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

interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC

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The EU Clinical Trials Register currently displays 44338 clinical trials with a EudraCT protocol, of which 7368 are clinical trials conducted with subjects less than 18 years old. The register also displays information on 18700 older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).

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Clinical Trial Results:
A Multicenter, Randomized, Double-Blind, Phase 3 Study of Ramucirumab (IMC-1121B) Drug Product and Best Supportive Care (BSC) Versus Placebo and BSC as Second-Line Treatment in Patients With Hepatocellular Carcinoma Following First-Line Therapy With Sorafenib (REACH)

Summary
EudraCT number	2010-019318-26
Trial protocol	FI DE CZ PT BE ES AT FR BG HU IT SE NO
Global end of trial date	17 Mar 2015

Results information
Results version number	v1(current)
This version publication date	02 Apr 2016
First version publication date	02 Apr 2016
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

I4T-IE-JVBF

ISRCTN number

-

US NCT number

NCT01140347

WHO universal trial number (UTN)

-

Other trial identifiers

Sponsor Trial Number: 13895, Sponsor Trial Alias: I4T-IE-JVBF, Alternate Trial Number: IMC-1121B

Sponsor organisation name

Eli Lilly and Company

Sponsor organisation address

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

Public contact

Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company, 1 877-CTLilly,

Scientific contact

Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, 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

17 Mar 2015

Is this the analysis of the primary completion data?

No

Global end of trial reached?

Yes

Global end of trial date

17 Mar 2015

Was the trial ended prematurely?

No

Main objective of the trial

The primary objective is to compare the overall survival (OS; time from randomization to death) in participants with hepatocellular carcinoma (HCC) who had disease progression during or following sorafenib therapy, or were intolerant to this agent. Participants will receive either ramucirumab (IMC 1121B) plus best supportive care (BSC) or placebo plus BSC.

Protection of trial subjects

This study was conducted in accordance with International Conference of 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 was conducted.

Background therapy

-

Evidence for comparator

-

Actual start date of recruitment

14 Oct 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

United States: 37

Country: Number of subjects enrolled

Portugal: 2

Country: Number of subjects enrolled

Philippines: 1

Country: Number of subjects enrolled

Taiwan: 58

Country: Number of subjects enrolled

Hong Kong: 24

Country: Number of subjects enrolled

Spain: 21

Country: Number of subjects enrolled

Thailand: 6

Country: Number of subjects enrolled

Israel: 2

Country: Number of subjects enrolled

Switzerland: 2

Country: Number of subjects enrolled

Italy: 51

Country: Number of subjects enrolled

France: 59

Country: Number of subjects enrolled

Australia: 11

Country: Number of subjects enrolled

Netherlands: 3

Country: Number of subjects enrolled

Korea, Republic of: 70

Country: Number of subjects enrolled

Finland: 3

Country: Number of subjects enrolled

Austria: 8

Country: Number of subjects enrolled

Czech Republic: 20

Country: Number of subjects enrolled

Hungary: 1

Country: Number of subjects enrolled

Canada: 1

Country: Number of subjects enrolled

Belgium: 8

Country: Number of subjects enrolled

Brazil: 27

Country: Number of subjects enrolled

Romania: 7

Country: Number of subjects enrolled

Bulgaria: 6

Country: Number of subjects enrolled

Germany: 40

Country: Number of subjects enrolled

Norway: 2

Country: Number of subjects enrolled

Japan: 93

Country: Number of subjects enrolled

Sweden: 2

Worldwide total number of subjects

565

EEA total number of subjects

233

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)

308

From 65 to 84 years

253

85 years and over

4

Subject disposition

Top of page

Recruitment details

-

Screening details

Participants who died due to any cause or were alive and on study at conclusion but off treatment were considered to have completed the study.

Period 1 title

Overall Study (overall period)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Investigator, Subject

Are arms mutually exclusive

Yes

Ramucirumab + BSC

Arm description

Ramucirumab: 8 milligrams/kilogram (mg/kg) intravenous (IV) infusion every 2 weeks. Best supportive care (BSC): Palliative and supportive care for disease-related symptoms and toxicity associated with treatment as deemed medically necessary and appropriate in the opinion of the investigator.

Arm type

Experimental

Investigational medicinal product name

Ramucirumab

Investigational medicinal product code

Other name

LY3009806, IMC-1121B

Pharmaceutical forms

Infusion

Routes of administration

Intravenous use

Dosage and administration details

8 milligrams/kilogram (mg/kg) intravenous (IV) every 2 weeks

Placebo + BSC

Arm description

Placebo: 8 mg/kg IV infusion every 2 weeks. BSC: Palliative and supportive care for disease-related symptoms and toxicity associated with treatment as deemed medically necessary and appropriate in the opinion of the investigator.

Arm type

Placebo

Investigational medicinal product name

Placebo + BSC

Investigational medicinal product code

Other name

Pharmaceutical forms

Infusion

Routes of administration

Intravenous use

Dosage and administration details

8 mg/kg IV every 2 weeks

Number of subjects in period 1	Ramucirumab + BSC	Placebo + BSC
Started	283	282
Received at Least 1 Dose of Study Drug	277	276
Completed	265	268
Not completed	18	14
Consent withdrawn by subject	13	8
Lost to follow-up	5	6

Baseline characteristics

Top of page

Reporting group title

Ramucirumab + BSC

Reporting group description

Ramucirumab: 8 milligrams/kilogram (mg/kg) intravenous (IV) infusion every 2 weeks. Best supportive care (BSC): Palliative and supportive care for disease-related symptoms and toxicity associated with treatment as deemed medically necessary and appropriate in the opinion of the investigator.

Reporting group title

Placebo + BSC

Reporting group description

Placebo: 8 mg/kg IV infusion every 2 weeks. BSC: Palliative and supportive care for disease-related symptoms and toxicity associated with treatment as deemed medically necessary and appropriate in the opinion of the investigator.

Reporting group values	Ramucirumab + BSC	Placebo + BSC	Total
Number of subjects	283	282	282
Age categorical
Unable to enter data due to EudraCT system limitation, see below for age categorical data.
Units: Subjects
Age Continuous
Units: years
arithmetic mean (standard deviation)	62.9 ( 11.56 )	62.5 ( 11.1 )	-
Gender categorical
Unable to enter ramucirumab data due to EudraCT system limitation, see below for gender categorical data.
Units: Subjects
Male		242	242
Female		40	40
Ethnicity
Units: Subjects
Hispanic or Latino	23	20	43
Not Hispanic or Latino	253	260	513
Unknown or Not Reported	7	2	9
Race
Units: Subjects
American Indian or Alaska Native	0	0	0
Asian	131	135	266
Native Hawaiian or Other Pacific Islander	0	0	0
Black or African American	5	3	8
White	139	137	276
More than one race	0	0	0
Unknown or Not Reported	8	7	15
Region of Enrollment
Units: Subjects
United States	17	20	37
Portugal	0	2	2
Philippines	1	0	1
Taiwan	33	25	58
Hong Kong	14	10	24
Spain	9	12	21
Thailand	5	1	6
Israel	1	1	2
Switzerland	1	1	2
Italy	33	18	51
France	32	27	59
Australia	3	8	11
Netherlands	2	1	3
Korea, Republic of	28	42	70
Finland	0	3	3
Austria	4	4	8
Czech Republic	11	9	20
Hungary	1	0	1
Canada	0	1	1
Belgium	3	5	8
Brazil	15	12	27
Romania	3	4	7
Bulgaria	2	4	6
Germany	19	21	40
Norway	1	1	2
Japan	45	48	93
Sweden	0	2	2
Age categorical
Units: Subjects
In utero	0	0	0
Preterm newborn infants (gestational age < 37 wks)	0	0	0
Newborns (0-27 days)	0	0	0
Infants and toddlers (28 days-23 months)	0	0	0
Children (2-11 years)	0	0	0
Adolescents (12-17 years)	0	0	0
Adults (18-64 years)	149	159	308
From 65-84 years	131	122	253
85 years and over	3	1	4
Gender categorical
Units: Subjects
Male	236	242	478
Female	47	40	87

End points

Top of page

Reporting group title

Ramucirumab + BSC

Reporting group description

Ramucirumab: 8 milligrams/kilogram (mg/kg) intravenous (IV) infusion every 2 weeks. Best supportive care (BSC): Palliative and supportive care for disease-related symptoms and toxicity associated with treatment as deemed medically necessary and appropriate in the opinion of the investigator.

Reporting group title

Placebo + BSC

Reporting group description

Placebo: 8 mg/kg IV infusion every 2 weeks. BSC: Palliative and supportive care for disease-related symptoms and toxicity associated with treatment as deemed medically necessary and appropriate in the opinion of the investigator.

Primary: Overall Survival (OS)

Top of page

End point title

Overall Survival (OS)

End point description

OS was defined as the time from the date of randomization to the date of death from any cause. Participants who were alive at the end of the follow-up period or were lost to follow-up were censored on the last date the participant was known to be alive.

End point type

Primary

End point timeframe

Randomization to death from any cause (up to 37 months)

End point values	Ramucirumab + BSC	Placebo + BSC
Number of subjects analysed	283	282
Units: months
median (confidence interval 95%)	9.17 (8.05 to 10.64)	7.62 (6.01 to 9.33)

STATISTICAL ANALYSIS 1

Comparison groups

Placebo + BSC v Ramucirumab + BSC

Number of subjects included in analysis

565

Analysis specification

Pre-specified

Analysis type

^[1]

P-value

= 0.1391

Method

Logrank

Parameter type

Hazard ratio (HR)

Point estimate

0.866

Confidence interval

level

95%

sides

2-sided

lower limit

0.717

upper limit

1.046

Notes
[1] - Hazard Ratio (HR) with 95% confidence interval (CI) was estimated using a stratified Cox proportional hazards regression model using the Interactive Web Response System (IWRS) stratification factors (geographical regions and etiology of liver disease).

Secondary: Progression-Free Survival (PFS)

Top of page

End point title

Progression-Free Survival (PFS)

End point description

PFS was defined as time from date of randomization until date of objectively determined progressive disease (PD) as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1 or death from any cause. PD was defined as ≥20% increase in sum of diameters (SOD) of target lesions, taking as reference smallest sum on study (including baseline sum if it was smallest). Sum must show a ≥5 millimeter (mm) increase. Appearance of ≥1 new lesions and unequivocal progression of existing non-target lesions were considered progression. In primary analysis, participants alive and without PD were censored at day of last adequate tumor assessment; progression or deaths without progression occurring immediately after ≥2 missed tumor assessments, were censored at day of the last adequate tumor assessment prior to missing assessments; participants who began new anticancer therapy were censored at day of the last adequate tumor assessment prior to start of new anticancer therapy.

End point type

Secondary

End point timeframe

Randomization to Progressive Disease (PD) (up to 36 months)

End point values	Ramucirumab + BSC	Placebo + BSC
Number of subjects analysed	283	282
Units: months
median (confidence interval 95%)	2.79 (2.69 to 3.94)	2.1 (1.58 to 2.69)

STATISTICAL ANALYSIS 1

Comparison groups

Placebo + BSC v Ramucirumab + BSC

Number of subjects included in analysis

565

Analysis specification

Pre-specified

Analysis type

^[2]

P-value

< 0.0001

Method

Logrank

Parameter type

Hazard ratio (HR)

Point estimate

0.625

Confidence interval

level

95%

sides

2-sided

lower limit

0.522

upper limit

0.75

Notes
[2] - HR with 95% CI was estimated using a stratified Cox proportional hazards regression model using the IWRS stratification factors (geographical regions and etiology of liver disease).

Secondary: Percentage of Participants with Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)]

Top of page

End point title

Percentage of Participants with Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)]

End point description

ORR was defined, using RECIST v1.1 criteria, as the percentage of participants who achieved a best overall response of CR or PR. CR was defined as the disappearance of all lesions and any intratumor arterial enhancement in target lesions, the normalization of the tumor marker level and all lymph nodes short axis reduced to <10 mm. PR was defined as ≥30% decrease in the SOD of target lesions, including the short axes of any target lymph nodes, taking as reference the baseline SOD of target lesions, no new lesions and stable nontarget lesions. Percentage of participants was calculated as: (number of participants with CR or PR / number of participants randomized) * 100.

End point type

Secondary

End point timeframe

Baseline to the date of first evidence of confirmed CR or PR (up to 37 months)

End point values	Ramucirumab + BSC	Placebo + BSC
Number of subjects analysed	283	282
Units: percentage of participants
number (confidence interval 95%)	7.1 (4.6 to 10.7)	0.7 (0.2 to 2.5)

STATISTICAL ANALYSIS 1

Comparison groups

Placebo + BSC v Ramucirumab + BSC

Number of subjects included in analysis

565

Analysis specification

Pre-specified

Analysis type

P-value

< 0.0001 ^[3]

Method

Cochran-Mantel-Haenszel

Confidence interval

sides

2-sided

lower limit

-

upper limit

-

Notes
[3] - Cochran-Mantel-Haenszel (CMH) adjusted for geographic region and etiology liver disease.

Secondary: Time to Radiographic Progression (TTP)

Top of page

End point title

Time to Radiographic Progression (TTP)

End point description

TTP was defined as the time from randomization to the first radiographically documented PD. PD was defined, using RECIST v1.1 criteria, as ≥20% increase in SOD of target lesions, taking as reference smallest sum on study (including baseline sum if it was the smallest). Sum must show an absolute increase of ≥5 mm. Appearance of ≥1 new lesions and unequivocal progression of existing non-target lesions were considered progression. Participants without PD were censored at the day of the last adequate tumor assessment. Progression occurred immediately after ≥2 missed tumor assessments and were censored at the day of the last adequate tumor assessment prior to the missing assessments. Participants who began new anticancer therapy were censored at the day of their last adequate tumor assessment prior to start of new anticancer therapy.

End point type

Secondary

End point timeframe

Randomization to PD (up to 36 months)

End point values	Ramucirumab + BSC	Placebo + BSC
Number of subjects analysed	283	282
Units: months
median (confidence interval 95%)	3.48 (2.76 to 4.47)	2.63 (1.58 to 2.76)

STATISTICAL ANALYSIS 1

Comparison groups

Placebo + BSC v Ramucirumab + BSC

Number of subjects included in analysis

565

Analysis specification

Pre-specified

Analysis type

^[4]

P-value

< 0.0001

Method

Logrank

Parameter type

Hazard ratio (HR)

Point estimate

0.593

Confidence interval

level

95%

sides

2-sided

lower limit

0.487

upper limit

0.722

Notes
[4] - HR with 95% CI was estimated using a stratified Cox proportional hazards regression model using the IWRS stratification factors (geographical regions and etiology of liver disease).

Secondary: Change from Baseline in the Functional Assessment of Cancer Therapy (FACT) Hepatobiliary Symptom Index-8 (FHSI-8)

Top of page

End point title

Change from Baseline in the Functional Assessment of Cancer Therapy (FACT) Hepatobiliary Symptom Index-8 (FHSI-8)

End point description

The FHSI-8 is a self-administered 8-item questionnaire that measures a participant's symptoms in the domains of jaundice, stomach pain/discomfort weight loss, and fatigue. Participants rated each item on a 5-point scale from 0 (not at all) to 4 (very much). Item scores were calculated as outlined in the FACIT manual. FHSI-8 total score was the sum of each item's score with a total score ranging from 0 (highly symptomatic) to 32 (asymptomatic).

End point type

Secondary

End point timeframe

Baseline, Prior to infusion on Day 1 of Cycle 4, Cycle 10, and Cycle 16 (14-day cycles), and end of treatment (up to 34 months)

End point values	Ramucirumab + BSC	Placebo + BSC
Number of subjects analysed	169	199
Units: units on a scale
arithmetic mean (standard deviation)
Cycle 4 (n=166, 147)	-1.26 ( 3.164 )	-0.81 ( 4.623 )
Cycle 10 (n=70, 45)	-1.28 ( 3.989 )	-0.01 ( 4.378 )
Cycle 16 (n=47, 24)	-0.97 ( 4.095 )	0.75 ( 3.768 )
End of Treatment (n=169, 199)	-2.44 ( 5.561 )	-2.86 ( 5.618 )

No statistical analyses for this end point

Secondary: Change from Baseline in European Quality of Life Questionnaire-5 Dimensions (EQ-5D) Health State Score

Top of page

End point title

Change from Baseline in European Quality of Life Questionnaire-5 Dimensions (EQ-5D) Health State Score

End point description

The EQ-5D is a self-reported, 5-dimension (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) questionnaire related to the participant's current health state. Each question was scored using a 3 level scale (no problems, some problems, or extreme problems). EQ-5D health state was defined by combining responses from each of the 5 dimensions into a weighted health-state index score according to the United Kingdom (UK) population based algorithm where 0 = death and 1 = perfect health.

End point type

Secondary

End point timeframe

Baseline, Prior to Infusion on Day 1 of Cycle 4, Cycle 10, and Cycle 16 (14-day cycles), end of treatment (up to 34 months)

End point values	Ramucirumab + BSC	Placebo + BSC
Number of subjects analysed	166	190
Units: units on a scale
arithmetic mean (standard deviation)
Cycle 4 (n=166, 145)	-0.038 ( 0.189 )	-0.046 ( 0.245 )
Cycle 10 (n=71, 45)	-0.054 ( 0.212 )	0.003 ( 0.148 )
Cycle 16 (n=47, 25)	-0.062 ( 0.214 )	-0.012 ( 0.085 )
End of Treatment (n=166, 190)	-0.129 ( 0.29 )	-0.144 ( 0.28 )

No statistical analyses for this end point

Secondary: Number of Participants with Adverse Events (AEs) and the Number of Participants Who Died

Top of page

End point title

Number of Participants with Adverse Events (AEs) and the Number of Participants Who Died

End point description

The number of participants with serious AEs (SAEs), other non-serious AEs and participants who died. A summary of SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module.

End point type

Secondary

End point timeframe

Baseline to study completion (up to 37 months)

End point values	Ramucirumab + BSC	Placebo + BSC
Number of subjects analysed	277	276
Units: participants
number (not applicable)
SAEs	123	92
Other Non-SAEs	254	235
Died	215	220

No statistical analyses for this end point

Secondary: Maximum Concentration (Cmax) of Ramucirumab, Cycle 1

Top of page

End point title

Maximum Concentration (Cmax) of Ramucirumab, Cycle 1 ^[5]

End point description

End point type

Secondary

End point timeframe

1 hour following the completion of Cycle 1 (14-day cycle) infusion

Notes
[5] - 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: Pharmacokinetic assays are only performed on specimens from participants with exposure to study drug.

End point values	Ramucirumab + BSC
Number of subjects analysed	247
Units: micrograms/milliliter (µg/mL)
geometric mean (geometric coefficient of variation)	149.6 ( 36.9 )

No statistical analyses for this end point

Secondary: Cmax of Ramucirumab, Cycle 4

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End point title

Cmax of Ramucirumab, Cycle 4 ^[6]

End point description

End point type

Secondary

End point timeframe

1 hour following completion of Cycle 4 (14-day cycles) infusion

Notes
[6] - 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: Pharmacokinetic assays are only performed on specimens from participants with exposure to study drug.

End point values	Ramucirumab + BSC
Number of subjects analysed	140
Units: µg/mL
geometric mean (geometric coefficient of variation)	189.5 ( 39.1 )

No statistical analyses for this end point

Secondary: Cmax of Ramucirumab, Cycle 7

Top of page

End point title

Cmax of Ramucirumab, Cycle 7 ^[7]

End point description

End point type

Secondary

End point timeframe

1 hour following completion of Cycle 7 (14-day cycles) infusion

Notes
[7] - 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: Pharmacokinetic assays are only performed on specimens from participants with exposure to study drug.

End point values	Ramucirumab + BSC
Number of subjects analysed	81
Units: µg/mL
geometric mean (geometric coefficient of variation)	184.4 ( 56.3 )

No statistical analyses for this end point

Secondary: Number of Participants with Treatment-Emergent Positive Anti-Ramucirumab Response [Serum Anti-Ramucirumab Antibody Assessment (Immunogenicity)]

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End point title

Number of Participants with Treatment-Emergent Positive Anti-Ramucirumab Response [Serum Anti-Ramucirumab Antibody Assessment (Immunogenicity)]

End point description

Participants were considered positive for anti-ramucirumab antibodies [anti-drug antibodies (ADA)] if the post-treatment sample had an increase of at least 4-fold in titer from the pretreatment values. If the pretreatment value was not detected or was not present, a 1:20 post-treatment titer was required to indicate treatment emergence of ADA.

End point type

Secondary

End point timeframe

Prior to treatment and 1 hour post end of infusion for Cycles 1, 4 and 7 (14-day cycles)

End point values	Ramucirumab + BSC	Placebo + BSC
Number of subjects analysed	241	231
Units: participants
number (not applicable)	10	7

No statistical analyses for this end point

Adverse events

Top of page

Timeframe for reporting adverse events

Entire Study

Adverse event reporting additional description

Safety population includes any participants who received at least 1 dose of study drug.

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

16.1

Reporting group title

Ramucirumab 8 mg/kg I.V. infusion every 2 weeks

Reporting group description

-

Reporting group title

Placebo 8 mg/kg I.V. infusion every 2 weeks

Reporting group description

-

Serious adverse events	Ramucirumab 8 mg/kg I.V. infusion every 2 weeks	Placebo 8 mg/kg I.V. infusion every 2 weeks
Total subjects affected by serious adverse events
subjects affected / exposed	124 / 277 (44.77%)	92 / 276 (33.33%)
number of deaths (all causes)	0	0
number of deaths resulting from adverse events	0	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
liver carcinoma ruptured
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	2 / 277 (0.72%)	2 / 276 (0.72%)
occurrences causally related to treatment / all	1 / 3	1 / 2
deaths causally related to treatment / all	0 / 1	0 / 0
malignant neoplasm progression
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	23 / 277 (8.30%)	16 / 276 (5.80%)
occurrences causally related to treatment / all	0 / 30	0 / 22
deaths causally related to treatment / all	0 / 17	0 / 14
metastases to bone
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	1 / 276 (0.36%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
metastases to central nervous system
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
metastases to lung
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
small intestine adenocarcinoma
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	1 / 276 (0.36%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
tumour associated fever
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
tumour pain
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	4 / 276 (1.45%)
occurrences causally related to treatment / all	0 / 0	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Vascular disorders
deep vein thrombosis
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	2 / 277 (0.72%)	0 / 276 (0.00%)
occurrences causally related to treatment / all	2 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
haemorrhage
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	1 / 276 (0.36%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
hypertension
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences causally related to treatment / all	2 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
shock haemorrhagic
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
General disorders and administration site conditions
asthenia
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	4 / 277 (1.44%)	1 / 276 (0.36%)
occurrences causally related to treatment / all	1 / 5	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 0
chills
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
death
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	1 / 1	0 / 0
extravasation
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	1 / 276 (0.36%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
fatigue
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	2 / 276 (0.72%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
general physical health deterioration
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	9 / 277 (3.25%)	3 / 276 (1.09%)
occurrences causally related to treatment / all	2 / 9	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
generalised oedema
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
hernia obstructive
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
hyperthermia
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
malaise
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	1 / 276 (0.36%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
multi-organ failure
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	2 / 277 (0.72%)	1 / 276 (0.36%)
occurrences causally related to treatment / all	1 / 2	0 / 2
deaths causally related to treatment / all	1 / 1	0 / 1
non-cardiac chest pain
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	1 / 276 (0.36%)
occurrences causally related to treatment / all	1 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
oedema
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	2 / 276 (0.72%)
occurrences causally related to treatment / all	0 / 0	1 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
oedema peripheral
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	2 / 277 (0.72%)	1 / 276 (0.36%)
occurrences causally related to treatment / all	1 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
pyrexia
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	7 / 277 (2.53%)	3 / 276 (1.09%)
occurrences causally related to treatment / all	2 / 8	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
sudden death
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Immune system disorders
anaphylactic reaction
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	2 / 277 (0.72%)	0 / 276 (0.00%)
occurrences causally related to treatment / all	2 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
acute respiratory distress syndrome
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	1 / 276 (0.36%)
occurrences causally related to treatment / all	0 / 0	2 / 2
deaths causally related to treatment / all	0 / 0	1 / 1
dyspnoea
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	2 / 276 (0.72%)
occurrences causally related to treatment / all	0 / 1	2 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
haemoptysis
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	2 / 277 (0.72%)	1 / 276 (0.36%)
occurrences causally related to treatment / all	1 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
hypoxia
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
pleural effusion
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	2 / 277 (0.72%)	3 / 276 (1.09%)
occurrences causally related to treatment / all	0 / 2	2 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
pneumonitis
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	1 / 276 (0.36%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
pulmonary embolism
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	2 / 276 (0.72%)
occurrences causally related to treatment / all	0 / 1	3 / 3
deaths causally related to treatment / all	0 / 0	1 / 1
pulmonary haemorrhage
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	1 / 276 (0.36%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Psychiatric disorders
mental status changes
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	1 / 276 (0.36%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Investigations
aspartate aminotransferase increased
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	1 / 276 (0.36%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
blood bilirubin increased
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	2 / 277 (0.72%)	0 / 276 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
blood creatinine increased
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
general physical condition abnormal
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
liver function test abnormal
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Injury, poisoning and procedural complications
fall
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	1 / 276 (0.36%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
femur fracture
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	1 / 276 (0.36%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
infusion related reaction
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac disorders
cardiac failure
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	1 / 276 (0.36%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
pericardial effusion
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
supraventricular tachycardia
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Nervous system disorders
central nervous system lesion
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
cerebral infarction
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	1 / 276 (0.36%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
coma hepatic
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
convulsion
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	2 / 277 (0.72%)	0 / 276 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
diplegia
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
dizziness
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	1 / 276 (0.36%)
occurrences causally related to treatment / all	1 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
encephalopathy
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
hepatic encephalopathy
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	12 / 277 (4.33%)	1 / 276 (0.36%)
occurrences causally related to treatment / all	8 / 16	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
mental impairment
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
peripheral motor neuropathy
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	1 / 276 (0.36%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
somnolence
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
spinal cord compression
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
subarachnoid haemorrhage
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	1 / 276 (0.36%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
tongue biting
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	1 / 276 (0.36%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Blood and lymphatic system disorders
anaemia
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	2 / 276 (0.72%)
occurrences causally related to treatment / all	0 / 0	2 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
disseminated intravascular coagulation
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
neutropenia
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
thrombocytopenia
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Eye disorders
retinal detachment
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal disorders
abdominal distension
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	1 / 276 (0.36%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
abdominal pain
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	6 / 277 (2.17%)	9 / 276 (3.26%)
occurrences causally related to treatment / all	1 / 7	1 / 10
deaths causally related to treatment / all	0 / 0	0 / 0
abdominal pain upper
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	1 / 276 (0.36%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
ascites
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	8 / 277 (2.89%)	3 / 276 (1.09%)
occurrences causally related to treatment / all	0 / 8	1 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
colitis
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	1 / 276 (0.36%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
diarrhoea
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
duodenal ulcer
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
dysphagia
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
food poisoning
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
gastric antral vascular ectasia
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
gastric haemorrhage
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	1 / 276 (0.36%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
gastric varices haemorrhage
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
gastroduodenitis
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
gastrointestinal haemorrhage
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	7 / 277 (2.53%)	0 / 276 (0.00%)
occurrences causally related to treatment / all	5 / 7	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
haemorrhoids
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	1 / 276 (0.36%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
ileus
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	1 / 276 (0.36%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
inguinal hernia
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	1 / 276 (0.36%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
intestinal obstruction
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	1 / 276 (0.36%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
irritable bowel syndrome
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
large intestine perforation
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
melaena
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	1 / 276 (0.36%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
nausea
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	2 / 277 (0.72%)	1 / 276 (0.36%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
oesophageal haemorrhage
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	1 / 276 (0.36%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 1
oesophageal varices haemorrhage
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	4 / 277 (1.44%)	10 / 276 (3.62%)
occurrences causally related to treatment / all	1 / 5	7 / 12
deaths causally related to treatment / all	0 / 1	1 / 1
pancreatitis
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	1 / 276 (0.36%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
peritoneal haemorrhage
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
small intestinal obstruction
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	1 / 276 (0.36%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
umbilical hernia
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
upper gastrointestinal haemorrhage
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	2 / 277 (0.72%)	1 / 276 (0.36%)
occurrences causally related to treatment / all	2 / 2	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
varices oesophageal
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences causally related to treatment / all	2 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
vomiting
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	1 / 276 (0.36%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatobiliary disorders
acute hepatic failure
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	1 / 1	0 / 0
bile duct stone
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	1 / 276 (0.36%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
cholangitis
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	5 / 277 (1.81%)	1 / 276 (0.36%)
occurrences causally related to treatment / all	0 / 8	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
cholangitis acute
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	1 / 276 (0.36%)
occurrences causally related to treatment / all	0 / 1	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
hepatic cirrhosis
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	1 / 276 (0.36%)
occurrences causally related to treatment / all	1 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
hepatic failure
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	6 / 277 (2.17%)	5 / 276 (1.81%)
occurrences causally related to treatment / all	5 / 9	0 / 9
deaths causally related to treatment / all	2 / 4	0 / 5
hepatic function abnormal
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	1 / 276 (0.36%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
hepatorenal syndrome
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	4 / 277 (1.44%)	1 / 276 (0.36%)
occurrences causally related to treatment / all	1 / 4	1 / 1
deaths causally related to treatment / all	0 / 1	0 / 0
hyperbilirubinaemia
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	3 / 276 (1.09%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
hypertransaminasaemia
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
jaundice
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	1 / 276 (0.36%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
jaundice cholestatic
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	2 / 276 (0.72%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
liver disorder
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
portal vein thrombosis
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	1 / 276 (0.36%)
occurrences causally related to treatment / all	0 / 1	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Skin and subcutaneous tissue disorders
dermatitis allergic
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
skin lesion
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
skin ulcer
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Renal and urinary disorders
renal failure
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	2 / 277 (0.72%)	0 / 276 (0.00%)
occurrences causally related to treatment / all	3 / 4	0 / 0
deaths causally related to treatment / all	1 / 1	0 / 0
renal failure acute
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	3 / 277 (1.08%)	1 / 276 (0.36%)
occurrences causally related to treatment / all	2 / 4	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 0
renal impairment
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (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
arthritis
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
back pain
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	4 / 276 (1.45%)
occurrences causally related to treatment / all	0 / 0	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
flank pain
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	1 / 276 (0.36%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
musculoskeletal chest pain
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	1 / 276 (0.36%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
neck pain
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
pathological fracture
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
spinal pain
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	1 / 276 (0.36%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Infections and infestations
anal abscess
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	2 / 277 (0.72%)	0 / 276 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
bacteraemia
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences causally related to treatment / all	1 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
campylobacter infection
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
candida sepsis
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
device related infection
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
device related sepsis
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
infection
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
influenza
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	1 / 276 (0.36%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
liver abscess
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
lobar pneumonia
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
lung infection
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	2 / 277 (0.72%)	0 / 276 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
peritonitis
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	1 / 276 (0.36%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
peritonitis bacterial
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
pneumonia
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	3 / 277 (1.08%)	3 / 276 (1.09%)
occurrences causally related to treatment / all	1 / 3	1 / 4
deaths causally related to treatment / all	0 / 0	0 / 1
pneumonia bacterial
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
pneumonia klebsiella
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	1 / 276 (0.36%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
pulmonary sepsis
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
sepsis
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	3 / 277 (1.08%)	2 / 276 (0.72%)
occurrences causally related to treatment / all	1 / 3	1 / 3
deaths causally related to treatment / all	1 / 2	0 / 1
septic shock
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	1 / 276 (0.36%)
occurrences causally related to treatment / all	0 / 0	2 / 2
deaths causally related to treatment / all	0 / 0	1 / 1
upper respiratory tract infection
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	1 / 276 (0.36%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
urinary tract infection
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	3 / 277 (1.08%)	0 / 276 (0.00%)
occurrences causally related to treatment / all	2 / 4	0 / 0
deaths causally related to treatment / all	1 / 1	0 / 0
Metabolism and nutrition disorders
cachexia
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	1 / 276 (0.36%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 1
decreased appetite
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	3 / 277 (1.08%)	0 / 276 (0.00%)
occurrences causally related to treatment / all	1 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
dehydration
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	2 / 277 (0.72%)	1 / 276 (0.36%)
occurrences causally related to treatment / all	1 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
diabetes mellitus
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
hypercalcaemia
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	1 / 276 (0.36%)
occurrences causally related to treatment / all	1 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
hyperglycaemia
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	2 / 276 (0.72%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
hyperkalaemia
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
hypertriglyceridaemia
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
hypocalcaemia
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
hypoglycaemia
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	1 / 276 (0.36%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
hyponatraemia
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	1 / 276 (0.36%)
occurrences causally related to treatment / all	1 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 0%

Non-serious adverse events	Ramucirumab 8 mg/kg I.V. infusion every 2 weeks	Placebo 8 mg/kg I.V. infusion every 2 weeks
Total subjects affected by non serious adverse events
subjects affected / exposed	265 / 277 (95.67%)	257 / 276 (93.12%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
cancer pain
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	3 / 276 (1.09%)
occurrences all number	1	3
haemangioma
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
haemangioma of skin
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	2	0
keratoacanthoma
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
malignant neoplasm progression
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	5 / 277 (1.81%)	3 / 276 (1.09%)
occurrences all number	6	3
melanocytic naevus
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
metastases to lung
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	2	0
metastatic pain
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	2 / 276 (0.72%)
occurrences all number	0	2
pyogenic granuloma
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	2 / 277 (0.72%)	0 / 276 (0.00%)
occurrences all number	2	0
skin papilloma
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	1 / 276 (0.36%)
occurrences all number	0	1
squamous cell carcinoma
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
tongue neoplasm malignant stage unspecified
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	1 / 276 (0.36%)
occurrences all number	0	2
tumour pain
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	4 / 277 (1.44%)	4 / 276 (1.45%)
occurrences all number	4	5
tumour thrombosis
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
Vascular disorders
deep vein thrombosis
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	1 / 276 (0.36%)
occurrences all number	1	1
embolism
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	1 / 276 (0.36%)
occurrences all number	0	1
extravasation blood
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	1 / 276 (0.36%)
occurrences all number	1	1
femoral artery occlusion
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	1 / 276 (0.36%)
occurrences all number	0	1
flushing
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	3 / 277 (1.08%)	0 / 276 (0.00%)
occurrences all number	3	0
haematoma
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	7 / 277 (2.53%)	2 / 276 (0.72%)
occurrences all number	7	2
haemorrhage
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
hot flush
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	2 / 276 (0.72%)
occurrences all number	0	2
hypertension
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	55 / 277 (19.86%)	20 / 276 (7.25%)
occurrences all number	104	43
hypotension
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	4 / 277 (1.44%)	4 / 276 (1.45%)
occurrences all number	5	4
intermittent claudication
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
lymphostasis
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
orthostatic hypotension
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	1 / 276 (0.36%)
occurrences all number	0	1
peripheral coldness
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
periphlebitis
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	1 / 276 (0.36%)
occurrences all number	0	1
thrombophlebitis
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	2 / 277 (0.72%)	0 / 276 (0.00%)
occurrences all number	3	0
vein disorder
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
venous insufficiency
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	2 / 276 (0.72%)
occurrences all number	1	3
venous lake
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	2 / 277 (0.72%)	0 / 276 (0.00%)
occurrences all number	2	0
General disorders and administration site conditions
application site pain
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	1 / 276 (0.36%)
occurrences all number	0	1
asthenia
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	50 / 277 (18.05%)	36 / 276 (13.04%)
occurrences all number	80	63
axillary pain
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
catheter site pain
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	2 / 277 (0.72%)	0 / 276 (0.00%)
occurrences all number	2	0
chest discomfort
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	2 / 277 (0.72%)	3 / 276 (1.09%)
occurrences all number	2	4
chest pain
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	3 / 277 (1.08%)	8 / 276 (2.90%)
occurrences all number	4	10
chills
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	11 / 277 (3.97%)	6 / 276 (2.17%)
occurrences all number	15	15
crepitations
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	2 / 277 (0.72%)	0 / 276 (0.00%)
occurrences all number	2	0
drug intolerance
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
drug withdrawal syndrome
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
effusion
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
face oedema
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	8 / 277 (2.89%)	1 / 276 (0.36%)
occurrences all number	9	1
fatigue
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	66 / 277 (23.83%)	60 / 276 (21.74%)
occurrences all number	97	99
feeling cold
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	1 / 276 (0.36%)
occurrences all number	1	1
gait disturbance
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	2 / 277 (0.72%)	1 / 276 (0.36%)
occurrences all number	2	1
general physical health deterioration
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	2 / 277 (0.72%)	2 / 276 (0.72%)
occurrences all number	2	2
generalised oedema
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	4	0
hernia
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	1 / 276 (0.36%)
occurrences all number	1	1
hyperthermia
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	3 / 277 (1.08%)	0 / 276 (0.00%)
occurrences all number	9	0
influenza like illness
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	6 / 277 (2.17%)	11 / 276 (3.99%)
occurrences all number	9	25
infusion site pruritus
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
infusion site swelling
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
injection site reaction
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
injection site pruritus
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	1 / 276 (0.36%)
occurrences all number	0	1
local swelling
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	3 / 277 (1.08%)	1 / 276 (0.36%)
occurrences all number	4	2
localised oedema
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	2 / 277 (0.72%)	0 / 276 (0.00%)
occurrences all number	3	0
malaise
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	5 / 277 (1.81%)	10 / 276 (3.62%)
occurrences all number	6	11
medical device complication
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
mucosal dryness
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	1 / 276 (0.36%)
occurrences all number	1	1
mucosal inflammation
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	6 / 277 (2.17%)	3 / 276 (1.09%)
occurrences all number	10	5
non-cardiac chest pain
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	3 / 277 (1.08%)	7 / 276 (2.54%)
occurrences all number	3	7
oedema
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	2 / 277 (0.72%)	3 / 276 (1.09%)
occurrences all number	3	6
oedema peripheral
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	100 / 277 (36.10%)	50 / 276 (18.12%)
occurrences all number	151	58
pain
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	4 / 277 (1.44%)	5 / 276 (1.81%)
occurrences all number	4	5
pyrexia
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	42 / 277 (15.16%)	25 / 276 (9.06%)
occurrences all number	59	32
suprapubic pain
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
systemic inflammatory response syndrome
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
thirst
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	2 / 277 (0.72%)	0 / 276 (0.00%)
occurrences all number	2	0
ulcer
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	1 / 276 (0.36%)
occurrences all number	0	1
xerosis
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	1 / 276 (0.36%)
occurrences all number	1	1
Immune system disorders
cytokine release syndrome
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	3 / 277 (1.08%)	0 / 276 (0.00%)
occurrences all number	4	0
hypersensitivity
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	4 / 277 (1.44%)	1 / 276 (0.36%)
occurrences all number	4	1
seasonal allergy
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
Reproductive system and breast disorders
balanitis
alternative dictionary used: MedDRA 16.1
subjects affected / exposed ^[1]	1 / 230 (0.43%)	0 / 236 (0.00%)
occurrences all number	1	0
benign prostatic hyperplasia
alternative dictionary used: MedDRA 16.1
subjects affected / exposed ^[2]	1 / 230 (0.43%)	1 / 236 (0.42%)
occurrences all number	1	1
breast pain
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	4 / 277 (1.44%)	1 / 276 (0.36%)
occurrences all number	5	1
genital rash
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
gynaecomastia
alternative dictionary used: MedDRA 16.1
subjects affected / exposed ^[3]	5 / 230 (2.17%)	0 / 236 (0.00%)
occurrences all number	6	0
pelvic pain
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	1 / 276 (0.36%)
occurrences all number	0	1
pruritus genital
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	2	0
rectocele
alternative dictionary used: MedDRA 16.1
subjects affected / exposed ^[4]	1 / 47 (2.13%)	0 / 40 (0.00%)
occurrences all number	1	0
scrotal swelling
alternative dictionary used: MedDRA 16.1
subjects affected / exposed ^[5]	0 / 230 (0.00%)	1 / 236 (0.42%)
occurrences all number	0	1
sexual dysfunction
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	1 / 276 (0.36%)
occurrences all number	0	1
Respiratory, thoracic and mediastinal disorders
asthma
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	1 / 276 (0.36%)
occurrences all number	0	1
atelectasis
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	2 / 277 (0.72%)	1 / 276 (0.36%)
occurrences all number	2	1
bronchial obstruction
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
chronic obstructive pulmonary disease
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	1 / 276 (0.36%)
occurrences all number	0	1
cough
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	41 / 277 (14.80%)	25 / 276 (9.06%)
occurrences all number	54	29
diaphragmalgia
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	1 / 276 (0.36%)
occurrences all number	0	1
dysphonia
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	9 / 277 (3.25%)	1 / 276 (0.36%)
occurrences all number	9	2
dyspnoea
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	26 / 277 (9.39%)	26 / 276 (9.42%)
occurrences all number	33	33
dyspnoea exertional
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	3 / 277 (1.08%)	3 / 276 (1.09%)
occurrences all number	5	3
epistaxis
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	38 / 277 (13.72%)	17 / 276 (6.16%)
occurrences all number	48	22
haemoptysis
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	8 / 277 (2.89%)	2 / 276 (0.72%)
occurrences all number	9	2
hiccups
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	6 / 277 (2.17%)	5 / 276 (1.81%)
occurrences all number	7	6
hypoxia
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	1 / 276 (0.36%)
occurrences all number	0	1
increased upper airway secretion
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
interstitial lung disease
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
laryngeal inflammation
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
lung infiltration
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
nasal discomfort
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	1 / 276 (0.36%)
occurrences all number	0	1
nasal dryness
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
nasal mucosal disorder
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
oropharyngeal pain
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	6 / 277 (2.17%)	2 / 276 (0.72%)
occurrences all number	6	2
pleural effusion
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	8 / 277 (2.89%)	9 / 276 (3.26%)
occurrences all number	11	11
pleurisy
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
pneumonitis
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	2 / 276 (0.72%)
occurrences all number	0	2
productive cough
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	7 / 277 (2.53%)	5 / 276 (1.81%)
occurrences all number	7	5
pulmonary artery thrombosis
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	1 / 276 (0.36%)
occurrences all number	0	1
pulmonary congestion
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
pulmonary embolism
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	1 / 276 (0.36%)
occurrences all number	0	1
rales
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	4 / 277 (1.44%)	1 / 276 (0.36%)
occurrences all number	4	1
rhinitis allergic
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	2 / 276 (0.72%)
occurrences all number	1	2
rhinorrhoea
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	2 / 277 (0.72%)	2 / 276 (0.72%)
occurrences all number	2	2
rhonchi
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
sinus congestion
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
tachypnoea
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	1 / 276 (0.36%)
occurrences all number	0	1
upper-airway cough syndrome
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
wheezing
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
Psychiatric disorders
abnormal dreams
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	1 / 276 (0.36%)
occurrences all number	0	1
agitation
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	1 / 276 (0.36%)
occurrences all number	1	1
anxiety
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	2 / 277 (0.72%)	7 / 276 (2.54%)
occurrences all number	2	18
bulimia nervosa
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	1 / 276 (0.36%)
occurrences all number	0	1
confusional state
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	8 / 277 (2.89%)	3 / 276 (1.09%)
occurrences all number	9	3
delirium
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	1 / 276 (0.36%)
occurrences all number	0	1
depressed mood
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	1 / 276 (0.36%)
occurrences all number	1	1
depression
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	9 / 277 (3.25%)	1 / 276 (0.36%)
occurrences all number	9	6
disorientation
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	1 / 276 (0.36%)
occurrences all number	1	1
insomnia
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	19 / 277 (6.86%)	20 / 276 (7.25%)
occurrences all number	20	20
mood altered
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
nightmare
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	1 / 276 (0.36%)
occurrences all number	0	1
psychotic disorder
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
psychomotor retardation
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
Investigations
activated partial thromboplastin time prolonged
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	2 / 276 (0.72%)
occurrences all number	1	2
alanine aminotransferase increased
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	13 / 277 (4.69%)	21 / 276 (7.61%)
occurrences all number	34	33
albumin urine present
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
alpha 1 foetoprotein increased
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	2 / 277 (0.72%)	1 / 276 (0.36%)
occurrences all number	2	1
ammonia increased
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	1 / 276 (0.36%)
occurrences all number	0	1
aspartate aminotransferase increased
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	30 / 277 (10.83%)	39 / 276 (14.13%)
occurrences all number	59	70
biopsy liver
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	1 / 276 (0.36%)
occurrences all number	0	1
blood albumin decreased
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	8 / 277 (2.89%)	1 / 276 (0.36%)
occurrences all number	37	1
blood alkaline phosphatase increased
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	18 / 277 (6.50%)	14 / 276 (5.07%)
occurrences all number	40	25
blood bilirubin increased
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	19 / 277 (6.86%)	24 / 276 (8.70%)
occurrences all number	39	38
blood chloride decreased
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	2 / 276 (0.72%)
occurrences all number	0	2
blood creatinine increased
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	5 / 277 (1.81%)	10 / 276 (3.62%)
occurrences all number	15	12
blood chloride increased
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	1 / 276 (0.36%)
occurrences all number	0	1
blood lactate dehydrogenase increased
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	2 / 277 (0.72%)	1 / 276 (0.36%)
occurrences all number	2	1
blood magnesium decreased
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	2 / 276 (0.72%)
occurrences all number	0	2
blood potassium increased
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	2 / 276 (0.72%)
occurrences all number	0	2
blood pressure abnormal
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	1 / 276 (0.36%)
occurrences all number	0	1
blood pressure increased
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
blood urea increased
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	1 / 276 (0.36%)
occurrences all number	1	2
blood urine present
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	2	0
blood uric acid increased
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	4 / 277 (1.44%)	1 / 276 (0.36%)
occurrences all number	7	1
body temperature increased
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	3 / 277 (1.08%)	1 / 276 (0.36%)
occurrences all number	4	1
breath sounds abnormal
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	1 / 276 (0.36%)
occurrences all number	0	1
breath sounds
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
c-reactive protein increased
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	3 / 276 (1.09%)
occurrences all number	1	4
cd4 lymphocytes increased
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	1 / 276 (0.36%)
occurrences all number	0	1
cardiac murmur
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	2 / 277 (0.72%)	1 / 276 (0.36%)
occurrences all number	2	2
coagulation time abnormal
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
ejection fraction decreased
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	1 / 276 (0.36%)
occurrences all number	0	1
electrocardiogram qt prolonged
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	2 / 276 (0.72%)
occurrences all number	0	2
electrocardiogram t wave inversion
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
gamma-glutamyltransferase increased
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	3 / 277 (1.08%)	6 / 276 (2.17%)
occurrences all number	14	8
general physical condition abnormal
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	2 / 276 (0.72%)
occurrences all number	0	2
haematocrit decreased
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	1 / 276 (0.36%)
occurrences all number	0	1
haemoglobin decreased
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	2 / 277 (0.72%)	1 / 276 (0.36%)
occurrences all number	5	1
heart sounds abnormal
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	1 / 276 (0.36%)
occurrences all number	0	1
international normalised ratio increased
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	2 / 277 (0.72%)	2 / 276 (0.72%)
occurrences all number	2	2
lipase increased
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	1 / 276 (0.36%)
occurrences all number	0	1
liver function test abnormal
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	2 / 277 (0.72%)	2 / 276 (0.72%)
occurrences all number	2	2
mean cell volume decreased
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	2 / 276 (0.72%)
occurrences all number	0	2
monocyte count increased
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
neutrophil count decreased
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	2	0
occult blood
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
platelet count decreased
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	1 / 276 (0.36%)
occurrences all number	2	1
protein total decreased
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	3	0
protein urine present
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	3 / 277 (1.08%)	0 / 276 (0.00%)
occurrences all number	7	0
prothrombin time prolonged
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	1 / 276 (0.36%)
occurrences all number	0	1
sputum abnormal
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
urine output decreased
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	1 / 276 (0.36%)
occurrences all number	1	1
urine ketone body present
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	1 / 276 (0.36%)
occurrences all number	0	1
waist circumference increased
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	2	0
weight decreased
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	9 / 277 (3.25%)	6 / 276 (2.17%)
occurrences all number	12	6
weight increased
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	4 / 277 (1.44%)	1 / 276 (0.36%)
occurrences all number	6	1
white blood cell count decreased
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	2	0
white blood cells urine positive
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	1 / 276 (0.36%)
occurrences all number	0	1
Injury, poisoning and procedural complications
anal injury
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
animal bite
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	1 / 276 (0.36%)
occurrences all number	0	1
chest injury
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
chillblains
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
clavicle fracture
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
contusion
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	4 / 277 (1.44%)	4 / 276 (1.45%)
occurrences all number	4	4
craniocerebral injury
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
excoriation
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	3 / 276 (1.09%)
occurrences all number	1	3
facial bones fracture
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	1 / 276 (0.36%)
occurrences all number	0	1
fall
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	7 / 277 (2.53%)	0 / 276 (0.00%)
occurrences all number	8	0
foreign body
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	1 / 276 (0.36%)
occurrences all number	0	1
incision site pruritus
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	1 / 276 (0.36%)
occurrences all number	0	1
infusion related reaction
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	12 / 277 (4.33%)	1 / 276 (0.36%)
occurrences all number	13	1
laceration
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
limb injury
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
lumbar vertebral fracture
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	1 / 276 (0.36%)
occurrences all number	0	1
postoperative wound complication
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	1 / 276 (0.36%)
occurrences all number	0	1
procedural pain
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	2 / 277 (0.72%)	1 / 276 (0.36%)
occurrences all number	2	1
rib fracture
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	1 / 276 (0.36%)
occurrences all number	1	1
sternal fracture
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	1 / 276 (0.36%)
occurrences all number	0	1
sternal injury
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
stress fracture
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	1 / 276 (0.36%)
occurrences all number	0	1
tongue injury
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
tooth fracture
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	1 / 276 (0.36%)
occurrences all number	1	1
wound
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	2 / 277 (0.72%)	1 / 276 (0.36%)
occurrences all number	2	1
wound haemorrhage
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
Cardiac disorders
aortic valve incompetence
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
bradycardia
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	1 / 276 (0.36%)
occurrences all number	1	1
bundle branch block right
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	1 / 276 (0.36%)
occurrences all number	0	1
cardiomyopathy
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
cyanosis
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
myocardial infarction
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
palpitations
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	2 / 277 (0.72%)	2 / 276 (0.72%)
occurrences all number	2	2
sinus arrhythmia
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	1 / 276 (0.36%)
occurrences all number	0	1
sinus tachycardia
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
supraventricular tachycardia
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
tachycardia
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	1 / 276 (0.36%)
occurrences all number	0	1
tricuspid valve disease
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
Nervous system disorders
ageusia
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
amnesia
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	4 / 277 (1.44%)	1 / 276 (0.36%)
occurrences all number	4	1
aphasia
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	2 / 277 (0.72%)	0 / 276 (0.00%)
occurrences all number	2	0
aphonia
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	1 / 276 (0.36%)
occurrences all number	0	1
asterixis
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
autonomic nervous system imbalance
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
balance disorder
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	2 / 277 (0.72%)	0 / 276 (0.00%)
occurrences all number	2	0
cerebral ischaemia
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
circadian rhythm sleep disorder
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
clumsiness
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	2 / 276 (0.72%)
occurrences all number	0	2
consciousness fluctuating
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
convulsion
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	2 / 277 (0.72%)	1 / 276 (0.36%)
occurrences all number	2	1
diabetic neuropathy
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	1 / 276 (0.36%)
occurrences all number	0	1
disturbance in attention
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	3 / 277 (1.08%)	0 / 276 (0.00%)
occurrences all number	3	0
dizziness
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	23 / 277 (8.30%)	16 / 276 (5.80%)
occurrences all number	25	18
dysaesthesia
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
dysgeusia
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	7 / 277 (2.53%)	3 / 276 (1.09%)
occurrences all number	9	3
encephalopathy
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
headache
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	53 / 277 (19.13%)	15 / 276 (5.43%)
occurrences all number	69	18
hemiparesis
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
hepatic encephalopathy
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	9 / 277 (3.25%)	3 / 276 (1.09%)
occurrences all number	10	3
hyperaesthesia
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	1 / 276 (0.36%)
occurrences all number	0	1
hypoaesthesia
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	3 / 277 (1.08%)	4 / 276 (1.45%)
occurrences all number	3	5
hypotonia
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	1 / 276 (0.36%)
occurrences all number	0	1
intercostal neuralgia
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
lethargy
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	1 / 276 (0.36%)
occurrences all number	0	1
loss of proprioception
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	1 / 276 (0.36%)
occurrences all number	0	1
memory impairment
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	3 / 277 (1.08%)	0 / 276 (0.00%)
occurrences all number	3	0
movement disorder
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	1 / 276 (0.36%)
occurrences all number	0	1
nervous system disorder
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
neuropathy peripheral
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	2 / 276 (0.72%)
occurrences all number	1	2
paraesthesia
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	8 / 277 (2.89%)	5 / 276 (1.81%)
occurrences all number	14	6
parkinson's disease
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	1 / 276 (0.36%)
occurrences all number	0	2
peripheral sensory neuropathy
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	2 / 277 (0.72%)	2 / 276 (0.72%)
occurrences all number	2	2
petit mal epilepsy
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
polyneuropathy
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	2 / 276 (0.72%)
occurrences all number	2	2
radiculitis
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
restless legs syndrome
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
sciatica
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	2 / 276 (0.72%)
occurrences all number	0	2
somnolence
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	4 / 277 (1.44%)	1 / 276 (0.36%)
occurrences all number	6	1
spinal cord compression
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
status epilepticus
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
stupor
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
syncope
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	2 / 277 (0.72%)	0 / 276 (0.00%)
occurrences all number	2	0
transient ischaemic attack
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	1 / 276 (0.36%)
occurrences all number	0	1
tremor
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	3 / 276 (1.09%)
occurrences all number	1	3
vocal cord paralysis
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
Blood and lymphatic system disorders
anaemia
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	29 / 277 (10.47%)	31 / 276 (11.23%)
occurrences all number	54	44
disseminated intravascular coagulation
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
eosinophilia
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	2 / 276 (0.72%)
occurrences all number	0	2
hypochromic anaemia
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	8	0
leukocytosis
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	3 / 277 (1.08%)	5 / 276 (1.81%)
occurrences all number	3	5
leukopenia
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	14 / 277 (5.05%)	7 / 276 (2.54%)
occurrences all number	54	19
lymphopenia
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	7 / 277 (2.53%)	4 / 276 (1.45%)
occurrences all number	16	7
lymphadenopathy
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	1 / 276 (0.36%)
occurrences all number	0	1
neutropenia
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	16 / 277 (5.78%)	4 / 276 (1.45%)
occurrences all number	80	8
neutrophilia
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
splenomegaly
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	1 / 276 (0.36%)
occurrences all number	1	1
thrombocytopenia
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	48 / 277 (17.33%)	12 / 276 (4.35%)
occurrences all number	189	26
thrombocytosis
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	1 / 276 (0.36%)
occurrences all number	0	1
Ear and labyrinth disorders
deafness
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	1 / 276 (0.36%)
occurrences all number	1	1
deafness neurosensory
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	1 / 276 (0.36%)
occurrences all number	0	1
ear congestion
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
ear discomfort
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
ear haemorrhage
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
hearing impaired
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	2 / 277 (0.72%)	0 / 276 (0.00%)
occurrences all number	2	0
tinnitus
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	4 / 277 (1.44%)	3 / 276 (1.09%)
occurrences all number	6	4
vertigo
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	4 / 277 (1.44%)	5 / 276 (1.81%)
occurrences all number	4	8
vestibular disorder
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	1 / 276 (0.36%)
occurrences all number	0	1
Eye disorders
asthenopia
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	1 / 276 (0.36%)
occurrences all number	0	1
cataract
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	3 / 276 (1.09%)
occurrences all number	1	3
conjunctival haemorrhage
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
conjunctival hyperaemia
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
conjunctivitis allergic
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
diabetic retinopathy
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
disorder of orbit
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	1 / 276 (0.36%)
occurrences all number	0	1
dry eye
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	2 / 276 (0.72%)
occurrences all number	0	2
entropion
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
eye disorder
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
eye irritation
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	1 / 276 (0.36%)
occurrences all number	0	1
eye pruritus
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	2 / 277 (0.72%)	2 / 276 (0.72%)
occurrences all number	2	2
eye swelling
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
eyelid oedema
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
foreign body sensation in eyes
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	1 / 276 (0.36%)
occurrences all number	0	1
hypermetropia
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
ocular hyperaemia
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
ocular icterus
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	2 / 277 (0.72%)	1 / 276 (0.36%)
occurrences all number	2	1
periorbital oedema
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
photophobia
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	1 / 276 (0.36%)
occurrences all number	1	1
presbyopia
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
retinal vascular disorder
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	1 / 276 (0.36%)
occurrences all number	0	1
retinopathy
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
visual impairment
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
vision blurred
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	4 / 277 (1.44%)	3 / 276 (1.09%)
occurrences all number	4	3
vitreous floaters
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	2 / 276 (0.72%)
occurrences all number	2	2
Gastrointestinal disorders
abdominal discomfort
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	2 / 277 (0.72%)	7 / 276 (2.54%)
occurrences all number	2	8
abdominal distension
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	19 / 277 (6.86%)	28 / 276 (10.14%)
occurrences all number	27	31
abdominal hernia
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
abdominal pain
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	45 / 277 (16.25%)	58 / 276 (21.01%)
occurrences all number	63	86
abdominal pain lower
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	2 / 276 (0.72%)
occurrences all number	0	2
abdominal pain upper
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	26 / 277 (9.39%)	25 / 276 (9.06%)
occurrences all number	34	32
abdominal rigidity
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	1 / 276 (0.36%)
occurrences all number	0	1
abdominal tenderness
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	2 / 277 (0.72%)	2 / 276 (0.72%)
occurrences all number	2	2
anal fissure
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
anal haemorrhage
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	1 / 276 (0.36%)
occurrences all number	1	1
anal pruritus
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
aphthous stomatitis
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
ascites
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	72 / 277 (25.99%)	40 / 276 (14.49%)
occurrences all number	110	47
breath odour
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	1 / 276 (0.36%)
occurrences all number	0	1
colitis
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	2 / 277 (0.72%)	0 / 276 (0.00%)
occurrences all number	3	0
constipation
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	36 / 277 (13.00%)	34 / 276 (12.32%)
occurrences all number	39	39
dental caries
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	2 / 277 (0.72%)	1 / 276 (0.36%)
occurrences all number	2	1
diarrhoea
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	50 / 277 (18.05%)	38 / 276 (13.77%)
occurrences all number	74	52
dry mouth
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	6 / 277 (2.17%)	4 / 276 (1.45%)
occurrences all number	7	4
duodenal ulcer
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	1 / 276 (0.36%)
occurrences all number	1	1
dyspepsia
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	6 / 277 (2.17%)	11 / 276 (3.99%)
occurrences all number	7	14
dysphagia
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	4 / 277 (1.44%)	2 / 276 (0.72%)
occurrences all number	4	3
enteritis
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	2 / 276 (0.72%)
occurrences all number	0	2
epigastric discomfort
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	2 / 277 (0.72%)	3 / 276 (1.09%)
occurrences all number	2	3
eructation
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
faecal incontinence
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	1 / 276 (0.36%)
occurrences all number	0	1
faeces discoloured
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	2 / 277 (0.72%)	0 / 276 (0.00%)
occurrences all number	2	0
flatulence
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	4 / 277 (1.44%)	6 / 276 (2.17%)
occurrences all number	4	7
food poisoning
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
frequent bowel movements
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	1 / 276 (0.36%)
occurrences all number	0	1
gastric mucosal lesion
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	1 / 276 (0.36%)
occurrences all number	0	1
gastric ulcer
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	2 / 277 (0.72%)	2 / 276 (0.72%)
occurrences all number	2	2
gastritis
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	5 / 277 (1.81%)	5 / 276 (1.81%)
occurrences all number	6	5
gastroduodenitis
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
gastrointestinal disorder
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	1 / 276 (0.36%)
occurrences all number	0	1
gastrointestinal haemorrhage
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	1 / 276 (0.36%)
occurrences all number	1	1
gastrointestinal pain
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	1 / 276 (0.36%)
occurrences all number	0	1
gastrooesophageal reflux disease
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	5 / 277 (1.81%)	4 / 276 (1.45%)
occurrences all number	6	4
gingival bleeding
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	18 / 277 (6.50%)	4 / 276 (1.45%)
occurrences all number	22	4
gingival disorder
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
gingival pain
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	2 / 277 (0.72%)	0 / 276 (0.00%)
occurrences all number	3	0
gingival swelling
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	1 / 276 (0.36%)
occurrences all number	0	1
glossodynia
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	1 / 276 (0.36%)
occurrences all number	0	1
haematemesis
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	2 / 276 (0.72%)
occurrences all number	0	2
haematochezia
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	2 / 277 (0.72%)	1 / 276 (0.36%)
occurrences all number	2	1
haemorrhoidal haemorrhage
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	5 / 277 (1.81%)	1 / 276 (0.36%)
occurrences all number	6	1
haemorrhoids
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	6 / 277 (2.17%)	4 / 276 (1.45%)
occurrences all number	6	4
inguinal hernia
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	2 / 277 (0.72%)	1 / 276 (0.36%)
occurrences all number	3	1
irritable bowel syndrome
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
lip dry
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	1 / 276 (0.36%)
occurrences all number	0	1
lower gastrointestinal haemorrhage
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	1 / 276 (0.36%)
occurrences all number	1	1
melaena
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	2 / 277 (0.72%)	3 / 276 (1.09%)
occurrences all number	2	3
mouth ulceration
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	3 / 277 (1.08%)	3 / 276 (1.09%)
occurrences all number	3	3
mouth haemorrhage
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	6 / 277 (2.17%)	0 / 276 (0.00%)
occurrences all number	20	0
nausea
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	52 / 277 (18.77%)	52 / 276 (18.84%)
occurrences all number	71	74
odynophagia
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	1 / 276 (0.36%)
occurrences all number	1	1
oesophageal varices haemorrhage
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	2 / 276 (0.72%)
occurrences all number	0	3
oesophagitis
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	2 / 277 (0.72%)	2 / 276 (0.72%)
occurrences all number	2	3
oral disorder
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
oral mucosal blistering
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	1 / 276 (0.36%)
occurrences all number	0	1
painful defaecation
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
paraesthesia oral
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	1 / 276 (0.36%)
occurrences all number	0	1
peptic ulcer
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	1 / 276 (0.36%)
occurrences all number	0	1
periodontal disease
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	2 / 277 (0.72%)	0 / 276 (0.00%)
occurrences all number	4	0
portal hypertensive gastropathy
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	1 / 276 (0.36%)
occurrences all number	0	1
proctalgia
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	1 / 276 (0.36%)
occurrences all number	1	1
rectal haemorrhage
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	5 / 277 (1.81%)	3 / 276 (1.09%)
occurrences all number	5	3
rectal tenesmus
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	1 / 276 (0.36%)
occurrences all number	0	1
small intestinal obstruction
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
steatorrhoea
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
stomatitis
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	8 / 277 (2.89%)	4 / 276 (1.45%)
occurrences all number	9	4
submaxillary gland enlargement
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
tongue geographic
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
tooth disorder
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
toothache
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	5 / 277 (1.81%)	2 / 276 (0.72%)
occurrences all number	7	2
umbilical hernia
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
upper gastrointestinal haemorrhage
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	1 / 276 (0.36%)
occurrences all number	1	1
varices oesophageal
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	3 / 277 (1.08%)	2 / 276 (0.72%)
occurrences all number	3	2
vomiting
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	30 / 277 (10.83%)	40 / 276 (14.49%)
occurrences all number	39	47
Hepatobiliary disorders
biliary colic
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	1 / 276 (0.36%)
occurrences all number	1	1
cholangitis
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	4 / 277 (1.44%)	0 / 276 (0.00%)
occurrences all number	6	0
cholangitis acute
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	1 / 276 (0.36%)
occurrences all number	0	3
cholecystitis
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
cholelithiasis
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	4	0
cholestasis
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
hepatic cirrhosis
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	2 / 277 (0.72%)	1 / 276 (0.36%)
occurrences all number	2	1
hepatic failure
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	2 / 277 (0.72%)	5 / 276 (1.81%)
occurrences all number	2	5
hepatic function abnormal
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	3 / 277 (1.08%)	1 / 276 (0.36%)
occurrences all number	3	1
hepatic pain
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	2 / 276 (0.72%)
occurrences all number	3	3
hepatobiliary disease
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	1 / 276 (0.36%)
occurrences all number	0	1
hepatocellular injury
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	1 / 276 (0.36%)
occurrences all number	1	1
hepatorenal syndrome
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	2 / 276 (0.72%)
occurrences all number	0	2
hepatomegaly
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	6 / 277 (2.17%)	8 / 276 (2.90%)
occurrences all number	6	8
hyperbilirubinaemia
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	10 / 277 (3.61%)	15 / 276 (5.43%)
occurrences all number	16	32
hypertransaminasaemia
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	3 / 277 (1.08%)	1 / 276 (0.36%)
occurrences all number	4	1
jaundice
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	12 / 277 (4.33%)	13 / 276 (4.71%)
occurrences all number	13	14
liver disorder
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
portal hypertension
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	1 / 276 (0.36%)
occurrences all number	1	1
portal vein thrombosis
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	4 / 276 (1.45%)
occurrences all number	0	4
Skin and subcutaneous tissue disorders
acne
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	3 / 276 (1.09%)
occurrences all number	0	3
alopecia
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	12 / 277 (4.33%)	12 / 276 (4.35%)
occurrences all number	13	13
asteatosis
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
blister
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
blood blister
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	1 / 276 (0.36%)
occurrences all number	0	1
cold sweat
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
cutis laxa
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
decubitus ulcer
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	2 / 277 (0.72%)	0 / 276 (0.00%)
occurrences all number	2	0
dermatitis
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
dermatitis acneiform
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	5 / 277 (1.81%)	2 / 276 (0.72%)
occurrences all number	5	3
dermatitis bullous
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	1 / 276 (0.36%)
occurrences all number	0	1
dermatitis contact
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	1 / 276 (0.36%)
occurrences all number	0	1
dermatitis diaper
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	1 / 276 (0.36%)
occurrences all number	0	1
dry skin
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	16 / 277 (5.78%)	12 / 276 (4.35%)
occurrences all number	17	13
ecchymosis
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	1 / 276 (0.36%)
occurrences all number	0	1
eczema
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	2 / 277 (0.72%)	1 / 276 (0.36%)
occurrences all number	2	1
erythema
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	4 / 277 (1.44%)	6 / 276 (2.17%)
occurrences all number	5	6
haemorrhage subcutaneous
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
hair colour changes
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
hand dermatitis
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
hyperhidrosis
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	5 / 276 (1.81%)
occurrences all number	1	5
hyperkeratosis
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	3 / 276 (1.09%)
occurrences all number	1	3
koilonychia
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	1 / 276 (0.36%)
occurrences all number	0	1
leukocytoclastic vasculitis
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	1 / 276 (0.36%)
occurrences all number	0	1
lichenoid keratosis
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
nail disorder
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	2	0
nail dystrophy
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
night sweats
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	1 / 276 (0.36%)
occurrences all number	1	1
onychoclasis
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	2 / 277 (0.72%)	1 / 276 (0.36%)
occurrences all number	2	1
onychomadesis
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
palmar-plantar erythrodysaesthesia syndrome
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	11 / 277 (3.97%)	5 / 276 (1.81%)
occurrences all number	19	5
papule
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	1 / 276 (0.36%)
occurrences all number	1	1
petechiae
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	2 / 277 (0.72%)	0 / 276 (0.00%)
occurrences all number	2	0
photodermatosis
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	1 / 276 (0.36%)
occurrences all number	0	1
photosensitivity reaction
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
pigmentation disorder
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	2 / 277 (0.72%)	0 / 276 (0.00%)
occurrences all number	2	0
prurigo
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
pruritus
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	28 / 277 (10.11%)	29 / 276 (10.51%)
occurrences all number	33	41
pruritus generalised
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	1 / 276 (0.36%)
occurrences all number	0	1
purpura
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	2 / 277 (0.72%)	1 / 276 (0.36%)
occurrences all number	2	1
purpura senile
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	1 / 276 (0.36%)
occurrences all number	0	1
rash
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	23 / 277 (8.30%)	12 / 276 (4.35%)
occurrences all number	27	16
rash erythematous
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	1 / 276 (0.36%)
occurrences all number	0	1
rash maculo-papular
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	3 / 277 (1.08%)	1 / 276 (0.36%)
occurrences all number	3	1
scar pain
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
skin atrophy
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
skin disorder
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	1 / 276 (0.36%)
occurrences all number	1	1
skin exfoliation
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	1 / 276 (0.36%)
occurrences all number	0	1
skin haemorrhage
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
skin hyperpigmentation
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	2 / 277 (0.72%)	0 / 276 (0.00%)
occurrences all number	2	0
skin hypopigmentation
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
skin lesion
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	3 / 277 (1.08%)	1 / 276 (0.36%)
occurrences all number	3	1
skin mass
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	3 / 277 (1.08%)	0 / 276 (0.00%)
occurrences all number	3	0
skin tightness
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
skin ulcer
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	3 / 277 (1.08%)	2 / 276 (0.72%)
occurrences all number	5	2
swelling face
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
urticaria
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	2 / 276 (0.72%)
occurrences all number	1	3
xeroderma
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	1 / 276 (0.36%)
occurrences all number	0	1
Renal and urinary disorders
anuria
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
dysuria
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	2 / 277 (0.72%)	1 / 276 (0.36%)
occurrences all number	2	1
haematuria
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	3 / 276 (1.09%)
occurrences all number	1	3
nephropathy
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
nocturia
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	2 / 277 (0.72%)	1 / 276 (0.36%)
occurrences all number	2	2
oliguria
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	2 / 277 (0.72%)	0 / 276 (0.00%)
occurrences all number	2	0
pollakiuria
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	4 / 277 (1.44%)	1 / 276 (0.36%)
occurrences all number	4	1
polyuria
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
proteinuria
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	46 / 277 (16.61%)	13 / 276 (4.71%)
occurrences all number	117	18
renal cyst
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	1 / 276 (0.36%)
occurrences all number	1	1
renal failure
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	2 / 277 (0.72%)	2 / 276 (0.72%)
occurrences all number	2	2
renal failure acute
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	2 / 277 (0.72%)	3 / 276 (1.09%)
occurrences all number	2	3
renal impairment
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	1 / 276 (0.36%)
occurrences all number	1	1
renal pain
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	1 / 276 (0.36%)
occurrences all number	0	1
renal vein thrombosis
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	1 / 276 (0.36%)
occurrences all number	0	1
urinary incontinence
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	2 / 277 (0.72%)	1 / 276 (0.36%)
occurrences all number	3	1
urinary retention
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	2 / 277 (0.72%)	1 / 276 (0.36%)
occurrences all number	3	1
Endocrine disorders
adrenal insufficiency
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
hyperparathyroidism
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
hyperthyroidism
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
hypothyroidism
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	3 / 277 (1.08%)	0 / 276 (0.00%)
occurrences all number	3	0
Musculoskeletal and connective tissue disorders
amyotrophy
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	1 / 276 (0.36%)
occurrences all number	1	1
arthralgia
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	19 / 277 (6.86%)	10 / 276 (3.62%)
occurrences all number	26	12
arthritis
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	2 / 277 (0.72%)	0 / 276 (0.00%)
occurrences all number	2	0
back pain
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	23 / 277 (8.30%)	23 / 276 (8.33%)
occurrences all number	27	32
bone pain
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	5 / 277 (1.81%)	4 / 276 (1.45%)
occurrences all number	20	4
bursitis
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	1 / 276 (0.36%)
occurrences all number	1	1
exostosis
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
flank pain
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	3 / 277 (1.08%)	11 / 276 (3.99%)
occurrences all number	3	16
groin pain
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	1 / 276 (0.36%)
occurrences all number	1	1
intervertebral disc protrusion
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	2 / 277 (0.72%)	1 / 276 (0.36%)
occurrences all number	2	1
joint crepitation
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
joint effusion
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
joint stiffness
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	1 / 276 (0.36%)
occurrences all number	0	1
joint swelling
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	2 / 276 (0.72%)
occurrences all number	0	4
lumbar spinal stenosis
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
metatarsalgia
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	1 / 276 (0.36%)
occurrences all number	0	1
mobility decreased
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
muscle atrophy
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	1 / 276 (0.36%)
occurrences all number	0	1
muscle spasms
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	6 / 277 (2.17%)	6 / 276 (2.17%)
occurrences all number	11	7
muscular weakness
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	5 / 277 (1.81%)	4 / 276 (1.45%)
occurrences all number	6	4
musculoskeletal chest pain
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	7 / 277 (2.53%)	11 / 276 (3.99%)
occurrences all number	9	13
musculoskeletal pain
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	18 / 277 (6.50%)	12 / 276 (4.35%)
occurrences all number	26	13
musculoskeletal stiffness
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	1 / 276 (0.36%)
occurrences all number	0	1
myalgia
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	11 / 277 (3.97%)	7 / 276 (2.54%)
occurrences all number	14	9
neck mass
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	1 / 276 (0.36%)
occurrences all number	0	1
neck pain
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	2 / 277 (0.72%)	2 / 276 (0.72%)
occurrences all number	2	2
osteoarthritis
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
osteonecrosis
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	1 / 276 (0.36%)
occurrences all number	0	1
pain in extremity
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	12 / 277 (4.33%)	6 / 276 (2.17%)
occurrences all number	14	8
pain in jaw
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	2 / 277 (0.72%)	0 / 276 (0.00%)
occurrences all number	2	0
pathological fracture
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	2 / 277 (0.72%)	0 / 276 (0.00%)
occurrences all number	2	0
rheumatic disorder
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
scleroderma
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
spinal osteoarthritis
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	1 / 276 (0.36%)
occurrences all number	0	1
spinal pain
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	4 / 276 (1.45%)
occurrences all number	0	4
temporomandibular joint syndrome
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
tenosynovitis
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
Infections and infestations
abdominal infection
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	1 / 276 (0.36%)
occurrences all number	0	1
anal abscess
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	2 / 277 (0.72%)	0 / 276 (0.00%)
occurrences all number	2	0
anisakiasis
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	1 / 276 (0.36%)
occurrences all number	0	1
biliary tract infection
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	1 / 276 (0.36%)
occurrences all number	0	1
bronchitis
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	5 / 277 (1.81%)	3 / 276 (1.09%)
occurrences all number	5	3
bronchopneumonia
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	2 / 277 (0.72%)	0 / 276 (0.00%)
occurrences all number	2	0
candida infection
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	2 / 276 (0.72%)
occurrences all number	0	2
cellulitis
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	1 / 276 (0.36%)
occurrences all number	0	1
cystitis
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	1 / 276 (0.36%)
occurrences all number	0	1
diarrhoea infectious
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	1 / 276 (0.36%)
occurrences all number	0	1
ear infection
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
erysipelas
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
fungal infection
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	1 / 276 (0.36%)
occurrences all number	0	1
gastroenteritis
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	3 / 277 (1.08%)	0 / 276 (0.00%)
occurrences all number	3	0
gastroenteritis bacterial
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	1 / 276 (0.36%)
occurrences all number	0	1
gingival abscess
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
gingivitis
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	4 / 277 (1.44%)	0 / 276 (0.00%)
occurrences all number	6	0
hepatitis a
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	1 / 276 (0.36%)
occurrences all number	0	1
herpes simplex
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	1 / 276 (0.36%)
occurrences all number	0	2
herpes zoster
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
infection
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	3 / 276 (1.09%)
occurrences all number	1	3
influenza
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	2 / 277 (0.72%)	1 / 276 (0.36%)
occurrences all number	2	1
kidney infection
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
labyrinthitis
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	1 / 276 (0.36%)
occurrences all number	0	1
laryngitis
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	2 / 277 (0.72%)	0 / 276 (0.00%)
occurrences all number	2	0
lip infection
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
liver abscess
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
localised infection
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
lung infection
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	1 / 276 (0.36%)
occurrences all number	1	1
nasopharyngitis
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	15 / 277 (5.42%)	14 / 276 (5.07%)
occurrences all number	15	16
oesophageal candidiasis
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	1 / 276 (0.36%)
occurrences all number	0	1
oral candidiasis
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	1 / 276 (0.36%)
occurrences all number	1	1
oral herpes
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	3 / 276 (1.09%)
occurrences all number	1	3
oral infection
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
paronychia
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	1 / 276 (0.36%)
occurrences all number	0	1
periodontitis
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
peritonitis bacterial
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
pharyngitis
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	1 / 276 (0.36%)
occurrences all number	1	1
pharyngotonsillitis
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
pneumonia
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	1 / 276 (0.36%)
occurrences all number	0	2
proteus infection
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
pyelonephritis acute
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
rash pustular
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	3 / 277 (1.08%)	0 / 276 (0.00%)
occurrences all number	3	0
respiratory tract infection
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	3 / 277 (1.08%)	1 / 276 (0.36%)
occurrences all number	3	1
rhinitis
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	6 / 277 (2.17%)	0 / 276 (0.00%)
occurrences all number	7	0
sepsis
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
sinusitis
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	4 / 277 (1.44%)	1 / 276 (0.36%)
occurrences all number	4	1
skin candida
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	1 / 276 (0.36%)
occurrences all number	0	1
staphylococcal infection
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
tinea cruris
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	1 / 276 (0.36%)
occurrences all number	0	1
tinea pedis
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	2 / 277 (0.72%)	1 / 276 (0.36%)
occurrences all number	2	1
tinea infection
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	1 / 276 (0.36%)
occurrences all number	1	1
tonsillitis
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
tooth abscess
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	2 / 277 (0.72%)	1 / 276 (0.36%)
occurrences all number	2	1
tooth infection
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
tracheitis
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	1 / 276 (0.36%)
occurrences all number	0	1
upper respiratory tract infection
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	11 / 277 (3.97%)	6 / 276 (2.17%)
occurrences all number	14	8
urinary tract infection
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	10 / 277 (3.61%)	6 / 276 (2.17%)
occurrences all number	10	6
urinary tract infection bacterial
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
vulvovaginal candidiasis
alternative dictionary used: MedDRA 16.1
subjects affected / exposed ^[6]	0 / 47 (0.00%)	1 / 40 (2.50%)
occurrences all number	0	2
vulvitis
alternative dictionary used: MedDRA 16.1
subjects affected / exposed ^[7]	1 / 47 (2.13%)	0 / 40 (0.00%)
occurrences all number	1	0
Metabolism and nutrition disorders
cachexia
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	1 / 276 (0.36%)
occurrences all number	1	1
decreased appetite
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	59 / 277 (21.30%)	50 / 276 (18.12%)
occurrences all number	81	62
dehydration
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	8 / 277 (2.89%)	5 / 276 (1.81%)
occurrences all number	9	5
diabetes mellitus
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	2 / 277 (0.72%)	4 / 276 (1.45%)
occurrences all number	2	4
fluid retention
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	2 / 277 (0.72%)	0 / 276 (0.00%)
occurrences all number	2	0
glucose tolerance impaired
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	2 / 277 (0.72%)	0 / 276 (0.00%)
occurrences all number	2	0
gout
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	1 / 276 (0.36%)
occurrences all number	1	1
hyperammonaemia
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	2 / 276 (0.72%)
occurrences all number	1	2
hypercalcaemia
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	2 / 277 (0.72%)	3 / 276 (1.09%)
occurrences all number	2	4
hypercreatininaemia
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	2 / 277 (0.72%)	0 / 276 (0.00%)
occurrences all number	3	0
hyperglycaemia
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	9 / 277 (3.25%)	11 / 276 (3.99%)
occurrences all number	26	15
hyperkalaemia
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	13 / 277 (4.69%)	11 / 276 (3.99%)
occurrences all number	17	11
hypernatraemia
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
hyperphagia
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
hypertriglyceridaemia
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	3	0
hyperuricaemia
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	8 / 277 (2.89%)	4 / 276 (1.45%)
occurrences all number	20	5
hypoalbuminaemia
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	33 / 277 (11.91%)	14 / 276 (5.07%)
occurrences all number	66	27
hypocalcaemia
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	4 / 277 (1.44%)	3 / 276 (1.09%)
occurrences all number	11	3
hypoglycaemia
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	1 / 276 (0.36%)
occurrences all number	1	1
hypokalaemia
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	7 / 277 (2.53%)	10 / 276 (3.62%)
occurrences all number	9	15
hypomagnesaemia
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	4 / 277 (1.44%)	3 / 276 (1.09%)
occurrences all number	5	3
hyponatraemia
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	13 / 277 (4.69%)	15 / 276 (5.43%)
occurrences all number	21	20
hypophosphataemia
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	5 / 277 (1.81%)	3 / 276 (1.09%)
occurrences all number	9	6
increased appetite
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	2 / 277 (0.72%)	0 / 276 (0.00%)
occurrences all number	2	0
iron deficiency
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	1 / 276 (0.36%)
occurrences all number	1	1
malnutrition
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	2 / 276 (0.72%)
occurrences all number	0	2
polydipsia
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
type 2 diabetes mellitus
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	0 / 277 (0.00%)	1 / 276 (0.36%)
occurrences all number	0	1
vitamin b1 deficiency
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
vitamin b6 deficiency
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	1	0
vitamin d deficiency
alternative dictionary used: MedDRA 16.1
subjects affected / exposed	1 / 277 (0.36%)	0 / 276 (0.00%)
occurrences all number	2	0

Notes
[1] - 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.
[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.
[5] - 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.
[6] - 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.
[7] - 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.

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Were there any global substantial amendments to the protocol? No

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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