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Clinical Trial Results:
A Multicenter, Open-label, Single-arm, Extension Study to Assess Long-term Safety of Evolocumab Therapy in Patients With Clinically Evident Cardiovascular Disease

Summary
EudraCT number	2015-004780-36
Trial protocol	SK PL HU CZ
Global end of trial date	21 Mar 2022

Results information
Results version number	v2(current)
This version publication date	21 Apr 2023
First version publication date	24 Feb 2023
Other versions	v1
Version creation reason	Correction of full data set enhancement of terminology for timeframe

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

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Trial information

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Sponsor protocol code

20130295

ISRCTN number

-

US NCT number

NCT02867813

WHO universal trial number (UTN)

-

Sponsor organisation name

Amgen Inc.

Sponsor organisation address

One Amgen Center Drive, Thousand Oaks, CA, United States,

Public contact

IHQ Medical Info-Clinical Trials, Amgen (EUROPE) GmbH, medinfo@amgen.com

Scientific contact

IHQ Medical Info-Clinical Trials, Amgen (EUROPE) GmbH, medinfo@amgen.com

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

No

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

No

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

No

Analysis stage

Final

Date of interim/final analysis

26 Jul 2022

Is this the analysis of the primary completion data?

No

Global end of trial reached?

Yes

Global end of trial date

21 Mar 2022

Was the trial ended prematurely?

No

Main objective of the trial

The primary objective of this study was to describe the safety and tolerability of long-term administration of evolocumab.

Protection of trial subjects

This study was conducted in accordance with International Council for Harmonisation (ICH) Good Clinical Practice (GCP) regulations/guidelines.

Background therapy

-

Evidence for comparator

-

Actual start date of recruitment

02 Sep 2016

Long term follow-up planned

No

Independent data monitoring committee (IDMC) involvement?

No

Number of subjects enrolled per country

Country: Number of subjects enrolled

Poland: 1348

Country: Number of subjects enrolled

United States: 2201

Country: Number of subjects enrolled

Czechia: 763

Country: Number of subjects enrolled

Hungary: 225

Country: Number of subjects enrolled

Russian Federation: 364

Country: Number of subjects enrolled

Slovakia: 79

Country: Number of subjects enrolled

Ukraine: 55

Worldwide total number of subjects

5035

EEA total number of subjects

2415

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)

2947

From 65 to 84 years

2083

85 years and over

5

Subject disposition

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Recruitment details

This was an open-label extension of study 20110118 (NCT01764633). Eligible participants were enrolled after the completion of the 20110118 study. 5035 participants were enrolled at 195 centers in Czech Republic, Hungary, Poland, Russia, Slovakia, Ukraine, and the United States from 02 September 2016 to 17 March 2022.

Screening details

5035 participants were enrolled and 5031 of those participants received study drug.

Period 1 title

Overall Study (overall period)

Is this the baseline period?

Yes

Allocation method

Non-randomised - controlled

Blinding used

Not blinded

Are arms mutually exclusive

Yes

Placebo Q2W or QM in Parent Study

Arm description

Participants in the parent study who received placebo subcutaneous injections either every 2 weeks (Q2W) or monthly (QM), and received evolocumab 140 mg Q2W or 420 mg QM in the open label extension according to the participant's preference.

Arm type

Experimental

Investigational medicinal product name

Evolocumab

Investigational medicinal product code

Other name

Repatha

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

140 mg every Q2W or 420 mg QM, according to the subject's preference.

Evolocumab Q2W or QM in Parent Study

Arm description

Participants in the parent study who received evolocumab subcutaneous injections either Q2W or QM, and received evolocumab 140 mg Q2W or 420 mg QM in the open label extension according to the participant's preference.

Arm type

Experimental

Investigational medicinal product name

Evolocumab

Investigational medicinal product code

Other name

Repatha

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

140 mg every Q2W or 420 mg QM, according to the subject's preference.

Number of subjects in period 1	Placebo Q2W or QM in Parent Study	Evolocumab Q2W or QM in Parent Study
Started	2535	2500
Completed	2084	2090
Not completed	451	410
Consent withdrawn by subject	57	56
Decision by Sponsor	7	7
Death	294	268
Lost to follow-up	91	78
Missing	2	1

Baseline characteristics

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Reporting group title

Placebo Q2W or QM in Parent Study

Reporting group description

Participants in the parent study who received placebo subcutaneous injections either every 2 weeks (Q2W) or monthly (QM), and received evolocumab 140 mg Q2W or 420 mg QM in the open label extension according to the participant's preference.

Reporting group title

Evolocumab Q2W or QM in Parent Study

Reporting group description

Participants in the parent study who received evolocumab subcutaneous injections either Q2W or QM, and received evolocumab 140 mg Q2W or 420 mg QM in the open label extension according to the participant's preference.

Reporting group values	Placebo Q2W or QM in Parent Study	Evolocumab Q2W or QM in Parent Study	Total
Number of subjects	2535	2500	5035
Age Categorical
Units: Subjects
Adults (18-64 years)	1512	1435	2947
From 65-84 years	1019	1064	2083
85 years and over	4	1	5
Gender Categorical
Units: Subjects
Female	638	622	1260
Male	1897	1878	3775
Ethnicity
Units: Subjects
Hispanic/Latino	55	63	118
Not Hispanic/Latino	2480	2437	4917
Race
Units: Subjects
American Indian or Alaska Native	5	2	7
Asian	9	21	30
Black or African American	112	117	229
Native Hawaiian or Other Pacific Islander	5	4	9
White	2394	2346	4740
Multiple	4	4	8
Other	6	6	12

End points

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Reporting group title

Placebo Q2W or QM in Parent Study

Reporting group description

Participants in the parent study who received placebo subcutaneous injections either every 2 weeks (Q2W) or monthly (QM), and received evolocumab 140 mg Q2W or 420 mg QM in the open label extension according to the participant's preference.

Reporting group title

Evolocumab Q2W or QM in Parent Study

Reporting group description

Participants in the parent study who received evolocumab subcutaneous injections either Q2W or QM, and received evolocumab 140 mg Q2W or 420 mg QM in the open label extension according to the participant's preference.

Primary: Number of Participants Who Experienced an Adverse Event

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End point title

Number of Participants Who Experienced an Adverse Event ^[1]

End point description

All adverse event summaries for the primary analysis of the primary endpoint (OLE study period only) included all treatment-emergent events reported on the Event electronic case report form (eCRF), including CEC positively reviewed events and disease-related events.

End point type

Primary

End point timeframe

Up to 5 years

Notes
[1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No statistical analysis was planned for this end point.

End point values	Placebo Q2W or QM in Parent Study	Evolocumab Q2W or QM in Parent Study
Number of subjects analysed	2532	2499
Units: Participants	2144	2084

No statistical analyses for this end point

Secondary: Percent Change of Low-density Lipoprotein Cholesterol (LDL-C) From Baseline at Each Scheduled Visit

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End point title

Percent Change of Low-density Lipoprotein Cholesterol (LDL-C) From Baseline at Each Scheduled Visit

End point description

End point type

Secondary

End point timeframe

Week 12, Week 24, Week 48, Week 72, Week 96, Week 120, Week 144, Week 168, Week 192, Week 216, Week 260

End point values	Placebo Q2W or QM in Parent Study	Evolocumab Q2W or QM in Parent Study
Number of subjects analysed	2532	2499
Units: Percent Change
arithmetic mean (standard deviation)
Week 12	-55.93 ± 33.73	-58.43 ± 30.64
Week 24	-56.69 ± 33.58	-58.38 ± 31.52
Week 48	-58.52 ± 33.66	-59.05 ± 33.06
Week 72	-56.35 ± 33.73	-56.90 ± 33.14
Week 96	-55.70 ± 33.72	-56.62 ± 33.36
Week 120	-53.37 ± 36.77	-54.89 ± 35.99
Week 144	-56.96 ± 32.82	-57.38 ± 32.34
Week 168	-56.49 ± 37.04	-58.22 ± 34.60
Week 192	-57.42 ± 35.43	-58.81 ± 33.27
Week 216	-54.68 ± 35.53	-57.11 ± 32.89
Week 260	-53.69 ± 37.51	-56.63 ± 36.14

No statistical analyses for this end point

Secondary: Percentage of Participants who Achieved an LDL-C level < 40 mg/dL

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End point title

Percentage of Participants who Achieved an LDL-C level < 40 mg/dL

End point description

End point type

Secondary

End point timeframe

Baseline, Week 12, Week 24, Week 48, Week 72, Week 96, Week 120, Week 144, Week 168, Week 192, Week 216, Week 260

End point values	Placebo Q2W or QM in Parent Study	Evolocumab Q2W or QM in Parent Study
Number of subjects analysed	2532	2499
Units: Percentage of Participants
number (confidence interval 95%)
Week 12	58.7 (56.7 to 60.6)	61.4 (59.4 to 63.3)
Week 24	60.2 (58.2 to 62.1)	61.6 (59.7 to 63.5)
Week 48	61.7 (59.8 to 63.7)	61.9 (60.0 to 63.9)
Week 72	59.7 (57.7 to 61.7)	58.5 (56.5 to 60.5)
Week 96	57.3 (55.3 to 59.3)	59.9 (57.8 to 61.9)
Week 120	54.6 (52.5 to 56.6)	56.4 (54.4 to 58.5)
Week 144	59.6 (57.6 to 61.7)	60.4 (58.3 to 62.4)
Week 168	60.9 (58.8 to 63.0)	61.5 (59.4 to 63.5)
Week 192	61.8 (59.4 to 64.1)	62.3 (59.9 to 64.7)
Week 216	56.0 (53.6 to 58.3)	59.2 (56.9 to 61.5)
Week 260	56.9 (54.6 to 59.1)	59.2 (56.9 to 61.4)

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

Day 1 up to approximately 5 years during the OLE study.

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

24.1

Reporting group title

Placebo in Parent Study

Reporting group description

-

Reporting group title

Evolocumab in Parent Study

Reporting group description

-

Serious adverse events	Placebo in Parent Study	Evolocumab in Parent Study
Total subjects affected by serious adverse events
subjects affected / exposed	1077 / 2532 (42.54%)	1045 / 2499 (41.82%)
number of deaths (all causes)	308	287
number of deaths resulting from adverse events	189	184
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell lymphoma
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Basal cell carcinoma
subjects affected / exposed	2 / 2532 (0.08%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Benign male reproductive tract neoplasm
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Benign neoplasm of ampulla of Vater
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Benign pancreatic neoplasm
subjects affected / exposed	1 / 2532 (0.04%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Benign spleen tumour
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Acute myeloid leukaemia
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Adenocarcinoma gastric
subjects affected / exposed	1 / 2532 (0.04%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 0
Adenocarcinoma of colon
subjects affected / exposed	5 / 2532 (0.20%)	10 / 2499 (0.40%)
occurrences causally related to treatment / all	0 / 5	0 / 10
deaths causally related to treatment / all	0 / 1	0 / 3
Adenocarcinoma pancreas
subjects affected / exposed	3 / 2532 (0.12%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Anal cancer metastatic
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
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 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Bladder neoplasm
subjects affected / exposed	2 / 2532 (0.08%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	1 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Bladder cancer stage I, without cancer in situ
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Bladder cancer stage I, with cancer in situ
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Bladder cancer recurrent
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Bladder cancer
subjects affected / exposed	6 / 2532 (0.24%)	5 / 2499 (0.20%)
occurrences causally related to treatment / all	0 / 7	0 / 5
deaths causally related to treatment / all	0 / 1	0 / 2
Bladder adenocarcinoma stage unspecified
subjects affected / exposed	0 / 2532 (0.00%)	2 / 2499 (0.08%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Breast cancer stage I
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Bladder transitional cell carcinoma
subjects affected / exposed	2 / 2532 (0.08%)	5 / 2499 (0.20%)
occurrences causally related to treatment / all	0 / 2	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Bladder transitional cell carcinoma metastatic
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Brain cancer metastatic
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Breast cancer
subjects affected / exposed	2 / 2532 (0.08%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Breast cancer female
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Breast cancer metastatic
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Bladder papilloma
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
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	0 / 2532 (0.00%)	2 / 2499 (0.08%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Chronic myeloid leukaemia
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Chronic lymphocytic leukaemia
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
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 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Carcinoid tumour pulmonary
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Bronchial carcinoma
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Colon adenoma
subjects affected / exposed	3 / 2532 (0.12%)	3 / 2499 (0.12%)
occurrences causally related to treatment / all	0 / 3	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Endometrial adenocarcinoma
subjects affected / exposed	1 / 2532 (0.04%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Ductal adenocarcinoma of pancreas
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Diffuse large B-cell lymphoma stage IV
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (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
subjects affected / exposed	0 / 2532 (0.00%)	3 / 2499 (0.12%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 1
Colorectal cancer
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Colorectal adenocarcinoma
subjects affected / exposed	0 / 2532 (0.00%)	2 / 2499 (0.08%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Colon cancer
subjects affected / exposed	1 / 2532 (0.04%)	2 / 2499 (0.08%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Endometrial cancer
subjects affected / exposed	0 / 2532 (0.00%)	2 / 2499 (0.08%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Follicular lymphoma
subjects affected / exposed	2 / 2532 (0.08%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gallbladder cancer metastatic
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Gastric cancer
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal cancer metastatic
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal tract adenoma
subjects affected / exposed	2 / 2532 (0.08%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Invasive lobular breast carcinoma
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Invasive breast carcinoma
subjects affected / exposed	2 / 2532 (0.08%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Intraductal proliferative breast lesion
subjects affected / exposed	2 / 2532 (0.08%)	3 / 2499 (0.12%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatocellular carcinoma
subjects affected / exposed	2 / 2532 (0.08%)	2 / 2499 (0.08%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 1	0 / 1
Hepatic cancer
subjects affected / exposed	1 / 2532 (0.04%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Glottis carcinoma
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Glioblastoma multiforme
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Invasive ductal breast carcinoma
subjects affected / exposed	1 / 2532 (0.04%)	2 / 2499 (0.08%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Keratoacanthoma
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Laryngeal cancer
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Laryngeal cancer stage III
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Laryngeal papilloma
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Laryngeal squamous cell carcinoma
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Leiomyoma
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Lip and/or oral cavity cancer
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Lung adenocarcinoma
subjects affected / exposed	10 / 2532 (0.39%)	6 / 2499 (0.24%)
occurrences causally related to treatment / all	0 / 10	0 / 6
deaths causally related to treatment / all	0 / 5	0 / 4
Lung adenocarcinoma stage I
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Lung adenocarcinoma stage IV
subjects affected / exposed	3 / 2532 (0.12%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 4	0 / 0
deaths causally related to treatment / all	0 / 3	0 / 0
Lung cancer metastatic
subjects affected / exposed	3 / 2532 (0.12%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 3	0 / 1
Lung carcinoma cell type unspecified stage I
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Lung neoplasm
subjects affected / exposed	1 / 2532 (0.04%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 0
Lung neoplasm malignant
subjects affected / exposed	5 / 2532 (0.20%)	6 / 2499 (0.24%)
occurrences causally related to treatment / all	0 / 5	0 / 6
deaths causally related to treatment / all	0 / 4	0 / 4
Metastatic neoplasm
subjects affected / exposed	1 / 2532 (0.04%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Metastatic squamous cell carcinoma
subjects affected / exposed	1 / 2532 (0.04%)	1 / 2499 (0.04%)
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	3 / 2532 (0.12%)	2 / 2499 (0.08%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Lymphoma
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
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	3 / 2532 (0.12%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Malignant pleural effusion
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Mantle cell lymphoma stage III
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Meningioma benign
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Metastases to bone
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Metastases to central nervous system
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Metastases to liver
subjects affected / exposed	1 / 2532 (0.04%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Metastases to lung
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Metastases to spinal cord
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Metastases to spine
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Nasopharyngeal cancer
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pancreatic carcinoma metastatic
subjects affected / exposed	0 / 2532 (0.00%)	2 / 2499 (0.08%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Neuroendocrine carcinoma of the skin
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Neuroendocrine tumour
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Nodular melanoma
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (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
subjects affected / exposed	2 / 2532 (0.08%)	2 / 2499 (0.08%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 2
Non-small cell lung cancer metastatic
subjects affected / exposed	2 / 2532 (0.08%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Non-small cell lung cancer stage IV
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Oesophageal adenocarcinoma stage III
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Oesophageal cancer metastatic
subjects affected / exposed	1 / 2532 (0.04%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 0
Oesophageal carcinoma
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Ovarian cancer
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 1
Ovarian cancer stage II
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Paget's disease of nipple
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pancreatic carcinoma
subjects affected / exposed	2 / 2532 (0.08%)	5 / 2499 (0.20%)
occurrences causally related to treatment / all	0 / 2	0 / 6
deaths causally related to treatment / all	0 / 1	0 / 4
Neoplasm malignant
subjects affected / exposed	1 / 2532 (0.04%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 1
Pancreatic carcinoma stage IV
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Prostatic adenoma
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Papillary cystadenoma lymphomatosum
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pelvic neoplasm
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Penile cancer
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Phosphaturic mesenchymal tumour
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Pituitary tumour benign
subjects affected / exposed	1 / 2532 (0.04%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Plasma cell myeloma
subjects affected / exposed	3 / 2532 (0.12%)	3 / 2499 (0.12%)
occurrences causally related to treatment / all	0 / 3	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 1
Pleomorphic adenoma
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Porocarcinoma
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
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	18 / 2532 (0.71%)	16 / 2499 (0.64%)
occurrences causally related to treatment / all	0 / 18	0 / 17
deaths causally related to treatment / all	0 / 0	0 / 2
Prostate cancer metastatic
subjects affected / exposed	3 / 2532 (0.12%)	3 / 2499 (0.12%)
occurrences causally related to treatment / all	0 / 3	0 / 3
deaths causally related to treatment / all	0 / 2	0 / 1
Prostate cancer stage I
subjects affected / exposed	0 / 2532 (0.00%)	2 / 2499 (0.08%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Prostate cancer stage IV
subjects affected / exposed	2 / 2532 (0.08%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Pancreatic neoplasm
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Rectal adenocarcinoma
subjects affected / exposed	3 / 2532 (0.12%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 1
Soft tissue sarcoma
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Rectal cancer metastatic
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Renal adenoma
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Renal cancer
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Renal cancer stage II
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Renal cancer stage IV
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Renal cell carcinoma
subjects affected / exposed	2 / 2532 (0.08%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Renal cell carcinoma stage I
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Renal neoplasm
subjects affected / exposed	1 / 2532 (0.04%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 0
Skin cancer
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Small cell carcinoma
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Small cell lung cancer
subjects affected / exposed	3 / 2532 (0.12%)	4 / 2499 (0.16%)
occurrences causally related to treatment / all	0 / 3	0 / 4
deaths causally related to treatment / all	0 / 2	0 / 2
Small cell lung cancer extensive stage
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Small cell lung cancer metastatic
subjects affected / exposed	1 / 2532 (0.04%)	2 / 2499 (0.08%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 1	0 / 2
Rectal cancer
subjects affected / exposed	1 / 2532 (0.04%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Squamous cell carcinoma
subjects affected / exposed	2 / 2532 (0.08%)	2 / 2499 (0.08%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Squamous cell carcinoma of skin
subjects affected / exposed	2 / 2532 (0.08%)	2 / 2499 (0.08%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Squamous cell carcinoma of the hypopharynx
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Squamous cell carcinoma of the tongue
subjects affected / exposed	0 / 2532 (0.00%)	2 / 2499 (0.08%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 1
Testis cancer
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Thyroid cancer
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Thyroid neoplasm
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Tonsil cancer
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Transitional cell carcinoma
subjects affected / exposed	4 / 2532 (0.16%)	2 / 2499 (0.08%)
occurrences causally related to treatment / all	0 / 4	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Transitional cell carcinoma urethra
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Uterine cancer
subjects affected / exposed	1 / 2532 (0.04%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Uterine leiomyoma
subjects affected / exposed	1 / 2532 (0.04%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Vulval cancer stage III
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Squamous cell carcinoma of lung
subjects affected / exposed	3 / 2532 (0.12%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 1
Vascular disorders
Aortic stenosis
subjects affected / exposed	7 / 2532 (0.28%)	10 / 2499 (0.40%)
occurrences causally related to treatment / all	0 / 8	0 / 11
deaths causally related to treatment / all	0 / 0	0 / 0
Aortic dissection
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Arterial perforation
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
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 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Arteriosclerosis
subjects affected / exposed	3 / 2532 (0.12%)	7 / 2499 (0.28%)
occurrences causally related to treatment / all	0 / 3	0 / 7
deaths causally related to treatment / all	0 / 2	0 / 1
Arteriovenous fistula
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Accelerated hypertension
subjects affected / exposed	1 / 2532 (0.04%)	2 / 2499 (0.08%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Aneurysm
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Aortic aneurysm
subjects affected / exposed	13 / 2532 (0.51%)	10 / 2499 (0.40%)
occurrences causally related to treatment / all	0 / 13	0 / 10
deaths causally related to treatment / all	0 / 1	0 / 1
Aortic aneurysm rupture
subjects affected / exposed	3 / 2532 (0.12%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 3	0 / 0
Aortic arteriosclerosis
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (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	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Bleeding varicose vein
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hypovolaemic shock
subjects affected / exposed	1 / 2532 (0.04%)	3 / 2499 (0.12%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Circulatory collapse
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Deep vein thrombosis
subjects affected / exposed	7 / 2532 (0.28%)	4 / 2499 (0.16%)
occurrences causally related to treatment / all	0 / 7	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Diabetic macroangiopathy
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Diabetic vascular disorder
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Dry gangrene
subjects affected / exposed	0 / 2532 (0.00%)	5 / 2499 (0.20%)
occurrences causally related to treatment / all	0 / 0	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Embolism arterial
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Extremity necrosis
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Femoral artery aneurysm
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Giant cell arteritis
subjects affected / exposed	0 / 2532 (0.00%)	2 / 2499 (0.08%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Haematoma
subjects affected / exposed	1 / 2532 (0.04%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hypertension
subjects affected / exposed	20 / 2532 (0.79%)	10 / 2499 (0.40%)
occurrences causally related to treatment / all	0 / 22	0 / 11
deaths causally related to treatment / all	0 / 0	0 / 0
Hypertensive crisis
subjects affected / exposed	3 / 2532 (0.12%)	4 / 2499 (0.16%)
occurrences causally related to treatment / all	0 / 3	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Hypertensive emergency
subjects affected / exposed	1 / 2532 (0.04%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hypertensive urgency
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hypotension
subjects affected / exposed	7 / 2532 (0.28%)	5 / 2499 (0.20%)
occurrences causally related to treatment / all	0 / 7	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Blue toe syndrome
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Iliac artery embolism
subjects affected / exposed	2 / 2532 (0.08%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Shock
subjects affected / exposed	2 / 2532 (0.08%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Intermittent claudication
subjects affected / exposed	1 / 2532 (0.04%)	2 / 2499 (0.08%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Internal haemorrhage
subjects affected / exposed	1 / 2532 (0.04%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Leriche syndrome
subjects affected / exposed	3 / 2532 (0.12%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Lymphoedema
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (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	5 / 2532 (0.20%)	5 / 2499 (0.20%)
occurrences causally related to treatment / all	0 / 5	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Peripheral arterial occlusive disease
subjects affected / exposed	24 / 2532 (0.95%)	26 / 2499 (1.04%)
occurrences causally related to treatment / all	0 / 26	0 / 32
deaths causally related to treatment / all	0 / 0	0 / 0
Peripheral artery aneurysm
subjects affected / exposed	4 / 2532 (0.16%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 5	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Peripheral artery occlusion
subjects affected / exposed	1 / 2532 (0.04%)	3 / 2499 (0.12%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Peripheral artery stenosis
subjects affected / exposed	1 / 2532 (0.04%)	3 / 2499 (0.12%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Peripheral artery thrombosis
subjects affected / exposed	1 / 2532 (0.04%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Peripheral circulatory failure
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Peripheral embolism
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Peripheral ischaemia
subjects affected / exposed	6 / 2532 (0.24%)	10 / 2499 (0.40%)
occurrences causally related to treatment / all	0 / 6	0 / 11
deaths causally related to treatment / all	0 / 0	0 / 1
Peripheral vascular disorder
subjects affected / exposed	4 / 2532 (0.16%)	10 / 2499 (0.40%)
occurrences causally related to treatment / all	0 / 5	0 / 13
deaths causally related to treatment / all	0 / 0	0 / 1
Peripheral venous disease
subjects affected / exposed	1 / 2532 (0.04%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Raynaud's phenomenon
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Iliac artery stenosis
subjects affected / exposed	1 / 2532 (0.04%)	2 / 2499 (0.08%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Shock haemorrhagic
subjects affected / exposed	0 / 2532 (0.00%)	2 / 2499 (0.08%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Subclavian artery embolism
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Subclavian artery occlusion
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Subclavian vein occlusion
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Superior vena cava stenosis
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Venous thrombosis limb
subjects affected / exposed	0 / 2532 (0.00%)	2 / 2499 (0.08%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Thrombosis
subjects affected / exposed	2 / 2532 (0.08%)	4 / 2499 (0.16%)
occurrences causally related to treatment / all	0 / 2	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 1
Varicose vein
subjects affected / exposed	0 / 2532 (0.00%)	2 / 2499 (0.08%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Vena cava thrombosis
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Venous haemorrhage
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Thrombophlebitis
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (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
Hip arthroplasty
subjects affected / exposed	2 / 2532 (0.08%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Skin neoplasm excision
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Tissue expansion procedure
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
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
Adverse drug reaction
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Asthenia
subjects affected / exposed	5 / 2532 (0.20%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	1 / 5	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Chest discomfort
subjects affected / exposed	2 / 2532 (0.08%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Chest pain
subjects affected / exposed	15 / 2532 (0.59%)	7 / 2499 (0.28%)
occurrences causally related to treatment / all	0 / 15	0 / 8
deaths causally related to treatment / all	0 / 0	0 / 0
Complication associated with device
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Implant site pain
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
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 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hernia
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (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	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Implant site haematoma
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Death
subjects affected / exposed	9 / 2532 (0.36%)	10 / 2499 (0.40%)
occurrences causally related to treatment / all	0 / 9	0 / 10
deaths causally related to treatment / all	0 / 9	0 / 10
Inflammation
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Multiple organ dysfunction syndrome
subjects affected / exposed	0 / 2532 (0.00%)	6 / 2499 (0.24%)
occurrences causally related to treatment / all	0 / 0	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 3
Non-cardiac chest pain
subjects affected / exposed	26 / 2532 (1.03%)	37 / 2499 (1.48%)
occurrences causally related to treatment / all	0 / 28	0 / 41
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumatosis
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Prosthetic cardiac valve stenosis
subjects affected / exposed	1 / 2532 (0.04%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Vascular stent occlusion
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Stent-graft endoleak
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
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	7 / 2532 (0.28%)	3 / 2499 (0.12%)
occurrences causally related to treatment / all	0 / 7	0 / 3
deaths causally related to treatment / all	0 / 7	0 / 3
Sudden death
subjects affected / exposed	10 / 2532 (0.39%)	6 / 2499 (0.24%)
occurrences causally related to treatment / all	1 / 10	0 / 6
deaths causally related to treatment / all	1 / 10	0 / 6
Systemic inflammatory response syndrome
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pyrexia
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Vascular stent stenosis
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Immune system disorders
Anaphylactic reaction
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Contrast media allergy
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Reproductive system and breast disorders
Prostatic dysplasia
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Prostatitis
subjects affected / exposed	0 / 2532 (0.00%)	2 / 2499 (0.08%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Adnexa uteri mass
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Balanoposthitis
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Benign prostatic hyperplasia
subjects affected / exposed	9 / 2532 (0.36%)	7 / 2499 (0.28%)
occurrences causally related to treatment / all	0 / 9	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
Breast cyst
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Endometrial hyperplasia
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Erectile dysfunction
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Genital haemorrhage
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Ovarian cyst
subjects affected / exposed	1 / 2532 (0.04%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pelvic haematoma
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pelvic organ prolapse
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Prostatomegaly
subjects affected / exposed	2 / 2532 (0.08%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Uterine polyp
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Uterine prolapse
subjects affected / exposed	1 / 2532 (0.04%)	2 / 2499 (0.08%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Vaginal prolapse
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Uterine inflammation
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (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
Dyspnoea
subjects affected / exposed	6 / 2532 (0.24%)	9 / 2499 (0.36%)
occurrences causally related to treatment / all	0 / 6	0 / 9
deaths causally related to treatment / all	0 / 0	0 / 0
Acute pulmonary oedema
subjects affected / exposed	0 / 2532 (0.00%)	2 / 2499 (0.08%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Acute respiratory distress syndrome
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Acute respiratory failure
subjects affected / exposed	8 / 2532 (0.32%)	23 / 2499 (0.92%)
occurrences causally related to treatment / all	0 / 9	0 / 23
deaths causally related to treatment / all	0 / 0	0 / 3
Aspiration
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Asthma
subjects affected / exposed	7 / 2532 (0.28%)	4 / 2499 (0.16%)
occurrences causally related to treatment / all	0 / 9	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Asthma late onset
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Bronchitis chronic
subjects affected / exposed	1 / 2532 (0.04%)	2 / 2499 (0.08%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Bronchopulmonary disease
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Bronchospasm
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Chronic obstructive pulmonary disease
subjects affected / exposed	25 / 2532 (0.99%)	30 / 2499 (1.20%)
occurrences causally related to treatment / all	0 / 42	0 / 39
deaths causally related to treatment / all	0 / 2	0 / 2
Chronic respiratory failure
subjects affected / exposed	0 / 2532 (0.00%)	2 / 2499 (0.08%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Cough
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Dyspnoea exertional
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pulmonary oedema
subjects affected / exposed	2 / 2532 (0.08%)	2 / 2499 (0.08%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 1	0 / 0
Epistaxis
subjects affected / exposed	2 / 2532 (0.08%)	2 / 2499 (0.08%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Haemoptysis
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hydrothorax
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hypoxia
subjects affected / exposed	3 / 2532 (0.12%)	3 / 2499 (0.12%)
occurrences causally related to treatment / all	0 / 3	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Idiopathic pulmonary fibrosis
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Interstitial lung disease
subjects affected / exposed	2 / 2532 (0.08%)	5 / 2499 (0.20%)
occurrences causally related to treatment / all	0 / 2	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Lung disorder
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Lung infiltration
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (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	1 / 2532 (0.04%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumonitis aspiration
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumothorax
subjects affected / exposed	1 / 2532 (0.04%)	3 / 2499 (0.12%)
occurrences causally related to treatment / all	0 / 1	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumothorax spontaneous
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pulmonary embolism
subjects affected / exposed	12 / 2532 (0.47%)	12 / 2499 (0.48%)
occurrences causally related to treatment / all	0 / 12	0 / 12
deaths causally related to treatment / all	0 / 1	0 / 0
Pulmonary fibrosis
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Pulmonary haemorrhage
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (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	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Epiglottic mass
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Respiratory arrest
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Respiratory failure
subjects affected / exposed	13 / 2532 (0.51%)	16 / 2499 (0.64%)
occurrences causally related to treatment / all	0 / 15	0 / 17
deaths causally related to treatment / all	0 / 3	0 / 2
Sleep apnoea syndrome
subjects affected / exposed	5 / 2532 (0.20%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 6	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Tracheal stenosis
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Respiratory distress
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Psychiatric disorders
Acute psychosis
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Alcohol withdrawal syndrome
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (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	1 / 2532 (0.04%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Anxiety disorder due to a general medical condition
subjects affected / exposed	2 / 2532 (0.08%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Completed suicide
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Confusional state
subjects affected / exposed	2 / 2532 (0.08%)	2 / 2499 (0.08%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Delirium
subjects affected / exposed	0 / 2532 (0.00%)	2 / 2499 (0.08%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Depression
subjects affected / exposed	2 / 2532 (0.08%)	2 / 2499 (0.08%)
occurrences causally related to treatment / all	0 / 4	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Major depression
subjects affected / exposed	1 / 2532 (0.04%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Mania
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Alcohol abuse
subjects affected / exposed	1 / 2532 (0.04%)	4 / 2499 (0.16%)
occurrences causally related to treatment / all	0 / 7	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 1
Mental status changes
subjects affected / exposed	9 / 2532 (0.36%)	3 / 2499 (0.12%)
occurrences causally related to treatment / all	0 / 10	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Post-traumatic stress disorder
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
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 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Suicidal ideation
subjects affected / exposed	1 / 2532 (0.04%)	1 / 2499 (0.04%)
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 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 1
Product issues
Device dislocation
subjects affected / exposed	2 / 2532 (0.08%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Device loosening
subjects affected / exposed	2 / 2532 (0.08%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Device failure
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Lead dislodgement
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Device malfunction
subjects affected / exposed	0 / 2532 (0.00%)	2 / 2499 (0.08%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Device mechanical issue
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Device occlusion
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Device power source issue
subjects affected / exposed	1 / 2532 (0.04%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Device stimulation issue
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatobiliary disorders
Alcoholic liver disease
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (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	1 / 2532 (0.04%)	2 / 2499 (0.08%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Biliary dilatation
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Biliary tract disorder
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cirrhosis alcoholic
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cholecystitis
subjects affected / exposed	1 / 2532 (0.04%)	4 / 2499 (0.16%)
occurrences causally related to treatment / all	0 / 1	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Cholecystitis acute
subjects affected / exposed	7 / 2532 (0.28%)	10 / 2499 (0.40%)
occurrences causally related to treatment / all	0 / 7	0 / 12
deaths causally related to treatment / all	0 / 0	0 / 0
Cholecystitis chronic
subjects affected / exposed	1 / 2532 (0.04%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cholelithiasis
subjects affected / exposed	13 / 2532 (0.51%)	11 / 2499 (0.44%)
occurrences causally related to treatment / all	0 / 14	0 / 11
deaths causally related to treatment / all	0 / 0	0 / 0
Chronic hepatic failure
subjects affected / exposed	2 / 2532 (0.08%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Cholangitis acute
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatic cirrhosis
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatic steatosis
subjects affected / exposed	2 / 2532 (0.08%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatitis
subjects affected / exposed	1 / 2532 (0.04%)	1 / 2499 (0.04%)
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	0 / 2532 (0.00%)	2 / 2499 (0.08%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Liver injury
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hyperplastic cholecystopathy
subjects affected / exposed	1 / 2532 (0.04%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Investigations
Squamous cell carcinoma antigen
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Anticoagulation drug level below therapeutic
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Blood creatinine increased
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatic enzyme increased
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
International normalised ratio decreased
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
International normalised ratio increased
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Respiratory syncytial virus test positive
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Anticoagulation drug level above therapeutic
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Transaminases increased
subjects affected / exposed	1 / 2532 (0.04%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Troponin increased
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Troponin I increased
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Injury, poisoning and procedural complications
Ankle fracture
subjects affected / exposed	5 / 2532 (0.20%)	2 / 2499 (0.08%)
occurrences causally related to treatment / all	0 / 5	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Aortic pseudoaneurysm
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Arterial injury
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Arthropod bite
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Brain contusion
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Burns second degree
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Anaemia postoperative
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Carbon monoxide poisoning
subjects affected / exposed	1 / 2532 (0.04%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Cardiac procedure complication
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cartilage injury
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
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 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Compression fracture
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Accidental overdose
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Burns third degree
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Concussion
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Contusion
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Coronary artery reocclusion
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Coronary artery restenosis
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Craniocerebral injury
subjects affected / exposed	0 / 2532 (0.00%)	2 / 2499 (0.08%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Crush injury
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Foot fracture
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Dural tear
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Face injury
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (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	9 / 2532 (0.36%)	10 / 2499 (0.40%)
occurrences causally related to treatment / all	0 / 12	0 / 11
deaths causally related to treatment / all	0 / 1	0 / 1
Femoral neck fracture
subjects affected / exposed	1 / 2532 (0.04%)	3 / 2499 (0.12%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Femoral nerve injury
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Femur fracture
subjects affected / exposed	6 / 2532 (0.24%)	3 / 2499 (0.12%)
occurrences causally related to treatment / all	0 / 6	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Dislocation of sternum
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Forearm fracture
subjects affected / exposed	1 / 2532 (0.04%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Foreign body in gastrointestinal tract
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Fracture
subjects affected / exposed	1 / 2532 (0.04%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Fractured sacrum
subjects affected / exposed	1 / 2532 (0.04%)	2 / 2499 (0.08%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Frostbite
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Graft haemorrhage
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gun shot wound
subjects affected / exposed	0 / 2532 (0.00%)	2 / 2499 (0.08%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 1
Head injury
subjects affected / exposed	1 / 2532 (0.04%)	2 / 2499 (0.08%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Hip fracture
subjects affected / exposed	5 / 2532 (0.20%)	9 / 2499 (0.36%)
occurrences causally related to treatment / all	0 / 5	0 / 9
deaths causally related to treatment / all	0 / 0	0 / 0
Humerus fracture
subjects affected / exposed	2 / 2532 (0.08%)	5 / 2499 (0.20%)
occurrences causally related to treatment / all	0 / 2	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Ilium fracture
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Incarcerated incisional hernia
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Incisional hernia
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Intentional overdose
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Intervertebral disc injury
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
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 / 2532 (0.04%)	1 / 2499 (0.04%)
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	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Ligament rupture
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (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 / 2532 (0.00%)	1 / 2499 (0.04%)
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 / 2532 (0.04%)	0 / 2499 (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	0 / 2532 (0.00%)	2 / 2499 (0.08%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Pelvic organ injury
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Lumbar vertebral fracture
subjects affected / exposed	1 / 2532 (0.04%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Meniscus injury
subjects affected / exposed	1 / 2532 (0.04%)	1 / 2499 (0.04%)
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	1 / 2532 (0.04%)	2 / 2499 (0.08%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 2
Overdose
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Patella fracture
subjects affected / exposed	2 / 2532 (0.08%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pelvic fracture
subjects affected / exposed	3 / 2532 (0.12%)	2 / 2499 (0.08%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Lower limb fracture
subjects affected / exposed	1 / 2532 (0.04%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Procedural pain
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Procedural pneumothorax
subjects affected / exposed	1 / 2532 (0.04%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Radiation proctitis
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Rib fracture
subjects affected / exposed	3 / 2532 (0.12%)	6 / 2499 (0.24%)
occurrences causally related to treatment / all	0 / 3	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Road traffic accident
subjects affected / exposed	0 / 2532 (0.00%)	4 / 2499 (0.16%)
occurrences causally related to treatment / all	0 / 0	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 3
Periprocedural myocardial infarction
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Postoperative wound complication
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Post procedural complication
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Post procedural haematoma
subjects affected / exposed	0 / 2532 (0.00%)	3 / 2499 (0.12%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Post procedural haemorrhage
subjects affected / exposed	2 / 2532 (0.08%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Post procedural hypotension
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Post procedural pulmonary embolism
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Postoperative respiratory failure
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumothorax traumatic
subjects affected / exposed	1 / 2532 (0.04%)	2 / 2499 (0.08%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Skin laceration
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Spinal compression fracture
subjects affected / exposed	2 / 2532 (0.08%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Spinal fracture
subjects affected / exposed	2 / 2532 (0.08%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Splenic rupture
subjects affected / exposed	3 / 2532 (0.12%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Subdural haematoma
subjects affected / exposed	4 / 2532 (0.16%)	5 / 2499 (0.20%)
occurrences causally related to treatment / all	0 / 5	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Tendon injury
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Vascular graft occlusion
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Thermal burn
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Thoracic vertebral fracture
subjects affected / exposed	2 / 2532 (0.08%)	1 / 2499 (0.04%)
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	0 / 2532 (0.00%)	2 / 2499 (0.08%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Upper limb fracture
subjects affected / exposed	1 / 2532 (0.04%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Vascular access complication
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Vascular graft complication
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Tendon rupture
subjects affected / exposed	4 / 2532 (0.16%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 4	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Vascular pseudoaneurysm
subjects affected / exposed	0 / 2532 (0.00%)	3 / 2499 (0.12%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Vascular pseudoaneurysm ruptured
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Wound
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Wound complication
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Wound dehiscence
subjects affected / exposed	2 / 2532 (0.08%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Wound necrosis
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Congenital, familial and genetic disorders
Gastrointestinal arteriovenous malformation
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hydrocele
subjects affected / exposed	1 / 2532 (0.04%)	2 / 2499 (0.08%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Talipes
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac disorders
Acute cardiac event
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Acute coronary syndrome
subjects affected / exposed	10 / 2532 (0.39%)	6 / 2499 (0.24%)
occurrences causally related to treatment / all	0 / 10	0 / 6
deaths causally related to treatment / all	0 / 2	0 / 1
Acute left ventricular failure
subjects affected / exposed	5 / 2532 (0.20%)	3 / 2499 (0.12%)
occurrences causally related to treatment / all	0 / 5	0 / 4
deaths causally related to treatment / all	0 / 1	0 / 0
Acute myocardial infarction
subjects affected / exposed	74 / 2532 (2.92%)	52 / 2499 (2.08%)
occurrences causally related to treatment / all	0 / 85	0 / 58
deaths causally related to treatment / all	0 / 5	0 / 6
Aortic valve stenosis
subjects affected / exposed	1 / 2532 (0.04%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Angina unstable
subjects affected / exposed	49 / 2532 (1.94%)	37 / 2499 (1.48%)
occurrences causally related to treatment / all	0 / 53	0 / 41
deaths causally related to treatment / all	0 / 0	0 / 0
Aortic valve disease mixed
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Aortic valve disease
subjects affected / exposed	1 / 2532 (0.04%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Angina pectoris
subjects affected / exposed	56 / 2532 (2.21%)	52 / 2499 (2.08%)
occurrences causally related to treatment / all	0 / 64	0 / 67
deaths causally related to treatment / all	0 / 0	0 / 0
Atrial fibrillation
subjects affected / exposed	57 / 2532 (2.25%)	47 / 2499 (1.88%)
occurrences causally related to treatment / all	0 / 68	0 / 64
deaths causally related to treatment / all	0 / 0	0 / 0
Arteriosclerosis coronary artery
subjects affected / exposed	2 / 2532 (0.08%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 0
Arrhythmic storm
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Arrhythmia
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
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	11 / 2532 (0.43%)	13 / 2499 (0.52%)
occurrences causally related to treatment / all	0 / 12	0 / 15
deaths causally related to treatment / all	0 / 0	0 / 0
Bundle branch block left
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Bradycardia
subjects affected / exposed	8 / 2532 (0.32%)	9 / 2499 (0.36%)
occurrences causally related to treatment / all	0 / 8	0 / 9
deaths causally related to treatment / all	0 / 0	0 / 0
Atrioventricular block second degree
subjects affected / exposed	4 / 2532 (0.16%)	5 / 2499 (0.20%)
occurrences causally related to treatment / all	0 / 4	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Atrioventricular block complete
subjects affected / exposed	9 / 2532 (0.36%)	9 / 2499 (0.36%)
occurrences causally related to treatment / all	0 / 9	0 / 9
deaths causally related to treatment / all	0 / 0	0 / 0
Atrioventricular block
subjects affected / exposed	1 / 2532 (0.04%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Atrial tachycardia
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac arrest
subjects affected / exposed	16 / 2532 (0.63%)	13 / 2499 (0.52%)
occurrences causally related to treatment / all	3 / 16	0 / 13
deaths causally related to treatment / all	1 / 13	0 / 6
Cardiac asthma
subjects affected / exposed	1 / 2532 (0.04%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiopulmonary failure
subjects affected / exposed	2 / 2532 (0.08%)	2 / 2499 (0.08%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 2	0 / 1
Cardiomyopathy
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiogenic shock
subjects affected / exposed	5 / 2532 (0.20%)	2 / 2499 (0.08%)
occurrences causally related to treatment / all	0 / 5	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Cardio-respiratory arrest
subjects affected / exposed	2 / 2532 (0.08%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 2	0 / 0
Cardiac failure congestive
subjects affected / exposed	37 / 2532 (1.46%)	40 / 2499 (1.60%)
occurrences causally related to treatment / all	0 / 48	0 / 50
deaths causally related to treatment / all	0 / 3	0 / 4
Cardiac failure chronic
subjects affected / exposed	13 / 2532 (0.51%)	23 / 2499 (0.92%)
occurrences causally related to treatment / all	0 / 17	0 / 25
deaths causally related to treatment / all	0 / 3	0 / 1
Cardiac failure acute
subjects affected / exposed	21 / 2532 (0.83%)	17 / 2499 (0.68%)
occurrences causally related to treatment / all	1 / 22	0 / 21
deaths causally related to treatment / all	1 / 5	0 / 3
Cardiac failure
subjects affected / exposed	46 / 2532 (1.82%)	44 / 2499 (1.76%)
occurrences causally related to treatment / all	0 / 68	0 / 58
deaths causally related to treatment / all	0 / 8	0 / 13
Cardiac disorder
subjects affected / exposed	0 / 2532 (0.00%)	2 / 2499 (0.08%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 1
Cardiovascular disorder
subjects affected / exposed	4 / 2532 (0.16%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 4	0 / 0
deaths causally related to treatment / all	0 / 4	0 / 0
Coronary artery disease
subjects affected / exposed	41 / 2532 (1.62%)	30 / 2499 (1.20%)
occurrences causally related to treatment / all	0 / 42	2 / 31
deaths causally related to treatment / all	0 / 3	0 / 0
Coronary artery insufficiency
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Coronary artery occlusion
subjects affected / exposed	4 / 2532 (0.16%)	5 / 2499 (0.20%)
occurrences causally related to treatment / all	0 / 5	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Coronary artery stenosis
subjects affected / exposed	8 / 2532 (0.32%)	4 / 2499 (0.16%)
occurrences causally related to treatment / all	0 / 8	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Ischaemic cardiomyopathy
subjects affected / exposed	1 / 2532 (0.04%)	5 / 2499 (0.20%)
occurrences causally related to treatment / all	0 / 1	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 1
Intracardiac thrombus
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Congestive cardiomyopathy
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Chronic left ventricular failure
subjects affected / exposed	0 / 2532 (0.00%)	3 / 2499 (0.12%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiovascular insufficiency
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Heart valve incompetence
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Paroxysmal atrioventricular block
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pericardial effusion
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pericarditis
subjects affected / exposed	2 / 2532 (0.08%)	2 / 2499 (0.08%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Left ventricular failure
subjects affected / exposed	8 / 2532 (0.32%)	4 / 2499 (0.16%)
occurrences causally related to treatment / all	0 / 9	0 / 4
deaths causally related to treatment / all	0 / 1	0 / 0
Mitral valve incompetence
subjects affected / exposed	1 / 2532 (0.04%)	3 / 2499 (0.12%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Mitral valve prolapse
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Mitral valve stenosis
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Myocardial infarction
subjects affected / exposed	25 / 2532 (0.99%)	20 / 2499 (0.80%)
occurrences causally related to treatment / all	0 / 26	0 / 22
deaths causally related to treatment / all	0 / 8	0 / 3
Myocardial ischaemia
subjects affected / exposed	15 / 2532 (0.59%)	11 / 2499 (0.44%)
occurrences causally related to treatment / all	0 / 16	0 / 11
deaths causally related to treatment / all	0 / 1	0 / 1
Nodal arrhythmia
subjects affected / exposed	1 / 2532 (0.04%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Palpitations
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
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	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Sinus arrhythmia
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Sinus bradycardia
subjects affected / exposed	1 / 2532 (0.04%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Sinus node dysfunction
subjects affected / exposed	7 / 2532 (0.28%)	8 / 2499 (0.32%)
occurrences causally related to treatment / all	0 / 7	0 / 8
deaths causally related to treatment / all	0 / 0	0 / 0
Supraventricular extrasystoles
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Ventricular arrhythmia
subjects affected / exposed	4 / 2532 (0.16%)	6 / 2499 (0.24%)
occurrences causally related to treatment / all	0 / 4	0 / 8
deaths causally related to treatment / all	0 / 0	0 / 1
Supraventricular tachycardia
subjects affected / exposed	2 / 2532 (0.08%)	8 / 2499 (0.32%)
occurrences causally related to treatment / all	0 / 2	0 / 9
deaths causally related to treatment / all	0 / 0	0 / 0
Tachyarrhythmia
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Tachycardia
subjects affected / exposed	3 / 2532 (0.12%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Tricuspid valve incompetence
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Supraventricular tachyarrhythmia
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Ventricular extrasystoles
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Ventricular fibrillation
subjects affected / exposed	4 / 2532 (0.16%)	3 / 2499 (0.12%)
occurrences causally related to treatment / all	0 / 5	0 / 3
deaths causally related to treatment / all	0 / 1	0 / 1
Ventricular tachycardia
subjects affected / exposed	17 / 2532 (0.67%)	14 / 2499 (0.56%)
occurrences causally related to treatment / all	1 / 19	0 / 19
deaths causally related to treatment / all	0 / 1	0 / 0
Wolff-Parkinson-White syndrome
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Ventricular tachyarrhythmia
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Nervous system disorders
Axonal neuropathy
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Aphasia
subjects affected / exposed	2 / 2532 (0.08%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Autonomic nervous system imbalance
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
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	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cognitive disorder
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Carotid arteriosclerosis
subjects affected / exposed	0 / 2532 (0.00%)	2 / 2499 (0.08%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Carotid artery disease
subjects affected / exposed	2 / 2532 (0.08%)	3 / 2499 (0.12%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Carotid artery occlusion
subjects affected / exposed	1 / 2532 (0.04%)	2 / 2499 (0.08%)
occurrences causally related to treatment / all	0 / 1	1 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Carotid artery stenosis
subjects affected / exposed	11 / 2532 (0.43%)	10 / 2499 (0.40%)
occurrences causally related to treatment / all	0 / 11	0 / 11
deaths causally related to treatment / all	0 / 0	0 / 0
Carpal tunnel syndrome
subjects affected / exposed	0 / 2532 (0.00%)	2 / 2499 (0.08%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Cauda equina syndrome
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cerebral amyloid angiopathy
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cerebral arteriosclerosis
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cerebral ataxia
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cerebral haemorrhage
subjects affected / exposed	5 / 2532 (0.20%)	2 / 2499 (0.08%)
occurrences causally related to treatment / all	0 / 5	0 / 2
deaths causally related to treatment / all	0 / 2	0 / 1
Cerebral infarction
subjects affected / exposed	4 / 2532 (0.16%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 4	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cerebral ischaemia
subjects affected / exposed	1 / 2532 (0.04%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cerebrovascular accident
subjects affected / exposed	25 / 2532 (0.99%)	20 / 2499 (0.80%)
occurrences causally related to treatment / all	0 / 25	1 / 20
deaths causally related to treatment / all	0 / 4	1 / 3
Cervical radiculopathy
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Basilar artery stenosis
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Dementia
subjects affected / exposed	2 / 2532 (0.08%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 0
Headache
subjects affected / exposed	2 / 2532 (0.08%)	3 / 2499 (0.12%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Dizziness
subjects affected / exposed	8 / 2532 (0.32%)	2 / 2499 (0.08%)
occurrences causally related to treatment / all	0 / 9	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Dizziness postural
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Embolic stroke
subjects affected / exposed	4 / 2532 (0.16%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 4	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Encephalopathy
subjects affected / exposed	2 / 2532 (0.08%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Epilepsy
subjects affected / exposed	1 / 2532 (0.04%)	2 / 2499 (0.08%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Facial paralysis
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Facial paresis
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Focal dyscognitive seizures
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Generalised tonic-clonic seizure
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Guillain-Barre syndrome
subjects affected / exposed	1 / 2532 (0.04%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Haemorrhage intracranial
subjects affected / exposed	3 / 2532 (0.12%)	2 / 2499 (0.08%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 1	0 / 1
Haemorrhagic cerebral infarction
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Haemorrhagic stroke
subjects affected / exposed	3 / 2532 (0.12%)	2 / 2499 (0.08%)
occurrences causally related to treatment / all	1 / 3	0 / 2
deaths causally related to treatment / all	0 / 2	0 / 1
Dementia Alzheimer's type
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hemianopia
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Migraine
subjects affected / exposed	2 / 2532 (0.08%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hemiparesis
subjects affected / exposed	2 / 2532 (0.08%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatic encephalopathy
subjects affected / exposed	1 / 2532 (0.04%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hypertensive encephalopathy
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hypoaesthesia
subjects affected / exposed	3 / 2532 (0.12%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hypoxic-ischaemic encephalopathy
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Intracranial aneurysm
subjects affected / exposed	0 / 2532 (0.00%)	2 / 2499 (0.08%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Ischaemic cerebral infarction
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Ischaemic stroke
subjects affected / exposed	18 / 2532 (0.71%)	27 / 2499 (1.08%)
occurrences causally related to treatment / all	0 / 19	2 / 29
deaths causally related to treatment / all	0 / 1	0 / 1
Lacunar infarction
subjects affected / exposed	1 / 2532 (0.04%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Lacunar stroke
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Loss of consciousness
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Lumbar radiculopathy
subjects affected / exposed	2 / 2532 (0.08%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Memory impairment
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Metabolic encephalopathy
subjects affected / exposed	3 / 2532 (0.12%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hemiparaesthesia
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Monoparesis
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Sciatica
subjects affected / exposed	4 / 2532 (0.16%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 4	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Myelopathy
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Nerve compression
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Paraesthesia
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Paresis cranial nerve
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Parkinson's disease
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Partial seizures
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Peripheral nerve lesion
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Peripheral sensorimotor neuropathy
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Peripheral sensory neuropathy
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Phantom limb syndrome
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Polyneuropathy
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Post stroke epilepsy
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (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	1 / 2532 (0.04%)	2 / 2499 (0.08%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Psychogenic seizure
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Radiculopathy
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Moyamoya disease
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Vocal cord paralysis
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Seizure
subjects affected / exposed	1 / 2532 (0.04%)	2 / 2499 (0.08%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Spinal cord compression
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Spondylitic myelopathy
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
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	2 / 2532 (0.08%)	4 / 2499 (0.16%)
occurrences causally related to treatment / all	0 / 2	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Syncope
subjects affected / exposed	19 / 2532 (0.75%)	14 / 2499 (0.56%)
occurrences causally related to treatment / all	0 / 20	0 / 15
deaths causally related to treatment / all	0 / 0	0 / 0
Thalamic infarction
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Toxic encephalopathy
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Transient global amnesia
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Transient ischaemic attack
subjects affected / exposed	11 / 2532 (0.43%)	14 / 2499 (0.56%)
occurrences causally related to treatment / all	0 / 12	0 / 16
deaths causally related to treatment / all	0 / 0	0 / 0
Vascular dementia
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Vascular encephalopathy
subjects affected / exposed	2 / 2532 (0.08%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Vertebrobasilar insufficiency
subjects affected / exposed	4 / 2532 (0.16%)	2 / 2499 (0.08%)
occurrences causally related to treatment / all	0 / 4	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Vertebrobasilar stroke
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (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 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Anaemia
subjects affected / exposed	13 / 2532 (0.51%)	18 / 2499 (0.72%)
occurrences causally related to treatment / all	0 / 13	0 / 20
deaths causally related to treatment / all	0 / 0	0 / 0
Anaemia macrocytic
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Anaemia of malignant disease
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Anaemia vitamin B12 deficiency
subjects affected / exposed	0 / 2532 (0.00%)	2 / 2499 (0.08%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Blood loss anaemia
subjects affected / exposed	5 / 2532 (0.20%)	8 / 2499 (0.32%)
occurrences causally related to treatment / all	0 / 5	0 / 9
deaths causally related to treatment / all	0 / 0	0 / 0
Febrile neutropenia
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Heparin-induced thrombocytopenia
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Microcytic anaemia
subjects affected / exposed	2 / 2532 (0.08%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Lymphadenopathy
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Iron deficiency anaemia
subjects affected / exposed	4 / 2532 (0.16%)	2 / 2499 (0.08%)
occurrences causally related to treatment / all	0 / 5	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Pancytopenia
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Splenic haemorrhage
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Polycythaemia
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (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
Deafness neurosensory
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Acute vestibular syndrome
subjects affected / exposed	1 / 2532 (0.04%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Deafness
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
External ear disorder
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hypoacusis
subjects affected / exposed	2 / 2532 (0.08%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Vestibular ataxia
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Tinnitus
subjects affected / exposed	4 / 2532 (0.16%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 4	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Vertigo
subjects affected / exposed	5 / 2532 (0.20%)	4 / 2499 (0.16%)
occurrences causally related to treatment / all	0 / 5	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Vertigo labyrinthine
subjects affected / exposed	2 / 2532 (0.08%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Vertigo positional
subjects affected / exposed	3 / 2532 (0.12%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Neurosensory hypoacusis
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Eye disorders
Amaurosis fugax
subjects affected / exposed	1 / 2532 (0.04%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cataract
subjects affected / exposed	11 / 2532 (0.43%)	8 / 2499 (0.32%)
occurrences causally related to treatment / all	0 / 16	0 / 9
deaths causally related to treatment / all	0 / 0	0 / 0
Choroidal detachment
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
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 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Diabetic retinopathy
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Retinal detachment
subjects affected / exposed	1 / 2532 (0.04%)	2 / 2499 (0.08%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Epiretinal membrane
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Eyelid bleeding
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Eyelid ptosis
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Glaucoma
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Macular rupture
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Diplopia
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Vision blurred
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Visual impairment
subjects affected / exposed	1 / 2532 (0.04%)	2 / 2499 (0.08%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal disorders
Abdominal adhesions
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (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	3 / 2532 (0.12%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Abdominal symptom
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Abdominal mass
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Abdominal pain
subjects affected / exposed	4 / 2532 (0.16%)	2 / 2499 (0.08%)
occurrences causally related to treatment / all	0 / 4	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Abdominal pain upper
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Abdominal incarcerated hernia
subjects affected / exposed	2 / 2532 (0.08%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Abdominal wall haematoma
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Abnormal faeces
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Anal fissure
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Anal fistula
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Anal stenosis
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Crohn's disease
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Colitis
subjects affected / exposed	2 / 2532 (0.08%)	5 / 2499 (0.20%)
occurrences causally related to treatment / all	0 / 3	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Colitis ischaemic
subjects affected / exposed	2 / 2532 (0.08%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Colitis ulcerative
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Colon dysplasia
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Barrett's oesophagus
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Diarrhoea
subjects affected / exposed	2 / 2532 (0.08%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Diverticular perforation
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Diverticulum
subjects affected / exposed	0 / 2532 (0.00%)	3 / 2499 (0.12%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Diverticulum intestinal
subjects affected / exposed	1 / 2532 (0.04%)	2 / 2499 (0.08%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Diverticulum intestinal haemorrhagic
subjects affected / exposed	4 / 2532 (0.16%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 4	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Faecaloma
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Duodenal ulcer haemorrhage
subjects affected / exposed	0 / 2532 (0.00%)	2 / 2499 (0.08%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Dyspepsia
subjects affected / exposed	1 / 2532 (0.04%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Dysphagia
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Erosive duodenitis
subjects affected / exposed	2 / 2532 (0.08%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Duodenal ulcer
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Femoral hernia
subjects affected / exposed	1 / 2532 (0.04%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Femoral hernia strangulated
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (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	1 / 2532 (0.04%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastric perforation
subjects affected / exposed	0 / 2532 (0.00%)	2 / 2499 (0.08%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Gastritis
subjects affected / exposed	3 / 2532 (0.12%)	2 / 2499 (0.08%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Gastric ulcer
subjects affected / exposed	2 / 2532 (0.08%)	2 / 2499 (0.08%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 1	0 / 0
Gastric ulcer haemorrhage
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastric ulcer perforation
subjects affected / exposed	2 / 2532 (0.08%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gastric volvulus
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (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	1 / 2532 (0.04%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastritis alcoholic
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastritis erosive
subjects affected / exposed	1 / 2532 (0.04%)	2 / 2499 (0.08%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Gastritis haemorrhagic
subjects affected / exposed	1 / 2532 (0.04%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal angiodysplasia
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal disorder
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Haemorrhoids
subjects affected / exposed	2 / 2532 (0.08%)	2 / 2499 (0.08%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal vascular malformation haemorrhagic
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrooesophageal reflux disease
subjects affected / exposed	6 / 2532 (0.24%)	2 / 2499 (0.08%)
occurrences causally related to treatment / all	0 / 6	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Haemorrhagic erosive gastritis
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Haemorrhoidal haemorrhage
subjects affected / exposed	0 / 2532 (0.00%)	2 / 2499 (0.08%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal haemorrhage
subjects affected / exposed	11 / 2532 (0.43%)	16 / 2499 (0.64%)
occurrences causally related to treatment / all	0 / 13	0 / 16
deaths causally related to treatment / all	0 / 0	0 / 2
Hiatus hernia
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Ileus
subjects affected / exposed	1 / 2532 (0.04%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Incarcerated inguinal hernia
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
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	8 / 2532 (0.32%)	11 / 2499 (0.44%)
occurrences causally related to treatment / all	0 / 8	0 / 11
deaths causally related to treatment / all	0 / 0	0 / 0
Inguinal hernia strangulated
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Large intestinal obstruction
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Intestinal ischaemia
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Intestinal perforation
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Intestinal pseudo-obstruction
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Irritable bowel syndrome
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Large intestinal haemorrhage
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Intestinal angina
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Large intestine perforation
subjects affected / exposed	2 / 2532 (0.08%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Large intestine polyp
subjects affected / exposed	3 / 2532 (0.12%)	6 / 2499 (0.24%)
occurrences causally related to treatment / all	0 / 3	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Lower gastrointestinal haemorrhage
subjects affected / exposed	7 / 2532 (0.28%)	2 / 2499 (0.08%)
occurrences causally related to treatment / all	0 / 7	0 / 2
deaths causally related to treatment / all	0 / 1	0 / 0
Melaena
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Mesenteric artery thrombosis
subjects affected / exposed	0 / 2532 (0.00%)	2 / 2499 (0.08%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 1
Nausea
subjects affected / exposed	2 / 2532 (0.08%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Obstructive pancreatitis
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Odynophagia
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Oedematous pancreatitis
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Oesophageal food impaction
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Oesophageal haemorrhage
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Oesophageal stenosis
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Oesophageal ulcer
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Oesophageal ulcer haemorrhage
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (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	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Oesophagitis
subjects affected / exposed	1 / 2532 (0.04%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pancreatic failure
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Peptic ulcer haemorrhage
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pancreatitis acute
subjects affected / exposed	5 / 2532 (0.20%)	10 / 2499 (0.40%)
occurrences causally related to treatment / all	1 / 6	1 / 12
deaths causally related to treatment / all	0 / 1	0 / 0
Pancreatitis chronic
subjects affected / exposed	1 / 2532 (0.04%)	3 / 2499 (0.12%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Pancreatitis necrotising
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Peptic ulcer
subjects affected / exposed	2 / 2532 (0.08%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pancreatitis
subjects affected / exposed	5 / 2532 (0.20%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 5	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Proctitis
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
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	1 / 2532 (0.04%)	4 / 2499 (0.16%)
occurrences causally related to treatment / all	0 / 2	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Rectal prolapse
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Retroperitoneal haemorrhage
subjects affected / exposed	2 / 2532 (0.08%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Salivary gland cyst
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Vomiting
subjects affected / exposed	3 / 2532 (0.12%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Small intestinal obstruction
subjects affected / exposed	6 / 2532 (0.24%)	4 / 2499 (0.16%)
occurrences causally related to treatment / all	0 / 7	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Subileus
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
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	6 / 2532 (0.24%)	2 / 2499 (0.08%)
occurrences causally related to treatment / all	0 / 6	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Upper gastrointestinal haemorrhage
subjects affected / exposed	5 / 2532 (0.20%)	8 / 2499 (0.32%)
occurrences causally related to treatment / all	0 / 5	0 / 9
deaths causally related to treatment / all	0 / 0	0 / 0
Varices oesophageal
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Small intestinal haemorrhage
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Skin and subcutaneous tissue disorders
Neuropathic ulcer
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Actinic keratosis
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Angioedema
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Blister
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cutaneous lupus erythematosus
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Dermal cyst
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Dermatitis
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Dermatitis bullous
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Dermatitis herpetiformis
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (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	3 / 2532 (0.12%)	4 / 2499 (0.16%)
occurrences causally related to treatment / all	0 / 3	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Erythema multiforme
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hyperkeratosis
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Ischaemic skin ulcer
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Psoriasis
subjects affected / exposed	1 / 2532 (0.04%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Skin lesion
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
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 / 2532 (0.08%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Renal and urinary disorders
Haemorrhage urinary tract
subjects affected / exposed	0 / 2532 (0.00%)	2 / 2499 (0.08%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Acute kidney injury
subjects affected / exposed	25 / 2532 (0.99%)	30 / 2499 (1.20%)
occurrences causally related to treatment / all	0 / 27	0 / 32
deaths causally related to treatment / all	0 / 0	0 / 0
Bladder stenosis
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Calculus bladder
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
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	1 / 2532 (0.04%)	3 / 2499 (0.12%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Chronic kidney disease
subjects affected / exposed	3 / 2532 (0.12%)	6 / 2499 (0.24%)
occurrences causally related to treatment / all	0 / 3	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Cystitis haemorrhagic
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
End stage renal disease
subjects affected / exposed	1 / 2532 (0.04%)	4 / 2499 (0.16%)
occurrences causally related to treatment / all	0 / 1	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Focal segmental glomerulosclerosis
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Glomerulonephritis membranous
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Haematuria
subjects affected / exposed	5 / 2532 (0.20%)	2 / 2499 (0.08%)
occurrences causally related to treatment / all	0 / 5	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Hydronephrosis
subjects affected / exposed	2 / 2532 (0.08%)	2 / 2499 (0.08%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Ureteric stenosis
subjects affected / exposed	1 / 2532 (0.04%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Nephrolithiasis
subjects affected / exposed	4 / 2532 (0.16%)	9 / 2499 (0.36%)
occurrences causally related to treatment / all	0 / 5	0 / 9
deaths causally related to treatment / all	0 / 0	0 / 0
Nephropathy toxic
subjects affected / exposed	0 / 2532 (0.00%)	2 / 2499 (0.08%)
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 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Obstructive nephropathy
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (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	0 / 2532 (0.00%)	1 / 2499 (0.04%)
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	2 / 2532 (0.08%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Renal cyst
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Renal embolism
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Renal failure
subjects affected / exposed	2 / 2532 (0.08%)	2 / 2499 (0.08%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Renal haematoma
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Renal haemorrhage
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Renal impairment
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Renal mass
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Ureteric obstruction
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (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	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Ureterolithiasis
subjects affected / exposed	1 / 2532 (0.04%)	5 / 2499 (0.20%)
occurrences causally related to treatment / all	0 / 1	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Urethral perforation
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
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	0 / 2532 (0.00%)	2 / 2499 (0.08%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Urinary retention
subjects affected / exposed	2 / 2532 (0.08%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Urinary tract disorder
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Urinary tract obstruction
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Endocrine disorders
Goitre
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hyperparathyroidism primary
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Inappropriate antidiuretic hormone secretion
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Musculoskeletal and connective tissue disorders
Arthralgia
subjects affected / exposed	2 / 2532 (0.08%)	2 / 2499 (0.08%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Arthropathy
subjects affected / exposed	1 / 2532 (0.04%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Back disorder
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Arthritis
subjects affected / exposed	6 / 2532 (0.24%)	3 / 2499 (0.12%)
occurrences causally related to treatment / all	0 / 7	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Intervertebral disc disorder
subjects affected / exposed	4 / 2532 (0.16%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 4	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Back pain
subjects affected / exposed	3 / 2532 (0.12%)	8 / 2499 (0.32%)
occurrences causally related to treatment / all	0 / 3	0 / 10
deaths causally related to treatment / all	0 / 0	0 / 0
Intervertebral disc protrusion
subjects affected / exposed	8 / 2532 (0.32%)	6 / 2499 (0.24%)
occurrences causally related to treatment / all	0 / 8	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Joint swelling
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Intervertebral disc displacement
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Bursitis
subjects affected / exposed	3 / 2532 (0.12%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cervical spinal stenosis
subjects affected / exposed	4 / 2532 (0.16%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 5	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Chondromalacia
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Chondropathy
subjects affected / exposed	0 / 2532 (0.00%)	2 / 2499 (0.08%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Compartment syndrome
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Exostosis
subjects affected / exposed	1 / 2532 (0.04%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gouty arthritis
subjects affected / exposed	1 / 2532 (0.04%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 1	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Haematoma muscle
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (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	0 / 2532 (0.00%)	3 / 2499 (0.12%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Osteolysis
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Knee impingement syndrome
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pain in jaw
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pathological fracture
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Osteonecrosis
subjects affected / exposed	0 / 2532 (0.00%)	2 / 2499 (0.08%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Kyphosis
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Lumbar spinal stenosis
subjects affected / exposed	4 / 2532 (0.16%)	9 / 2499 (0.36%)
occurrences causally related to treatment / all	0 / 4	0 / 9
deaths causally related to treatment / all	0 / 0	0 / 0
Muscular weakness
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Musculoskeletal chest pain
subjects affected / exposed	6 / 2532 (0.24%)	6 / 2499 (0.24%)
occurrences causally related to treatment / all	1 / 6	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
Musculoskeletal discomfort
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Musculoskeletal pain
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Myalgia
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (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 / 2532 (0.04%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Osteoarthritis
subjects affected / exposed	37 / 2532 (1.46%)	36 / 2499 (1.44%)
occurrences causally related to treatment / all	0 / 42	0 / 37
deaths causally related to treatment / all	0 / 0	0 / 0
Spinal stenosis
subjects affected / exposed	1 / 2532 (0.04%)	5 / 2499 (0.20%)
occurrences causally related to treatment / all	0 / 1	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Spondylitis
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Spondyloarthropathy
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Spondylolisthesis
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Spinal pain
subjects affected / exposed	3 / 2532 (0.12%)	3 / 2499 (0.12%)
occurrences causally related to treatment / all	0 / 3	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Spinal osteoarthritis
subjects affected / exposed	1 / 2532 (0.04%)	8 / 2499 (0.32%)
occurrences causally related to treatment / all	0 / 1	0 / 9
deaths causally related to treatment / all	0 / 0	0 / 0
Polyarthritis
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Scoliosis
subjects affected / exposed	1 / 2532 (0.04%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Rotator cuff syndrome
subjects affected / exposed	3 / 2532 (0.12%)	2 / 2499 (0.08%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Rheumatoid arthritis
subjects affected / exposed	2 / 2532 (0.08%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Rhabdomyolysis
subjects affected / exposed	2 / 2532 (0.08%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Psoriatic arthropathy
subjects affected / exposed	1 / 2532 (0.04%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Polymyalgia rheumatica
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Spinal disorder
subjects affected / exposed	1 / 2532 (0.04%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Synovial cyst
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Vertebral foraminal stenosis
subjects affected / exposed	3 / 2532 (0.12%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 4	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Infections and infestations
Abscess bacterial
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Abdominal abscess
subjects affected / exposed	1 / 2532 (0.04%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Abscess
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
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 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Acute endocarditis
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Anal abscess
subjects affected / exposed	2 / 2532 (0.08%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Appendicitis
subjects affected / exposed	7 / 2532 (0.28%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 7	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Appendicitis perforated
subjects affected / exposed	4 / 2532 (0.16%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 4	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Breast abscess
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Arthritis infective
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Asymptomatic COVID-19
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Atypical pneumonia
subjects affected / exposed	2 / 2532 (0.08%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Bacteraemia
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Bacterial infection
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Arthritis bacterial
subjects affected / exposed	1 / 2532 (0.04%)	2 / 2499 (0.08%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Coccidioidomycosis
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Colonic abscess
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Coronavirus infection
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cystitis
subjects affected / exposed	3 / 2532 (0.12%)	3 / 2499 (0.12%)
occurrences causally related to treatment / all	0 / 3	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Bronchitis
subjects affected / exposed	8 / 2532 (0.32%)	10 / 2499 (0.40%)
occurrences causally related to treatment / all	0 / 8	0 / 10
deaths causally related to treatment / all	0 / 0	0 / 0
Clostridium difficile infection
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
COVID-19 pneumonia
subjects affected / exposed	32 / 2532 (1.26%)	23 / 2499 (0.92%)
occurrences causally related to treatment / all	0 / 32	0 / 23
deaths causally related to treatment / all	0 / 7	0 / 7
Cellulitis
subjects affected / exposed	17 / 2532 (0.67%)	20 / 2499 (0.80%)
occurrences causally related to treatment / all	0 / 21	0 / 26
deaths causally related to treatment / all	0 / 0	0 / 0
Cholecystitis infective
subjects affected / exposed	1 / 2532 (0.04%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cholera
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (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	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
COVID-19
subjects affected / exposed	15 / 2532 (0.59%)	15 / 2499 (0.60%)
occurrences causally related to treatment / all	0 / 16	0 / 16
deaths causally related to treatment / all	0 / 3	0 / 4
Cystitis klebsiella
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
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	0 / 2532 (0.00%)	2 / 2499 (0.08%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Diabetic foot infection
subjects affected / exposed	1 / 2532 (0.04%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Diabetic gangrene
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Diverticulitis
subjects affected / exposed	11 / 2532 (0.43%)	7 / 2499 (0.28%)
occurrences causally related to treatment / all	0 / 12	0 / 8
deaths causally related to treatment / all	0 / 0	0 / 0
Erysipelas
subjects affected / exposed	1 / 2532 (0.04%)	2 / 2499 (0.08%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Eczema infected
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Endocarditis bacterial
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Enterocolitis bacterial
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Epididymitis
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Diverticulitis intestinal haemorrhagic
subjects affected / exposed	0 / 2532 (0.00%)	2 / 2499 (0.08%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Escherichia bacteraemia
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Escherichia sepsis
subjects affected / exposed	1 / 2532 (0.04%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Escherichia urinary tract infection
subjects affected / exposed	1 / 2532 (0.04%)	2 / 2499 (0.08%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Extradural abscess
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Fungal skin infection
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (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	2 / 2532 (0.08%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gallbladder empyema
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gangrene
subjects affected / exposed	3 / 2532 (0.12%)	5 / 2499 (0.20%)
occurrences causally related to treatment / all	0 / 3	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Gastroenteritis
subjects affected / exposed	4 / 2532 (0.16%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 4	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastroenteritis bacterial
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gallbladder abscess
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
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 / 2532 (0.04%)	0 / 2499 (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	3 / 2532 (0.12%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Infected skin ulcer
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Infection
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Infectious pleural effusion
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Influenza
subjects affected / exposed	11 / 2532 (0.43%)	6 / 2499 (0.24%)
occurrences causally related to treatment / all	0 / 11	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Lung abscess
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Joint abscess
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Kidney infection
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Klebsiella infection
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Klebsiella sepsis
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Localised infection
subjects affected / exposed	2 / 2532 (0.08%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Intervertebral discitis
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Lyme disease
subjects affected / exposed	2 / 2532 (0.08%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Meningoencephalitis viral
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Metapneumovirus infection
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Neutropenic sepsis
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Otitis media chronic
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Osteomyelitis
subjects affected / exposed	6 / 2532 (0.24%)	2 / 2499 (0.08%)
occurrences causally related to treatment / all	0 / 6	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Osteomyelitis acute
subjects affected / exposed	1 / 2532 (0.04%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Osteomyelitis chronic
subjects affected / exposed	1 / 2532 (0.04%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Orchitis
subjects affected / exposed	0 / 2532 (0.00%)	2 / 2499 (0.08%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Paronychia
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Parotid abscess
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Perihepatic abscess
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Perineal abscess
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Peritonitis
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumonia legionella
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (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	50 / 2532 (1.97%)	74 / 2499 (2.96%)
occurrences causally related to treatment / all	0 / 55	0 / 83
deaths causally related to treatment / all	0 / 6	0 / 10
Pneumonia aspiration
subjects affected / exposed	4 / 2532 (0.16%)	5 / 2499 (0.20%)
occurrences causally related to treatment / all	0 / 4	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 1
Pneumonia bacterial
subjects affected / exposed	9 / 2532 (0.36%)	3 / 2499 (0.12%)
occurrences causally related to treatment / all	0 / 9	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 2
Pneumonia escherichia
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pharyngeal abscess
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumonia pseudomonal
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumonia streptococcal
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumonia viral
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Post procedural infection
subjects affected / exposed	2 / 2532 (0.08%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Post procedural sepsis
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Rocky mountain spotted fever
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pulmonary tuberculosis
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pyelonephritis
subjects affected / exposed	0 / 2532 (0.00%)	2 / 2499 (0.08%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Pyelonephritis acute
subjects affected / exposed	0 / 2532 (0.00%)	2 / 2499 (0.08%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Rectal abscess
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Respiratory tract infection
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Postoperative wound infection
subjects affected / exposed	5 / 2532 (0.20%)	2 / 2499 (0.08%)
occurrences causally related to treatment / all	0 / 5	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Sepsis
subjects affected / exposed	14 / 2532 (0.55%)	23 / 2499 (0.92%)
occurrences causally related to treatment / all	0 / 14	0 / 24
deaths causally related to treatment / all	0 / 0	0 / 3
Septic arthritis staphylococcal
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Septic shock
subjects affected / exposed	3 / 2532 (0.12%)	3 / 2499 (0.12%)
occurrences causally related to treatment / all	0 / 3	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Serratia infection
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Staphylococcal abscess
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
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	1 / 2532 (0.04%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Staphylococcal infection
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Staphylococcal osteomyelitis
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Staphylococcal sepsis
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Streptococcal bacteraemia
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Streptococcal sepsis
subjects affected / exposed	1 / 2532 (0.04%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Staphylococcal bacteraemia
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Tracheobronchitis
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Tuberculosis
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Upper respiratory tract infection
subjects affected / exposed	1 / 2532 (0.04%)	2 / 2499 (0.08%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Urinary tract infection
subjects affected / exposed	14 / 2532 (0.55%)	13 / 2499 (0.52%)
occurrences causally related to treatment / all	0 / 15	0 / 13
deaths causally related to treatment / all	0 / 0	0 / 0
Urinary tract infection bacterial
subjects affected / exposed	3 / 2532 (0.12%)	3 / 2499 (0.12%)
occurrences causally related to treatment / all	0 / 3	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Wound sepsis
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Urosepsis
subjects affected / exposed	7 / 2532 (0.28%)	4 / 2499 (0.16%)
occurrences causally related to treatment / all	0 / 7	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 1
Vestibular neuronitis
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Viral upper respiratory tract infection
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Wound infection
subjects affected / exposed	1 / 2532 (0.04%)	2 / 2499 (0.08%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Wound infection bacterial
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Urinary tract infection pseudomonal
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Metabolism and nutrition disorders
Hypertriglyceridaemia
subjects affected / exposed	0 / 2532 (0.00%)	2 / 2499 (0.08%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Decreased appetite
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Dehydration
subjects affected / exposed	6 / 2532 (0.24%)	10 / 2499 (0.40%)
occurrences causally related to treatment / all	0 / 6	0 / 10
deaths causally related to treatment / all	0 / 0	0 / 0
Diabetes mellitus
subjects affected / exposed	8 / 2532 (0.32%)	12 / 2499 (0.48%)
occurrences causally related to treatment / all	0 / 9	1 / 12
deaths causally related to treatment / all	0 / 0	0 / 0
Diabetes mellitus inadequate control
subjects affected / exposed	2 / 2532 (0.08%)	4 / 2499 (0.16%)
occurrences causally related to treatment / all	0 / 2	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Diabetic ketoacidosis
subjects affected / exposed	5 / 2532 (0.20%)	2 / 2499 (0.08%)
occurrences causally related to treatment / all	0 / 5	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 1
Failure to thrive
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gout
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hypercalcaemia
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hyperglycaemia
subjects affected / exposed	1 / 2532 (0.04%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hyperglycaemic hyperosmolar nonketotic syndrome
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hyperkalaemia
subjects affected / exposed	2 / 2532 (0.08%)	2 / 2499 (0.08%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Type 2 diabetes mellitus
subjects affected / exposed	1 / 2532 (0.04%)	2 / 2499 (0.08%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Obesity
subjects affected / exposed	2 / 2532 (0.08%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Mineral deficiency
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Malnutrition
subjects affected / exposed	1 / 2532 (0.04%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Lactic acidosis
subjects affected / exposed	0 / 2532 (0.00%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hypovolaemia
subjects affected / exposed	1 / 2532 (0.04%)	1 / 2499 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hyponatraemia
subjects affected / exposed	2 / 2532 (0.08%)	5 / 2499 (0.20%)
occurrences causally related to treatment / all	0 / 2	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Hypokalaemia
subjects affected / exposed	5 / 2532 (0.20%)	0 / 2499 (0.00%)
occurrences causally related to treatment / all	0 / 5	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hypoglycaemia
subjects affected / exposed	1 / 2532 (0.04%)	3 / 2499 (0.12%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Hypervolaemia
subjects affected / exposed	1 / 2532 (0.04%)	2 / 2499 (0.08%)
occurrences causally related to treatment / all	0 / 1	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 1

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

Non-serious adverse events	Placebo in Parent Study	Evolocumab in Parent Study
Total subjects affected by non serious adverse events
subjects affected / exposed	956 / 2532 (37.76%)	959 / 2499 (38.38%)
Vascular disorders
Hypertension
subjects affected / exposed	327 / 2532 (12.91%)	355 / 2499 (14.21%)
occurrences all number	386	416
Musculoskeletal and connective tissue disorders
Arthralgia
subjects affected / exposed	144 / 2532 (5.69%)	138 / 2499 (5.52%)
occurrences all number	169	172
Back pain
subjects affected / exposed	133 / 2532 (5.25%)	137 / 2499 (5.48%)
occurrences all number	153	156
Infections and infestations
Bronchitis
subjects affected / exposed	162 / 2532 (6.40%)	173 / 2499 (6.92%)
occurrences all number	205	212
Upper respiratory tract infection
subjects affected / exposed	208 / 2532 (8.21%)	162 / 2499 (6.48%)
occurrences all number	284	225
Nasopharyngitis
subjects affected / exposed	157 / 2532 (6.20%)	156 / 2499 (6.24%)
occurrences all number	199	176
Metabolism and nutrition disorders
Diabetes mellitus
subjects affected / exposed	139 / 2532 (5.49%)	135 / 2499 (5.40%)
occurrences all number	150	144

More information

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Were there any global substantial amendments to the protocol? Yes

20 Nov 2017

The protocol was amended for the following reasons: • Updated method of evolocumab distribution to subjects • Updated primary completion and end of study definitions • Replaced end of study visit with safety follow-up phone call • Clarified collection of demographic and baseline data • Clarified that subjects who discontinue evolocumab should remain on-study when possible • Defined lost to follow-up

08 Apr 2019

The protocol was amended for the following reasons: • Added exploratory endpoint • Added that subjects would be followed through study termination irrespective of receiving treatment, unless subject withdrew consent • Added concomitant therapy instructions • Added instructions for investigators for handling subjects who become pregnant • Updated list of analysis sets to include long-term safety analysis set, OLE Safety Analysis Set, and OLE CANTAB analysis set • Clarified which endpoints would use which analysis sets • Added list of adverse events to be reviewed by CEC

26 Feb 2020

The protocol was amended for the following reasons: • Clarified that all serious drug-related events must be recorded and reported to sponsor or designee within 24 hours • Added coronary revascularization procedure and death information to schedule of assessments • Clarified that all adverse event summaries for the primary analysis of the primary endpoint would include all treatment-emergent events reported on the event eCRF, including CEC reviewed events and disease-related events • Replaced “automated mini-doser (AMD)” with “personal injector (PI)” to align with program-level naming convention

Were there any global interruptions to the trial? No

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

None reported

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