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Clinical Trial Results:
A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Effect of Efpeglenatide on Cardiovascular Outcomes in Type 2 Diabetes Patients at High Cardiovascular Risk

Summary
EudraCT number	2017-002954-35
Trial protocol	SK HU LV SE NO LT EE DK ES FI BG IT RO
Global end of trial date	10 Dec 2020

Results information
Results version number	v1(current)
This version publication date	06 Nov 2021
First version publication date	06 Nov 2021
Other versions

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

Collapse all Expand all

Trial information

Top of page

Sponsor protocol code

EFC14828

ISRCTN number

-

US NCT number

NCT03496298

WHO universal trial number (UTN)

U1111-1186-2533

Sponsor organisation name

Sanofi-aventis Recherche & Développement

Sponsor organisation address

1 avenue Pierre Brossolette, Chilly Mazarin Cedex, France, 91380

Public contact

Sanofi aventis recherche & développement, Trial Transparency Team, Contact-US@sanofi.com

Scientific contact

Sanofi aventis recherche & développement, Trial Transparency Team, Contact-US@sanofi.com

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

No

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

No

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

No

Analysis stage

Final

Date of interim/final analysis

15 Apr 2021

Is this the analysis of the primary completion data?

No

Global end of trial reached?

Yes

Global end of trial date

10 Dec 2020

Was the trial ended prematurely?

Yes

Main objective of the trial

To demonstrate that, efpeglenatide 4 and 6 miligrams (mg) was noninferior to placebo on 3-point major adverse cardiac event (MACE) in Type 2 diabetes mellitus (T2DM) subjects at high cardiovascular (CV) risk.

Protection of trial subjects

Subjects were fully informed of all pertinent aspects of the clinical trial as well as the possibility to discontinue at any time in language and terms appropriate for the subject and considering the local culture. During the course of the trial, subjects were provided with individual subject cards indicating the nature of the trial the subject is participating, contact details and any information needed in the event of a medical emergency. Collected personal data and human biological samples were processed in compliance with the Sanofi-Aventis Group Personal Data Protection Charter ensuring that the Group abides by the laws governing personal data protection in force in all countries in which it operates.

Background therapy

Any antihyperglycemic treatment was allowed as background therapy with the exception of glucagon-like peptide-1 receptor agonists and dipeptidyl peptidase-4 inhibitors.

Evidence for comparator

-

Actual start date of recruitment

27 Apr 2018

Long term follow-up planned

No

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

Norway: 25

Country: Number of subjects enrolled

Poland: 164

Country: Number of subjects enrolled

Slovakia: 132

Country: Number of subjects enrolled

Spain: 56

Country: Number of subjects enrolled

Sweden: 41

Country: Number of subjects enrolled

Bulgaria: 184

Country: Number of subjects enrolled

Denmark: 20

Country: Number of subjects enrolled

Estonia: 30

Country: Number of subjects enrolled

Finland: 34

Country: Number of subjects enrolled

Germany: 107

Country: Number of subjects enrolled

Hungary: 181

Country: Number of subjects enrolled

Italy: 60

Country: Number of subjects enrolled

Latvia: 35

Country: Number of subjects enrolled

Lithuania: 44

Country: Number of subjects enrolled

Argentina: 380

Country: Number of subjects enrolled

Canada: 325

Country: Number of subjects enrolled

Chile: 212

Country: Number of subjects enrolled

India: 98

Country: Number of subjects enrolled

Mexico: 251

Country: Number of subjects enrolled

Peru: 81

Country: Number of subjects enrolled

Romania: 96

Country: Number of subjects enrolled

Russian Federation: 224

Country: Number of subjects enrolled

Serbia: 76

Country: Number of subjects enrolled

South Africa: 90

Country: Number of subjects enrolled

Turkey: 118

Country: Number of subjects enrolled

United States: 754

Country: Number of subjects enrolled

Ukraine: 194

Country: Number of subjects enrolled

Korea, Republic of: 64

Worldwide total number of subjects

4076

EEA total number of subjects

1209

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)

1954

From 65 to 84 years

2108

85 years and over

14

Subject disposition

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Recruitment details

Study was conducted at 344 active sites in 28 countries. 5732 subjects were screened between 27 April 2018 and 25 April 2019; of whom 4076 subjects were randomised by interactive response technology (1:1:1 ratio) to receive placebo, efpeglenatide 4 mg or efpeglenatide 6 mg. Screen failures were mainly due to inclusion criteria not met.

Screening details

Randomisation was stratified by the current or potential future use of a sodium-glucose co-transporter-2 (SGLT2) inhibitor: current use; potential future use; neither current nor potential future use.

Period 1 title

Overall study (overall period)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator, Carer, Assessor

Are arms mutually exclusive

Yes

Placebo

Arm description

Subjects received placebo (matched to Efpeglenatide) as subcutaneous (SC) injection once weekly up to end of treatment (median duration: 19.8 months).

Arm type

Placebo

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection in pre-filled syringe

Routes of administration

Subcutaneous use

Dosage and administration details

Placebo (matched to Efpeglenatide) as SC injection once weekly up to end of treatment.

Efpeglenatide 4mg

Arm description

Subjects received Efpeglenatide as SC injection 2 milligrams (mg) per week for 4 weeks then 4 mg per week up to end of treatment (median duration: 19.9 months).

Arm type

Experimental

Investigational medicinal product name

Efpeglenatide 4mg

Investigational medicinal product code

SAR439977

Other name

Pharmaceutical forms

Solution for injection in pre-filled syringe

Routes of administration

Subcutaneous use

Dosage and administration details

Efpeglenatide as SC injection 2 mg per week for 4 weeks then 4 mg per week up to end of treatment.

Efpeglenatide 6 mg

Arm description

Subjects received Efpeglenatide as SC injection 2 mg per week for 4 weeks, then 4 mg per week for 4 weeks and then 6 mg per week up to end of treatment (median duration: 20 months).

Arm type

Experimental

Investigational medicinal product name

Efpeglenatide 6 mg

Investigational medicinal product code

SAR439977

Other name

Pharmaceutical forms

Solution for injection in pre-filled syringe

Routes of administration

Subcutaneous use

Dosage and administration details

Efpeglenatide as SC injection 2 mg per week for 4 weeks, then 4 mg per week for 4 weeks and then 6 mg per week up to end of treatment.

Number of subjects in period 1	Placebo	Efpeglenatide 4mg	Efpeglenatide 6 mg
Started	1359	1359	1358
Randomised and treated	1358	1358	1357
Completed	42	36	23
Not completed	1317	1323	1335
Randomised and not treated	1	1	1
Study terminated by Sponsor	1050	1063	1071
Adverse event	49	68	79
Unspecified	29	20	23
Physician decision (other than adverse event)	12	17	10
Withdrawal by subject	176	154	151

Baseline characteristics

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Reporting group title

Placebo

Reporting group description

Subjects received placebo (matched to Efpeglenatide) as subcutaneous (SC) injection once weekly up to end of treatment (median duration: 19.8 months).

Reporting group title

Efpeglenatide 4mg

Reporting group description

Subjects received Efpeglenatide as SC injection 2 milligrams (mg) per week for 4 weeks then 4 mg per week up to end of treatment (median duration: 19.9 months).

Reporting group title

Efpeglenatide 6 mg

Reporting group description

Subjects received Efpeglenatide as SC injection 2 mg per week for 4 weeks, then 4 mg per week for 4 weeks and then 6 mg per week up to end of treatment (median duration: 20 months).

Reporting group values	Placebo	Efpeglenatide 4mg	Efpeglenatide 6 mg	Total
Number of subjects	1359	1359	1358	4076
Age categorical
Units: Subjects
Age continuous
Units: years
arithmetic mean (standard deviation)	64.4 ( 8.3 )	64.6 ( 8.2 )	64.7 ( 8.2 )	-
Gender categorical
Units: Subjects
Female	419	442	483	1344
Male	940	917	875	2732
Race (NIH/OMB)
Units: Subjects
American Indian or Alaska Native	11	8	8	27
Asian	98	87	82	267
Native Hawaiian or Other Pacific Islander	0	1	2	3
Black or African American	50	38	55	143
White	1162	1192	1180	3534
More than one race	4	9	5	18
Unknown or Not Reported	34	24	26	84
Body Mass Index (BMI)
In both Efpeglenatide 4 mg and Efpeglenatide 6 mg arm, only 1357 subjects were involved in the evaluation of the specified baseline measure.
Units: kilogram metre per square (kg/m^2)
arithmetic mean (standard deviation)	32.40 ( 6.01 )	32.81 ( 6.22 )	32.90 ( 6.21 )	-

End points

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Reporting group title

Placebo

Reporting group description

Subjects received placebo (matched to Efpeglenatide) as subcutaneous (SC) injection once weekly up to end of treatment (median duration: 19.8 months).

Reporting group title

Efpeglenatide 4mg

Reporting group description

Subjects received Efpeglenatide as SC injection 2 milligrams (mg) per week for 4 weeks then 4 mg per week up to end of treatment (median duration: 19.9 months).

Reporting group title

Efpeglenatide 6 mg

Reporting group description

Subjects received Efpeglenatide as SC injection 2 mg per week for 4 weeks, then 4 mg per week for 4 weeks and then 6 mg per week up to end of treatment (median duration: 20 months).

Subject analysis set title

Efpeglenatide 4 mg+6 mg

Subject analysis set type

Intention-to-treat

Subject analysis set description

Included all subjects who received either Efpeglenatide 4 mg or 6 mg as SC injection once weekly up to end of treatment (median duration: 19.9 months).

Primary: Time to First Occurrence of Major Adverse Cardiovascular Events (MACE): Event Rate Per 100 Subject-years for First Occurrence of Major Cardiovascular (CV) Event - Non-Inferiority Analysis

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End point title

Time to First Occurrence of Major Adverse Cardiovascular Events (MACE): Event Rate Per 100 Subject-years for First Occurrence of Major Cardiovascular (CV) Event - Non-Inferiority Analysis ^[1]

End point description

All MACE positively adjudicated by the clinical endpoint committee (CEC) were used in the analysis of the composite outcome of first occurrence to CV death, non-fatal myocardial infarction (MI), and non-fatal stroke. Kaplan-Meier curves of the cumulative event rate by treatment groups were used to depict the first occurrence of MACE over time. The event rate per 100 subject-years (calculated by 100*number of subjects with events/sum of time at risk (days) over all subjects/365.25) measured in terms of number of events per 100 subject-years was reported. Analysis was performed on intent-to-treat (ITT) population that included all randomised subjects irrespective of compliance with the study protocol and procedures and were analysed in the treatment group to which they were randomised. Data for this endpoint was planned to be collected and analysed for pooled population of subjects who received Efpeglenatide (at any dose: 4 mg and 6 mg) as pre-specified in the protocol.

End point type

Primary

End point timeframe

From Day 1 until the date of first adjudicated and confirmed occurrence of major CV event (maximum duration: up to 31.5 months)

Notes
[1] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Data was reported for applicable arms in the endpoint.

End point values	Placebo	Efpeglenatide 4 mg+6 mg
Number of subjects analysed	1359	2717
Units: events per 100 subject-years
number (confidence interval 95%)	5.3 (4.4 to 6.3)	3.9 (3.4 to 4.5)

Efpeglenatide 4 mg+6 mg versus Placebo

Statistical analysis description

Hazard ratio and 95% Confidence Interval (CI) were obtained from a Cox proportional hazards model with region (North America, Latin America, Europe, other), randomisation stratum of SGLT2 inhibitor use (current use, potential future use, neither current nor potential future use) and treatment (efpeglenatide 4 mg, efpeglenatide 6 mg, placebo) as fixed effect factor.

Comparison groups

Placebo v Efpeglenatide 4 mg+6 mg

Number of subjects included in analysis

4076

Analysis specification

Pre-specified

Analysis type

non-inferiority ^[2]

P-value

< 0.0001 ^[3]

Method

Logrank

Parameter type

Hazard ratio (HR)

Point estimate

0.732

Confidence interval

level

95%

sides

2-sided

lower limit

0.583

upper limit

0.918

Notes
[2] - Non-inferiority of efpeglenatide 4 mg+6 mg versus placebo was to be claimed if the upper bound of the 2-sided 95% CI of the hazard ratio for the incidence was <=1.8 and <=1.3.
[3] - One-sided p-value based on log rank test of hazard ratio for the incidence <=1.8 and <=1.3.

Secondary: Time to First Occurrence of Major Adverse Cardiovascular Events: Event Rate Per 100 Subject-years for First Occurrence of Major Cardiovascular Event - Superiority Analysis

Top of page

End point title

Time to First Occurrence of Major Adverse Cardiovascular Events: Event Rate Per 100 Subject-years for First Occurrence of Major Cardiovascular Event - Superiority Analysis ^[4]

End point description

All MACE positively adjudicated by the CEC were used in the analysis of the composite outcome of first occurrence to CV death, non-fatal MI, and non-fatal stroke. Kaplan-Meier curves of the cumulative event rate by treatment groups were used to depict the first occurrence of MACE over time. The event rate per 100 subject-years (calculated by 100*number of subjects with events/sum of time at risk (days) over all subjects/365.25) measured in terms of number of events per 100 subject-years was reported. Analysis was performed on ITT population. Data for this endpoint was planned to be collected and analysed for pooled population of subjects who received Efpeglenatide (at any dose: 4 mg and 6 mg) as pre-specified in the protocol.

End point type

Secondary

End point timeframe

From Day 1 until the date of first adjudicated and confirmed occurrence of major CV event (maximum duration: up to 31.5 months)

Notes
[4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Data was reported for applicable arms in the endpoint.

End point values	Placebo	Efpeglenatide 4 mg+6 mg
Number of subjects analysed	1359	2717
Units: events per 100 subject-years
number (confidence interval 95%)	5.3 (4.4 to 6.3)	3.9 (3.4 to 4.5)

Efpeglenatide 4 mg+6 mg versus Placebo

Statistical analysis description

Hazard ratio and 95% CI were obtained from a Cox proportional hazards model with region (North America, Latin America, Europe, other), randomisation stratum of SGLT2 inhibitor use (current use, potential future use, neither current nor potential future use) and treatment (efpeglenatide 4 mg, efpeglenatide 6 mg, placebo) as fixed effect factor.

Comparison groups

Placebo v Efpeglenatide 4 mg+6 mg

Number of subjects included in analysis

4076

Analysis specification

Pre-specified

Analysis type

superiority ^[5]

P-value

= 0.0069 ^[6]

Method

Logrank

Parameter type

Hazard ratio (HR)

Point estimate

0.732

Confidence interval

level

95%

sides

2-sided

lower limit

0.583

upper limit

0.918

Notes
[5] - Superiority was claimed when the upper bound of the 2-sided 95% CI of hazard ratio was less than 1.
[6] - Two-sided p-values based on log rank test of hazard ratio.

Secondary: Time to First Occurrence of the Expanded Major Adverse Cardiovascular Events Composite Events: Event Rate Per 100 Subject-years for First Occurrence of Expanded Major Cardiovascular Event

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End point title

Time to First Occurrence of the Expanded Major Adverse Cardiovascular Events Composite Events: Event Rate Per 100 Subject-years for First Occurrence of Expanded Major Cardiovascular Event ^[7]

End point description

All MACE positively adjudicated by the CEC were used in the analysis of the expanded outcome of first occurrence to CV death (including fatal MI and fatal stroke), non-fatal MI, non-fatal stroke, coronary revascularisation or hospitalisation for unstable angina. Kaplan-Meier curves of the cumulative event rate by treatment groups were used to depict the first occurrence of MACE over time. The event rate per 100 subject-years (calculated by 100*number of subjects with events/sum of time at risk (days) over all subjects/365.25) measured in terms of number of events per 100 subject-years was reported. Data analysis was also performed independently by external steering committee for the publication. Analysis was performed on ITT population. Data for this endpoint was planned to be collected and analysed for pooled population of subjects who received Efpeglenatide (at any dose: 4 mg and 6 mg) as pre-specified in the protocol.

End point type

Secondary

End point timeframe

From Day 1 until the date of first adjudicated and confirmed occurrence of major CV event (maximum duration: up to 31.5 months)

Notes
[7] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Data was reported for applicable arms in the endpoint.

End point values	Placebo	Efpeglenatide 4 mg+6 mg
Number of subjects analysed	1359	2717
Units: events per 100 subject-years
number (not applicable)	6.8	5.4

Efpeglenatide 4 mg+6 mg versus Placebo

Statistical analysis description

Hazard ratio and 95% CI were obtained from a Cox proportional hazards model with region (North America, Latin America, Europe, other), randomisation stratum of SGLT2 inhibitor use (current use, potential future use, neither current nor potential future use) and treatment (efpeglenatide 4 mg, efpeglenatide 6 mg, placebo) as fixed effect factor.

Comparison groups

Placebo v Efpeglenatide 4 mg+6 mg

Number of subjects included in analysis

4076

Analysis specification

Pre-specified

Analysis type

superiority ^[8]

P-value

= 0.02 ^[9]

Method

Logrank

Parameter type

Hazard ratio (HR)

Point estimate

0.79

Confidence interval

level

95%

sides

2-sided

lower limit

0.65

upper limit

0.96

Notes
[8] - Superiority was claimed when the upper bound of the 2-sided 95% CI of hazard ratio was less than 1.
[9] - Two-sided p-values based on log rank test of hazard ratio.

Secondary: Time to First Occurrence of Composite Renal Endpoint: Event Rate Per 100 Subject-years for First Occurrence of Composite Renal Endpoint

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End point title

Time to First Occurrence of Composite Renal Endpoint: Event Rate Per 100 Subject-years for First Occurrence of Composite Renal Endpoint ^[10]

End point description

Composite renal endpoint: incident macroalbuminuria (defined as urinary albumin-to-creatinine ratio of greater than (>) 300, measured in mg of albumin to grams of creatinine or >33.9, measured in mg of albumin to millimoles of creatinine), plus increase in urinary albumin-to-creatinine ratio of at least 30% from Baseline, sustained decrease in eGFR of at least 40% for 30 days or more, renal-replacement therapy for 90 days or more and sustained eGFR of less than 15 ml per minute per 1.73 m^2 for 30 days or more. Kaplan-Meier curves of cumulative event rate depicted 1st occurrence of renal endpoint over time. Event rate per 100 subject-years (calculated by 100*number of subjects with events/sum of time at risk (days) over all subjects/365.25) measured in terms of number of events per 100 subject-years was reported. ITT population. Data was planned to be collected and analysed for pooled population of subjects who received Efpeglenatide (at any dose:4mg/6mg) as pre-specified in protocol.

End point type

Secondary

End point timeframe

From Day 1 until the confirmed occurrence of composite renal endpoint (maximum duration: up to 31.5 months)

Notes
[10] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Data was reported for applicable arms in the endpoint.

End point values	Placebo	Efpeglenatide 4 mg+6 mg
Number of subjects analysed	1359	2717
Units: events per 100 subject-years
number (confidence interval 95%)	11.6 (10.2 to 13.1)	7.7 (6.9 to 8.6)

Efpeglenatide 4 mg+6 mg versus Placebo

Statistical analysis description

Hazard ratio and 95% CI were obtained from a Cox proportional hazards model with region (North America, Latin America, Europe, other), randomisation stratum of SGLT2 inhibitor use (current use, potential future use, neither current nor potential future use) and treatment (efpeglenatide 4 mg, efpeglenatide 6 mg, placebo) as fixed effect factor.

Comparison groups

Placebo v Efpeglenatide 4 mg+6 mg

Number of subjects included in analysis

4076

Analysis specification

Pre-specified

Analysis type

superiority ^[11]

P-value

< 0.0001 ^[12]

Method

Logrank

Parameter type

Hazard ratio (HR)

Point estimate

0.675

Confidence interval

level

95%

sides

2-sided

lower limit

0.574

upper limit

0.794

Notes
[11] - Superiority was claimed when the upper bound of the 2-sided 95% CI of hazard ratio was less than 1.
[12] - Two-sided p-values based on log rank test of hazard ratio.

Adverse events

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Timeframe for reporting adverse events

Adverse events (AEs) data were collected from time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months).

Adverse event reporting additional description

AEs and deaths were treatment-emergent AEs (TEAEs): AEs that developed/worsened/became serious during the TEAE period (time from 1st to last injection of IMP + 30 days). Safety population: all randomised subjects who received at least 1 dose of double-blind treatment, regardless of amount of treatment administered, analysed according to treatment.

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

23.1

Reporting group title

Placebo

Reporting group description

Subjects received placebo (matched to Efpeglenatide) as SC injection once weekly up to end of treatment (median duration: 19.8 months).

Reporting group title

Efpeglenatide 4 mg

Reporting group description

Subjects received Efpeglenatide as SC injection 2 mg per week for 4 weeks then 4 mg per week up to end of treatment (median duration: 19.9 months).

Reporting group title

Efpeglenatide 6 mg

Reporting group description

Subjects received Efpeglenatide as SC injection 2 mg per week for 4 weeks, then 4 mg per week for 4 weeks and then 6 mg per week up to end of treatment (median duration: 20 months).

Serious adverse events	Placebo	Efpeglenatide 4 mg	Efpeglenatide 6 mg
Total subjects affected by serious adverse events
subjects affected / exposed	298 / 1355 (21.99%)	312 / 1360 (22.94%)	275 / 1358 (20.25%)
number of deaths (all causes)	49	40	25
number of deaths resulting from adverse events
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma Metastatic
subjects affected / exposed	1 / 1355 (0.07%)	0 / 1360 (0.00%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0	0 / 0
Adenocarcinoma Of Colon
subjects affected / exposed	1 / 1355 (0.07%)	1 / 1360 (0.07%)	3 / 1358 (0.22%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Adenocarcinoma Pancreas
subjects affected / exposed	1 / 1355 (0.07%)	0 / 1360 (0.00%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Basal Cell Carcinoma
subjects affected / exposed	0 / 1355 (0.00%)	1 / 1360 (0.07%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Benign Neoplasm Of Scrotum
subjects affected / exposed	1 / 1355 (0.07%)	0 / 1360 (0.00%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Benign Neoplasm Of Skin
subjects affected / exposed	0 / 1355 (0.00%)	1 / 1360 (0.07%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Bladder Cancer
subjects affected / exposed	2 / 1355 (0.15%)	1 / 1360 (0.07%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Bladder Cancer Recurrent
subjects affected / exposed	2 / 1355 (0.15%)	0 / 1360 (0.00%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Bladder Neoplasm
subjects affected / exposed	0 / 1355 (0.00%)	0 / 1360 (0.00%)	1 / 1358 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Bladder Transitional Cell Carcinoma
subjects affected / exposed	0 / 1355 (0.00%)	3 / 1360 (0.22%)	1 / 1358 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Breast Cancer
subjects affected / exposed	1 / 1355 (0.07%)	1 / 1360 (0.07%)	2 / 1358 (0.15%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Breast Cancer Metastatic
subjects affected / exposed	0 / 1355 (0.00%)	0 / 1360 (0.00%)	1 / 1358 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 1
Cholangiocarcinoma
subjects affected / exposed	1 / 1355 (0.07%)	1 / 1360 (0.07%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 1	0 / 0
Chronic Lymphocytic Leukaemia
subjects affected / exposed	0 / 1355 (0.00%)	1 / 1360 (0.07%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Colon Cancer
subjects affected / exposed	1 / 1355 (0.07%)	0 / 1360 (0.00%)	1 / 1358 (0.07%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Colorectal Cancer Metastatic
subjects affected / exposed	1 / 1355 (0.07%)	0 / 1360 (0.00%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0	0 / 0
Cutaneous T-Cell Lymphoma
subjects affected / exposed	0 / 1355 (0.00%)	1 / 1360 (0.07%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Diffuse Large B-Cell Lymphoma Stage Iv
subjects affected / exposed	0 / 1355 (0.00%)	0 / 1360 (0.00%)	1 / 1358 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Endometrial Cancer
subjects affected / exposed	1 / 1355 (0.07%)	0 / 1360 (0.00%)	1 / 1358 (0.07%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hepatocellular Carcinoma
subjects affected / exposed	1 / 1355 (0.07%)	0 / 1360 (0.00%)	1 / 1358 (0.07%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Leiomyosarcoma
subjects affected / exposed	1 / 1355 (0.07%)	0 / 1360 (0.00%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Lung Adenocarcinoma
subjects affected / exposed	1 / 1355 (0.07%)	0 / 1360 (0.00%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Lung Neoplasm Malignant
subjects affected / exposed	4 / 1355 (0.30%)	0 / 1360 (0.00%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 4	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 2	0 / 0	0 / 0
Lung Cancer Metastatic
subjects affected / exposed	1 / 1355 (0.07%)	0 / 1360 (0.00%)	1 / 1358 (0.07%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 1
Metastases To Liver
subjects affected / exposed	2 / 1355 (0.15%)	0 / 1360 (0.00%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0	0 / 0
Metastases To Lung
subjects affected / exposed	1 / 1355 (0.07%)	0 / 1360 (0.00%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0	0 / 0
Neuroendocrine Tumour Of The Lung Metastatic
subjects affected / exposed	1 / 1355 (0.07%)	0 / 1360 (0.00%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Non-Small Cell Lung Cancer Stage Iv
subjects affected / exposed	1 / 1355 (0.07%)	0 / 1360 (0.00%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Oesophageal Adenocarcinoma Stage Iv
subjects affected / exposed	0 / 1355 (0.00%)	1 / 1360 (0.07%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 1	0 / 0
Oesophageal Carcinoma
subjects affected / exposed	1 / 1355 (0.07%)	0 / 1360 (0.00%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pancreatic Carcinoma
subjects affected / exposed	1 / 1355 (0.07%)	0 / 1360 (0.00%)	1 / 1358 (0.07%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 0	0 / 0
Pancreatic Carcinoma Metastatic
subjects affected / exposed	1 / 1355 (0.07%)	0 / 1360 (0.00%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Papillary Thyroid Cancer
subjects affected / exposed	0 / 1355 (0.00%)	1 / 1360 (0.07%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Prostate Cancer
subjects affected / exposed	1 / 1355 (0.07%)	2 / 1360 (0.15%)	3 / 1358 (0.22%)
occurrences causally related to treatment / all	0 / 1	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Prostate Cancer Metastatic
subjects affected / exposed	1 / 1355 (0.07%)	0 / 1360 (0.00%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Prostate Cancer Recurrent
subjects affected / exposed	0 / 1355 (0.00%)	1 / 1360 (0.07%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Prostatic Adenoma
subjects affected / exposed	0 / 1355 (0.00%)	0 / 1360 (0.00%)	1 / 1358 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Rectal Adenocarcinoma
subjects affected / exposed	0 / 1355 (0.00%)	1 / 1360 (0.07%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Rectal Cancer
subjects affected / exposed	0 / 1355 (0.00%)	1 / 1360 (0.07%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Rectosigmoid Cancer Metastatic
subjects affected / exposed	1 / 1355 (0.07%)	0 / 1360 (0.00%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Renal Cancer
subjects affected / exposed	0 / 1355 (0.00%)	1 / 1360 (0.07%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Renal Cell Carcinoma
subjects affected / exposed	1 / 1355 (0.07%)	1 / 1360 (0.07%)	1 / 1358 (0.07%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Renal Cell Carcinoma Stage Iv
subjects affected / exposed	0 / 1355 (0.00%)	0 / 1360 (0.00%)	1 / 1358 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Renal Neoplasm
subjects affected / exposed	1 / 1355 (0.07%)	1 / 1360 (0.07%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Renal Oncocytoma
subjects affected / exposed	0 / 1355 (0.00%)	1 / 1360 (0.07%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Small Cell Lung Cancer Metastatic
subjects affected / exposed	0 / 1355 (0.00%)	0 / 1360 (0.00%)	1 / 1358 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 1
Spinal Cord Neoplasm
subjects affected / exposed	0 / 1355 (0.00%)	0 / 1360 (0.00%)	1 / 1358 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Squamous Cell Carcinoma
subjects affected / exposed	0 / 1355 (0.00%)	1 / 1360 (0.07%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Squamous Cell Carcinoma Of The Oral Cavity
subjects affected / exposed	0 / 1355 (0.00%)	0 / 1360 (0.00%)	1 / 1358 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Thyroid Cancer
subjects affected / exposed	0 / 1355 (0.00%)	0 / 1360 (0.00%)	1 / 1358 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Transitional Cell Carcinoma
subjects affected / exposed	0 / 1355 (0.00%)	0 / 1360 (0.00%)	1 / 1358 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Vascular disorders
Arterial Haemorrhage
subjects affected / exposed	0 / 1355 (0.00%)	1 / 1360 (0.07%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Aortic Stenosis
subjects affected / exposed	1 / 1355 (0.07%)	1 / 1360 (0.07%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Arterial Occlusive Disease
subjects affected / exposed	0 / 1355 (0.00%)	0 / 1360 (0.00%)	1 / 1358 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Deep Vein Thrombosis
subjects affected / exposed	0 / 1355 (0.00%)	1 / 1360 (0.07%)	2 / 1358 (0.15%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Arteriosclerosis
subjects affected / exposed	0 / 1355 (0.00%)	0 / 1360 (0.00%)	1 / 1358 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Dry Gangrene
subjects affected / exposed	2 / 1355 (0.15%)	0 / 1360 (0.00%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Diabetic Vascular Disorder
subjects affected / exposed	1 / 1355 (0.07%)	0 / 1360 (0.00%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Essential Hypertension
subjects affected / exposed	0 / 1355 (0.00%)	0 / 1360 (0.00%)	1 / 1358 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Extremity Necrosis
subjects affected / exposed	2 / 1355 (0.15%)	2 / 1360 (0.15%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hypertension
subjects affected / exposed	3 / 1355 (0.22%)	1 / 1360 (0.07%)	2 / 1358 (0.15%)
occurrences causally related to treatment / all	0 / 3	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hypertensive Emergency
subjects affected / exposed	2 / 1355 (0.15%)	0 / 1360 (0.00%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hypertensive Crisis
subjects affected / exposed	4 / 1355 (0.30%)	4 / 1360 (0.29%)	3 / 1358 (0.22%)
occurrences causally related to treatment / all	0 / 4	0 / 4	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 1	0 / 0
Hypotension
subjects affected / exposed	2 / 1355 (0.15%)	4 / 1360 (0.29%)	2 / 1358 (0.15%)
occurrences causally related to treatment / all	0 / 2	0 / 4	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Intermittent Claudication
subjects affected / exposed	1 / 1355 (0.07%)	1 / 1360 (0.07%)	1 / 1358 (0.07%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Orthostatic Hypotension
subjects affected / exposed	0 / 1355 (0.00%)	1 / 1360 (0.07%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Lymphoedema
subjects affected / exposed	1 / 1355 (0.07%)	0 / 1360 (0.00%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Peripheral Arterial Occlusive Disease
subjects affected / exposed	8 / 1355 (0.59%)	7 / 1360 (0.51%)	10 / 1358 (0.74%)
occurrences causally related to treatment / all	0 / 8	0 / 8	0 / 10
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Peripheral Artery Stenosis
subjects affected / exposed	1 / 1355 (0.07%)	1 / 1360 (0.07%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Peripheral Artery Occlusion
subjects affected / exposed	0 / 1355 (0.00%)	1 / 1360 (0.07%)	1 / 1358 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Peripheral Circulatory Failure
subjects affected / exposed	0 / 1355 (0.00%)	1 / 1360 (0.07%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Peripheral Artery Thrombosis
subjects affected / exposed	0 / 1355 (0.00%)	2 / 1360 (0.15%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 1	0 / 0
Peripheral Embolism
subjects affected / exposed	0 / 1355 (0.00%)	0 / 1360 (0.00%)	1 / 1358 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Peripheral Ischaemia
subjects affected / exposed	3 / 1355 (0.22%)	1 / 1360 (0.07%)	2 / 1358 (0.15%)
occurrences causally related to treatment / all	0 / 3	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Peripheral Vascular Disorder
subjects affected / exposed	5 / 1355 (0.37%)	2 / 1360 (0.15%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 5	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Thrombosis
subjects affected / exposed	1 / 1355 (0.07%)	0 / 1360 (0.00%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Venous Thrombosis Limb
subjects affected / exposed	0 / 1355 (0.00%)	1 / 1360 (0.07%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
General disorders and administration site conditions
Accidental Death
subjects affected / exposed	0 / 1355 (0.00%)	0 / 1360 (0.00%)	1 / 1358 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 1
Asthenia
subjects affected / exposed	1 / 1355 (0.07%)	1 / 1360 (0.07%)	3 / 1358 (0.22%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cardiac Death
subjects affected / exposed	1 / 1355 (0.07%)	1 / 1360 (0.07%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 1	0 / 0
Chest Pain
subjects affected / exposed	1 / 1355 (0.07%)	2 / 1360 (0.15%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Death
subjects affected / exposed	4 / 1355 (0.30%)	5 / 1360 (0.37%)	4 / 1358 (0.29%)
occurrences causally related to treatment / all	0 / 4	1 / 5	0 / 4
deaths causally related to treatment / all	0 / 4	1 / 5	0 / 4
Fatigue
subjects affected / exposed	0 / 1355 (0.00%)	1 / 1360 (0.07%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Impaired Healing
subjects affected / exposed	0 / 1355 (0.00%)	1 / 1360 (0.07%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Non-Cardiac Chest Pain
subjects affected / exposed	2 / 1355 (0.15%)	6 / 1360 (0.44%)	5 / 1358 (0.37%)
occurrences causally related to treatment / all	0 / 2	0 / 6	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Peripheral Swelling
subjects affected / exposed	0 / 1355 (0.00%)	1 / 1360 (0.07%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pyrexia
subjects affected / exposed	1 / 1355 (0.07%)	0 / 1360 (0.00%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Sudden Cardiac Death
subjects affected / exposed	2 / 1355 (0.15%)	5 / 1360 (0.37%)	2 / 1358 (0.15%)
occurrences causally related to treatment / all	0 / 2	1 / 5	0 / 2
deaths causally related to treatment / all	0 / 2	1 / 5	0 / 2
Vascular Stent Stenosis
subjects affected / exposed	0 / 1355 (0.00%)	0 / 1360 (0.00%)	1 / 1358 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Sudden Death
subjects affected / exposed	1 / 1355 (0.07%)	2 / 1360 (0.15%)	1 / 1358 (0.07%)
occurrences causally related to treatment / all	0 / 1	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 2	0 / 1
Vascular Stent Thrombosis
subjects affected / exposed	1 / 1355 (0.07%)	0 / 1360 (0.00%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Immune system disorders
Drug Hypersensitivity
subjects affected / exposed	0 / 1355 (0.00%)	0 / 1360 (0.00%)	1 / 1358 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hypersensitivity
subjects affected / exposed	0 / 1355 (0.00%)	1 / 1360 (0.07%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Reproductive system and breast disorders
Cervical Polyp
subjects affected / exposed	1 / 1355 (0.07%)	0 / 1360 (0.00%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Benign Prostatic Hyperplasia
subjects affected / exposed	0 / 1355 (0.00%)	2 / 1360 (0.15%)	2 / 1358 (0.15%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Endometriosis
subjects affected / exposed	1 / 1355 (0.07%)	0 / 1360 (0.00%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Postmenopausal Haemorrhage
subjects affected / exposed	0 / 1355 (0.00%)	1 / 1360 (0.07%)	2 / 1358 (0.15%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Prostatic Atrophy
subjects affected / exposed	0 / 1355 (0.00%)	1 / 1360 (0.07%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Prostatitis
subjects affected / exposed	1 / 1355 (0.07%)	0 / 1360 (0.00%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
Acute Pulmonary Oedema
subjects affected / exposed	1 / 1355 (0.07%)	0 / 1360 (0.00%)	1 / 1358 (0.07%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 1
Acute Respiratory Distress Syndrome
subjects affected / exposed	1 / 1355 (0.07%)	0 / 1360 (0.00%)	1 / 1358 (0.07%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 0	0 / 0
Acute Respiratory Failure
subjects affected / exposed	0 / 1355 (0.00%)	2 / 1360 (0.15%)	2 / 1358 (0.15%)
occurrences causally related to treatment / all	0 / 0	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 1	0 / 0
Asthma
subjects affected / exposed	0 / 1355 (0.00%)	0 / 1360 (0.00%)	1 / 1358 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Bronchitis Chronic
subjects affected / exposed	0 / 1355 (0.00%)	0 / 1360 (0.00%)	1 / 1358 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Chronic Obstructive Pulmonary Disease
subjects affected / exposed	2 / 1355 (0.15%)	4 / 1360 (0.29%)	4 / 1358 (0.29%)
occurrences causally related to treatment / all	0 / 2	0 / 4	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Dyspnoea
subjects affected / exposed	0 / 1355 (0.00%)	2 / 1360 (0.15%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Epistaxis
subjects affected / exposed	1 / 1355 (0.07%)	0 / 1360 (0.00%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Lung Disorder
subjects affected / exposed	0 / 1355 (0.00%)	1 / 1360 (0.07%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pleural Effusion
subjects affected / exposed	1 / 1355 (0.07%)	1 / 1360 (0.07%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 1	0 / 0
Pleurocutaneous Fistula
subjects affected / exposed	1 / 1355 (0.07%)	0 / 1360 (0.00%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pneumonia Aspiration
subjects affected / exposed	1 / 1355 (0.07%)	0 / 1360 (0.00%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pneumonitis
subjects affected / exposed	0 / 1355 (0.00%)	1 / 1360 (0.07%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pneumothorax
subjects affected / exposed	1 / 1355 (0.07%)	1 / 1360 (0.07%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pulmonary Embolism
subjects affected / exposed	2 / 1355 (0.15%)	2 / 1360 (0.15%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 1	0 / 0
Pulmonary Oedema
subjects affected / exposed	0 / 1355 (0.00%)	3 / 1360 (0.22%)	1 / 1358 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Respiratory Failure
subjects affected / exposed	3 / 1355 (0.22%)	1 / 1360 (0.07%)	2 / 1358 (0.15%)
occurrences causally related to treatment / all	0 / 3	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 1
Sleep Apnoea Syndrome
subjects affected / exposed	1 / 1355 (0.07%)	0 / 1360 (0.00%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Psychiatric disorders
Delirium
subjects affected / exposed	1 / 1355 (0.07%)	0 / 1360 (0.00%)	1 / 1358 (0.07%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Depression
subjects affected / exposed	2 / 1355 (0.15%)	0 / 1360 (0.00%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Major Depression
subjects affected / exposed	0 / 1355 (0.00%)	1 / 1360 (0.07%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Panic Attack
subjects affected / exposed	0 / 1355 (0.00%)	1 / 1360 (0.07%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Suicidal Ideation
subjects affected / exposed	0 / 1355 (0.00%)	0 / 1360 (0.00%)	1 / 1358 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Product issues
Device Fastener Issue
subjects affected / exposed	0 / 1355 (0.00%)	1 / 1360 (0.07%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Device Lead Issue
subjects affected / exposed	0 / 1355 (0.00%)	0 / 1360 (0.00%)	1 / 1358 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Device Loosening
subjects affected / exposed	1 / 1355 (0.07%)	0 / 1360 (0.00%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Investigations
Alanine Aminotransferase Increased
subjects affected / exposed	0 / 1355 (0.00%)	0 / 1360 (0.00%)	1 / 1358 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Anticoagulation Drug Level Above Therapeutic
subjects affected / exposed	1 / 1355 (0.07%)	0 / 1360 (0.00%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Aspartate Aminotransferase Increased
subjects affected / exposed	0 / 1355 (0.00%)	0 / 1360 (0.00%)	1 / 1358 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Blood Glucose Increased
subjects affected / exposed	1 / 1355 (0.07%)	0 / 1360 (0.00%)	1 / 1358 (0.07%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Blood Pressure Decreased
subjects affected / exposed	0 / 1355 (0.00%)	1 / 1360 (0.07%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Blood Pressure Increased
subjects affected / exposed	0 / 1355 (0.00%)	1 / 1360 (0.07%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Heart Rate Abnormal
subjects affected / exposed	1 / 1355 (0.07%)	0 / 1360 (0.00%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hepatic Enzyme Increased
subjects affected / exposed	0 / 1355 (0.00%)	0 / 1360 (0.00%)	1 / 1358 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Lipase Increased
subjects affected / exposed	0 / 1355 (0.00%)	1 / 1360 (0.07%)	1 / 1358 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Liver Function Test Abnormal
subjects affected / exposed	0 / 1355 (0.00%)	1 / 1360 (0.07%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Plasminogen Activator Inhibitor Increased
subjects affected / exposed	0 / 1355 (0.00%)	1 / 1360 (0.07%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Troponin Increased
subjects affected / exposed	1 / 1355 (0.07%)	0 / 1360 (0.00%)	1 / 1358 (0.07%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Weight Decreased
subjects affected / exposed	1 / 1355 (0.07%)	1 / 1360 (0.07%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0	0 / 0
Injury, poisoning and procedural complications
Accidental Overdose
subjects affected / exposed	2 / 1355 (0.15%)	2 / 1360 (0.15%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Ankle Fracture
subjects affected / exposed	1 / 1355 (0.07%)	1 / 1360 (0.07%)	2 / 1358 (0.15%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Anastomotic Complication
subjects affected / exposed	0 / 1355 (0.00%)	0 / 1360 (0.00%)	1 / 1358 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Arterial Bypass Occlusion
subjects affected / exposed	1 / 1355 (0.07%)	1 / 1360 (0.07%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Arterial Bypass Stenosis
subjects affected / exposed	1 / 1355 (0.07%)	0 / 1360 (0.00%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Brachial Plexus Injury
subjects affected / exposed	0 / 1355 (0.00%)	1 / 1360 (0.07%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Craniocerebral Injury
subjects affected / exposed	0 / 1355 (0.00%)	1 / 1360 (0.07%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Fall
subjects affected / exposed	0 / 1355 (0.00%)	2 / 1360 (0.15%)	4 / 1358 (0.29%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Femoral Neck Fracture
subjects affected / exposed	0 / 1355 (0.00%)	1 / 1360 (0.07%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Femur Fracture
subjects affected / exposed	0 / 1355 (0.00%)	3 / 1360 (0.22%)	3 / 1358 (0.22%)
occurrences causally related to treatment / all	0 / 0	0 / 3	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Fibula Fracture
subjects affected / exposed	1 / 1355 (0.07%)	1 / 1360 (0.07%)	1 / 1358 (0.07%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Foot Fracture
subjects affected / exposed	0 / 1355 (0.00%)	0 / 1360 (0.00%)	2 / 1358 (0.15%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Heat Exhaustion
subjects affected / exposed	0 / 1355 (0.00%)	1 / 1360 (0.07%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hip Fracture
subjects affected / exposed	1 / 1355 (0.07%)	1 / 1360 (0.07%)	1 / 1358 (0.07%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Humerus Fracture
subjects affected / exposed	0 / 1355 (0.00%)	0 / 1360 (0.00%)	1 / 1358 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Joint Dislocation
subjects affected / exposed	0 / 1355 (0.00%)	1 / 1360 (0.07%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Joint Injury
subjects affected / exposed	1 / 1355 (0.07%)	0 / 1360 (0.00%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Limb Injury
subjects affected / exposed	0 / 1355 (0.00%)	1 / 1360 (0.07%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Limb Traumatic Amputation
subjects affected / exposed	0 / 1355 (0.00%)	1 / 1360 (0.07%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Lower Limb Fracture
subjects affected / exposed	1 / 1355 (0.07%)	1 / 1360 (0.07%)	1 / 1358 (0.07%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Lumbar Vertebral Fracture
subjects affected / exposed	0 / 1355 (0.00%)	0 / 1360 (0.00%)	1 / 1358 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Meniscus Injury
subjects affected / exposed	1 / 1355 (0.07%)	2 / 1360 (0.15%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Neck Injury
subjects affected / exposed	0 / 1355 (0.00%)	1 / 1360 (0.07%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 1	0 / 0
Patella Fracture
subjects affected / exposed	0 / 1355 (0.00%)	0 / 1360 (0.00%)	1 / 1358 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Peripheral Artery Restenosis
subjects affected / exposed	1 / 1355 (0.07%)	0 / 1360 (0.00%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Periprosthetic Fracture
subjects affected / exposed	0 / 1355 (0.00%)	0 / 1360 (0.00%)	1 / 1358 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Postoperative Respiratory Failure
subjects affected / exposed	0 / 1355 (0.00%)	1 / 1360 (0.07%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Procedural Site Reaction
subjects affected / exposed	1 / 1355 (0.07%)	0 / 1360 (0.00%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Radius Fracture
subjects affected / exposed	0 / 1355 (0.00%)	0 / 1360 (0.00%)	1 / 1358 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Rib Fracture
subjects affected / exposed	0 / 1355 (0.00%)	0 / 1360 (0.00%)	2 / 1358 (0.15%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Road Traffic Accident
subjects affected / exposed	2 / 1355 (0.15%)	2 / 1360 (0.15%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0	0 / 0
Scapula Fracture
subjects affected / exposed	0 / 1355 (0.00%)	1 / 1360 (0.07%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Skin Laceration
subjects affected / exposed	1 / 1355 (0.07%)	0 / 1360 (0.00%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Spinal Compression Fracture
subjects affected / exposed	0 / 1355 (0.00%)	0 / 1360 (0.00%)	1 / 1358 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Spinal Fracture
subjects affected / exposed	1 / 1355 (0.07%)	1 / 1360 (0.07%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Stomal Hernia
subjects affected / exposed	1 / 1355 (0.07%)	0 / 1360 (0.00%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Subdural Haematoma
subjects affected / exposed	2 / 1355 (0.15%)	0 / 1360 (0.00%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	1 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0	0 / 0
Tibia Fracture
subjects affected / exposed	2 / 1355 (0.15%)	0 / 1360 (0.00%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Upper Limb Fracture
subjects affected / exposed	1 / 1355 (0.07%)	0 / 1360 (0.00%)	1 / 1358 (0.07%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Vascular Graft Thrombosis
subjects affected / exposed	0 / 1355 (0.00%)	1 / 1360 (0.07%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Vascular Pseudoaneurysm
subjects affected / exposed	0 / 1355 (0.00%)	1 / 1360 (0.07%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Wrist Fracture
subjects affected / exposed	0 / 1355 (0.00%)	0 / 1360 (0.00%)	1 / 1358 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Congenital, familial and genetic disorders
Hypertrophic Cardiomyopathy
subjects affected / exposed	0 / 1355 (0.00%)	1 / 1360 (0.07%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cardiac disorders
Acute Coronary Syndrome
subjects affected / exposed	0 / 1355 (0.00%)	1 / 1360 (0.07%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Acute Left Ventricular Failure
subjects affected / exposed	0 / 1355 (0.00%)	1 / 1360 (0.07%)	2 / 1358 (0.15%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Acute Myocardial Infarction
subjects affected / exposed	2 / 1355 (0.15%)	1 / 1360 (0.07%)	2 / 1358 (0.15%)
occurrences causally related to treatment / all	0 / 2	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 2	0 / 0	0 / 1
Angina Pectoris
subjects affected / exposed	10 / 1355 (0.74%)	8 / 1360 (0.59%)	17 / 1358 (1.25%)
occurrences causally related to treatment / all	0 / 13	0 / 8	1 / 17
deaths causally related to treatment / all	0 / 1	0 / 0	0 / 0
Angina Unstable
subjects affected / exposed	23 / 1355 (1.70%)	20 / 1360 (1.47%)	10 / 1358 (0.74%)
occurrences causally related to treatment / all	0 / 29	0 / 23	0 / 11
deaths causally related to treatment / all	0 / 1	0 / 1	0 / 0
Aortic Valve Stenosis
subjects affected / exposed	0 / 1355 (0.00%)	2 / 1360 (0.15%)	1 / 1358 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Arrhythmia Supraventricular
subjects affected / exposed	1 / 1355 (0.07%)	0 / 1360 (0.00%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Arteriosclerosis Coronary Artery
subjects affected / exposed	0 / 1355 (0.00%)	0 / 1360 (0.00%)	2 / 1358 (0.15%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Atrial Fibrillation
subjects affected / exposed	12 / 1355 (0.89%)	15 / 1360 (1.10%)	12 / 1358 (0.88%)
occurrences causally related to treatment / all	0 / 16	0 / 17	0 / 13
deaths causally related to treatment / all	0 / 0	0 / 1	0 / 0
Atrial Flutter
subjects affected / exposed	2 / 1355 (0.15%)	2 / 1360 (0.15%)	5 / 1358 (0.37%)
occurrences causally related to treatment / all	0 / 2	0 / 2	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Atrial Tachycardia
subjects affected / exposed	1 / 1355 (0.07%)	1 / 1360 (0.07%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Atrioventricular Block
subjects affected / exposed	0 / 1355 (0.00%)	1 / 1360 (0.07%)	1 / 1358 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Atrioventricular Block Complete
subjects affected / exposed	4 / 1355 (0.30%)	1 / 1360 (0.07%)	1 / 1358 (0.07%)
occurrences causally related to treatment / all	0 / 4	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Bradyarrhythmia
subjects affected / exposed	0 / 1355 (0.00%)	0 / 1360 (0.00%)	1 / 1358 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Bradycardia
subjects affected / exposed	1 / 1355 (0.07%)	0 / 1360 (0.00%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Bundle Branch Block Left
subjects affected / exposed	0 / 1355 (0.00%)	0 / 1360 (0.00%)	1 / 1358 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cardiac Arrest
subjects affected / exposed	5 / 1355 (0.37%)	2 / 1360 (0.15%)	1 / 1358 (0.07%)
occurrences causally related to treatment / all	0 / 5	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 4	0 / 1	0 / 0
Cardiac Discomfort
subjects affected / exposed	0 / 1355 (0.00%)	0 / 1360 (0.00%)	1 / 1358 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cardiac Failure
subjects affected / exposed	12 / 1355 (0.89%)	4 / 1360 (0.29%)	1 / 1358 (0.07%)
occurrences causally related to treatment / all	0 / 12	0 / 4	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 3	0 / 0
Cardiac Failure Acute
subjects affected / exposed	3 / 1355 (0.22%)	1 / 1360 (0.07%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0	0 / 0
Cardiac Failure Chronic
subjects affected / exposed	2 / 1355 (0.15%)	4 / 1360 (0.29%)	1 / 1358 (0.07%)
occurrences causally related to treatment / all	0 / 2	0 / 4	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1	0 / 0
Cardiac Failure Congestive
subjects affected / exposed	3 / 1355 (0.22%)	2 / 1360 (0.15%)	2 / 1358 (0.15%)
occurrences causally related to treatment / all	0 / 3	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 2	0 / 2	0 / 0
Cardiac Valve Disease
subjects affected / exposed	1 / 1355 (0.07%)	0 / 1360 (0.00%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cardio-Respiratory Arrest
subjects affected / exposed	1 / 1355 (0.07%)	0 / 1360 (0.00%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0	0 / 0
Cardiogenic Shock
subjects affected / exposed	1 / 1355 (0.07%)	1 / 1360 (0.07%)	1 / 1358 (0.07%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 1	0 / 1
Cardiomyopathy
subjects affected / exposed	1 / 1355 (0.07%)	0 / 1360 (0.00%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cardiomyopathy Acute
subjects affected / exposed	0 / 1355 (0.00%)	0 / 1360 (0.00%)	1 / 1358 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cardiovascular Insufficiency
subjects affected / exposed	0 / 1355 (0.00%)	1 / 1360 (0.07%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 1	0 / 0
Coronary Artery Disease
subjects affected / exposed	10 / 1355 (0.74%)	14 / 1360 (1.03%)	5 / 1358 (0.37%)
occurrences causally related to treatment / all	0 / 11	0 / 14	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 1	0 / 0
Coronary Artery Occlusion
subjects affected / exposed	2 / 1355 (0.15%)	2 / 1360 (0.15%)	2 / 1358 (0.15%)
occurrences causally related to treatment / all	0 / 2	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Coronary Artery Stenosis
subjects affected / exposed	1 / 1355 (0.07%)	3 / 1360 (0.22%)	3 / 1358 (0.22%)
occurrences causally related to treatment / all	0 / 1	0 / 3	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Left Ventricular Dysfunction
subjects affected / exposed	2 / 1355 (0.15%)	1 / 1360 (0.07%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Left Ventricular Failure
subjects affected / exposed	1 / 1355 (0.07%)	0 / 1360 (0.00%)	2 / 1358 (0.15%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 1	0 / 0	0 / 0
Mitral Valve Incompetence
subjects affected / exposed	0 / 1355 (0.00%)	0 / 1360 (0.00%)	2 / 1358 (0.15%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Myocardial Infarction
subjects affected / exposed	9 / 1355 (0.66%)	4 / 1360 (0.29%)	6 / 1358 (0.44%)
occurrences causally related to treatment / all	0 / 10	0 / 4	0 / 6
deaths causally related to treatment / all	0 / 5	0 / 2	0 / 3
Myocardial Ischaemia
subjects affected / exposed	4 / 1355 (0.30%)	0 / 1360 (0.00%)	2 / 1358 (0.15%)
occurrences causally related to treatment / all	0 / 4	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pericarditis
subjects affected / exposed	0 / 1355 (0.00%)	1 / 1360 (0.07%)	1 / 1358 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Sinus Node Dysfunction
subjects affected / exposed	0 / 1355 (0.00%)	1 / 1360 (0.07%)	3 / 1358 (0.22%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Sinus Tachycardia
subjects affected / exposed	0 / 1355 (0.00%)	0 / 1360 (0.00%)	1 / 1358 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Supraventricular Tachycardia
subjects affected / exposed	0 / 1355 (0.00%)	1 / 1360 (0.07%)	3 / 1358 (0.22%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Tachycardia
subjects affected / exposed	0 / 1355 (0.00%)	2 / 1360 (0.15%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Tricuspid Valve Incompetence
subjects affected / exposed	0 / 1355 (0.00%)	0 / 1360 (0.00%)	1 / 1358 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Ventricular Arrhythmia
subjects affected / exposed	1 / 1355 (0.07%)	0 / 1360 (0.00%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Ventricular Tachycardia
subjects affected / exposed	3 / 1355 (0.22%)	3 / 1360 (0.22%)	2 / 1358 (0.15%)
occurrences causally related to treatment / all	0 / 3	0 / 4	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Nervous system disorders
Brain Injury
subjects affected / exposed	1 / 1355 (0.07%)	0 / 1360 (0.00%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Carotid Artery Disease
subjects affected / exposed	1 / 1355 (0.07%)	0 / 1360 (0.00%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Carotid Artery Stenosis
subjects affected / exposed	2 / 1355 (0.15%)	3 / 1360 (0.22%)	4 / 1358 (0.29%)
occurrences causally related to treatment / all	0 / 2	0 / 3	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Carotid Sinus Syndrome
subjects affected / exposed	0 / 1355 (0.00%)	1 / 1360 (0.07%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Carpal Tunnel Syndrome
subjects affected / exposed	0 / 1355 (0.00%)	3 / 1360 (0.22%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cerebrovascular Accident
subjects affected / exposed	1 / 1355 (0.07%)	2 / 1360 (0.15%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 1	0 / 0
Cerebrovascular Disorder
subjects affected / exposed	1 / 1355 (0.07%)	1 / 1360 (0.07%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 1	0 / 0
Cerebrovascular Insufficiency
subjects affected / exposed	0 / 1355 (0.00%)	1 / 1360 (0.07%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cervical Radiculopathy
subjects affected / exposed	0 / 1355 (0.00%)	0 / 1360 (0.00%)	1 / 1358 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cervicobrachial Syndrome
subjects affected / exposed	0 / 1355 (0.00%)	1 / 1360 (0.07%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Diabetic Hyperosmolar Coma
subjects affected / exposed	1 / 1355 (0.07%)	1 / 1360 (0.07%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Dizziness
subjects affected / exposed	0 / 1355 (0.00%)	0 / 1360 (0.00%)	2 / 1358 (0.15%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Encephalopathy
subjects affected / exposed	1 / 1355 (0.07%)	1 / 1360 (0.07%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Facial Paralysis
subjects affected / exposed	0 / 1355 (0.00%)	1 / 1360 (0.07%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Haemorrhagic Stroke
subjects affected / exposed	0 / 1355 (0.00%)	0 / 1360 (0.00%)	1 / 1358 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 1
Headache
subjects affected / exposed	0 / 1355 (0.00%)	1 / 1360 (0.07%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hepatic Encephalopathy
subjects affected / exposed	1 / 1355 (0.07%)	0 / 1360 (0.00%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 4	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hydrocephalus
subjects affected / exposed	1 / 1355 (0.07%)	0 / 1360 (0.00%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hypoglycaemic Encephalopathy
subjects affected / exposed	0 / 1355 (0.00%)	1 / 1360 (0.07%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hypoglycaemic Seizure
subjects affected / exposed	0 / 1355 (0.00%)	0 / 1360 (0.00%)	2 / 1358 (0.15%)
occurrences causally related to treatment / all	0 / 0	0 / 0	2 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hypoglycaemic Unconsciousness
subjects affected / exposed	4 / 1355 (0.30%)	2 / 1360 (0.15%)	2 / 1358 (0.15%)
occurrences causally related to treatment / all	1 / 4	0 / 2	2 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Ischaemic Stroke
subjects affected / exposed	1 / 1355 (0.07%)	1 / 1360 (0.07%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Lacunar Stroke
subjects affected / exposed	0 / 1355 (0.00%)	0 / 1360 (0.00%)	1 / 1358 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Lumbosacral Radiculopathy
subjects affected / exposed	0 / 1355 (0.00%)	0 / 1360 (0.00%)	1 / 1358 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Metabolic Encephalopathy
subjects affected / exposed	1 / 1355 (0.07%)	0 / 1360 (0.00%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Myasthenia Gravis
subjects affected / exposed	0 / 1355 (0.00%)	1 / 1360 (0.07%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Myelopathy
subjects affected / exposed	0 / 1355 (0.00%)	1 / 1360 (0.07%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Neuropathy Peripheral
subjects affected / exposed	0 / 1355 (0.00%)	1 / 1360 (0.07%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Paraesthesia
subjects affected / exposed	1 / 1355 (0.07%)	0 / 1360 (0.00%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Presyncope
subjects affected / exposed	0 / 1355 (0.00%)	1 / 1360 (0.07%)	1 / 1358 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Radiculopathy
subjects affected / exposed	1 / 1355 (0.07%)	0 / 1360 (0.00%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Sciatica
subjects affected / exposed	1 / 1355 (0.07%)	1 / 1360 (0.07%)	1 / 1358 (0.07%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Seizure
subjects affected / exposed	0 / 1355 (0.00%)	1 / 1360 (0.07%)	3 / 1358 (0.22%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Senile Dementia
subjects affected / exposed	0 / 1355 (0.00%)	1 / 1360 (0.07%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Syncope
subjects affected / exposed	4 / 1355 (0.30%)	4 / 1360 (0.29%)	7 / 1358 (0.52%)
occurrences causally related to treatment / all	0 / 4	0 / 5	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Toxic Encephalopathy
subjects affected / exposed	0 / 1355 (0.00%)	1 / 1360 (0.07%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Transient Ischaemic Attack
subjects affected / exposed	3 / 1355 (0.22%)	4 / 1360 (0.29%)	2 / 1358 (0.15%)
occurrences causally related to treatment / all	0 / 3	0 / 4	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Vith Nerve Paralysis
subjects affected / exposed	0 / 1355 (0.00%)	1 / 1360 (0.07%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Vocal Cord Paresis
subjects affected / exposed	0 / 1355 (0.00%)	0 / 1360 (0.00%)	1 / 1358 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Blood and lymphatic system disorders
Acquired Haemophilia
subjects affected / exposed	0 / 1355 (0.00%)	1 / 1360 (0.07%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Anaemia
subjects affected / exposed	3 / 1355 (0.22%)	2 / 1360 (0.15%)	2 / 1358 (0.15%)
occurrences causally related to treatment / all	0 / 3	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Anaemia Vitamin B12 Deficiency
subjects affected / exposed	1 / 1355 (0.07%)	0 / 1360 (0.00%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Autoimmune Haemolytic Anaemia
subjects affected / exposed	0 / 1355 (0.00%)	0 / 1360 (0.00%)	1 / 1358 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Blood Loss Anaemia
subjects affected / exposed	0 / 1355 (0.00%)	1 / 1360 (0.07%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hypochromic Anaemia
subjects affected / exposed	1 / 1355 (0.07%)	0 / 1360 (0.00%)	1 / 1358 (0.07%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Iron Deficiency Anaemia
subjects affected / exposed	2 / 1355 (0.15%)	1 / 1360 (0.07%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Ear and labyrinth disorders
Deafness Neurosensory
subjects affected / exposed	0 / 1355 (0.00%)	0 / 1360 (0.00%)	1 / 1358 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Deafness Unilateral
subjects affected / exposed	0 / 1355 (0.00%)	0 / 1360 (0.00%)	1 / 1358 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Meniere's Disease
subjects affected / exposed	1 / 1355 (0.07%)	0 / 1360 (0.00%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Vertigo
subjects affected / exposed	1 / 1355 (0.07%)	0 / 1360 (0.00%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Vertigo Positional
subjects affected / exposed	0 / 1355 (0.00%)	0 / 1360 (0.00%)	1 / 1358 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Vestibular Disorder
subjects affected / exposed	0 / 1355 (0.00%)	0 / 1360 (0.00%)	1 / 1358 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Eye disorders
Cataract
subjects affected / exposed	1 / 1355 (0.07%)	1 / 1360 (0.07%)	1 / 1358 (0.07%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Eyelid Ptosis
subjects affected / exposed	0 / 1355 (0.00%)	1 / 1360 (0.07%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Open Angle Glaucoma
subjects affected / exposed	0 / 1355 (0.00%)	0 / 1360 (0.00%)	1 / 1358 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Retinal Artery Embolism
subjects affected / exposed	0 / 1355 (0.00%)	1 / 1360 (0.07%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Retinal Detachment
subjects affected / exposed	0 / 1355 (0.00%)	0 / 1360 (0.00%)	1 / 1358 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Vitreous Haemorrhage
subjects affected / exposed	0 / 1355 (0.00%)	0 / 1360 (0.00%)	1 / 1358 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Gastrointestinal disorders
Abdominal Incarcerated Hernia
subjects affected / exposed	0 / 1355 (0.00%)	1 / 1360 (0.07%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Abdominal Pain
subjects affected / exposed	1 / 1355 (0.07%)	1 / 1360 (0.07%)	1 / 1358 (0.07%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Abdominal Pain Upper
subjects affected / exposed	0 / 1355 (0.00%)	0 / 1360 (0.00%)	1 / 1358 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Abdominal Strangulated Hernia
subjects affected / exposed	1 / 1355 (0.07%)	0 / 1360 (0.00%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Ascites
subjects affected / exposed	1 / 1355 (0.07%)	0 / 1360 (0.00%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Chronic Gastritis
subjects affected / exposed	0 / 1355 (0.00%)	2 / 1360 (0.15%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Colitis
subjects affected / exposed	0 / 1355 (0.00%)	0 / 1360 (0.00%)	5 / 1358 (0.37%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Colitis Ischaemic
subjects affected / exposed	0 / 1355 (0.00%)	0 / 1360 (0.00%)	1 / 1358 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Diabetic Gastroparesis
subjects affected / exposed	1 / 1355 (0.07%)	0 / 1360 (0.00%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Diarrhoea
subjects affected / exposed	3 / 1355 (0.22%)	2 / 1360 (0.15%)	1 / 1358 (0.07%)
occurrences causally related to treatment / all	0 / 3	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Diverticulum
subjects affected / exposed	1 / 1355 (0.07%)	0 / 1360 (0.00%)	1 / 1358 (0.07%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Diverticulum Intestinal Haemorrhagic
subjects affected / exposed	1 / 1355 (0.07%)	0 / 1360 (0.00%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Duodenal Ulcer
subjects affected / exposed	1 / 1355 (0.07%)	0 / 1360 (0.00%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Duodenitis
subjects affected / exposed	1 / 1355 (0.07%)	0 / 1360 (0.00%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Dyspepsia
subjects affected / exposed	0 / 1355 (0.00%)	0 / 1360 (0.00%)	1 / 1358 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Faecaloma
subjects affected / exposed	0 / 1355 (0.00%)	2 / 1360 (0.15%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Gastric Ulcer
subjects affected / exposed	0 / 1355 (0.00%)	1 / 1360 (0.07%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Gastric Ulcer Haemorrhage
subjects affected / exposed	0 / 1355 (0.00%)	0 / 1360 (0.00%)	1 / 1358 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Gastritis
subjects affected / exposed	2 / 1355 (0.15%)	0 / 1360 (0.00%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Gastritis Erosive
subjects affected / exposed	1 / 1355 (0.07%)	0 / 1360 (0.00%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Gastrointestinal Haemorrhage
subjects affected / exposed	0 / 1355 (0.00%)	1 / 1360 (0.07%)	2 / 1358 (0.15%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Gastrointestinal Perforation
subjects affected / exposed	0 / 1355 (0.00%)	1 / 1360 (0.07%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Gastrooesophageal Reflux Disease
subjects affected / exposed	0 / 1355 (0.00%)	1 / 1360 (0.07%)	1 / 1358 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 1	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Gastrooesophageal Sphincter Insufficiency
subjects affected / exposed	1 / 1355 (0.07%)	0 / 1360 (0.00%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Ileus
subjects affected / exposed	0 / 1355 (0.00%)	1 / 1360 (0.07%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 1	0 / 0
Inguinal Hernia
subjects affected / exposed	1 / 1355 (0.07%)	2 / 1360 (0.15%)	1 / 1358 (0.07%)
occurrences causally related to treatment / all	0 / 1	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Intestinal Ischaemia
subjects affected / exposed	0 / 1355 (0.00%)	0 / 1360 (0.00%)	1 / 1358 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 1
Intestinal Obstruction
subjects affected / exposed	1 / 1355 (0.07%)	0 / 1360 (0.00%)	2 / 1358 (0.15%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Intra-Abdominal Haemorrhage
subjects affected / exposed	0 / 1355 (0.00%)	1 / 1360 (0.07%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Large Intestine Polyp
subjects affected / exposed	0 / 1355 (0.00%)	1 / 1360 (0.07%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Mallory-Weiss Syndrome
subjects affected / exposed	0 / 1355 (0.00%)	0 / 1360 (0.00%)	1 / 1358 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Mechanical Ileus
subjects affected / exposed	0 / 1355 (0.00%)	0 / 1360 (0.00%)	1 / 1358 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Mesenteric Artery Stenosis
subjects affected / exposed	0 / 1355 (0.00%)	2 / 1360 (0.15%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Nausea
subjects affected / exposed	0 / 1355 (0.00%)	1 / 1360 (0.07%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Obstructive Pancreatitis
subjects affected / exposed	1 / 1355 (0.07%)	1 / 1360 (0.07%)	1 / 1358 (0.07%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Oesophageal Disorder
subjects affected / exposed	0 / 1355 (0.00%)	1 / 1360 (0.07%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Oesophagitis
subjects affected / exposed	0 / 1355 (0.00%)	1 / 1360 (0.07%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Palatal Disorder
subjects affected / exposed	0 / 1355 (0.00%)	0 / 1360 (0.00%)	1 / 1358 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pancreatitis Acute
subjects affected / exposed	4 / 1355 (0.30%)	3 / 1360 (0.22%)	2 / 1358 (0.15%)
occurrences causally related to treatment / all	3 / 4	3 / 3	1 / 2
deaths causally related to treatment / all	1 / 2	0 / 0	0 / 1
Pancreatitis Chronic
subjects affected / exposed	1 / 1355 (0.07%)	0 / 1360 (0.00%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Peptic Ulcer
subjects affected / exposed	1 / 1355 (0.07%)	1 / 1360 (0.07%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Retroperitoneal Haemorrhage
subjects affected / exposed	1 / 1355 (0.07%)	0 / 1360 (0.00%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Small Intestinal Obstruction
subjects affected / exposed	0 / 1355 (0.00%)	1 / 1360 (0.07%)	1 / 1358 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Subileus
subjects affected / exposed	0 / 1355 (0.00%)	0 / 1360 (0.00%)	1 / 1358 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Umbilical Hernia
subjects affected / exposed	0 / 1355 (0.00%)	0 / 1360 (0.00%)	1 / 1358 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Varices Oesophageal
subjects affected / exposed	1 / 1355 (0.07%)	0 / 1360 (0.00%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Vomiting
subjects affected / exposed	1 / 1355 (0.07%)	3 / 1360 (0.22%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	1 / 1	1 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hepatobiliary disorders
Autoimmune Hepatitis
subjects affected / exposed	1 / 1355 (0.07%)	0 / 1360 (0.00%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0	0 / 0
Bile Duct Stone
subjects affected / exposed	0 / 1355 (0.00%)	0 / 1360 (0.00%)	2 / 1358 (0.15%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cholecystitis
subjects affected / exposed	1 / 1355 (0.07%)	4 / 1360 (0.29%)	3 / 1358 (0.22%)
occurrences causally related to treatment / all	0 / 1	0 / 4	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cholecystitis Acute
subjects affected / exposed	0 / 1355 (0.00%)	4 / 1360 (0.29%)	3 / 1358 (0.22%)
occurrences causally related to treatment / all	0 / 0	2 / 4	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cholecystitis Chronic
subjects affected / exposed	0 / 1355 (0.00%)	0 / 1360 (0.00%)	2 / 1358 (0.15%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cholelithiasis
subjects affected / exposed	2 / 1355 (0.15%)	1 / 1360 (0.07%)	1 / 1358 (0.07%)
occurrences causally related to treatment / all	0 / 2	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cholestasis
subjects affected / exposed	1 / 1355 (0.07%)	0 / 1360 (0.00%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Chronic Hepatitis
subjects affected / exposed	0 / 1355 (0.00%)	1 / 1360 (0.07%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hepatic Cirrhosis
subjects affected / exposed	0 / 1355 (0.00%)	0 / 1360 (0.00%)	1 / 1358 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hepatic Cyst
subjects affected / exposed	1 / 1355 (0.07%)	0 / 1360 (0.00%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hyperbilirubinaemia
subjects affected / exposed	0 / 1355 (0.00%)	1 / 1360 (0.07%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hyperplastic Cholecystopathy
subjects affected / exposed	0 / 1355 (0.00%)	1 / 1360 (0.07%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Jaundice
subjects affected / exposed	0 / 1355 (0.00%)	1 / 1360 (0.07%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Skin and subcutaneous tissue disorders
Angioedema
subjects affected / exposed	0 / 1355 (0.00%)	2 / 1360 (0.15%)	1 / 1358 (0.07%)
occurrences causally related to treatment / all	0 / 0	1 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Dermal Cyst
subjects affected / exposed	0 / 1355 (0.00%)	0 / 1360 (0.00%)	2 / 1358 (0.15%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Diabetic Foot
subjects affected / exposed	8 / 1355 (0.59%)	8 / 1360 (0.59%)	4 / 1358 (0.29%)
occurrences causally related to treatment / all	0 / 9	0 / 8	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Haemorrhage Subcutaneous
subjects affected / exposed	0 / 1355 (0.00%)	1 / 1360 (0.07%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Ischaemic Skin Ulcer
subjects affected / exposed	1 / 1355 (0.07%)	0 / 1360 (0.00%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Skin Ulcer
subjects affected / exposed	2 / 1355 (0.15%)	5 / 1360 (0.37%)	1 / 1358 (0.07%)
occurrences causally related to treatment / all	0 / 2	0 / 5	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Renal and urinary disorders
Acute Kidney Injury
subjects affected / exposed	9 / 1355 (0.66%)	10 / 1360 (0.74%)	10 / 1358 (0.74%)
occurrences causally related to treatment / all	0 / 9	0 / 10	0 / 11
deaths causally related to treatment / all	0 / 0	0 / 1	0 / 2
Chronic Kidney Disease
subjects affected / exposed	1 / 1355 (0.07%)	2 / 1360 (0.15%)	1 / 1358 (0.07%)
occurrences causally related to treatment / all	0 / 1	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Diabetic Nephropathy
subjects affected / exposed	0 / 1355 (0.00%)	1 / 1360 (0.07%)	1 / 1358 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Haematuria
subjects affected / exposed	1 / 1355 (0.07%)	1 / 1360 (0.07%)	1 / 1358 (0.07%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hydronephrosis
subjects affected / exposed	2 / 1355 (0.15%)	1 / 1360 (0.07%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Nephrolithiasis
subjects affected / exposed	1 / 1355 (0.07%)	2 / 1360 (0.15%)	1 / 1358 (0.07%)
occurrences causally related to treatment / all	0 / 1	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Nephropathy Toxic
subjects affected / exposed	1 / 1355 (0.07%)	0 / 1360 (0.00%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Renal Colic
subjects affected / exposed	0 / 1355 (0.00%)	0 / 1360 (0.00%)	1 / 1358 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Renal Failure
subjects affected / exposed	0 / 1355 (0.00%)	0 / 1360 (0.00%)	1 / 1358 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Renal Impairment
subjects affected / exposed	0 / 1355 (0.00%)	2 / 1360 (0.15%)	1 / 1358 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Tubulointerstitial Nephritis
subjects affected / exposed	0 / 1355 (0.00%)	0 / 1360 (0.00%)	1 / 1358 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Ureterolithiasis
subjects affected / exposed	1 / 1355 (0.07%)	0 / 1360 (0.00%)	1 / 1358 (0.07%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Urinary Bladder Polyp
subjects affected / exposed	0 / 1355 (0.00%)	0 / 1360 (0.00%)	1 / 1358 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Urinary Retention
subjects affected / exposed	1 / 1355 (0.07%)	0 / 1360 (0.00%)	1 / 1358 (0.07%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Endocrine disorders
Goitre
subjects affected / exposed	0 / 1355 (0.00%)	0 / 1360 (0.00%)	1 / 1358 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Thyroid Mass
subjects affected / exposed	0 / 1355 (0.00%)	1 / 1360 (0.07%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Thyroiditis Chronic
subjects affected / exposed	0 / 1355 (0.00%)	1 / 1360 (0.07%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Musculoskeletal and connective tissue disorders
Arthralgia
subjects affected / exposed	2 / 1355 (0.15%)	0 / 1360 (0.00%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Arthropathy
subjects affected / exposed	0 / 1355 (0.00%)	1 / 1360 (0.07%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Back Pain
subjects affected / exposed	1 / 1355 (0.07%)	2 / 1360 (0.15%)	1 / 1358 (0.07%)
occurrences causally related to treatment / all	0 / 1	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Bursitis
subjects affected / exposed	1 / 1355 (0.07%)	0 / 1360 (0.00%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cervical Spinal Stenosis
subjects affected / exposed	1 / 1355 (0.07%)	0 / 1360 (0.00%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Exostosis
subjects affected / exposed	1 / 1355 (0.07%)	0 / 1360 (0.00%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Groin Pain
subjects affected / exposed	0 / 1355 (0.00%)	1 / 1360 (0.07%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Intervertebral Disc Degeneration
subjects affected / exposed	0 / 1355 (0.00%)	1 / 1360 (0.07%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Intervertebral Disc Protrusion
subjects affected / exposed	3 / 1355 (0.22%)	1 / 1360 (0.07%)	2 / 1358 (0.15%)
occurrences causally related to treatment / all	0 / 3	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Lumbar Spinal Stenosis
subjects affected / exposed	0 / 1355 (0.00%)	2 / 1360 (0.15%)	1 / 1358 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Meniscal Degeneration
subjects affected / exposed	1 / 1355 (0.07%)	0 / 1360 (0.00%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Muscular Weakness
subjects affected / exposed	1 / 1355 (0.07%)	1 / 1360 (0.07%)	1 / 1358 (0.07%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Osteoarthritis
subjects affected / exposed	4 / 1355 (0.30%)	2 / 1360 (0.15%)	2 / 1358 (0.15%)
occurrences causally related to treatment / all	0 / 4	0 / 4	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Osteochondritis
subjects affected / exposed	0 / 1355 (0.00%)	1 / 1360 (0.07%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Osteochondrosis
subjects affected / exposed	0 / 1355 (0.00%)	0 / 1360 (0.00%)	1 / 1358 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pain In Extremity
subjects affected / exposed	1 / 1355 (0.07%)	1 / 1360 (0.07%)	1 / 1358 (0.07%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pathological Fracture
subjects affected / exposed	0 / 1355 (0.00%)	0 / 1360 (0.00%)	1 / 1358 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Polymyalgia Rheumatica
subjects affected / exposed	0 / 1355 (0.00%)	0 / 1360 (0.00%)	1 / 1358 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Rotator Cuff Syndrome
subjects affected / exposed	1 / 1355 (0.07%)	3 / 1360 (0.22%)	1 / 1358 (0.07%)
occurrences causally related to treatment / all	0 / 1	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Spinal Osteoarthritis
subjects affected / exposed	0 / 1355 (0.00%)	1 / 1360 (0.07%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Spinal Pain
subjects affected / exposed	1 / 1355 (0.07%)	0 / 1360 (0.00%)	1 / 1358 (0.07%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Spinal Stenosis
subjects affected / exposed	0 / 1355 (0.00%)	0 / 1360 (0.00%)	1 / 1358 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Infections and infestations
Abscess Soft Tissue
subjects affected / exposed	2 / 1355 (0.15%)	0 / 1360 (0.00%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Appendicitis
subjects affected / exposed	3 / 1355 (0.22%)	1 / 1360 (0.07%)	1 / 1358 (0.07%)
occurrences causally related to treatment / all	0 / 3	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Arthritis Bacterial
subjects affected / exposed	0 / 1355 (0.00%)	2 / 1360 (0.15%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 1	0 / 0
Atypical Pneumonia
subjects affected / exposed	0 / 1355 (0.00%)	1 / 1360 (0.07%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Bronchitis
subjects affected / exposed	4 / 1355 (0.30%)	1 / 1360 (0.07%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 4	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Bronchitis Bacterial
subjects affected / exposed	1 / 1355 (0.07%)	0 / 1360 (0.00%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0	0 / 0
Covid-19
subjects affected / exposed	5 / 1355 (0.37%)	1 / 1360 (0.07%)	5 / 1358 (0.37%)
occurrences causally related to treatment / all	0 / 5	0 / 1	0 / 5
deaths causally related to treatment / all	0 / 2	0 / 0	0 / 2
Covid-19 Pneumonia
subjects affected / exposed	5 / 1355 (0.37%)	7 / 1360 (0.51%)	6 / 1358 (0.44%)
occurrences causally related to treatment / all	0 / 5	0 / 7	0 / 6
deaths causally related to treatment / all	0 / 1	0 / 2	0 / 3
Campylobacter Gastroenteritis
subjects affected / exposed	0 / 1355 (0.00%)	1 / 1360 (0.07%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cellulitis
subjects affected / exposed	6 / 1355 (0.44%)	3 / 1360 (0.22%)	2 / 1358 (0.15%)
occurrences causally related to treatment / all	0 / 7	0 / 3	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cholangitis Infective
subjects affected / exposed	1 / 1355 (0.07%)	0 / 1360 (0.00%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0	0 / 0
Chronic Sinusitis
subjects affected / exposed	0 / 1355 (0.00%)	0 / 1360 (0.00%)	1 / 1358 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cystitis
subjects affected / exposed	0 / 1355 (0.00%)	2 / 1360 (0.15%)	2 / 1358 (0.15%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Dermatitis Infected
subjects affected / exposed	0 / 1355 (0.00%)	0 / 1360 (0.00%)	1 / 1358 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Diabetic Foot Infection
subjects affected / exposed	1 / 1355 (0.07%)	0 / 1360 (0.00%)	1 / 1358 (0.07%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Diabetic Gangrene
subjects affected / exposed	2 / 1355 (0.15%)	1 / 1360 (0.07%)	1 / 1358 (0.07%)
occurrences causally related to treatment / all	0 / 4	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Disseminated Tuberculosis
subjects affected / exposed	0 / 1355 (0.00%)	1 / 1360 (0.07%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Diverticulitis
subjects affected / exposed	2 / 1355 (0.15%)	3 / 1360 (0.22%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Enterococcal Bacteraemia
subjects affected / exposed	0 / 1355 (0.00%)	0 / 1360 (0.00%)	1 / 1358 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Escherichia Bacteraemia
subjects affected / exposed	0 / 1355 (0.00%)	1 / 1360 (0.07%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Escherichia Sepsis
subjects affected / exposed	0 / 1355 (0.00%)	1 / 1360 (0.07%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Escherichia Urinary Tract Infection
subjects affected / exposed	0 / 1355 (0.00%)	1 / 1360 (0.07%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Gangrene
subjects affected / exposed	3 / 1355 (0.22%)	1 / 1360 (0.07%)	2 / 1358 (0.15%)
occurrences causally related to treatment / all	0 / 3	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Gastroenteritis
subjects affected / exposed	2 / 1355 (0.15%)	0 / 1360 (0.00%)	6 / 1358 (0.44%)
occurrences causally related to treatment / all	0 / 2	0 / 0	1 / 7
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Gastroenteritis Salmonella
subjects affected / exposed	0 / 1355 (0.00%)	0 / 1360 (0.00%)	1 / 1358 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Gastroenteritis Viral
subjects affected / exposed	0 / 1355 (0.00%)	0 / 1360 (0.00%)	2 / 1358 (0.15%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Gastrointestinal Infection
subjects affected / exposed	1 / 1355 (0.07%)	0 / 1360 (0.00%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Groin Abscess
subjects affected / exposed	1 / 1355 (0.07%)	0 / 1360 (0.00%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
H1n1 Influenza
subjects affected / exposed	0 / 1355 (0.00%)	0 / 1360 (0.00%)	1 / 1358 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hepatitis C
subjects affected / exposed	1 / 1355 (0.07%)	0 / 1360 (0.00%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hepatitis E
subjects affected / exposed	0 / 1355 (0.00%)	0 / 1360 (0.00%)	1 / 1358 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Herpes Zoster Infection Neurological
subjects affected / exposed	0 / 1355 (0.00%)	0 / 1360 (0.00%)	1 / 1358 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Influenza
subjects affected / exposed	1 / 1355 (0.07%)	4 / 1360 (0.29%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 4	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Joint Abscess
subjects affected / exposed	0 / 1355 (0.00%)	0 / 1360 (0.00%)	1 / 1358 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Klebsiella Sepsis
subjects affected / exposed	0 / 1355 (0.00%)	1 / 1360 (0.07%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Large Intestine Infection
subjects affected / exposed	0 / 1355 (0.00%)	1 / 1360 (0.07%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Laryngitis
subjects affected / exposed	0 / 1355 (0.00%)	0 / 1360 (0.00%)	1 / 1358 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Localised Infection
subjects affected / exposed	4 / 1355 (0.30%)	2 / 1360 (0.15%)	1 / 1358 (0.07%)
occurrences causally related to treatment / all	0 / 7	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Mastoiditis
subjects affected / exposed	0 / 1355 (0.00%)	1 / 1360 (0.07%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Mediastinitis
subjects affected / exposed	1 / 1355 (0.07%)	0 / 1360 (0.00%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Oesophageal Abscess
subjects affected / exposed	0 / 1355 (0.00%)	1 / 1360 (0.07%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Osteomyelitis
subjects affected / exposed	5 / 1355 (0.37%)	2 / 1360 (0.15%)	3 / 1358 (0.22%)
occurrences causally related to treatment / all	0 / 5	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Peritonitis
subjects affected / exposed	0 / 1355 (0.00%)	2 / 1360 (0.15%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pilonidal Cyst
subjects affected / exposed	1 / 1355 (0.07%)	1 / 1360 (0.07%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pneumonia
subjects affected / exposed	15 / 1355 (1.11%)	14 / 1360 (1.03%)	9 / 1358 (0.66%)
occurrences causally related to treatment / all	0 / 16	0 / 14	0 / 9
deaths causally related to treatment / all	0 / 2	0 / 1	0 / 2
Pneumonia Bacterial
subjects affected / exposed	0 / 1355 (0.00%)	0 / 1360 (0.00%)	1 / 1358 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pneumonia Influenzal
subjects affected / exposed	0 / 1355 (0.00%)	1 / 1360 (0.07%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pneumonia Klebsiella
subjects affected / exposed	0 / 1355 (0.00%)	0 / 1360 (0.00%)	1 / 1358 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pneumonia Mycoplasmal
subjects affected / exposed	1 / 1355 (0.07%)	0 / 1360 (0.00%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pneumonia Staphylococcal
subjects affected / exposed	0 / 1355 (0.00%)	1 / 1360 (0.07%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pneumonia Viral
subjects affected / exposed	0 / 1355 (0.00%)	1 / 1360 (0.07%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Postoperative Wound Infection
subjects affected / exposed	0 / 1355 (0.00%)	5 / 1360 (0.37%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 5	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pulmonary Tuberculosis
subjects affected / exposed	0 / 1355 (0.00%)	1 / 1360 (0.07%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pyelonephritis
subjects affected / exposed	2 / 1355 (0.15%)	0 / 1360 (0.00%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pyelonephritis Acute
subjects affected / exposed	0 / 1355 (0.00%)	0 / 1360 (0.00%)	1 / 1358 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pyelonephritis Chronic
subjects affected / exposed	0 / 1355 (0.00%)	1 / 1360 (0.07%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Renal Cyst Infection
subjects affected / exposed	1 / 1355 (0.07%)	0 / 1360 (0.00%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Salpingitis
subjects affected / exposed	0 / 1355 (0.00%)	0 / 1360 (0.00%)	1 / 1358 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Scrub Typhus
subjects affected / exposed	1 / 1355 (0.07%)	0 / 1360 (0.00%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Sepsis
subjects affected / exposed	9 / 1355 (0.66%)	4 / 1360 (0.29%)	4 / 1358 (0.29%)
occurrences causally related to treatment / all	0 / 9	0 / 4	0 / 4
deaths causally related to treatment / all	0 / 1	0 / 0	0 / 1
Septic Shock
subjects affected / exposed	0 / 1355 (0.00%)	2 / 1360 (0.15%)	3 / 1358 (0.22%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 1	0 / 1
Sinusitis
subjects affected / exposed	0 / 1355 (0.00%)	0 / 1360 (0.00%)	1 / 1358 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Skin Infection
subjects affected / exposed	1 / 1355 (0.07%)	0 / 1360 (0.00%)	1 / 1358 (0.07%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Soft Tissue Infection
subjects affected / exposed	0 / 1355 (0.00%)	1 / 1360 (0.07%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Staphylococcal Bacteraemia
subjects affected / exposed	0 / 1355 (0.00%)	1 / 1360 (0.07%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Staphylococcal Sepsis
subjects affected / exposed	2 / 1355 (0.15%)	1 / 1360 (0.07%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 1	0 / 0
Subcutaneous Abscess
subjects affected / exposed	0 / 1355 (0.00%)	1 / 1360 (0.07%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Suspected Covid-19
subjects affected / exposed	1 / 1355 (0.07%)	1 / 1360 (0.07%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 1	0 / 0
Tuberculosis
subjects affected / exposed	0 / 1355 (0.00%)	1 / 1360 (0.07%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Tuberculosis Gastrointestinal
subjects affected / exposed	0 / 1355 (0.00%)	1 / 1360 (0.07%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Upper Respiratory Tract Infection
subjects affected / exposed	0 / 1355 (0.00%)	0 / 1360 (0.00%)	1 / 1358 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Urinary Tract Infection
subjects affected / exposed	2 / 1355 (0.15%)	7 / 1360 (0.51%)	2 / 1358 (0.15%)
occurrences causally related to treatment / all	0 / 2	0 / 7	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Urinary Tract Infection Enterococcal
subjects affected / exposed	0 / 1355 (0.00%)	0 / 1360 (0.00%)	1 / 1358 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Urosepsis
subjects affected / exposed	1 / 1355 (0.07%)	1 / 1360 (0.07%)	1 / 1358 (0.07%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Vulval Abscess
subjects affected / exposed	1 / 1355 (0.07%)	0 / 1360 (0.00%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Wound Infection
subjects affected / exposed	1 / 1355 (0.07%)	0 / 1360 (0.00%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Wound Sepsis
subjects affected / exposed	0 / 1355 (0.00%)	1 / 1360 (0.07%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Metabolism and nutrition disorders
Dehydration
subjects affected / exposed	5 / 1355 (0.37%)	3 / 1360 (0.22%)	6 / 1358 (0.44%)
occurrences causally related to treatment / all	0 / 5	0 / 3	1 / 6
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Diabetes Mellitus
subjects affected / exposed	3 / 1355 (0.22%)	0 / 1360 (0.00%)	3 / 1358 (0.22%)
occurrences causally related to treatment / all	0 / 3	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Diabetes Mellitus Inadequate Control
subjects affected / exposed	0 / 1355 (0.00%)	3 / 1360 (0.22%)	1 / 1358 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 5	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Diabetic Ketoacidosis
subjects affected / exposed	3 / 1355 (0.22%)	2 / 1360 (0.15%)	2 / 1358 (0.15%)
occurrences causally related to treatment / all	0 / 3	1 / 2	0 / 2
deaths causally related to treatment / all	0 / 1	0 / 0	0 / 0
Diabetic Metabolic Decompensation
subjects affected / exposed	0 / 1355 (0.00%)	2 / 1360 (0.15%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Food Intolerance
subjects affected / exposed	1 / 1355 (0.07%)	0 / 1360 (0.00%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Gout
subjects affected / exposed	1 / 1355 (0.07%)	1 / 1360 (0.07%)	2 / 1358 (0.15%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hyperglycaemia
subjects affected / exposed	5 / 1355 (0.37%)	8 / 1360 (0.59%)	2 / 1358 (0.15%)
occurrences causally related to treatment / all	0 / 7	0 / 9	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hyperglycaemic Hyperosmolar Nonketotic Syndrome
subjects affected / exposed	1 / 1355 (0.07%)	0 / 1360 (0.00%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hyperkalaemia
subjects affected / exposed	1 / 1355 (0.07%)	0 / 1360 (0.00%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hypoalbuminaemia
subjects affected / exposed	0 / 1355 (0.00%)	0 / 1360 (0.00%)	1 / 1358 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hypoglycaemia
subjects affected / exposed	3 / 1355 (0.22%)	8 / 1360 (0.59%)	4 / 1358 (0.29%)
occurrences causally related to treatment / all	0 / 3	1 / 8	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hypokalaemia
subjects affected / exposed	0 / 1355 (0.00%)	1 / 1360 (0.07%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hypomagnesaemia
subjects affected / exposed	1 / 1355 (0.07%)	0 / 1360 (0.00%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hyponatraemia
subjects affected / exposed	2 / 1355 (0.15%)	0 / 1360 (0.00%)	1 / 1358 (0.07%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 0	0 / 0
Hypovolaemia
subjects affected / exposed	1 / 1355 (0.07%)	0 / 1360 (0.00%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Lactic Acidosis
subjects affected / exposed	1 / 1355 (0.07%)	0 / 1360 (0.00%)	1 / 1358 (0.07%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Metabolic Acidosis
subjects affected / exposed	0 / 1355 (0.00%)	0 / 1360 (0.00%)	2 / 1358 (0.15%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Type 2 Diabetes Mellitus
subjects affected / exposed	2 / 1355 (0.15%)	0 / 1360 (0.00%)	0 / 1358 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0

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

Non-serious adverse events	Placebo	Efpeglenatide 4 mg	Efpeglenatide 6 mg
Total subjects affected by non serious adverse events
subjects affected / exposed	151 / 1355 (11.14%)	348 / 1360 (25.59%)	342 / 1358 (25.18%)
Gastrointestinal disorders
Diarrhoea
subjects affected / exposed	64 / 1355 (4.72%)	116 / 1360 (8.53%)	117 / 1358 (8.62%)
occurrences all number	69	139	153
Nausea
subjects affected / exposed	51 / 1355 (3.76%)	196 / 1360 (14.41%)	167 / 1358 (12.30%)
occurrences all number	60	282	194
Vomiting
subjects affected / exposed	18 / 1355 (1.33%)	85 / 1360 (6.25%)	75 / 1358 (5.52%)
occurrences all number	19	106	95
Metabolism and nutrition disorders
Decreased Appetite
subjects affected / exposed	15 / 1355 (1.11%)	68 / 1360 (5.00%)	77 / 1358 (5.67%)
occurrences all number	16	74	80
Hypoglycaemia
subjects affected / exposed	37 / 1355 (2.73%)	73 / 1360 (5.37%)	53 / 1358 (3.90%)
occurrences all number	81	159	97

More information

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Were there any global substantial amendments to the protocol? Yes

28 May 2018

The following substantial amendment was done - Clarified the contraception requirements for male and woman of childbearing potential (WOCBP): contraception for male subjects not required, ova donation restrictions added, change in contraceptive methods to be used for WOCBP, follow-up of pregnancy extended to one year.

30 Jul 2018

The following substantial amendment was done - Added an electrocardiogram assessment at Week 12, when steady state had been achieved, to allow Investigators to assess the effects of efpeglenatide on the heart earlier in the study.

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.

The study was terminated early by the Sponsor but not due to any safety concerns.

http://www.ncbi.nlm.nih.gov/pubmed/34215025

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