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Clinical Trial Results:
A Randomized, Double-Masked, Placebo-Controlled, Multicenter, Phase 2 Study to Evaluate the Safety and Renal Efficacy of LY2382770 in Patients With Diabetic Kidney Disease Due to Type 1 or Type 2 Diabetes.

Summary
EudraCT number	2010-020404-29
Trial protocol	HU CZ
Global end of trial date	22 Jul 2014

Results information
Results version number	v1(current)
This version publication date	14 Oct 2017
First version publication date	14 Oct 2017
Other versions

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

Collapse all Expand all

Trial information

Top of page

Sponsor protocol code

H9V-MC-GFRF

ISRCTN number

-

US NCT number

NCT01113801

WHO universal trial number (UTN)

-

Other trial identifiers

Trial Number: 10168

Sponsor organisation name

Eli Lilly and Company

Sponsor organisation address

Lilly Corporate Center, Indianapolis, IN, United States, 46285

Public contact

Available Mon ‐ Fri 9 AM ‐ 5 PM EST, Eli Lilly and Company, 1 877‐CTLilly,

Scientific contact

Available Mon ‐ Fri 9 AM ‐ 5 PM EST, Eli Lilly and Company, 1 877‐285‐4559,

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

22 Jul 2014

Is this the analysis of the primary completion data?

No

Global end of trial reached?

Yes

Global end of trial date

22 Jul 2014

Was the trial ended prematurely?

Yes

Main objective of the trial

The purpose of this study is to determine if LY2382770 is safe and effective at protecting kidney function in participants with kidney disease due to diabetes.

Protection of trial subjects

This study was conducted in accordance with International Conference on Harmonization (ICH) Good Clinical Practice, and the principles of the Declaration of Helsinki, in addition to following the laws and regulations of the country or countries in which a study is conducted.

Background therapy

Stable dose of angiotensin-converting enzyme (ACE) inhibitor or angiotensin II receptor blocker (ARB).

Evidence for comparator

-

Actual start date of recruitment

12 Jul 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

France: 32

Country: Number of subjects enrolled

United States: 145

Country: Number of subjects enrolled

Czech Republic: 45

Country: Number of subjects enrolled

Hungary: 57

Country: Number of subjects enrolled

Puerto Rico: 15

Country: Number of subjects enrolled

Australia: 40

Country: Number of subjects enrolled

Israel: 82

Worldwide total number of subjects

416

EEA total number of subjects

134

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)

245

From 65 to 84 years

168

85 years and over

3

Subject disposition

Top of page

Recruitment details

-

Screening details

No Text Entered

Period 1 title

Overall Study (overall period)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator, Carer

Are arms mutually exclusive

Yes

Placebo

Arm description

Placebo given subcutaneous (SC) injection monthly for 12 months

Arm type

Placebo

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

Placebo given subcutaneous (SC) injection monthly for 12 months.

2 mg LY2382770

Arm description

2 milligrams (mg) LY2382770 given (SC) injection monthly for 12 months

Arm type

Experimental

Investigational medicinal product name

LY2382770

Investigational medicinal product code

Other name

TGF-β1 monoclonal antibody

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

2 milligrams (mg) LY2382770 given (SC) injection monthly for 12 months

10 mg LY2382770

Arm description

10 mg LY2382770 given SC injection monthly for 12 months

Arm type

Experimental

Investigational medicinal product name

LY2382770

Investigational medicinal product code

Other name

TGF-β1 monoclonal antibody

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

10 mg LY2382770 given SC injection monthly for 12 months.

50 mg LY2382770

Arm description

50 mg LY2382770 given SC injection monthly for 12 months. The number of participants stated is based on those who were randomized and received at least one 50 mg dose of study drug? The number of participants randomized is 106.

Arm type

Experimental

Investigational medicinal product name

LY2382770

Investigational medicinal product code

Other name

TGF-β1 monoclonal antibody

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

50 mg LY2382770 given SC injection monthly for 12 months.

Number of subjects in period 1	Placebo	2 mg LY2382770	10 mg LY2382770	50 mg LY2382770
Started	103	105	103	105
Received at least one dose of drug	103	105	103	105
Completed	62	65	66	65
Not completed	41	40	37	40
Consent withdrawn by subject	9	7	7	8
Physician decision	2	2	3	2
Clinical Endpoint (ESRD)	7	4	2	5
Adverse event, non-fatal	4	-	2	6
Sponsor Decision	15	21	20	15
Death	4	5	3	4
Protocol deviation	-	1	-	-

Baseline characteristics

Top of page

Reporting group title

Overall Study

Reporting group description

Baseline Analysis Population Description: All participants who received at least 1 dose of study drug.

Reporting group values	Overall Study	Total
Number of subjects	416	416
Age categorical
Units: Subjects
In utero		0
Preterm newborn infants (gestational age < 37 wks)		0
Newborns (0-27 days)		0
Infants and toddlers (28 days-23 months)		0
Children (2-11 years)		0
Adolescents (12-17 years)		0
Adults (18-64 years)		0
From 65-84 years		0
85 years and over		0
Age Continuous
All participants who received at least 1 dose of study drug.
Units: years
arithmetic mean (standard deviation)	62.2 ± 10.16	-
Gender, Male/Female
Units:
Male	320	320
Female	96	96
Region of Enrollment
Units: Subjects
France	32	32
United States	145	145
Czech Republic	45	45
Hungary	57	57
Puerto Rico	15	15
Australia	40	40
Israel	82	82
Ethnicity
Units: Subjects
Hispanic or Latino	45	45
Not Hispanic or Latino	211	211
Unknown or Not Reported	160	160
Race
Units: Subjects
American Indian or Alaska Native	0	0
Asian	8	8
Native Hawaiian or Other Pacific Islander	2	2
Black or African American	39	39
White	347	347
More than one race	3	3
Unknown or Not Reported	17	17
Serum Creatinine
Units: milligram/deciliter (mg/dl)
arithmetic mean (standard deviation)	2.14 ± 0.6141	-
Urine Protein/Creatinine Ratio
Units: gram/gram
arithmetic mean (standard deviation)	3.262 ± 2.5148	-
Estimated Glomerular Filtration Rate (eGFR)
Units: milliliter/minute/1.73 meter squared
arithmetic mean (standard deviation)	35.464 ± 11.8539	-

End points

Top of page

Reporting group title

Placebo

Reporting group description

Placebo given subcutaneous (SC) injection monthly for 12 months

Reporting group title

2 mg LY2382770

Reporting group description

2 milligrams (mg) LY2382770 given (SC) injection monthly for 12 months

Reporting group title

10 mg LY2382770

Reporting group description

10 mg LY2382770 given SC injection monthly for 12 months

Reporting group title

50 mg LY2382770

Reporting group description

50 mg LY2382770 given SC injection monthly for 12 months. The number of participants stated is based on those who were randomized and received at least one 50 mg dose of study drug? The number of participants randomized is 106.

Subject analysis set title

Overall Study

Subject analysis set type

Full analysis

Subject analysis set description

All participants who received at least 1 dose of study drug.

Primary: Change in Log Transformed (in) Serum Creatinine from baseline to 12 month endpoint

Top of page

End point title

Change in Log Transformed (in) Serum Creatinine from baseline to 12 month endpoint

End point description

Log-transformed serum creatinine change from baseline. Analysis of covariance (ANCOVA) model was used with treatment, visit, and treatment-by-visit interaction as fixed effects, subject as random effect, baseline Serum Creatinine log transformed (ln) and first morning urine protein to creatinine ratio (PCR) log transformed (ln) as covariates. Analysis Population Description: All randomized participants who received at least 1 dose of drug and had evaluable baseline and post baseline serum creatinine values.

End point type

Primary

End point timeframe

Baseline, 12 months

End point values	Placebo	2 mg LY2382770	10 mg LY2382770	50 mg LY2382770
Number of subjects analysed	85	90	91	82
Units: ln milligrams per deciliter [ln(mg/dL)]
least squares mean (standard error)	0.13 ± 0.019	0.18 ± 0.019	0.17 ± 0.019	0.17 ± 0.02

Primary : Serum Creatinine (log transformed)

Comparison groups

Placebo v 2 mg LY2382770 v 10 mg LY2382770 v 50 mg LY2382770

Number of subjects included in analysis

348

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.89

Method

Maximum trend multivariate ttest,1-sided

Confidence interval

Secondary: Change in Log Transformed (in) Urine Protein/Creatinine Ratio from baseline to 12 month endpoint

Top of page

End point title

Change in Log Transformed (in) Urine Protein/Creatinine Ratio from baseline to 12 month endpoint

End point description

Log transformed urine protein to creatinine ratio change from baseline. Analysis of covariance (ANCOVA) model was used with treatment, visit, and treatment-by-visit interaction as fixed effects, subject as random effect, baseline Serum Creatinine log transformed (ln) and first morning urine protein to creatinine ratio (PCR) log transformed (ln) as covariates. Analysis Population Description: All randomized participants who received at least 1 dose of drug and had evaluable urine protein and creatinine ratio values.

End point type

Secondary

End point timeframe

Baseline, 12 months

End point values	Placebo	2 mg LY2382770	10 mg LY2382770	50 mg LY2382770
Number of subjects analysed	82	87	85	81
Units: ln grams/grams [ln( g/g)]
least squares mean (standard error)	0.06 ± 0.076	0.05 ± 0.072	0.05 ± 0.073	-0.01 ± 0.075

No statistical analyses for this end point

Secondary: Population Pharmacokinetics (PK) - Model-Estimated Area Under the Concentration –Time Curve (AUC ) Over a Dosing Interval

Top of page

End point title

Population Pharmacokinetics (PK) - Model-Estimated Area Under the Concentration –Time Curve (AUC ) Over a Dosing Interval

End point description

Analysis Population Description : All randomized participants who received at least 1 dose of drug and had evaluable PK data.

End point type

Secondary

End point timeframe

Baseline through 12 months (samples collected pre and/or postdose at monthly intervals)

End point values	Placebo	2 mg LY2382770	10 mg LY2382770	50 mg LY2382770
Number of subjects analysed	0 ^[1]	105	101	104
Units: microgram*hour per milliliter(µg•hr/mL)
geometric mean (geometric coefficient of variation)	±	54.4 ± 49	197 ± 45	957 ± 44

Notes
[1] - There were no participants analyzed in the placebo arm.

No statistical analyses for this end point

Secondary: Log Transformed (in) Serum creatinine slope of change from baseline through 12 months

Top of page

End point title

Log Transformed (in) Serum creatinine slope of change from baseline through 12 months

End point description

Log transformed serum creatinine slope of change from baseline through 12 months. Analysis of covariance (ANCOVA) model was used with treatment as fixed effects and baseline Serum Creatinine log transformed (ln) and first morning urine protein to creatinine ratio (PCR) log transformed (ln) as covariates. Analysis Population Description: All randomized participants who received at least 1 dose of drug.

End point type

Secondary

End point timeframe

Baseline through 12 months

End point values	Placebo	2 mg LY2382770	10 mg LY2382770	50 mg LY2382770
Number of subjects analysed	103	105	103	105
Units: ln milligrams per deciliter(mg/dL)/month
least squares mean (standard error)	0.01605 ± 0.002685	0.01408 ± 0.002731	0.01716 ± 0.002658	0.01337 ± 0.002712

No statistical analyses for this end point

Secondary: Estimated Glomerular Filtration Rate (eGFR) Slope of Change from Baseline Through 12 Months

Top of page

End point title

Estimated Glomerular Filtration Rate (eGFR) Slope of Change from Baseline Through 12 Months

End point description

eGFR slope of change from baseline through 12 months. Analysis of covariance (ANCOVA) model was used with treatment as fixed effects, baseline Serum Creatinine log transformed (ln) and first morning urine protein to creatinine ratio (PCR) log transformed (ln) as covariates. Analysis Population Description: All randomized participants who received at least 1 dose of drug.

End point type

Secondary

End point timeframe

Baseline through 12 months

End point values	Placebo	2 mg LY2382770	10 mg LY2382770	50 mg LY2382770
Number of subjects analysed	103	105	103	105
Units: mL/min/1.73 m²/month
least squares mean (standard error)	-0.3727 ± 0.08599	-0.3664 ± 0.08742	-0.5554 ± 0.08512	-0.398 ± 0.08683

No statistical analyses for this end point

Adverse events

Top of page

Timeframe for reporting adverse events

Entire Study All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.

Adverse event reporting additional description

H9V-MC-GFRF

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

17.0

Reporting group title

LY2382770 2 mg

Reporting group description

-

Reporting group title

LY2382770 10 mg

Reporting group description

-

Reporting group title

LY2382770 50 mg

Reporting group description

-

Reporting group title

Placebo

Reporting group description

-

Serious adverse events	LY2382770 2 mg	LY2382770 10 mg	LY2382770 50 mg	Placebo
Total subjects affected by serious adverse events
subjects affected / exposed	44 / 105 (41.90%)	37 / 103 (35.92%)	41 / 105 (39.05%)	39 / 103 (37.86%)
number of deaths (all causes)	5	3	4	4
number of deaths resulting from adverse events	0	0	1	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
adenocarcinoma pancreas
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	0 / 105 (0.00%)	0 / 103 (0.00%)	1 / 105 (0.95%)	0 / 103 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	1 / 1	0 / 0
melanocytic naevus
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	0 / 105 (0.00%)	0 / 103 (0.00%)	0 / 105 (0.00%)	1 / 103 (0.97%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
non-small cell lung cancer
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	0 / 105 (0.00%)	0 / 103 (0.00%)	0 / 105 (0.00%)	1 / 103 (0.97%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
renal cell carcinoma
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	1 / 105 (0.95%)	0 / 103 (0.00%)	0 / 105 (0.00%)	0 / 103 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
sweat gland tumour
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	1 / 105 (0.95%)	0 / 103 (0.00%)	0 / 105 (0.00%)	0 / 103 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Vascular disorders
arteriosclerosis
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	1 / 105 (0.95%)	0 / 103 (0.00%)	0 / 105 (0.00%)	0 / 103 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
hypertension
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	1 / 105 (0.95%)	1 / 103 (0.97%)	1 / 105 (0.95%)	2 / 103 (1.94%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
hypertensive crisis
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	0 / 105 (0.00%)	0 / 103 (0.00%)	1 / 105 (0.95%)	1 / 103 (0.97%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
hypotension
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	1 / 105 (0.95%)	0 / 103 (0.00%)	0 / 105 (0.00%)	0 / 103 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
orthostatic hypotension
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	0 / 105 (0.00%)	0 / 103 (0.00%)	0 / 105 (0.00%)	1 / 103 (0.97%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
peripheral ischaemia
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	0 / 105 (0.00%)	0 / 103 (0.00%)	1 / 105 (0.95%)	0 / 103 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
vena cava thrombosis
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	0 / 105 (0.00%)	0 / 103 (0.00%)	1 / 105 (0.95%)	0 / 103 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
General disorders and administration site conditions
chest pain
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	1 / 105 (0.95%)	0 / 103 (0.00%)	0 / 105 (0.00%)	0 / 103 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
chills
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	0 / 105 (0.00%)	0 / 103 (0.00%)	0 / 105 (0.00%)	1 / 103 (0.97%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
device failure
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	1 / 105 (0.95%)	0 / 103 (0.00%)	0 / 105 (0.00%)	0 / 103 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
generalised oedema
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	0 / 105 (0.00%)	0 / 103 (0.00%)	1 / 105 (0.95%)	0 / 103 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
multi-organ failure
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	0 / 105 (0.00%)	0 / 103 (0.00%)	0 / 105 (0.00%)	1 / 103 (0.97%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
non-cardiac chest pain
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	1 / 105 (0.95%)	0 / 103 (0.00%)	1 / 105 (0.95%)	1 / 103 (0.97%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
oedema peripheral
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	0 / 105 (0.00%)	2 / 103 (1.94%)	1 / 105 (0.95%)	1 / 103 (0.97%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
pyrexia
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	0 / 105 (0.00%)	0 / 103 (0.00%)	0 / 105 (0.00%)	1 / 103 (0.97%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
sudden death
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	1 / 105 (0.95%)	0 / 103 (0.00%)	0 / 105 (0.00%)	0 / 103 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
acute pulmonary oedema
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	0 / 105 (0.00%)	0 / 103 (0.00%)	0 / 105 (0.00%)	1 / 103 (0.97%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
acute respiratory failure
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	0 / 105 (0.00%)	1 / 103 (0.97%)	0 / 105 (0.00%)	2 / 103 (1.94%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
asthma
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	0 / 105 (0.00%)	0 / 103 (0.00%)	1 / 105 (0.95%)	0 / 103 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
chronic obstructive pulmonary disease
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	1 / 105 (0.95%)	0 / 103 (0.00%)	2 / 105 (1.90%)	0 / 103 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
dyspnoea
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	2 / 105 (1.90%)	0 / 103 (0.00%)	0 / 105 (0.00%)	2 / 103 (1.94%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 0	1 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
dyspnoea exertional
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	0 / 105 (0.00%)	0 / 103 (0.00%)	1 / 105 (0.95%)	0 / 103 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
lung disorder
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	0 / 105 (0.00%)	1 / 103 (0.97%)	0 / 105 (0.00%)	0 / 103 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
pneumonia aspiration
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	0 / 105 (0.00%)	0 / 103 (0.00%)	0 / 105 (0.00%)	1 / 103 (0.97%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
pulmonary congestion
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	1 / 105 (0.95%)	0 / 103 (0.00%)	1 / 105 (0.95%)	0 / 103 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
pulmonary hypertension
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	0 / 105 (0.00%)	2 / 103 (1.94%)	0 / 105 (0.00%)	0 / 103 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
pulmonary oedema
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	0 / 105 (0.00%)	0 / 103 (0.00%)	1 / 105 (0.95%)	1 / 103 (0.97%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
respiratory failure
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	1 / 105 (0.95%)	0 / 103 (0.00%)	0 / 105 (0.00%)	0 / 103 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
Psychiatric disorders
anxiety
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	0 / 105 (0.00%)	0 / 103 (0.00%)	1 / 105 (0.95%)	0 / 103 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Injury, poisoning and procedural complications
ankle fracture
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	1 / 105 (0.95%)	0 / 103 (0.00%)	0 / 105 (0.00%)	0 / 103 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
arteriovenous fistula occlusion
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	0 / 105 (0.00%)	1 / 103 (0.97%)	0 / 105 (0.00%)	0 / 103 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
fall
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	1 / 105 (0.95%)	1 / 103 (0.97%)	0 / 105 (0.00%)	0 / 103 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
foot fracture
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	0 / 105 (0.00%)	0 / 103 (0.00%)	1 / 105 (0.95%)	0 / 103 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
humerus fracture
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	0 / 105 (0.00%)	1 / 103 (0.97%)	0 / 105 (0.00%)	0 / 103 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
postoperative thoracic procedure complication
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	0 / 105 (0.00%)	0 / 103 (0.00%)	1 / 105 (0.95%)	0 / 103 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
spinal compression fracture
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	0 / 105 (0.00%)	1 / 103 (0.97%)	0 / 105 (0.00%)	0 / 103 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
upper limb fracture
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	1 / 105 (0.95%)	0 / 103 (0.00%)	0 / 105 (0.00%)	0 / 103 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
urinary retention postoperative
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	0 / 105 (0.00%)	0 / 103 (0.00%)	0 / 105 (0.00%)	1 / 103 (0.97%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Cardiac disorders
acute coronary syndrome
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	1 / 105 (0.95%)	1 / 103 (0.97%)	2 / 105 (1.90%)	0 / 103 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
acute myocardial infarction
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	4 / 105 (3.81%)	1 / 103 (0.97%)	3 / 105 (2.86%)	3 / 103 (2.91%)
occurrences causally related to treatment / all	0 / 5	0 / 1	0 / 5	0 / 3
deaths causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
angina pectoris
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	2 / 105 (1.90%)	0 / 103 (0.00%)	1 / 105 (0.95%)	0 / 103 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
angina unstable
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	2 / 105 (1.90%)	2 / 103 (1.94%)	1 / 105 (0.95%)	0 / 103 (0.00%)
occurrences causally related to treatment / all	1 / 3	0 / 2	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
atrial fibrillation
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	0 / 105 (0.00%)	0 / 103 (0.00%)	0 / 105 (0.00%)	4 / 103 (3.88%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	1 / 4
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
bradycardia
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	1 / 105 (0.95%)	0 / 103 (0.00%)	1 / 105 (0.95%)	0 / 103 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
cardiac arrest
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	0 / 105 (0.00%)	0 / 103 (0.00%)	1 / 105 (0.95%)	0 / 103 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
cardiac failure
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	1 / 105 (0.95%)	3 / 103 (2.91%)	1 / 105 (0.95%)	5 / 103 (4.85%)
occurrences causally related to treatment / all	0 / 1	1 / 3	0 / 1	1 / 5
deaths causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 1
cardiac failure congestive
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	0 / 105 (0.00%)	4 / 103 (3.88%)	6 / 105 (5.71%)	2 / 103 (1.94%)
occurrences causally related to treatment / all	0 / 0	0 / 4	0 / 8	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 1	0 / 1	0 / 0
cardiomegaly
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	0 / 105 (0.00%)	0 / 103 (0.00%)	1 / 105 (0.95%)	0 / 103 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
coronary artery disease
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	1 / 105 (0.95%)	1 / 103 (0.97%)	1 / 105 (0.95%)	0 / 103 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
mitral valve disease
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	0 / 105 (0.00%)	0 / 103 (0.00%)	1 / 105 (0.95%)	0 / 103 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
myocardial infarction
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	2 / 105 (1.90%)	2 / 103 (1.94%)	1 / 105 (0.95%)	1 / 103 (0.97%)
occurrences causally related to treatment / all	0 / 2	0 / 2	1 / 1	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 1	0 / 0	0 / 1
myocardial ischaemia
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	1 / 105 (0.95%)	0 / 103 (0.00%)	1 / 105 (0.95%)	0 / 103 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
pericardial effusion
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	0 / 105 (0.00%)	0 / 103 (0.00%)	0 / 105 (0.00%)	1 / 103 (0.97%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
tachycardia
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	0 / 105 (0.00%)	1 / 103 (0.97%)	0 / 105 (0.00%)	0 / 103 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Nervous system disorders
carotid artery stenosis
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	1 / 105 (0.95%)	0 / 103 (0.00%)	0 / 105 (0.00%)	1 / 103 (0.97%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
central nervous system lesion
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	0 / 105 (0.00%)	0 / 103 (0.00%)	0 / 105 (0.00%)	1 / 103 (0.97%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
cerebellar ischaemia
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	0 / 105 (0.00%)	0 / 103 (0.00%)	0 / 105 (0.00%)	1 / 103 (0.97%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
cerebral ischaemia
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	1 / 105 (0.95%)	0 / 103 (0.00%)	0 / 105 (0.00%)	0 / 103 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
cerebrovascular accident
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	3 / 105 (2.86%)	1 / 103 (0.97%)	1 / 105 (0.95%)	0 / 103 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
diabetic hyperosmolar coma
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	0 / 105 (0.00%)	0 / 103 (0.00%)	1 / 105 (0.95%)	0 / 103 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
diabetic mononeuropathy
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	1 / 105 (0.95%)	0 / 103 (0.00%)	0 / 105 (0.00%)	0 / 103 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
dysarthria
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	1 / 105 (0.95%)	0 / 103 (0.00%)	0 / 105 (0.00%)	0 / 103 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
epilepsy
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	0 / 105 (0.00%)	1 / 103 (0.97%)	0 / 105 (0.00%)	0 / 103 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
hemiparesis
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	1 / 105 (0.95%)	0 / 103 (0.00%)	0 / 105 (0.00%)	0 / 103 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
hydrocephalus
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	0 / 105 (0.00%)	1 / 103 (0.97%)	0 / 105 (0.00%)	0 / 103 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
hypoglycaemic coma
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	0 / 105 (0.00%)	1 / 103 (0.97%)	0 / 105 (0.00%)	0 / 103 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
hypoglycaemic seizure
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	1 / 105 (0.95%)	1 / 103 (0.97%)	0 / 105 (0.00%)	0 / 103 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
ischaemic cerebral infarction
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	0 / 105 (0.00%)	1 / 103 (0.97%)	0 / 105 (0.00%)	0 / 103 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
ischaemic stroke
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	0 / 105 (0.00%)	2 / 103 (1.94%)	0 / 105 (0.00%)	2 / 103 (1.94%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
transient ischaemic attack
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	1 / 105 (0.95%)	0 / 103 (0.00%)	0 / 105 (0.00%)	2 / 103 (1.94%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	1 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
vertebrobasilar insufficiency
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	0 / 105 (0.00%)	0 / 103 (0.00%)	1 / 105 (0.95%)	0 / 103 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Blood and lymphatic system disorders
anaemia
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	0 / 105 (0.00%)	1 / 103 (0.97%)	2 / 105 (1.90%)	2 / 103 (1.94%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Ear and labyrinth disorders
vertigo positional
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	1 / 105 (0.95%)	0 / 103 (0.00%)	0 / 105 (0.00%)	0 / 103 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Eye disorders
cataract
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	0 / 105 (0.00%)	0 / 103 (0.00%)	1 / 105 (0.95%)	0 / 103 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
corneal oedema
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	1 / 105 (0.95%)	0 / 103 (0.00%)	0 / 105 (0.00%)	0 / 103 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
macular hole
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	0 / 105 (0.00%)	1 / 103 (0.97%)	0 / 105 (0.00%)	0 / 103 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
posterior capsule rupture
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	1 / 105 (0.95%)	0 / 103 (0.00%)	0 / 105 (0.00%)	0 / 103 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
retinal artery occlusion
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	1 / 105 (0.95%)	0 / 103 (0.00%)	0 / 105 (0.00%)	0 / 103 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
retinal detachment
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	1 / 105 (0.95%)	0 / 103 (0.00%)	0 / 105 (0.00%)	0 / 103 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
vitreous haemorrhage
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	0 / 105 (0.00%)	1 / 103 (0.97%)	1 / 105 (0.95%)	0 / 103 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 4	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Gastrointestinal disorders
abdominal pain
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	1 / 105 (0.95%)	1 / 103 (0.97%)	0 / 105 (0.00%)	0 / 103 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
colitis ischaemic
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	0 / 105 (0.00%)	1 / 103 (0.97%)	0 / 105 (0.00%)	0 / 103 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
colitis ulcerative
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	0 / 105 (0.00%)	0 / 103 (0.00%)	0 / 105 (0.00%)	1 / 103 (0.97%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
diarrhoea
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	0 / 105 (0.00%)	2 / 103 (1.94%)	0 / 105 (0.00%)	0 / 103 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
gastritis
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	0 / 105 (0.00%)	0 / 103 (0.00%)	0 / 105 (0.00%)	1 / 103 (0.97%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
gastrointestinal haemorrhage
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	1 / 105 (0.95%)	1 / 103 (0.97%)	0 / 105 (0.00%)	1 / 103 (0.97%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
gastrointestinal inflammation
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	0 / 105 (0.00%)	0 / 103 (0.00%)	0 / 105 (0.00%)	1 / 103 (0.97%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
gastrointestinal ulcer haemorrhage
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	1 / 105 (0.95%)	0 / 103 (0.00%)	0 / 105 (0.00%)	0 / 103 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
haematemesis
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	0 / 105 (0.00%)	0 / 103 (0.00%)	0 / 105 (0.00%)	1 / 103 (0.97%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
haemorrhoidal haemorrhage
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	0 / 105 (0.00%)	0 / 103 (0.00%)	0 / 105 (0.00%)	1 / 103 (0.97%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
inguinal hernia, obstructive
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	1 / 105 (0.95%)	0 / 103 (0.00%)	0 / 105 (0.00%)	0 / 103 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
intestinal obstruction
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	0 / 105 (0.00%)	0 / 103 (0.00%)	0 / 105 (0.00%)	1 / 103 (0.97%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
intestinal polyp
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	1 / 105 (0.95%)	0 / 103 (0.00%)	0 / 105 (0.00%)	0 / 103 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
large intestine polyp
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	0 / 105 (0.00%)	1 / 103 (0.97%)	0 / 105 (0.00%)	0 / 103 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
mallory-weiss syndrome
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	0 / 105 (0.00%)	0 / 103 (0.00%)	0 / 105 (0.00%)	1 / 103 (0.97%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
nausea
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	1 / 105 (0.95%)	0 / 103 (0.00%)	0 / 105 (0.00%)	0 / 103 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
vomiting
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	2 / 105 (1.90%)	0 / 103 (0.00%)	0 / 105 (0.00%)	0 / 103 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Hepatobiliary disorders
cholecystitis acute
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	0 / 105 (0.00%)	0 / 103 (0.00%)	1 / 105 (0.95%)	0 / 103 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
liver disorder
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	1 / 105 (0.95%)	0 / 103 (0.00%)	0 / 105 (0.00%)	0 / 103 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Skin and subcutaneous tissue disorders
angioedema
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	1 / 105 (0.95%)	0 / 103 (0.00%)	0 / 105 (0.00%)	0 / 103 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
skin ulcer
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	1 / 105 (0.95%)	0 / 103 (0.00%)	1 / 105 (0.95%)	0 / 103 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Renal and urinary disorders
azotaemia
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	0 / 105 (0.00%)	0 / 103 (0.00%)	0 / 105 (0.00%)	1 / 103 (0.97%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
diabetic nephropathy
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	1 / 105 (0.95%)	1 / 103 (0.97%)	0 / 105 (0.00%)	0 / 103 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
dysuria
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	1 / 105 (0.95%)	0 / 103 (0.00%)	0 / 105 (0.00%)	0 / 103 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
nephrolithiasis
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	0 / 105 (0.00%)	0 / 103 (0.00%)	0 / 105 (0.00%)	1 / 103 (0.97%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
nephropathy
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	0 / 105 (0.00%)	0 / 103 (0.00%)	0 / 105 (0.00%)	1 / 103 (0.97%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
renal failure
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	2 / 105 (1.90%)	1 / 103 (0.97%)	2 / 105 (1.90%)	1 / 103 (0.97%)
occurrences causally related to treatment / all	0 / 2	0 / 1	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
renal failure acute
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	5 / 105 (4.76%)	3 / 103 (2.91%)	8 / 105 (7.62%)	2 / 103 (1.94%)
occurrences causally related to treatment / all	0 / 5	0 / 3	1 / 10	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
renal failure chronic
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	4 / 105 (3.81%)	2 / 103 (1.94%)	1 / 105 (0.95%)	5 / 103 (4.85%)
occurrences causally related to treatment / all	0 / 4	0 / 2	0 / 1	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
renal impairment
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	0 / 105 (0.00%)	0 / 103 (0.00%)	0 / 105 (0.00%)	1 / 103 (0.97%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Musculoskeletal and connective tissue disorders
back pain
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	1 / 105 (0.95%)	0 / 103 (0.00%)	0 / 105 (0.00%)	0 / 103 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
myopathy
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	1 / 105 (0.95%)	0 / 103 (0.00%)	0 / 105 (0.00%)	0 / 103 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
neuropathic arthropathy
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	0 / 105 (0.00%)	0 / 103 (0.00%)	0 / 105 (0.00%)	1 / 103 (0.97%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
osteoarthritis
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	1 / 105 (0.95%)	0 / 103 (0.00%)	0 / 105 (0.00%)	1 / 103 (0.97%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
vertebral foraminal stenosis
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	0 / 105 (0.00%)	0 / 103 (0.00%)	0 / 105 (0.00%)	1 / 103 (0.97%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Infections and infestations
bacteraemia
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	0 / 105 (0.00%)	0 / 103 (0.00%)	0 / 105 (0.00%)	1 / 103 (0.97%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
breast abscess
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	1 / 105 (0.95%)	0 / 103 (0.00%)	0 / 105 (0.00%)	0 / 103 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
bronchiolitis
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	0 / 105 (0.00%)	0 / 103 (0.00%)	0 / 105 (0.00%)	1 / 103 (0.97%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
bronchopneumonia
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	0 / 105 (0.00%)	0 / 103 (0.00%)	0 / 105 (0.00%)	1 / 103 (0.97%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
cellulitis
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	2 / 105 (1.90%)	2 / 103 (1.94%)	2 / 105 (1.90%)	2 / 103 (1.94%)
occurrences causally related to treatment / all	0 / 2	0 / 2	0 / 3	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
clostridium difficile colitis
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	0 / 105 (0.00%)	0 / 103 (0.00%)	1 / 105 (0.95%)	1 / 103 (0.97%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
dermatitis infected
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	0 / 105 (0.00%)	0 / 103 (0.00%)	1 / 105 (0.95%)	0 / 103 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
device related infection
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	0 / 105 (0.00%)	0 / 103 (0.00%)	1 / 105 (0.95%)	0 / 103 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
enterobacter bacteraemia
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	0 / 105 (0.00%)	0 / 103 (0.00%)	1 / 105 (0.95%)	0 / 103 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
furuncle
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	0 / 105 (0.00%)	0 / 103 (0.00%)	1 / 105 (0.95%)	0 / 103 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
gangrene
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	0 / 105 (0.00%)	1 / 103 (0.97%)	0 / 105 (0.00%)	0 / 103 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
gastroenteritis
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	0 / 105 (0.00%)	1 / 103 (0.97%)	0 / 105 (0.00%)	0 / 103 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
gastroenteritis viral
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	0 / 105 (0.00%)	0 / 103 (0.00%)	2 / 105 (1.90%)	0 / 103 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
infective exacerbation of bronchiectasis
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	0 / 105 (0.00%)	0 / 103 (0.00%)	0 / 105 (0.00%)	1 / 103 (0.97%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
intervertebral discitis
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	0 / 105 (0.00%)	1 / 103 (0.97%)	0 / 105 (0.00%)	0 / 103 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
klebsiella sepsis
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	0 / 105 (0.00%)	1 / 103 (0.97%)	0 / 105 (0.00%)	0 / 103 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
orchitis
alternative dictionary used: MedDRA 17.0
subjects affected / exposed ^[1]	1 / 84 (1.19%)	0 / 74 (0.00%)	0 / 86 (0.00%)	0 / 76 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
osteomyelitis
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	0 / 105 (0.00%)	0 / 103 (0.00%)	0 / 105 (0.00%)	1 / 103 (0.97%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
otitis externa
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	0 / 105 (0.00%)	0 / 103 (0.00%)	0 / 105 (0.00%)	1 / 103 (0.97%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
pneumonia
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	2 / 105 (1.90%)	0 / 103 (0.00%)	4 / 105 (3.81%)	1 / 103 (0.97%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 4	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
pneumonia bacterial
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	0 / 105 (0.00%)	0 / 103 (0.00%)	1 / 105 (0.95%)	0 / 103 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
pneumonia staphylococcal
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	1 / 105 (0.95%)	0 / 103 (0.00%)	0 / 105 (0.00%)	0 / 103 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
pseudomembranous colitis
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	0 / 105 (0.00%)	1 / 103 (0.97%)	0 / 105 (0.00%)	0 / 103 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
sepsis
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	1 / 105 (0.95%)	0 / 103 (0.00%)	1 / 105 (0.95%)	1 / 103 (0.97%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
staphylococcal abscess
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	0 / 105 (0.00%)	1 / 103 (0.97%)	0 / 105 (0.00%)	0 / 103 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
staphylococcal bacteraemia
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	0 / 105 (0.00%)	0 / 103 (0.00%)	1 / 105 (0.95%)	0 / 103 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
streptococcal urinary tract infection
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	0 / 105 (0.00%)	0 / 103 (0.00%)	1 / 105 (0.95%)	0 / 103 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
subcutaneous abscess
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	1 / 105 (0.95%)	0 / 103 (0.00%)	0 / 105 (0.00%)	0 / 103 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
superinfection bacterial
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	0 / 105 (0.00%)	0 / 103 (0.00%)	1 / 105 (0.95%)	0 / 103 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
tonsillitis
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	0 / 105 (0.00%)	0 / 103 (0.00%)	0 / 105 (0.00%)	1 / 103 (0.97%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
upper respiratory tract infection
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	1 / 105 (0.95%)	0 / 103 (0.00%)	1 / 105 (0.95%)	0 / 103 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
urinary tract infection
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	0 / 105 (0.00%)	0 / 103 (0.00%)	2 / 105 (1.90%)	0 / 103 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Metabolism and nutrition disorders
dehydration
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	1 / 105 (0.95%)	0 / 103 (0.00%)	1 / 105 (0.95%)	0 / 103 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
diabetes mellitus inadequate control
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	1 / 105 (0.95%)	0 / 103 (0.00%)	0 / 105 (0.00%)	0 / 103 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
diabetic ketoacidosis
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	1 / 105 (0.95%)	0 / 103 (0.00%)	0 / 105 (0.00%)	3 / 103 (2.91%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
fluid overload
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	1 / 105 (0.95%)	1 / 103 (0.97%)	1 / 105 (0.95%)	1 / 103 (0.97%)
occurrences causally related to treatment / all	0 / 3	0 / 1	2 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
hyperglycaemia
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	2 / 105 (1.90%)	0 / 103 (0.00%)	1 / 105 (0.95%)	1 / 103 (0.97%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
hyperglycaemic hyperosmolar nonketotic syndrome
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	0 / 105 (0.00%)	0 / 103 (0.00%)	1 / 105 (0.95%)	0 / 103 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
hyperkalaemia
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	2 / 105 (1.90%)	1 / 103 (0.97%)	1 / 105 (0.95%)	2 / 103 (1.94%)
occurrences causally related to treatment / all	0 / 2	0 / 1	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
hypoglycaemia
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	2 / 105 (1.90%)	1 / 103 (0.97%)	2 / 105 (1.90%)	1 / 103 (0.97%)
occurrences causally related to treatment / all	0 / 3	0 / 1	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
hypokalaemia
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	0 / 105 (0.00%)	0 / 103 (0.00%)	1 / 105 (0.95%)	0 / 103 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
type 1 diabetes mellitus
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	0 / 105 (0.00%)	1 / 103 (0.97%)	0 / 105 (0.00%)	0 / 103 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0

Notes
[1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: This event is gender specific, only occurring in male or female subjects. The number of subjects exposed has been adjusted accordingly.

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

Non-serious adverse events	LY2382770 2 mg	LY2382770 10 mg	LY2382770 50 mg	Placebo
Total subjects affected by non serious adverse events
subjects affected / exposed	67 / 105 (63.81%)	62 / 103 (60.19%)	62 / 105 (59.05%)	57 / 103 (55.34%)
Vascular disorders
hypertension
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	6 / 105 (5.71%)	9 / 103 (8.74%)	5 / 105 (4.76%)	6 / 103 (5.83%)
occurrences all number	6	9	5	6
Nervous system disorders
dizziness
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	8 / 105 (7.62%)	4 / 103 (3.88%)	9 / 105 (8.57%)	8 / 103 (7.77%)
occurrences all number	9	4	12	9
headache
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	7 / 105 (6.67%)	8 / 103 (7.77%)	2 / 105 (1.90%)	3 / 103 (2.91%)
occurrences all number	7	9	2	5
Blood and lymphatic system disorders
anaemia
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	6 / 105 (5.71%)	4 / 103 (3.88%)	5 / 105 (4.76%)	7 / 103 (6.80%)
occurrences all number	6	4	5	7
General disorders and administration site conditions
fatigue
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	3 / 105 (2.86%)	6 / 103 (5.83%)	5 / 105 (4.76%)	8 / 103 (7.77%)
occurrences all number	3	6	5	9
local swelling
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	2 / 105 (1.90%)	1 / 103 (0.97%)	1 / 105 (0.95%)	7 / 103 (6.80%)
occurrences all number	3	2	2	7
oedema peripheral
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	20 / 105 (19.05%)	11 / 103 (10.68%)	5 / 105 (4.76%)	15 / 103 (14.56%)
occurrences all number	22	11	5	15
Gastrointestinal disorders
constipation
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	8 / 105 (7.62%)	8 / 103 (7.77%)	5 / 105 (4.76%)	4 / 103 (3.88%)
occurrences all number	10	8	7	4
diarrhoea
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	10 / 105 (9.52%)	11 / 103 (10.68%)	6 / 105 (5.71%)	4 / 103 (3.88%)
occurrences all number	15	14	6	8
nausea
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	7 / 105 (6.67%)	5 / 103 (4.85%)	7 / 105 (6.67%)	5 / 103 (4.85%)
occurrences all number	8	5	8	5
vomiting
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	3 / 105 (2.86%)	5 / 103 (4.85%)	8 / 105 (7.62%)	4 / 103 (3.88%)
occurrences all number	3	6	10	4
Reproductive system and breast disorders
uterine polyp
alternative dictionary used: MedDRA 17.0
subjects affected / exposed ^[2]	0 / 21 (0.00%)	0 / 29 (0.00%)	1 / 19 (5.26%)	0 / 27 (0.00%)
occurrences all number	0	0	1	0
vaginal discharge
alternative dictionary used: MedDRA 17.0
subjects affected / exposed ^[3]	0 / 21 (0.00%)	0 / 29 (0.00%)	1 / 19 (5.26%)	0 / 27 (0.00%)
occurrences all number	0	0	1	0
vulvovaginal pruritus
alternative dictionary used: MedDRA 17.0
subjects affected / exposed ^[4]	0 / 21 (0.00%)	0 / 29 (0.00%)	1 / 19 (5.26%)	0 / 27 (0.00%)
occurrences all number	0	0	1	0
Respiratory, thoracic and mediastinal disorders
cough
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	7 / 105 (6.67%)	5 / 103 (4.85%)	9 / 105 (8.57%)	2 / 103 (1.94%)
occurrences all number	7	6	10	2
dyspnoea
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	4 / 105 (3.81%)	2 / 103 (1.94%)	6 / 105 (5.71%)	4 / 103 (3.88%)
occurrences all number	4	2	6	4
Musculoskeletal and connective tissue disorders
arthralgia
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	7 / 105 (6.67%)	6 / 103 (5.83%)	3 / 105 (2.86%)	4 / 103 (3.88%)
occurrences all number	8	7	3	5
back pain
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	8 / 105 (7.62%)	9 / 103 (8.74%)	5 / 105 (4.76%)	6 / 103 (5.83%)
occurrences all number	8	9	5	6
muscle spasms
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	6 / 105 (5.71%)	4 / 103 (3.88%)	4 / 105 (3.81%)	3 / 103 (2.91%)
occurrences all number	6	5	4	3
pain in extremity
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	8 / 105 (7.62%)	4 / 103 (3.88%)	5 / 105 (4.76%)	4 / 103 (3.88%)
occurrences all number	11	4	6	4
Infections and infestations
bronchitis
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	8 / 105 (7.62%)	4 / 103 (3.88%)	6 / 105 (5.71%)	5 / 103 (4.85%)
occurrences all number	8	4	6	5
influenza
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	6 / 105 (5.71%)	4 / 103 (3.88%)	2 / 105 (1.90%)	4 / 103 (3.88%)
occurrences all number	8	4	2	4
nasopharyngitis
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	6 / 105 (5.71%)	3 / 103 (2.91%)	2 / 105 (1.90%)	8 / 103 (7.77%)
occurrences all number	6	5	2	8
upper respiratory tract infection
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	11 / 105 (10.48%)	13 / 103 (12.62%)	11 / 105 (10.48%)	10 / 103 (9.71%)
occurrences all number	11	16	13	11
urinary tract infection
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	10 / 105 (9.52%)	1 / 103 (0.97%)	3 / 105 (2.86%)	6 / 103 (5.83%)
occurrences all number	11	2	3	6
Metabolism and nutrition disorders
hyperkalaemia
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	6 / 105 (5.71%)	8 / 103 (7.77%)	4 / 105 (3.81%)	1 / 103 (0.97%)
occurrences all number	6	8	4	1
hypoglycaemia
alternative dictionary used: MedDRA 17.0
subjects affected / exposed	13 / 105 (12.38%)	9 / 103 (8.74%)	7 / 105 (6.67%)	10 / 103 (9.71%)
occurrences all number	20	25	15	16

Notes
[2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: This event is gender specific, only occurring in male or female subjects. The number of subjects exposed has been adjusted accordingly.
[3] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: This event is gender specific, only occurring in male or female subjects. The number of subjects exposed has been adjusted accordingly.
[4] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: This event is gender specific, only occurring in male or female subjects. The number of subjects exposed has been adjusted accordingly.

More information

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Were there any global substantial amendments to the protocol? Yes

10 Apr 2012

Lowering the proteinuria threshold for study entry from 1200 mg/g to 800 mg/g and a change in the planned interim analysis that in turn allowed for the early termination of the study for efficacy futility.

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.

Study was stopped early for efficacy futility per recommendation by the independent Data Safety Monitoring Committee.

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