0 / 0 0 / 0 Skull fractured base      subjects affected / exposed 2 / 9539 (0.02%) 4 / 9544 (0.04%)      occurrences causally related to treatment / all 0 / 2 0 / 4      deaths causally related to treatment / all 0 / 0 0 / 0 Spinal column injury      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (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 3 / 9539 (0.03%) 4 / 9544 (0.04%)      occurrences causally related to treatment / all 0 / 4 0 / 4      deaths causally related to treatment / all 0 / 0 0 / 0 Spinal fracture      subjects affected / exposed 5 / 9539 (0.05%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 5 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 Splenic rupture      subjects affected / exposed 1 / 9539 (0.01%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 1 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 Stab wound      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Sternal fracture      subjects affected / exposed 2 / 9539 (0.02%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 2 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Subcutaneous haematoma      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Subdural haematoma      subjects affected / exposed 8 / 9539 (0.08%) 7 / 9544 (0.07%)      occurrences causally related to treatment / all 0 / 8 0 / 7      deaths causally related to treatment / all 0 / 0 0 / 0 Subdural haemorrhage      subjects affected / exposed 1 / 9539 (0.01%) 3 / 9544 (0.03%)      occurrences causally related to treatment / all 0 / 1 0 / 3      deaths causally related to treatment / all 0 / 0 0 / 1 Suture related complication      subjects affected / exposed 2 / 9539 (0.02%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 2 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Tendon injury      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Tendon rupture      subjects affected / exposed 1 / 9539 (0.01%) 6 / 9544 (0.06%)      occurrences causally related to treatment / all 0 / 1 0 / 6      deaths causally related to treatment / all 0 / 0 0 / 0 Thoracic vertebral fracture      subjects affected / exposed 1 / 9539 (0.01%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 2 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Tibia fracture      subjects affected / exposed 6 / 9539 (0.06%) 3 / 9544 (0.03%)      occurrences causally related to treatment / all 0 / 6 0 / 3      deaths causally related to treatment / all 0 / 0 0 / 0 Tongue injury      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (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 1 / 9539 (0.01%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 1 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 Transfusion reaction      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Traumatic haematoma      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (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 3 / 9539 (0.03%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 3 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 1 Traumatic ulcer      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (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 2 / 9539 (0.02%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 2 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Upper limb fracture      subjects affected / exposed 3 / 9539 (0.03%) 4 / 9544 (0.04%)      occurrences causally related to treatment / all 0 / 3 0 / 4      deaths causally related to treatment / all 0 / 0 0 / 0 Vascular graft complication      subjects affected / exposed 1 / 9539 (0.01%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 1 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Vascular graft occlusion      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (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 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Vasoplegia syndrome      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Vascular pseudoaneurysm      subjects affected / exposed 4 / 9539 (0.04%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 4 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Wound complication      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (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 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Wrist fracture      subjects affected / exposed 2 / 9539 (0.02%) 3 / 9544 (0.03%)      occurrences causally related to treatment / all 0 / 2 0 / 3      deaths causally related to treatment / all 0 / 0 0 / 0 Congenital, familial and genetic disorders Adenomatous polyposis coli      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Congenital umbilical hernia      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Factor V Leiden mutation      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Metabolic myopathy      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Pyloric stenosis      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Cardiac disorders Accelerated idioventricular rhythm      subjects affected / exposed 1 / 9539 (0.01%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 1 / 1 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Acute coronary syndrome      subjects affected / exposed 17 / 9539 (0.18%) 21 / 9544 (0.22%)      occurrences causally related to treatment / all 1 / 18 0 / 24      deaths causally related to treatment / all 0 / 4 0 / 1 Acute left ventricular failure      subjects affected / exposed 2 / 9539 (0.02%) 5 / 9544 (0.05%)      occurrences causally related to treatment / all 0 / 3 0 / 5      deaths causally related to treatment / all 0 / 1 0 / 1 Acute myocardial infarction      subjects affected / exposed 200 / 9539 (2.10%) 208 / 9544 (2.18%)      occurrences causally related to treatment / all 2 / 216 0 / 229      deaths causally related to treatment / all 0 / 23 0 / 23 Adams-Stokes syndrome      subjects affected / exposed 0 / 9539 (0.00%) 3 / 9544 (0.03%)      occurrences causally related to treatment / all 0 / 0 1 / 3      deaths causally related to treatment / all 0 / 0 0 / 0 Angina pectoris      subjects affected / exposed 294 / 9539 (3.08%) 330 / 9544 (3.46%)      occurrences causally related to treatment / all 3 / 314 2 / 361      deaths causally related to treatment / all 0 / 1 0 / 0 Angina unstable      subjects affected / exposed 409 / 9539 (4.29%) 433 / 9544 (4.54%)      occurrences causally related to treatment / all 4 / 479 0 / 524      deaths causally related to treatment / all 0 / 2 0 / 0 Aortic valve disease      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Aortic valve disease mixed      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Aortic valve incompetence      subjects affected / exposed 3 / 9539 (0.03%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 3 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 Aortic valve sclerosis      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Arrhythmia      subjects affected / exposed 2 / 9539 (0.02%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 1 / 2 0 / 0      deaths causally related to treatment / all 1 / 1 0 / 0 Aortic valve stenosis      subjects affected / exposed 12 / 9539 (0.13%) 9 / 9544 (0.09%)      occurrences causally related to treatment / all 0 / 12 0 / 9      deaths causally related to treatment / all 0 / 0 0 / 0 Arrhythmia supraventricular      subjects affected / exposed 2 / 9539 (0.02%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 1 / 2 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Arteriosclerosis coronary artery      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Arteriospasm coronary      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Atrial flutter      subjects affected / exposed 49 / 9539 (0.51%) 41 / 9544 (0.43%)      occurrences causally related to treatment / all 0 / 52 0 / 45      deaths causally related to treatment / all 0 / 0 0 / 0 Atrial fibrillation      subjects affected / exposed 336 / 9539 (3.52%) 232 / 9544 (2.43%)      occurrences causally related to treatment / all 22 / 381 2 / 262      deaths causally related to treatment / all 0 / 0 0 / 0 Atrial tachycardia      subjects affected / exposed 4 / 9539 (0.04%) 5 / 9544 (0.05%)      occurrences causally related to treatment / all 0 / 4 0 / 5      deaths causally related to treatment / all 0 / 0 0 / 0 Atrioventricular block      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Atrioventricular block complete      subjects affected / exposed 17 / 9539 (0.18%) 13 / 9544 (0.14%)      occurrences causally related to treatment / all 4 / 17 1 / 13      deaths causally related to treatment / all 0 / 0 0 / 0 Atrioventricular block first degree      subjects affected / exposed 4 / 9539 (0.04%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 2 / 4 1 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Atrioventricular block second degree      subjects affected / exposed 22 / 9539 (0.23%) 13 / 9544 (0.14%)      occurrences causally related to treatment / all 10 / 22 7 / 13      deaths causally related to treatment / all 0 / 0 0 / 0 Atrioventricular dissociation      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Bradycardia      subjects affected / exposed 101 / 9539 (1.06%) 21 / 9544 (0.22%)      occurrences causally related to treatment / all 91 / 102 15 / 21      deaths causally related to treatment / all 0 / 0 0 / 0 Bundle branch block      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Bundle branch block left      subjects affected / exposed 7 / 9539 (0.07%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 7 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Cardiac aneurysm      subjects affected / exposed 5 / 9539 (0.05%) 9 / 9544 (0.09%)      occurrences causally related to treatment / all 0 / 5 0 / 9      deaths causally related to treatment / all 0 / 0 0 / 0 Cardiac arrest      subjects affected / exposed 15 / 9539 (0.16%) 8 / 9544 (0.08%)      occurrences causally related to treatment / all 0 / 16 0 / 8      deaths causally related to treatment / all 0 / 1 0 / 1 Cardiac asthma      subjects affected / exposed 2 / 9539 (0.02%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 2 0 / 2      deaths causally related to treatment / all 0 / 1 0 / 0 Cardiac failure      subjects affected / exposed 357 / 9539 (3.74%) 346 / 9544 (3.63%)      occurrences causally related to treatment / all 13 / 415 2 / 394      deaths causally related to treatment / all 0 / 16 0 / 14 Cardiac failure acute      subjects affected / exposed 37 / 9539 (0.39%) 23 / 9544 (0.24%)      occurrences causally related to treatment / all 0 / 45 0 / 26      deaths causally related to treatment / all 0 / 7 0 / 9 Cardiac failure congestive      subjects affected / exposed 31 / 9539 (0.32%) 24 / 9544 (0.25%)      occurrences causally related to treatment / all 0 / 33 0 / 26      deaths causally related to treatment / all 0 / 0 0 / 2 Cardiac failure chronic      subjects affected / exposed 25 / 9539 (0.26%) 29 / 9544 (0.30%)      occurrences causally related to treatment / all 1 / 28 0 / 36      deaths causally related to treatment / all 0 / 1 0 / 1 Cardiac tamponade      subjects affected / exposed 1 / 9539 (0.01%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 1 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Cardio-respiratory arrest      subjects affected / exposed 3 / 9539 (0.03%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 3 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Cardiogenic shock      subjects affected / exposed 30 / 9539 (0.31%) 22 / 9544 (0.23%)      occurrences causally related to treatment / all 0 / 30 0 / 22      deaths causally related to treatment / all 0 / 12 0 / 9 Cardiomegaly      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (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 3 / 9539 (0.03%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 3 0 / 1      deaths causally related to treatment / all 0 / 1 0 / 1 Cardiomyopathy      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Cardiovascular insufficiency      subjects affected / exposed 1 / 9539 (0.01%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 1 0 / 2      deaths causally related to treatment / all 0 / 1 0 / 2 Congestive cardiomyopathy      subjects affected / exposed 2 / 9539 (0.02%) 4 / 9544 (0.04%)      occurrences causally related to treatment / all 0 / 2 0 / 4      deaths causally related to treatment / all 0 / 0 0 / 1 Cor pulmonale      subjects affected / exposed 6 / 9539 (0.06%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 6 0 / 0      deaths causally related to treatment / all 0 / 1 0 / 0 Coronary artery disease      subjects affected / exposed 20 / 9539 (0.21%) 25 / 9544 (0.26%)      occurrences causally related to treatment / all 0 / 21 0 / 25      deaths causally related to treatment / all 0 / 0 0 / 0 Cor pulmonale chronic      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Coronary artery dissection      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 2 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Coronary artery insufficiency      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Coronary artery occlusion      subjects affected / exposed 14 / 9539 (0.15%) 7 / 9544 (0.07%)      occurrences causally related to treatment / all 0 / 14 0 / 7      deaths causally related to treatment / all 0 / 0 0 / 0 Coronary artery stenosis      subjects affected / exposed 18 / 9539 (0.19%) 26 / 9544 (0.27%)      occurrences causally related to treatment / all 0 / 19 0 / 26      deaths causally related to treatment / all 0 / 0 0 / 0 Coronary artery thrombosis      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Dressler's syndrome      subjects affected / exposed 1 / 9539 (0.01%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 1 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Endocarditis noninfective      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (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 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Hypertensive heart disease      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Intracardiac thrombus      subjects affected / exposed 5 / 9539 (0.05%) 9 / 9544 (0.09%)      occurrences causally related to treatment / all 0 / 5 0 / 9      deaths causally related to treatment / all 0 / 0 0 / 0 Ischaemic cardiomyopathy      subjects affected / exposed 3 / 9539 (0.03%) 6 / 9544 (0.06%)      occurrences causally related to treatment / all 0 / 5 0 / 6      deaths causally related to treatment / all 0 / 0 0 / 0 Left atrial dilatation      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Left ventricular dysfunction      subjects affected / exposed 1 / 9539 (0.01%) 3 / 9544 (0.03%)      occurrences causally related to treatment / all 0 / 1 0 / 3      deaths causally related to treatment / all 0 / 0 0 / 0 Left ventricular failure      subjects affected / exposed 9 / 9539 (0.09%) 10 / 9544 (0.10%)      occurrences causally related to treatment / all 0 / 10 0 / 10      deaths causally related to treatment / all 0 / 0 0 / 1 Left ventricular hypertrophy      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Low cardiac output syndrome      subjects affected / exposed 1 / 9539 (0.01%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 1 / 1 1 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 Mitral valve incompetence      subjects affected / exposed 16 / 9539 (0.17%) 14 / 9544 (0.15%)      occurrences causally related to treatment / all 0 / 16 0 / 14      deaths causally related to treatment / all 0 / 0 0 / 0 Mitral valve prolapse      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Myocardial depression      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Myocardial fibrosis      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 1 0 / 0 Myocardial infarction      subjects affected / exposed 98 / 9539 (1.03%) 83 / 9544 (0.87%)      occurrences causally related to treatment / all 0 / 104 0 / 88      deaths causally related to treatment / all 0 / 15 0 / 14 Myocardial ischaemia      subjects affected / exposed 23 / 9539 (0.24%) 27 / 9544 (0.28%)      occurrences causally related to treatment / all 0 / 23 0 / 27      deaths causally related to treatment / all 0 / 1 0 / 0 Myocarditis      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Nodal arrhythmia      subjects affected / exposed 1 / 9539 (0.01%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 1 1 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 Nodal rhythm      subjects affected / exposed 5 / 9539 (0.05%) 3 / 9544 (0.03%)      occurrences causally related to treatment / all 1 / 5 0 / 3      deaths causally related to treatment / all 0 / 0 0 / 0 Palpitations      subjects affected / exposed 2 / 9539 (0.02%) 4 / 9544 (0.04%)      occurrences causally related to treatment / all 0 / 2 0 / 4      deaths causally related to treatment / all 0 / 0 0 / 0 Pericardial effusion      subjects affected / exposed 1 / 9539 (0.01%) 5 / 9544 (0.05%)      occurrences causally related to treatment / all 0 / 1 0 / 5      deaths causally related to treatment / all 0 / 0 0 / 0 Pericarditis      subjects affected / exposed 3 / 9539 (0.03%) 8 / 9544 (0.08%)      occurrences causally related to treatment / all 0 / 3 0 / 8      deaths causally related to treatment / all 0 / 0 0 / 0 Postinfarction angina      subjects affected / exposed 1 / 9539 (0.01%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 1 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 Prinzmetal angina      subjects affected / exposed 0 / 9539 (0.00%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 0 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 Rhythm idioventricular      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Right ventricular failure      subjects affected / exposed 8 / 9539 (0.08%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 8 0 / 1      deaths causally related to treatment / all 0 / 2 0 / 0 Sick sinus syndrome      subjects affected / exposed 9 / 9539 (0.09%) 5 / 9544 (0.05%)      occurrences causally related to treatment / all 4 / 9 4 / 5      deaths causally related to treatment / all 0 / 0 0 / 0 Silent myocardial infarction      subjects affected / exposed 5 / 9539 (0.05%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 5 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Sinoatrial block      subjects affected / exposed 0 / 9539 (0.00%) 3 / 9544 (0.03%)      occurrences causally related to treatment / all 0 / 0 2 / 3      deaths causally related to treatment / all 0 / 0 0 / 0 Sinus arrest      subjects affected / exposed 9 / 9539 (0.09%) 9 / 9544 (0.09%)      occurrences causally related to treatment / all 8 / 9 4 / 9      deaths causally related to treatment / all 0 / 0 0 / 0 Sinus arrhythmia      subjects affected / exposed 2 / 9539 (0.02%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 2 / 2 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Sinus bradycardia      subjects affected / exposed 48 / 9539 (0.50%) 7 / 9544 (0.07%)      occurrences causally related to treatment / all 42 / 49 4 / 7      deaths causally related to treatment / all 0 / 0 0 / 0 Sinus tachycardia      subjects affected / exposed 6 / 9539 (0.06%) 12 / 9544 (0.13%)      occurrences causally related to treatment / all 0 / 6 0 / 12      deaths causally related to treatment / all 0 / 0 0 / 0 Supraventricular extrasystoles      subjects affected / exposed 8 / 9539 (0.08%) 15 / 9544 (0.16%)      occurrences causally related to treatment / all 1 / 8 2 / 15      deaths causally related to treatment / all 0 / 0 0 / 0 Supraventricular tachycardia      subjects affected / exposed 17 / 9539 (0.18%) 21 / 9544 (0.22%)      occurrences causally related to treatment / all 1 / 18 0 / 24      deaths causally related to treatment / all 0 / 0 0 / 0 Supraventricular tachyarrhythmia      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Tachyarrhythmia      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Tachycardia      subjects affected / exposed 2 / 9539 (0.02%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 2 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 Torsade de pointes      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (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 6 / 9539 (0.06%) 5 / 9544 (0.05%)      occurrences causally related to treatment / all 0 / 6 0 / 5      deaths causally related to treatment / all 0 / 0 0 / 0 Trifascicular block      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Ventricular arrhythmia      subjects affected / exposed 1 / 9539 (0.01%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 1 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 1 Ventricular extrasystoles      subjects affected / exposed 32 / 9539 (0.34%) 21 / 9544 (0.22%)      occurrences causally related to treatment / all 2 / 32 2 / 21      deaths causally related to treatment / all 0 / 0 0 / 0 Ventricular failure      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 1 Ventricular fibrillation      subjects affected / exposed 20 / 9539 (0.21%) 20 / 9544 (0.21%)      occurrences causally related to treatment / all 0 / 20 0 / 22      deaths causally related to treatment / all 0 / 1 0 / 6 Ventricular tachycardia      subjects affected / exposed 35 / 9539 (0.37%) 21 / 9544 (0.22%)      occurrences causally related to treatment / all 3 / 39 0 / 23      deaths causally related to treatment / all 0 / 1 0 / 0 Wolff-Parkinson-White syndrome      subjects affected / exposed 0 / 9539 (0.00%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 0 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 Nervous system disorders Amnesia      subjects affected / exposed 5 / 9539 (0.05%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 1 / 5 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 Altered state of consciousness      subjects affected / exposed 1 / 9539 (0.01%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 1 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Amyotrophic lateral sclerosis      subjects affected / exposed 0 / 9539 (0.00%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 0 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 Anticholinergic syndrome      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Aphasia      subjects affected / exposed 2 / 9539 (0.02%) 3 / 9544 (0.03%)      occurrences causally related to treatment / all 1 / 2 0 / 3      deaths causally related to treatment / all 0 / 0 0 / 0 Ataxia      subjects affected / exposed 1 / 9539 (0.01%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 1 1 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 Autonomic neuropathy      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Balance disorder      subjects affected / exposed 1 / 9539 (0.01%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 1 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Brain hypoxia      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Brain injury      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Brain oedema      subjects affected / exposed 1 / 9539 (0.01%) 4 / 9544 (0.04%)      occurrences causally related to treatment / all 0 / 1 0 / 4      deaths causally related to treatment / all 0 / 0 0 / 0 Brain stem infarction      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Carotid aneurysm rupture      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Carotid arteriosclerosis      subjects affected / exposed 4 / 9539 (0.04%) 3 / 9544 (0.03%)      occurrences causally related to treatment / all 0 / 4 0 / 3      deaths causally related to treatment / all 0 / 0 0 / 0 Carotid artery aneurysm      subjects affected / exposed 1 / 9539 (0.01%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 1 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Carotid artery disease      subjects affected / exposed 2 / 9539 (0.02%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 2 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Carotid artery dissection      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (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 3 / 9539 (0.03%) 3 / 9544 (0.03%)      occurrences causally related to treatment / all 0 / 3 0 / 3      deaths causally related to treatment / all 0 / 0 0 / 0 Carotid artery stenosis      subjects affected / exposed 51 / 9539 (0.53%) 43 / 9544 (0.45%)      occurrences causally related to treatment / all 0 / 57 0 / 45      deaths causally related to treatment / all 0 / 0 0 / 0 Carotid sinus syndrome      subjects affected / exposed 0 / 9539 (0.00%) 4 / 9544 (0.04%)      occurrences causally related to treatment / all 0 / 0 0 / 4      deaths causally related to treatment / all 0 / 0 0 / 0 Carpal tunnel syndrome      subjects affected / exposed 4 / 9539 (0.04%) 6 / 9544 (0.06%)      occurrences causally related to treatment / all 0 / 4 0 / 6      deaths causally related to treatment / all 0 / 0 0 / 0 Cerebellar atrophy      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Cerebellar haemorrhage      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 1 0 / 0 Cerebellar ischaemia      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Cerebellar syndrome      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Cerebral arteriosclerosis      subjects affected / exposed 1 / 9539 (0.01%) 3 / 9544 (0.03%)      occurrences causally related to treatment / all 0 / 1 0 / 3      deaths causally related to treatment / all 0 / 0 0 / 0 Cerebral artery stenosis      subjects affected / exposed 1 / 9539 (0.01%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 1 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Cerebral atrophy      subjects affected / exposed 4 / 9539 (0.04%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 4 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Cerebral haematoma      subjects affected / exposed 2 / 9539 (0.02%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 2 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Cerebral haemorrhage      subjects affected / exposed 3 / 9539 (0.03%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 3 0 / 2      deaths causally related to treatment / all 0 / 1 0 / 1 Cerebral infarction      subjects affected / exposed 15 / 9539 (0.16%) 13 / 9544 (0.14%)      occurrences causally related to treatment / all 0 / 15 0 / 13      deaths causally related to treatment / all 0 / 1 0 / 1 Cerebral ischaemia      subjects affected / exposed 8 / 9539 (0.08%) 3 / 9544 (0.03%)      occurrences causally related to treatment / all 0 / 9 0 / 3      deaths causally related to treatment / all 0 / 0 0 / 0 Cerebral microangiopathy      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Cerebrovascular accident      subjects affected / exposed 31 / 9539 (0.32%) 40 / 9544 (0.42%)      occurrences causally related to treatment / all 0 / 32 0 / 44      deaths causally related to treatment / all 0 / 5 0 / 5 Cerebrovascular disorder      subjects affected / exposed 5 / 9539 (0.05%) 3 / 9544 (0.03%)      occurrences causally related to treatment / all 0 / 5 0 / 3      deaths causally related to treatment / all 0 / 0 0 / 0 Cerebrovascular insufficiency      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Cervical cord compression      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Cervical myelopathy      subjects affected / exposed 0 / 9539 (0.00%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 0 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 Cervicobrachial syndrome      subjects affected / exposed 1 / 9539 (0.01%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 1 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 Cognitive disorder      subjects affected / exposed 1 / 9539 (0.01%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 1 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 Coma      subjects affected / exposed 2 / 9539 (0.02%) 3 / 9544 (0.03%)      occurrences causally related to treatment / all 0 / 2 0 / 3      deaths causally related to treatment / all 0 / 1 0 / 0 Convulsion      subjects affected / exposed 1 / 9539 (0.01%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 1 / 1 0 / 2      deaths causally related to treatment / all 1 / 1 0 / 0 Coordination abnormal      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Cranial nerve disorder      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Cranial nerve paralysis      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Cubital tunnel syndrome      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Dementia      subjects affected / exposed 4 / 9539 (0.04%) 4 / 9544 (0.04%)      occurrences causally related to treatment / all 0 / 4 0 / 4      deaths causally related to treatment / all 0 / 0 0 / 0 Dementia Alzheimer's type      subjects affected / exposed 2 / 9539 (0.02%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 2 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Dementia of the Alzheimer's type, with delusions      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Demyelinating polyneuropathy      subjects affected / exposed 1 / 9539 (0.01%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 1 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 Depressed level of consciousness      subjects affected / exposed 1 / 9539 (0.01%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 1 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Diabetic hyperglycaemic coma      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 1 0 / 0 Diabetic neuropathy      subjects affected / exposed 10 / 9539 (0.10%) 10 / 9544 (0.10%)      occurrences causally related to treatment / all 0 / 10 0 / 10      deaths causally related to treatment / all 0 / 0 0 / 0 Dizziness      subjects affected / exposed 19 / 9539 (0.20%) 18 / 9544 (0.19%)      occurrences causally related to treatment / all 3 / 19 3 / 20      deaths causally related to treatment / all 0 / 0 0 / 0 Dizziness postural      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 1 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Drop attacks      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (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 2 / 9539 (0.02%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 2 1 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 Dystonic tremor      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Encephalitis      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Encephalomyelitis      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Encephalopathy      subjects affected / exposed 4 / 9539 (0.04%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 4 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 Epilepsy      subjects affected / exposed 7 / 9539 (0.07%) 5 / 9544 (0.05%)      occurrences causally related to treatment / all 0 / 9 0 / 5      deaths causally related to treatment / all 0 / 0 0 / 0 Essential tremor      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Extrapyramidal disorder      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Facial nerve disorder      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Grand mal convulsion      subjects affected / exposed 4 / 9539 (0.04%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 4 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Facial paresis      subjects affected / exposed 1 / 9539 (0.01%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 1 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Guillain-Barre syndrome      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Haemorrhage intracranial      subjects affected / exposed 0 / 9539 (0.00%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 0 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 Haemorrhagic stroke      subjects affected / exposed 5 / 9539 (0.05%) 12 / 9544 (0.13%)      occurrences causally related to treatment / all 0 / 6 0 / 12      deaths causally related to treatment / all 0 / 4 0 / 5 Headache      subjects affected / exposed 5 / 9539 (0.05%) 8 / 9544 (0.08%)      occurrences causally related to treatment / all 0 / 5 0 / 8      deaths causally related to treatment / all 0 / 0 0 / 0 Hemianopia homonymous      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (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 6 / 9539 (0.06%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 7 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Horner's syndrome      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Hydrocephalus      subjects affected / exposed 2 / 9539 (0.02%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 2 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Hypertensive encephalopathy      subjects affected / exposed 2 / 9539 (0.02%) 6 / 9544 (0.06%)      occurrences causally related to treatment / all 0 / 2 0 / 6      deaths causally related to treatment / all 0 / 0 0 / 0 Hypoaesthesia      subjects affected / exposed 3 / 9539 (0.03%) 9 / 9544 (0.09%)      occurrences causally related to treatment / all 1 / 3 0 / 10      deaths causally related to treatment / all 0 / 0 0 / 0 Hypoglycaemic coma      subjects affected / exposed 2 / 9539 (0.02%) 5 / 9544 (0.05%)      occurrences causally related to treatment / all 0 / 3 0 / 5      deaths causally related to treatment / all 0 / 1 0 / 0 Hypoglycaemic unconsciousness      subjects affected / exposed 4 / 9539 (0.04%) 9 / 9544 (0.09%)      occurrences causally related to treatment / all 0 / 4 0 / 9      deaths causally related to treatment / all 0 / 0 0 / 0 Hyporeflexia      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (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 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 1 0 / 0 IIIrd nerve paralysis      subjects affected / exposed 1 / 9539 (0.01%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 1 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 Intercostal neuralgia      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Intracranial aneurysm      subjects affected / exposed 4 / 9539 (0.04%) 5 / 9544 (0.05%)      occurrences causally related to treatment / all 0 / 4 0 / 5      deaths causally related to treatment / all 0 / 0 0 / 0 Intracranial hypotension      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Intracranial pressure increased      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Intracranial venous sinus thrombosis      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Ischaemic cerebral infarction      subjects affected / exposed 1 / 9539 (0.01%) 1 / 9544 (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 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Ischaemic stroke      subjects affected / exposed 97 / 9539 (1.02%) 90 / 9544 (0.94%)      occurrences causally related to treatment / all 1 / 100 0 / 95      deaths causally related to treatment / all 0 / 13 0 / 6 Lacunar infarction      subjects affected / exposed 5 / 9539 (0.05%) 6 / 9544 (0.06%)      occurrences causally related to treatment / all 0 / 5 0 / 6      deaths causally related to treatment / all 0 / 0 0 / 0 Lethargy      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Loss of consciousness      subjects affected / exposed 32 / 9539 (0.34%) 22 / 9544 (0.23%)      occurrences causally related to treatment / all 3 / 32 1 / 22      deaths causally related to treatment / all 0 / 0 0 / 0 Lumbar radiculopathy      subjects affected / exposed 1 / 9539 (0.01%) 4 / 9544 (0.04%)      occurrences causally related to treatment / all 0 / 1 0 / 4      deaths causally related to treatment / all 0 / 0 0 / 0 Memory impairment      subjects affected / exposed 4 / 9539 (0.04%) 3 / 9544 (0.03%)      occurrences causally related to treatment / all 0 / 4 0 / 3      deaths causally related to treatment / all 0 / 0 0 / 0 Migraine      subjects affected / exposed 1 / 9539 (0.01%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 1 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 Monoplegia      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 1 0 / 0 Movement disorder      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Multiple sclerosis      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Myasthenia gravis      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Myelitis transverse      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Myelopathy      subjects affected / exposed 1 / 9539 (0.01%) 1 / 9544 (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 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Nerve root compression      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Nerve root lesion      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Neuralgia      subjects affected / exposed 2 / 9539 (0.02%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 2 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Neuritis cranial      subjects affected / exposed 0 / 9539 (0.00%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 0 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 Neurodegenerative disorder      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Neurological decompensation      subjects affected / exposed 1 / 9539 (0.01%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 1 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Neuropathy peripheral      subjects affected / exposed 1 / 9539 (0.01%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 1 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 Normal pressure hydrocephalus      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Paraesthesia      subjects affected / exposed 1 / 9539 (0.01%) 3 / 9544 (0.03%)      occurrences causally related to treatment / all 0 / 1 1 / 3      deaths causally related to treatment / all 0 / 0 0 / 0 Paraplegia      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (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 6 / 9539 (0.06%) 8 / 9544 (0.08%)      occurrences causally related to treatment / all 0 / 6 0 / 8      deaths causally related to treatment / all 0 / 0 0 / 0 Parkinsonism      subjects affected / exposed 2 / 9539 (0.02%) 3 / 9544 (0.03%)      occurrences causally related to treatment / all 0 / 2 0 / 3      deaths causally related to treatment / all 0 / 0 0 / 0 Partial seizures      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Peripheral sensorimotor neuropathy      subjects affected / exposed 0 / 9539 (0.00%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 0 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 Peripheral sensory neuropathy      subjects affected / exposed 1 / 9539 (0.01%) 1 / 9544 (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 0 / 9539 (0.00%) 4 / 9544 (0.04%)      occurrences causally related to treatment / all 0 / 0 0 / 4      deaths causally related to treatment / all 0 / 0 0 / 0 Petit mal epilepsy      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Poor quality sleep      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Post-injection delirium sedation syndrome      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Post-traumatic headache      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (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 15 / 9539 (0.16%) 8 / 9544 (0.08%)      occurrences causally related to treatment / all 4 / 15 1 / 8      deaths causally related to treatment / all 0 / 0 0 / 0 Posterior reversible encephalopathy syndrome      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Psychomotor hyperactivity      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Pyramidal tract syndrome      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Radial nerve compression      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (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 0 / 9539 (0.00%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 0 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 Radicular syndrome      subjects affected / exposed 2 / 9539 (0.02%) 1 / 9544 (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 5 / 9539 (0.05%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 5 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 Restless legs syndrome      subjects affected / exposed 1 / 9539 (0.01%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 1 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Retrograde amnesia      subjects affected / exposed 1 / 9539 (0.01%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 1 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Sciatica      subjects affected / exposed 2 / 9539 (0.02%) 8 / 9544 (0.08%)      occurrences causally related to treatment / all 0 / 2 0 / 9      deaths causally related to treatment / all 0 / 0 0 / 0 Senile dementia      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Speech disorder      subjects affected / exposed 2 / 9539 (0.02%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 2 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Somnolence      subjects affected / exposed 4 / 9539 (0.04%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 1 / 4 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Spinal cord compression      subjects affected / exposed 2 / 9539 (0.02%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 2 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Spinal vascular disorder      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Spondylitic myelopathy      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Subarachnoid haemorrhage      subjects affected / exposed 5 / 9539 (0.05%) 3 / 9544 (0.03%)      occurrences causally related to treatment / all 0 / 5 0 / 3      deaths causally related to treatment / all 0 / 1 0 / 0 Subdural hygroma      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Syncope      subjects affected / exposed 91 / 9539 (0.95%) 89 / 9544 (0.93%)      occurrences causally related to treatment / all 23 / 102 6 / 96      deaths causally related to treatment / all 0 / 0 0 / 0 Thalamic infarction      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Thalamus haemorrhage      subjects affected / exposed 0 / 9539 (0.00%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 0 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 1 Thrombotic stroke      subjects affected / exposed 0 / 9539 (0.00%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 0 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 Tonic convulsion      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Transient global amnesia      subjects affected / exposed 2 / 9539 (0.02%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 2 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Tremor      subjects affected / exposed 0 / 9539 (0.00%) 3 / 9544 (0.03%)      occurrences causally related to treatment / all 0 / 0 1 / 3      deaths causally related to treatment / all 0 / 0 0 / 0 Transient ischaemic attack      subjects affected / exposed 56 / 9539 (0.59%) 50 / 9544 (0.52%)      occurrences causally related to treatment / all 3 / 59 0 / 50      deaths causally related to treatment / all 0 / 0 0 / 0 Ulnar neurapraxia      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Ulnar tunnel syndrome      subjects affected / exposed 1 / 9539 (0.01%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 1 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 VIIth nerve paralysis      subjects affected / exposed 1 / 9539 (0.01%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 1 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 VIth nerve disorder      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 VIth nerve paralysis      subjects affected / exposed 0 / 9539 (0.00%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 0 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 Vascular dementia      subjects affected / exposed 3 / 9539 (0.03%) 3 / 9544 (0.03%)      occurrences causally related to treatment / all 0 / 3 0 / 3      deaths causally related to treatment / all 0 / 0 0 / 0 Vascular encephalopathy      subjects affected / exposed 11 / 9539 (0.12%) 9 / 9544 (0.09%)      occurrences causally related to treatment / all 0 / 11 0 / 9      deaths causally related to treatment / all 0 / 0 0 / 0 Vertebral artery occlusion      subjects affected / exposed 2 / 9539 (0.02%) 0 / 9544 (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 3 / 9539 (0.03%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 3 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Vertebrobasilar insufficiency      subjects affected / exposed 15 / 9539 (0.16%) 12 / 9544 (0.13%)      occurrences causally related to treatment / all 0 / 15 0 / 16      deaths causally related to treatment / all 0 / 0 0 / 0 Vertigo CNS origin      subjects affected / exposed 2 / 9539 (0.02%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 2 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Vocal cord paresis      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Wernicke-Korsakoff syndrome      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (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 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Anaemia      subjects affected / exposed 30 / 9539 (0.31%) 45 / 9544 (0.47%)      occurrences causally related to treatment / all 0 / 30 0 / 45      deaths causally related to treatment / all 0 / 0 0 / 0 Anaemia folate deficiency      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Anaemia megaloblastic      subjects affected / exposed 2 / 9539 (0.02%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 2 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Anaemia vitamin B12 deficiency      subjects affected / exposed 1 / 9539 (0.01%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 1 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 Bone marrow failure      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Deficiency anaemia      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (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 1 / 9539 (0.01%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 1 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Febrile neutropenia      subjects affected / exposed 2 / 9539 (0.02%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 2 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 1 Haemorrhagic diathesis      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Haemorrhagic anaemia      subjects affected / exposed 14 / 9539 (0.15%) 15 / 9544 (0.16%)      occurrences causally related to treatment / all 0 / 14 0 / 15      deaths causally related to treatment / all 0 / 0 0 / 0 Haemorrhagic disorder      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Heparin-induced thrombocytopenia      subjects affected / exposed 2 / 9539 (0.02%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 3 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Hypochromic anaemia      subjects affected / exposed 8 / 9539 (0.08%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 8 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Hypoprothrombinaemia      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Idiopathic thrombocytopenic purpura      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Leukocytosis      subjects affected / exposed 1 / 9539 (0.01%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 1 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Iron deficiency anaemia      subjects affected / exposed 7 / 9539 (0.07%) 8 / 9544 (0.08%)      occurrences causally related to treatment / all 0 / 7 0 / 8      deaths causally related to treatment / all 0 / 0 0 / 0 Leukopenia      subjects affected / exposed 2 / 9539 (0.02%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 2 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Lymphadenopathy      subjects affected / exposed 3 / 9539 (0.03%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 3 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Lymphadenopathy mediastinal      subjects affected / exposed 0 / 9539 (0.00%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 0 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 Lymphopenia      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Microcytic anaemia      subjects affected / exposed 4 / 9539 (0.04%) 3 / 9544 (0.03%)      occurrences causally related to treatment / all 0 / 4 0 / 3      deaths causally related to treatment / all 0 / 0 0 / 0 Nephrogenic anaemia      subjects affected / exposed 0 / 9539 (0.00%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 0 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 Neutropenia      subjects affected / exposed 3 / 9539 (0.03%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 3 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Normochromic normocytic anaemia      subjects affected / exposed 4 / 9539 (0.04%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 4 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 Pancytopenia      subjects affected / exposed 4 / 9539 (0.04%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 4 0 / 1      deaths causally related to treatment / all 0 / 1 0 / 0 Platelet dysfunction      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Sideroblastic anaemia      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (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 15 / 9539 (0.16%) 12 / 9544 (0.13%)      occurrences causally related to treatment / all 0 / 17 1 / 12      deaths causally related to treatment / all 0 / 0 0 / 0 Thrombocytopenic purpura      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Thrombocytosis      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Ear and labyrinth disorders Acute vestibular syndrome      subjects affected / exposed 4 / 9539 (0.04%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 4 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Deafness neurosensory      subjects affected / exposed 2 / 9539 (0.02%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 2 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Deafness unilateral      subjects affected / exposed 2 / 9539 (0.02%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 2 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Haematotympanum      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Hearing impaired      subjects affected / exposed 2 / 9539 (0.02%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 2 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Hypoacusis      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Meniere's disease      subjects affected / exposed 0 / 9539 (0.00%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 0 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 Neurosensory hypoacusis      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Sudden hearing loss      subjects affected / exposed 1 / 9539 (0.01%) 1 / 9544 (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 3 / 9539 (0.03%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 3 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Tympanic membrane disorder      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Vertigo      subjects affected / exposed 9 / 9539 (0.09%) 7 / 9544 (0.07%)      occurrences causally related to treatment / all 2 / 9 0 / 9      deaths causally related to treatment / all 0 / 0 0 / 0 Vestibular ataxia      subjects affected / exposed 1 / 9539 (0.01%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 1 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Vestibular disorder      subjects affected / exposed 2 / 9539 (0.02%) 3 / 9544 (0.03%)      occurrences causally related to treatment / all 0 / 2 0 / 3      deaths causally related to treatment / all 0 / 0 0 / 0 Eye disorders Age-related macular degeneration      subjects affected / exposed 4 / 9539 (0.04%) 4 / 9544 (0.04%)      occurrences causally related to treatment / all 0 / 4 0 / 4      deaths causally related to treatment / all 0 / 0 0 / 0 Amaurosis      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (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 2 / 9539 (0.02%) 4 / 9544 (0.04%)      occurrences causally related to treatment / all 0 / 2 0 / 4      deaths causally related to treatment / all 0 / 0 0 / 0 Angle closure glaucoma      subjects affected / exposed 1 / 9539 (0.01%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 1 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Blindness      subjects affected / exposed 1 / 9539 (0.01%) 3 / 9544 (0.03%)      occurrences causally related to treatment / all 0 / 1 0 / 3      deaths causally related to treatment / all 0 / 0 0 / 0 Cataract      subjects affected / exposed 39 / 9539 (0.41%) 32 / 9544 (0.34%)      occurrences causally related to treatment / all 0 / 43 0 / 32      deaths causally related to treatment / all 0 / 0 0 / 0 Blindness unilateral      subjects affected / exposed 1 / 9539 (0.01%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 1 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Cataract diabetic      subjects affected / exposed 1 / 9539 (0.01%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 1 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Cataract nuclear      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Cataract subcapsular      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Choroidal effusion      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Choroidal neovascularisation      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Conjunctival haemorrhage      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Dacryoadenitis acquired      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (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 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Diabetic glaucoma      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (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 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Diabetic retinopathy      subjects affected / exposed 9 / 9539 (0.09%) 18 / 9544 (0.19%)      occurrences causally related to treatment / all 0 / 9 0 / 20      deaths causally related to treatment / all 0 / 0 0 / 0 Diplopia      subjects affected / exposed 2 / 9539 (0.02%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 1 / 2 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Eye haemorrhage      subjects affected / exposed 1 / 9539 (0.01%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 1 0 / 3      deaths causally related to treatment / all 0 / 0 0 / 0 Glaucoma      subjects affected / exposed 20 / 9539 (0.21%) 19 / 9544 (0.20%)      occurrences causally related to treatment / all 0 / 20 0 / 19      deaths causally related to treatment / all 0 / 0 0 / 0 Glaucomatous optic disc atrophy      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Keratitis      subjects affected / exposed 1 / 9539 (0.01%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 1 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Macular degeneration      subjects affected / exposed 7 / 9539 (0.07%) 6 / 9544 (0.06%)      occurrences causally related to treatment / all 0 / 8 0 / 6      deaths causally related to treatment / all 0 / 0 0 / 0 Macular fibrosis      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Macular oedema      subjects affected / exposed 2 / 9539 (0.02%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 2 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Normal tension glaucoma      subjects affected / exposed 2 / 9539 (0.02%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 2 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Ocular hypertension      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Ocular icterus      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Open angle glaucoma      subjects affected / exposed 3 / 9539 (0.03%) 4 / 9544 (0.04%)      occurrences causally related to treatment / all 0 / 3 0 / 4      deaths causally related to treatment / all 0 / 0 0 / 0 Optic atrophy      subjects affected / exposed 0 / 9539 (0.00%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 0 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 Ophthalmoplegia      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Optic ischaemic neuropathy      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Papilloedema      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Periorbital oedema      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Photophobia      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 1 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Pterygium      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Photopsia      subjects affected / exposed 28 / 9539 (0.29%) 3 / 9544 (0.03%)      occurrences causally related to treatment / all 29 / 31 2 / 3      deaths causally related to treatment / all 0 / 0 0 / 0 Retinal aneurysm      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Retinal artery occlusion      subjects affected / exposed 2 / 9539 (0.02%) 4 / 9544 (0.04%)      occurrences causally related to treatment / all 0 / 2 0 / 4      deaths causally related to treatment / all 0 / 0 0 / 0 Retinal artery thrombosis      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Retinal detachment      subjects affected / exposed 4 / 9539 (0.04%) 6 / 9544 (0.06%)      occurrences causally related to treatment / all 0 / 4 0 / 6      deaths causally related to treatment / all 0 / 0 0 / 0 Retinal haemorrhage      subjects affected / exposed 10 / 9539 (0.10%) 4 / 9544 (0.04%)      occurrences causally related to treatment / all 0 / 10 0 / 4      deaths causally related to treatment / all 0 / 0 0 / 0 Retinal tear      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Retinal vascular thrombosis      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Retinal vein occlusion      subjects affected / exposed 1 / 9539 (0.01%) 3 / 9544 (0.03%)      occurrences causally related to treatment / all 0 / 1 0 / 3      deaths causally related to treatment / all 0 / 0 0 / 0 Retinal vein thrombosis      subjects affected / exposed 2 / 9539 (0.02%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 2 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Retinopathy haemorrhagic      subjects affected / exposed 1 / 9539 (0.01%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 1 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Retinopathy hypertensive      subjects affected / exposed 1 / 9539 (0.01%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 1 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 Retinoschisis      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (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 13 / 9539 (0.14%) 5 / 9544 (0.05%)      occurrences causally related to treatment / all 11 / 14 0 / 5      deaths causally related to treatment / all 0 / 0 0 / 0 Visual acuity reduced      subjects affected / exposed 1 / 9539 (0.01%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 1 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Visual impairment      subjects affected / exposed 3 / 9539 (0.03%) 3 / 9544 (0.03%)      occurrences causally related to treatment / all 2 / 3 1 / 3      deaths causally related to treatment / all 0 / 0 0 / 0 Vitreous detachment      subjects affected / exposed 3 / 9539 (0.03%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 3 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Vitreous floaters      subjects affected / exposed 0 / 9539 (0.00%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 0 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 Vitreous haemorrhage      subjects affected / exposed 8 / 9539 (0.08%) 4 / 9544 (0.04%)      occurrences causally related to treatment / all 0 / 10 0 / 4      deaths causally related to treatment / all 0 / 0 0 / 0 Gastrointestinal disorders Abdominal adhesions      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Abdominal discomfort      subjects affected / exposed 2 / 9539 (0.02%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 2 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 Abdominal distension      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Abdominal hernia      subjects affected / exposed 2 / 9539 (0.02%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 2 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 Abdominal hernia obstructive      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (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 6 / 9539 (0.06%) 7 / 9544 (0.07%)      occurrences causally related to treatment / all 0 / 6 0 / 7      deaths causally related to treatment / all 0 / 0 0 / 0 Abdominal pain upper      subjects affected / exposed 4 / 9539 (0.04%) 8 / 9544 (0.08%)      occurrences causally related to treatment / all 0 / 4 0 / 8      deaths causally related to treatment / all 0 / 0 0 / 0 Abdominal rigidity      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Abdominal strangulated hernia      subjects affected / exposed 2 / 9539 (0.02%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 2 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Acquired oesophageal web      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Acute abdomen      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Anal fissure      subjects affected / exposed 1 / 9539 (0.01%) 1 / 9544 (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 1 / 9539 (0.01%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 1 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Anal polyp      subjects affected / exposed 1 / 9539 (0.01%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 1 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Anal ulcer      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Ascites      subjects affected / exposed 3 / 9539 (0.03%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 3 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Barrett's oesophagus      subjects affected / exposed 2 / 9539 (0.02%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 2 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Colitis      subjects affected / exposed 2 / 9539 (0.02%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 2 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Colitis ischaemic      subjects affected / exposed 2 / 9539 (0.02%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 2 0 / 1      deaths causally related to treatment / all 0 / 1 0 / 0 Colitis ulcerative      subjects affected / exposed 3 / 9539 (0.03%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 3 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 Colonic pseudo-obstruction      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Colonic stenosis      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 2 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Constipation      subjects affected / exposed 4 / 9539 (0.04%) 5 / 9544 (0.05%)      occurrences causally related to treatment / all 0 / 4 0 / 5      deaths causally related to treatment / all 0 / 0 0 / 0 Crohn's disease      subjects affected / exposed 1 / 9539 (0.01%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 1 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 Dental alveolar anomaly      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Diabetic gastroparesis      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Diaphragmatic hernia      subjects affected / exposed 0 / 9539 (0.00%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 0 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 Diarrhoea      subjects affected / exposed 10 / 9539 (0.10%) 9 / 9544 (0.09%)      occurrences causally related to treatment / all 1 / 10 0 / 9      deaths causally related to treatment / all 0 / 0 0 / 0 Diarrhoea haemorrhagic      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Diverticular perforation      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Diverticulitis intestinal haemorrhagic      subjects affected / exposed 2 / 9539 (0.02%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 2 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Diverticulum      subjects affected / exposed 1 / 9539 (0.01%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 1 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Diverticulum intestinal      subjects affected / exposed 3 / 9539 (0.03%) 4 / 9544 (0.04%)      occurrences causally related to treatment / all 0 / 3 0 / 4      deaths causally related to treatment / all 0 / 0 0 / 0 Dry mouth      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Diverticulum intestinal haemorrhagic      subjects affected / exposed 3 / 9539 (0.03%) 6 / 9544 (0.06%)      occurrences causally related to treatment / all 0 / 4 0 / 6      deaths causally related to treatment / all 0 / 0 0 / 0 Duodenal obstruction      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 1 0 / 0 Duodenal polyp      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Duodenal ulcer      subjects affected / exposed 4 / 9539 (0.04%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 4 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 Duodenal ulcer haemorrhage      subjects affected / exposed 7 / 9539 (0.07%) 11 / 9544 (0.12%)      occurrences causally related to treatment / all 0 / 7 0 / 11      deaths causally related to treatment / all 0 / 0 0 / 0 Duodenal ulcer perforation      subjects affected / exposed 2 / 9539 (0.02%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 2 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Duodenitis haemorrhagic      subjects affected / exposed 2 / 9539 (0.02%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 2 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Duodenitis      subjects affected / exposed 0 / 9539 (0.00%) 3 / 9544 (0.03%)      occurrences causally related to treatment / all 0 / 0 0 / 3      deaths causally related to treatment / all 0 / 0 0 / 0 Dyspepsia      subjects affected / exposed 4 / 9539 (0.04%) 5 / 9544 (0.05%)      occurrences causally related to treatment / all 0 / 4 0 / 6      deaths causally related to treatment / all 0 / 0 0 / 0 Dysphagia      subjects affected / exposed 1 / 9539 (0.01%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 1 1 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 Enteritis      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Enterocolitis      subjects affected / exposed 0 / 9539 (0.00%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 0 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 Enterocolitis haemorrhagic      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Epigastric discomfort      subjects affected / exposed 1 / 9539 (0.01%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 1 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Erosive duodenitis      subjects affected / exposed 2 / 9539 (0.02%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 2 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Erosive oesophagitis      subjects affected / exposed 3 / 9539 (0.03%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 3 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 Faecal incontinence      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Flatulence      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Food poisoning      subjects affected / exposed 3 / 9539 (0.03%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 3 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Functional gastrointestinal disorder      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Gastric haemorrhage      subjects affected / exposed 0 / 9539 (0.00%) 4 / 9544 (0.04%)      occurrences causally related to treatment / all 0 / 0 0 / 4      deaths causally related to treatment / all 0 / 0 0 / 1 Gastric mucosa erythema      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Gastric polyps      subjects affected / exposed 2 / 9539 (0.02%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 2 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Gastric ulcer      subjects affected / exposed 8 / 9539 (0.08%) 8 / 9544 (0.08%)      occurrences causally related to treatment / all 0 / 8 0 / 8      deaths causally related to treatment / all 0 / 0 0 / 0 Gastric ulcer haemorrhage      subjects affected / exposed 10 / 9539 (0.10%) 15 / 9544 (0.16%)      occurrences causally related to treatment / all 0 / 12 0 / 16      deaths causally related to treatment / all 0 / 0 0 / 0 Gastric ulcer perforation      subjects affected / exposed 2 / 9539 (0.02%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 2 0 / 0      deaths causally related to treatment / all 0 / 1 0 / 0 Gastric varices      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Gastric varices haemorrhage      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Gastritis      subjects affected / exposed 14 / 9539 (0.15%) 13 / 9544 (0.14%)      occurrences causally related to treatment / all 0 / 14 0 / 13      deaths causally related to treatment / all 0 / 0 0 / 0 Gastritis atrophic      subjects affected / exposed 5 / 9539 (0.05%) 3 / 9544 (0.03%)      occurrences causally related to treatment / all 0 / 5 0 / 3      deaths causally related to treatment / all 0 / 0 0 / 0 Gastritis erosive      subjects affected / exposed 10 / 9539 (0.10%) 10 / 9544 (0.10%)      occurrences causally related to treatment / all 0 / 10 0 / 10      deaths causally related to treatment / all 0 / 0 0 / 0 Gastritis haemorrhagic      subjects affected / exposed 5 / 9539 (0.05%) 7 / 9544 (0.07%)      occurrences causally related to treatment / all 0 / 5 0 / 7      deaths causally related to treatment / all 0 / 0 0 / 0 Gastroduodenal haemorrhage      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Gastroduodenitis      subjects affected / exposed 1 / 9539 (0.01%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 1 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Gastroduodenitis haemorrhagic      subjects affected / exposed 0 / 9539 (0.00%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 0 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 Gastrointestinal angiodysplasia      subjects affected / exposed 1 / 9539 (0.01%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 1 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Gastrointestinal angiodysplasia haemorrhagic      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Gastrointestinal dysplasia      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Gastrointestinal erosion      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (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 13 / 9539 (0.14%) 11 / 9544 (0.12%)      occurrences causally related to treatment / all 0 / 13 0 / 11      deaths causally related to treatment / all 0 / 1 0 / 1 Gastrooesophageal reflux disease      subjects affected / exposed 12 / 9539 (0.13%) 9 / 9544 (0.09%)      occurrences causally related to treatment / all 0 / 12 0 / 10      deaths causally related to treatment / all 0 / 0 0 / 0 Gastrooesophagitis      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (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 1 / 9539 (0.01%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 1 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Haematochezia      subjects affected / exposed 1 / 9539 (0.01%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 1 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Haemorrhagic erosive gastritis      subjects affected / exposed 7 / 9539 (0.07%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 7 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 Haemorrhoidal haemorrhage      subjects affected / exposed 4 / 9539 (0.04%) 7 / 9544 (0.07%)      occurrences causally related to treatment / all 0 / 4 0 / 7      deaths causally related to treatment / all 0 / 0 0 / 0 Haemorrhoids      subjects affected / exposed 0 / 9539 (0.00%) 3 / 9544 (0.03%)      occurrences causally related to treatment / all 0 / 0 0 / 3      deaths causally related to treatment / all 0 / 0 0 / 0 Hernial eventration      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (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 7 / 9539 (0.07%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 7 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Ileal stenosis      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Ileus      subjects affected / exposed 3 / 9539 (0.03%) 3 / 9544 (0.03%)      occurrences causally related to treatment / all 0 / 3 0 / 3      deaths causally related to treatment / all 0 / 0 0 / 1 Ileus paralytic      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Impaired gastric emptying      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Inguinal hernia      subjects affected / exposed 29 / 9539 (0.30%) 18 / 9544 (0.19%)      occurrences causally related to treatment / all 0 / 31 0 / 18      deaths causally related to treatment / all 0 / 0 0 / 0 Inguinal hernia strangulated      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Inguinal hernia, obstructive      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Intestinal angina      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Intestinal fistula      subjects affected / exposed 0 / 9539 (0.00%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 0 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 Intestinal haemorrhage      subjects affected / exposed 1 / 9539 (0.01%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 1 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Intestinal ischaemia      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Intestinal mass      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (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 5 / 9539 (0.05%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 5 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 Intestinal polyp      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Intestinal polyp haemorrhage      subjects affected / exposed 1 / 9539 (0.01%) 3 / 9544 (0.03%)      occurrences causally related to treatment / all 0 / 1 0 / 3      deaths causally related to treatment / all 0 / 0 0 / 0 Irritable bowel syndrome      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Large intestinal haemorrhage      subjects affected / exposed 1 / 9539 (0.01%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 1 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Large intestine perforation      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Large intestine polyp      subjects affected / exposed 11 / 9539 (0.12%) 3 / 9544 (0.03%)      occurrences causally related to treatment / all 0 / 11 0 / 3      deaths causally related to treatment / all 0 / 0 0 / 0 Leukoplakia oral      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Lip swelling      subjects affected / exposed 1 / 9539 (0.01%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 1 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Lower gastrointestinal haemorrhage      subjects affected / exposed 5 / 9539 (0.05%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 5 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Mallory-Weiss syndrome      subjects affected / exposed 1 / 9539 (0.01%) 3 / 9544 (0.03%)      occurrences causally related to treatment / all 0 / 1 0 / 3      deaths causally related to treatment / all 0 / 0 0 / 0 Mechanical ileus      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Melaena      subjects affected / exposed 6 / 9539 (0.06%) 4 / 9544 (0.04%)      occurrences causally related to treatment / all 0 / 6 0 / 4      deaths causally related to treatment / all 0 / 0 0 / 0 Mesenteric artery thrombosis      subjects affected / exposed 1 / 9539 (0.01%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 1 0 / 1      deaths causally related to treatment / all 0 / 1 0 / 0 Mesenteric haemorrhage      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Mesenteric occlusion      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Mikulicz's disease      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Nausea      subjects affected / exposed 12 / 9539 (0.13%) 8 / 9544 (0.08%)      occurrences causally related to treatment / all 0 / 12 0 / 8      deaths causally related to treatment / all 0 / 0 0 / 0 Oedematous pancreatitis      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Oesophageal achalasia      subjects affected / exposed 1 / 9539 (0.01%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 1 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 Oesophageal stenosis      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Oesophageal ulcer haemorrhage      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Oesophageal varices haemorrhage      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Oesophagitis      subjects affected / exposed 2 / 9539 (0.02%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 2 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Oesophagitis haemorrhagic      subjects affected / exposed 2 / 9539 (0.02%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 2 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Oesophagitis ulcerative      subjects affected / exposed 1 / 9539 (0.01%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 1 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Oral submucosal fibrosis      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Pancreatic pseudocyst      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Pancreatitis      subjects affected / exposed 4 / 9539 (0.04%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 4 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Pancreatitis acute      subjects affected / exposed 9 / 9539 (0.09%) 17 / 9544 (0.18%)      occurrences causally related to treatment / all 1 / 9 0 / 19      deaths causally related to treatment / all 0 / 0 0 / 1 Pancreatitis chronic      subjects affected / exposed 11 / 9539 (0.12%) 7 / 9544 (0.07%)      occurrences causally related to treatment / all 0 / 11 0 / 7      deaths causally related to treatment / all 0 / 0 0 / 0 Peptic ulcer      subjects affected / exposed 1 / 9539 (0.01%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 1 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 Peptic ulcer haemorrhage      subjects affected / exposed 1 / 9539 (0.01%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 1 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Periproctitis      subjects affected / exposed 2 / 9539 (0.02%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 2 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Proctitis ulcerative      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Rectal haemorrhage      subjects affected / exposed 5 / 9539 (0.05%) 8 / 9544 (0.08%)      occurrences causally related to treatment / all 0 / 5 0 / 8      deaths causally related to treatment / all 0 / 0 0 / 0 Rectal polyp      subjects affected / exposed 3 / 9539 (0.03%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 3 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 Rectal prolapse      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Rectal ulcer haemorrhage      subjects affected / exposed 3 / 9539 (0.03%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 3 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Reflux gastritis      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Retching      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Retroperitoneal haemorrhage      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Salivary gland calculus      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Sigmoiditis      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (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 1 / 9539 (0.01%) 0 / 9544 (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 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Splenic artery aneurysm      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Subileus      subjects affected / exposed 3 / 9539 (0.03%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 3 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 Swollen tongue      subjects affected / exposed 1 / 9539 (0.01%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 1 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Thrombosis mesenteric vessel      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 1 0 / 0 Tongue ulceration      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Umbilical hernia      subjects affected / exposed 4 / 9539 (0.04%) 6 / 9544 (0.06%)      occurrences causally related to treatment / all 0 / 4 0 / 6      deaths causally related to treatment / all 0 / 0 0 / 0 Umbilical hernia, obstructive      subjects affected / exposed 2 / 9539 (0.02%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 2 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Upper gastrointestinal haemorrhage      subjects affected / exposed 8 / 9539 (0.08%) 7 / 9544 (0.07%)      occurrences causally related to treatment / all 0 / 8 0 / 7      deaths causally related to treatment / all 0 / 0 0 / 0 Varices oesophageal      subjects affected / exposed 4 / 9539 (0.04%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 4 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Volvulus      subjects affected / exposed 1 / 9539 (0.01%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 1 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Vomiting      subjects affected / exposed 9 / 9539 (0.09%) 11 / 9544 (0.12%)      occurrences causally related to treatment / all 1 / 9 0 / 11      deaths causally related to treatment / all 0 / 0 0 / 0 Skin and subcutaneous tissue disorders Angioedema      subjects affected / exposed 4 / 9539 (0.04%) 7 / 9544 (0.07%)      occurrences causally related to treatment / all 0 / 4 3 / 7      deaths causally related to treatment / all 0 / 0 0 / 0 Cold sweat      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Decubitus ulcer      subjects affected / exposed 2 / 9539 (0.02%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 2 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Dermatitis      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Dermatitis allergic      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 1 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Dermatitis bullous      subjects affected / exposed 2 / 9539 (0.02%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 2 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Dermatomyositis      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Diabetic foot      subjects affected / exposed 4 / 9539 (0.04%) 9 / 9544 (0.09%)      occurrences causally related to treatment / all 0 / 4 0 / 10      deaths causally related to treatment / all 0 / 0 0 / 0 Dry gangrene      subjects affected / exposed 2 / 9539 (0.02%) 4 / 9544 (0.04%)      occurrences causally related to treatment / all 0 / 2 0 / 4      deaths causally related to treatment / all 0 / 0 0 / 0 Ecchymosis      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Eczema      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 1 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Erythema      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 1 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Hidradenitis      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Hyperhidrosis      subjects affected / exposed 3 / 9539 (0.03%) 5 / 9544 (0.05%)      occurrences causally related to treatment / all 0 / 3 1 / 5      deaths causally related to treatment / all 0 / 0 0 / 0 Keloid scar      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Leukocytoclastic vasculitis      subjects affected / exposed 1 / 9539 (0.01%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 1 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Lichen planus      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Necrobiosis lipoidica diabeticorum      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Neuropathic ulcer      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Panniculitis      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Parapsoriasis      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Pruritus      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 1 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Pemphigus      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 1 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Pruritus allergic      subjects affected / exposed 3 / 9539 (0.03%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 3 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Psoriasis      subjects affected / exposed 3 / 9539 (0.03%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 3 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Purpura      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Rash generalised      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Skin lesion      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Skin necrosis      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Skin ulcer      subjects affected / exposed 2 / 9539 (0.02%) 10 / 9544 (0.10%)      occurrences causally related to treatment / all 0 / 2 0 / 11      deaths causally related to treatment / all 0 / 0 0 / 0 Skin ulcer haemorrhage      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Swelling face      subjects affected / exposed 0 / 9539 (0.00%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 0 1 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 Toxic skin eruption      subjects affected / exposed 1 / 9539 (0.01%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 1 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 Urticaria      subjects affected / exposed 0 / 9539 (0.00%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 0 2 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 Renal and urinary disorders Acute prerenal failure      subjects affected / exposed 0 / 9539 (0.00%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 0 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 Anuria      subjects affected / exposed 1 / 9539 (0.01%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 1 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Bladder dilatation      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Bladder diverticulum      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Bladder neck sclerosis      subjects affected / exposed 0 / 9539 (0.00%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 0 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 Bladder prolapse      subjects affected / exposed 0 / 9539 (0.00%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 0 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 Bladder perforation      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Bladder stenosis      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Bladder tamponade      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 Calculus bladder      subjects affected / exposed 2 / 9539 (0.02%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 2 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 Calculus ureteric      subjects affected / exposed 7 / 9539 (0.07%) 6 / 9544 (0.06%)      occurrences causally related to treatment / all 0 / 7 0 / 6      deaths causally related to treatment / all 0 / 0 0 / 0 Calculus urethral      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Calculus urinary      subjects affected / exposed 10 / 9539 (0.10%) 7 / 9544 (0.07%)      occurrences causally related to treatment / all 0 / 10 0 / 7      deaths causally related to treatment / all 0 / 0 0 / 0 Cystitis glandularis      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Cystitis haemorrhagic      subjects affected / exposed 4 / 9539 (0.04%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 4 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Cystitis noninfective      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Diabetic nephropathy      subjects affected / exposed 11 / 9539 (0.12%) 7 / 9544 (0.07%)      occurrences causally related to treatment / all 0 / 12 0 / 7      deaths causally related to treatment / all 0 / 0 0 / 0 Dysuria      subjects affected / exposed 3 / 9539 (0.03%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 3 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Glomerulonephritis      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Haematuria      subjects affected / exposed 6 / 9539 (0.06%) 6 / 9544 (0.06%)      occurrences causally related to treatment / all 0 / 6 0 / 6      deaths causally related to treatment / all 0 / 0 0 / 0 Hydronephrosis      subjects affected / exposed 6 / 9539 (0.06%) 5 / 9544 (0.05%)      occurrences causally related to treatment / all 0 / 6 0 / 6      deaths causally related to treatment / all 0 / 0 0 / 0 Hydroureter      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Hypertensive nephropathy      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Hypertonic bladder      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 IgA nephropathy      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Incontinence      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Nephroangiosclerosis      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Nephrolithiasis      subjects affected / exposed 7 / 9539 (0.07%) 14 / 9544 (0.15%)      occurrences causally related to treatment / all 0 / 7 0 / 14      deaths causally related to treatment / all 0 / 0 0 / 0 Nephropathy      subjects affected / exposed 1 / 9539 (0.01%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 1 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Nephropathy toxic      subjects affected / exposed 0 / 9539 (0.00%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 0 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 Nephrotic syndrome      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Obstructive uropathy      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Pollakiuria      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Prerenal failure      subjects affected / exposed 1 / 9539 (0.01%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 1 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Renal artery occlusion      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Renal artery stenosis      subjects affected / exposed 6 / 9539 (0.06%) 3 / 9544 (0.03%)      occurrences causally related to treatment / all 0 / 6 0 / 3      deaths causally related to treatment / all 0 / 0 0 / 0 Renal artery thrombosis      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Renal colic      subjects affected / exposed 3 / 9539 (0.03%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 3 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 Renal cyst      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (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 38 / 9539 (0.40%) 30 / 9544 (0.31%)      occurrences causally related to treatment / all 1 / 39 0 / 30      deaths causally related to treatment / all 0 / 0 0 / 3 Renal failure acute      subjects affected / exposed 29 / 9539 (0.30%) 35 / 9544 (0.37%)      occurrences causally related to treatment / all 0 / 31 0 / 38      deaths causally related to treatment / all 0 / 0 0 / 1 Renal failure chronic      subjects affected / exposed 34 / 9539 (0.36%) 17 / 9544 (0.18%)      occurrences causally related to treatment / all 1 / 35 0 / 17      deaths causally related to treatment / all 0 / 1 0 / 0 Renal impairment      subjects affected / exposed 13 / 9539 (0.14%) 5 / 9544 (0.05%)      occurrences causally related to treatment / all 0 / 14 0 / 5      deaths causally related to treatment / all 0 / 0 0 / 0 Renal infarct      subjects affected / exposed 0 / 9539 (0.00%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 0 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 Renal ischaemia      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Renal tubular acidosis      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Stress urinary incontinence      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Tubulointerstitial nephritis      subjects affected / exposed 2 / 9539 (0.02%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 2 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Ureteric obstruction      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Ureteric stenosis      subjects affected / exposed 1 / 9539 (0.01%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 1 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Urethral disorder      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Urethral obstruction      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (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 3 / 9539 (0.03%) 6 / 9544 (0.06%)      occurrences causally related to treatment / all 0 / 3 0 / 6      deaths causally related to treatment / all 0 / 0 0 / 0 Urinary bladder haemorrhage      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 Urinary bladder polyp      subjects affected / exposed 0 / 9539 (0.00%) 3 / 9544 (0.03%)      occurrences causally related to treatment / all 0 / 0 0 / 3      deaths causally related to treatment / all 0 / 0 0 / 0 Urinary incontinence      subjects affected / exposed 1 / 9539 (0.01%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 1 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Urinary retention      subjects affected / exposed 12 / 9539 (0.13%) 18 / 9544 (0.19%)      occurrences causally related to treatment / all 0 / 14 0 / 18      deaths causally related to treatment / all 0 / 0 0 / 0 Urinary tract obstruction      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Vesicoureteric reflux      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Endocrine disorders Autoimmune thyroiditis      subjects affected / exposed 2 / 9539 (0.02%) 3 / 9544 (0.03%)      occurrences causally related to treatment / all 0 / 2 0 / 3      deaths causally related to treatment / all 0 / 0 0 / 0 Adrenal insufficiency      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Basedow's disease      subjects affected / exposed 2 / 9539 (0.02%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 2 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 Cushing's syndrome      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Empty sella syndrome      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (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 4 / 9539 (0.04%) 3 / 9544 (0.03%)      occurrences causally related to treatment / all 0 / 4 0 / 3      deaths causally related to treatment / all 0 / 0 0 / 0 Hyperthyroidism      subjects affected / exposed 6 / 9539 (0.06%) 5 / 9544 (0.05%)      occurrences causally related to treatment / all 0 / 7 0 / 5      deaths causally related to treatment / all 0 / 0 0 / 0 Hypothyroidism      subjects affected / exposed 2 / 9539 (0.02%) 3 / 9544 (0.03%)      occurrences causally related to treatment / all 0 / 2 0 / 3      deaths causally related to treatment / all 0 / 0 0 / 0 Inappropriate antidiuretic hormone secretion      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (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 / 9539 (0.01%) 0 / 9544 (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 Amyotrophy      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Ankylosing spondylitis      subjects affected / exposed 2 / 9539 (0.02%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 2 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Arthralgia      subjects affected / exposed 1 / 9539 (0.01%) 3 / 9544 (0.03%)      occurrences causally related to treatment / all 0 / 1 0 / 3      deaths causally related to treatment / all 0 / 0 0 / 0 Arthritis      subjects affected / exposed 1 / 9539 (0.01%) 3 / 9544 (0.03%)      occurrences causally related to treatment / all 0 / 2 0 / 3      deaths causally related to treatment / all 0 / 0 0 / 0 Bursitis      subjects affected / exposed 1 / 9539 (0.01%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 1 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Back pain      subjects affected / exposed 7 / 9539 (0.07%) 7 / 9544 (0.07%)      occurrences causally related to treatment / all 0 / 7 0 / 7      deaths causally related to treatment / all 0 / 0 0 / 0 CREST syndrome      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Cervical spinal stenosis      subjects affected / exposed 1 / 9539 (0.01%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 1 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Chondrocalcinosis pyrophosphate      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Chondromalacia      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Chondropathy      subjects affected / exposed 0 / 9539 (0.00%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 0 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 Costochondritis      subjects affected / exposed 3 / 9539 (0.03%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 3 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Dupuytren's contracture      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Exostosis      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Exostosis of jaw      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Fasciitis      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Fistula      subjects affected / exposed 1 / 9539 (0.01%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 1 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Foot deformity      subjects affected / exposed 2 / 9539 (0.02%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 2 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Gouty arthritis      subjects affected / exposed 1 / 9539 (0.01%) 3 / 9544 (0.03%)      occurrences causally related to treatment / all 0 / 1 1 / 3      deaths causally related to treatment / all 0 / 0 0 / 0 Gouty tophus      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Groin pain      subjects affected / exposed 1 / 9539 (0.01%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 1 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Haemarthrosis      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Intervertebral disc compression      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Intervertebral disc degeneration      subjects affected / exposed 1 / 9539 (0.01%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 1 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Intervertebral disc disorder      subjects affected / exposed 4 / 9539 (0.04%) 3 / 9544 (0.03%)      occurrences causally related to treatment / all 0 / 6 0 / 3      deaths causally related to treatment / all 0 / 0 0 / 0 Intervertebral disc displacement      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Intervertebral disc protrusion      subjects affected / exposed 12 / 9539 (0.13%) 20 / 9544 (0.21%)      occurrences causally related to treatment / all 0 / 12 0 / 20      deaths causally related to treatment / all 0 / 0 0 / 0 Kyphosis      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (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 9 / 9539 (0.09%) 8 / 9544 (0.08%)      occurrences causally related to treatment / all 0 / 9 0 / 8      deaths causally related to treatment / all 0 / 0 0 / 0 Mobility decreased      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (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 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Muscle tightness      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (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 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Musculoskeletal chest pain      subjects affected / exposed 3 / 9539 (0.03%) 11 / 9544 (0.12%)      occurrences causally related to treatment / all 0 / 3 0 / 11      deaths causally related to treatment / all 0 / 0 0 / 0 Musculoskeletal pain      subjects affected / exposed 3 / 9539 (0.03%) 6 / 9544 (0.06%)      occurrences causally related to treatment / all 0 / 3 0 / 6      deaths causally related to treatment / all 0 / 0 0 / 0 Musculoskeletal stiffness      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Myopathy      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Myopathy toxic      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Neck pain      subjects affected / exposed 1 / 9539 (0.01%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 1 1 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 Neuropathic arthropathy      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Osteitis      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Osteoarthritis      subjects affected / exposed 46 / 9539 (0.48%) 43 / 9544 (0.45%)      occurrences causally related to treatment / all 0 / 47 0 / 48      deaths causally related to treatment / all 0 / 0 0 / 0 Osteochondritis      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Osteochondrosis      subjects affected / exposed 1 / 9539 (0.01%) 8 / 9544 (0.08%)      occurrences causally related to treatment / all 0 / 1 0 / 8      deaths causally related to treatment / all 0 / 0 0 / 0 Osteonecrosis      subjects affected / exposed 5 / 9539 (0.05%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 5 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Osteoporosis      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Osteoporosis postmenopausal      subjects affected / exposed 1 / 9539 (0.01%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 1 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 Osteoporotic fracture      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Pain in extremity      subjects affected / exposed 4 / 9539 (0.04%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 4 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 Patellofemoral pain syndrome      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Periarthritis      subjects affected / exposed 1 / 9539 (0.01%) 3 / 9544 (0.03%)      occurrences causally related to treatment / all 0 / 1 0 / 3      deaths causally related to treatment / all 0 / 0 0 / 0 Polymyalgia rheumatica      subjects affected / exposed 1 / 9539 (0.01%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 1 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Pseudarthrosis      subjects affected / exposed 1 / 9539 (0.01%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 1 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Psoriatic arthropathy      subjects affected / exposed 1 / 9539 (0.01%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 2 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Rhabdomyolysis      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (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 2 / 9539 (0.02%) 3 / 9544 (0.03%)      occurrences causally related to treatment / all 0 / 2 0 / 3      deaths causally related to treatment / all 0 / 0 0 / 0 Rotator cuff syndrome      subjects affected / exposed 4 / 9539 (0.04%) 5 / 9544 (0.05%)      occurrences causally related to treatment / all 0 / 4 0 / 5      deaths causally related to treatment / all 0 / 0 0 / 0 Scoliosis      subjects affected / exposed 2 / 9539 (0.02%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 2 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Spinal column stenosis      subjects affected / exposed 3 / 9539 (0.03%) 10 / 9544 (0.10%)      occurrences causally related to treatment / all 0 / 3 0 / 10      deaths causally related to treatment / all 0 / 0 0 / 0 Spinal osteoarthritis      subjects affected / exposed 18 / 9539 (0.19%) 16 / 9544 (0.17%)      occurrences causally related to treatment / all 0 / 18 0 / 18      deaths causally related to treatment / all 0 / 0 0 / 0 Spondyloarthropathy      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Spondylolisthesis      subjects affected / exposed 2 / 9539 (0.02%) 3 / 9544 (0.03%)      occurrences causally related to treatment / all 0 / 2 0 / 3      deaths causally related to treatment / all 0 / 0 0 / 0 Sympathetic posterior cervical syndrome      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Synovitis      subjects affected / exposed 3 / 9539 (0.03%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 4 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Systemic sclerosis      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Tenosynovitis      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (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 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Infections and infestations Abdominal wall abscess      subjects affected / exposed 1 / 9539 (0.01%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 1 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Abscess jaw      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Abscess limb      subjects affected / exposed 1 / 9539 (0.01%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 1 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 Acute hepatitis C      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (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 / 9539 (0.01%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 1 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 Anal abscess      subjects affected / exposed 1 / 9539 (0.01%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 1 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Anal candidiasis      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Appendiceal abscess      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Appendicitis      subjects affected / exposed 16 / 9539 (0.17%) 9 / 9544 (0.09%)      occurrences causally related to treatment / all 0 / 18 0 / 9      deaths causally related to treatment / all 0 / 0 0 / 0 Appendicitis perforated      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Arteriosclerotic gangrene      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Arteriovenous graft site infection      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Arthritis bacterial      subjects affected / exposed 0 / 9539 (0.00%) 3 / 9544 (0.03%)      occurrences causally related to treatment / all 0 / 0 0 / 3      deaths causally related to treatment / all 0 / 0 0 / 0 Atypical pneumonia      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Bacteraemia      subjects affected / exposed 3 / 9539 (0.03%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 3 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Bacterial diarrhoea      subjects affected / exposed 0 / 9539 (0.00%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 0 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 Bacterial infection      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Bacterial prostatitis      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (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 2 / 9539 (0.02%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 2 0 / 2      deaths causally related to treatment / all 0 / 1 0 / 0 Biliary tract infection      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Borrelia infection      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Brain abscess      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Bronchiolitis      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Bronchitis      subjects affected / exposed 16 / 9539 (0.17%) 22 / 9544 (0.23%)      occurrences causally related to treatment / all 0 / 16 0 / 28      deaths causally related to treatment / all 0 / 0 0 / 0 Bronchopneumonia      subjects affected / exposed 29 / 9539 (0.30%) 24 / 9544 (0.25%)      occurrences causally related to treatment / all 0 / 33 0 / 26      deaths causally related to treatment / all 0 / 1 0 / 2 Bronchitis bacterial      subjects affected / exposed 4 / 9539 (0.04%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 4 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Bronchopulmonary aspergillosis      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Campylobacter gastroenteritis      subjects affected / exposed 3 / 9539 (0.03%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 3 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 Candida pneumonia      subjects affected / exposed 1 / 9539 (0.01%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 1 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Candidiasis      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Carbuncle      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (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 23 / 9539 (0.24%) 18 / 9544 (0.19%)      occurrences causally related to treatment / all 0 / 23 0 / 19      deaths causally related to treatment / all 0 / 0 0 / 0 Cellulitis gangrenous      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Cervicitis      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Cholangitis suppurative      subjects affected / exposed 0 / 9539 (0.00%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 0 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 Cholecystitis infective      subjects affected / exposed 5 / 9539 (0.05%) 3 / 9544 (0.03%)      occurrences causally related to treatment / all 0 / 5 0 / 3      deaths causally related to treatment / all 0 / 0 0 / 0 Chronic hepatitis C      subjects affected / exposed 1 / 9539 (0.01%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 1 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 Chronic sinusitis      subjects affected / exposed 1 / 9539 (0.01%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 1 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Cystitis      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Clostridium difficile colitis      subjects affected / exposed 4 / 9539 (0.04%) 4 / 9544 (0.04%)      occurrences causally related to treatment / all 0 / 4 0 / 5      deaths causally related to treatment / all 0 / 1 0 / 0 Cystitis klebsiella      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (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 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Device related infection      subjects affected / exposed 1 / 9539 (0.01%) 4 / 9544 (0.04%)      occurrences causally related to treatment / all 0 / 1 0 / 4      deaths causally related to treatment / all 0 / 0 0 / 0 Diabetic foot infection      subjects affected / exposed 5 / 9539 (0.05%) 8 / 9544 (0.08%)      occurrences causally related to treatment / all 0 / 6 0 / 8      deaths causally related to treatment / all 0 / 0 0 / 0 Diabetic gangrene      subjects affected / exposed 4 / 9539 (0.04%) 13 / 9544 (0.14%)      occurrences causally related to treatment / all 0 / 4 0 / 15      deaths causally related to treatment / all 0 / 0 0 / 0 Diarrhoea infectious      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Diverticulitis      subjects affected / exposed 5 / 9539 (0.05%) 8 / 9544 (0.08%)      occurrences causally related to treatment / all 0 / 5 0 / 9      deaths causally related to treatment / all 0 / 0 0 / 0 Ear infection      subjects affected / exposed 2 / 9539 (0.02%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 2 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Echinococciasis      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Emphysematous cholecystitis      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 1 0 / 0 Empyema      subjects affected / exposed 2 / 9539 (0.02%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 2 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Endocarditis      subjects affected / exposed 2 / 9539 (0.02%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 2 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Endocarditis bacterial      subjects affected / exposed 2 / 9539 (0.02%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 2 0 / 0      deaths causally related to treatment / all 0 / 2 0 / 0 Endocarditis enterococcal      subjects affected / exposed 1 / 9539 (0.01%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 1 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Endocarditis staphylococcal      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 1 0 / 0 Enterobacter sepsis      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Enterococcal sepsis      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Enterocolitis bacterial      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Enterocolitis infectious      subjects affected / exposed 0 / 9539 (0.00%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 0 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 Epiglottitis      subjects affected / exposed 0 / 9539 (0.00%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 0 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 Erysipelas      subjects affected / exposed 20 / 9539 (0.21%) 15 / 9544 (0.16%)      occurrences causally related to treatment / all 0 / 20 0 / 15      deaths causally related to treatment / all 0 / 0 0 / 0 Escherichia infection      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Escherichia urinary tract infection      subjects affected / exposed 2 / 9539 (0.02%) 7 / 9544 (0.07%)      occurrences causally related to treatment / all 0 / 2 0 / 7      deaths causally related to treatment / all 0 / 0 0 / 0 Folliculitis      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Gallbladder empyema      subjects affected / exposed 1 / 9539 (0.01%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 1 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Gangrene      subjects affected / exposed 7 / 9539 (0.07%) 5 / 9544 (0.05%)      occurrences causally related to treatment / all 0 / 9 0 / 5      deaths causally related to treatment / all 0 / 1 0 / 0 Gastroenteritis      subjects affected / exposed 16 / 9539 (0.17%) 16 / 9544 (0.17%)      occurrences causally related to treatment / all 0 / 16 0 / 16      deaths causally related to treatment / all 0 / 0 0 / 0 Gastroenteritis bacterial      subjects affected / exposed 0 / 9539 (0.00%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 0 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 Gastroenteritis clostridial      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Gastroenteritis salmonella      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Gastroenteritis shigella      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Gastroenteritis viral      subjects affected / exposed 0 / 9539 (0.00%) 3 / 9544 (0.03%)      occurrences causally related to treatment / all 0 / 0 0 / 3      deaths causally related to treatment / all 0 / 0 0 / 0 Gastrointestinal bacterial infection      subjects affected / exposed 1 / 9539 (0.01%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 1 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Gastrointestinal viral infection      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Groin abscess      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Haemophilus infection      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Helicobacter gastritis      subjects affected / exposed 2 / 9539 (0.02%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 2 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Helicobacter infection      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Hepatitis A      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Hepatitis B      subjects affected / exposed 1 / 9539 (0.01%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 1 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Hepatitis C      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Herpes zoster      subjects affected / exposed 1 / 9539 (0.01%) 3 / 9544 (0.03%)      occurrences causally related to treatment / all 0 / 1 0 / 3      deaths causally related to treatment / all 0 / 0 0 / 0 Herpes zoster infection neurological      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Herpes zoster ophthalmic      subjects affected / exposed 2 / 9539 (0.02%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 2 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Herpes zoster oticus      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Infected cyst      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Infected dermal cyst      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (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 0 / 9539 (0.00%) 3 / 9544 (0.03%)      occurrences causally related to treatment / all 0 / 0 0 / 4      deaths causally related to treatment / all 0 / 0 0 / 0 Infection      subjects affected / exposed 0 / 9539 (0.00%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 0 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 Infectious pleural effusion      subjects affected / exposed 1 / 9539 (0.01%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 1 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 Infective exacerbation of bronchiectasis      subjects affected / exposed 3 / 9539 (0.03%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 4 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 Infective exacerbation of chronic obstructive airways disease      subjects affected / exposed 5 / 9539 (0.05%) 6 / 9544 (0.06%)      occurrences causally related to treatment / all 0 / 5 0 / 7      deaths causally related to treatment / all 0 / 0 0 / 0 Infective myositis      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Influenza      subjects affected / exposed 3 / 9539 (0.03%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 3 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Injection site abscess      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Intervertebral discitis      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Joint abscess      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Keratitis herpetic      subjects affected / exposed 2 / 9539 (0.02%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 2 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Laryngitis      subjects affected / exposed 2 / 9539 (0.02%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 2 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Laryngitis bacterial      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Laryngitis fungal      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (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 / 9539 (0.00%) 1 / 9544 (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 3 / 9539 (0.03%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 3 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Lobar pneumonia      subjects affected / exposed 6 / 9539 (0.06%) 13 / 9544 (0.14%)      occurrences causally related to treatment / all 0 / 6 0 / 13      deaths causally related to treatment / all 0 / 1 0 / 0 Localised infection      subjects affected / exposed 0 / 9539 (0.00%) 3 / 9544 (0.03%)      occurrences causally related to treatment / all 0 / 0 0 / 3      deaths causally related to treatment / all 0 / 0 0 / 0 Lower respiratory tract infection      subjects affected / exposed 5 / 9539 (0.05%) 9 / 9544 (0.09%)      occurrences causally related to treatment / all 0 / 5 0 / 10      deaths causally related to treatment / all 0 / 0 0 / 0 Lower respiratory tract infection bacterial      subjects affected / exposed 1 / 9539 (0.01%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 1 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Lung abscess      subjects affected / exposed 4 / 9539 (0.04%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 4 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Lung infection      subjects affected / exposed 11 / 9539 (0.12%) 8 / 9544 (0.08%)      occurrences causally related to treatment / all 0 / 11 0 / 11      deaths causally related to treatment / all 0 / 0 0 / 0 Lyme disease      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Lymphangitis      subjects affected / exposed 1 / 9539 (0.01%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 1 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Malaria      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Mastoiditis      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Mediastinal abscess      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Mediastinitis      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Meningitis      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Meningitis tuberculous      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Meningitis viral      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Muscle abscess      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Necrotising fasciitis      subjects affected / exposed 0 / 9539 (0.00%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 0 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 Oesophageal candidiasis      subjects affected / exposed 0 / 9539 (0.00%) 2 / 9544 (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 2 / 9539 (0.02%) 3 / 9544 (0.03%)      occurrences causally related to treatment / all 0 / 2 0 / 3      deaths causally related to treatment / all 0 / 0 0 / 0 Osteomyelitis      subjects affected / exposed 2 / 9539 (0.02%) 11 / 9544 (0.12%)      occurrences causally related to treatment / all 0 / 2 0 / 11      deaths causally related to treatment / all 0 / 0 0 / 0 Osteomyelitis bacterial      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Osteomyelitis chronic      subjects affected / exposed 0 / 9539 (0.00%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 0 0 / 4      deaths causally related to treatment / all 0 / 0 0 / 0 Otitis media      subjects affected / exposed 1 / 9539 (0.01%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 1 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Otitis media acute      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Otitis media chronic      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Pelvic abscess      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Perihepatic abscess      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Perineal abscess      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (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 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Peritoneal abscess      subjects affected / exposed 2 / 9539 (0.02%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 2 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Peritonitis      subjects affected / exposed 9 / 9539 (0.09%) 9 / 9544 (0.09%)      occurrences causally related to treatment / all 0 / 9 0 / 9      deaths causally related to treatment / all 0 / 0 0 / 2 Peritonitis bacterial      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (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 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Pertussis      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Pharyngitis      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Pneumococcal sepsis      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Pneumonia      subjects affected / exposed 122 / 9539 (1.28%) 102 / 9544 (1.07%)      occurrences causally related to treatment / all 0 / 129 0 / 112      deaths causally related to treatment / all 0 / 6 0 / 3 Pneumonia bacterial      subjects affected / exposed 7 / 9539 (0.07%) 7 / 9544 (0.07%)      occurrences causally related to treatment / all 0 / 8 0 / 7      deaths causally related to treatment / all 0 / 1 0 / 0 Pneumonia escherichia      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Pneumonia haemophilus      subjects affected / exposed 1 / 9539 (0.01%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 1 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 Pneumonia klebsiella      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Pneumonia moraxella      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Pneumonia mycoplasmal      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Pneumonia pneumococcal      subjects affected / exposed 1 / 9539 (0.01%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 1 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 Pneumonia pseudomonas aeruginosa      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Pneumonia streptococcal      subjects affected / exposed 1 / 9539 (0.01%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 1 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Pneumonia viral      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Post procedural cellulitis      subjects affected / exposed 0 / 9539 (0.00%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 0 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 Post procedural infection      subjects affected / exposed 1 / 9539 (0.01%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 1 0 / 1      deaths causally related to treatment / all 0 / 1 0 / 0 Post procedural sepsis      subjects affected / exposed 1 / 9539 (0.01%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 1 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 Postoperative abscess      subjects affected / exposed 0 / 9539 (0.00%) 3 / 9544 (0.03%)      occurrences causally related to treatment / all 0 / 0 0 / 3      deaths causally related to treatment / all 0 / 0 0 / 0 Postoperative wound infection      subjects affected / exposed 6 / 9539 (0.06%) 12 / 9544 (0.13%)      occurrences causally related to treatment / all 0 / 6 0 / 13      deaths causally related to treatment / all 0 / 0 0 / 0 Pseudomembranous colitis      subjects affected / exposed 0 / 9539 (0.00%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 0 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 Pseudomonal bacteraemia      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (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 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Pulmonary tuberculoma      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Pulmonary tuberculosis      subjects affected / exposed 4 / 9539 (0.04%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 4 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Puncture site abscess      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Puncture site infection      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (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 3 / 9539 (0.03%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 3 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 Pyelonephritis acute      subjects affected / exposed 5 / 9539 (0.05%) 8 / 9544 (0.08%)      occurrences causally related to treatment / all 0 / 5 0 / 8      deaths causally related to treatment / all 0 / 0 0 / 0 Pyelonephritis chronic      subjects affected / exposed 7 / 9539 (0.07%) 6 / 9544 (0.06%)      occurrences causally related to treatment / all 0 / 7 0 / 8      deaths causally related to treatment / all 0 / 0 0 / 0 Pyoderma      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Pyonephrosis      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Renal tuberculosis      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Respiratory syncytial virus infection      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Respiratory moniliasis      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Respiratory tract infection      subjects affected / exposed 5 / 9539 (0.05%) 12 / 9544 (0.13%)      occurrences causally related to treatment / all 0 / 5 0 / 13      deaths causally related to treatment / all 0 / 0 0 / 0 Respiratory tract infection bacterial      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Respiratory tract infection viral      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Salmonellosis      subjects affected / exposed 1 / 9539 (0.01%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 1 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Sepsis      subjects affected / exposed 11 / 9539 (0.12%) 11 / 9544 (0.12%)      occurrences causally related to treatment / all 0 / 11 0 / 11      deaths causally related to treatment / all 0 / 5 0 / 3 Scrotal abscess      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Septic arthritis staphylococcal      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Septic shock      subjects affected / exposed 9 / 9539 (0.09%) 13 / 9544 (0.14%)      occurrences causally related to treatment / all 0 / 9 0 / 13      deaths causally related to treatment / all 0 / 6 0 / 5 Sinusitis      subjects affected / exposed 0 / 9539 (0.00%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 0 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 Skin infection      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Small intestine gangrene      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 1 Sputum purulent      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Staphylococcal infection      subjects affected / exposed 2 / 9539 (0.02%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 2 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Staphylococcal osteomyelitis      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Staphylococcal sepsis      subjects affected / exposed 2 / 9539 (0.02%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 2 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 1 Streptococcal sepsis      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Subcutaneous abscess      subjects affected / exposed 4 / 9539 (0.04%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 4 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 Systemic candida      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Tonsillitis bacterial      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Tooth infection      subjects affected / exposed 1 / 9539 (0.01%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 1 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Toxic shock syndrome      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (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 3 / 9539 (0.03%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 3 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Tuberculosis gastrointestinal      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Tuberculous pleurisy      subjects affected / exposed 2 / 9539 (0.02%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 2 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Tubo-ovarian abscess      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Typhoid fever      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (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 6 / 9539 (0.06%) 4 / 9544 (0.04%)      occurrences causally related to treatment / all 0 / 6 0 / 4      deaths causally related to treatment / all 0 / 0 0 / 0 Urinary tract infection      subjects affected / exposed 26 / 9539 (0.27%) 17 / 9544 (0.18%)      occurrences causally related to treatment / all 0 / 26 0 / 18      deaths causally related to treatment / all 0 / 0 0 / 0 Urinary tract infection bacterial      subjects affected / exposed 7 / 9539 (0.07%) 3 / 9544 (0.03%)      occurrences causally related to treatment / all 0 / 7 0 / 3      deaths causally related to treatment / all 0 / 0 0 / 0 Urinary tract infection enterococcal      subjects affected / exposed 2 / 9539 (0.02%) 0 / 9544 (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 4 / 9539 (0.04%) 13 / 9544 (0.14%)      occurrences causally related to treatment / all 0 / 4 0 / 14      deaths causally related to treatment / all 0 / 0 0 / 1 Viral infection      subjects affected / exposed 3 / 9539 (0.03%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 3 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Viral pericarditis      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Wound infection      subjects affected / exposed 1 / 9539 (0.01%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 1 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Wound infection bacterial      subjects affected / exposed 3 / 9539 (0.03%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 3 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Wound infection pseudomonas      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (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 Acidosis      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Cachexia      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Decreased appetite      subjects affected / exposed 4 / 9539 (0.04%) 3 / 9544 (0.03%)      occurrences causally related to treatment / all 1 / 4 0 / 3      deaths causally related to treatment / all 0 / 0 0 / 0 Dehydration      subjects affected / exposed 19 / 9539 (0.20%) 19 / 9544 (0.20%)      occurrences causally related to treatment / all 0 / 20 0 / 19      deaths causally related to treatment / all 0 / 0 0 / 0 Diabetes mellitus      subjects affected / exposed 59 / 9539 (0.62%) 82 / 9544 (0.86%)      occurrences causally related to treatment / all 0 / 65 0 / 87      deaths causally related to treatment / all 0 / 0 0 / 1 Diabetes mellitus inadequate control      subjects affected / exposed 34 / 9539 (0.36%) 50 / 9544 (0.52%)      occurrences causally related to treatment / all 0 / 36 0 / 53      deaths causally related to treatment / all 0 / 0 0 / 0 Diabetic complication      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (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 1 / 9539 (0.01%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 1 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Fluid retention      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Gout      subjects affected / exposed 4 / 9539 (0.04%) 3 / 9544 (0.03%)      occurrences causally related to treatment / all 0 / 4 0 / 3      deaths causally related to treatment / all 0 / 0 0 / 0 Hypercholesterolaemia      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Hyperglycaemia      subjects affected / exposed 10 / 9539 (0.10%) 4 / 9544 (0.04%)      occurrences causally related to treatment / all 0 / 11 0 / 4      deaths causally related to treatment / all 0 / 0 0 / 0 Hyperkalaemia      subjects affected / exposed 13 / 9539 (0.14%) 10 / 9544 (0.10%)      occurrences causally related to treatment / all 0 / 14 0 / 10      deaths causally related to treatment / all 0 / 0 0 / 0 Hypertriglyceridaemia      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Hypocalcaemia      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Hypoglycaemia      subjects affected / exposed 19 / 9539 (0.20%) 12 / 9544 (0.13%)      occurrences causally related to treatment / all 0 / 20 0 / 13      deaths causally related to treatment / all 0 / 0 0 / 0 Hypokalaemia      subjects affected / exposed 4 / 9539 (0.04%) 5 / 9544 (0.05%)      occurrences causally related to treatment / all 0 / 5 0 / 5      deaths causally related to treatment / all 0 / 0 0 / 0 Hypomagnesaemia      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Hyponatraemia      subjects affected / exposed 1 / 9539 (0.01%) 7 / 9544 (0.07%)      occurrences causally related to treatment / all 0 / 1 0 / 7      deaths causally related to treatment / all 0 / 0 0 / 0 Hypoproteinaemia      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Insulin-requiring type 2 diabetes mellitus      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Ketoacidosis      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (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 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Malnutrition      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Metabolic acidosis      subjects affected / exposed 1 / 9539 (0.01%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 1 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 Metabolic alkalosis      subjects affected / exposed 0 / 9539 (0.00%) 2 / 9544 (0.02%)      occurrences causally related to treatment / all 0 / 0 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 0 Obesity      subjects affected / exposed 0 / 9539 (0.00%) 1 / 9544 (0.01%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Type 1 diabetes mellitus      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Type 2 diabetes mellitus      subjects affected / exposed 25 / 9539 (0.26%) 47 / 9544 (0.49%)      occurrences causally related to treatment / all 0 / 26 0 / 52      deaths causally related to treatment / all 0 / 0 0 / 0 Type 3 diabetes mellitus      subjects affected / exposed 1 / 9539 (0.01%) 0 / 9544 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0
Frequency threshold for reporting non-serious adverse events: 1%
Non-serious adverse events Ivabradine Placebo Total subjects affected by non serious adverse events      subjects affected / exposed 6920 / 9539 (72.54%) 6321 / 9544 (66.23%) Vascular disorders Hypertensive crisis      subjects affected / exposed 129 / 9539 (1.35%) 140 / 9544 (1.47%)      occurrences all number 147 160 Hypertension      subjects affected / exposed 1129 / 9539 (11.84%) 923 / 9544 (9.67%)      occurrences all number 1322 1070 Hypotension      subjects affected / exposed 178 / 9539 (1.87%) 190 / 9544 (1.99%)      occurrences all number 187 198 Peripheral arterial occlusive disease      subjects affected / exposed 122 / 9539 (1.28%) 128 / 9544 (1.34%)      occurrences all number 131 135 General disorders and administration site conditions Chest pain      subjects affected / exposed 108 / 9539 (1.13%) 132 / 9544 (1.38%)      occurrences all number 121 158 Non-cardiac chest pain      subjects affected / exposed 119 / 9539 (1.25%) 114 / 9544 (1.19%)      occurrences all number 131 123 Fatigue      subjects affected / exposed 126 / 9539 (1.32%) 110 / 9544 (1.15%)      occurrences all number 131 116 Oedema peripheral      subjects affected / exposed 214 / 9539 (2.24%) 170 / 9544 (1.78%)      occurrences all number 234 178 Reproductive system and breast disorders Benign prostatic hyperplasia      subjects affected / exposed 121 / 9539 (1.27%) 132 / 9544 (1.38%)      occurrences all number 121 132 Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease      subjects affected / exposed 168 / 9539 (1.76%) 152 / 9544 (1.59%)      occurrences all number 211 198 Cough      subjects affected / exposed 154 / 9539 (1.61%) 138 / 9544 (1.45%)      occurrences all number 165 146 Dyspnoea      subjects affected / exposed 136 / 9539 (1.43%) 114 / 9544 (1.19%)      occurrences all number 144 121 Psychiatric disorders Insomnia      subjects affected / exposed 100 / 9539 (1.05%) 99 / 9544 (1.04%)      occurrences all number 102 102 Investigations Blood pressure increased      subjects affected / exposed 118 / 9539 (1.24%) 117 / 9544 (1.23%)      occurrences all number 145 145 Blood creatinine increased      subjects affected / exposed 114 / 9539 (1.20%) 88 / 9544 (0.92%)      occurrences all number 118 89 C-reactive protein increased      subjects affected / exposed 155 / 9539 (1.62%) 140 / 9544 (1.47%)      occurrences all number 159 143 Electrocardiogram QT prolonged      subjects affected / exposed 161 / 9539 (1.69%) 58 / 9544 (0.61%)      occurrences all number 178 62 Heart rate decreased      subjects affected / exposed 1032 / 9539 (10.82%) 112 / 9544 (1.17%)      occurrences all number 1173 123 Injury, poisoning and procedural complications Fall      subjects affected / exposed 259 / 9539 (2.72%) 287 / 9544 (3.01%)      occurrences all number 284 313 Cardiac disorders Acute myocardial infarction      subjects affected / exposed 200 / 9539 (2.10%) 208 / 9544 (2.18%)      occurrences all number 216 229 Angina pectoris      subjects affected / exposed 611 / 9539 (6.41%) 692 / 9544 (7.25%)      occurrences all number 684 774 Angina unstable      subjects affected / exposed 412 / 9539 (4.32%) 436 / 9544 (4.57%)      occurrences all number 482 527 Atrioventricular block first degree      subjects affected / exposed 251 / 9539 (2.63%) 204 / 9544 (2.14%)      occurrences all number 269 222 Atrial fibrillation      subjects affected / exposed 438 / 9539 (4.59%) 316 / 9544 (3.31%)      occurrences all number 538 370 Cardiac failure      subjects affected / exposed 469 / 9539 (4.92%) 464 / 9544 (4.86%)      occurrences all number 546 531 Bradycardia      subjects affected / exposed 569 / 9539 (5.96%) 77 / 9544 (0.81%)      occurrences all number 613 84 Myocardial infarction      subjects affected / exposed 98 / 9539 (1.03%) 83 / 9544 (0.87%)      occurrences all number 104 88 Sinus bradycardia      subjects affected / exposed 189 / 9539 (1.98%) 22 / 9544 (0.23%)      occurrences all number 199 24 Sinus tachycardia      subjects affected / exposed 46 / 9539 (0.48%) 170 / 9544 (1.78%)      occurrences all number 46 193 Supraventricular extrasystoles      subjects affected / exposed 184 / 9539 (1.93%) 143 / 9544 (1.50%)      occurrences all number 194 144 Ventricular extrasystoles      subjects affected / exposed 335 / 9539 (3.51%) 264 / 9544 (2.77%)      occurrences all number 363 288 Nervous system disorders Dizziness      subjects affected / exposed 291 / 9539 (3.05%) 217 / 9544 (2.27%)      occurrences all number 311 235 Headache      subjects affected / exposed 170 / 9539 (1.78%) 146 / 9544 (1.53%)      occurrences all number 195 162 Ischaemic stroke      subjects affected / exposed 97 / 9539 (1.02%) 90 / 9544 (0.94%)      occurrences all number 100 95 Blood and lymphatic system disorders Anaemia      subjects affected / exposed 214 / 9539 (2.24%) 240 / 9544 (2.51%)      occurrences all number 221 249 Eye disorders Cataract      subjects affected / exposed 157 / 9539 (1.65%) 189 / 9544 (1.98%)      occurrences all number 175 203 Photopsia      subjects affected / exposed 509 / 9539 (5.34%) 51 / 9544 (0.53%)      occurrences all number 567 52 Vision blurred      subjects affected / exposed 115 / 9539 (1.21%) 36 / 9544 (0.38%)      occurrences all number 119 36 Gastrointestinal disorders Constipation      subjects affected / exposed 99 / 9539 (1.04%) 102 / 9544 (1.07%)      occurrences all number 106 107 Diarrhoea      subjects affected / exposed 125 / 9539 (1.31%) 121 / 9544 (1.27%)      occurrences all number 131 129 Gastritis      subjects affected / exposed 108 / 9539 (1.13%) 124 / 9544 (1.30%)      occurrences all number 111 127 Nausea      subjects affected / exposed 96 / 9539 (1.01%) 83 / 9544 (0.87%)      occurrences all number 102 87 Renal and urinary disorders Renal failure      subjects affected / exposed 112 / 9539 (1.17%) 89 / 9544 (0.93%)      occurrences all number 118 90 Renal failure chronic      subjects affected / exposed 105 / 9539 (1.10%) 82 / 9544 (0.86%)      occurrences all number 109 82 Musculoskeletal and connective tissue disorders Back pain      subjects affected / exposed 102 / 9539 (1.07%) 115 / 9544 (1.20%)      occurrences all number 107 121 Arthralgia      subjects affected / exposed 71 / 9539 (0.74%) 98 / 9544 (1.03%)      occurrences all number 75 102 Osteoarthritis      subjects affected / exposed 148 / 9539 (1.55%) 192 / 9544 (2.01%)      occurrences all number 163 209 Spinal osteoarthritis      subjects affected / exposed 125 / 9539 (1.31%) 134 / 9544 (1.40%)      occurrences all number 131 143 Infections and infestations Bronchitis      subjects affected / exposed 228 / 9539 (2.39%) 201 / 9544 (2.11%)      occurrences all number 257 226 Influenza      subjects affected / exposed 116 / 9539 (1.22%) 169 / 9544 (1.77%)      occurrences all number 126 177 Pneumonia      subjects affected / exposed 170 / 9539 (1.78%) 146 / 9544 (1.53%)      occurrences all number 183 161 Nasopharyngitis      subjects affected / exposed 172 / 9539 (1.80%) 172 / 9544 (1.80%)      occurrences all number 195 198 Upper respiratory tract infection      subjects affected / exposed 172 / 9539 (1.80%) 179 / 9544 (1.88%)      occurrences all number 200 219 Urinary tract infection      subjects affected / exposed 129 / 9539 (1.35%) 116 / 9544 (1.22%)      occurrences all number 137 136 Metabolism and nutrition disorders Diabetes mellitus      subjects affected / exposed 241 / 9539 (2.53%) 320 / 9544 (3.35%)      occurrences all number 264 347 Diabetes mellitus inadequate control      subjects affected / exposed 109 / 9539 (1.14%) 132 / 9544 (1.38%)      occurrences all number 115 141 Hyperglycaemia      subjects affected / exposed 109 / 9539 (1.14%) 103 / 9544 (1.08%)      occurrences all number 113 108 Hypercholesterolaemia      subjects affected / exposed 155 / 9539 (1.62%) 175 / 9544 (1.83%)      occurrences all number 162 184 Hyperkalaemia      subjects affected / exposed 152 / 9539 (1.59%) 121 / 9544 (1.27%)      occurrences all number 159 131 Type 2 diabetes mellitus      subjects affected / exposed 161 / 9539 (1.69%) 217 / 9544 (2.27%)      occurrences all number 167 231 Hypertriglyceridaemia      subjects affected / exposed 150 / 9539 (1.57%) 159 / 9544 (1.67%)      occurrences all number 154 162