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Clinical Trial Results:
A 24-month, multi-center, open-label, randomized, controlled trial to investigate efficacy, safety and evolution of cardiovascular parameters in de novo renal transplant recipients after early calcineurin inhibitor to everolimus conversion

Summary
EudraCT number	2009-015918-22
Trial protocol	PT ES AT BE GR LV EE LT DE IT
Global end of trial date	30 Oct 2014

Results information
Results version number	v1(current)
This version publication date	23 Jul 2016
First version publication date	23 Jul 2016
Other versions

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

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Trial information

Top of page

Sponsor protocol code

CRAD001A2429

ISRCTN number

-

US NCT number

NCT01114529

WHO universal trial number (UTN)

-

Sponsor organisation name

Novartis Pharma AG

Sponsor organisation address

CH-4002, Basel, Switzerland,

Public contact

Clinical Disclosure Office, Novartis Pharma AG, 41 613241111,

Scientific contact

Clinical Disclosure Office, Novartis Pharma AG, 41 613241111,

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

31 Jul 2015

Is this the analysis of the primary completion data?

No

Global end of trial reached?

Yes

Global end of trial date

30 Oct 2014

Was the trial ended prematurely?

No

Main objective of the trial

The purpose of this study was to determine whether an early Calcineurin Inhibitor (CNI) to everolimus conversion at 10-14 weeks post transplantation improves renal allograft function without compromising efficacy compared to standard CNI treatment in de novo renal allograft recipients. In addition, the study was designed to evaluate the impact of a CNI-free regimen on evolution of cardiovascular parameters in de novo renal allograft recipients

Protection of trial subjects

The study was in compliance with the ethical principles derived from the Declaration of Helsinki and the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines. All the local regulatory requirements pertinent to safety of trial subjects were also followed during the conduct of the trial.

Background therapy

-

Evidence for comparator

-

Actual start date of recruitment

09 Aug 2010

Long term follow-up planned

No

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

Argentina: 55

Country: Number of subjects enrolled

Australia: 50

Country: Number of subjects enrolled

Austria: 25

Country: Number of subjects enrolled

Belgium: 6

Country: Number of subjects enrolled

France: 34

Country: Number of subjects enrolled

Germany: 67

Country: Number of subjects enrolled

Greece: 12

Country: Number of subjects enrolled

India: 71

Country: Number of subjects enrolled

Italy: 17

Country: Number of subjects enrolled

Latvia: 8

Country: Number of subjects enrolled

Mexico: 32

Country: Number of subjects enrolled

Netherlands: 93

Country: Number of subjects enrolled

Norway: 47

Country: Number of subjects enrolled

Portugal: 4

Country: Number of subjects enrolled

Romania: 2

Country: Number of subjects enrolled

Russian Federation: 43

Country: Number of subjects enrolled

Spain: 75

Country: Number of subjects enrolled

Thailand: 48

Country: Number of subjects enrolled

Turkey: 19

Country: Number of subjects enrolled

Estonia: 1

Worldwide total number of subjects

709

EEA total number of subjects

391

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)

619

From 65 to 84 years

90

85 years and over

0

Subject disposition

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Recruitment details

Full analysis set (24 month analysis)

Screening details

Full analysis set (24 month analysis)

Period 1 title

Completed Study Medication (overall period)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator

Are arms mutually exclusive

Yes

Everolimus

Arm description

Conversion from Calcineurin inhibitor (CNI) to everolimus in combination with Myfortic (mycophenolic acid) and steroids

Arm type

Experimental

Investigational medicinal product name

Everolimus

Investigational medicinal product code

Other name

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

(0.25 mg, 0.5 mg, 0.75 mg or 1.0 mg).

Standard CNI (Tac)

Arm description

Calcineurin inhibitor (CNI), Prograf: CNI continuation with Prograf (tacrolimus) in combination with Myfortic (mycophenolic acid), and steroids

Arm type

Experimental

Investigational medicinal product name

Tacrolimus

Investigational medicinal product code

Other name

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

(0.5 mg, 1 mg, or 5 mg). twice a Day each 12-hours

Standard CNI (CsA)

Arm description

Calcineurin inhibitor (CNI), Neoral: CNI continuation with Neoral(cyclosporine) in combination with Myfortic (mycophenolic acid), and steroids

Arm type

Experimental

Investigational medicinal product name

Neoral

Investigational medicinal product code

Other name

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

(10, 25, 50, or 100 mg). twice a Day each 12-hour

Number of subjects in period 1	Everolimus	Standard CNI (Tac)	Standard CNI (CsA)
Started	353	231	125
Completed	229	190	93
Not completed	124	41	32
Abnormal laboratory value(s)	6	-	1
Adverse event, serious fatal	2	1	2
Consent withdrawn by subject	18	8	2
Graft loss	-	2	-
Adverse event, non-fatal	87	18	17
Administrative problems	2	1	2
Subject's no longer required drug	1	1	1
Lost to follow-up	1	4	2
Abnormal test procedure result(s)	3	-	1
Missing	2	-	-
Lack of efficacy	2	1	2
Protocol deviation	-	5	2

Baseline characteristics

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Reporting group title

Everolimus

Reporting group description

Conversion from Calcineurin inhibitor (CNI) to everolimus in combination with Myfortic (mycophenolic acid) and steroids

Reporting group title

Standard CNI (Tac)

Reporting group description

Calcineurin inhibitor (CNI), Prograf: CNI continuation with Prograf (tacrolimus) in combination with Myfortic (mycophenolic acid), and steroids

Reporting group title

Standard CNI (CsA)

Reporting group description

Calcineurin inhibitor (CNI), Neoral: CNI continuation with Neoral(cyclosporine) in combination with Myfortic (mycophenolic acid), and steroids

Reporting group values	Everolimus	Standard CNI (Tac)	Standard CNI (CsA)	Total
Number of subjects	353	231	125	709
Age categorical
Units: Subjects
Adults (18-64 years)	313	200	106	619
From 65-84 years	40	31	19	90
Age Continuous
Age
Units: years
arithmetic mean (standard deviation)	46 ± 14.4	47.3 ± 14.5	45.4 ± 15.6	-
Gender, Male/Female
Units: participants
Male	242	160	92	494
Female	111	71	33	215
Race/Ethnicity, Customized
Units: Subjects
Caucasian	246	173	97	516
Black	4	5	0	9
Asian	66	41	20	127
Native American	1	0	0	1
Pacific Islander	0	1	1	2
Other	36	11	7	54

Subject analysis set title

Difference (Everolimus - Standard CNI)

Subject analysis set type

Full analysis

Subject analysis set description

Least Squares Mean vs Standard Error(Change in eGFR)

Subject analysis set title

Difference (Everolimus - Standard CNI)

Subject analysis set type

Full analysis

Subject analysis set description

Least Squares Mean vs Standard Error(Change in eGFR)

Subject analysis set title

Standard CNI (Tac and CsA)

Subject analysis set type

Full analysis

Subject analysis set description

Conversion from Calcineurin inhibitor (CNI) to Standard CNI (Tac or CsA) in combination with Myfortic (mycophenolic acid) and steroidsRisk diff (%)

Subject analysis sets values	Difference (Everolimus - Standard CNI)	Difference (Everolimus - Standard CNI)	Standard CNI (Tac and CsA)
Number of subjects	321	353	356
Age categorical
Units: Subjects
Adults (18-64 years)	113	207	320
From 65-84 years	9	21	30
Age Continuous
Age
Units: years
arithmetic mean (standard deviation)	±	±	±
Gender, Male/Female
Units: participants
Male
Female
Race/Ethnicity, Customized
Units: Subjects
Caucasian
Black
Asian
Native American
Pacific Islander
Other

End points

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Reporting group title

Everolimus

Reporting group description

Conversion from Calcineurin inhibitor (CNI) to everolimus in combination with Myfortic (mycophenolic acid) and steroids

Reporting group title

Standard CNI (Tac)

Reporting group description

Calcineurin inhibitor (CNI), Prograf: CNI continuation with Prograf (tacrolimus) in combination with Myfortic (mycophenolic acid), and steroids

Reporting group title

Standard CNI (CsA)

Reporting group description

Calcineurin inhibitor (CNI), Neoral: CNI continuation with Neoral(cyclosporine) in combination with Myfortic (mycophenolic acid), and steroids

Subject analysis set title

Difference (Everolimus - Standard CNI)

Subject analysis set type

Full analysis

Subject analysis set description

Least Squares Mean vs Standard Error(Change in eGFR)

Subject analysis set title

Difference (Everolimus - Standard CNI)

Subject analysis set type

Full analysis

Subject analysis set description

Least Squares Mean vs Standard Error(Change in eGFR)

Subject analysis set title

Standard CNI (Tac and CsA)

Subject analysis set type

Full analysis

Subject analysis set description

Conversion from Calcineurin inhibitor (CNI) to Standard CNI (Tac or CsA) in combination with Myfortic (mycophenolic acid) and steroidsRisk diff (%)

Primary: Change in eGFR from randomization to Month 24: Difference (Everolimus-Standard CNI)

Top of page

End point title

Change in eGFR from randomization to Month 24: Difference (Everolimus-Standard CNI)

End point description

Difference (Everolimus-Standard CNI): Assessment of renal function by comparing change from randomization to Month 24 in eGFR ‎‎(MDRD4) between treatment arms‎

End point type

Primary

End point timeframe

Change in eGFR ‎‎(MDRD4) from randomization to Month 24

End point values	Everolimus	Standard CNI (Tac)	Standard CNI (CsA)	Standard CNI (Tac and CsA)
Number of subjects analysed	321	213	116	321
Units: participants
least squares mean (standard error)
Difference (Everolimus - Standard CNI)	1.61 ± 1.48	1.93 ± 0.25	1.98 ± 0.1	1.9 ± 1.1

Difference (Everolimus - Standard CNI)

Statistical analysis description

Change in eGFR (MDRD4) from randomization to month 12

Comparison groups

Everolimus v Standard CNI (Tac and CsA)

Number of subjects included in analysis

642

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0847 ^[1]

Method

ANCOVA

Confidence interval

Notes
[1] - Comparison between treatment arms by change from randomization to Month 12 in estimated Glomerular Filtration Rate (eGFR) ‎‎(MDRD4)

Difference (Everolimus - Standard CNI: TAC)

Statistical analysis description

Everolimus vs Standard CNI

Comparison groups

Standard CNI (Tac) v Everolimus

Number of subjects included in analysis

534

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.1963

Method

ANCOVA

Parameter type

Mean difference (net)

Point estimate

1.68

Confidence interval

level

90%

sides

2-sided

lower limit

-0.87

upper limit

4.24

Variability estimate

Standard error of the mean

Dispersion value

1.3

Difference (Everolimus - Standard CNI CsA)

Statistical analysis description

Difference (Everolimus - Standard CNI CsA)

Comparison groups

Everolimus v Standard CNI (CsA)

Number of subjects included in analysis

437

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.1963

Method

ANCOVA

Parameter type

Mean difference (net)

Point estimate

2.08

Confidence interval

level

95%

sides

2-sided

lower limit

-1.05

upper limit

5.22

Variability estimate

Standard error of the mean

Dispersion value

1.59

Secondary: Comparison of Kaplan-Meier incidence rates of composite efficacy endpoint for each arm at Month 24 (Full analysis set)

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End point title

Comparison of Kaplan-Meier incidence rates of composite efficacy endpoint for each arm at Month 24 (Full analysis set)

End point description

To demonstrate non-inferior efficacy (defined by a composite efficacy endpoint of treated Biopsy Proven Acute Rejection (tBPAR) ≥ IB, graft loss or death) at month 24.

End point type

Secondary

End point timeframe

at 24 months post-transplantation

End point values	Everolimus	Standard CNI (Tac)	Standard CNI (CsA)
Number of subjects analysed	353	231	125
Units: KM estimate of incidence rate
number (not applicable)
Number of composite endpoint *	21	8	8
KM estimate of incidence rate (%)	6.2	3.5	6.4
Difference in KM estimate (%)	3.6	4.6	1.7

No statistical analyses for this end point

Secondary: Comparison between treatment arms' change from randomization to Month 24 in left ventricular mass index (LVMi)

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End point title

Comparison between treatment arms' change from randomization to Month 24 in left ventricular mass index (LVMi)

End point description

Comparison between treatment arms for change from randomization to Month 12 in left ventricular mass index (LVMi) (FAS - 12 month analysis)

End point type

Secondary

End point timeframe

baseline to 24 months

End point values	Difference (Everolimus - Standard CNI)
Number of subjects analysed	353
Units: participants
least squares mean (standard error)
Everolimus (N=247)	0.05 ± 0
Standard CNI (N=284)	-1.14 ± 1.19
Tac (N=187)	-1.76 ± 1.81
CsA (N=97)	0.06 ± 0

No statistical analyses for this end point

Secondary: Comparison of incidence rates of efficacy endpoints between treatment arms (Full analysis set - 24 month analysis)

Top of page

End point title

Comparison of incidence rates of efficacy endpoints between treatment arms (Full analysis set - 24 month analysis) ^[2]

End point description

Incidence, time to event and severity of treated BPAR ≥ IB; incidence of BPAR that need antibody treatment; incidence of humoral rejection; incidence of treated BPAR ≥ IB

End point type

Secondary

End point timeframe

at 24 months post-transplantation

Notes
[2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: See primary end point

End point values	Everolimus	Standard CNI (Tac and CsA)
Number of subjects analysed	353	356
Units: participants
number (not applicable)
Composite failure:‎ tBPAR>=IB, graft loss, death‎	27	3.2
Composite tBPAR>=IB, graft loss, death, loss f/u	35	1.8
Composite of graft loss or Death	10	0
tBPAR>=IB	18	2.9
Graft loss	4	0
Death	8	-0.3
Suspected Acute rejection	61	4.4
Subclinical Acute rejection	0	0
Acute rejection (AR)	52	6.6
Treated Acute rejection (tAR)	40	4.9
biopsy proven acute rejection (BPAR)	37	4.6
treated biopsy proven acute rejection (tBPAR)	32	3.4
tBPAR=IA	16	1.4
tBPAR=IB	14	1.7
tBPAR=IIA	3	0.6
tBPAR=IIB	2	0.6
tBPAR=III	0	0
Antibody tBPAR	0	0
Antibody mediated rejection (AMR)	16	2.6

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.

Adverse event reporting additional description

Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field “number of deaths resulting from adverse events” all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

17.1

Reporting group title

Standard CNI

Reporting group description

Standard CNI

Reporting group title

Everolimus

Reporting group description

Everolimus

Serious adverse events	Standard CNI	Everolimus
Total subjects affected by serious adverse events
subjects affected / exposed	176 / 359 (49.03%)	188 / 346 (54.34%)
number of deaths (all causes)	9	8
number of deaths resulting from adverse events	0	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma gastric
subjects affected / exposed	1 / 359 (0.28%)	0 / 346 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Basal cell carcinoma
subjects affected / exposed	3 / 359 (0.84%)	0 / 346 (0.00%)
occurrences causally related to treatment / all	3 / 4	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Bowen's disease
subjects affected / exposed	1 / 359 (0.28%)	0 / 346 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Brain neoplasm malignant
subjects affected / exposed	1 / 359 (0.28%)	0 / 346 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Bronchial carcinoma
subjects affected / exposed	1 / 359 (0.28%)	0 / 346 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Colon cancer
subjects affected / exposed	1 / 359 (0.28%)	0 / 346 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gastric cancer
subjects affected / exposed	1 / 359 (0.28%)	0 / 346 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Glioblastoma
subjects affected / exposed	0 / 359 (0.00%)	1 / 346 (0.29%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatic cancer
subjects affected / exposed	2 / 359 (0.56%)	0 / 346 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Hepatic cancer metastatic
subjects affected / exposed	1 / 359 (0.28%)	0 / 346 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Invasive ductal breast carcinoma
subjects affected / exposed	1 / 359 (0.28%)	0 / 346 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Lentigo maligna
subjects affected / exposed	0 / 359 (0.00%)	1 / 346 (0.29%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Lung adenocarcinoma
subjects affected / exposed	0 / 359 (0.00%)	1 / 346 (0.29%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Lung neoplasm malignant
subjects affected / exposed	2 / 359 (0.56%)	0 / 346 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Metastases to spine
subjects affected / exposed	1 / 359 (0.28%)	0 / 346 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Papillary thyroid cancer
subjects affected / exposed	1 / 359 (0.28%)	0 / 346 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Prostate cancer
subjects affected / exposed	0 / 359 (0.00%)	1 / 346 (0.29%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Parathyroid tumour benign
subjects affected / exposed	1 / 359 (0.28%)	2 / 346 (0.58%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Rectal neoplasm
subjects affected / exposed	1 / 359 (0.28%)	0 / 346 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Renal cancer
subjects affected / exposed	1 / 359 (0.28%)	0 / 346 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Renal cell carcinoma
subjects affected / exposed	1 / 359 (0.28%)	0 / 346 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Small cell lung cancer
subjects affected / exposed	1 / 359 (0.28%)	1 / 346 (0.29%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 0
Squamous cell carcinoma
subjects affected / exposed	3 / 359 (0.84%)	2 / 346 (0.58%)
occurrences causally related to treatment / all	6 / 6	1 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Squamous cell carcinoma of skin
subjects affected / exposed	0 / 359 (0.00%)	1 / 346 (0.29%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Vascular disorders
Arteriovenous fistula
subjects affected / exposed	2 / 359 (0.56%)	0 / 346 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Deep vein thrombosis
subjects affected / exposed	2 / 359 (0.56%)	6 / 346 (1.73%)
occurrences causally related to treatment / all	0 / 2	4 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Haematoma
subjects affected / exposed	2 / 359 (0.56%)	1 / 346 (0.29%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Haemodynamic instability
subjects affected / exposed	0 / 359 (0.00%)	1 / 346 (0.29%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hypertension
subjects affected / exposed	2 / 359 (0.56%)	0 / 346 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hypotension
subjects affected / exposed	0 / 359 (0.00%)	1 / 346 (0.29%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Lymphocele
subjects affected / exposed	2 / 359 (0.56%)	2 / 346 (0.58%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Lymphoedema
subjects affected / exposed	1 / 359 (0.28%)	0 / 346 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Necrosis ischaemic
subjects affected / exposed	1 / 359 (0.28%)	0 / 346 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Orthostatic hypotension
subjects affected / exposed	1 / 359 (0.28%)	0 / 346 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Peripheral artery thrombosis
subjects affected / exposed	2 / 359 (0.56%)	0 / 346 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Peripheral artery stenosis
subjects affected / exposed	1 / 359 (0.28%)	0 / 346 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Peripheral vascular disorder
subjects affected / exposed	0 / 359 (0.00%)	1 / 346 (0.29%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Thrombophlebitis
subjects affected / exposed	1 / 359 (0.28%)	2 / 346 (0.58%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Vena cava thrombosis
subjects affected / exposed	0 / 359 (0.00%)	1 / 346 (0.29%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Thrombosis
subjects affected / exposed	2 / 359 (0.56%)	1 / 346 (0.29%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Venous thrombosis limb
subjects affected / exposed	0 / 359 (0.00%)	1 / 346 (0.29%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
General disorders and administration site conditions
Death
subjects affected / exposed	2 / 359 (0.56%)	1 / 346 (0.29%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Device leakage
subjects affected / exposed	1 / 359 (0.28%)	0 / 346 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
General physical health deterioration
subjects affected / exposed	1 / 359 (0.28%)	0 / 346 (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 / 359 (0.00%)	1 / 346 (0.29%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Generalised oedema
subjects affected / exposed	0 / 359 (0.00%)	1 / 346 (0.29%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Impaired healing
subjects affected / exposed	0 / 359 (0.00%)	1 / 346 (0.29%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Malaise
subjects affected / exposed	0 / 359 (0.00%)	2 / 346 (0.58%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Oedema peripheral
subjects affected / exposed	3 / 359 (0.84%)	2 / 346 (0.58%)
occurrences causally related to treatment / all	0 / 3	1 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Oedema
subjects affected / exposed	1 / 359 (0.28%)	0 / 346 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pyrexia
subjects affected / exposed	9 / 359 (2.51%)	25 / 346 (7.23%)
occurrences causally related to treatment / all	3 / 10	7 / 28
deaths causally related to treatment / all	0 / 0	0 / 0
Sudden death
subjects affected / exposed	0 / 359 (0.00%)	2 / 346 (0.58%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 1
Surgical failure
subjects affected / exposed	1 / 359 (0.28%)	0 / 346 (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
Drug hypersensitivity
subjects affected / exposed	1 / 359 (0.28%)	0 / 346 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Kidney transplant rejection
subjects affected / exposed	13 / 359 (3.62%)	19 / 346 (5.49%)
occurrences causally related to treatment / all	5 / 15	8 / 20
deaths causally related to treatment / all	0 / 0	0 / 0
Transplant rejection
subjects affected / exposed	14 / 359 (3.90%)	23 / 346 (6.65%)
occurrences causally related to treatment / all	3 / 15	11 / 25
deaths causally related to treatment / all	0 / 0	0 / 0
Reproductive system and breast disorders
Benign prostatic hyperplasia
subjects affected / exposed	1 / 359 (0.28%)	1 / 346 (0.29%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Epididymitis
subjects affected / exposed	1 / 359 (0.28%)	0 / 346 (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	1 / 359 (0.28%)	1 / 346 (0.29%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pelvic haematoma
subjects affected / exposed	0 / 359 (0.00%)	1 / 346 (0.29%)
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 / 359 (0.00%)	4 / 346 (1.16%)
occurrences causally related to treatment / all	0 / 0	2 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
Dyspnoea
subjects affected / exposed	0 / 359 (0.00%)	5 / 346 (1.45%)
occurrences causally related to treatment / all	0 / 0	2 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Epistaxis
subjects affected / exposed	0 / 359 (0.00%)	1 / 346 (0.29%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Lung disorder
subjects affected / exposed	1 / 359 (0.28%)	3 / 346 (0.87%)
occurrences causally related to treatment / all	0 / 1	2 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Obstructive airways disorder
subjects affected / exposed	1 / 359 (0.28%)	0 / 346 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pleural effusion
subjects affected / exposed	1 / 359 (0.28%)	1 / 346 (0.29%)
occurrences causally related to treatment / all	0 / 1	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumonia aspiration
subjects affected / exposed	0 / 359 (0.00%)	1 / 346 (0.29%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumonitis
subjects affected / exposed	0 / 359 (0.00%)	3 / 346 (0.87%)
occurrences causally related to treatment / all	0 / 0	3 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Pulmonary alveolar haemorrhage
subjects affected / exposed	0 / 359 (0.00%)	1 / 346 (0.29%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumothorax
subjects affected / exposed	0 / 359 (0.00%)	1 / 346 (0.29%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pulmonary embolism
subjects affected / exposed	0 / 359 (0.00%)	3 / 346 (0.87%)
occurrences causally related to treatment / all	0 / 0	2 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Pulmonary oedema
subjects affected / exposed	3 / 359 (0.84%)	0 / 346 (0.00%)
occurrences causally related to treatment / all	0 / 4	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Respiratory failure
subjects affected / exposed	1 / 359 (0.28%)	0 / 346 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Psychiatric disorders
Confusional state
subjects affected / exposed	1 / 359 (0.28%)	0 / 346 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Delirium
subjects affected / exposed	1 / 359 (0.28%)	0 / 346 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Psychotic disorder
subjects affected / exposed	1 / 359 (0.28%)	0 / 346 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Investigations
Biopsy
subjects affected / exposed	0 / 359 (0.00%)	2 / 346 (0.58%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Blood creatine increased
subjects affected / exposed	0 / 359 (0.00%)	1 / 346 (0.29%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Blood creatinine abnormal
subjects affected / exposed	1 / 359 (0.28%)	0 / 346 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
C-reactive protein increased
subjects affected / exposed	1 / 359 (0.28%)	1 / 346 (0.29%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Blood creatinine increased
subjects affected / exposed	11 / 359 (3.06%)	17 / 346 (4.91%)
occurrences causally related to treatment / all	1 / 13	4 / 18
deaths causally related to treatment / all	0 / 0	0 / 0
Creatinine renal clearance decreased
subjects affected / exposed	1 / 359 (0.28%)	0 / 346 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Haemoglobin decreased
subjects affected / exposed	0 / 359 (0.00%)	1 / 346 (0.29%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Haemoglobin urine present
subjects affected / exposed	1 / 359 (0.28%)	0 / 346 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatic enzyme increased
subjects affected / exposed	0 / 359 (0.00%)	1 / 346 (0.29%)
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	0 / 359 (0.00%)	1 / 346 (0.29%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Protein urine present
subjects affected / exposed	1 / 359 (0.28%)	0 / 346 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Weight decreased
subjects affected / exposed	1 / 359 (0.28%)	0 / 346 (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
Abdominal wound dehiscence
subjects affected / exposed	1 / 359 (0.28%)	0 / 346 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Animal bite
subjects affected / exposed	1 / 359 (0.28%)	0 / 346 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Arteriovenous fistula thrombosis
subjects affected / exposed	1 / 359 (0.28%)	0 / 346 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Carbon monoxide poisoning
subjects affected / exposed	1 / 359 (0.28%)	0 / 346 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Cervical vertebral fracture
subjects affected / exposed	0 / 359 (0.00%)	1 / 346 (0.29%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Colon injury
subjects affected / exposed	1 / 359 (0.28%)	0 / 346 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Complications of transplanted kidney
subjects affected / exposed	5 / 359 (1.39%)	5 / 346 (1.45%)
occurrences causally related to treatment / all	1 / 7	2 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Face injury
subjects affected / exposed	1 / 359 (0.28%)	0 / 346 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Graft dysfunction
subjects affected / exposed	5 / 359 (1.39%)	1 / 346 (0.29%)
occurrences causally related to treatment / all	0 / 5	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Graft loss
subjects affected / exposed	3 / 359 (0.84%)	2 / 346 (0.58%)
occurrences causally related to treatment / all	1 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Humerus fracture
subjects affected / exposed	0 / 359 (0.00%)	1 / 346 (0.29%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Incisional hernia
subjects affected / exposed	0 / 359 (0.00%)	3 / 346 (0.87%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Limb traumatic amputation
subjects affected / exposed	1 / 359 (0.28%)	0 / 346 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Post procedural haematuria
subjects affected / exposed	1 / 359 (0.28%)	0 / 346 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Post procedural haemorrhage
subjects affected / exposed	0 / 359 (0.00%)	1 / 346 (0.29%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Postoperative wound complication
subjects affected / exposed	0 / 359 (0.00%)	1 / 346 (0.29%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Renal graft loss
subjects affected / exposed	2 / 359 (0.56%)	1 / 346 (0.29%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Rib fracture
subjects affected / exposed	1 / 359 (0.28%)	1 / 346 (0.29%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Shunt aneurysm
subjects affected / exposed	2 / 359 (0.56%)	0 / 346 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Spinal fracture
subjects affected / exposed	0 / 359 (0.00%)	2 / 346 (0.58%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Shunt thrombosis
subjects affected / exposed	0 / 359 (0.00%)	1 / 346 (0.29%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Tibia fracture
subjects affected / exposed	0 / 359 (0.00%)	1 / 346 (0.29%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Toxicity to various agents
subjects affected / exposed	2 / 359 (0.56%)	0 / 346 (0.00%)
occurrences causally related to treatment / all	1 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Transplant dysfunction
subjects affected / exposed	1 / 359 (0.28%)	0 / 346 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Transplant failure
subjects affected / exposed	3 / 359 (0.84%)	2 / 346 (0.58%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Traumatic arthritis
subjects affected / exposed	1 / 359 (0.28%)	0 / 346 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Ureteric anastomosis complication
subjects affected / exposed	1 / 359 (0.28%)	1 / 346 (0.29%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Vascular pseudoaneurysm
subjects affected / exposed	1 / 359 (0.28%)	0 / 346 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Wound
subjects affected / exposed	1 / 359 (0.28%)	0 / 346 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Wound necrosis
subjects affected / exposed	0 / 359 (0.00%)	1 / 346 (0.29%)
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
Congenital cystic kidney disease
subjects affected / exposed	0 / 359 (0.00%)	1 / 346 (0.29%)
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	1 / 359 (0.28%)	0 / 346 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Angina pectoris
subjects affected / exposed	2 / 359 (0.56%)	0 / 346 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Atrial fibrillation
subjects affected / exposed	4 / 359 (1.11%)	3 / 346 (0.87%)
occurrences causally related to treatment / all	0 / 4	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Atrial flutter
subjects affected / exposed	0 / 359 (0.00%)	1 / 346 (0.29%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Bradycardia
subjects affected / exposed	1 / 359 (0.28%)	0 / 346 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac arrest
subjects affected / exposed	2 / 359 (0.56%)	1 / 346 (0.29%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 2	0 / 1
Cardiac failure
subjects affected / exposed	3 / 359 (0.84%)	4 / 346 (1.16%)
occurrences causally related to treatment / all	0 / 5	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Coronary artery disease
subjects affected / exposed	0 / 359 (0.00%)	1 / 346 (0.29%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cyanosis
subjects affected / exposed	1 / 359 (0.28%)	0 / 346 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Mitral valve incompetence
subjects affected / exposed	1 / 359 (0.28%)	0 / 346 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Myocardial infarction
subjects affected / exposed	4 / 359 (1.11%)	1 / 346 (0.29%)
occurrences causally related to treatment / all	0 / 4	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 0
Myocardial ischaemia
subjects affected / exposed	0 / 359 (0.00%)	1 / 346 (0.29%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Palpitations
subjects affected / exposed	0 / 359 (0.00%)	1 / 346 (0.29%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pericarditis
subjects affected / exposed	2 / 359 (0.56%)	0 / 346 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Supraventricular tachycardia
subjects affected / exposed	0 / 359 (0.00%)	1 / 346 (0.29%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Nervous system disorders
Cerebral infarction
subjects affected / exposed	0 / 359 (0.00%)	2 / 346 (0.58%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Cerebrovascular accident
subjects affected / exposed	0 / 359 (0.00%)	1 / 346 (0.29%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Dementia Alzheimer's type
subjects affected / exposed	1 / 359 (0.28%)	0 / 346 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Dementia with Lewy bodies
subjects affected / exposed	1 / 359 (0.28%)	0 / 346 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Dizziness
subjects affected / exposed	0 / 359 (0.00%)	1 / 346 (0.29%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Headache
subjects affected / exposed	0 / 359 (0.00%)	2 / 346 (0.58%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Ischaemic stroke
subjects affected / exposed	0 / 359 (0.00%)	2 / 346 (0.58%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Migraine
subjects affected / exposed	0 / 359 (0.00%)	1 / 346 (0.29%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Peripheral sensory neuropathy
subjects affected / exposed	0 / 359 (0.00%)	1 / 346 (0.29%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Multifocal motor neuropathy
subjects affected / exposed	1 / 359 (0.28%)	0 / 346 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Blood and lymphatic system disorders
Agranulocytosis
subjects affected / exposed	1 / 359 (0.28%)	0 / 346 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Anaemia
subjects affected / exposed	1 / 359 (0.28%)	1 / 346 (0.29%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Coagulopathy
subjects affected / exposed	1 / 359 (0.28%)	0 / 346 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Febrile neutropenia
subjects affected / exposed	1 / 359 (0.28%)	1 / 346 (0.29%)
occurrences causally related to treatment / all	0 / 1	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hypochromic anaemia
subjects affected / exposed	0 / 359 (0.00%)	1 / 346 (0.29%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Leukopenia
subjects affected / exposed	6 / 359 (1.67%)	4 / 346 (1.16%)
occurrences causally related to treatment / all	2 / 6	2 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Lymphadenopathy
subjects affected / exposed	0 / 359 (0.00%)	1 / 346 (0.29%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Lymphocytic infiltration
subjects affected / exposed	0 / 359 (0.00%)	1 / 346 (0.29%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Neutropenia
subjects affected / exposed	2 / 359 (0.56%)	2 / 346 (0.58%)
occurrences causally related to treatment / all	0 / 2	2 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Normochromic normocytic anaemia
subjects affected / exposed	0 / 359 (0.00%)	1 / 346 (0.29%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Thrombocytopenia
subjects affected / exposed	1 / 359 (0.28%)	0 / 346 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Thrombotic microangiopathy
subjects affected / exposed	0 / 359 (0.00%)	1 / 346 (0.29%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Ear and labyrinth disorders
Vertigo
subjects affected / exposed	0 / 359 (0.00%)	2 / 346 (0.58%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal disorders
Abdominal hernia
subjects affected / exposed	2 / 359 (0.56%)	0 / 346 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Abdominal pain
subjects affected / exposed	2 / 359 (0.56%)	2 / 346 (0.58%)
occurrences causally related to treatment / all	0 / 3	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Abdominal pain upper
subjects affected / exposed	0 / 359 (0.00%)	2 / 346 (0.58%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Anal fistula
subjects affected / exposed	0 / 359 (0.00%)	1 / 346 (0.29%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Colitis
subjects affected / exposed	3 / 359 (0.84%)	0 / 346 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Constipation
subjects affected / exposed	1 / 359 (0.28%)	0 / 346 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Crohn's disease
subjects affected / exposed	1 / 359 (0.28%)	0 / 346 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Diarrhoea
subjects affected / exposed	13 / 359 (3.62%)	15 / 346 (4.34%)
occurrences causally related to treatment / all	5 / 13	4 / 15
deaths causally related to treatment / all	0 / 0	0 / 0
Food poisoning
subjects affected / exposed	1 / 359 (0.28%)	1 / 346 (0.29%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastric ulcer haemorrhage
subjects affected / exposed	0 / 359 (0.00%)	1 / 346 (0.29%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal haemorrhage
subjects affected / exposed	1 / 359 (0.28%)	0 / 346 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal obstruction
subjects affected / exposed	1 / 359 (0.28%)	0 / 346 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal toxicity
subjects affected / exposed	1 / 359 (0.28%)	0 / 346 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Haematemesis
subjects affected / exposed	1 / 359 (0.28%)	0 / 346 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Ileal fistula
subjects affected / exposed	1 / 359 (0.28%)	0 / 346 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Intestinal ischaemia
subjects affected / exposed	1 / 359 (0.28%)	0 / 346 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Ileus
subjects affected / exposed	1 / 359 (0.28%)	0 / 346 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Large intestine perforation
subjects affected / exposed	0 / 359 (0.00%)	1 / 346 (0.29%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Melaena
subjects affected / exposed	0 / 359 (0.00%)	1 / 346 (0.29%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Mouth ulceration
subjects affected / exposed	0 / 359 (0.00%)	2 / 346 (0.58%)
occurrences causally related to treatment / all	0 / 0	3 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Nausea
subjects affected / exposed	1 / 359 (0.28%)	3 / 346 (0.87%)
occurrences causally related to treatment / all	1 / 1	1 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Oedematous pancreatitis
subjects affected / exposed	1 / 359 (0.28%)	0 / 346 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pancreatitis
subjects affected / exposed	1 / 359 (0.28%)	1 / 346 (0.29%)
occurrences causally related to treatment / all	0 / 1	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pancreatitis acute
subjects affected / exposed	2 / 359 (0.56%)	0 / 346 (0.00%)
occurrences causally related to treatment / all	1 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Rectal haemorrhage
subjects affected / exposed	1 / 359 (0.28%)	0 / 346 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Small intestinal obstruction
subjects affected / exposed	1 / 359 (0.28%)	0 / 346 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Stomatitis
subjects affected / exposed	0 / 359 (0.00%)	1 / 346 (0.29%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Subileus
subjects affected / exposed	1 / 359 (0.28%)	0 / 346 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Umbilical hernia
subjects affected / exposed	0 / 359 (0.00%)	2 / 346 (0.58%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Vomiting
subjects affected / exposed	0 / 359 (0.00%)	3 / 346 (0.87%)
occurrences causally related to treatment / all	0 / 0	1 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatobiliary disorders
Cholangitis
subjects affected / exposed	1 / 359 (0.28%)	0 / 346 (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	2 / 359 (0.56%)	0 / 346 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cholelithiasis
subjects affected / exposed	1 / 359 (0.28%)	0 / 346 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatitis
subjects affected / exposed	1 / 359 (0.28%)	0 / 346 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hydrocholecystis
subjects affected / exposed	0 / 359 (0.00%)	1 / 346 (0.29%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Liver disorder
subjects affected / exposed	1 / 359 (0.28%)	0 / 346 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Skin and subcutaneous tissue disorders
Diabetic foot
subjects affected / exposed	0 / 359 (0.00%)	2 / 346 (0.58%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Skin ulcer
subjects affected / exposed	1 / 359 (0.28%)	3 / 346 (0.87%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Renal and urinary disorders
Acute prerenal failure
subjects affected / exposed	1 / 359 (0.28%)	0 / 346 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Bladder obstruction
subjects affected / exposed	1 / 359 (0.28%)	1 / 346 (0.29%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Calculus urinary
subjects affected / exposed	1 / 359 (0.28%)	0 / 346 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cystitis haemorrhagic
subjects affected / exposed	0 / 359 (0.00%)	1 / 346 (0.29%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Dysuria
subjects affected / exposed	0 / 359 (0.00%)	1 / 346 (0.29%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Haematuria
subjects affected / exposed	4 / 359 (1.11%)	5 / 346 (1.45%)
occurrences causally related to treatment / all	0 / 4	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Hydronephrosis
subjects affected / exposed	3 / 359 (0.84%)	3 / 346 (0.87%)
occurrences causally related to treatment / all	0 / 4	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Kidney fibrosis
subjects affected / exposed	0 / 359 (0.00%)	1 / 346 (0.29%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Nephritis haemorrhagic
subjects affected / exposed	0 / 359 (0.00%)	1 / 346 (0.29%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Nephropathy toxic
subjects affected / exposed	2 / 359 (0.56%)	0 / 346 (0.00%)
occurrences causally related to treatment / all	1 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Obstructive uropathy
subjects affected / exposed	0 / 359 (0.00%)	1 / 346 (0.29%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Oliguria
subjects affected / exposed	0 / 359 (0.00%)	1 / 346 (0.29%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Prerenal failure
subjects affected / exposed	1 / 359 (0.28%)	0 / 346 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Proteinuria
subjects affected / exposed	0 / 359 (0.00%)	8 / 346 (2.31%)
occurrences causally related to treatment / all	0 / 0	3 / 8
deaths causally related to treatment / all	0 / 0	0 / 0
Renal artery stenosis
subjects affected / exposed	2 / 359 (0.56%)	0 / 346 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Renal cyst
subjects affected / exposed	0 / 359 (0.00%)	1 / 346 (0.29%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Renal cyst haemorrhage
subjects affected / exposed	1 / 359 (0.28%)	0 / 346 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Renal failure
subjects affected / exposed	1 / 359 (0.28%)	2 / 346 (0.58%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 1
Renal failure acute
subjects affected / exposed	10 / 359 (2.79%)	7 / 346 (2.02%)
occurrences causally related to treatment / all	4 / 11	0 / 10
deaths causally related to treatment / all	0 / 0	0 / 0
Renal failure chronic
subjects affected / exposed	1 / 359 (0.28%)	0 / 346 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Renal impairment
subjects affected / exposed	8 / 359 (2.23%)	6 / 346 (1.73%)
occurrences causally related to treatment / all	2 / 12	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Renal tubular atrophy
subjects affected / exposed	0 / 359 (0.00%)	1 / 346 (0.29%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Renal tubular necrosis
subjects affected / exposed	0 / 359 (0.00%)	1 / 346 (0.29%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Tubulointerstitial nephritis
subjects affected / exposed	0 / 359 (0.00%)	2 / 346 (0.58%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Ureteric obstruction
subjects affected / exposed	1 / 359 (0.28%)	0 / 346 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Ureteric stenosis
subjects affected / exposed	2 / 359 (0.56%)	4 / 346 (1.16%)
occurrences causally related to treatment / all	0 / 3	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Urethral obstruction
subjects affected / exposed	1 / 359 (0.28%)	0 / 346 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Urethral stenosis
subjects affected / exposed	1 / 359 (0.28%)	0 / 346 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Urinary fistula
subjects affected / exposed	0 / 359 (0.00%)	1 / 346 (0.29%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Urinary tract obstruction
subjects affected / exposed	0 / 359 (0.00%)	1 / 346 (0.29%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Endocrine disorders
Hyperparathyroidism
subjects affected / exposed	1 / 359 (0.28%)	0 / 346 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Musculoskeletal and connective tissue disorders
Arthralgia
subjects affected / exposed	1 / 359 (0.28%)	0 / 346 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Back pain
subjects affected / exposed	1 / 359 (0.28%)	1 / 346 (0.29%)
occurrences causally related to treatment / all	1 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Intervertebral disc protrusion
subjects affected / exposed	2 / 359 (0.56%)	0 / 346 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Lumbar spinal stenosis
subjects affected / exposed	1 / 359 (0.28%)	0 / 346 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Muscle haemorrhage
subjects affected / exposed	0 / 359 (0.00%)	1 / 346 (0.29%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Myopathy
subjects affected / exposed	0 / 359 (0.00%)	2 / 346 (0.58%)
occurrences causally related to treatment / all	0 / 0	2 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Osteoarthritis
subjects affected / exposed	2 / 359 (0.56%)	1 / 346 (0.29%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Osteonecrosis
subjects affected / exposed	1 / 359 (0.28%)	3 / 346 (0.87%)
occurrences causally related to treatment / all	0 / 1	1 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Pain in extremity
subjects affected / exposed	1 / 359 (0.28%)	0 / 346 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Spinal osteoarthritis
subjects affected / exposed	0 / 359 (0.00%)	1 / 346 (0.29%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Infections and infestations
Abdominal abscess
subjects affected / exposed	0 / 359 (0.00%)	1 / 346 (0.29%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Abscess limb
subjects affected / exposed	0 / 359 (0.00%)	1 / 346 (0.29%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Acute sinusitis
subjects affected / exposed	1 / 359 (0.28%)	0 / 346 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Arthritis bacterial
subjects affected / exposed	0 / 359 (0.00%)	1 / 346 (0.29%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Asymptomatic bacteriuria
subjects affected / exposed	0 / 359 (0.00%)	1 / 346 (0.29%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
BK virus infection
subjects affected / exposed	1 / 359 (0.28%)	0 / 346 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Bacterial infection
subjects affected / exposed	1 / 359 (0.28%)	0 / 346 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Bacterial pyelonephritis
subjects affected / exposed	1 / 359 (0.28%)	1 / 346 (0.29%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Bacterial sepsis
subjects affected / exposed	1 / 359 (0.28%)	0 / 346 (0.00%)
occurrences causally related to treatment / all	2 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Bronchitis
subjects affected / exposed	1 / 359 (0.28%)	3 / 346 (0.87%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Bronchopneumonia
subjects affected / exposed	2 / 359 (0.56%)	0 / 346 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Catheter site abscess
subjects affected / exposed	1 / 359 (0.28%)	0 / 346 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cellulitis
subjects affected / exposed	1 / 359 (0.28%)	1 / 346 (0.29%)
occurrences causally related to treatment / all	1 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Clostridium difficile colitis
subjects affected / exposed	1 / 359 (0.28%)	0 / 346 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Clostridium difficile infection
subjects affected / exposed	0 / 359 (0.00%)	2 / 346 (0.58%)
occurrences causally related to treatment / all	0 / 0	1 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Corona virus infection
subjects affected / exposed	0 / 359 (0.00%)	1 / 346 (0.29%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cytomegalovirus colitis
subjects affected / exposed	1 / 359 (0.28%)	0 / 346 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cytomegalovirus infection
subjects affected / exposed	7 / 359 (1.95%)	4 / 346 (1.16%)
occurrences causally related to treatment / all	2 / 9	1 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Cytomegalovirus viraemia
subjects affected / exposed	2 / 359 (0.56%)	1 / 346 (0.29%)
occurrences causally related to treatment / all	2 / 2	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Dengue fever
subjects affected / exposed	0 / 359 (0.00%)	1 / 346 (0.29%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Device related infection
subjects affected / exposed	0 / 359 (0.00%)	1 / 346 (0.29%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Diarrhoea infectious
subjects affected / exposed	1 / 359 (0.28%)	1 / 346 (0.29%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Endocarditis
subjects affected / exposed	1 / 359 (0.28%)	0 / 346 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Escherichia urinary tract infection
subjects affected / exposed	0 / 359 (0.00%)	1 / 346 (0.29%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Erysipelas
subjects affected / exposed	1 / 359 (0.28%)	0 / 346 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gastroenteritis norovirus
subjects affected / exposed	0 / 359 (0.00%)	2 / 346 (0.58%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Gastroenteritis
subjects affected / exposed	14 / 359 (3.90%)	11 / 346 (3.18%)
occurrences causally related to treatment / all	1 / 15	3 / 12
deaths causally related to treatment / all	0 / 0	0 / 0
Gastroenteritis viral
subjects affected / exposed	1 / 359 (0.28%)	0 / 346 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal infection
subjects affected / exposed	1 / 359 (0.28%)	3 / 346 (0.87%)
occurrences causally related to treatment / all	1 / 1	2 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Gingivitis
subjects affected / exposed	0 / 359 (0.00%)	1 / 346 (0.29%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Graft infection
subjects affected / exposed	0 / 359 (0.00%)	1 / 346 (0.29%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
H1N1 influenza
subjects affected / exposed	0 / 359 (0.00%)	2 / 346 (0.58%)
occurrences causally related to treatment / all	0 / 0	1 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Herpes simplex
subjects affected / exposed	0 / 359 (0.00%)	2 / 346 (0.58%)
occurrences causally related to treatment / all	0 / 0	1 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Herpes zoster
subjects affected / exposed	1 / 359 (0.28%)	3 / 346 (0.87%)
occurrences causally related to treatment / all	0 / 1	2 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Infected lymphocele
subjects affected / exposed	0 / 359 (0.00%)	1 / 346 (0.29%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Infection
subjects affected / exposed	0 / 359 (0.00%)	1 / 346 (0.29%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Infectious pleural effusion
subjects affected / exposed	1 / 359 (0.28%)	0 / 346 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Influenza
subjects affected / exposed	1 / 359 (0.28%)	1 / 346 (0.29%)
occurrences causally related to treatment / all	0 / 2	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Intervertebral discitis
subjects affected / exposed	0 / 359 (0.00%)	1 / 346 (0.29%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Kidney infection
subjects affected / exposed	1 / 359 (0.28%)	0 / 346 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Liver abscess
subjects affected / exposed	0 / 359 (0.00%)	1 / 346 (0.29%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Lobar pneumonia
subjects affected / exposed	0 / 359 (0.00%)	1 / 346 (0.29%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Localised infection
subjects affected / exposed	0 / 359 (0.00%)	1 / 346 (0.29%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Lower respiratory tract infection
subjects affected / exposed	1 / 359 (0.28%)	1 / 346 (0.29%)
occurrences causally related to treatment / all	0 / 2	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Lung infection
subjects affected / exposed	0 / 359 (0.00%)	1 / 346 (0.29%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Mastitis
subjects affected / exposed	0 / 359 (0.00%)	1 / 346 (0.29%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Metapneumovirus infection
subjects affected / exposed	0 / 359 (0.00%)	1 / 346 (0.29%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Ophthalmic herpes zoster
subjects affected / exposed	0 / 359 (0.00%)	1 / 346 (0.29%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Osteomyelitis
subjects affected / exposed	0 / 359 (0.00%)	2 / 346 (0.58%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Peritoneal tuberculosis
subjects affected / exposed	0 / 359 (0.00%)	1 / 346 (0.29%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Peritonitis
subjects affected / exposed	1 / 359 (0.28%)	0 / 346 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Peritonsillar abscess
subjects affected / exposed	1 / 359 (0.28%)	0 / 346 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pharyngitis
subjects affected / exposed	2 / 359 (0.56%)	0 / 346 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumocystis jirovecii pneumonia
subjects affected / exposed	0 / 359 (0.00%)	1 / 346 (0.29%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumonia
subjects affected / exposed	9 / 359 (2.51%)	14 / 346 (4.05%)
occurrences causally related to treatment / all	5 / 10	9 / 22
deaths causally related to treatment / all	0 / 0	0 / 1
Pneumonia cytomegaloviral
subjects affected / exposed	0 / 359 (0.00%)	1 / 346 (0.29%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumonia klebsiella
subjects affected / exposed	0 / 359 (0.00%)	1 / 346 (0.29%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumonia mycoplasmal
subjects affected / exposed	0 / 359 (0.00%)	1 / 346 (0.29%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Polyomavirus-associated nephropathy
subjects affected / exposed	1 / 359 (0.28%)	0 / 346 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Post procedural infection
subjects affected / exposed	0 / 359 (0.00%)	1 / 346 (0.29%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Postoperative wound infection
subjects affected / exposed	1 / 359 (0.28%)	1 / 346 (0.29%)
occurrences causally related to treatment / all	0 / 1	2 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Pulmonary tuberculosis
subjects affected / exposed	1 / 359 (0.28%)	1 / 346 (0.29%)
occurrences causally related to treatment / all	0 / 1	2 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Pulmonary sepsis
subjects affected / exposed	0 / 359 (0.00%)	1 / 346 (0.29%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pyelonephritis acute
subjects affected / exposed	1 / 359 (0.28%)	4 / 346 (1.16%)
occurrences causally related to treatment / all	1 / 1	1 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Pyelonephritis
subjects affected / exposed	9 / 359 (2.51%)	13 / 346 (3.76%)
occurrences causally related to treatment / all	6 / 16	13 / 19
deaths causally related to treatment / all	0 / 0	0 / 0
Pyelonephritis chronic
subjects affected / exposed	1 / 359 (0.28%)	0 / 346 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Renal cyst infection
subjects affected / exposed	1 / 359 (0.28%)	0 / 346 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Respiratory tract infection
subjects affected / exposed	1 / 359 (0.28%)	0 / 346 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Rhinitis
subjects affected / exposed	0 / 359 (0.00%)	1 / 346 (0.29%)
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	0 / 359 (0.00%)	1 / 346 (0.29%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Salmonellosis
subjects affected / exposed	0 / 359 (0.00%)	1 / 346 (0.29%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Scrub typhus
subjects affected / exposed	0 / 359 (0.00%)	1 / 346 (0.29%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Sepsis
subjects affected / exposed	1 / 359 (0.28%)	6 / 346 (1.73%)
occurrences causally related to treatment / all	0 / 1	1 / 6
deaths causally related to treatment / all	0 / 0	0 / 1
Septic necrosis
subjects affected / exposed	0 / 359 (0.00%)	1 / 346 (0.29%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Septic shock
subjects affected / exposed	0 / 359 (0.00%)	2 / 346 (0.58%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 1
Shunt infection
subjects affected / exposed	0 / 359 (0.00%)	1 / 346 (0.29%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Systemic candida
subjects affected / exposed	1 / 359 (0.28%)	0 / 346 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Tuberculosis
subjects affected / exposed	1 / 359 (0.28%)	1 / 346 (0.29%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Upper respiratory tract infection
subjects affected / exposed	2 / 359 (0.56%)	2 / 346 (0.58%)
occurrences causally related to treatment / all	1 / 2	1 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Urinary tract infection
subjects affected / exposed	27 / 359 (7.52%)	25 / 346 (7.23%)
occurrences causally related to treatment / all	9 / 35	3 / 36
deaths causally related to treatment / all	0 / 0	0 / 0
Urinary tract infection bacterial
subjects affected / exposed	0 / 359 (0.00%)	1 / 346 (0.29%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Urinary tract infection fungal
subjects affected / exposed	1 / 359 (0.28%)	0 / 346 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Urosepsis
subjects affected / exposed	9 / 359 (2.51%)	9 / 346 (2.60%)
occurrences causally related to treatment / all	1 / 12	2 / 10
deaths causally related to treatment / all	0 / 0	0 / 0
Vestibular neuronitis
subjects affected / exposed	1 / 359 (0.28%)	1 / 346 (0.29%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Viral infection
subjects affected / exposed	1 / 359 (0.28%)	0 / 346 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Wound infection
subjects affected / exposed	0 / 359 (0.00%)	1 / 346 (0.29%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Zygomycosis
subjects affected / exposed	0 / 359 (0.00%)	1 / 346 (0.29%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Metabolism and nutrition disorders
Dehydration
subjects affected / exposed	1 / 359 (0.28%)	3 / 346 (0.87%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Diabetes mellitus
subjects affected / exposed	6 / 359 (1.67%)	1 / 346 (0.29%)
occurrences causally related to treatment / all	4 / 6	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Diabetes mellitus inadequate control
subjects affected / exposed	0 / 359 (0.00%)	2 / 346 (0.58%)
occurrences causally related to treatment / all	0 / 0	2 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Diabetic ketoacidosis
subjects affected / exposed	1 / 359 (0.28%)	0 / 346 (0.00%)
occurrences causally related to treatment / all	2 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Diabetes with hyperosmolarity
subjects affected / exposed	0 / 359 (0.00%)	1 / 346 (0.29%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Fluid retention
subjects affected / exposed	0 / 359 (0.00%)	1 / 346 (0.29%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hypercalcaemia
subjects affected / exposed	0 / 359 (0.00%)	2 / 346 (0.58%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Hyperglycaemia
subjects affected / exposed	1 / 359 (0.28%)	2 / 346 (0.58%)
occurrences causally related to treatment / all	1 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Hyperosmolar state
subjects affected / exposed	0 / 359 (0.00%)	1 / 346 (0.29%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hypocalcaemia
subjects affected / exposed	0 / 359 (0.00%)	1 / 346 (0.29%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hyponatraemia
subjects affected / exposed	0 / 359 (0.00%)	1 / 346 (0.29%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hypokalaemia
subjects affected / exposed	0 / 359 (0.00%)	1 / 346 (0.29%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hypophosphataemia
subjects affected / exposed	0 / 359 (0.00%)	1 / 346 (0.29%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Obesity
subjects affected / exposed	1 / 359 (0.28%)	0 / 346 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Type 1 diabetes mellitus
subjects affected / exposed	1 / 359 (0.28%)	0 / 346 (0.00%)
occurrences causally related to treatment / all	1 / 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	Standard CNI	Everolimus
Total subjects affected by non serious adverse events
subjects affected / exposed	246 / 359 (68.52%)	254 / 346 (73.41%)
Investigations
Blood creatinine increased
subjects affected / exposed	34 / 359 (9.47%)	18 / 346 (5.20%)
occurrences all number	39	19
Vascular disorders
Hypertension
subjects affected / exposed	35 / 359 (9.75%)	35 / 346 (10.12%)
occurrences all number	37	37
Blood and lymphatic system disorders
Anaemia
subjects affected / exposed	25 / 359 (6.96%)	40 / 346 (11.56%)
occurrences all number	28	44
Leukopenia
subjects affected / exposed	41 / 359 (11.42%)	46 / 346 (13.29%)
occurrences all number	52	51
General disorders and administration site conditions
Oedema peripheral
subjects affected / exposed	31 / 359 (8.64%)	60 / 346 (17.34%)
occurrences all number	38	77
Pyrexia
subjects affected / exposed	25 / 359 (6.96%)	41 / 346 (11.85%)
occurrences all number	30	49
Gastrointestinal disorders
Diarrhoea
subjects affected / exposed	57 / 359 (15.88%)	70 / 346 (20.23%)
occurrences all number	71	79
Mouth ulceration
subjects affected / exposed	3 / 359 (0.84%)	24 / 346 (6.94%)
occurrences all number	3	31
Nausea
subjects affected / exposed	17 / 359 (4.74%)	18 / 346 (5.20%)
occurrences all number	20	19
Vomiting
subjects affected / exposed	12 / 359 (3.34%)	18 / 346 (5.20%)
occurrences all number	13	20
Respiratory, thoracic and mediastinal disorders
Cough
subjects affected / exposed	19 / 359 (5.29%)	29 / 346 (8.38%)
occurrences all number	21	31
Skin and subcutaneous tissue disorders
Acne
subjects affected / exposed	11 / 359 (3.06%)	19 / 346 (5.49%)
occurrences all number	12	23
Renal and urinary disorders
Proteinuria
subjects affected / exposed	13 / 359 (3.62%)	46 / 346 (13.29%)
occurrences all number	15	51
Infections and infestations
Upper respiratory tract infection
subjects affected / exposed	19 / 359 (5.29%)	18 / 346 (5.20%)
occurrences all number	22	26
Nasopharyngitis
subjects affected / exposed	33 / 359 (9.19%)	31 / 346 (8.96%)
occurrences all number	45	40
Urinary tract infection
subjects affected / exposed	51 / 359 (14.21%)	62 / 346 (17.92%)
occurrences all number	87	114
Metabolism and nutrition disorders
Diabetes mellitus
subjects affected / exposed	18 / 359 (5.01%)	14 / 346 (4.05%)
occurrences all number	18	16
Dyslipidaemia
subjects affected / exposed	15 / 359 (4.18%)	26 / 346 (7.51%)
occurrences all number	17	27
Hypercholesterolaemia
subjects affected / exposed	22 / 359 (6.13%)	40 / 346 (11.56%)
occurrences all number	22	40
Hyperlipidaemia
subjects affected / exposed	20 / 359 (5.57%)	17 / 346 (4.91%)
occurrences all number	21	17
Hypokalaemia
subjects affected / exposed	14 / 359 (3.90%)	23 / 346 (6.65%)
occurrences all number	15	27

More information

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Were there any global substantial amendments to the protocol? Yes

30 Nov 2010

 Investigational drug and concomitant medication definitions were further clarified

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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