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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 43862 clinical trials with a EudraCT protocol, of which 7285 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:
The Effect of Dulaglutide on Major Cardiovascular Events in Patients with Type 2 Diabetes: Researching Cardiovascular Events with a Weekly INcretin in Diabetes (REWIND)

Summary
EudraCT number	2010-023799-21
Trial protocol	SE LT LV CZ HU GB PL ES BG DE
Global end of trial date	21 Aug 2018

Results information
Results version number	v2(current)
This version publication date	04 Oct 2019
First version publication date	25 Aug 2019
Other versions	v1
Version creation reason	Correction of full data set Correction of full data set

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

Collapse all Expand all

Trial information

Top of page

Sponsor protocol code

H9X-MC-GBDJ

ISRCTN number

-

US NCT number

NCT01394952

WHO universal trial number (UTN)

-

Other trial identifiers

Trial Number: 13438

Sponsor organisation name

Eli Lilly and Company

Sponsor organisation address

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

Public contact

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

Scientific contact

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

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

No

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

No

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

No

Analysis stage

Final

Date of interim/final analysis

19 Oct 2018

Is this the analysis of the primary completion data?

No

Global end of trial reached?

Yes

Global end of trial date

21 Aug 2018

Was the trial ended prematurely?

No

Main objective of the trial

The purpose of this trial is to assess whether dulaglutide can reduce major cardiovascular events and other serious outcomes in persons with type 2 diabetes, when added to their anti-hyperglycemic regimen.

Protection of trial subjects

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

Background therapy

-

Evidence for comparator

-

Actual start date of recruitment

22 Jul 2011

Long term follow-up planned

No

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

Czech Republic: 213

Country: Number of subjects enrolled

United States: 943

Country: Number of subjects enrolled

Russian Federation: 101

Country: Number of subjects enrolled

Korea, Republic of: 122

Country: Number of subjects enrolled

Sweden: 236

Country: Number of subjects enrolled

Latvia: 78

Country: Number of subjects enrolled

Brazil: 275

Country: Number of subjects enrolled

Poland: 608

Country: Number of subjects enrolled

Chile: 128

Country: Number of subjects enrolled

Bulgaria: 101

Country: Number of subjects enrolled

Lithuania: 105

Country: Number of subjects enrolled

Colombia: 785

Country: Number of subjects enrolled

Argentina: 1395

Country: Number of subjects enrolled

Romania: 1085

Country: Number of subjects enrolled

Hungary: 223

Country: Number of subjects enrolled

United Kingdom: 136

Country: Number of subjects enrolled

Spain: 127

Country: Number of subjects enrolled

New Zealand: 234

Country: Number of subjects enrolled

Canada: 1128

Country: Number of subjects enrolled

Taiwan: 26

Country: Number of subjects enrolled

South Africa: 741

Country: Number of subjects enrolled

Mexico: 438

Country: Number of subjects enrolled

Australia: 88

Country: Number of subjects enrolled

Germany: 585

Worldwide total number of subjects

9901

EEA total number of subjects

3497

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)

4645

From 65 to 84 years

5213

85 years and over

43

Subject disposition

Top of page

Recruitment details

No Text Available

Screening details

Participants were randomized to either placebo or Dulaglutide. Completers included participants for whom vital status was ascertained during the study close-out period and endpoint completers.

Period 1 title

Overall Study (overall period)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator

Are arms mutually exclusive

Yes

Placebo

Arm description

Placebo was administered once weekly, subcutaneously

Arm type

Placebo

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Placebo

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

Administered subcutaneously

Dulaglutide

Arm description

Dulaglutide 1.5 mg was administered once weekly, subcutaneously

Arm type

Experimental

Investigational medicinal product name

Dulaglutide

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

1.5 mg Dulaglutide was administered once weekly, subcutaneously

Number of subjects in period 1	Placebo	Dulaglutide
Started	4952	4949
Received at least one dose of study drug	4949	4943
Completed	4935	4932
Not completed	17	17
Consent withdrawn by subject	10	5
Physician decision	2	-
Sponsor Decision	5	7
Lost to follow-up	-	5

Baseline characteristics

Top of page

Reporting group title

Overall Study

Reporting group description

-

Reporting group values	Overall Study	Total
Number of subjects	9901	9901
Age categorical
Units: Subjects
<=18 years	0	0
Between 18 and 65 years	4645	4645
>=65 years	5256	5256
Age continuous
Units: years
arithmetic mean (standard deviation)	66.2 ( 6.5 )	-
Gender categorical
Units: Subjects
Female	4589	4589
Male	5312	5312
Ethnicity (NIH/OMB)
Units: Subjects
Hispanic or Latino	124	124
Not Hispanic or Latino	802	802
Unknown or Not Reported	8975	8975
Race (NIH/OMB)
Units: Subjects
American Indian or Alaska Native	1092	1092
Asian	434	434
Native Hawaiian or Other Pacific Islander	34	34
Black or African American	677	677
White	7498	7498
More than one race	166	166
Unknown or Not Reported	0	0
Region of Enrollment
Puerto Rico is combined with the United States for this study.
Units: Subjects
United States	943	943
Czechia	213	213
Russia	101	101
South Korea	122	122
Sweden	236	236
Latvia	78	78
Brazil	275	275
Poland	608	608
Chile	128	128
Bulgaria	101	101
Lithuania	105	105
Colombia	785	785
Argentina	1395	1395
Romania	1085	1085
Hungary	223	223
United Kingdom	136	136
Spain	127	127
New Zealand	234	234
Canada	1128	1128
Taiwan	26	26
South Africa	741	741
Mexico	438	438
Australia	88	88
Germany	585	585

End points

Top of page

Reporting group title

Placebo

Reporting group description

Placebo was administered once weekly, subcutaneously

Reporting group title

Dulaglutide

Reporting group description

Dulaglutide 1.5 mg was administered once weekly, subcutaneously

Primary: Number of Participants Who Experienced an Event for Time From Randomization to First Occurrence of Cardiovascular Death, Non-fatal Myocardial Infarction, or Non-fatal Stroke (a Composite Cardiovascular Outcome)

Top of page

End point title

Number of Participants Who Experienced an Event for Time From Randomization to First Occurrence of Cardiovascular Death, Non-fatal Myocardial Infarction, or Non-fatal Stroke (a Composite Cardiovascular Outcome)

End point description

The time from randomization to first occurrence of cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke (a composite endpoint) was evaluated using time-to-event analysis. The primary analysis model was a Cox proportional hazards regression model for the time to the first occurrence of a primary endpoint event, with treatment as a fixed effect using the intent-to-treat population. The number of participants who experienced primary cardiovascular (CV) endpoint event is presented.

End point type

Primary

End point timeframe

From randomization to first occurrence or death from any cause or study completion (Median Follow-Up of 5.4 Years)

End point values	Placebo	Dulaglutide
Number of subjects analysed	4952 ^[1]	4949 ^[2]
Units: participants	663	594

Notes
[1] - All randomized participants.
[2] - All randomized participants.

Number of Participants Who Experienced an Event

Statistical analysis description

Primary CV endpoint

Comparison groups

Placebo v Dulaglutide

Number of subjects included in analysis

9901

Analysis specification

Pre-specified

Analysis type

superiority ^[3]

P-value

= 0.026

Method

Regression, Cox

Parameter type

Hazard ratio (HR)

Point estimate

0.88

Confidence interval

level

95.33%

sides

2-sided

lower limit

0.79

upper limit

0.99

Notes
[3] - Superiority was declared if the upper limit of the 2-sided 95.33% CI of the hazard ratio was below 1.0 (after adjustment for the interim analysis). Once superiority was achieved for the primary endpoint, multiplicity adjustments using the graphical approach were performed for secondary efficacy endpoints in order to control the overall Type I error rate at a 2-sided alpha level of 0.0467.

Secondary: Number of Participants Who Experienced an Event for Time to first occurrence after randomization of cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke, individually

Top of page

End point title

Number of Participants Who Experienced an Event for Time to first occurrence after randomization of cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke, individually

End point description

The time from randomization to first occurrence of cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke (individually) was evaluated using time-to-event analysis via the Cox proportional hazards regression model where response equals treatment. Death from CV causes is defined as a death resulting from an acute myocardial infarction (MI), sudden cardiac death, death due to heart failure, death due to stroke, or death due to other CV causes. The number of participants who experienced an event is presented.

End point type

Secondary

End point timeframe

From randomization to first occurrence or study completion (Median Follow-Up of 5.4 Years)

End point values	Placebo	Dulaglutide
Number of subjects analysed	4952 ^[4]	4949 ^[5]
Units: participants
Death from CV causes	346	317
Nonfatal MI	212	205
Nonfatal stroke	175	135

Notes
[4] - All randomized participants.
[5] - All randomized participants.

Number of Participants Who Experienced an Event

Statistical analysis description

Death from CV causes

Comparison groups

Placebo v Dulaglutide

Number of subjects included in analysis

9901

Analysis specification

Pre-specified

Analysis type

superiority ^[6]

P-value

= 0.211

Method

Regression, Cox

Parameter type

Hazard ratio (HR)

Point estimate

0.91

Confidence interval

level

95%

sides

2-sided

lower limit

0.78

upper limit

1.06

Notes
[6] - Death from CV causes. Multiplicity adjustments using the graphical approach were performed for secondary efficacy endpoints in order to control the overall Type I error rate at a 2-sided alpha level of 0.0467.

Number of Participants Who Experienced an Event

Statistical analysis description

Nonfatal MI

Comparison groups

Placebo v Dulaglutide

Number of subjects included in analysis

9901

Analysis specification

Pre-specified

Analysis type

superiority ^[7]

P-value

= 0.652

Method

Regression, Cox

Parameter type

Hazard ratio (HR)

Point estimate

0.96

Confidence interval

level

95%

sides

2-sided

lower limit

0.79

upper limit

1.16

Notes
[7] - Nonfatal MI. Multiplicity adjustments using the graphical approach were performed for secondary efficacy endpoints in order to control the overall Type I error rate at a 2-sided alpha level of 0.0467.

Number of Participants Who Experienced an Event

Statistical analysis description

Nonfatal stroke

Comparison groups

Placebo v Dulaglutide

Number of subjects included in analysis

9901

Analysis specification

Pre-specified

Analysis type

superiority ^[8]

P-value

= 0.017

Method

Regression, Cox

Parameter type

Hazard ratio (HR)

Point estimate

0.76

Confidence interval

level

95%

sides

2-sided

lower limit

0.61

upper limit

0.95

Notes
[8] - Nonfatal stroke. Multiplicity adjustments using the graphical approach were performed for secondary efficacy endpoints in order to control the overall Type I error rate at a 2-sided alpha level of 0.0467.

Secondary: Number of Participants Who Experienced an Event for Time to all-cause mortality

Top of page

End point title

Number of Participants Who Experienced an Event for Time to all-cause mortality

End point description

The time to all-cause mortality was evaluated using time-to-event analysis via the Cox proportional hazards regression model where response equals treatment. The number of participants who experienced an event is presented.

End point type

Secondary

End point timeframe

From randomization to study completion (Median Follow-Up of 5.4 Years)

End point values	Placebo	Dulaglutide
Number of subjects analysed	4952 ^[9]	4949 ^[10]
Units: participants	592	536

Notes
[9] - All randomized participants.
[10] - All randomized participants.

Number of Participants Who Experienced an Event

Statistical analysis description

Time to all cause mortality

Comparison groups

Placebo v Dulaglutide

Number of subjects included in analysis

9901

Analysis specification

Pre-specified

Analysis type

superiority ^[11]

P-value

= 0.067

Method

Regression, Cox

Parameter type

Hazard ratio (HR)

Point estimate

0.9

Confidence interval

level

95%

sides

2-sided

lower limit

0.8

upper limit

1.01

Notes
[11] - Time to all cause mortality. Multiplicity adjustments using the graphical approach were performed for secondary efficacy endpoints in order to control the overall Type I error rate at a 2-sided alpha level of 0.0467.

Secondary: Number of Participants Who Experienced an Event for Time to first occurrence after randomization of the composite microvascular endpoint

Top of page

End point title

Number of Participants Who Experienced an Event for Time to first occurrence after randomization of the composite microvascular endpoint

End point description

The time from randomization to first occurrence of the composite microvascular endpoint was evaluated using time-to-event analysis via the Cox proportional hazards regression model where response equals treatment. The composite microvascular endpoint is defined as diabetic retinopathy requiring laser therapy, vitrectomy, or anti-vascular endothelial growth factor therapy (VEGF), clinical proteinuria, a ≥ 30% decline in estimated glomerular filtration rate, or need for chronic renal replacement therapy. The number of participants who experienced the composite microvascular endpoint event is presented.

End point type

Secondary

End point timeframe

From randomization to first occurrence or study completion (Median Follow-Up of 5.4 Years)

End point values	Placebo	Dulaglutide
Number of subjects analysed	4952 ^[12]	4949 ^[13]
Units: participants	1241	1099

Notes
[12] - All randomized participants.
[13] - All randomized participants.

Number of Participants Who Experienced an Event

Statistical analysis description

microvascular endpoint

Comparison groups

Placebo v Dulaglutide

Number of subjects included in analysis

9901

Analysis specification

Pre-specified

Analysis type

superiority ^[14]

P-value

< 0.001

Method

Regression, Cox

Parameter type

Hazard ratio (HR)

Point estimate

0.86

Confidence interval

level

95%

sides

2-sided

lower limit

0.79

upper limit

0.93

Notes
[14] - microvascular endpoint. Multiplicity adjustments using the graphical approach were performed for secondary efficacy endpoints in order to control the overall Type I error rate at a 2-sided alpha level of 0.0467.

Secondary: Number of Participants Who Experienced An Event for Time to first occurrence after randomization of heart failure requiring hospitalization or an urgent heart failure clinic visit

Top of page

End point title

Number of Participants Who Experienced An Event for Time to first occurrence after randomization of heart failure requiring hospitalization or an urgent heart failure clinic visit

End point description

The time to first occurrence after randomization of heart failure requiring hospitalization or an urgent heart failure clinic visit was evaluated using time-to-event analysis via the Cox proportional hazards regression model where response equals treatment. The number of participants who experienced an event is presented.

End point type

Secondary

End point timeframe

From randomization to first occurrence or study completion (Median Follow-Up of 5.4 Years)

End point values	Placebo	Dulaglutide
Number of subjects analysed	4952 ^[15]	4949 ^[16]
Units: participants	226	213

Notes
[15] - All randomized participants.
[16] - All randomized participants.

Number of Participants Who Experienced An Event

Statistical analysis description

Heart failure requiring hospitalization or an urgent heart failure clinic visit

Comparison groups

Placebo v Dulaglutide

Number of subjects included in analysis

9901

Analysis specification

Pre-specified

Analysis type

superiority ^[17]

P-value

= 0.456

Method

Regression, Cox

Parameter type

Hazard ratio (HR)

Point estimate

0.93

Confidence interval

level

95%

sides

2-sided

lower limit

0.77

upper limit

1.12

Notes
[17] - Heart failure requiring hospitalization or an urgent heart failure clinic visit. Multiplicity adjustments using the graphical approach were performed for secondary efficacy endpoints in order to control the overall Type I error rate at a 2-sided alpha level of 0.0467.

Secondary: Number of Participants Who Experienced an Event for Time to first occurrence after randomization of first hospitalization for unstable angina

Top of page

End point title

Number of Participants Who Experienced an Event for Time to first occurrence after randomization of first hospitalization for unstable angina

End point description

Time to first occurrence after randomization of first hospitalization for unstable angina was evaluated using time-to-event analysis via the Cox proportional hazards regression model where response equals treatment. The number of participants who experienced an event is presented.

End point type

Secondary

End point timeframe

From randomization to first occurrence or study completion (Median Follow-Up of 5.4 Years)

End point values	Placebo	Dulaglutide
Number of subjects analysed	4952 ^[18]	4949 ^[19]
Units: participants	77	88

Notes
[18] - All randomized participants.
[19] - All randomized participants.

Number of Participants Who Experienced an Event

Statistical analysis description

Hospitalization for unstable angina

Comparison groups

Placebo v Dulaglutide

Number of subjects included in analysis

9901

Analysis specification

Pre-specified

Analysis type

superiority ^[20]

P-value

= 0.413

Method

Regression, Cox

Parameter type

Hazard ratio (HR)

Point estimate

1.14

Confidence interval

level

95%

sides

2-sided

lower limit

0.84

upper limit

1.54

Notes
[20] - Hospitalization for unstable angina. Multiplicity adjustments using the graphical approach were performed for secondary efficacy endpoints in order to control the overall Type I error rate at a 2-sided alpha level of 0.0467.

Adverse events

Top of page

Timeframe for reporting adverse events

From Randomization to Study Completion (Up to 7 Years)

Adverse event reporting additional description

All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

21.0

Reporting group title

Placebo

Reporting group description

Placebo was administered once weekly, subcutaneously

Reporting group title

Dulaglutide

Reporting group description

1.5 mg Dulaglutide was administered once weekly, subcutaneously

Serious adverse events	Placebo	Dulaglutide
Total subjects affected by serious adverse events
subjects affected / exposed	2044 / 4949 (41.30%)	1991 / 4943 (40.28%)
number of deaths (all causes)	277	242
number of deaths resulting from adverse events	13	8
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
acute myeloid leukaemia
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
adenocarcinoma
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	2 / 4943 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 1
adenocarcinoma gastric
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	10 / 4949 (0.20%)	7 / 4943 (0.14%)
occurrences causally related to treatment / all	1 / 11	1 / 7
deaths causally related to treatment / all	1 / 4	0 / 1
adenocarcinoma of colon
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	14 / 4949 (0.28%)	17 / 4943 (0.34%)
occurrences causally related to treatment / all	1 / 14	1 / 17
deaths causally related to treatment / all	0 / 1	1 / 4
adenocarcinoma of the cervix
alternative dictionary used: MedDRA 21.0
subjects affected / exposed ^[1]	1 / 2282 (0.04%)	1 / 2303 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
adenocarcinoma pancreas
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	4 / 4943 (0.08%)
occurrences causally related to treatment / all	0 / 0	2 / 4
deaths causally related to treatment / all	0 / 0	1 / 2
adenoma benign
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
adenosquamous cell carcinoma
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
adrenal adenoma
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	3 / 4949 (0.06%)	3 / 4943 (0.06%)
occurrences causally related to treatment / all	0 / 3	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
adrenal neoplasm
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	2 / 4943 (0.04%)
occurrences causally related to treatment / all	0 / 1	1 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
anal squamous cell carcinoma
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
anaplastic astrocytoma
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
anogenital warts
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
astrocytoma
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
b-cell lymphoma
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	2 / 4943 (0.04%)
occurrences causally related to treatment / all	0 / 1	1 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
b-cell lymphoma stage i
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
b-cell lymphoma stage ii
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
b-cell small lymphocytic lymphoma
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	2 / 4943 (0.04%)
occurrences causally related to treatment / all	0 / 0	1 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
basal cell carcinoma
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	11 / 4949 (0.22%)	7 / 4943 (0.14%)
occurrences causally related to treatment / all	0 / 11	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
benign gastric neoplasm
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
benign hepatic neoplasm
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
benign neoplasm of adrenal gland
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
benign neoplasm of thyroid gland
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
bile duct adenocarcinoma
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
bile duct cancer
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	3 / 4943 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 1
biliary cancer metastatic
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
bladder cancer
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	6 / 4949 (0.12%)	5 / 4943 (0.10%)
occurrences causally related to treatment / all	0 / 6	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 1
bladder cancer recurrent
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
bladder neoplasm
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	5 / 4949 (0.10%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	1 / 5	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
bladder papilloma
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
bladder transitional cell carcinoma
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	6 / 4949 (0.12%)	3 / 4943 (0.06%)
occurrences causally related to treatment / all	1 / 6	0 / 3
deaths causally related to treatment / all	0 / 2	0 / 0
bladder transitional cell carcinoma recurrent
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
bladder transitional cell carcinoma stage i
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
bone cancer
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
bone cancer metastatic
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
bone neoplasm
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
borderline ovarian tumour
alternative dictionary used: MedDRA 21.0
subjects affected / exposed ^[2]	0 / 2282 (0.00%)	1 / 2303 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
bowen's disease
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
brain neoplasm
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	3 / 4949 (0.06%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 2	0 / 0
brain neoplasm malignant
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
breast cancer
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	8 / 4949 (0.16%)	11 / 4943 (0.22%)
occurrences causally related to treatment / all	0 / 8	1 / 11
deaths causally related to treatment / all	0 / 0	0 / 0
breast cancer metastatic
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	3 / 4949 (0.06%)	2 / 4943 (0.04%)
occurrences causally related to treatment / all	0 / 3	1 / 2
deaths causally related to treatment / all	0 / 2	0 / 1
breast cancer recurrent
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
breast cancer stage iii
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
brenner tumour
alternative dictionary used: MedDRA 21.0
subjects affected / exposed ^[3]	0 / 2282 (0.00%)	1 / 2303 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
bronchial carcinoma
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	2 / 4943 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
cancer pain
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
carcinoid tumour pulmonary
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	2 / 4943 (0.04%)
occurrences causally related to treatment / all	0 / 0	1 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
cardiac myxoma
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
cerebral haemangioma
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
cervix carcinoma
alternative dictionary used: MedDRA 21.0
subjects affected / exposed ^[4]	2 / 2282 (0.09%)	4 / 2303 (0.17%)
occurrences causally related to treatment / all	0 / 2	0 / 4
deaths causally related to treatment / all	0 / 1	0 / 0
cervix carcinoma stage 0
alternative dictionary used: MedDRA 21.0
subjects affected / exposed ^[5]	2 / 2282 (0.09%)	0 / 2303 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
cholangiocarcinoma
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	2 / 4949 (0.04%)	4 / 4943 (0.08%)
occurrences causally related to treatment / all	0 / 3	0 / 4
deaths causally related to treatment / all	0 / 1	0 / 0
chronic lymphocytic leukaemia
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	4 / 4943 (0.08%)
occurrences causally related to treatment / all	0 / 1	1 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
chronic myeloid leukaemia
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
clear cell renal cell carcinoma
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	3 / 4949 (0.06%)	6 / 4943 (0.12%)
occurrences causally related to treatment / all	0 / 3	1 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
colon adenoma
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	8 / 4949 (0.16%)	5 / 4943 (0.10%)
occurrences causally related to treatment / all	0 / 9	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
colon cancer
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	5 / 4949 (0.10%)	6 / 4943 (0.12%)
occurrences causally related to treatment / all	2 / 5	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 2
colon cancer metastatic
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	2 / 4943 (0.04%)
occurrences causally related to treatment / all	0 / 0	1 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
colon cancer stage ii
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
colon cancer stage iv
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
colon neoplasm
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	3 / 4949 (0.06%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
colorectal adenocarcinoma
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
colorectal cancer
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	2 / 4943 (0.04%)
occurrences causally related to treatment / all	0 / 0	2 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
colorectal cancer metastatic
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
diffuse large b-cell lymphoma
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	2 / 4949 (0.04%)	3 / 4943 (0.06%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 1	0 / 0
diffuse large b-cell lymphoma stage iv
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	2 / 4943 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
ductal adenocarcinoma of pancreas
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
endometrial adenocarcinoma
alternative dictionary used: MedDRA 21.0
subjects affected / exposed ^[6]	9 / 2282 (0.39%)	6 / 2303 (0.26%)
occurrences causally related to treatment / all	1 / 9	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
endometrial cancer
alternative dictionary used: MedDRA 21.0
subjects affected / exposed ^[7]	1 / 2282 (0.04%)	3 / 2303 (0.13%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
extranodal marginal zone b-cell lymphoma (malt type)
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	2 / 4943 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 1
fibroadenoma of breast
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
fibrosarcoma
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
gallbladder cancer metastatic
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
gallbladder squamous cell carcinoma
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
gastric cancer
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	4 / 4949 (0.08%)	6 / 4943 (0.12%)
occurrences causally related to treatment / all	0 / 4	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 3
gastric neoplasm
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	3 / 4949 (0.06%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	1 / 3	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 0
gastrointestinal stromal cancer
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
gastrointestinal stromal tumour
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
glioblastoma
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	2 / 4949 (0.04%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
hepatic angiosarcoma
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	1 / 1
hepatic cancer
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	5 / 4949 (0.10%)	2 / 4943 (0.04%)
occurrences causally related to treatment / all	0 / 5	0 / 2
deaths causally related to treatment / all	0 / 3	0 / 0
hepatic cancer metastatic
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	2 / 4943 (0.04%)
occurrences causally related to treatment / all	1 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 1
hepatic neoplasm
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
hepatocellular carcinoma
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	6 / 4949 (0.12%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	3 / 6	0 / 1
deaths causally related to treatment / all	2 / 2	0 / 1
hodgkin's disease
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
huerthle cell carcinoma
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
intraductal proliferative breast lesion
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
invasive breast carcinoma
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
invasive ductal breast carcinoma
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	11 / 4949 (0.22%)	7 / 4943 (0.14%)
occurrences causally related to treatment / all	0 / 11	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
invasive lobular breast carcinoma
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
keratoacanthoma
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	2 / 4943 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
large intestine benign neoplasm
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
laryngeal cancer
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	2 / 4949 (0.04%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
laryngeal squamous cell carcinoma
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	3 / 4949 (0.06%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
leiomyosarcoma
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
leiomyosarcoma metastatic
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
lip squamous cell carcinoma
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
lipoma
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
liposarcoma
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
liposarcoma metastatic
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
lung adenocarcinoma
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	8 / 4949 (0.16%)	6 / 4943 (0.12%)
occurrences causally related to treatment / all	0 / 8	0 / 7
deaths causally related to treatment / all	0 / 2	0 / 1
lung adenocarcinoma stage ii
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
lung adenocarcinoma stage iii
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
lung adenocarcinoma stage iv
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	2 / 4943 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 1
lung cancer metastatic
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	3 / 4949 (0.06%)	3 / 4943 (0.06%)
occurrences causally related to treatment / all	0 / 3	0 / 3
deaths causally related to treatment / all	0 / 1	0 / 1
lung neoplasm
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	2 / 4949 (0.04%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
lung neoplasm malignant
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	6 / 4949 (0.12%)	9 / 4943 (0.18%)
occurrences causally related to treatment / all	1 / 6	0 / 9
deaths causally related to treatment / all	1 / 4	0 / 3
lymphoma
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	2 / 4949 (0.04%)	2 / 4943 (0.04%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 1
malignant joint neoplasm
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
malignant melanoma
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	5 / 4949 (0.10%)	5 / 4943 (0.10%)
occurrences causally related to treatment / all	0 / 5	0 / 5
deaths causally related to treatment / all	0 / 1	0 / 0
malignant melanoma stage iii
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
malignant neoplasm of ampulla of vater
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
malignant pleural effusion
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	2 / 4949 (0.04%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
mediastinum neoplasm
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
medullary thyroid cancer
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
meningeal neoplasm
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
meningioma
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	2 / 4943 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
mesothelioma
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
mesothelioma malignant
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
metastases to adrenals
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
metastases to bone
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
metastases to central nervous system
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	2 / 4949 (0.04%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 0
metastases to chest wall
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
metastases to kidney
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
metastases to liver
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	4 / 4949 (0.08%)	7 / 4943 (0.14%)
occurrences causally related to treatment / all	0 / 4	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
metastases to lung
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	6 / 4949 (0.12%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 6	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 0
metastases to lymph nodes
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	4 / 4949 (0.08%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 4	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
metastases to pelvis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
metastases to peritoneum
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	3 / 4943 (0.06%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
metastases to pleura
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
metastatic bronchial carcinoma
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	1 / 1	0 / 1
deaths causally related to treatment / all	1 / 1	0 / 1
metastatic gastric cancer
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	2 / 4943 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 1
metastatic neoplasm
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	5 / 4949 (0.10%)	2 / 4943 (0.04%)
occurrences causally related to treatment / all	0 / 5	0 / 2
deaths causally related to treatment / all	0 / 3	0 / 0
metastatic renal cell carcinoma
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 1	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
myelodysplastic syndrome
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	3 / 4943 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
nasal sinus cancer
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	2 / 4943 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
neoplasm
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
neoplasm malignant
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	2 / 4949 (0.04%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
neoplasm prostate
alternative dictionary used: MedDRA 21.0
subjects affected / exposed ^[8]	0 / 2667 (0.00%)	3 / 2640 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
neuroendocrine carcinoma
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	2 / 4949 (0.04%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	1 / 2	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 1
neuroendocrine carcinoma of the skin
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
neuroendocrine tumour
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	2 / 4949 (0.04%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	1 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
non-hodgkin's lymphoma
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	1 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
non-small cell lung cancer
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	3 / 4949 (0.06%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
non-small cell lung cancer metastatic
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
non-small cell lung cancer stage ii
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
non-small cell lung cancer stage iv
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
oesophageal adenocarcinoma
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	3 / 4949 (0.06%)	2 / 4943 (0.04%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
oesophageal carcinoma
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	3 / 4949 (0.06%)	3 / 4943 (0.06%)
occurrences causally related to treatment / all	0 / 3	0 / 3
deaths causally related to treatment / all	0 / 1	0 / 2
oesophageal squamous cell carcinoma
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
ovarian adenoma
alternative dictionary used: MedDRA 21.0
subjects affected / exposed ^[9]	2 / 2282 (0.09%)	0 / 2303 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
ovarian cancer
alternative dictionary used: MedDRA 21.0
subjects affected / exposed ^[10]	2 / 2282 (0.09%)	0 / 2303 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
ovarian cancer metastatic
alternative dictionary used: MedDRA 21.0
subjects affected / exposed ^[11]	1 / 2282 (0.04%)	0 / 2303 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
ovarian cancer stage iii
alternative dictionary used: MedDRA 21.0
subjects affected / exposed ^[12]	1 / 2282 (0.04%)	0 / 2303 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
ovarian epithelial cancer
alternative dictionary used: MedDRA 21.0
subjects affected / exposed ^[13]	0 / 2282 (0.00%)	2 / 2303 (0.09%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
pancreatic carcinoma
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	5 / 4949 (0.10%)	8 / 4943 (0.16%)
occurrences causally related to treatment / all	0 / 5	1 / 8
deaths causally related to treatment / all	0 / 2	0 / 1
pancreatic carcinoma metastatic
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	5 / 4949 (0.10%)	4 / 4943 (0.08%)
occurrences causally related to treatment / all	3 / 5	3 / 4
deaths causally related to treatment / all	0 / 0	1 / 2
pancreatic neoplasm
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	2 / 4943 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 2
papillary thyroid cancer
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	4 / 4943 (0.08%)
occurrences causally related to treatment / all	0 / 0	1 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
paraganglion neoplasm
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
parathyroid tumour benign
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
penile squamous cell carcinoma
alternative dictionary used: MedDRA 21.0
subjects affected / exposed ^[14]	1 / 2667 (0.04%)	0 / 2640 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
pericardial effusion malignant
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
phaeochromocytoma
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
pituitary tumour
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
pituitary tumour benign
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	2 / 4943 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
plasma cell leukaemia
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
plasma cell myeloma
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	2 / 4949 (0.04%)	5 / 4943 (0.10%)
occurrences causally related to treatment / all	0 / 2	0 / 6
deaths causally related to treatment / all	0 / 1	0 / 2
prostate cancer
alternative dictionary used: MedDRA 21.0
subjects affected / exposed ^[15]	33 / 2667 (1.24%)	33 / 2640 (1.25%)
occurrences causally related to treatment / all	1 / 34	1 / 33
deaths causally related to treatment / all	0 / 2	0 / 0
prostate cancer metastatic
alternative dictionary used: MedDRA 21.0
subjects affected / exposed ^[16]	4 / 2667 (0.15%)	2 / 2640 (0.08%)
occurrences causally related to treatment / all	1 / 4	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 2
prostate cancer recurrent
alternative dictionary used: MedDRA 21.0
subjects affected / exposed ^[17]	1 / 2667 (0.04%)	1 / 2640 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
prostate cancer stage i
alternative dictionary used: MedDRA 21.0
subjects affected / exposed ^[18]	1 / 2667 (0.04%)	0 / 2640 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
prostatic adenoma
alternative dictionary used: MedDRA 21.0
subjects affected / exposed ^[19]	3 / 2667 (0.11%)	6 / 2640 (0.23%)
occurrences causally related to treatment / all	0 / 3	1 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
rectal adenocarcinoma
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	2 / 4949 (0.04%)	4 / 4943 (0.08%)
occurrences causally related to treatment / all	0 / 2	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
rectal adenoma
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	2 / 4943 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
rectal cancer
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	3 / 4949 (0.06%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	1 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
rectal cancer metastatic
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
rectal neoplasm
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
rectosigmoid cancer
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
renal cancer
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	4 / 4949 (0.08%)	5 / 4943 (0.10%)
occurrences causally related to treatment / all	0 / 4	1 / 5
deaths causally related to treatment / all	0 / 0	0 / 1
renal cancer metastatic
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	2 / 4949 (0.04%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
renal cell carcinoma
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	7 / 4949 (0.14%)	4 / 4943 (0.08%)
occurrences causally related to treatment / all	0 / 7	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
renal neoplasm
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	3 / 4949 (0.06%)	2 / 4943 (0.04%)
occurrences causally related to treatment / all	0 / 3	1 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
renal oncocytoma
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	2 / 4949 (0.04%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
sarcoma
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
small cell lung cancer
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	3 / 4949 (0.06%)	6 / 4943 (0.12%)
occurrences causally related to treatment / all	0 / 3	0 / 6
deaths causally related to treatment / all	0 / 2	0 / 2
small cell lung cancer metastatic
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
spinal meningioma benign
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
spindle cell sarcoma
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
squamous cell carcinoma
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	4 / 4943 (0.08%)
occurrences causally related to treatment / all	0 / 1	1 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
squamous cell carcinoma of lung
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	7 / 4949 (0.14%)	3 / 4943 (0.06%)
occurrences causally related to treatment / all	0 / 8	0 / 3
deaths causally related to treatment / all	0 / 1	0 / 2
squamous cell carcinoma of skin
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	3 / 4949 (0.06%)	3 / 4943 (0.06%)
occurrences causally related to treatment / all	0 / 4	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
squamous cell carcinoma of the cervix
alternative dictionary used: MedDRA 21.0
subjects affected / exposed ^[20]	0 / 2282 (0.00%)	1 / 2303 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
squamous cell carcinoma of the vagina
alternative dictionary used: MedDRA 21.0
subjects affected / exposed ^[21]	0 / 2282 (0.00%)	1 / 2303 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
squamous cell carcinoma of the vulva
alternative dictionary used: MedDRA 21.0
subjects affected / exposed ^[22]	0 / 2282 (0.00%)	2 / 2303 (0.09%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
sweat gland tumour
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
throat cancer
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	1 / 1	0 / 0
thymoma
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
thyroid adenoma
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
thyroid cancer
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
tongue carcinoma stage iv
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
tongue neoplasm malignant stage unspecified
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
tonsil cancer
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	2 / 4949 (0.04%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
transitional cell cancer of the renal pelvis and ureter
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
transitional cell carcinoma
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	3 / 4949 (0.06%)	7 / 4943 (0.14%)
occurrences causally related to treatment / all	0 / 3	1 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
transitional cell carcinoma recurrent
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
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 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
tumour of ampulla of vater
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
urethral cancer
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
uterine cancer
alternative dictionary used: MedDRA 21.0
subjects affected / exposed ^[23]	2 / 2282 (0.09%)	4 / 2303 (0.17%)
occurrences causally related to treatment / all	1 / 2	0 / 4
deaths causally related to treatment / all	1 / 1	0 / 1
uterine leiomyoma
alternative dictionary used: MedDRA 21.0
subjects affected / exposed ^[24]	1 / 2282 (0.04%)	3 / 2303 (0.13%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
uterine neoplasm
alternative dictionary used: MedDRA 21.0
subjects affected / exposed ^[25]	1 / 2282 (0.04%)	1 / 2303 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
vascular neoplasm
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Vascular disorders
angiodysplasia
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
aortic aneurysm
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	2 / 4949 (0.04%)	10 / 4943 (0.20%)
occurrences causally related to treatment / all	0 / 2	0 / 10
deaths causally related to treatment / all	0 / 0	0 / 2
aortic aneurysm rupture
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
aortic arteriosclerosis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
aortic dissection
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	2 / 4943 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 1
aortic stenosis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	16 / 4949 (0.32%)	21 / 4943 (0.42%)
occurrences causally related to treatment / all	0 / 17	0 / 21
deaths causally related to treatment / all	0 / 0	0 / 1
arterial occlusive disease
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	3 / 4949 (0.06%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 4	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
arterial stenosis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
arteriosclerosis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	1 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
bleeding varicose vein
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
circulatory collapse
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	6 / 4949 (0.12%)	4 / 4943 (0.08%)
occurrences causally related to treatment / all	0 / 6	0 / 4
deaths causally related to treatment / all	0 / 2	0 / 3
deep vein thrombosis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	10 / 4949 (0.20%)	16 / 4943 (0.32%)
occurrences causally related to treatment / all	0 / 10	0 / 16
deaths causally related to treatment / all	0 / 0	0 / 0
dry gangrene
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	2 / 4949 (0.04%)	3 / 4943 (0.06%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
essential hypertension
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
extremity necrosis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	3 / 4949 (0.06%)	3 / 4943 (0.06%)
occurrences causally related to treatment / all	0 / 4	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
haematoma
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	4 / 4943 (0.08%)
occurrences causally related to treatment / all	0 / 1	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
haemodynamic instability
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
haemorrhage
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
hypertension
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	27 / 4949 (0.55%)	22 / 4943 (0.45%)
occurrences causally related to treatment / all	0 / 29	0 / 24
deaths causally related to treatment / all	0 / 0	0 / 0
hypertensive crisis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	21 / 4949 (0.42%)	14 / 4943 (0.28%)
occurrences causally related to treatment / all	0 / 21	1 / 14
deaths causally related to treatment / all	0 / 0	0 / 0
hypertensive emergency
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	3 / 4949 (0.06%)	4 / 4943 (0.08%)
occurrences causally related to treatment / all	0 / 3	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
hypotension
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	7 / 4949 (0.14%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	2 / 7	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
hypovolaemic shock
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
iliac artery embolism
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
intermittent claudication
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	4 / 4949 (0.08%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 4	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
lymphatic fistula
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
lymphoedema
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	2 / 4949 (0.04%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
neurogenic shock
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
orthostatic hypotension
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	5 / 4949 (0.10%)	6 / 4943 (0.12%)
occurrences causally related to treatment / all	0 / 5	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
peripheral arterial occlusive disease
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	25 / 4949 (0.51%)	17 / 4943 (0.34%)
occurrences causally related to treatment / all	0 / 26	0 / 18
deaths causally related to treatment / all	0 / 0	0 / 0
peripheral artery occlusion
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	4 / 4949 (0.08%)	8 / 4943 (0.16%)
occurrences causally related to treatment / all	0 / 4	0 / 9
deaths causally related to treatment / all	0 / 0	0 / 0
peripheral artery stenosis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	3 / 4949 (0.06%)	2 / 4943 (0.04%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
peripheral artery thrombosis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
peripheral embolism
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
peripheral ischaemia
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	8 / 4949 (0.16%)	9 / 4943 (0.18%)
occurrences causally related to treatment / all	0 / 9	0 / 13
deaths causally related to treatment / all	0 / 0	0 / 0
peripheral vascular disorder
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	7 / 4949 (0.14%)	8 / 4943 (0.16%)
occurrences causally related to treatment / all	0 / 8	0 / 8
deaths causally related to treatment / all	0 / 1	0 / 0
peripheral venous disease
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
phlebitis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	3 / 4943 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
shock
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
shock haemorrhagic
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
subclavian artery stenosis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
superior vena cava syndrome
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
temporal arteritis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
thrombophlebitis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	2 / 4949 (0.04%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
thrombosis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	2 / 4949 (0.04%)	2 / 4943 (0.04%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 1
varicose vein
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	4 / 4949 (0.08%)	3 / 4943 (0.06%)
occurrences causally related to treatment / all	0 / 4	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
vena cava thrombosis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
venous thrombosis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	2 / 4949 (0.04%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
venous thrombosis limb
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	2 / 4943 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
General disorders and administration site conditions
adverse drug reaction
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	3 / 4943 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
asthenia
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	5 / 4949 (0.10%)	5 / 4943 (0.10%)
occurrences causally related to treatment / all	1 / 5	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
chest discomfort
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
chest pain
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	14 / 4949 (0.28%)	7 / 4943 (0.14%)
occurrences causally related to treatment / all	1 / 15	1 / 7
deaths causally related to treatment / all	0 / 1	0 / 0
death
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	9 / 4949 (0.18%)	9 / 4943 (0.18%)
occurrences causally related to treatment / all	1 / 9	1 / 9
deaths causally related to treatment / all	1 / 9	1 / 9
device intolerance
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
drug effect increased
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
drug intolerance
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
fatigue
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	3 / 4943 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 1
gait disturbance
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
general physical health deterioration
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	4 / 4943 (0.08%)
occurrences causally related to treatment / all	0 / 0	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 1
generalised oedema
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	4 / 4949 (0.08%)	2 / 4943 (0.04%)
occurrences causally related to treatment / all	0 / 4	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
hernia perforation
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
hyperthermia
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
impaired healing
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	5 / 4949 (0.10%)	4 / 4943 (0.08%)
occurrences causally related to treatment / all	0 / 5	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
inflammation
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	2 / 4943 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
malaise
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
metaplasia
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
multiple organ dysfunction syndrome
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	4 / 4949 (0.08%)	5 / 4943 (0.10%)
occurrences causally related to treatment / all	0 / 4	0 / 5
deaths causally related to treatment / all	0 / 4	0 / 3
necrosis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
non-cardiac chest pain
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	37 / 4949 (0.75%)	26 / 4943 (0.53%)
occurrences causally related to treatment / all	0 / 44	1 / 28
deaths causally related to treatment / all	0 / 0	0 / 0
oedema peripheral
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	7 / 4949 (0.14%)	4 / 4943 (0.08%)
occurrences causally related to treatment / all	0 / 7	1 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
pain
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	2 / 4949 (0.04%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
peripheral swelling
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	4 / 4949 (0.08%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 4	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
pyrexia
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	7 / 4949 (0.14%)	7 / 4943 (0.14%)
occurrences causally related to treatment / all	0 / 7	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
strangulated hernia
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
sudden cardiac death
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	2 / 4949 (0.04%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 2	0 / 0
sudden death
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	5 / 4949 (0.10%)	3 / 4943 (0.06%)
occurrences causally related to treatment / all	0 / 5	0 / 3
deaths causally related to treatment / all	0 / 5	0 / 3
systemic inflammatory response syndrome
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	2 / 4949 (0.04%)	2 / 4943 (0.04%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
vascular stent occlusion
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
vascular stent stenosis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Immune system disorders
anaphylactic reaction
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	2 / 4949 (0.04%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
anti-neutrophil cytoplasmic antibody positive vasculitis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
contrast media allergy
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
drug hypersensitivity
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
hypersensitivity
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
immunodeficiency
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
sarcoidosis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Social circumstances
diet noncompliance
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
organ donor
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Reproductive system and breast disorders
acquired phimosis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
benign prostatic hyperplasia
alternative dictionary used: MedDRA 21.0
subjects affected / exposed ^[26]	18 / 2667 (0.67%)	21 / 2640 (0.80%)
occurrences causally related to treatment / all	1 / 20	0 / 21
deaths causally related to treatment / all	0 / 0	0 / 0
breast pain
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
cervical polyp
alternative dictionary used: MedDRA 21.0
subjects affected / exposed ^[27]	1 / 2282 (0.04%)	2 / 2303 (0.09%)
occurrences causally related to treatment / all	0 / 1	1 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
cystocele
alternative dictionary used: MedDRA 21.0
subjects affected / exposed ^[28]	4 / 2282 (0.18%)	3 / 2303 (0.13%)
occurrences causally related to treatment / all	0 / 5	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
endometrial hyperplasia
alternative dictionary used: MedDRA 21.0
subjects affected / exposed ^[29]	0 / 2282 (0.00%)	1 / 2303 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
endometrial hypertrophy
alternative dictionary used: MedDRA 21.0
subjects affected / exposed ^[30]	0 / 2282 (0.00%)	1 / 2303 (0.04%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
endometriosis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed ^[31]	0 / 2282 (0.00%)	1 / 2303 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
erectile dysfunction
alternative dictionary used: MedDRA 21.0
subjects affected / exposed ^[32]	1 / 2667 (0.04%)	0 / 2640 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
female genital tract fistula
alternative dictionary used: MedDRA 21.0
subjects affected / exposed ^[33]	0 / 2282 (0.00%)	2 / 2303 (0.09%)
occurrences causally related to treatment / all	0 / 0	1 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
fibrocystic breast disease
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	2 / 4949 (0.04%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
genital prolapse
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	2 / 4949 (0.04%)	3 / 4943 (0.06%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
gynaecomastia
alternative dictionary used: MedDRA 21.0
subjects affected / exposed ^[34]	0 / 2667 (0.00%)	2 / 2640 (0.08%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
metrorrhagia
alternative dictionary used: MedDRA 21.0
subjects affected / exposed ^[35]	0 / 2282 (0.00%)	2 / 2303 (0.09%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
ovarian cyst
alternative dictionary used: MedDRA 21.0
subjects affected / exposed ^[36]	1 / 2282 (0.04%)	6 / 2303 (0.26%)
occurrences causally related to treatment / all	0 / 1	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
pelvic fluid collection
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
pelvic prolapse
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
prostatism
alternative dictionary used: MedDRA 21.0
subjects affected / exposed ^[37]	2 / 2667 (0.07%)	0 / 2640 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
prostatitis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed ^[38]	2 / 2667 (0.07%)	4 / 2640 (0.15%)
occurrences causally related to treatment / all	0 / 2	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
prostatomegaly
alternative dictionary used: MedDRA 21.0
subjects affected / exposed ^[39]	1 / 2667 (0.04%)	0 / 2640 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
rectocele
alternative dictionary used: MedDRA 21.0
subjects affected / exposed ^[40]	1 / 2282 (0.04%)	1 / 2303 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
uterine disorder
alternative dictionary used: MedDRA 21.0
subjects affected / exposed ^[41]	0 / 2282 (0.00%)	1 / 2303 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
uterine polyp
alternative dictionary used: MedDRA 21.0
subjects affected / exposed ^[42]	2 / 2282 (0.09%)	3 / 2303 (0.13%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
uterine prolapse
alternative dictionary used: MedDRA 21.0
subjects affected / exposed ^[43]	0 / 2282 (0.00%)	3 / 2303 (0.13%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
uterovaginal prolapse
alternative dictionary used: MedDRA 21.0
subjects affected / exposed ^[44]	2 / 2282 (0.09%)	2 / 2303 (0.09%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
vaginal haemorrhage
alternative dictionary used: MedDRA 21.0
subjects affected / exposed ^[45]	1 / 2282 (0.04%)	1 / 2303 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
vaginal polyp
alternative dictionary used: MedDRA 21.0
subjects affected / exposed ^[46]	1 / 2282 (0.04%)	0 / 2303 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
vaginal prolapse
alternative dictionary used: MedDRA 21.0
subjects affected / exposed ^[47]	0 / 2282 (0.00%)	2 / 2303 (0.09%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
acquired diaphragmatic eventration
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
acute pulmonary oedema
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	2 / 4949 (0.04%)	4 / 4943 (0.08%)
occurrences causally related to treatment / all	0 / 2	0 / 5
deaths causally related to treatment / all	0 / 1	0 / 0
acute respiratory failure
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	17 / 4949 (0.34%)	6 / 4943 (0.12%)
occurrences causally related to treatment / all	0 / 17	0 / 7
deaths causally related to treatment / all	0 / 4	0 / 1
alveolitis allergic
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
asphyxia
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 0
aspiration
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	3 / 4949 (0.06%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	1 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
asthma
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	8 / 4949 (0.16%)	8 / 4943 (0.16%)
occurrences causally related to treatment / all	0 / 13	0 / 8
deaths causally related to treatment / all	0 / 0	0 / 0
atelectasis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
bronchial hyperreactivity
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
bronchial polyp
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
bronchitis chronic
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	3 / 4949 (0.06%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
bronchopneumopathy
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
chronic obstructive pulmonary disease
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	35 / 4949 (0.71%)	25 / 4943 (0.51%)
occurrences causally related to treatment / all	0 / 45	0 / 32
deaths causally related to treatment / all	0 / 1	0 / 1
chronic respiratory failure
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	2 / 4949 (0.04%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
cough
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
dysphonia
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	2 / 4943 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
dyspnoea
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	15 / 4949 (0.30%)	11 / 4943 (0.22%)
occurrences causally related to treatment / all	0 / 15	0 / 12
deaths causally related to treatment / all	0 / 1	0 / 0
dyspnoea exertional
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	6 / 4949 (0.12%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 6	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
emphysema
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
epistaxis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	5 / 4949 (0.10%)	5 / 4943 (0.10%)
occurrences causally related to treatment / all	0 / 5	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
haemoptysis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	2 / 4949 (0.04%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
haemothorax
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
hypercapnia
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
hyperventilation
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	2 / 4943 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
hypoxia
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	3 / 4949 (0.06%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
interstitial lung disease
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	7 / 4949 (0.14%)	13 / 4943 (0.26%)
occurrences causally related to treatment / all	0 / 7	0 / 14
deaths causally related to treatment / all	0 / 0	0 / 0
lung disorder
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	2 / 4949 (0.04%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 0
lung infiltration
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
nasal polyps
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
nasal septum deviation
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
obstructive airways disorder
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
pharyngeal haemorrhage
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
pickwickian syndrome
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
pleural effusion
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	8 / 4949 (0.16%)	13 / 4943 (0.26%)
occurrences causally related to treatment / all	0 / 10	0 / 13
deaths causally related to treatment / all	0 / 0	0 / 0
pleural thickening
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
pleurisy
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
pneumonia aspiration
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	4 / 4949 (0.08%)	2 / 4943 (0.04%)
occurrences causally related to treatment / all	0 / 4	0 / 3
deaths causally related to treatment / all	0 / 1	0 / 1
pneumonitis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
pneumothorax
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	6 / 4949 (0.12%)	4 / 4943 (0.08%)
occurrences causally related to treatment / all	1 / 6	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
pneumothorax spontaneous
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
pulmonary congestion
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	2 / 4943 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
pulmonary embolism
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	21 / 4949 (0.42%)	22 / 4943 (0.45%)
occurrences causally related to treatment / all	1 / 22	1 / 23
deaths causally related to treatment / all	0 / 0	0 / 5
pulmonary fibrosis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	4 / 4949 (0.08%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 4	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
pulmonary hypertension
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	4 / 4949 (0.08%)	3 / 4943 (0.06%)
occurrences causally related to treatment / all	0 / 4	0 / 3
deaths causally related to treatment / all	0 / 1	0 / 0
pulmonary mass
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	2 / 4949 (0.04%)	4 / 4943 (0.08%)
occurrences causally related to treatment / all	0 / 2	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
pulmonary oedema
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	20 / 4949 (0.40%)	6 / 4943 (0.12%)
occurrences causally related to treatment / all	0 / 20	1 / 6
deaths causally related to treatment / all	0 / 0	0 / 1
pulmonary thrombosis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
respiratory arrest
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	3 / 4943 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
respiratory distress
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	2 / 4943 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 1
respiratory failure
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	20 / 4949 (0.40%)	16 / 4943 (0.32%)
occurrences causally related to treatment / all	0 / 22	0 / 16
deaths causally related to treatment / all	0 / 6	0 / 5
respiratory tract oedema
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
restrictive pulmonary disease
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
rhinitis hypertrophic
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
sleep apnoea syndrome
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	6 / 4949 (0.12%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 6	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Psychiatric disorders
abnormal behaviour
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
adjustment disorder
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
adjustment disorder with depressed mood
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
affective disorder
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
aggression
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
alcohol abuse
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
alcohol withdrawal syndrome
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
anxiety
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	2 / 4949 (0.04%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
anxiety disorder
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
bipolar disorder
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
confusional state
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	7 / 4949 (0.14%)	9 / 4943 (0.18%)
occurrences causally related to treatment / all	0 / 7	0 / 9
deaths causally related to treatment / all	0 / 0	0 / 0
delirium
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	8 / 4949 (0.16%)	10 / 4943 (0.20%)
occurrences causally related to treatment / all	0 / 10	0 / 10
deaths causally related to treatment / all	0 / 0	0 / 1
delusion
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
depression
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	7 / 4949 (0.14%)	6 / 4943 (0.12%)
occurrences causally related to treatment / all	0 / 8	1 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
depression suicidal
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
disorientation
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	2 / 4949 (0.04%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
emotional distress
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
generalised anxiety disorder
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
hypomania
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
major depression
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	3 / 4943 (0.06%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
mania
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
mental disorder
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	3 / 4949 (0.06%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
mental status changes
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
panic disorder
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
personality change due to a general medical condition
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
psychogenic seizure
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
psychotic disorder
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
restlessness
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
somatic delusion
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
somatic symptom disorder
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
suicidal ideation
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 1	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
suicide attempt
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Product issues
device damage
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
device dislocation
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	4 / 4949 (0.08%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 4	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
device failure
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	4 / 4949 (0.08%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 4	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
device loosening
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
device malfunction
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	2 / 4943 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
device occlusion
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatobiliary disorders
acute hepatic failure
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
bile duct obstruction
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
bile duct stenosis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
bile duct stone
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	7 / 4949 (0.14%)	8 / 4943 (0.16%)
occurrences causally related to treatment / all	1 / 7	0 / 8
deaths causally related to treatment / all	0 / 0	0 / 0
biliary colic
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	1 / 1	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
biliary dyspepsia
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
cholangitis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	2 / 4949 (0.04%)	6 / 4943 (0.12%)
occurrences causally related to treatment / all	0 / 2	2 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
cholangitis acute
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	3 / 4943 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
cholangitis chronic
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
cholecystitis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	15 / 4949 (0.30%)	25 / 4943 (0.51%)
occurrences causally related to treatment / all	0 / 15	6 / 28
deaths causally related to treatment / all	0 / 1	0 / 0
cholecystitis acute
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	17 / 4949 (0.34%)	26 / 4943 (0.53%)
occurrences causally related to treatment / all	0 / 17	4 / 27
deaths causally related to treatment / all	0 / 0	0 / 0
cholecystitis chronic
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	2 / 4949 (0.04%)	7 / 4943 (0.14%)
occurrences causally related to treatment / all	0 / 2	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
cholelithiasis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	49 / 4949 (0.99%)	42 / 4943 (0.85%)
occurrences causally related to treatment / all	2 / 51	8 / 43
deaths causally related to treatment / all	0 / 0	0 / 0
cholestasis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	3 / 4949 (0.06%)	2 / 4943 (0.04%)
occurrences causally related to treatment / all	1 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
drug-induced liver injury
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	2 / 4949 (0.04%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
gallbladder cholesterolosis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
gallbladder necrosis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
gallbladder perforation
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	2 / 4943 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
gallbladder polyp
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
hepatic cirrhosis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	4 / 4949 (0.08%)	5 / 4943 (0.10%)
occurrences causally related to treatment / all	0 / 4	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
hepatic failure
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	3 / 4949 (0.06%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
hepatic mass
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
hepatic steatosis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
hepatitis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	2 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
hepatorenal syndrome
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
ischaemic hepatitis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (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 21.0
subjects affected / exposed	1 / 4949 (0.02%)	1 / 4943 (0.02%)
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 21.0
subjects affected / exposed	3 / 4949 (0.06%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
liver disorder
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 0
non-alcoholic fatty liver
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
non-alcoholic steatohepatitis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
portal hypertension
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
portal vein thrombosis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
post cholecystectomy syndrome
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	2 / 4943 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Investigations
amylase increased
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
anticoagulation drug level above therapeutic
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
blood calcitonin increased
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
blood calcium increased
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
blood creatinine increased
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
blood glucose decreased
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
blood glucose fluctuation
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	3 / 4943 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
blood glucose increased
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	4 / 4949 (0.08%)	5 / 4943 (0.10%)
occurrences causally related to treatment / all	0 / 4	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
blood pressure increased
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
c-reactive protein increased
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
coagulation test abnormal
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
electrocardiogram abnormal
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
gamma-glutamyltransferase increased
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
glomerular filtration rate decreased
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
glycosylated haemoglobin increased
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	2 / 4949 (0.04%)	2 / 4943 (0.04%)
occurrences causally related to treatment / all	1 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
haemoglobin decreased
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	2 / 4949 (0.04%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
hepatic enzyme increased
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 1	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
oxygen saturation decreased
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
transaminases increased
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
troponin t increased
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
troponin increased
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	2 / 4943 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
urine albumin/creatinine ratio increased
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
weight decreased
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	4 / 4949 (0.08%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	1 / 4	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Injury, poisoning and procedural complications
accident
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
accident at work
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
accidental overdose
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	2 / 4949 (0.04%)	8 / 4943 (0.16%)
occurrences causally related to treatment / all	0 / 2	1 / 8
deaths causally related to treatment / all	0 / 0	0 / 0
acetabulum fracture
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
alcohol poisoning
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	3 / 4949 (0.06%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
anaemia postoperative
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
anastomotic complication
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
anastomotic leak
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	2 / 4943 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
ankle fracture
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	20 / 4949 (0.40%)	21 / 4943 (0.42%)
occurrences causally related to treatment / all	0 / 20	0 / 21
deaths causally related to treatment / all	0 / 0	0 / 0
arterial injury
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
arteriovenous fistula occlusion
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
arthropod bite
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
back injury
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
brain contusion
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
burns second degree
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
burns third degree
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
carbon monoxide poisoning
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
cartilage injury
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
cervical vertebral fracture
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	4 / 4943 (0.08%)
occurrences causally related to treatment / all	0 / 1	1 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
chemical poisoning
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
clavicle fracture
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	2 / 4949 (0.04%)	2 / 4943 (0.04%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
concussion
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	2 / 4949 (0.04%)	4 / 4943 (0.08%)
occurrences causally related to treatment / all	0 / 2	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
contusion
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	3 / 4949 (0.06%)	6 / 4943 (0.12%)
occurrences causally related to treatment / all	0 / 3	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
coronary vascular graft occlusion
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
craniocerebral injury
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	4 / 4949 (0.08%)	7 / 4943 (0.14%)
occurrences causally related to treatment / all	0 / 4	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 2
craniofacial fracture
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
deep vein thrombosis postoperative
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
delayed recovery from anaesthesia
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
facial bones fracture
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
failure to anastomose
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
fall
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	124 / 4949 (2.51%)	110 / 4943 (2.23%)
occurrences causally related to treatment / all	0 / 137	2 / 123
deaths causally related to treatment / all	0 / 2	0 / 0
femoral neck fracture
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	7 / 4949 (0.14%)	4 / 4943 (0.08%)
occurrences causally related to treatment / all	0 / 7	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
femur fracture
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	21 / 4949 (0.42%)	18 / 4943 (0.36%)
occurrences causally related to treatment / all	0 / 22	0 / 18
deaths causally related to treatment / all	0 / 0	0 / 1
fibula fracture
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	3 / 4949 (0.06%)	5 / 4943 (0.10%)
occurrences causally related to treatment / all	0 / 3	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
foot fracture
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	4 / 4949 (0.08%)	3 / 4943 (0.06%)
occurrences causally related to treatment / all	0 / 4	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
forearm fracture
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	2 / 4949 (0.04%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
foreign body
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
foreign body aspiration
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
foreign body in gastrointestinal tract
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
gastroenteritis radiation
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
gastrointestinal injury
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
gastrointestinal stoma complication
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
graft thrombosis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
gun shot wound
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
hand fracture
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	2 / 4949 (0.04%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
head injury
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	2 / 4949 (0.04%)	2 / 4943 (0.04%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
hip fracture
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	17 / 4949 (0.34%)	12 / 4943 (0.24%)
occurrences causally related to treatment / all	0 / 17	0 / 12
deaths causally related to treatment / all	0 / 2	0 / 0
humerus fracture
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	20 / 4949 (0.40%)	12 / 4943 (0.24%)
occurrences causally related to treatment / all	1 / 20	0 / 12
deaths causally related to treatment / all	0 / 0	0 / 0
hyphaema
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
incisional hernia
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	6 / 4949 (0.12%)	6 / 4943 (0.12%)
occurrences causally related to treatment / all	0 / 7	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
incisional hernia, obstructive
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
intentional overdose
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
intestinal anastomosis complication
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	2 / 4943 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
jaw fracture
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
joint dislocation
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	4 / 4949 (0.08%)	5 / 4943 (0.10%)
occurrences causally related to treatment / all	0 / 6	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
joint injury
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	3 / 4949 (0.06%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
laceration
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	2 / 4949 (0.04%)	4 / 4943 (0.08%)
occurrences causally related to treatment / all	0 / 2	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
ligament rupture
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	2 / 4943 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
ligament sprain
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	3 / 4943 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
limb crushing injury
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
limb injury
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	2 / 4949 (0.04%)	5 / 4943 (0.10%)
occurrences causally related to treatment / all	0 / 2	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
lower limb fracture
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	2 / 4949 (0.04%)	5 / 4943 (0.10%)
occurrences causally related to treatment / all	0 / 2	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
lumbar vertebral fracture
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	2 / 4949 (0.04%)	2 / 4943 (0.04%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
lumbosacral plexus injury
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
meniscus injury
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	4 / 4949 (0.08%)	12 / 4943 (0.24%)
occurrences causally related to treatment / all	0 / 4	0 / 12
deaths causally related to treatment / all	0 / 0	0 / 0
multiple fractures
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	3 / 4943 (0.06%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
multiple injuries
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	3 / 4949 (0.06%)	2 / 4943 (0.04%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 1
muscle rupture
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
muscle strain
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	2 / 4949 (0.04%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
overdose
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	2 / 4943 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
patella fracture
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	3 / 4949 (0.06%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
pelvic fracture
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	2 / 4949 (0.04%)	6 / 4943 (0.12%)
occurrences causally related to treatment / all	0 / 2	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
periprosthetic fracture
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	2 / 4943 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
pneumothorax traumatic
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	2 / 4949 (0.04%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
post concussion syndrome
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	2 / 4949 (0.04%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
post procedural bile leak
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
post procedural complication
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	3 / 4949 (0.06%)	2 / 4943 (0.04%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 1	0 / 1
post procedural discharge
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
post procedural haematoma
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	2 / 4949 (0.04%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
post procedural haematuria
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	2 / 4949 (0.04%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
post procedural haemorrhage
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	7 / 4943 (0.14%)
occurrences causally related to treatment / all	0 / 1	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
post procedural swelling
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
post-traumatic pain
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
postoperative adhesion
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
postoperative delirium
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
postoperative thoracic procedure complication
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	2 / 4943 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
postoperative wound complication
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
procedural hypotension
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
procedural pain
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	2 / 4949 (0.04%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
pubis fracture
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	3 / 4949 (0.06%)	2 / 4943 (0.04%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
radiation pneumonitis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	2 / 4949 (0.04%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
radius fracture
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	6 / 4949 (0.12%)	8 / 4943 (0.16%)
occurrences causally related to treatment / all	0 / 6	0 / 8
deaths causally related to treatment / all	0 / 0	0 / 0
rib fracture
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	14 / 4949 (0.28%)	10 / 4943 (0.20%)
occurrences causally related to treatment / all	0 / 14	0 / 10
deaths causally related to treatment / all	0 / 0	0 / 0
road traffic accident
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	9 / 4949 (0.18%)	13 / 4943 (0.26%)
occurrences causally related to treatment / all	0 / 10	0 / 13
deaths causally related to treatment / all	0 / 1	0 / 1
scapula fracture
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	3 / 4943 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
sciatic nerve injury
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	2 / 4949 (0.04%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
scrotal haematoma
alternative dictionary used: MedDRA 21.0
subjects affected / exposed ^[48]	1 / 2667 (0.04%)	0 / 2640 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
skin injury
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
skull fracture
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
skull fractured base
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
soft tissue injury
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
spinal compression fracture
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	4 / 4943 (0.08%)
occurrences causally related to treatment / all	0 / 1	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
spinal cord injury cervical
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	2 / 4949 (0.04%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
spinal fracture
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	3 / 4949 (0.06%)	2 / 4943 (0.04%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
splenic rupture
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
stab wound
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
sternal fracture
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
stoma site haemorrhage
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (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 21.0
subjects affected / exposed	2 / 4949 (0.04%)	7 / 4943 (0.14%)
occurrences causally related to treatment / all	0 / 2	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
subdural haematoma
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	7 / 4949 (0.14%)	7 / 4943 (0.14%)
occurrences causally related to treatment / all	0 / 7	0 / 8
deaths causally related to treatment / all	0 / 0	0 / 2
subdural haemorrhage
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	2 / 4949 (0.04%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
suture rupture
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
tendon injury
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	3 / 4943 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
tendon rupture
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	3 / 4949 (0.06%)	3 / 4943 (0.06%)
occurrences causally related to treatment / all	0 / 4	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
thermal burn
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	2 / 4949 (0.04%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
thoracic vertebral fracture
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	4 / 4949 (0.08%)	4 / 4943 (0.08%)
occurrences causally related to treatment / all	0 / 4	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
tibia fracture
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	8 / 4949 (0.16%)	4 / 4943 (0.08%)
occurrences causally related to treatment / all	0 / 8	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
tongue injury
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
toxicity to various agents
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	4 / 4949 (0.08%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 4	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
transfusion-related acute lung injury
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
traumatic fracture
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
traumatic haematoma
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	3 / 4943 (0.06%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
traumatic haemothorax
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
traumatic intracranial haemorrhage
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	2 / 4949 (0.04%)	2 / 4943 (0.04%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
ulna fracture
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	2 / 4943 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
upper limb fracture
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	5 / 4943 (0.10%)
occurrences causally related to treatment / all	0 / 1	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
vascular graft occlusion
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
vascular pseudoaneurysm
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	3 / 4949 (0.06%)	4 / 4943 (0.08%)
occurrences causally related to treatment / all	0 / 3	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 1
wound
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
wound dehiscence
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
wound secretion
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
wrist fracture
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	5 / 4949 (0.10%)	2 / 4943 (0.04%)
occurrences causally related to treatment / all	0 / 5	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Congenital, familial and genetic disorders
adenomatous polyposis coli
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
atrial septal defect
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
chronic granulomatous disease
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
congenital cerebrovascular anomaly
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
developmental hip dysplasia
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
exomphalos
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
gastrointestinal arteriovenous malformation
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
heart disease congenital
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
hereditary motor and sensory neuropathy
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
hydrocele
alternative dictionary used: MedDRA 21.0
subjects affected / exposed ^[49]	0 / 2667 (0.00%)	2 / 2640 (0.08%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
hypertrophic cardiomyopathy
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
phimosis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed ^[50]	1 / 2667 (0.04%)	3 / 2640 (0.11%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
vascular malformation
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac disorders
acute coronary syndrome
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	41 / 4949 (0.83%)	43 / 4943 (0.87%)
occurrences causally related to treatment / all	0 / 43	0 / 44
deaths causally related to treatment / all	0 / 9	0 / 7
acute left ventricular failure
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	3 / 4943 (0.06%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
acute myocardial infarction
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	53 / 4949 (1.07%)	39 / 4943 (0.79%)
occurrences causally related to treatment / all	4 / 59	0 / 40
deaths causally related to treatment / all	0 / 14	0 / 15
angina pectoris
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	58 / 4949 (1.17%)	56 / 4943 (1.13%)
occurrences causally related to treatment / all	1 / 67	1 / 61
deaths causally related to treatment / all	0 / 0	0 / 0
angina unstable
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	54 / 4949 (1.09%)	44 / 4943 (0.89%)
occurrences causally related to treatment / all	1 / 58	1 / 47
deaths causally related to treatment / all	0 / 1	0 / 0
aortic valve disease mixed
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
aortic valve incompetence
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	5 / 4943 (0.10%)
occurrences causally related to treatment / all	0 / 1	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
aortic valve stenosis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	6 / 4949 (0.12%)	9 / 4943 (0.18%)
occurrences causally related to treatment / all	0 / 7	0 / 9
deaths causally related to treatment / all	0 / 0	0 / 0
arrhythmia
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	3 / 4949 (0.06%)	6 / 4943 (0.12%)
occurrences causally related to treatment / all	0 / 3	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 1
arteriosclerosis coronary artery
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	9 / 4949 (0.18%)	7 / 4943 (0.14%)
occurrences causally related to treatment / all	0 / 9	0 / 7
deaths causally related to treatment / all	0 / 1	0 / 1
atrial fibrillation
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	62 / 4949 (1.25%)	90 / 4943 (1.82%)
occurrences causally related to treatment / all	2 / 79	3 / 107
deaths causally related to treatment / all	0 / 0	0 / 0
atrial flutter
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	18 / 4949 (0.36%)	15 / 4943 (0.30%)
occurrences causally related to treatment / all	1 / 19	1 / 19
deaths causally related to treatment / all	0 / 0	0 / 0
atrial tachycardia
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	2 / 4943 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
atrial thrombosis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
atrioventricular block
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	6 / 4949 (0.12%)	7 / 4943 (0.14%)
occurrences causally related to treatment / all	0 / 6	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 1
atrioventricular block complete
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	11 / 4949 (0.22%)	8 / 4943 (0.16%)
occurrences causally related to treatment / all	0 / 12	0 / 8
deaths causally related to treatment / all	0 / 0	0 / 0
atrioventricular block first degree
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
atrioventricular block second degree
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	9 / 4949 (0.18%)	8 / 4943 (0.16%)
occurrences causally related to treatment / all	0 / 9	1 / 8
deaths causally related to treatment / all	0 / 0	0 / 0
bifascicular block
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
bradyarrhythmia
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	3 / 4949 (0.06%)	3 / 4943 (0.06%)
occurrences causally related to treatment / all	0 / 3	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
bradycardia
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	10 / 4949 (0.20%)	16 / 4943 (0.32%)
occurrences causally related to treatment / all	0 / 10	0 / 17
deaths causally related to treatment / all	0 / 0	0 / 0
bundle branch block left
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	3 / 4949 (0.06%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
bundle branch block right
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	2 / 4943 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
cardiac arrest
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	14 / 4949 (0.28%)	11 / 4943 (0.22%)
occurrences causally related to treatment / all	0 / 15	0 / 14
deaths causally related to treatment / all	0 / 7	0 / 6
cardiac disorder
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
cardiac failure
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	104 / 4949 (2.10%)	78 / 4943 (1.58%)
occurrences causally related to treatment / all	3 / 124	2 / 87
deaths causally related to treatment / all	0 / 21	0 / 10
cardiac failure acute
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	9 / 4949 (0.18%)	8 / 4943 (0.16%)
occurrences causally related to treatment / all	0 / 10	0 / 11
deaths causally related to treatment / all	0 / 2	0 / 3
cardiac failure chronic
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	21 / 4949 (0.42%)	14 / 4943 (0.28%)
occurrences causally related to treatment / all	0 / 24	0 / 15
deaths causally related to treatment / all	0 / 1	0 / 0
cardiac failure congestive
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	47 / 4949 (0.95%)	38 / 4943 (0.77%)
occurrences causally related to treatment / all	5 / 52	4 / 42
deaths causally related to treatment / all	0 / 4	0 / 8
cardiac tamponade
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
cardio-respiratory arrest
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	7 / 4949 (0.14%)	5 / 4943 (0.10%)
occurrences causally related to treatment / all	1 / 7	0 / 5
deaths causally related to treatment / all	0 / 4	0 / 3
cardiogenic shock
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	3 / 4949 (0.06%)	5 / 4943 (0.10%)
occurrences causally related to treatment / all	0 / 3	0 / 5
deaths causally related to treatment / all	0 / 1	0 / 2
cardiomyopathy
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	5 / 4949 (0.10%)	2 / 4943 (0.04%)
occurrences causally related to treatment / all	0 / 5	0 / 2
deaths causally related to treatment / all	0 / 1	0 / 0
cardiomyopathy alcoholic
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
cardiopulmonary failure
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	2 / 4943 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 1	0 / 1
cardiorenal syndrome
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
cardiovascular disorder
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
cardiovascular insufficiency
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
chronic left ventricular failure
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
congestive cardiomyopathy
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	3 / 4949 (0.06%)	7 / 4943 (0.14%)
occurrences causally related to treatment / all	1 / 3	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
cor pulmonale
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
coronary artery disease
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	57 / 4949 (1.15%)	57 / 4943 (1.15%)
occurrences causally related to treatment / all	1 / 64	0 / 63
deaths causally related to treatment / all	0 / 2	0 / 0
coronary artery insufficiency
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
coronary artery occlusion
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	3 / 4949 (0.06%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
coronary artery perforation
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
coronary artery stenosis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	4 / 4949 (0.08%)	5 / 4943 (0.10%)
occurrences causally related to treatment / all	0 / 4	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
defect conduction intraventricular
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	2 / 4949 (0.04%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
diastolic dysfunction
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
dressler's syndrome
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
extrasystoles
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
gastrocardiac syndrome
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
hypertensive heart disease
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	2 / 4943 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
ischaemic cardiomyopathy
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	2 / 4949 (0.04%)	10 / 4943 (0.20%)
occurrences causally related to treatment / all	0 / 2	0 / 11
deaths causally related to treatment / all	0 / 0	0 / 0
left ventricular dysfunction
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	2 / 4943 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
left ventricular failure
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	8 / 4949 (0.16%)	13 / 4943 (0.26%)
occurrences causally related to treatment / all	0 / 8	0 / 13
deaths causally related to treatment / all	0 / 0	0 / 0
metabolic cardiomyopathy
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
microvascular coronary artery disease
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
mitral valve disease
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
mitral valve incompetence
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	7 / 4949 (0.14%)	9 / 4943 (0.18%)
occurrences causally related to treatment / all	0 / 7	0 / 9
deaths causally related to treatment / all	0 / 0	0 / 0
mitral valve prolapse
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
mitral valve stenosis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
myocardial infarction
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	35 / 4949 (0.71%)	30 / 4943 (0.61%)
occurrences causally related to treatment / all	0 / 37	4 / 30
deaths causally related to treatment / all	0 / 8	2 / 8
myocardial ischaemia
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	23 / 4949 (0.46%)	19 / 4943 (0.38%)
occurrences causally related to treatment / all	0 / 23	0 / 20
deaths causally related to treatment / all	0 / 2	0 / 1
myocarditis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
nodal rhythm
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
palpitations
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
pericardial effusion
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	2 / 4949 (0.04%)	2 / 4943 (0.04%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
pericarditis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	6 / 4949 (0.12%)	2 / 4943 (0.04%)
occurrences causally related to treatment / all	0 / 6	1 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
prinzmetal angina
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
right ventricular dysfunction
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
right ventricular failure
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	2 / 4949 (0.04%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
silent myocardial infarction
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	2 / 4943 (0.04%)
occurrences causally related to treatment / all	0 / 1	1 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
sinoatrial block
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
sinus arrest
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	2 / 4943 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
sinus bradycardia
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	6 / 4949 (0.12%)	2 / 4943 (0.04%)
occurrences causally related to treatment / all	0 / 6	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
sinus node dysfunction
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	9 / 4949 (0.18%)	6 / 4943 (0.12%)
occurrences causally related to treatment / all	0 / 9	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
sinus tachycardia
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
stress cardiomyopathy
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	2 / 4949 (0.04%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
supraventricular extrasystoles
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
supraventricular tachycardia
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	9 / 4949 (0.18%)	7 / 4943 (0.14%)
occurrences causally related to treatment / all	0 / 9	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
tachyarrhythmia
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
tachycardia
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	2 / 4949 (0.04%)	3 / 4943 (0.06%)
occurrences causally related to treatment / all	0 / 2	2 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
tachycardia induced cardiomyopathy
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
tricuspid valve incompetence
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	3 / 4949 (0.06%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
ventricular arrhythmia
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 0
ventricular extrasystoles
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	4 / 4943 (0.08%)
occurrences causally related to treatment / all	0 / 1	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
ventricular fibrillation
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	3 / 4949 (0.06%)	4 / 4943 (0.08%)
occurrences causally related to treatment / all	0 / 3	1 / 4
deaths causally related to treatment / all	0 / 0	0 / 1
ventricular tachycardia
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	5 / 4949 (0.10%)	7 / 4943 (0.14%)
occurrences causally related to treatment / all	0 / 10	0 / 11
deaths causally related to treatment / all	0 / 0	0 / 0
Nervous system disorders
acoustic neuritis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
altered state of consciousness
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	2 / 4943 (0.04%)
occurrences causally related to treatment / all	1 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
amnesia
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
amputation stump pain
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
aphasia
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	3 / 4943 (0.06%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
ataxia
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	2 / 4949 (0.04%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	1 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
autonomic nervous system imbalance
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
balance disorder
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
basal ganglia haemorrhage
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
brain injury
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
brain stem haemorrhage
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
brain stem infarction
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 0
carotid arteriosclerosis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
carotid artery occlusion
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	4 / 4949 (0.08%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 4	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
carotid artery stenosis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	9 / 4949 (0.18%)	5 / 4943 (0.10%)
occurrences causally related to treatment / all	0 / 10	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
carotid sinus syndrome
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
carpal tunnel syndrome
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	5 / 4949 (0.10%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 5	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
cauda equina syndrome
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
cerebellar ataxia
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
cerebellar atrophy
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
cerebellar infarction
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
cerebral arteriosclerosis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
cerebral atrophy
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
cerebral circulatory failure
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
cerebral haematoma
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	3 / 4949 (0.06%)	2 / 4943 (0.04%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
cerebral haemorrhage
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	2 / 4949 (0.04%)	2 / 4943 (0.04%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 1
cerebral infarction
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	4 / 4949 (0.08%)	5 / 4943 (0.10%)
occurrences causally related to treatment / all	0 / 4	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
cerebral ischaemia
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	4 / 4949 (0.08%)	5 / 4943 (0.10%)
occurrences causally related to treatment / all	0 / 4	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
cerebrovascular accident
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	31 / 4949 (0.63%)	24 / 4943 (0.49%)
occurrences causally related to treatment / all	1 / 34	0 / 25
deaths causally related to treatment / all	1 / 2	0 / 1
cerebrovascular disorder
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	3 / 4943 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 1
cerebrovascular insufficiency
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	3 / 4949 (0.06%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
cervical radiculopathy
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
cervicobrachial syndrome
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
cognitive disorder
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	3 / 4949 (0.06%)	2 / 4943 (0.04%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
coma
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	2 / 4943 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
dementia
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	2 / 4949 (0.04%)	4 / 4943 (0.08%)
occurrences causally related to treatment / all	0 / 2	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
dementia alzheimer's type
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	2 / 4949 (0.04%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
demyelinating polyneuropathy
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
depressed level of consciousness
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
diabetic coma
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
diabetic hyperglycaemic coma
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
diabetic hyperosmolar coma
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
diabetic mononeuropathy
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
diabetic neuropathy
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	8 / 4949 (0.16%)	3 / 4943 (0.06%)
occurrences causally related to treatment / all	0 / 8	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
dizziness
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	2 / 4949 (0.04%)	9 / 4943 (0.18%)
occurrences causally related to treatment / all	0 / 2	1 / 9
deaths causally related to treatment / all	0 / 0	0 / 0
dizziness postural
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
dysarthria
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
embolic stroke
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
encephalopathy
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	2 / 4949 (0.04%)	4 / 4943 (0.08%)
occurrences causally related to treatment / all	0 / 2	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 1
epilepsy
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	8 / 4949 (0.16%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 8	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
facial paralysis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	3 / 4949 (0.06%)	5 / 4943 (0.10%)
occurrences causally related to treatment / all	0 / 3	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
frontal lobe epilepsy
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
generalised tonic-clonic seizure
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
guillain-barre syndrome
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
haemorrhage intracranial
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	3 / 4949 (0.06%)	3 / 4943 (0.06%)
occurrences causally related to treatment / all	0 / 3	0 / 3
deaths causally related to treatment / all	0 / 1	0 / 1
haemorrhagic cerebral infarction
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
haemorrhagic stroke
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	2 / 4949 (0.04%)	4 / 4943 (0.08%)
occurrences causally related to treatment / all	0 / 2	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 1
headache
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	2 / 4949 (0.04%)	2 / 4943 (0.04%)
occurrences causally related to treatment / all	1 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
hemiparesis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	5 / 4949 (0.10%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 5	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
hemiplegia
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	2 / 4949 (0.04%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
hepatic encephalopathy
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
hydrocephalus
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	4 / 4949 (0.08%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 6	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
hypertensive encephalopathy
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	2 / 4949 (0.04%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
hypoaesthesia
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
iiird nerve paralysis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
intracranial aneurysm
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	2 / 4943 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
intracranial haematoma
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
ischaemic cerebral infarction
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
ischaemic neuropathy
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	2 / 4943 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
ischaemic stroke
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	18 / 4949 (0.36%)	14 / 4943 (0.28%)
occurrences causally related to treatment / all	1 / 22	0 / 15
deaths causally related to treatment / all	0 / 5	0 / 1
lacunar infarction
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	3 / 4943 (0.06%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
lacunar stroke
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	2 / 4949 (0.04%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
language disorder
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
loss of consciousness
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	3 / 4943 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
lumbar radiculopathy
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	4 / 4949 (0.08%)	2 / 4943 (0.04%)
occurrences causally related to treatment / all	0 / 4	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
lumbosacral radiculopathy
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	2 / 4943 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
metabolic encephalopathy
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	5 / 4943 (0.10%)
occurrences causally related to treatment / all	0 / 1	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
migraine
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	2 / 4943 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
mixed dementia
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
monoparesis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
motor neurone disease
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
myasthenia gravis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	3 / 4949 (0.06%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
myelopathy
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	2 / 4949 (0.04%)	2 / 4943 (0.04%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
myoclonus
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
nerve root compression
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
nervous system disorder
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
neuritis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
neuropathy peripheral
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	2 / 4949 (0.04%)	5 / 4943 (0.10%)
occurrences causally related to treatment / all	0 / 2	1 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
normal pressure hydrocephalus
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	2 / 4943 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
optic neuritis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
paralysis recurrent laryngeal nerve
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
parkinson's disease
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	2 / 4949 (0.04%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 2	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
parkinsonism
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
partial seizures
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	3 / 4949 (0.06%)	2 / 4943 (0.04%)
occurrences causally related to treatment / all	0 / 3	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
peripheral nerve paresis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
peripheral sensorimotor neuropathy
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
peroneal nerve palsy
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	2 / 4949 (0.04%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
piriformis syndrome
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
polyneuropathy
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
post herpetic neuralgia
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	2 / 4949 (0.04%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
presyncope
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	2 / 4949 (0.04%)	4 / 4943 (0.08%)
occurrences causally related to treatment / all	0 / 2	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
pseudobulbar palsy
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
psychomotor hyperactivity
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
quadriplegia
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	3 / 4943 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
radiculopathy
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	3 / 4949 (0.06%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
sciatica
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	7 / 4949 (0.14%)	6 / 4943 (0.12%)
occurrences causally related to treatment / all	0 / 8	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
seizure
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	5 / 4949 (0.10%)	7 / 4943 (0.14%)
occurrences causally related to treatment / all	0 / 5	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
sensory disturbance
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
serotonin syndrome
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
spinal claudication
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
syncope
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	33 / 4949 (0.67%)	36 / 4943 (0.73%)
occurrences causally related to treatment / all	1 / 34	5 / 38
deaths causally related to treatment / all	0 / 1	0 / 0
thrombotic stroke
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
toxic encephalopathy
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
transient global amnesia
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	2 / 4943 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
transient ischaemic attack
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	23 / 4949 (0.46%)	22 / 4943 (0.45%)
occurrences causally related to treatment / all	0 / 24	0 / 25
deaths causally related to treatment / all	0 / 0	0 / 0
tremor
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
trigeminal neuralgia
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
uraemic encephalopathy
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
vith nerve paralysis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
vascular dementia
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	4 / 4949 (0.08%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 4	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
vascular encephalopathy
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	2 / 4949 (0.04%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
vascular parkinsonism
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
vertebrobasilar insufficiency
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	2 / 4949 (0.04%)	2 / 4943 (0.04%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
wernicke's encephalopathy
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
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
agranulocytosis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
anaemia
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	23 / 4949 (0.46%)	29 / 4943 (0.59%)
occurrences causally related to treatment / all	1 / 24	0 / 30
deaths causally related to treatment / all	0 / 0	0 / 0
anaemia folate deficiency
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
anaemia macrocytic
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
anaemia of malignant disease
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	2 / 4943 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
anaemia vitamin b12 deficiency
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
blood disorder
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
deficiency anaemia
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
disseminated intravascular coagulation
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
febrile neutropenia
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	4 / 4949 (0.08%)	2 / 4943 (0.04%)
occurrences causally related to treatment / all	0 / 5	0 / 2
deaths causally related to treatment / all	0 / 1	0 / 0
haemolytic anaemia
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
haemorrhagic anaemia
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	2 / 4949 (0.04%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
histiocytosis haematophagic
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
hypochromic anaemia
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	2 / 4943 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
immune thrombocytopenic purpura
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
iron deficiency anaemia
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	9 / 4949 (0.18%)	14 / 4943 (0.28%)
occurrences causally related to treatment / all	1 / 10	0 / 14
deaths causally related to treatment / all	0 / 0	0 / 0
lymphadenopathy
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
lymphadenopathy mediastinal
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 1	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
microcytic anaemia
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
nephrogenic anaemia
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
neutropenia
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
normochromic normocytic anaemia
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
normocytic anaemia
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
pancytopenia
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	3 / 4943 (0.06%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
polycythaemia
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
splenic haemorrhage
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
splenomegaly
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
thrombocytopenia
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	2 / 4949 (0.04%)	3 / 4943 (0.06%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Ear and labyrinth disorders
deafness
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
deafness neurosensory
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	3 / 4949 (0.06%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
deafness unilateral
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
hypoacusis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
sudden hearing loss
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
vertigo
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	6 / 4949 (0.12%)	4 / 4943 (0.08%)
occurrences causally related to treatment / all	0 / 6	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
vertigo positional
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	3 / 4949 (0.06%)	4 / 4943 (0.08%)
occurrences causally related to treatment / all	0 / 3	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
vestibular ataxia
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
vestibular disorder
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	3 / 4949 (0.06%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Eye disorders
amaurosis fugax
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
amblyopia
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
angle closure glaucoma
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
blepharochalasis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
cataract
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	29 / 4949 (0.59%)	19 / 4943 (0.38%)
occurrences causally related to treatment / all	0 / 34	0 / 27
deaths causally related to treatment / all	0 / 0	0 / 0
cataract diabetic
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
cataract nuclear
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	3 / 4949 (0.06%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 4	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
cataract subcapsular
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	2 / 4949 (0.04%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
dacryostenosis acquired
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	2 / 4949 (0.04%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
diabetic retinopathy
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	4 / 4949 (0.08%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 8	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
diplopia
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
eye haemorrhage
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
glaucoma
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	6 / 4949 (0.12%)	3 / 4943 (0.06%)
occurrences causally related to treatment / all	0 / 6	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
hypermetropia
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
iridodialysis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
lens dislocation
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
macular fibrosis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	2 / 4943 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
macular hole
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
macular oedema
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
maculopathy
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
neurotrophic keratopathy
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
open angle glaucoma
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	2 / 4949 (0.04%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
ophthalmic vein thrombosis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
optic ischaemic neuropathy
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
retinal artery embolism
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
retinal artery occlusion
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
retinal detachment
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	3 / 4943 (0.06%)
occurrences causally related to treatment / all	0 / 1	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
retinal haemorrhage
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
retinal tear
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
strabismus
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
vitreous haemorrhage
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	3 / 4943 (0.06%)
occurrences causally related to treatment / all	0 / 1	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal disorders
abdominal adhesions
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	2 / 4949 (0.04%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
abdominal compartment syndrome
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
abdominal discomfort
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
abdominal hernia
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	7 / 4949 (0.14%)	7 / 4943 (0.14%)
occurrences causally related to treatment / all	0 / 7	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
abdominal hernia obstructive
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
abdominal incarcerated hernia
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	2 / 4949 (0.04%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
abdominal mass
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
abdominal pain
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	10 / 4949 (0.20%)	10 / 4943 (0.20%)
occurrences causally related to treatment / all	1 / 11	1 / 12
deaths causally related to treatment / all	0 / 0	0 / 2
abdominal pain upper
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	5 / 4949 (0.10%)	3 / 4943 (0.06%)
occurrences causally related to treatment / all	0 / 5	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
abdominal wall haematoma
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	1 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
acute abdomen
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
anal fistula
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
anal incontinence
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	2 / 4949 (0.04%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
ascites
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
barrett's oesophagus
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
chronic gastritis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	2 / 4949 (0.04%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
colitis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	7 / 4949 (0.14%)	4 / 4943 (0.08%)
occurrences causally related to treatment / all	0 / 9	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
colitis ischaemic
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	3 / 4949 (0.06%)	4 / 4943 (0.08%)
occurrences causally related to treatment / all	0 / 3	1 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
colitis microscopic
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	2 / 4943 (0.04%)
occurrences causally related to treatment / all	1 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
colitis ulcerative
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	2 / 4943 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
constipation
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	6 / 4949 (0.12%)	6 / 4943 (0.12%)
occurrences causally related to treatment / all	0 / 6	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
crohn's disease
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
dental cyst
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
diabetic gastroparesis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
diaphragmatic hernia
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
diarrhoea
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	8 / 4949 (0.16%)	10 / 4943 (0.20%)
occurrences causally related to treatment / all	0 / 8	4 / 10
deaths causally related to treatment / all	0 / 0	0 / 0
diverticular perforation
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
diverticulum
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	2 / 4949 (0.04%)	5 / 4943 (0.10%)
occurrences causally related to treatment / all	0 / 2	1 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
diverticulum intestinal
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	2 / 4949 (0.04%)	5 / 4943 (0.10%)
occurrences causally related to treatment / all	0 / 2	1 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
diverticulum intestinal haemorrhagic
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	3 / 4949 (0.06%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	1 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
duodenal ulcer
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	4 / 4949 (0.08%)	3 / 4943 (0.06%)
occurrences causally related to treatment / all	0 / 4	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
duodenal ulcer haemorrhage
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	3 / 4949 (0.06%)	3 / 4943 (0.06%)
occurrences causally related to treatment / all	0 / 3	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
duodenitis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
dyspepsia
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	2 / 4949 (0.04%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
dysphagia
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	2 / 4949 (0.04%)	2 / 4943 (0.04%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
enteritis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	3 / 4949 (0.06%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
enterovesical fistula
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
erosive duodenitis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
faecaloma
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	2 / 4949 (0.04%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	1 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
fistula of small intestine
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (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 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
gallstone ileus
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
gastric dilatation
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
gastric dysplasia
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
gastric haemorrhage
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
gastric polyps
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	2 / 4943 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
gastric ulcer
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	7 / 4949 (0.14%)	6 / 4943 (0.12%)
occurrences causally related to treatment / all	0 / 7	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
gastric ulcer haemorrhage
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	2 / 4949 (0.04%)	8 / 4943 (0.16%)
occurrences causally related to treatment / all	0 / 3	0 / 8
deaths causally related to treatment / all	0 / 0	0 / 0
gastritis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	17 / 4949 (0.34%)	13 / 4943 (0.26%)
occurrences causally related to treatment / all	1 / 17	3 / 13
deaths causally related to treatment / all	0 / 0	0 / 0
gastritis erosive
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	2 / 4943 (0.04%)
occurrences causally related to treatment / all	0 / 1	1 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
gastroduodenitis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	2 / 4943 (0.04%)
occurrences causally related to treatment / all	0 / 0	1 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
gastrointestinal haemorrhage
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	13 / 4949 (0.26%)	12 / 4943 (0.24%)
occurrences causally related to treatment / all	1 / 14	1 / 13
deaths causally related to treatment / all	0 / 2	0 / 3
gastrointestinal inflammation
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
gastrointestinal motility disorder
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
gastrointestinal mucocoele
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
gastrointestinal necrosis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
gastrointestinal polyp
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
gastrointestinal polyp haemorrhage
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
gastrointestinal ulcer
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
gastrointestinal ulcer haemorrhage
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
gastrointestinal vascular malformation haemorrhagic
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
gastrooesophageal reflux disease
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	6 / 4949 (0.12%)	9 / 4943 (0.18%)
occurrences causally related to treatment / all	0 / 6	0 / 9
deaths causally related to treatment / all	0 / 0	0 / 0
haematemesis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
haematochezia
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
haemorrhagic erosive gastritis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
haemorrhoidal haemorrhage
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	2 / 4943 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
haemorrhoids
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	2 / 4949 (0.04%)	5 / 4943 (0.10%)
occurrences causally related to treatment / all	0 / 2	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
haemorrhoids thrombosed
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
hernial eventration
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	2 / 4943 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
heyde's syndrome
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
hiatus hernia
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	7 / 4943 (0.14%)
occurrences causally related to treatment / all	0 / 1	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
ileus
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	2 / 4949 (0.04%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
ileus paralytic
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	2 / 4949 (0.04%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
impaired gastric emptying
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
incarcerated inguinal hernia
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	2 / 4949 (0.04%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
incarcerated umbilical hernia
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
inguinal hernia
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	11 / 4949 (0.22%)	17 / 4943 (0.34%)
occurrences causally related to treatment / all	0 / 11	0 / 17
deaths causally related to treatment / all	0 / 0	0 / 0
intestinal haemorrhage
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 1
intestinal ischaemia
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	2 / 4943 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 1	0 / 0
intestinal mass
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
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 21.0
subjects affected / exposed	14 / 4949 (0.28%)	9 / 4943 (0.18%)
occurrences causally related to treatment / all	1 / 15	2 / 9
deaths causally related to treatment / all	0 / 2	0 / 0
intestinal perforation
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
intestinal polyp
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
intestinal stenosis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
intra-abdominal haemorrhage
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
intussusception
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	2 / 4943 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
irritable bowel syndrome
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	2 / 4949 (0.04%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
large intestine perforation
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	1 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
large intestine polyp
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	4 / 4949 (0.08%)	4 / 4943 (0.08%)
occurrences causally related to treatment / all	0 / 4	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
lower gastrointestinal haemorrhage
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	6 / 4949 (0.12%)	6 / 4943 (0.12%)
occurrences causally related to treatment / all	0 / 6	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
mallory-weiss syndrome
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
mechanical ileus
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
megacolon
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
melaena
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	3 / 4949 (0.06%)	2 / 4943 (0.04%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
mesenteric arterial occlusion
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
mesenteric artery thrombosis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	2 / 4949 (0.04%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
mouth haemorrhage
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
nausea
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	2 / 4949 (0.04%)	2 / 4943 (0.04%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
necrotising oesophagitis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
obstructive pancreatitis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	2 / 4949 (0.04%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
oesophageal achalasia
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
oesophageal spasm
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
oesophageal stenosis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	2 / 4943 (0.04%)
occurrences causally related to treatment / all	0 / 1	1 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
oesophageal varices haemorrhage
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	3 / 4943 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
oesophagitis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	2 / 4949 (0.04%)	2 / 4943 (0.04%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
palatal disorder
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
pancreatic cyst
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	2 / 4949 (0.04%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	1 / 2	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
pancreatic pseudocyst
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
pancreatitis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	5 / 4949 (0.10%)	9 / 4943 (0.18%)
occurrences causally related to treatment / all	1 / 5	5 / 9
deaths causally related to treatment / all	0 / 0	0 / 0
pancreatitis acute
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	8 / 4949 (0.16%)	15 / 4943 (0.30%)
occurrences causally related to treatment / all	5 / 10	5 / 15
deaths causally related to treatment / all	1 / 1	0 / 0
pancreatitis chronic
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
peptic ulcer
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	3 / 4949 (0.06%)	2 / 4943 (0.04%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
peritoneal adhesions
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
peritoneal haematoma
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
peritoneal hernia
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
portal venous gas
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
proctitis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
rectal haemorrhage
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	5 / 4949 (0.10%)	5 / 4943 (0.10%)
occurrences causally related to treatment / all	0 / 5	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
rectal polyp
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	2 / 4943 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
retroperitoneal haemorrhage
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
salivary gland calculus
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
small intestinal obstruction
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	10 / 4949 (0.20%)	5 / 4943 (0.10%)
occurrences causally related to treatment / all	0 / 12	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
spigelian hernia
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
strangulated umbilical hernia
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	2 / 4949 (0.04%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
thrombosis mesenteric vessel
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	2 / 4949 (0.04%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
umbilical hernia
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	7 / 4949 (0.14%)	3 / 4943 (0.06%)
occurrences causally related to treatment / all	0 / 7	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
umbilical hernia, obstructive
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	2 / 4949 (0.04%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
upper gastrointestinal haemorrhage
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	10 / 4949 (0.20%)	7 / 4943 (0.14%)
occurrences causally related to treatment / all	0 / 10	1 / 7
deaths causally related to treatment / all	0 / 1	0 / 0
varices oesophageal
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
volvulus of small bowel
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
vomiting
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	5 / 4949 (0.10%)	6 / 4943 (0.12%)
occurrences causally related to treatment / all	0 / 5	2 / 8
deaths causally related to treatment / all	0 / 0	0 / 0
Skin and subcutaneous tissue disorders
angioedema
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	3 / 4949 (0.06%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	1 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
decubitus ulcer
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
dermatitis allergic
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	2 / 4949 (0.04%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
dermatitis atopic
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
diabetic foot
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	19 / 4949 (0.38%)	14 / 4943 (0.28%)
occurrences causally related to treatment / all	0 / 24	0 / 17
deaths causally related to treatment / all	0 / 0	0 / 1
diabetic neuropathic ulcer
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
diabetic ulcer
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	2 / 4949 (0.04%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
erythrodermic psoriasis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
hypersensitivity vasculitis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	2 / 4949 (0.04%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	1 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
ischaemic skin ulcer
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
neuropathic ulcer
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
pemphigoid
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
psoriasis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
pyoderma gangrenosum
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
rash generalised
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
rash papular
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
skin disorder
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (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 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
skin ulcer
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	15 / 4949 (0.30%)	9 / 4943 (0.18%)
occurrences causally related to treatment / all	0 / 16	0 / 13
deaths causally related to treatment / all	0 / 2	0 / 0
stasis dermatitis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
subcutaneous emphysema
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
urticaria
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
vasculitic ulcer
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Renal and urinary disorders
acute kidney injury
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	67 / 4949 (1.35%)	61 / 4943 (1.23%)
occurrences causally related to treatment / all	7 / 74	2 / 72
deaths causally related to treatment / all	1 / 7	1 / 2
atonic urinary bladder
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
azotaemia
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	2 / 4943 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
bladder dysfunction
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	2 / 4949 (0.04%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
bladder fibrosis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
bladder hypertrophy
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
bladder mass
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
bladder neck obstruction
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
bladder neck sclerosis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
bladder obstruction
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
bladder outlet obstruction
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
bladder pain
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
calculus bladder
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	2 / 4949 (0.04%)	5 / 4943 (0.10%)
occurrences causally related to treatment / all	0 / 2	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
calculus urethral
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
calculus urinary
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
chronic kidney disease
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	19 / 4949 (0.38%)	13 / 4943 (0.26%)
occurrences causally related to treatment / all	0 / 20	0 / 13
deaths causally related to treatment / all	0 / 2	0 / 0
cystitis haemorrhagic
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
diabetic nephropathy
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	5 / 4949 (0.10%)	3 / 4943 (0.06%)
occurrences causally related to treatment / all	0 / 5	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 1
dysuria
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
end stage renal disease
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	6 / 4949 (0.12%)	3 / 4943 (0.06%)
occurrences causally related to treatment / all	2 / 6	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 1
haematuria
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	7 / 4949 (0.14%)	2 / 4943 (0.04%)
occurrences causally related to treatment / all	0 / 8	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
haemorrhage urinary tract
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
hydronephrosis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	4 / 4949 (0.08%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 4	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
hydroureter
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
hypertensive nephropathy
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
hypertonic bladder
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
kidney perforation
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
nephrolithiasis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	17 / 4949 (0.34%)	18 / 4943 (0.36%)
occurrences causally related to treatment / all	0 / 18	0 / 19
deaths causally related to treatment / all	0 / 0	0 / 0
nephropathy
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	2 / 4949 (0.04%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
pelvi-ureteric obstruction
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
proteinuria
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	2 / 4949 (0.04%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	1 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
renal colic
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	6 / 4949 (0.12%)	7 / 4943 (0.14%)
occurrences causally related to treatment / all	0 / 7	1 / 8
deaths causally related to treatment / all	0 / 0	0 / 0
renal cyst
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
renal failure
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	17 / 4949 (0.34%)	16 / 4943 (0.32%)
occurrences causally related to treatment / all	1 / 17	0 / 16
deaths causally related to treatment / all	1 / 6	0 / 4
renal haematoma
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
renal haemorrhage
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
renal impairment
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	6 / 4949 (0.12%)	7 / 4943 (0.14%)
occurrences causally related to treatment / all	0 / 6	0 / 8
deaths causally related to treatment / all	0 / 0	0 / 1
renal infarct
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
renal mass
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	2 / 4949 (0.04%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 0
stress urinary incontinence
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	2 / 4943 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
tubulointerstitial nephritis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
ureteric dilatation
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
ureteric stenosis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
ureterolithiasis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	9 / 4949 (0.18%)	9 / 4943 (0.18%)
occurrences causally related to treatment / all	0 / 10	0 / 9
deaths causally related to treatment / all	0 / 0	0 / 0
urethral caruncle
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
urethral disorder
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
urethral stenosis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	4 / 4949 (0.08%)	4 / 4943 (0.08%)
occurrences causally related to treatment / all	0 / 4	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
urinary bladder polyp
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
urinary incontinence
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	4 / 4949 (0.08%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 4	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
urinary retention
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	9 / 4949 (0.18%)	3 / 4943 (0.06%)
occurrences causally related to treatment / all	1 / 9	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
urinary tract obstruction
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Endocrine disorders
acromegaly
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
adrenal insufficiency
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
adrenocortical insufficiency acute
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
autoimmune thyroiditis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
cushing's syndrome
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
goitre
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	8 / 4949 (0.16%)	12 / 4943 (0.24%)
occurrences causally related to treatment / all	0 / 8	1 / 12
deaths causally related to treatment / all	0 / 0	0 / 0
hyperaldosteronism
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
hyperparathyroidism
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	2 / 4943 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
hyperparathyroidism primary
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
hyperparathyroidism secondary
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
hyperthyroidism
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	2 / 4943 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
hypoparathyroidism secondary
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
parathyroid disorder
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
primary hyperaldosteronism
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
thyroid mass
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	2 / 4949 (0.04%)	2 / 4943 (0.04%)
occurrences causally related to treatment / all	1 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
thyroiditis subacute
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
toxic nodular goitre
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Musculoskeletal and connective tissue disorders
arthralgia
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	6 / 4949 (0.12%)	9 / 4943 (0.18%)
occurrences causally related to treatment / all	0 / 6	0 / 9
deaths causally related to treatment / all	0 / 0	0 / 0
arthritis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	7 / 4949 (0.14%)	6 / 4943 (0.12%)
occurrences causally related to treatment / all	0 / 7	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
arthritis reactive
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
arthrofibrosis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
arthropathy
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
articular calcification
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (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 21.0
subjects affected / exposed	9 / 4949 (0.18%)	6 / 4943 (0.12%)
occurrences causally related to treatment / all	0 / 10	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
bone lesion
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
bursitis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	2 / 4949 (0.04%)	2 / 4943 (0.04%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
cervical spinal stenosis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	2 / 4949 (0.04%)	5 / 4943 (0.10%)
occurrences causally related to treatment / all	0 / 2	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
chondrocalcinosis pyrophosphate
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
chondromalacia
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
chondropathy
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	3 / 4949 (0.06%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
costochondritis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
diabetic amyotrophy
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
diabetic arthropathy
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
dupuytren's contracture
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
exostosis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
fistula
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
foot deformity
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	2 / 4943 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
fracture malunion
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
gouty arthritis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	3 / 4949 (0.06%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
gouty tophus
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
intervertebral disc degeneration
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	3 / 4949 (0.06%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
intervertebral disc disorder
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	2 / 4949 (0.04%)	3 / 4943 (0.06%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
intervertebral disc protrusion
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	21 / 4949 (0.42%)	15 / 4943 (0.30%)
occurrences causally related to treatment / all	0 / 22	0 / 16
deaths causally related to treatment / all	0 / 0	0 / 0
joint ankylosis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
joint noise
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
joint swelling
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
lumbar spinal stenosis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	11 / 4949 (0.22%)	10 / 4943 (0.20%)
occurrences causally related to treatment / all	0 / 14	0 / 10
deaths causally related to treatment / all	0 / 0	0 / 0
mobility decreased
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
muscle haemorrhage
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
muscle spasms
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
muscular weakness
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
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 21.0
subjects affected / exposed	6 / 4949 (0.12%)	10 / 4943 (0.20%)
occurrences causally related to treatment / all	0 / 6	0 / 10
deaths causally related to treatment / all	0 / 0	0 / 0
musculoskeletal pain
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	3 / 4949 (0.06%)	2 / 4943 (0.04%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
myalgia
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	2 / 4949 (0.04%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
neck pain
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	2 / 4949 (0.04%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
neuropathic arthropathy
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	2 / 4949 (0.04%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
osteitis deformans
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
osteoarthritis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	110 / 4949 (2.22%)	136 / 4943 (2.75%)
occurrences causally related to treatment / all	0 / 128	0 / 155
deaths causally related to treatment / all	0 / 0	0 / 0
osteochondrosis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	4 / 4943 (0.08%)
occurrences causally related to treatment / all	0 / 0	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
osteonecrosis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	3 / 4949 (0.06%)	4 / 4943 (0.08%)
occurrences causally related to treatment / all	0 / 3	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
osteopenia
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
osteoporosis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
pain in extremity
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	3 / 4949 (0.06%)	2 / 4943 (0.04%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
patellofemoral pain syndrome
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
pathological fracture
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	2 / 4943 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
periarthritis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	3 / 4943 (0.06%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
plantar fascial fibromatosis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
polymyalgia rheumatica
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	2 / 4949 (0.04%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
pseudarthrosis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
rhabdomyolysis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	2 / 4943 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
rheumatic disorder
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
rheumatoid arthritis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	2 / 4949 (0.04%)	3 / 4943 (0.06%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
rotator cuff syndrome
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	10 / 4949 (0.20%)	8 / 4943 (0.16%)
occurrences causally related to treatment / all	0 / 11	0 / 8
deaths causally related to treatment / all	0 / 0	0 / 0
spinal column stenosis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	7 / 4949 (0.14%)	13 / 4943 (0.26%)
occurrences causally related to treatment / all	0 / 7	0 / 13
deaths causally related to treatment / all	0 / 0	0 / 0
spinal osteoarthritis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	21 / 4949 (0.42%)	16 / 4943 (0.32%)
occurrences causally related to treatment / all	0 / 23	0 / 19
deaths causally related to treatment / all	0 / 0	0 / 1
spinal pain
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	4 / 4949 (0.08%)	5 / 4943 (0.10%)
occurrences causally related to treatment / all	0 / 4	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
spondylitis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	2 / 4949 (0.04%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
spondyloarthropathy
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
spondylolisthesis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	3 / 4949 (0.06%)	6 / 4943 (0.12%)
occurrences causally related to treatment / all	0 / 3	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
spondylolysis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
synovial cyst
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	2 / 4943 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
synovitis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	2 / 4943 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
tendon disorder
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
tendonitis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
tenosynovitis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
vertebral foraminal stenosis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
vertebral osteophyte
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Infections and infestations
abdominal abscess
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	2 / 4949 (0.04%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	1 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
abscess
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
abscess intestinal
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
abscess limb
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	3 / 4949 (0.06%)	3 / 4943 (0.06%)
occurrences causally related to treatment / all	0 / 4	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
abscess neck
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
abscess oral
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
anal abscess
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	4 / 4949 (0.08%)	4 / 4943 (0.08%)
occurrences causally related to treatment / all	0 / 4	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
anal infection
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
aortitis salmonella
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
appendiceal abscess
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
appendicitis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	2 / 4949 (0.04%)	6 / 4943 (0.12%)
occurrences causally related to treatment / all	0 / 2	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
appendicitis perforated
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 1	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
arthritis bacterial
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	4 / 4949 (0.08%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 4	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
arthritis infective
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	4 / 4949 (0.08%)	2 / 4943 (0.04%)
occurrences causally related to treatment / all	0 / 4	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
atypical pneumonia
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
bacteraemia
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	6 / 4949 (0.12%)	2 / 4943 (0.04%)
occurrences causally related to treatment / all	0 / 6	0 / 2
deaths causally related to treatment / all	0 / 1	0 / 0
bacterial infection
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
biliary sepsis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
brain abscess
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
breast abscess
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
breast cellulitis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
bronchitis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	12 / 4949 (0.24%)	13 / 4943 (0.26%)
occurrences causally related to treatment / all	0 / 12	0 / 13
deaths causally related to treatment / all	0 / 1	0 / 1
bronchitis bacterial
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
bronchitis fungal
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
bronchitis viral
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
burn infection
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
campylobacter gastroenteritis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	2 / 4949 (0.04%)	2 / 4943 (0.04%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
candida sepsis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 0
candiduria
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
carbuncle
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	2 / 4949 (0.04%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
cellulitis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	42 / 4949 (0.85%)	38 / 4943 (0.77%)
occurrences causally related to treatment / all	0 / 48	0 / 39
deaths causally related to treatment / all	0 / 0	0 / 1
cellulitis streptococcal
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
cervicitis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed ^[51]	0 / 2282 (0.00%)	1 / 2303 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
cholecystitis infective
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	2 / 4949 (0.04%)	2 / 4943 (0.04%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
chronic hepatitis b
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
clostridium colitis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
clostridium difficile colitis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	5 / 4943 (0.10%)
occurrences causally related to treatment / all	0 / 1	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
clostridium difficile infection
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	3 / 4949 (0.06%)	2 / 4943 (0.04%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
corneal abscess
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
cystitis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	6 / 4949 (0.12%)	3 / 4943 (0.06%)
occurrences causally related to treatment / all	0 / 6	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
cystitis escherichia
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
cytomegalovirus colitis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
dengue fever
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	3 / 4949 (0.06%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
dengue haemorrhagic fever
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
device related infection
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	3 / 4949 (0.06%)	3 / 4943 (0.06%)
occurrences causally related to treatment / all	0 / 3	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
device related sepsis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
diabetic foot infection
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	5 / 4949 (0.10%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 5	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
diabetic gangrene
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	3 / 4949 (0.06%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
diarrhoea infectious
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
diverticulitis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	10 / 4949 (0.20%)	15 / 4943 (0.30%)
occurrences causally related to treatment / all	0 / 12	1 / 17
deaths causally related to treatment / all	0 / 0	0 / 0
dysentery
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
echinococciasis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
empyema
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
endocarditis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	2 / 4949 (0.04%)	4 / 4943 (0.08%)
occurrences causally related to treatment / all	0 / 2	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
endocarditis bacterial
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
enterococcal sepsis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
enterocolitis bacterial
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
epididymitis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed ^[52]	0 / 2667 (0.00%)	4 / 2640 (0.15%)
occurrences causally related to treatment / all	0 / 0	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
erysipelas
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	15 / 4949 (0.30%)	11 / 4943 (0.22%)
occurrences causally related to treatment / all	0 / 18	0 / 12
deaths causally related to treatment / all	0 / 0	0 / 0
escherichia bacteraemia
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	3 / 4943 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
escherichia sepsis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	2 / 4949 (0.04%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	1 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
escherichia urinary tract infection
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	2 / 4943 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
extradural abscess
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
gallbladder abscess
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	2 / 4949 (0.04%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
gallbladder empyema
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
gangrene
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	11 / 4949 (0.22%)	8 / 4943 (0.16%)
occurrences causally related to treatment / all	0 / 11	0 / 18
deaths causally related to treatment / all	0 / 0	0 / 0
gastroenteritis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	10 / 4949 (0.20%)	21 / 4943 (0.42%)
occurrences causally related to treatment / all	0 / 10	1 / 22
deaths causally related to treatment / all	0 / 1	0 / 0
gastroenteritis clostridial
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	2 / 4943 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
gastroenteritis norovirus
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
gastroenteritis viral
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	5 / 4949 (0.10%)	2 / 4943 (0.04%)
occurrences causally related to treatment / all	0 / 5	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
gastrointestinal infection
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
genitourinary tract infection
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
groin abscess
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
h1n1 influenza
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
haematoma infection
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	3 / 4949 (0.06%)	2 / 4943 (0.04%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
helicobacter gastritis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
helicobacter infection
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	2 / 4949 (0.04%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
hepatitis b
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
hepatitis c
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
hepatitis e
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
hepatitis infectious mononucleosis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
herpes zoster
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	5 / 4949 (0.10%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 5	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
herpes zoster meningoencephalitis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
herpes zoster pharyngitis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
hydrocele male infected
alternative dictionary used: MedDRA 21.0
subjects affected / exposed ^[53]	0 / 2667 (0.00%)	1 / 2640 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
implant site infection
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	2 / 4943 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
infected skin ulcer
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	3 / 4949 (0.06%)	4 / 4943 (0.08%)
occurrences causally related to treatment / all	0 / 3	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
infection
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
infectious colitis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
infective exacerbation of chronic obstructive airways disease
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	6 / 4949 (0.12%)	3 / 4943 (0.06%)
occurrences causally related to treatment / all	0 / 8	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
influenza
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	8 / 4949 (0.16%)	5 / 4943 (0.10%)
occurrences causally related to treatment / all	0 / 8	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
injection site abscess
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
intervertebral discitis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
intestinal sepsis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
joint abscess
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	2 / 4949 (0.04%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
kidney infection
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
labyrinthitis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
laryngitis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
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 21.0
subjects affected / exposed	1 / 4949 (0.02%)	4 / 4943 (0.08%)
occurrences causally related to treatment / all	0 / 1	1 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
localised infection
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	8 / 4949 (0.16%)	8 / 4943 (0.16%)
occurrences causally related to treatment / all	0 / 8	0 / 8
deaths causally related to treatment / all	0 / 1	0 / 1
lower respiratory tract infection
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	11 / 4949 (0.22%)	12 / 4943 (0.24%)
occurrences causally related to treatment / all	0 / 12	0 / 13
deaths causally related to treatment / all	0 / 0	0 / 0
lower respiratory tract infection bacterial
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
lower respiratory tract infection viral
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
lung abscess
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
lung infection
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	3 / 4943 (0.06%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
lymphangitis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
mastitis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
mastoiditis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
mediastinitis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
medical device site infection
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
medical device site joint infection
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
meningitis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
meningitis aseptic
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
myiasis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
necrotising fasciitis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	2 / 4949 (0.04%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
neutropenic sepsis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	2 / 4943 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
oesophageal candidiasis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
orchitis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed ^[54]	2 / 2667 (0.07%)	3 / 2640 (0.11%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
osteomyelitis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	11 / 4949 (0.22%)	10 / 4943 (0.20%)
occurrences causally related to treatment / all	0 / 13	0 / 11
deaths causally related to treatment / all	0 / 0	0 / 0
osteomyelitis acute
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	2 / 4943 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
osteomyelitis chronic
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	2 / 4943 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
otitis externa
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
otitis media chronic
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
pancreatic abscess
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
paronychia
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	2 / 4943 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
pelvic abscess
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 1	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
pelvic infection
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
perihepatic abscess
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
perineal abscess
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	2 / 4949 (0.04%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
periodontitis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
perirectal abscess
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
peritonitis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	3 / 4943 (0.06%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
pharyngeal abscess
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
pneumonia
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	151 / 4949 (3.05%)	135 / 4943 (2.73%)
occurrences causally related to treatment / all	0 / 174	1 / 152
deaths causally related to treatment / all	0 / 15	0 / 14
pneumonia bacterial
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	2 / 4949 (0.04%)	2 / 4943 (0.04%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
pneumonia influenzal
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
pneumonia klebsiella
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
pneumonia legionella
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
pneumonia streptococcal
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	2 / 4949 (0.04%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	1 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
pneumonia viral
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
post procedural infection
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	2 / 4949 (0.04%)	3 / 4943 (0.06%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
post procedural pneumonia
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
post procedural sepsis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	2 / 4943 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
postoperative abscess
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
postoperative wound infection
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	3 / 4949 (0.06%)	7 / 4943 (0.14%)
occurrences causally related to treatment / all	0 / 3	0 / 7
deaths causally related to treatment / all	0 / 1	0 / 0
pseudomonal sepsis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
pulmonary mycosis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
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 21.0
subjects affected / exposed	2 / 4949 (0.04%)	4 / 4943 (0.08%)
occurrences causally related to treatment / all	0 / 2	0 / 4
deaths causally related to treatment / all	0 / 1	0 / 1
pulmonary tuberculosis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
pyelitis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
pyelonephritis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	15 / 4949 (0.30%)	8 / 4943 (0.16%)
occurrences causally related to treatment / all	0 / 15	0 / 8
deaths causally related to treatment / all	0 / 0	0 / 0
pyelonephritis acute
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	8 / 4949 (0.16%)	7 / 4943 (0.14%)
occurrences causally related to treatment / all	0 / 8	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
pyelonephritis chronic
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
pyonephrosis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
renal abscess
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
renal cyst infection
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
respiratory syncytial virus infection
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
respiratory tract infection
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	2 / 4949 (0.04%)	3 / 4943 (0.06%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
salmonella sepsis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
salmonellosis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
scrotal infection
alternative dictionary used: MedDRA 21.0
subjects affected / exposed ^[55]	1 / 2667 (0.04%)	0 / 2640 (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 21.0
subjects affected / exposed	35 / 4949 (0.71%)	30 / 4943 (0.61%)
occurrences causally related to treatment / all	2 / 37	0 / 33
deaths causally related to treatment / all	1 / 7	0 / 4
septic shock
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	22 / 4949 (0.44%)	15 / 4943 (0.30%)
occurrences causally related to treatment / all	0 / 24	0 / 16
deaths causally related to treatment / all	0 / 9	0 / 5
sinusitis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
skin graft infection
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
skin infection
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	2 / 4949 (0.04%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
soft tissue infection
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	3 / 4949 (0.06%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
staphylococcal bacteraemia
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	3 / 4949 (0.06%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
staphylococcal infection
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	2 / 4943 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
staphylococcal mediastinitis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
staphylococcal sepsis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
staphylococcal skin infection
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	2 / 4949 (0.04%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
streptococcal bacteraemia
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
subcutaneous abscess
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	2 / 4949 (0.04%)	3 / 4943 (0.06%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
subdiaphragmatic abscess
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
systemic candida
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
tooth abscess
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
tracheobronchitis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
tuberculosis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	2 / 4949 (0.04%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
tuberculosis gastrointestinal
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
upper respiratory tract infection
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	5 / 4949 (0.10%)	2 / 4943 (0.04%)
occurrences causally related to treatment / all	0 / 5	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
urinary tract infection
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	61 / 4949 (1.23%)	64 / 4943 (1.29%)
occurrences causally related to treatment / all	2 / 65	0 / 78
deaths causally related to treatment / all	0 / 1	0 / 1
urinary tract infection bacterial
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	2 / 4943 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
urinary tract infection pseudomonal
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	2 / 4949 (0.04%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
urosepsis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	19 / 4949 (0.38%)	24 / 4943 (0.49%)
occurrences causally related to treatment / all	0 / 20	1 / 26
deaths causally related to treatment / all	0 / 1	0 / 2
vestibular neuronitis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	3 / 4949 (0.06%)	4 / 4943 (0.08%)
occurrences causally related to treatment / all	0 / 3	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
viraemia
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
viral infection
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	3 / 4949 (0.06%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
viral myocarditis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
wound infection
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	5 / 4949 (0.10%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 5	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
wound sepsis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	3 / 4949 (0.06%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Metabolism and nutrition disorders
abnormal loss of weight
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
cachexia
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
decreased appetite
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	2 / 4949 (0.04%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	1 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
dehydration
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	14 / 4949 (0.28%)	23 / 4943 (0.47%)
occurrences causally related to treatment / all	0 / 15	3 / 24
deaths causally related to treatment / all	0 / 0	0 / 1
diabetes mellitus
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
diabetes mellitus inadequate control
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	3 / 4949 (0.06%)	4 / 4943 (0.08%)
occurrences causally related to treatment / all	1 / 3	1 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
diabetic ketoacidosis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	2 / 4949 (0.04%)	6 / 4943 (0.12%)
occurrences causally related to treatment / all	0 / 2	1 / 6
deaths causally related to treatment / all	0 / 0	0 / 1
electrolyte imbalance
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
failure to thrive
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
fluid overload
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	2 / 4943 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
food intolerance
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
gout
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	4 / 4949 (0.08%)	4 / 4943 (0.08%)
occurrences causally related to treatment / all	0 / 4	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
hypercalcaemia
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	2 / 4949 (0.04%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	1 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
hyperglycaemia
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	67 / 4949 (1.35%)	46 / 4943 (0.93%)
occurrences causally related to treatment / all	3 / 75	0 / 52
deaths causally related to treatment / all	0 / 1	0 / 0
hyperglycaemic hyperosmolar nonketotic syndrome
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	2 / 4949 (0.04%)	2 / 4943 (0.04%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
hyperkalaemia
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	12 / 4949 (0.24%)	8 / 4943 (0.16%)
occurrences causally related to treatment / all	0 / 12	0 / 9
deaths causally related to treatment / all	0 / 1	0 / 1
hyperosmolar state
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 0
hypocalcaemia
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
hypoglycaemia
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	72 / 4949 (1.45%)	62 / 4943 (1.25%)
occurrences causally related to treatment / all	34 / 80	31 / 69
deaths causally related to treatment / all	0 / 0	0 / 0
hypokalaemia
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	5 / 4949 (0.10%)	6 / 4943 (0.12%)
occurrences causally related to treatment / all	0 / 5	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
hypomagnesaemia
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	2 / 4943 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
hyponatraemia
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	11 / 4949 (0.22%)	8 / 4943 (0.16%)
occurrences causally related to treatment / all	0 / 12	0 / 8
deaths causally related to treatment / all	0 / 0	0 / 0
iron deficiency
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
ketoacidosis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 4949 (0.02%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
lactic acidosis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	3 / 4949 (0.06%)	0 / 4943 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
metabolic acidosis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	3 / 4949 (0.06%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
obesity
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	5 / 4949 (0.10%)	5 / 4943 (0.10%)
occurrences causally related to treatment / all	0 / 5	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
type 2 diabetes mellitus
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	0 / 4949 (0.00%)	1 / 4943 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0

Notes
[1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: This event is gender specific, only occurring in male or female subject. 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 to this adverse event. These numbers are expected to be equal.
Justification: This event is gender specific, only occurring in male or female subject. 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 to this adverse event. These numbers are expected to be equal.
Justification: This event is gender specific, only occurring in male or female subject. 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 to this adverse event. These numbers are expected to be equal.
Justification: This event is gender specific, only occurring in male or female subject. 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 to this adverse event. These numbers are expected to be equal.
Justification: This event is gender specific, only occurring in male or female subject. 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 to this adverse event. These numbers are expected to be equal.
Justification: This event is gender specific, only occurring in male or female subject. 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 to this adverse event. These numbers are expected to be equal.
Justification: This event is gender specific, only occurring in male or female subject. The number of subjects exposed has been adjusted accordingly.
[8] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: This event is gender specific, only occurring in male or female subject. The number of subjects exposed has been adjusted accordingly.
[9] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: This event is gender specific, only occurring in male or female subject. The number of subjects exposed has been adjusted accordingly.
[10] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: This event is gender specific, only occurring in male or female subject. The number of subjects exposed has been adjusted accordingly.
[11] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: This event is gender specific, only occurring in male or female subject. The number of subjects exposed has been adjusted accordingly.
[12] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: This event is gender specific, only occurring in male or female subject. The number of subjects exposed has been adjusted accordingly.
[13] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: This event is gender specific, only occurring in male or female subject. The number of subjects exposed has been adjusted accordingly.
[14] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: This event is gender specific, only occurring in male or female subject. The number of subjects exposed has been adjusted accordingly.
[15] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: This event is gender specific, only occurring in male or female subject. The number of subjects exposed has been adjusted accordingly.
[16] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: This event is gender specific, only occurring in male or female subject. The number of subjects exposed has been adjusted accordingly.
[17] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: This event is gender specific, only occurring in male or female subject. The number of subjects exposed has been adjusted accordingly.
[18] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: This event is gender specific, only occurring in male or female subject. The number of subjects exposed has been adjusted accordingly.
[19] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: This event is gender specific, only occurring in male or female subject. The number of subjects exposed has been adjusted accordingly.
[20] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: This event is gender specific, only occurring in male or female subject. The number of subjects exposed has been adjusted accordingly.
[21] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: This event is gender specific, only occurring in male or female subject. The number of subjects exposed has been adjusted accordingly.
[22] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: This event is gender specific, only occurring in male or female subject. The number of subjects exposed has been adjusted accordingly.
[23] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: This event is gender specific, only occurring in male or female subject. The number of subjects exposed has been adjusted accordingly.
[24] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: This event is gender specific, only occurring in male or female subject. The number of subjects exposed has been adjusted accordingly.
[25] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: This event is gender specific, only occurring in male or female subject. The number of subjects exposed has been adjusted accordingly.
[26] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: This event is gender specific, only occurring in male or female subject. The number of subjects exposed has been adjusted accordingly.
[27] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: This event is gender specific, only occurring in male or female subject. The number of subjects exposed has been adjusted accordingly.
[28] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: This event is gender specific, only occurring in male or female subject. The number of subjects exposed has been adjusted accordingly.
[29] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: This event is gender specific, only occurring in male or female subject. The number of subjects exposed has been adjusted accordingly.
[30] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: This event is gender specific, only occurring in male or female subject. The number of subjects exposed has been adjusted accordingly.
[31] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: This event is gender specific, only occurring in male or female subject. The number of subjects exposed has been adjusted accordingly.
[32] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: This event is gender specific, only occurring in male or female subject. The number of subjects exposed has been adjusted accordingly.
[33] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: This event is gender specific, only occurring in male or female subject. The number of subjects exposed has been adjusted accordingly.
[34] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: This event is gender specific, only occurring in male or female subject. The number of subjects exposed has been adjusted accordingly.
[35] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: This event is gender specific, only occurring in male or female subject. The number of subjects exposed has been adjusted accordingly.
[36] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: This event is gender specific, only occurring in male or female subject. The number of subjects exposed has been adjusted accordingly.
[37] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: This event is gender specific, only occurring in male or female subject. The number of subjects exposed has been adjusted accordingly.
[38] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: This event is gender specific, only occurring in male or female subject. The number of subjects exposed has been adjusted accordingly.
[39] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: This event is gender specific, only occurring in male or female subject. The number of subjects exposed has been adjusted accordingly.
[40] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: This event is gender specific, only occurring in male or female subject. The number of subjects exposed has been adjusted accordingly.
[41] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: This event is gender specific, only occurring in male or female subject. The number of subjects exposed has been adjusted accordingly.
[42] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: This event is gender specific, only occurring in male or female subject. The number of subjects exposed has been adjusted accordingly.
[43] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: This event is gender specific, only occurring in male or female subject. The number of subjects exposed has been adjusted accordingly.
[44] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: This event is gender specific, only occurring in male or female subject. The number of subjects exposed has been adjusted accordingly.
[45] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: This event is gender specific, only occurring in male or female subject. The number of subjects exposed has been adjusted accordingly.
[46] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: This event is gender specific, only occurring in male or female subject. The number of subjects exposed has been adjusted accordingly.
[47] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: This event is gender specific, only occurring in male or female subject. The number of subjects exposed has been adjusted accordingly.
[48] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: This event is gender specific, only occurring in male or female subject. The number of subjects exposed has been adjusted accordingly.
[49] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: This event is gender specific, only occurring in male or female subject. The number of subjects exposed has been adjusted accordingly.
[50] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: This event is gender specific, only occurring in male or female subject. The number of subjects exposed has been adjusted accordingly.
[51] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: This event is gender specific, only occurring in male or female subject. The number of subjects exposed has been adjusted accordingly.
[52] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: This event is gender specific, only occurring in male or female subject. The number of subjects exposed has been adjusted accordingly.
[53] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: This event is gender specific, only occurring in male or female subject. The number of subjects exposed has been adjusted accordingly.
[54] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: This event is gender specific, only occurring in male or female subject. The number of subjects exposed has been adjusted accordingly.
[55] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: This event is gender specific, only occurring in male or female subject. The number of subjects exposed has been adjusted accordingly.

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

Non-serious adverse events	Placebo	Dulaglutide
Total subjects affected by non serious adverse events
subjects affected / exposed	3363 / 4949 (67.95%)	3574 / 4943 (72.30%)
Vascular disorders
hypertension
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	432 / 4949 (8.73%)	345 / 4943 (6.98%)
occurrences all number	491	405
Nervous system disorders
dizziness
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	296 / 4949 (5.98%)	318 / 4943 (6.43%)
occurrences all number	339	373
headache
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	288 / 4949 (5.82%)	324 / 4943 (6.55%)
occurrences all number	382	414
Eye disorders
cataract
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	368 / 4949 (7.44%)	363 / 4943 (7.34%)
occurrences all number	417	427
Reproductive system and breast disorders
benign prostatic hyperplasia
alternative dictionary used: MedDRA 21.0
subjects affected / exposed ^[56]	135 / 2667 (5.06%)	140 / 2640 (5.30%)
occurrences all number	137	144
Gastrointestinal disorders
constipation
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	208 / 4949 (4.20%)	361 / 4943 (7.30%)
occurrences all number	223	409
diarrhoea
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	436 / 4949 (8.81%)	665 / 4943 (13.45%)
occurrences all number	546	843
dyspepsia
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	147 / 4949 (2.97%)	291 / 4943 (5.89%)
occurrences all number	150	331
nausea
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	269 / 4949 (5.44%)	735 / 4943 (14.87%)
occurrences all number	310	968
vomiting
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	154 / 4949 (3.11%)	325 / 4943 (6.57%)
occurrences all number	165	498
Respiratory, thoracic and mediastinal disorders
cough
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	256 / 4949 (5.17%)	239 / 4943 (4.84%)
occurrences all number	292	265
Renal and urinary disorders
microalbuminuria
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	259 / 4949 (5.23%)	232 / 4943 (4.69%)
occurrences all number	263	241
Musculoskeletal and connective tissue disorders
arthralgia
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	389 / 4949 (7.86%)	371 / 4943 (7.51%)
occurrences all number	469	446
back pain
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	416 / 4949 (8.41%)	447 / 4943 (9.04%)
occurrences all number	484	494
osteoarthritis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	318 / 4949 (6.43%)	329 / 4943 (6.66%)
occurrences all number	373	372
pain in extremity
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	245 / 4949 (4.95%)	260 / 4943 (5.26%)
occurrences all number	280	296
Infections and infestations
bronchitis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	421 / 4949 (8.51%)	408 / 4943 (8.25%)
occurrences all number	554	528
influenza
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	404 / 4949 (8.16%)	369 / 4943 (7.47%)
occurrences all number	488	435
nasopharyngitis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	535 / 4949 (10.81%)	564 / 4943 (11.41%)
occurrences all number	771	800
upper respiratory tract infection
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	407 / 4949 (8.22%)	368 / 4943 (7.44%)
occurrences all number	589	533
urinary tract infection
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	517 / 4949 (10.45%)	545 / 4943 (11.03%)
occurrences all number	749	795
Metabolism and nutrition disorders
decreased appetite
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	104 / 4949 (2.10%)	325 / 4943 (6.57%)
occurrences all number	109	379
hyperglycaemia
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	315 / 4949 (6.36%)	158 / 4943 (3.20%)
occurrences all number	445	190
hypoglycaemia
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	354 / 4949 (7.15%)	413 / 4943 (8.36%)
occurrences all number	1160	1477

Notes
[56] - 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 subject. 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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