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

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Clinical Trial Results:
Phase 3, Randomized, Open-Label, Active-Controlled Study Evaluating the Efficacy and Safety of Oral Vadadustat for the Maintenance Treatment of Anemia in Subjects with Dialysis-Dependent Chronic Kidney Disease (DD-CKD) (INNO2VATE – Conversion)

Summary
EudraCT number	2016-001360-11
Trial protocol	DE GB PT BG FR IT
Global end of trial date	16 Jan 2020

Results information
Results version number	v1(current)
This version publication date	15 Apr 2021
First version publication date	15 Apr 2021
Other versions

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

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Trial information

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Sponsor protocol code

AKB-6548-CI-0017

ISRCTN number

-

US NCT number

NCT02892149

WHO universal trial number (UTN)

-

Sponsor organisation name

Akebia Therapeutics, Inc.

Sponsor organisation address

245 First Street, Suite 1400, Cambridge, Massachusetts, United States, 02142

Public contact

Clinical Trial Information Desk, Akebia Therapeutics, Inc., +1 617-844-6128, trials@akebia.com

Scientific contact

Steven Burke, Chief Medical Officer, Akebia Therapeutics, Inc., +1 617-844-6128, trials@akebia.com

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

No

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

No

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

No

Analysis stage

Final

Date of interim/final analysis

16 Jan 2020

Is this the analysis of the primary completion data?

No

Global end of trial reached?

Yes

Global end of trial date

16 Jan 2020

Was the trial ended prematurely?

No

Main objective of the trial

The primary objective of this study was to demonstrate the efficacy and safety of vadadustat compared with darbepoetin alfa for the maintenance treatment of anemia in subjects with dialysis-dependent chronic kidney disease (DD-CKD).

Protection of trial subjects

The study was conducted in full compliance with the principles of the “Declaration of Helsinki” (as amended in Tokyo, Venice, Hong Kong, and South Africa), International Council for Harmonisation (ICH) guidelines, and all of the applicable United States Code of Federal Regulations 21 (US CFR 21, CFR Part 50 and 312).

Background therapy

-

Evidence for comparator

-

Actual start date of recruitment

17 Aug 2016

Long term follow-up planned

Yes

Long term follow-up rationale

Safety

Long term follow-up duration

2 Years

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

Argentina: 88

Country: Number of subjects enrolled

Australia: 38

Country: Number of subjects enrolled

Brazil: 307

Country: Number of subjects enrolled

Bulgaria: 208

Country: Number of subjects enrolled

Canada: 48

Country: Number of subjects enrolled

France: 40

Country: Number of subjects enrolled

Germany: 17

Country: Number of subjects enrolled

Israel: 32

Country: Number of subjects enrolled

Italy: 12

Country: Number of subjects enrolled

Korea, Democratic People's Republic of: 92

Country: Number of subjects enrolled

Mexico: 26

Country: Number of subjects enrolled

Poland: 76

Country: Number of subjects enrolled

Portugal: 30

Country: Number of subjects enrolled

Russian Federation: 92

Country: Number of subjects enrolled

Serbia: 131

Country: Number of subjects enrolled

Ukraine: 120

Country: Number of subjects enrolled

United Kingdom: 21

Country: Number of subjects enrolled

United States: 2176

Worldwide total number of subjects

3554

EEA total number of subjects

383

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)

2328

From 65 to 84 years

1174

85 years and over

52

Subject disposition

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Recruitment details

-

Screening details

A total of 4944 subjects were screened for entry into the study. Of these, 3554 subjects were enrolled and randomized in the study.

Period 1 title

Overall Study (overall period)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Not blinded

Are arms mutually exclusive

Yes

Vadadustat

Arm description

Subjects were randomized to receive vadadustat at an initial oral dose of 300 milligrams per day (mg/day). Thereafter, vadadustat was taken once daily on an outpatient basis. Up-and-down titration to 150, 300, 450, and 600 mg (available tablet strength was administered as the appropriate number of 150 mg tablets) was allowed during the study based on hemoglobin (Hb) level measurements every 4 weeks to maintain target Hb levels.

Arm type

Experimental

Investigational medicinal product name

Vadadustat

Investigational medicinal product code

AKB-6548

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

150 mg white to off-white, round, bi-convex film-coated tablets for oral administration with a starting dose of 300 mg/day

Darbepoetin Alfa

Arm description

Subjects were randomized to darbepoetin alfa at an initial dose that was based on the current package insert for investigational sites in the United States (US), and the Summary of Product Characteristics (SmPC) for all other investigational sites (non-US) for adult subjects with chronic kidney disease on dialysis. For subjects already on darbepoetin alfa, the initial dosing regimen in the study was based on the prior dosing regimen.

Arm type

Active comparator

Investigational medicinal product name

Darbepoetin Alfa

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection in pre-filled syringe

Routes of administration

Intravenous bolus use

Dosage and administration details

pre-filled syringes as an injectable solution for intravenous (IV) administration

Investigational medicinal product name

Darbepoetin Alfa

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection in pre-filled syringe

Routes of administration

Subcutaneous use

Dosage and administration details

pre-filled syringes as an injectable solution for subcutaneous (SC) administration

Number of subjects in period 1	Vadadustat	Darbepoetin Alfa
Started	1777	1777
Completed	1425	1421
Not completed	352	356
Consent withdrawn by subject	53	47
Death	262	278
Lost to follow-up	37	31

Baseline characteristics

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Reporting group title

Vadadustat

Reporting group description

Subjects were randomized to receive vadadustat at an initial oral dose of 300 milligrams per day (mg/day). Thereafter, vadadustat was taken once daily on an outpatient basis. Up-and-down titration to 150, 300, 450, and 600 mg (available tablet strength was administered as the appropriate number of 150 mg tablets) was allowed during the study based on hemoglobin (Hb) level measurements every 4 weeks to maintain target Hb levels.

Reporting group title

Darbepoetin Alfa

Reporting group description

Subjects were randomized to darbepoetin alfa at an initial dose that was based on the current package insert for investigational sites in the United States (US), and the Summary of Product Characteristics (SmPC) for all other investigational sites (non-US) for adult subjects with chronic kidney disease on dialysis. For subjects already on darbepoetin alfa, the initial dosing regimen in the study was based on the prior dosing regimen.

Reporting group values	Vadadustat	Darbepoetin Alfa	Total
Number of subjects	1777	1777	3554
Age categorical
Units:
Age continuous
Units: years
arithmetic mean (standard deviation)	57.9 ( 13.86 )	58.4 ( 13.84 )	-
Gender categorical
Units: subjects
Female	787	773	1560
Male	990	1004	1994
Race/Ethnicity, Customized
Units: Subjects
American Indian or Alaska Native	19	30	49
Asian	76	99	175
Black or African American	432	444	876
Native Hawaiian or Other Pacific Islander	13	6	19
White	1135	1096	2231
Not Reported	52	52	104
Reported as Other	42	45	87
Multiple	8	5	13
Average hemoglobin
Units: milligrams per deciliter (mg/dL)
arithmetic mean (standard deviation)	10.249 ( 0.8502 )	10.229 ( 0.8245 )	-

End points

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Reporting group title

Vadadustat

Reporting group description

Subjects were randomized to receive vadadustat at an initial oral dose of 300 milligrams per day (mg/day). Thereafter, vadadustat was taken once daily on an outpatient basis. Up-and-down titration to 150, 300, 450, and 600 mg (available tablet strength was administered as the appropriate number of 150 mg tablets) was allowed during the study based on hemoglobin (Hb) level measurements every 4 weeks to maintain target Hb levels.

Reporting group title

Darbepoetin Alfa

Reporting group description

Subjects were randomized to darbepoetin alfa at an initial dose that was based on the current package insert for investigational sites in the United States (US), and the Summary of Product Characteristics (SmPC) for all other investigational sites (non-US) for adult subjects with chronic kidney disease on dialysis. For subjects already on darbepoetin alfa, the initial dosing regimen in the study was based on the prior dosing regimen.

Primary: Change in Average Hemoglobin (Hb) between Baseline and the Primary Efficacy Period (Weeks 24 to 36)

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End point title

Change in Average Hemoglobin (Hb) between Baseline and the Primary Efficacy Period (Weeks 24 to 36)

End point description

Change from Baseline was calculated as the Primary Efficacy Period value minus the Baseline value. The Primary Efficacy Period was comprised of Weeks 24 to 36. Analysis was conducted in members of the Randomized Population, comprised of all subjects randomized. Analyses of this population were based on the randomized treatment. Analysis was conducted using an analysis of covariance (ANCOVA) model with multiple imputation for missing data with Baseline hemoglobin concentration, region, and New York Heart Association congestive heart failure (NYHA CHF) class as covariates.

End point type

Primary

End point timeframe

Baseline; Weeks 24 to 36

End point values	Vadadustat	Darbepoetin Alfa
Number of subjects analysed	1777 ^[1]	1777 ^[2]
Units: grams per deciliter (g/dL)
least squares mean (standard error)	0.19 ( 0.032 )	0.36 ( 0.032 )

Notes
[1] - Randomized Population
[2] - Randomized Population

ANCOVA with Multiple Imputation

Statistical analysis description

Treatment Comparison: Vadadustat minus Darbepoetin Alfa

Comparison groups

Vadadustat v Darbepoetin Alfa

Number of subjects included in analysis

3554

Analysis specification

Pre-specified

Analysis type

non-inferiority ^[3]

Method

Parameter type

Least squares mean difference

Point estimate

-0.17

Confidence interval

level

95%

sides

2-sided

lower limit

-0.23

upper limit

-0.1

Variability estimate

Standard error of the mean

Dispersion value

0.03

Notes
[3] - Establishment of non-inferiority was based on a margin of -0.75 g/dL applied to the difference in mean change: vadadustat minus darbepoetin alfa.

Secondary: Change in Average Hb Value between Baseline and the Secondary Efficacy Period (Weeks 40 to 52)

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End point title

Change in Average Hb Value between Baseline and the Secondary Efficacy Period (Weeks 40 to 52)

End point description

Change from Baseline was calculated as the Secondary Efficacy Period value minus the Baseline value. The Secondary Efficacy Period was comprised of Weeks 40 to 52. Analysis was conducted using an ANCOVA model with multiple imputation for missing data with Baseline hemoglobin concentration, region, and NYHA CHF class as covariates.

End point type

Secondary

End point timeframe

Baseline; Weeks 40 to 52

End point values	Vadadustat	Darbepoetin Alfa
Number of subjects analysed	1777 ^[4]	1777 ^[5]
Units: g/dL
least squares mean (standard error)	0.23 ( 0.035 )	0.41 ( 0.033 )

Notes
[4] - Randomized Population
[5] - Randomized Population

ANCOVA with Multiple Imputation

Statistical analysis description

Treatment Comparison: Vadadustat minus Darbepoetin Alfa

Comparison groups

Vadadustat v Darbepoetin Alfa

Number of subjects included in analysis

3554

Analysis specification

Pre-specified

Analysis type

non-inferiority ^[6]

Method

Parameter type

Least squares mean difference

Point estimate

-0.18

Confidence interval

level

95%

sides

2-sided

lower limit

-0.25

upper limit

-0.12

Variability estimate

Standard error of the mean

Dispersion value

0.04

Notes
[6] - Establishment of non-inferiority was based on a margin of -0.75 g/dL applied to the difference in mean change: vadadustat minus darbepoetin alfa.

Adverse events

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Timeframe for reporting adverse events

up to approximately 168 weeks

Adverse event reporting additional description

Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose, are reported.

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

22.1

Reporting group title

Vadadustat

Reporting group description

Subjects were randomized to receive vadadustat at an initial oral dose of 300 milligrams per day (mg/day). Thereafter, vadadustat was taken once daily on an outpatient basis. Up-and-down titration to 150, 300, 450, and 600 mg (available tablet strength was administered as the appropriate number of 150 mg tablets) was allowed during the study based on hemoglobin (Hb) level measurements every 4 weeks to maintain target Hb levels.

Reporting group title

Darbepoetin Alfa

Reporting group description

Subjects were randomized to darbepoetin alfa at an initial dose that was based on the current package insert for investigational sites in the United States (US), and the Summary of Product Characteristics (SmPC) for all other investigational sites (non-US) for adult subjects with chronic kidney disease on dialysis. For subjects already on darbepoetin alfa, the initial dosing regimen in the study was based on the prior dosing regimen.

Serious adverse events	Vadadustat	Darbepoetin Alfa
Total subjects affected by serious adverse events
subjects affected / exposed	973 / 1768 (55.03%)	1032 / 1769 (58.34%)
number of deaths (all causes)	276	290
number of deaths resulting from adverse events	266	276
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Clear cell renal cell carcinoma
subjects affected / exposed	1 / 1768 (0.06%)	3 / 1769 (0.17%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Prostate cancer
subjects affected / exposed	2 / 1768 (0.11%)	2 / 1769 (0.11%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Renal cell carcinoma
subjects affected / exposed	2 / 1768 (0.11%)	2 / 1769 (0.11%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 1	0 / 0
Adenocarcinoma
subjects affected / exposed	1 / 1768 (0.06%)	2 / 1769 (0.11%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 2
Adenocarcinoma of colon
subjects affected / exposed	0 / 1768 (0.00%)	3 / 1769 (0.17%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Breast cancer
subjects affected / exposed	2 / 1768 (0.11%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Colon cancer
subjects affected / exposed	1 / 1768 (0.06%)	2 / 1769 (0.11%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Metastatic renal cell carcinoma
subjects affected / exposed	0 / 1768 (0.00%)	3 / 1769 (0.17%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 1
Bladder cancer
subjects affected / exposed	0 / 1768 (0.00%)	2 / 1769 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Colon adenoma
subjects affected / exposed	0 / 1768 (0.00%)	2 / 1769 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Gastric cancer
subjects affected / exposed	1 / 1768 (0.06%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatocellular carcinoma
subjects affected / exposed	1 / 1768 (0.06%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Invasive ductal breast carcinoma
subjects affected / exposed	1 / 1768 (0.06%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Lung adenocarcinoma
subjects affected / exposed	1 / 1768 (0.06%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Myelodysplastic syndrome
subjects affected / exposed	0 / 1768 (0.00%)	2 / 1769 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Pancreatic carcinoma
subjects affected / exposed	2 / 1768 (0.11%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pancreatic carcinoma metastatic
subjects affected / exposed	0 / 1768 (0.00%)	2 / 1769 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 1
Papillary thyroid cancer
subjects affected / exposed	1 / 1768 (0.06%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Parathyroid tumour benign
subjects affected / exposed	1 / 1768 (0.06%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Prostate cancer metastatic
subjects affected / exposed	2 / 1768 (0.11%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Rectal neoplasm
subjects affected / exposed	0 / 1768 (0.00%)	2 / 1769 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Renal cancer
subjects affected / exposed	0 / 1768 (0.00%)	2 / 1769 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Squamous cell carcinoma
subjects affected / exposed	1 / 1768 (0.06%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Adenocarcinoma pancreas
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Benign ovarian tumour
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Bladder cancer recurrent
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Bladder neoplasm
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Borderline ovarian tumour
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (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 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Carcinoid tumour
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Chronic lymphocytic leukaemia
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
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	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Endometrial adenocarcinoma
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Follicular thyroid cancer
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Genitourinary tract neoplasm
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Glioma
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Invasive lobular breast carcinoma
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (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	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Lung cancer metastatic
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Lung carcinoma cell type unspecified stage IV
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (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 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Lung neoplasm malignant
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Lung squamous cell carcinoma metastatic
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Malignant melanoma
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Malignant neoplasm of pleura
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (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 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Mixed hepatocellular cholangiocarcinoma
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Non-Hodgkin's lymphoma
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Non-small cell lung cancer
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Oesophageal adenocarcinoma stage II
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pancreatic neoplasm
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Paraneoplastic syndrome
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Pelvic neoplasm
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pleural mesothelioma malignant
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Prostate cancer stage II
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Rectal cancer
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Refractory cytopenia with unilineage dysplasia
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Renal adenoma
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Renal cancer metastatic
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Renal cell carcinoma stage I
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Sarcoma metastatic
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Small cell lung cancer metastatic
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Squamous cell carcinoma of the tongue
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Thyroid neoplasm
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Uterine leiomyoma
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Vulval cancer
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Vulval cancer metastatic
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Vulval cancer stage 0
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Vascular disorders
Hypotension
subjects affected / exposed	29 / 1768 (1.64%)	30 / 1769 (1.70%)
occurrences causally related to treatment / all	0 / 32	0 / 33
deaths causally related to treatment / all	0 / 1	0 / 0
Hypertensive urgency
subjects affected / exposed	19 / 1768 (1.07%)	25 / 1769 (1.41%)
occurrences causally related to treatment / all	0 / 20	0 / 31
deaths causally related to treatment / all	0 / 0	0 / 0
Hypertension
subjects affected / exposed	20 / 1768 (1.13%)	22 / 1769 (1.24%)
occurrences causally related to treatment / all	0 / 21	0 / 22
deaths causally related to treatment / all	0 / 0	0 / 0
Hypertensive emergency
subjects affected / exposed	16 / 1768 (0.90%)	18 / 1769 (1.02%)
occurrences causally related to treatment / all	0 / 21	1 / 23
deaths causally related to treatment / all	0 / 0	0 / 0
Hypertensive crisis
subjects affected / exposed	12 / 1768 (0.68%)	13 / 1769 (0.73%)
occurrences causally related to treatment / all	0 / 12	1 / 13
deaths causally related to treatment / all	0 / 0	0 / 0
Deep vein thrombosis
subjects affected / exposed	13 / 1768 (0.74%)	10 / 1769 (0.57%)
occurrences causally related to treatment / all	1 / 13	2 / 10
deaths causally related to treatment / all	0 / 0	0 / 0
Peripheral vascular disorder
subjects affected / exposed	13 / 1768 (0.74%)	10 / 1769 (0.57%)
occurrences causally related to treatment / all	0 / 16	0 / 10
deaths causally related to treatment / all	0 / 1	0 / 1
Peripheral arterial occlusive disease
subjects affected / exposed	7 / 1768 (0.40%)	8 / 1769 (0.45%)
occurrences causally related to treatment / all	0 / 7	0 / 9
deaths causally related to treatment / all	0 / 0	0 / 1
Extremity necrosis
subjects affected / exposed	8 / 1768 (0.45%)	6 / 1769 (0.34%)
occurrences causally related to treatment / all	0 / 9	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
Peripheral ischaemia
subjects affected / exposed	7 / 1768 (0.40%)	6 / 1769 (0.34%)
occurrences causally related to treatment / all	0 / 9	0 / 8
deaths causally related to treatment / all	0 / 0	0 / 0
Haematoma
subjects affected / exposed	9 / 1768 (0.51%)	2 / 1769 (0.11%)
occurrences causally related to treatment / all	0 / 9	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Shock haemorrhagic
subjects affected / exposed	8 / 1768 (0.45%)	3 / 1769 (0.17%)
occurrences causally related to treatment / all	0 / 8	0 / 3
deaths causally related to treatment / all	0 / 2	0 / 0
Aortic stenosis
subjects affected / exposed	3 / 1768 (0.17%)	7 / 1769 (0.40%)
occurrences causally related to treatment / all	0 / 3	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
Jugular vein thrombosis
subjects affected / exposed	3 / 1768 (0.17%)	7 / 1769 (0.40%)
occurrences causally related to treatment / all	0 / 4	1 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
Shock
subjects affected / exposed	5 / 1768 (0.28%)	5 / 1769 (0.28%)
occurrences causally related to treatment / all	0 / 5	0 / 5
deaths causally related to treatment / all	0 / 3	0 / 2
Dry gangrene
subjects affected / exposed	3 / 1768 (0.17%)	4 / 1769 (0.23%)
occurrences causally related to treatment / all	0 / 3	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Peripheral artery thrombosis
subjects affected / exposed	4 / 1768 (0.23%)	3 / 1769 (0.17%)
occurrences causally related to treatment / all	0 / 4	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Arteriosclerosis
subjects affected / exposed	2 / 1768 (0.11%)	3 / 1769 (0.17%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 2	0 / 3
Hypovolaemic shock
subjects affected / exposed	3 / 1768 (0.17%)	2 / 1769 (0.11%)
occurrences causally related to treatment / all	0 / 4	0 / 2
deaths causally related to treatment / all	0 / 1	0 / 1
Orthostatic hypotension
subjects affected / exposed	1 / 1768 (0.06%)	4 / 1769 (0.23%)
occurrences causally related to treatment / all	0 / 1	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Peripheral artery occlusion
subjects affected / exposed	1 / 1768 (0.06%)	4 / 1769 (0.23%)
occurrences causally related to treatment / all	0 / 1	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Steal syndrome
subjects affected / exposed	4 / 1768 (0.23%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 4	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Malignant hypertension
subjects affected / exposed	2 / 1768 (0.11%)	2 / 1769 (0.11%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Brachiocephalic vein occlusion
subjects affected / exposed	2 / 1768 (0.11%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Haemorrhage
subjects affected / exposed	2 / 1768 (0.11%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Superior vena cava syndrome
subjects affected / exposed	2 / 1768 (0.11%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Venous stenosis
subjects affected / exposed	2 / 1768 (0.11%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Brachiocephalic vein thrombosis
subjects affected / exposed	0 / 1768 (0.00%)	2 / 1769 (0.11%)
occurrences causally related to treatment / all	0 / 0	1 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Peripheral artery stenosis
subjects affected / exposed	1 / 1768 (0.06%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 1	1 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Subclavian vein thrombosis
subjects affected / exposed	0 / 1768 (0.00%)	2 / 1769 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Thrombophlebitis superficial
subjects affected / exposed	2 / 1768 (0.11%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Superior vena cava occlusion
subjects affected / exposed	0 / 1768 (0.00%)	2 / 1769 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Thrombosis
subjects affected / exposed	1 / 1768 (0.06%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Venous thrombosis
subjects affected / exposed	0 / 1768 (0.00%)	2 / 1769 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Accelerated hypertension
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Aortic dissection
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Arterial haemorrhage
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Arterial insufficiency
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Arterial occlusive disease
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Axillary vein thrombosis
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Brachiocephalic vein stenosis
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Circulatory collapse
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Distributive shock
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Embolism
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Embolism venous
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (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	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Ischaemic limb pain
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Necrosis ischaemic
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Neurogenic shock
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Obstructive shock
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Peripheral artery aneurysm
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Peripheral embolism
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Post thrombotic syndrome
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Subclavian vein occlusion
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Subclavian vein stenosis
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Subgaleal haemorrhage
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Superior vena cava stenosis
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Thrombophlebitis
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Vascular stenosis
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Vasculitis necrotising
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Vein rupture
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Vena cava thrombosis
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Venous thrombosis limb
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Surgical and medical procedures
Hospitalisation
subjects affected / exposed	1 / 1768 (0.06%)	3 / 1769 (0.17%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Therapy cessation
subjects affected / exposed	1 / 1768 (0.06%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 1
Arteriovenous fistula operation
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac pacemaker insertion
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Haemodialysis
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Large intestinal polypectomy
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Procoagulant therapy
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Vascular access placement
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Breech presentation
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cephalhaematoma
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Premature baby
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cervical incompetence
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
General disorders and administration site conditions
Non-cardiac chest pain
subjects affected / exposed	34 / 1768 (1.92%)	22 / 1769 (1.24%)
occurrences causally related to treatment / all	0 / 35	0 / 22
deaths causally related to treatment / all	0 / 0	0 / 0
Death
subjects affected / exposed	24 / 1768 (1.36%)	14 / 1769 (0.79%)
occurrences causally related to treatment / all	0 / 24	0 / 14
deaths causally related to treatment / all	0 / 24	0 / 14
Chest pain
subjects affected / exposed	14 / 1768 (0.79%)	15 / 1769 (0.85%)
occurrences causally related to treatment / all	0 / 18	0 / 15
deaths causally related to treatment / all	0 / 0	0 / 0
Asthenia
subjects affected / exposed	6 / 1768 (0.34%)	6 / 1769 (0.34%)
occurrences causally related to treatment / all	0 / 6	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Sudden death
subjects affected / exposed	3 / 1768 (0.17%)	9 / 1769 (0.51%)
occurrences causally related to treatment / all	0 / 3	0 / 9
deaths causally related to treatment / all	0 / 3	0 / 9
Pyrexia
subjects affected / exposed	3 / 1768 (0.17%)	8 / 1769 (0.45%)
occurrences causally related to treatment / all	0 / 3	0 / 8
deaths causally related to treatment / all	0 / 0	0 / 0
Multiple organ dysfunction syndrome
subjects affected / exposed	2 / 1768 (0.11%)	7 / 1769 (0.40%)
occurrences causally related to treatment / all	0 / 2	0 / 7
deaths causally related to treatment / all	0 / 2	0 / 6
Catheter site thrombosis
subjects affected / exposed	5 / 1768 (0.28%)	3 / 1769 (0.17%)
occurrences causally related to treatment / all	1 / 5	1 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Impaired healing
subjects affected / exposed	6 / 1768 (0.34%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 8	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Systemic inflammatory response syndrome
subjects affected / exposed	4 / 1768 (0.23%)	3 / 1769 (0.17%)
occurrences causally related to treatment / all	0 / 5	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Catheter site haemorrhage
subjects affected / exposed	2 / 1768 (0.11%)	3 / 1769 (0.17%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Generalised oedema
subjects affected / exposed	3 / 1768 (0.17%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Sudden cardiac death
subjects affected / exposed	3 / 1768 (0.17%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 3	0 / 1
Physical deconditioning
subjects affected / exposed	2 / 1768 (0.11%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Treatment noncompliance
subjects affected / exposed	2 / 1768 (0.11%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 0
Catheter site pain
subjects affected / exposed	1 / 1768 (0.06%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Complication associated with device
subjects affected / exposed	1 / 1768 (0.06%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Oedema peripheral
subjects affected / exposed	0 / 1768 (0.00%)	2 / 1769 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Pain
subjects affected / exposed	2 / 1768 (0.11%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Peripheral swelling
subjects affected / exposed	1 / 1768 (0.06%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Surgical failure
subjects affected / exposed	1 / 1768 (0.06%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac death
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Catheter site inflammation
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Catheter site related reaction
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Chest discomfort
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Drug withdrawal syndrome
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Fatigue
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gait disturbance
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hernia pain
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hypothermia
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Incarcerated hernia
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Necrosis
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Oedema
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Soft tissue inflammation
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Strangulated hernia
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Swelling
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Ulcer
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Vascular stent occlusion
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Immune system disorders
Kidney transplant rejection
subjects affected / exposed	1 / 1768 (0.06%)	4 / 1769 (0.23%)
occurrences causally related to treatment / all	0 / 1	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Anaphylactic reaction
subjects affected / exposed	1 / 1768 (0.06%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	1 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Anaphylactic shock
subjects affected / exposed	1 / 1768 (0.06%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Anti-neutrophil cytoplasmic antibody positive vasculitis
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (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 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Contrast media reaction
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Food allergy
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hypersensitivity
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Renal transplant failure
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Transplant rejection
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Social circumstances
Living in residential institution
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Reproductive system and breast disorders
Dysfunctional uterine bleeding
subjects affected / exposed	2 / 1768 (0.11%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Menorrhagia
subjects affected / exposed	1 / 1768 (0.06%)	2 / 1769 (0.11%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Balanoposthitis
subjects affected / exposed	1 / 1768 (0.06%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Benign prostatic hyperplasia
subjects affected / exposed	2 / 1768 (0.11%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Menometrorrhagia
subjects affected / exposed	0 / 1768 (0.00%)	2 / 1769 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Penile vascular disorder
subjects affected / exposed	0 / 1768 (0.00%)	2 / 1769 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Vaginal haemorrhage
subjects affected / exposed	0 / 1768 (0.00%)	2 / 1769 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Female genital tract fistula
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Metrorrhagia
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Ovarian cyst
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Ovarian cyst ruptured
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pelvic fluid collection
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Postmenopausal haemorrhage
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
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 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Testicular oedema
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Uterine haemorrhage
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
subjects affected / exposed	44 / 1768 (2.49%)	50 / 1769 (2.83%)
occurrences causally related to treatment / all	0 / 49	0 / 55
deaths causally related to treatment / all	0 / 7	0 / 6
Respiratory failure
subjects affected / exposed	27 / 1768 (1.53%)	42 / 1769 (2.37%)
occurrences causally related to treatment / all	0 / 32	0 / 42
deaths causally related to treatment / all	0 / 2	0 / 9
Pulmonary oedema
subjects affected / exposed	26 / 1768 (1.47%)	33 / 1769 (1.87%)
occurrences causally related to treatment / all	0 / 27	0 / 37
deaths causally related to treatment / all	0 / 0	0 / 0
Pleural effusion
subjects affected / exposed	26 / 1768 (1.47%)	26 / 1769 (1.47%)
occurrences causally related to treatment / all	0 / 30	0 / 37
deaths causally related to treatment / all	0 / 0	0 / 0
Acute pulmonary oedema
subjects affected / exposed	19 / 1768 (1.07%)	13 / 1769 (0.73%)
occurrences causally related to treatment / all	0 / 20	0 / 14
deaths causally related to treatment / all	0 / 2	0 / 0
Chronic obstructive pulmonary disease
subjects affected / exposed	16 / 1768 (0.90%)	12 / 1769 (0.68%)
occurrences causally related to treatment / all	0 / 22	0 / 17
deaths causally related to treatment / all	0 / 0	0 / 0
Dyspnoea
subjects affected / exposed	19 / 1768 (1.07%)	9 / 1769 (0.51%)
occurrences causally related to treatment / all	0 / 20	0 / 9
deaths causally related to treatment / all	0 / 0	0 / 0
Pulmonary hypertension
subjects affected / exposed	10 / 1768 (0.57%)	10 / 1769 (0.57%)
occurrences causally related to treatment / all	0 / 10	0 / 10
deaths causally related to treatment / all	0 / 0	0 / 0
Pulmonary embolism
subjects affected / exposed	5 / 1768 (0.28%)	9 / 1769 (0.51%)
occurrences causally related to treatment / all	1 / 6	2 / 10
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumonia aspiration
subjects affected / exposed	5 / 1768 (0.28%)	4 / 1769 (0.23%)
occurrences causally related to treatment / all	0 / 5	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Acute respiratory distress syndrome
subjects affected / exposed	2 / 1768 (0.11%)	5 / 1769 (0.28%)
occurrences causally related to treatment / all	0 / 2	0 / 5
deaths causally related to treatment / all	0 / 1	0 / 0
Asthma
subjects affected / exposed	4 / 1768 (0.23%)	2 / 1769 (0.11%)
occurrences causally related to treatment / all	0 / 4	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Epistaxis
subjects affected / exposed	4 / 1768 (0.23%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 4	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hypoxia
subjects affected / exposed	2 / 1768 (0.11%)	3 / 1769 (0.17%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumothorax
subjects affected / exposed	3 / 1768 (0.17%)	2 / 1769 (0.11%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Pulmonary congestion
subjects affected / exposed	1 / 1768 (0.06%)	4 / 1769 (0.23%)
occurrences causally related to treatment / all	0 / 1	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 1
Respiratory arrest
subjects affected / exposed	0 / 1768 (0.00%)	5 / 1769 (0.28%)
occurrences causally related to treatment / all	0 / 0	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 2
Respiratory distress
subjects affected / exposed	2 / 1768 (0.11%)	3 / 1769 (0.17%)
occurrences causally related to treatment / all	0 / 4	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Chronic respiratory failure
subjects affected / exposed	2 / 1768 (0.11%)	2 / 1769 (0.11%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Aspiration
subjects affected / exposed	1 / 1768 (0.06%)	2 / 1769 (0.11%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Atelectasis
subjects affected / exposed	1 / 1768 (0.06%)	2 / 1769 (0.11%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Respiratory acidosis
subjects affected / exposed	3 / 1768 (0.17%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Haemoptysis
subjects affected / exposed	1 / 1768 (0.06%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Haemothorax
subjects affected / exposed	1 / 1768 (0.06%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hypercapnia
subjects affected / exposed	1 / 1768 (0.06%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Lung disorder
subjects affected / exposed	1 / 1768 (0.06%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 0
Pleurisy
subjects affected / exposed	1 / 1768 (0.06%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pulmonary arterial hypertension
subjects affected / exposed	2 / 1768 (0.11%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Bronchospasm
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cough
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Diaphragmatic disorder
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hiccups
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hypoventilation
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Interstitial lung disease
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Laryngeal oedema
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Lung opacity
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pharyngeal oedema
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumonitis
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Productive cough
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pulmonary alveolar haemorrhage
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Respiratory disorder
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Psychiatric disorders
Mental status changes
subjects affected / exposed	11 / 1768 (0.62%)	23 / 1769 (1.30%)
occurrences causally related to treatment / all	0 / 11	0 / 25
deaths causally related to treatment / all	0 / 0	0 / 0
Anxiety
subjects affected / exposed	2 / 1768 (0.11%)	2 / 1769 (0.11%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Delirium
subjects affected / exposed	1 / 1768 (0.06%)	3 / 1769 (0.17%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Confusional state
subjects affected / exposed	3 / 1768 (0.17%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Depression
subjects affected / exposed	1 / 1768 (0.06%)	2 / 1769 (0.11%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Acute psychosis
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Acute stress disorder
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Alcohol abuse
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Alcohol withdrawal syndrome
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Completed suicide
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Delirium tremens
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Delusion
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Depression suicidal
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hallucination, visual
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Major depression
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Post-traumatic stress disorder
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Substance abuse
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Suicide attempt
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Product issues
Device dislocation
subjects affected / exposed	6 / 1768 (0.34%)	4 / 1769 (0.23%)
occurrences causally related to treatment / all	0 / 7	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Device malfunction
subjects affected / exposed	4 / 1768 (0.23%)	2 / 1769 (0.11%)
occurrences causally related to treatment / all	0 / 4	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Device occlusion
subjects affected / exposed	1 / 1768 (0.06%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Thrombosis in device
subjects affected / exposed	1 / 1768 (0.06%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Device extrusion
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Device failure
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Device leakage
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Device physical property issue
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Patient-device incompatibility
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatobiliary disorders
Cholelithiasis
subjects affected / exposed	7 / 1768 (0.40%)	9 / 1769 (0.51%)
occurrences causally related to treatment / all	0 / 8	0 / 9
deaths causally related to treatment / all	0 / 0	0 / 0
Cholecystitis acute
subjects affected / exposed	6 / 1768 (0.34%)	9 / 1769 (0.51%)
occurrences causally related to treatment / all	0 / 6	0 / 9
deaths causally related to treatment / all	0 / 1	0 / 0
Cholecystitis
subjects affected / exposed	7 / 1768 (0.40%)	3 / 1769 (0.17%)
occurrences causally related to treatment / all	0 / 7	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Bile duct stone
subjects affected / exposed	1 / 1768 (0.06%)	6 / 1769 (0.34%)
occurrences causally related to treatment / all	0 / 1	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatic cirrhosis
subjects affected / exposed	4 / 1768 (0.23%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 4	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Ischaemic hepatitis
subjects affected / exposed	2 / 1768 (0.11%)	2 / 1769 (0.11%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Liver injury
subjects affected / exposed	1 / 1768 (0.06%)	2 / 1769 (0.11%)
occurrences causally related to treatment / all	1 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Biliary colic
subjects affected / exposed	1 / 1768 (0.06%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cholestasis
subjects affected / exposed	1 / 1768 (0.06%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatic failure
subjects affected / exposed	0 / 1768 (0.00%)	2 / 1769 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 1
Acute hepatic failure
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Bile duct stenosis
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cholangitis
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cholecystitis chronic
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cholelithiasis obstructive
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Chronic hepatic failure
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Hepatic haematoma
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatic mass
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatitis acute
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Investigations
Hepatic enzyme increased
subjects affected / exposed	7 / 1768 (0.40%)	8 / 1769 (0.45%)
occurrences causally related to treatment / all	0 / 7	0 / 8
deaths causally related to treatment / all	0 / 0	0 / 0
Alanine aminotransferase increased
subjects affected / exposed	7 / 1768 (0.40%)	6 / 1769 (0.34%)
occurrences causally related to treatment / all	1 / 7	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Aspartate aminotransferase increased
subjects affected / exposed	6 / 1768 (0.34%)	6 / 1769 (0.34%)
occurrences causally related to treatment / all	0 / 6	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Transaminases increased
subjects affected / exposed	8 / 1768 (0.45%)	3 / 1769 (0.17%)
occurrences causally related to treatment / all	0 / 9	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Liver function test increased
subjects affected / exposed	2 / 1768 (0.11%)	4 / 1769 (0.23%)
occurrences causally related to treatment / all	0 / 2	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Troponin increased
subjects affected / exposed	2 / 1768 (0.11%)	2 / 1769 (0.11%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Anticoagulation drug level above therapeutic
subjects affected / exposed	1 / 1768 (0.06%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
False positive investigation result
subjects affected / exposed	2 / 1768 (0.11%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Ammonia increased
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Blood alkaline phosphatase increased
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Ejection fraction decreased
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Electrocardiogram QT prolonged
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Haemoglobin decreased
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Heart rate increased
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Influenza B virus test positive
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
International normalised ratio increased
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Liver function test abnormal
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Respiratory syncytial virus test positive
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (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
Arteriovenous fistula thrombosis
subjects affected / exposed	56 / 1768 (3.17%)	38 / 1769 (2.15%)
occurrences causally related to treatment / all	2 / 66	7 / 46
deaths causally related to treatment / all	0 / 0	0 / 0
Arteriovenous graft thrombosis
subjects affected / exposed	22 / 1768 (1.24%)	20 / 1769 (1.13%)
occurrences causally related to treatment / all	1 / 28	1 / 31
deaths causally related to treatment / all	0 / 0	0 / 0
Fall
subjects affected / exposed	17 / 1768 (0.96%)	18 / 1769 (1.02%)
occurrences causally related to treatment / all	0 / 17	0 / 21
deaths causally related to treatment / all	0 / 0	0 / 0
Arteriovenous fistula site complication
subjects affected / exposed	16 / 1768 (0.90%)	18 / 1769 (1.02%)
occurrences causally related to treatment / all	0 / 17	0 / 19
deaths causally related to treatment / all	0 / 0	0 / 0
Arteriovenous fistula site haemorrhage
subjects affected / exposed	11 / 1768 (0.62%)	12 / 1769 (0.68%)
occurrences causally related to treatment / all	0 / 11	0 / 13
deaths causally related to treatment / all	0 / 0	0 / 0
Femur fracture
subjects affected / exposed	15 / 1768 (0.85%)	7 / 1769 (0.40%)
occurrences causally related to treatment / all	0 / 15	0 / 8
deaths causally related to treatment / all	0 / 0	0 / 0
Vascular access malfunction
subjects affected / exposed	10 / 1768 (0.57%)	10 / 1769 (0.57%)
occurrences causally related to treatment / all	0 / 10	0 / 11
deaths causally related to treatment / all	0 / 0	0 / 0
Vascular access site thrombosis
subjects affected / exposed	7 / 1768 (0.40%)	13 / 1769 (0.73%)
occurrences causally related to treatment / all	0 / 8	1 / 17
deaths causally related to treatment / all	0 / 0	0 / 0
Hip fracture
subjects affected / exposed	6 / 1768 (0.34%)	11 / 1769 (0.62%)
occurrences causally related to treatment / all	0 / 8	0 / 12
deaths causally related to treatment / all	0 / 0	0 / 0
Subdural haematoma
subjects affected / exposed	6 / 1768 (0.34%)	7 / 1769 (0.40%)
occurrences causally related to treatment / all	0 / 6	0 / 8
deaths causally related to treatment / all	0 / 0	0 / 2
Ankle fracture
subjects affected / exposed	6 / 1768 (0.34%)	4 / 1769 (0.23%)
occurrences causally related to treatment / all	0 / 7	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Post procedural haemorrhage
subjects affected / exposed	3 / 1768 (0.17%)	7 / 1769 (0.40%)
occurrences causally related to treatment / all	0 / 3	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
Arteriovenous graft site haemorrhage
subjects affected / exposed	4 / 1768 (0.23%)	5 / 1769 (0.28%)
occurrences causally related to treatment / all	0 / 4	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Femoral neck fracture
subjects affected / exposed	6 / 1768 (0.34%)	3 / 1769 (0.17%)
occurrences causally related to treatment / all	0 / 6	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Wound dehiscence
subjects affected / exposed	2 / 1768 (0.11%)	7 / 1769 (0.40%)
occurrences causally related to treatment / all	0 / 2	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
Fibula fracture
subjects affected / exposed	4 / 1768 (0.23%)	4 / 1769 (0.23%)
occurrences causally related to treatment / all	0 / 4	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Tibia fracture
subjects affected / exposed	4 / 1768 (0.23%)	4 / 1769 (0.23%)
occurrences causally related to treatment / all	0 / 4	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Vascular pseudoaneurysm
subjects affected / exposed	4 / 1768 (0.23%)	4 / 1769 (0.23%)
occurrences causally related to treatment / all	0 / 4	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Spinal compression fracture
subjects affected / exposed	1 / 1768 (0.06%)	6 / 1769 (0.34%)
occurrences causally related to treatment / all	0 / 1	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Vascular pseudoaneurysm ruptured
subjects affected / exposed	4 / 1768 (0.23%)	3 / 1769 (0.17%)
occurrences causally related to treatment / all	0 / 4	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Arteriovenous fistula aneurysm
subjects affected / exposed	4 / 1768 (0.23%)	2 / 1769 (0.11%)
occurrences causally related to treatment / all	0 / 4	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Contusion
subjects affected / exposed	3 / 1768 (0.17%)	3 / 1769 (0.17%)
occurrences causally related to treatment / all	0 / 3	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Graft thrombosis
subjects affected / exposed	5 / 1768 (0.28%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 5	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Humerus fracture
subjects affected / exposed	2 / 1768 (0.11%)	4 / 1769 (0.23%)
occurrences causally related to treatment / all	0 / 3	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Lower limb fracture
subjects affected / exposed	2 / 1768 (0.11%)	4 / 1769 (0.23%)
occurrences causally related to treatment / all	0 / 2	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Perirenal haematoma
subjects affected / exposed	3 / 1768 (0.17%)	3 / 1769 (0.17%)
occurrences causally related to treatment / all	0 / 3	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Toxicity to various agents
subjects affected / exposed	3 / 1768 (0.17%)	3 / 1769 (0.17%)
occurrences causally related to treatment / all	0 / 3	0 / 3
deaths causally related to treatment / all	0 / 1	0 / 1
Pubis fracture
subjects affected / exposed	3 / 1768 (0.17%)	3 / 1769 (0.17%)
occurrences causally related to treatment / all	0 / 3	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Arteriovenous fistula occlusion
subjects affected / exposed	1 / 1768 (0.06%)	4 / 1769 (0.23%)
occurrences causally related to treatment / all	0 / 1	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Head injury
subjects affected / exposed	3 / 1768 (0.17%)	2 / 1769 (0.11%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Procedural pain
subjects affected / exposed	2 / 1768 (0.11%)	3 / 1769 (0.17%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Rib fracture
subjects affected / exposed	2 / 1768 (0.11%)	3 / 1769 (0.17%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Vascular graft complication
subjects affected / exposed	4 / 1768 (0.23%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 5	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Arteriovenous graft site stenosis
subjects affected / exposed	0 / 1768 (0.00%)	4 / 1769 (0.23%)
occurrences causally related to treatment / all	0 / 0	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Delayed graft function
subjects affected / exposed	1 / 1768 (0.06%)	3 / 1769 (0.17%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Eschar
subjects affected / exposed	1 / 1768 (0.06%)	3 / 1769 (0.17%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Pelvic fracture
subjects affected / exposed	2 / 1768 (0.11%)	2 / 1769 (0.11%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Road traffic accident
subjects affected / exposed	0 / 1768 (0.00%)	4 / 1769 (0.23%)
occurrences causally related to treatment / all	0 / 0	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Foot fracture
subjects affected / exposed	1 / 1768 (0.06%)	2 / 1769 (0.11%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Joint dislocation
subjects affected / exposed	1 / 1768 (0.06%)	2 / 1769 (0.11%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Joint injury
subjects affected / exposed	2 / 1768 (0.11%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Peritoneal dialysis complication
subjects affected / exposed	1 / 1768 (0.06%)	2 / 1769 (0.11%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Post procedural haematoma
subjects affected / exposed	2 / 1768 (0.11%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Postoperative hypotension
subjects affected / exposed	2 / 1768 (0.11%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 0
Procedural hypotension
subjects affected / exposed	1 / 1768 (0.06%)	2 / 1769 (0.11%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Shunt thrombosis
subjects affected / exposed	2 / 1768 (0.11%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Vascular access site haemorrhage
subjects affected / exposed	1 / 1768 (0.06%)	2 / 1769 (0.11%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Vascular access site pseudoaneurysm
subjects affected / exposed	1 / 1768 (0.06%)	2 / 1769 (0.11%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Wound necrosis
subjects affected / exposed	0 / 1768 (0.00%)	3 / 1769 (0.17%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Acetabulum fracture
subjects affected / exposed	1 / 1768 (0.06%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Anaemia postoperative
subjects affected / exposed	1 / 1768 (0.06%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Arteriovenous fistula site haematoma
subjects affected / exposed	1 / 1768 (0.06%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Clavicle fracture
subjects affected / exposed	0 / 1768 (0.00%)	2 / 1769 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Facial bones fracture
subjects affected / exposed	1 / 1768 (0.06%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Ligament sprain
subjects affected / exposed	1 / 1768 (0.06%)	1 / 1769 (0.06%)
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	0 / 1768 (0.00%)	2 / 1769 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 2
Overdose
subjects affected / exposed	1 / 1768 (0.06%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Patella fracture
subjects affected / exposed	0 / 1768 (0.00%)	2 / 1769 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Postoperative respiratory failure
subjects affected / exposed	1 / 1768 (0.06%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Renal lymphocele
subjects affected / exposed	2 / 1768 (0.11%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Skin laceration
subjects affected / exposed	0 / 1768 (0.00%)	2 / 1769 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Ulna fracture
subjects affected / exposed	0 / 1768 (0.00%)	2 / 1769 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Vascular access site complication
subjects affected / exposed	2 / 1768 (0.11%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Vascular graft thrombosis
subjects affected / exposed	1 / 1768 (0.06%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Abdominal wound dehiscence
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Accidental overdose
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Anastomotic leak
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Anastomotic ulcer
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Anastomotic ulcer haemorrhage
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
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 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Arteriovenous graft site haematoma
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac valve replacement complication
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
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	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Comminuted fracture
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Complications of transplanted kidney
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (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 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Dialysis disequilibrium syndrome
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrostomy tube site complication
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Incision site impaired healing
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Incision site swelling
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (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 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Inflammation of wound
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Injury
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Joint dislocation postoperative
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Kidney rupture
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Limb injury
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Meniscus injury
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Multiple fractures
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pharyngeal injury
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Poisoning deliberate
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Post concussion syndrome
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Post procedural bile leak
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Post procedural diarrhoea
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Post procedural discharge
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Post procedural fever
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Post procedural swelling
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Post-traumatic pain
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Postoperative ileus
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Procedural haemorrhage
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Procedural shock
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Radius fracture
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Reactive gastropathy
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Scapula fracture
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Seroma
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Skin injury
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Skull fracture
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Soft tissue injury
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Spinal fracture
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Splenic rupture
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Subdural haemorrhage
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
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	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Traumatic fracture
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Traumatic haematoma
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Unintentional medical device removal
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Upper limb fracture
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Vascular access complication
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Vascular access site rupture
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Wound complication
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Wound haemorrhage
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Wrist fracture
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Congenital, familial and genetic disorders
Gastrointestinal arteriovenous malformation
subjects affected / exposed	1 / 1768 (0.06%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Haemorrhagic arteriovenous malformation
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac disorders
Acute myocardial infarction
subjects affected / exposed	81 / 1768 (4.58%)	78 / 1769 (4.41%)
occurrences causally related to treatment / all	1 / 97	3 / 89
deaths causally related to treatment / all	0 / 14	1 / 6
Cardiac arrest
subjects affected / exposed	49 / 1768 (2.77%)	60 / 1769 (3.39%)
occurrences causally related to treatment / all	0 / 52	0 / 61
deaths causally related to treatment / all	0 / 35	0 / 37
Cardiac failure congestive
subjects affected / exposed	45 / 1768 (2.55%)	50 / 1769 (2.83%)
occurrences causally related to treatment / all	1 / 54	0 / 57
deaths causally related to treatment / all	0 / 1	0 / 3
Atrial fibrillation
subjects affected / exposed	44 / 1768 (2.49%)	37 / 1769 (2.09%)
occurrences causally related to treatment / all	0 / 49	0 / 43
deaths causally related to treatment / all	0 / 1	0 / 0
Coronary artery disease
subjects affected / exposed	28 / 1768 (1.58%)	32 / 1769 (1.81%)
occurrences causally related to treatment / all	0 / 31	0 / 35
deaths causally related to treatment / all	0 / 1	0 / 3
Cardio-respiratory arrest
subjects affected / exposed	28 / 1768 (1.58%)	26 / 1769 (1.47%)
occurrences causally related to treatment / all	0 / 31	1 / 26
deaths causally related to treatment / all	0 / 22	0 / 23
Cardiac failure acute
subjects affected / exposed	18 / 1768 (1.02%)	26 / 1769 (1.47%)
occurrences causally related to treatment / all	0 / 22	0 / 29
deaths causally related to treatment / all	0 / 3	0 / 0
Acute left ventricular failure
subjects affected / exposed	13 / 1768 (0.74%)	23 / 1769 (1.30%)
occurrences causally related to treatment / all	0 / 20	0 / 25
deaths causally related to treatment / all	0 / 1	0 / 0
Cardiogenic shock
subjects affected / exposed	10 / 1768 (0.57%)	14 / 1769 (0.79%)
occurrences causally related to treatment / all	0 / 10	0 / 14
deaths causally related to treatment / all	0 / 4	0 / 9
Myocardial infarction
subjects affected / exposed	10 / 1768 (0.57%)	12 / 1769 (0.68%)
occurrences causally related to treatment / all	0 / 11	0 / 12
deaths causally related to treatment / all	0 / 3	0 / 3
Angina unstable
subjects affected / exposed	8 / 1768 (0.45%)	13 / 1769 (0.73%)
occurrences causally related to treatment / all	1 / 9	0 / 13
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac failure
subjects affected / exposed	9 / 1768 (0.51%)	11 / 1769 (0.62%)
occurrences causally related to treatment / all	0 / 9	0 / 11
deaths causally related to treatment / all	0 / 1	0 / 1
Angina pectoris
subjects affected / exposed	8 / 1768 (0.45%)	11 / 1769 (0.62%)
occurrences causally related to treatment / all	0 / 8	0 / 14
deaths causally related to treatment / all	0 / 0	0 / 0
Ventricular tachycardia
subjects affected / exposed	9 / 1768 (0.51%)	7 / 1769 (0.40%)
occurrences causally related to treatment / all	0 / 9	0 / 8
deaths causally related to treatment / all	0 / 1	0 / 2
Atrial flutter
subjects affected / exposed	6 / 1768 (0.34%)	9 / 1769 (0.51%)
occurrences causally related to treatment / all	0 / 7	0 / 9
deaths causally related to treatment / all	0 / 0	0 / 0
Bradycardia
subjects affected / exposed	4 / 1768 (0.23%)	11 / 1769 (0.62%)
occurrences causally related to treatment / all	0 / 4	0 / 12
deaths causally related to treatment / all	0 / 0	0 / 0
Pericardial effusion
subjects affected / exposed	2 / 1768 (0.11%)	12 / 1769 (0.68%)
occurrences causally related to treatment / all	0 / 3	0 / 13
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiopulmonary failure
subjects affected / exposed	8 / 1768 (0.45%)	5 / 1769 (0.28%)
occurrences causally related to treatment / all	0 / 8	0 / 5
deaths causally related to treatment / all	0 / 7	0 / 5
Left ventricular failure
subjects affected / exposed	4 / 1768 (0.23%)	7 / 1769 (0.40%)
occurrences causally related to treatment / all	0 / 4	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
Acute coronary syndrome
subjects affected / exposed	2 / 1768 (0.11%)	8 / 1769 (0.45%)
occurrences causally related to treatment / all	0 / 2	1 / 9
deaths causally related to treatment / all	0 / 0	0 / 0
Mitral valve incompetence
subjects affected / exposed	2 / 1768 (0.11%)	8 / 1769 (0.45%)
occurrences causally related to treatment / all	0 / 2	0 / 8
deaths causally related to treatment / all	0 / 0	0 / 0
Myocardial ischaemia
subjects affected / exposed	4 / 1768 (0.23%)	4 / 1769 (0.23%)
occurrences causally related to treatment / all	0 / 4	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 1
Pulseless electrical activity
subjects affected / exposed	4 / 1768 (0.23%)	3 / 1769 (0.17%)
occurrences causally related to treatment / all	0 / 4	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Ventricular fibrillation
subjects affected / exposed	3 / 1768 (0.17%)	4 / 1769 (0.23%)
occurrences causally related to treatment / all	0 / 3	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Arrhythmia
subjects affected / exposed	1 / 1768 (0.06%)	5 / 1769 (0.28%)
occurrences causally related to treatment / all	0 / 1	0 / 5
deaths causally related to treatment / all	0 / 1	0 / 2
Atrioventricular block complete
subjects affected / exposed	2 / 1768 (0.11%)	4 / 1769 (0.23%)
occurrences causally related to treatment / all	0 / 2	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Chronic left ventricular failure
subjects affected / exposed	3 / 1768 (0.17%)	3 / 1769 (0.17%)
occurrences causally related to treatment / all	0 / 3	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Supraventricular tachycardia
subjects affected / exposed	2 / 1768 (0.11%)	4 / 1769 (0.23%)
occurrences causally related to treatment / all	0 / 2	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Tachycardia
subjects affected / exposed	1 / 1768 (0.06%)	5 / 1769 (0.28%)
occurrences causally related to treatment / all	0 / 1	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac failure chronic
subjects affected / exposed	5 / 1768 (0.28%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 5	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Coronary artery stenosis
subjects affected / exposed	1 / 1768 (0.06%)	4 / 1769 (0.23%)
occurrences causally related to treatment / all	0 / 1	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Ischaemic cardiomyopathy
subjects affected / exposed	2 / 1768 (0.11%)	3 / 1769 (0.17%)
occurrences causally related to treatment / all	0 / 2	0 / 4
deaths causally related to treatment / all	0 / 1	0 / 2
Sinus node dysfunction
subjects affected / exposed	2 / 1768 (0.11%)	3 / 1769 (0.17%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Coronary artery occlusion
subjects affected / exposed	2 / 1768 (0.11%)	2 / 1769 (0.11%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 1
Pericarditis
subjects affected / exposed	1 / 1768 (0.06%)	3 / 1769 (0.17%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Tricuspid valve incompetence
subjects affected / exposed	3 / 1768 (0.17%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac tamponade
subjects affected / exposed	1 / 1768 (0.06%)	2 / 1769 (0.11%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 1	0 / 1
Congestive cardiomyopathy
subjects affected / exposed	1 / 1768 (0.06%)	2 / 1769 (0.11%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Palpitations
subjects affected / exposed	1 / 1768 (0.06%)	2 / 1769 (0.11%)
occurrences causally related to treatment / all	1 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Sinus tachycardia
subjects affected / exposed	3 / 1768 (0.17%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Aortic valve incompetence
subjects affected / exposed	2 / 1768 (0.11%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Arteriosclerosis coronary artery
subjects affected / exposed	0 / 1768 (0.00%)	2 / 1769 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 1
Atrial tachycardia
subjects affected / exposed	1 / 1768 (0.06%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Atrial thrombosis
subjects affected / exposed	1 / 1768 (0.06%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 1	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Atrioventricular block
subjects affected / exposed	1 / 1768 (0.06%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Atrioventricular block first degree
subjects affected / exposed	2 / 1768 (0.11%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Atrioventricular block second degree
subjects affected / exposed	1 / 1768 (0.06%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiomyopathy
subjects affected / exposed	0 / 1768 (0.00%)	2 / 1769 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 1
Coronary artery thrombosis
subjects affected / exposed	1 / 1768 (0.06%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Diastolic dysfunction
subjects affected / exposed	1 / 1768 (0.06%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Nodal arrhythmia
subjects affected / exposed	1 / 1768 (0.06%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hypertensive heart disease
subjects affected / exposed	1 / 1768 (0.06%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 1
Ventricular arrhythmia
subjects affected / exposed	1 / 1768 (0.06%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 1
Aortic valve disease
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Aortic valve stenosis
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Bradyarrhythmia
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Cardiac disorder
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac valve disease
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Cardiomegaly
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Cardiovascular disorder
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cor pulmonale
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Coronary artery insufficiency
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Dressler's syndrome
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Intracardiac mass
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Intracardiac thrombus
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Left ventricular hypertrophy
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Mitral valve calcification
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Mitral valve disease
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Myocarditis
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pericardial haemorrhage
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pericarditis uraemic
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Right ventricular failure
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Silent myocardial infarction
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Sinus bradycardia
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Stress cardiomyopathy
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Ventricular hypokinesia
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Nervous system disorders
Metabolic encephalopathy
subjects affected / exposed	20 / 1768 (1.13%)	25 / 1769 (1.41%)
occurrences causally related to treatment / all	0 / 22	0 / 26
deaths causally related to treatment / all	0 / 0	0 / 0
Syncope
subjects affected / exposed	22 / 1768 (1.24%)	18 / 1769 (1.02%)
occurrences causally related to treatment / all	0 / 24	0 / 20
deaths causally related to treatment / all	0 / 0	0 / 0
Cerebrovascular accident
subjects affected / exposed	14 / 1768 (0.79%)	16 / 1769 (0.90%)
occurrences causally related to treatment / all	1 / 15	3 / 16
deaths causally related to treatment / all	0 / 2	0 / 2
Encephalopathy
subjects affected / exposed	13 / 1768 (0.74%)	12 / 1769 (0.68%)
occurrences causally related to treatment / all	0 / 17	0 / 15
deaths causally related to treatment / all	0 / 2	0 / 0
Ischaemic stroke
subjects affected / exposed	13 / 1768 (0.74%)	12 / 1769 (0.68%)
occurrences causally related to treatment / all	0 / 13	0 / 12
deaths causally related to treatment / all	0 / 1	0 / 5
Seizure
subjects affected / exposed	6 / 1768 (0.34%)	14 / 1769 (0.79%)
occurrences causally related to treatment / all	0 / 6	0 / 18
deaths causally related to treatment / all	0 / 0	0 / 0
Transient ischaemic attack
subjects affected / exposed	15 / 1768 (0.85%)	5 / 1769 (0.28%)
occurrences causally related to treatment / all	1 / 15	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
Haemorrhagic stroke
subjects affected / exposed	3 / 1768 (0.17%)	7 / 1769 (0.40%)
occurrences causally related to treatment / all	0 / 3	0 / 7
deaths causally related to treatment / all	0 / 1	0 / 3
Hepatic encephalopathy
subjects affected / exposed	3 / 1768 (0.17%)	6 / 1769 (0.34%)
occurrences causally related to treatment / all	0 / 4	0 / 8
deaths causally related to treatment / all	0 / 0	0 / 1
Hypoxic-ischaemic encephalopathy
subjects affected / exposed	5 / 1768 (0.28%)	4 / 1769 (0.23%)
occurrences causally related to treatment / all	0 / 5	0 / 4
deaths causally related to treatment / all	0 / 2	0 / 1
Dizziness
subjects affected / exposed	4 / 1768 (0.23%)	4 / 1769 (0.23%)
occurrences causally related to treatment / all	0 / 4	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Cerebral haemorrhage
subjects affected / exposed	3 / 1768 (0.17%)	4 / 1769 (0.23%)
occurrences causally related to treatment / all	0 / 3	1 / 4
deaths causally related to treatment / all	0 / 2	0 / 1
Cerebral infarction
subjects affected / exposed	3 / 1768 (0.17%)	4 / 1769 (0.23%)
occurrences causally related to treatment / all	0 / 3	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Presyncope
subjects affected / exposed	2 / 1768 (0.11%)	5 / 1769 (0.28%)
occurrences causally related to treatment / all	0 / 2	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Carotid artery stenosis
subjects affected / exposed	1 / 1768 (0.06%)	5 / 1769 (0.28%)
occurrences causally related to treatment / all	0 / 1	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Haemorrhage intracranial
subjects affected / exposed	5 / 1768 (0.28%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 5	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 0
Hypertensive encephalopathy
subjects affected / exposed	3 / 1768 (0.17%)	3 / 1769 (0.17%)
occurrences causally related to treatment / all	0 / 3	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Brain injury
subjects affected / exposed	4 / 1768 (0.23%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 4	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Uraemic encephalopathy
subjects affected / exposed	3 / 1768 (0.17%)	2 / 1769 (0.11%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Status epilepticus
subjects affected / exposed	2 / 1768 (0.11%)	2 / 1769 (0.11%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Subarachnoid haemorrhage
subjects affected / exposed	0 / 1768 (0.00%)	4 / 1769 (0.23%)
occurrences causally related to treatment / all	0 / 0	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 1
Altered state of consciousness
subjects affected / exposed	3 / 1768 (0.17%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Brain hypoxia
subjects affected / exposed	1 / 1768 (0.06%)	2 / 1769 (0.11%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 1	0 / 1
Brain oedema
subjects affected / exposed	1 / 1768 (0.06%)	2 / 1769 (0.11%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Cerebellar infarction
subjects affected / exposed	2 / 1768 (0.11%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 0
Cerebral haematoma
subjects affected / exposed	1 / 1768 (0.06%)	2 / 1769 (0.11%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 1
Embolic stroke
subjects affected / exposed	1 / 1768 (0.06%)	2 / 1769 (0.11%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Generalised tonic-clonic seizure
subjects affected / exposed	1 / 1768 (0.06%)	2 / 1769 (0.11%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Hypoglycaemic encephalopathy
subjects affected / exposed	2 / 1768 (0.11%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 0
Lacunar infarction
subjects affected / exposed	0 / 1768 (0.00%)	3 / 1769 (0.17%)
occurrences causally related to treatment / all	0 / 0	1 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Coma
subjects affected / exposed	1 / 1768 (0.06%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Diabetic neuropathy
subjects affected / exposed	1 / 1768 (0.06%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Haemorrhagic cerebral infarction
subjects affected / exposed	1 / 1768 (0.06%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hypoglycaemic seizure
subjects affected / exposed	0 / 1768 (0.00%)	2 / 1769 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Myoclonus
subjects affected / exposed	0 / 1768 (0.00%)	2 / 1769 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Neurotoxicity
subjects affected / exposed	1 / 1768 (0.06%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Toxic encephalopathy
subjects affected / exposed	1 / 1768 (0.06%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Amnesia
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Amputation stump pain
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Basal ganglia infarction
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Carotid artery aneurysm
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Central nervous system lupus
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cerebellar stroke
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cerebral artery occlusion
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cerebral artery thrombosis
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cerebral microhaemorrhage
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cervical radiculopathy
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
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	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Dementia
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Diabetic hyperosmolar coma
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Dyskinesia
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Epilepsy
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Facial paralysis
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
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	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Guillain-Barre syndrome
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Headache
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hemiparesis
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hyperammonaemic encephalopathy
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
IIIrd nerve paralysis
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Jugular vein occlusion
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Lumbar radiculopathy
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Microvascular cranial nerve palsy
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Migraine
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Myelopathy
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Neuropathy peripheral
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Paraesthesia
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (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 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Post cardiac arrest syndrome
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Posterior reversible encephalopathy syndrome
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Postictal state
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Radiculopathy
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Spinal cord compression
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Trigeminal neuralgia
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Vasogenic cerebral oedema
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Vertebral artery stenosis
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Blood and lymphatic system disorders
Anaemia
subjects affected / exposed	35 / 1768 (1.98%)	37 / 1769 (2.09%)
occurrences causally related to treatment / all	2 / 38	0 / 40
deaths causally related to treatment / all	0 / 0	0 / 0
Blood loss anaemia
subjects affected / exposed	16 / 1768 (0.90%)	24 / 1769 (1.36%)
occurrences causally related to treatment / all	0 / 16	0 / 34
deaths causally related to treatment / all	0 / 0	0 / 0
Nephrogenic anaemia
subjects affected / exposed	6 / 1768 (0.34%)	2 / 1769 (0.11%)
occurrences causally related to treatment / all	0 / 8	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Pancytopenia
subjects affected / exposed	4 / 1768 (0.23%)	2 / 1769 (0.11%)
occurrences causally related to treatment / all	1 / 4	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Splenic infarction
subjects affected / exposed	1 / 1768 (0.06%)	2 / 1769 (0.11%)
occurrences causally related to treatment / all	0 / 1	1 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Leukocytosis
subjects affected / exposed	2 / 1768 (0.11%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Thrombocytopenia
subjects affected / exposed	0 / 1768 (0.00%)	2 / 1769 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Autoimmune haemolytic anaemia
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Bicytopenia
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Bone marrow failure
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Coagulopathy
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Disseminated intravascular coagulation
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Haemolytic uraemic syndrome
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Haemorrhagic diathesis
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Haemorrhagic disorder
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Iron deficiency anaemia
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Leukopenia
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Lymphadenopathy
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Macrocytosis
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Normocytic anaemia
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Splenic artery perforation
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Splenomegaly
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Thrombotic thrombocytopenic purpura
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Ear and labyrinth disorders
Vertigo
subjects affected / exposed	2 / 1768 (0.11%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Vertigo positional
subjects affected / exposed	1 / 1768 (0.06%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Eye disorders
Cataract
subjects affected / exposed	3 / 1768 (0.17%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Blindness
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Blindness unilateral
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Diabetic retinopathy
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Diplopia
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Mydriasis
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Optic ischaemic neuropathy
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Retinal artery thrombosis
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Uveitis
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Vitreous haemorrhage
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal disorders
Gastrointestinal haemorrhage
subjects affected / exposed	34 / 1768 (1.92%)	29 / 1769 (1.64%)
occurrences causally related to treatment / all	0 / 35	0 / 33
deaths causally related to treatment / all	0 / 3	0 / 2
Abdominal pain
subjects affected / exposed	8 / 1768 (0.45%)	12 / 1769 (0.68%)
occurrences causally related to treatment / all	0 / 8	0 / 13
deaths causally related to treatment / all	0 / 0	0 / 1
Pancreatitis acute
subjects affected / exposed	10 / 1768 (0.57%)	8 / 1769 (0.45%)
occurrences causally related to treatment / all	0 / 12	0 / 8
deaths causally related to treatment / all	0 / 0	0 / 0
Colitis
subjects affected / exposed	8 / 1768 (0.45%)	9 / 1769 (0.51%)
occurrences causally related to treatment / all	0 / 9	0 / 9
deaths causally related to treatment / all	0 / 0	0 / 0
Gastritis
subjects affected / exposed	9 / 1768 (0.51%)	8 / 1769 (0.45%)
occurrences causally related to treatment / all	2 / 9	0 / 9
deaths causally related to treatment / all	0 / 0	0 / 0
Upper gastrointestinal haemorrhage
subjects affected / exposed	5 / 1768 (0.28%)	12 / 1769 (0.68%)
occurrences causally related to treatment / all	1 / 5	0 / 12
deaths causally related to treatment / all	0 / 0	0 / 0
Small intestinal obstruction
subjects affected / exposed	7 / 1768 (0.40%)	9 / 1769 (0.51%)
occurrences causally related to treatment / all	0 / 7	0 / 11
deaths causally related to treatment / all	0 / 0	0 / 1
Diarrhoea
subjects affected / exposed	6 / 1768 (0.34%)	7 / 1769 (0.40%)
occurrences causally related to treatment / all	0 / 6	0 / 8
deaths causally related to treatment / all	0 / 0	0 / 0
Ascites
subjects affected / exposed	3 / 1768 (0.17%)	9 / 1769 (0.51%)
occurrences causally related to treatment / all	0 / 6	0 / 10
deaths causally related to treatment / all	0 / 0	0 / 0
Lower gastrointestinal haemorrhage
subjects affected / exposed	5 / 1768 (0.28%)	7 / 1769 (0.40%)
occurrences causally related to treatment / all	0 / 5	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
Impaired gastric emptying
subjects affected / exposed	6 / 1768 (0.34%)	5 / 1769 (0.28%)
occurrences causally related to treatment / all	0 / 23	0 / 11
deaths causally related to treatment / all	0 / 0	0 / 0
Intestinal ischaemia
subjects affected / exposed	8 / 1768 (0.45%)	3 / 1769 (0.17%)
occurrences causally related to treatment / all	0 / 8	0 / 3
deaths causally related to treatment / all	0 / 3	0 / 1
Pancreatitis
subjects affected / exposed	5 / 1768 (0.28%)	6 / 1769 (0.34%)
occurrences causally related to treatment / all	0 / 6	0 / 10
deaths causally related to treatment / all	0 / 0	0 / 0
Colitis ischaemic
subjects affected / exposed	5 / 1768 (0.28%)	5 / 1769 (0.28%)
occurrences causally related to treatment / all	0 / 5	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 2
Intestinal obstruction
subjects affected / exposed	7 / 1768 (0.40%)	2 / 1769 (0.11%)
occurrences causally related to treatment / all	0 / 7	0 / 2
deaths causally related to treatment / all	0 / 1	0 / 0
Constipation
subjects affected / exposed	6 / 1768 (0.34%)	2 / 1769 (0.11%)
occurrences causally related to treatment / all	0 / 6	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Duodenal ulcer
subjects affected / exposed	6 / 1768 (0.34%)	2 / 1769 (0.11%)
occurrences causally related to treatment / all	2 / 6	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Inguinal hernia
subjects affected / exposed	3 / 1768 (0.17%)	4 / 1769 (0.23%)
occurrences causally related to treatment / all	0 / 3	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Nausea
subjects affected / exposed	2 / 1768 (0.11%)	5 / 1769 (0.28%)
occurrences causally related to treatment / all	0 / 2	0 / 8
deaths causally related to treatment / all	0 / 0	0 / 0
Chronic gastritis
subjects affected / exposed	2 / 1768 (0.11%)	4 / 1769 (0.23%)
occurrences causally related to treatment / all	1 / 2	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Gastritis erosive
subjects affected / exposed	4 / 1768 (0.23%)	2 / 1769 (0.11%)
occurrences causally related to treatment / all	0 / 4	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Ileus
subjects affected / exposed	4 / 1768 (0.23%)	2 / 1769 (0.11%)
occurrences causally related to treatment / all	0 / 4	0 / 2
deaths causally related to treatment / all	0 / 1	0 / 0
Melaena
subjects affected / exposed	4 / 1768 (0.23%)	2 / 1769 (0.11%)
occurrences causally related to treatment / all	1 / 4	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Rectal haemorrhage
subjects affected / exposed	4 / 1768 (0.23%)	2 / 1769 (0.11%)
occurrences causally related to treatment / all	1 / 4	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Vomiting
subjects affected / exposed	3 / 1768 (0.17%)	3 / 1769 (0.17%)
occurrences causally related to treatment / all	0 / 3	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Abdominal pain upper
subjects affected / exposed	5 / 1768 (0.28%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 5	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Diabetic gastroparesis
subjects affected / exposed	2 / 1768 (0.11%)	3 / 1769 (0.17%)
occurrences causally related to treatment / all	0 / 7	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Duodenal ulcer haemorrhage
subjects affected / exposed	2 / 1768 (0.11%)	3 / 1769 (0.17%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrooesophageal reflux disease
subjects affected / exposed	1 / 1768 (0.06%)	4 / 1769 (0.23%)
occurrences causally related to treatment / all	0 / 2	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Haemorrhoidal haemorrhage
subjects affected / exposed	3 / 1768 (0.17%)	2 / 1769 (0.11%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Diverticular perforation
subjects affected / exposed	3 / 1768 (0.17%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 0
Faecaloma
subjects affected / exposed	2 / 1768 (0.11%)	2 / 1769 (0.11%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Haematochezia
subjects affected / exposed	0 / 1768 (0.00%)	4 / 1769 (0.23%)
occurrences causally related to treatment / all	0 / 0	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Haemorrhoids
subjects affected / exposed	3 / 1768 (0.17%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Peptic ulcer haemorrhage
subjects affected / exposed	2 / 1768 (0.11%)	2 / 1769 (0.11%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Peritoneal haemorrhage
subjects affected / exposed	3 / 1768 (0.17%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 0
Abdominal wall haematoma
subjects affected / exposed	3 / 1768 (0.17%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Enteritis
subjects affected / exposed	3 / 1768 (0.17%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gastric ulcer
subjects affected / exposed	2 / 1768 (0.11%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastric ulcer haemorrhage
subjects affected / exposed	0 / 1768 (0.00%)	3 / 1769 (0.17%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Gastritis haemorrhagic
subjects affected / exposed	2 / 1768 (0.11%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Hiatus hernia
subjects affected / exposed	0 / 1768 (0.00%)	3 / 1769 (0.17%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Intestinal haemorrhage
subjects affected / exposed	2 / 1768 (0.11%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 4	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pancreatitis chronic
subjects affected / exposed	3 / 1768 (0.17%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 4	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Peptic ulcer
subjects affected / exposed	3 / 1768 (0.17%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Abdominal distension
subjects affected / exposed	1 / 1768 (0.06%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Abdominal hernia obstructive
subjects affected / exposed	2 / 1768 (0.11%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Diverticulum
subjects affected / exposed	1 / 1768 (0.06%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Diverticulum intestinal haemorrhagic
subjects affected / exposed	1 / 1768 (0.06%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Duodenitis
subjects affected / exposed	0 / 1768 (0.00%)	2 / 1769 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Dysphagia
subjects affected / exposed	0 / 1768 (0.00%)	2 / 1769 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Erosive oesophagitis
subjects affected / exposed	2 / 1768 (0.11%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	1 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gastric antral vascular ectasia
subjects affected / exposed	0 / 1768 (0.00%)	2 / 1769 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Gastric ulcer perforation
subjects affected / exposed	2 / 1768 (0.11%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal necrosis
subjects affected / exposed	1 / 1768 (0.06%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Haematemesis
subjects affected / exposed	0 / 1768 (0.00%)	2 / 1769 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Haemorrhagic erosive gastritis
subjects affected / exposed	0 / 1768 (0.00%)	2 / 1769 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Ileus paralytic
subjects affected / exposed	1 / 1768 (0.06%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Incarcerated umbilical hernia
subjects affected / exposed	0 / 1768 (0.00%)	2 / 1769 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Intra-abdominal haematoma
subjects affected / exposed	1 / 1768 (0.06%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Obstructive pancreatitis
subjects affected / exposed	2 / 1768 (0.11%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Oesophageal ulcer
subjects affected / exposed	1 / 1768 (0.06%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Retroperitoneal haemorrhage
subjects affected / exposed	1 / 1768 (0.06%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Umbilical hernia
subjects affected / exposed	1 / 1768 (0.06%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Abdominal adhesions
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Abdominal discomfort
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Abdominal hernia
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
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	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Abdominal wall oedema
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Anal fissure
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Dental caries
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Diabetic gastropathy
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Dieulafoy's vascular malformation
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Diverticulum intestinal
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Duodenal polyp
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Dyspepsia
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Enterocolitis
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Epigastric discomfort
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal angiectasia
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal angiodysplasia
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal inflammation
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal vascular malformation haemorrhagic
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal wall thickening
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hypoaesthesia oral
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Ileal perforation
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Ileal ulcer
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Incarcerated inguinal hernia
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Inflammatory bowel disease
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Inguinal hernia, obstructive
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Intestinal infarction
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Intestinal perforation
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (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 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Intra-abdominal fluid collection
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Intussusception
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
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	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Large intestinal obstruction
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Large intestinal ulcer
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Large intestinal ulcer haemorrhage
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Large intestine perforation
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Mesenteric vein thrombosis
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Oesophageal motility disorder
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Oesophagitis ulcerative
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pancreatic duct dilatation
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pancreatitis necrotising
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Pneumoperitoneum
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Portal hypertensive gastropathy
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Rectal polyp
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Rectal ulcer
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Rectal ulcer haemorrhage
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Retroperitoneal haematoma
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (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 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Subileus
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Thrombosis mesenteric vessel
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Uraemic gastropathy
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Varices oesophageal
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Skin and subcutaneous tissue disorders
Diabetic foot
subjects affected / exposed	7 / 1768 (0.40%)	12 / 1769 (0.68%)
occurrences causally related to treatment / all	0 / 7	0 / 14
deaths causally related to treatment / all	0 / 0	0 / 0
Skin ulcer
subjects affected / exposed	4 / 1768 (0.23%)	7 / 1769 (0.40%)
occurrences causally related to treatment / all	0 / 4	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
Decubitus ulcer
subjects affected / exposed	4 / 1768 (0.23%)	4 / 1769 (0.23%)
occurrences causally related to treatment / all	0 / 4	0 / 4
deaths causally related to treatment / all	0 / 1	0 / 0
Angioedema
subjects affected / exposed	1 / 1768 (0.06%)	3 / 1769 (0.17%)
occurrences causally related to treatment / all	0 / 1	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Diabetic ulcer
subjects affected / exposed	1 / 1768 (0.06%)	3 / 1769 (0.17%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Skin necrosis
subjects affected / exposed	1 / 1768 (0.06%)	3 / 1769 (0.17%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Ischaemic skin ulcer
subjects affected / exposed	1 / 1768 (0.06%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Blister
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cutaneous vasculitis
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Dermatitis contact
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hidradenitis
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Stevens-Johnson syndrome
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Urticaria
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Renal and urinary disorders
End stage renal disease
subjects affected / exposed	15 / 1768 (0.85%)	9 / 1769 (0.51%)
occurrences causally related to treatment / all	0 / 15	0 / 9
deaths causally related to treatment / all	0 / 11	0 / 6
Azotaemia
subjects affected / exposed	10 / 1768 (0.57%)	5 / 1769 (0.28%)
occurrences causally related to treatment / all	0 / 10	0 / 5
deaths causally related to treatment / all	0 / 4	0 / 1
Acute kidney injury
subjects affected / exposed	4 / 1768 (0.23%)	3 / 1769 (0.17%)
occurrences causally related to treatment / all	0 / 4	0 / 3
deaths causally related to treatment / all	0 / 1	0 / 0
Haematuria
subjects affected / exposed	2 / 1768 (0.11%)	4 / 1769 (0.23%)
occurrences causally related to treatment / all	0 / 2	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Chronic kidney disease
subjects affected / exposed	3 / 1768 (0.17%)	2 / 1769 (0.11%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 2	0 / 2
Nephrolithiasis
subjects affected / exposed	2 / 1768 (0.11%)	1 / 1769 (0.06%)
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	2 / 1768 (0.11%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hydronephrosis
subjects affected / exposed	1 / 1768 (0.06%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Renal failure
subjects affected / exposed	1 / 1768 (0.06%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 1
Tubulointerstitial nephritis
subjects affected / exposed	1 / 1768 (0.06%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Urethral stenosis
subjects affected / exposed	1 / 1768 (0.06%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cystitis haemorrhagic
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Neurogenic bladder
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Renal cyst ruptured
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Renal haemorrhage
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Renal impairment
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Renal infarct
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Renal mass
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Renal tubular necrosis
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (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 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Urinary bladder rupture
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Endocrine disorders
Hyperparathyroidism
subjects affected / exposed	3 / 1768 (0.17%)	2 / 1769 (0.11%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Hyperparathyroidism secondary
subjects affected / exposed	2 / 1768 (0.11%)	3 / 1769 (0.17%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Hyperthyroidism
subjects affected / exposed	2 / 1768 (0.11%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hyperparathyroidism tertiary
subjects affected / exposed	2 / 1768 (0.11%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Adrenal mass
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hypothyroidism
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Thyroid mass
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Musculoskeletal and connective tissue disorders
Back pain
subjects affected / exposed	5 / 1768 (0.28%)	9 / 1769 (0.51%)
occurrences causally related to treatment / all	0 / 5	0 / 9
deaths causally related to treatment / all	0 / 0	0 / 0
Musculoskeletal chest pain
subjects affected / exposed	5 / 1768 (0.28%)	7 / 1769 (0.40%)
occurrences causally related to treatment / all	0 / 5	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
Pain in extremity
subjects affected / exposed	7 / 1768 (0.40%)	4 / 1769 (0.23%)
occurrences causally related to treatment / all	0 / 7	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Osteoarthritis
subjects affected / exposed	5 / 1768 (0.28%)	4 / 1769 (0.23%)
occurrences causally related to treatment / all	0 / 6	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Muscular weakness
subjects affected / exposed	1 / 1768 (0.06%)	4 / 1769 (0.23%)
occurrences causally related to treatment / all	0 / 1	1 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Musculoskeletal pain
subjects affected / exposed	3 / 1768 (0.17%)	2 / 1769 (0.11%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Lumbar spinal stenosis
subjects affected / exposed	1 / 1768 (0.06%)	3 / 1769 (0.17%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Myositis
subjects affected / exposed	1 / 1768 (0.06%)	3 / 1769 (0.17%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Flank pain
subjects affected / exposed	1 / 1768 (0.06%)	2 / 1769 (0.11%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Arthralgia
subjects affected / exposed	2 / 1768 (0.11%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cervical spinal stenosis
subjects affected / exposed	1 / 1768 (0.06%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Myopathy
subjects affected / exposed	1 / 1768 (0.06%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Neck pain
subjects affected / exposed	1 / 1768 (0.06%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Neuropathic arthropathy
subjects affected / exposed	1 / 1768 (0.06%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Osteitis
subjects affected / exposed	1 / 1768 (0.06%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Osteonecrosis
subjects affected / exposed	2 / 1768 (0.11%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Spinal osteoarthritis
subjects affected / exposed	2 / 1768 (0.11%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Spinal stenosis
subjects affected / exposed	1 / 1768 (0.06%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Vertebral foraminal stenosis
subjects affected / exposed	2 / 1768 (0.11%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Arthritis
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Bone metabolism disorder
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Bursitis
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Chondrocalcinosis pyrophosphate
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Chronic kidney disease-mineral and bone disorder
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Compartment syndrome
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Costochondritis
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Fracture nonunion
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gouty arthritis
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Haemarthrosis
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Haematoma muscle
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hungry bone syndrome
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Intervertebral disc degeneration
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Intervertebral disc protrusion
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Osteochondrosis
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Osteoporosis
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pain in jaw
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Rhabdomyolysis
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Spondylolysis
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Systemic lupus erythematosus
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Trigger finger
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Infections and infestations
Pneumonia
subjects affected / exposed	140 / 1768 (7.92%)	119 / 1769 (6.73%)
occurrences causally related to treatment / all	0 / 180	0 / 142
deaths causally related to treatment / all	0 / 5	0 / 6
Sepsis
subjects affected / exposed	76 / 1768 (4.30%)	88 / 1769 (4.97%)
occurrences causally related to treatment / all	0 / 83	0 / 96
deaths causally related to treatment / all	0 / 13	0 / 13
Septic shock
subjects affected / exposed	44 / 1768 (2.49%)	45 / 1769 (2.54%)
occurrences causally related to treatment / all	0 / 46	0 / 47
deaths causally related to treatment / all	0 / 23	0 / 21
Cellulitis
subjects affected / exposed	43 / 1768 (2.43%)	38 / 1769 (2.15%)
occurrences causally related to treatment / all	0 / 47	0 / 41
deaths causally related to treatment / all	0 / 0	0 / 0
Osteomyelitis
subjects affected / exposed	31 / 1768 (1.75%)	39 / 1769 (2.20%)
occurrences causally related to treatment / all	0 / 35	0 / 47
deaths causally related to treatment / all	0 / 0	0 / 1
Peritonitis
subjects affected / exposed	21 / 1768 (1.19%)	32 / 1769 (1.81%)
occurrences causally related to treatment / all	0 / 22	0 / 35
deaths causally related to treatment / all	0 / 0	0 / 1
Device related infection
subjects affected / exposed	25 / 1768 (1.41%)	23 / 1769 (1.30%)
occurrences causally related to treatment / all	0 / 25	0 / 24
deaths causally related to treatment / all	0 / 0	0 / 1
Gangrene
subjects affected / exposed	24 / 1768 (1.36%)	23 / 1769 (1.30%)
occurrences causally related to treatment / all	0 / 31	0 / 26
deaths causally related to treatment / all	0 / 1	0 / 0
Urinary tract infection
subjects affected / exposed	15 / 1768 (0.85%)	32 / 1769 (1.81%)
occurrences causally related to treatment / all	0 / 18	0 / 36
deaths causally related to treatment / all	0 / 0	0 / 0
Influenza
subjects affected / exposed	20 / 1768 (1.13%)	15 / 1769 (0.85%)
occurrences causally related to treatment / all	0 / 21	0 / 15
deaths causally related to treatment / all	0 / 0	0 / 0
Staphylococcal sepsis
subjects affected / exposed	16 / 1768 (0.90%)	18 / 1769 (1.02%)
occurrences causally related to treatment / all	0 / 16	0 / 20
deaths causally related to treatment / all	0 / 2	0 / 1
Staphylococcal bacteraemia
subjects affected / exposed	17 / 1768 (0.96%)	15 / 1769 (0.85%)
occurrences causally related to treatment / all	0 / 19	0 / 17
deaths causally related to treatment / all	0 / 0	0 / 0
Bronchitis
subjects affected / exposed	12 / 1768 (0.68%)	19 / 1769 (1.07%)
occurrences causally related to treatment / all	0 / 12	0 / 19
deaths causally related to treatment / all	0 / 0	0 / 0
Arteriovenous graft site infection
subjects affected / exposed	8 / 1768 (0.45%)	14 / 1769 (0.79%)
occurrences causally related to treatment / all	0 / 9	0 / 17
deaths causally related to treatment / all	0 / 0	0 / 0
Gastroenteritis
subjects affected / exposed	8 / 1768 (0.45%)	14 / 1769 (0.79%)
occurrences causally related to treatment / all	0 / 9	0 / 14
deaths causally related to treatment / all	0 / 0	0 / 1
Bacteraemia
subjects affected / exposed	9 / 1768 (0.51%)	11 / 1769 (0.62%)
occurrences causally related to treatment / all	0 / 9	0 / 11
deaths causally related to treatment / all	0 / 0	0 / 0
Endocarditis
subjects affected / exposed	5 / 1768 (0.28%)	15 / 1769 (0.85%)
occurrences causally related to treatment / all	0 / 5	0 / 17
deaths causally related to treatment / all	0 / 0	0 / 3
Arteriovenous fistula site infection
subjects affected / exposed	12 / 1768 (0.68%)	7 / 1769 (0.40%)
occurrences causally related to treatment / all	0 / 14	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
Clostridium difficile colitis
subjects affected / exposed	7 / 1768 (0.40%)	12 / 1769 (0.68%)
occurrences causally related to treatment / all	0 / 7	0 / 12
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumonia bacterial
subjects affected / exposed	7 / 1768 (0.40%)	12 / 1769 (0.68%)
occurrences causally related to treatment / all	0 / 7	0 / 12
deaths causally related to treatment / all	0 / 0	0 / 0
Diverticulitis
subjects affected / exposed	9 / 1768 (0.51%)	10 / 1769 (0.57%)
occurrences causally related to treatment / all	0 / 12	0 / 11
deaths causally related to treatment / all	0 / 0	0 / 0
Postoperative wound infection
subjects affected / exposed	5 / 1768 (0.28%)	13 / 1769 (0.73%)
occurrences causally related to treatment / all	0 / 5	0 / 14
deaths causally related to treatment / all	0 / 0	0 / 1
Device related sepsis
subjects affected / exposed	7 / 1768 (0.40%)	7 / 1769 (0.40%)
occurrences causally related to treatment / all	0 / 7	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
Abscess limb
subjects affected / exposed	7 / 1768 (0.40%)	6 / 1769 (0.34%)
occurrences causally related to treatment / all	0 / 7	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Diabetic foot infection
subjects affected / exposed	3 / 1768 (0.17%)	8 / 1769 (0.45%)
occurrences causally related to treatment / all	0 / 4	0 / 8
deaths causally related to treatment / all	0 / 0	0 / 0
Catheter site infection
subjects affected / exposed	4 / 1768 (0.23%)	6 / 1769 (0.34%)
occurrences causally related to treatment / all	0 / 4	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Localised infection
subjects affected / exposed	5 / 1768 (0.28%)	5 / 1769 (0.28%)
occurrences causally related to treatment / all	0 / 5	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Wound infection
subjects affected / exposed	5 / 1768 (0.28%)	5 / 1769 (0.28%)
occurrences causally related to treatment / all	0 / 5	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Appendicitis
subjects affected / exposed	4 / 1768 (0.23%)	5 / 1769 (0.28%)
occurrences causally related to treatment / all	0 / 4	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Staphylococcal infection
subjects affected / exposed	4 / 1768 (0.23%)	5 / 1769 (0.28%)
occurrences causally related to treatment / all	0 / 4	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 1
Cytomegalovirus infection
subjects affected / exposed	3 / 1768 (0.17%)	4 / 1769 (0.23%)
occurrences causally related to treatment / all	0 / 3	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Osteomyelitis acute
subjects affected / exposed	1 / 1768 (0.06%)	6 / 1769 (0.34%)
occurrences causally related to treatment / all	0 / 1	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Peritonitis bacterial
subjects affected / exposed	3 / 1768 (0.17%)	4 / 1769 (0.23%)
occurrences causally related to treatment / all	0 / 4	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Urosepsis
subjects affected / exposed	1 / 1768 (0.06%)	6 / 1769 (0.34%)
occurrences causally related to treatment / all	0 / 1	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 1
Arthritis bacterial
subjects affected / exposed	2 / 1768 (0.11%)	4 / 1769 (0.23%)
occurrences causally related to treatment / all	0 / 2	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Fungal peritonitis
subjects affected / exposed	3 / 1768 (0.17%)	3 / 1769 (0.17%)
occurrences causally related to treatment / all	0 / 3	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Gastroenteritis viral
subjects affected / exposed	3 / 1768 (0.17%)	2 / 1769 (0.11%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Infected skin ulcer
subjects affected / exposed	3 / 1768 (0.17%)	2 / 1769 (0.11%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Pyelonephritis
subjects affected / exposed	2 / 1768 (0.11%)	3 / 1769 (0.17%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Streptococcal bacteraemia
subjects affected / exposed	2 / 1768 (0.11%)	3 / 1769 (0.17%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Subcutaneous abscess
subjects affected / exposed	3 / 1768 (0.17%)	2 / 1769 (0.11%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Upper respiratory tract infection
subjects affected / exposed	1 / 1768 (0.06%)	4 / 1769 (0.23%)
occurrences causally related to treatment / all	0 / 1	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Bronchitis viral
subjects affected / exposed	3 / 1768 (0.17%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Enterococcal bacteraemia
subjects affected / exposed	1 / 1768 (0.06%)	3 / 1769 (0.17%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Gas gangrene
subjects affected / exposed	0 / 1768 (0.00%)	4 / 1769 (0.23%)
occurrences causally related to treatment / all	0 / 0	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Intervertebral discitis
subjects affected / exposed	2 / 1768 (0.11%)	2 / 1769 (0.11%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Large intestine infection
subjects affected / exposed	2 / 1768 (0.11%)	2 / 1769 (0.11%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Lower respiratory tract infection
subjects affected / exposed	1 / 1768 (0.06%)	3 / 1769 (0.17%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumonia viral
subjects affected / exposed	2 / 1768 (0.11%)	2 / 1769 (0.11%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Pseudomonal bacteraemia
subjects affected / exposed	2 / 1768 (0.11%)	2 / 1769 (0.11%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Vascular access site infection
subjects affected / exposed	0 / 1768 (0.00%)	4 / 1769 (0.23%)
occurrences causally related to treatment / all	0 / 0	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Viral infection
subjects affected / exposed	3 / 1768 (0.17%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Abdominal abscess
subjects affected / exposed	1 / 1768 (0.06%)	2 / 1769 (0.11%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Acute hepatitis B
subjects affected / exposed	2 / 1768 (0.11%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Bacterial sepsis
subjects affected / exposed	2 / 1768 (0.11%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Candida infection
subjects affected / exposed	1 / 1768 (0.06%)	2 / 1769 (0.11%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Cholecystitis infective
subjects affected / exposed	2 / 1768 (0.11%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Clostridium difficile infection
subjects affected / exposed	0 / 1768 (0.00%)	3 / 1769 (0.17%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Diabetic gangrene
subjects affected / exposed	0 / 1768 (0.00%)	3 / 1769 (0.17%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Endocarditis bacterial
subjects affected / exposed	2 / 1768 (0.11%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Endocarditis staphylococcal
subjects affected / exposed	1 / 1768 (0.06%)	2 / 1769 (0.11%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Escherichia bacteraemia
subjects affected / exposed	3 / 1768 (0.17%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Infection
subjects affected / exposed	2 / 1768 (0.11%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Otitis externa
subjects affected / exposed	2 / 1768 (0.11%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumonia influenzal
subjects affected / exposed	1 / 1768 (0.06%)	2 / 1769 (0.11%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Pyelonephritis acute
subjects affected / exposed	2 / 1768 (0.11%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Sinusitis
subjects affected / exposed	1 / 1768 (0.06%)	2 / 1769 (0.11%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Soft tissue infection
subjects affected / exposed	1 / 1768 (0.06%)	2 / 1769 (0.11%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Staphylococcal abscess
subjects affected / exposed	2 / 1768 (0.11%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Tooth abscess
subjects affected / exposed	2 / 1768 (0.11%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Tracheobronchitis
subjects affected / exposed	3 / 1768 (0.17%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Adenovirus infection
subjects affected / exposed	1 / 1768 (0.06%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Arthritis infective
subjects affected / exposed	1 / 1768 (0.06%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Atypical pneumonia
subjects affected / exposed	0 / 1768 (0.00%)	2 / 1769 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 1
Breast abscess
subjects affected / exposed	0 / 1768 (0.00%)	2 / 1769 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Catheter site abscess
subjects affected / exposed	1 / 1768 (0.06%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cellulitis staphylococcal
subjects affected / exposed	2 / 1768 (0.11%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Chronic hepatitis B
subjects affected / exposed	2 / 1768 (0.11%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	1 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cystitis
subjects affected / exposed	1 / 1768 (0.06%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Empyema
subjects affected / exposed	1 / 1768 (0.06%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Enterococcal infection
subjects affected / exposed	1 / 1768 (0.06%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Enterococcal sepsis
subjects affected / exposed	0 / 1768 (0.00%)	2 / 1769 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Escherichia pyelonephritis
subjects affected / exposed	1 / 1768 (0.06%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Escherichia sepsis
subjects affected / exposed	2 / 1768 (0.11%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gastroenteritis bacterial
subjects affected / exposed	1 / 1768 (0.06%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Graft infection
subjects affected / exposed	1 / 1768 (0.06%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Herpes zoster
subjects affected / exposed	1 / 1768 (0.06%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Infectious pleural effusion
subjects affected / exposed	0 / 1768 (0.00%)	2 / 1769 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Klebsiella infection
subjects affected / exposed	1 / 1768 (0.06%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Meningitis
subjects affected / exposed	2 / 1768 (0.11%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Orchitis
subjects affected / exposed	2 / 1768 (0.11%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Perineal abscess
subjects affected / exposed	2 / 1768 (0.11%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumonia klebsiella
subjects affected / exposed	1 / 1768 (0.06%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumonia necrotising
subjects affected / exposed	1 / 1768 (0.06%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Pneumonia serratia
subjects affected / exposed	1 / 1768 (0.06%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Post procedural cellulitis
subjects affected / exposed	1 / 1768 (0.06%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pseudomonas infection
subjects affected / exposed	1 / 1768 (0.06%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pyelonephritis chronic
subjects affected / exposed	1 / 1768 (0.06%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Renal graft infection
subjects affected / exposed	1 / 1768 (0.06%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Respiratory tract infection
subjects affected / exposed	0 / 1768 (0.00%)	2 / 1769 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 1
Scrotal abscess
subjects affected / exposed	2 / 1768 (0.11%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Staphylococcal osteomyelitis
subjects affected / exposed	0 / 1768 (0.00%)	2 / 1769 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 1
Streptococcal sepsis
subjects affected / exposed	0 / 1768 (0.00%)	2 / 1769 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Tooth infection
subjects affected / exposed	1 / 1768 (0.06%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Vascular device infection
subjects affected / exposed	2 / 1768 (0.11%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Viral upper respiratory tract infection
subjects affected / exposed	1 / 1768 (0.06%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Vulval abscess
subjects affected / exposed	1 / 1768 (0.06%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Wound infection staphylococcal
subjects affected / exposed	1 / 1768 (0.06%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Abdominal sepsis
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Abscess
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Abscess jaw
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Abscess neck
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Achromobacter infection
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Acute sinusitis
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
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	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Appendicitis perforated
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Atypical mycobacterial pneumonia
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Bacterial diarrhoea
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (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 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Bacteriuria
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Bone abscess
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Bone tuberculosis
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Bronchitis bacterial
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Bullous impetigo
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Candida sepsis
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Carbuncle
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cellulitis gangrenous
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cerebral septic infarct
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Colonic abscess
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Conjunctivitis
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Corona virus infection
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cystitis klebsiella
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Diverticulitis intestinal haemorrhagic
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Ear infection
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Emphysematous cholecystitis
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Encephalitis
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Enterobacter sepsis
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Epididymitis
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Erysipelas
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Extradural abscess
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Fournier's gangrene
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Furuncle
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal bacterial overgrowth
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal viral infection
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Genital herpes
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Giardiasis
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Groin infection
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Implant site cellulitis
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Incision site abscess
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Infected seroma
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Klebsiella sepsis
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Labyrinthitis
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Mastoiditis
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Mediastinitis
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Meningitis viral
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Mycobacterium fortuitum infection
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Necrotising fasciitis
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Oesophageal candidiasis
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Oral candidiasis
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Osteomyelitis bacterial
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Osteomyelitis chronic
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Otitis media
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Paraspinal abscess
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pelvic abscess
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Perinephric abscess
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Periorbital cellulitis
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Perirectal abscess
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Peritoneal abscess
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Peritonsillar abscess
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
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 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pharyngitis
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pharyngitis streptococcal
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumonia cytomegaloviral
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumonia haemophilus
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumonia moraxella
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumonia mycoplasmal
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumonia pneumococcal
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumonia pseudomonal
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumonia staphylococcal
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Post procedural sepsis
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pseudomembranous colitis
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pseudomonas peritonitis
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Pulmonary sepsis
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
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 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pyuria
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Renal abscess
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Respiratory syncytial virus bronchitis
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Retroperitoneal abscess
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Rhinovirus infection
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Rhodococcus infection
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Septic embolus
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Septic encephalopathy
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Sialoadenitis
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Splenic infection
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Staphylococcal skin infection
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Systemic infection
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Testicular abscess
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Tracheitis
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Tracheobronchitis viral
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Transplant abscess
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (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 bacterial
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Vessel puncture site infection
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Viral diarrhoea
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Viral sepsis
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Metabolism and nutrition disorders
Fluid overload
subjects affected / exposed	98 / 1768 (5.54%)	98 / 1769 (5.54%)
occurrences causally related to treatment / all	0 / 138	0 / 132
deaths causally related to treatment / all	0 / 0	0 / 0
Hyperkalaemia
subjects affected / exposed	55 / 1768 (3.11%)	76 / 1769 (4.30%)
occurrences causally related to treatment / all	1 / 60	1 / 89
deaths causally related to treatment / all	0 / 2	0 / 2
Hypoglycaemia
subjects affected / exposed	22 / 1768 (1.24%)	18 / 1769 (1.02%)
occurrences causally related to treatment / all	0 / 23	0 / 19
deaths causally related to treatment / all	0 / 0	0 / 0
Hyperglycaemia
subjects affected / exposed	6 / 1768 (0.34%)	6 / 1769 (0.34%)
occurrences causally related to treatment / all	0 / 7	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Hyponatraemia
subjects affected / exposed	6 / 1768 (0.34%)	6 / 1769 (0.34%)
occurrences causally related to treatment / all	0 / 6	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Hypervolaemia
subjects affected / exposed	5 / 1768 (0.28%)	6 / 1769 (0.34%)
occurrences causally related to treatment / all	0 / 6	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Diabetic ketoacidosis
subjects affected / exposed	5 / 1768 (0.28%)	5 / 1769 (0.28%)
occurrences causally related to treatment / all	0 / 5	0 / 6
deaths causally related to treatment / all	0 / 1	0 / 0
Hypocalcaemia
subjects affected / exposed	6 / 1768 (0.34%)	3 / 1769 (0.17%)
occurrences causally related to treatment / all	0 / 8	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Hypokalaemia
subjects affected / exposed	3 / 1768 (0.17%)	4 / 1769 (0.23%)
occurrences causally related to treatment / all	0 / 3	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Lactic acidosis
subjects affected / exposed	2 / 1768 (0.11%)	2 / 1769 (0.11%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Calciphylaxis
subjects affected / exposed	2 / 1768 (0.11%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Malnutrition
subjects affected / exposed	2 / 1768 (0.11%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 0
Dehydration
subjects affected / exposed	2 / 1768 (0.11%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Diabetes mellitus inadequate control
subjects affected / exposed	0 / 1768 (0.00%)	2 / 1769 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 1
Failure to thrive
subjects affected / exposed	1 / 1768 (0.06%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Metabolic acidosis
subjects affected / exposed	1 / 1768 (0.06%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Obesity
subjects affected / exposed	2 / 1768 (0.11%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Diabetes mellitus
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Haemosiderosis
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hyperglycaemic hyperosmolar nonketotic syndrome
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hyperphosphataemia
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hypomagnesaemia
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hypovolaemia
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Metabolic disorder
subjects affected / exposed	0 / 1768 (0.00%)	1 / 1769 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Type 2 diabetes mellitus
subjects affected / exposed	1 / 1768 (0.06%)	0 / 1769 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0

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

Non-serious adverse events	Vadadustat	Darbepoetin Alfa
Total subjects affected by non serious adverse events
subjects affected / exposed	964 / 1768 (54.52%)	993 / 1769 (56.13%)
Injury, poisoning and procedural complications
Fall
subjects affected / exposed	136 / 1768 (7.69%)	144 / 1769 (8.14%)
occurrences all number	184	201
Dialysis related complication
subjects affected / exposed	99 / 1768 (5.60%)	122 / 1769 (6.90%)
occurrences all number	141	224
Arteriovenous fistula site complication
subjects affected / exposed	80 / 1768 (4.52%)	107 / 1769 (6.05%)
occurrences all number	134	144
Vascular disorders
Hypertension
subjects affected / exposed	175 / 1768 (9.90%)	232 / 1769 (13.11%)
occurrences all number	219	300
Hypotension
subjects affected / exposed	124 / 1768 (7.01%)	119 / 1769 (6.73%)
occurrences all number	188	170
Nervous system disorders
Headache
subjects affected / exposed	160 / 1768 (9.05%)	134 / 1769 (7.57%)
occurrences all number	331	207
Gastrointestinal disorders
Diarrhoea
subjects affected / exposed	226 / 1768 (12.78%)	173 / 1769 (9.78%)
occurrences all number	264	219
Nausea
subjects affected / exposed	148 / 1768 (8.37%)	131 / 1769 (7.41%)
occurrences all number	190	161
Vomiting
subjects affected / exposed	119 / 1768 (6.73%)	123 / 1769 (6.95%)
occurrences all number	142	150
Respiratory, thoracic and mediastinal disorders
Cough
subjects affected / exposed	99 / 1768 (5.60%)	120 / 1769 (6.78%)
occurrences all number	124	143
Dyspnoea
subjects affected / exposed	79 / 1768 (4.47%)	111 / 1769 (6.27%)
occurrences all number	94	133
Musculoskeletal and connective tissue disorders
Pain in extremity
subjects affected / exposed	84 / 1768 (4.75%)	113 / 1769 (6.39%)
occurrences all number	110	132
Back pain
subjects affected / exposed	71 / 1768 (4.02%)	92 / 1769 (5.20%)
occurrences all number	89	110
Infections and infestations
Upper respiratory tract infection
subjects affected / exposed	98 / 1768 (5.54%)	108 / 1769 (6.11%)
occurrences all number	118	123
Urinary tract infection
subjects affected / exposed	100 / 1768 (5.66%)	93 / 1769 (5.26%)
occurrences all number	114	135
Nasopharyngitis
subjects affected / exposed	92 / 1768 (5.20%)	84 / 1769 (4.75%)
occurrences all number	131	108
Metabolism and nutrition disorders
Hyperkalaemia
subjects affected / exposed	123 / 1768 (6.96%)	137 / 1769 (7.74%)
occurrences all number	148	159

More information

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Were there any global substantial amendments to the protocol? Yes

07 Jun 2017

• Updated the study design from the current screening period of up to 4 weeks to up to 8 weeks and allowed iron, vitamin B12, and folate supplementation as needed during the screening period. o Screening period changed from up to 4 weeks to up to 8 weeks. o One retest was allowed for each laboratory parameter, within the screening period. o Subjects who received iron replacement therapy may have had a retest screening hemoglobin (Hb) a minimum of 3 weeks after completion of iron replacement therapy. • Updated Exclusion Criteria • Vadadustat dosing and dose adjustment guidelines were updated to clarify that subjects who received 1 tablet of dosing prior to interruption resumed treatment with 1 tablet after interruption. • Updated to reflect information from recently completed studies. • Section 6.4.1 (Executive Steering Committee) details were added. • To clarify darbepoetin alfa administration and accountability, the following details were added: o Darbepoetin alfa was administered per the label; o Darbepoetin alfa doses may have been self-administered or administered by health care professional at the clinics, site facility, or at subject’s home according to the investigator’s determination and local practice; o Added additional information on return of darbepoetin alfa for drug accountability and compliance assessment. • Section 9.2.2 (Laboratory Evaluations) was revised to reflect the following: o Modification to the frequency of protocol-specified biomarker sample collection. o Additional exploratory sample collection. • Section 11.2 (Study Analysis Populations) clarified the study analysis populations.

18 Jan 2018

• Updated to reflect information from recently completed studies and for alignment with vadadustat Investigator’s Brochure. • Updated to reflect addition of endpoints in alignment with the Statistical Analysis Plan. • Updated with an increase in enrollment number. • Section 7.4.1 Retesting was updated for simplification. • Updated to add Lack of Efficacy as a reason for permanent discontinuation of study drug or study participation. • Clarified that all enrolled subjects in this study will have completed (at least) the Week 36 visit. • Revised to guide investigators to follow printed dose adjustment algorithms. • Updated to align with published guidelines to prescribe iron supplementation and for initiation of ESA rescue. • Updated to specify a dosing compliance range of 80% to 120%. • Updated to clarify that if the screening period was less than 30 days, all medications taken within 30 days prior to first dose of study drug were to be recorded. • Updated to require monthly monitoring of Hb drawn as part of local standard of care or via an unscheduled visit. • Updated to require that all new and recurrent malignancies (with a few exceptions) be reported as serious adverse events (SAEs) to standardize reporting. • Updated to define overdose of study drugs. • Updated to reflect a change in the non inferiority margin from -0.5 to -1.0 g/dL. • Updated with enrollment projections and median study drug exposure times. • Updated definition of missing data updated to align with the SAP. • Updated to prespecify key subgroups for subsequent analysis. • Updated to provide AE summaries for specific subgroups.

13 Sep 2018

• Revised subject numbering. • Clarified that all enrolled subjects were to be allowed to complete the primary efficacy period prior to global study completion. • Clarified procedures at time of global study completion. • Emphasized subjects to be followed through global study completion. • Stated that if study drug was temporarily interrupted for more than 60 days, the Medical Monitor had to be contacted before resuming study drug. • End of Treatment/Follow-up visits to be performed at the time of permanent discontinuation of study drug. • Updated to reflect all options that had to be considered by the investigator before a subject withdrew consent and all options available to the investigator to follow subjects that permanently discontinued study drug. • Detailed steps to identify subjects lost to follow-up. • Updated with information for which the study teams will remain blinded. • Clarified restarting of study drug after ESA rescue/red blood cell transfusion. • Provided clarity on study drug dosing following ESA administration. • Provided guidance on how to manage the concomitant use of statins with vadadustat. • Included details for AE collection. • Included detail on managing subjects that permanently stop study medication during the study. • Defined the End of Study assessments that documented subject status at the global study completion or at the time of subject withdrawal, or when subject is deemed lost to follow-up or upon death. • Added guidance on managing subjects who developed malignancy while on study drug. • Updated to reflect how Baseline was calculated for Hb. • Updated to reflect a change in the non-inferiority margin from -1.0 to -0.75 grams per deciliter (g/dL). • Modified to include an updated definition for the primary safety endpoint and how non-inferiority was established between treatment groups. • Added a definition of Full Analysis Set population. • Updated with use of analysis of covariance with multiple imputation.

18 Dec 2018

• Included reference to the Pharmacy Manual which provided further details on storage and managing temperature excursions. • Provided further guidance regarding concomitant use of simvastatin drug interactions with vadadustat. • Provided guidance regarding concomitant use of breast cancer resistance protein (BCRP) substrates with vadadustat. • Updated to reflect recent results of investigative toxicology studies. • Liver function tests (LFTs) were increased in Year 2, 3, and 4 to include Weeks 64, 88, 116, 140, 168, and 192.

26 Feb 2019

• Updated to include a reference to Study Drug Stopping Rules for management of subjects with alanine aminotransferase (ALT) and aspartate aminotransferase (AST) abnormalities. • Include the table of LFT results that would require permanent discontinuation of vadadustat. • Updated to exclude subjects with elevations in ALT or AST >3 times upper limit of normal (ULN) with an elevation of total serum bilirubin >2 times ULN from conditions of temporary discontinuation, as this is now a condition for permanent discontinuation. • Updated to include information defining designated medical events.

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

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