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Clinical Trial Results:
A Randomized, Double-blind, Phase 3 Trial to Assess Clinical Efficacy, Safety and Reactogenicity of the Recombinant MVA-BN®-RSV Vaccine in Adults ≥60 Years of Age

Summary
EudraCT number	2021-004923-34
Trial protocol	DE
Global end of trial date	10 Oct 2023

Results information
Results version number	v1(current)
This version publication date	14 Sep 2024
First version publication date	14 Sep 2024
Other versions
Summary report(s)	Summary of Secondary Safety Endpoints

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

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Trial information

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Sponsor protocol code

RSV-MVA-004

ISRCTN number

US NCT number

NCT05238025

WHO universal trial number (UTN)

Sponsor organisation name

Bavarian Nordic A/S

Sponsor organisation address

Philip Heymans Alle 3, Hellerup, Denmark, 2900

Public contact

clinical-mailbox , Bavarian Nordic GmbH, clinical-mailbox@bavarian-nordic.com

Scientific contact

clinical-mailbox , Bavarian Nordic GmbH, clinical-mailbox@bavarian-nordic.com

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

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

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

Analysis stage

Final

Date of interim/final analysis

10 Oct 2023

Is this the analysis of the primary completion data?

Yes

Primary completion date

29 Jun 2023

Global end of trial reached?

Yes

Global end of trial date

10 Oct 2023

Was the trial ended prematurely?

Yes

Main objective of the trial

To assess the clinical efficacy of MVA-BN-RSV vaccine against lower respiratory tract disease (LRTD) associated with RSV.

Protection of trial subjects

This study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with Good Clinical Practice and applicable regulatory requirements.

Background therapy

Evidence for comparator

Actual start date of recruitment

19 Apr 2022

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

United States: 16913

Country: Number of subjects enrolled

Germany: 1435

Worldwide total number of subjects

18348

EEA total number of subjects

1435

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

1864

From 65 to 84 years

16122

85 years and over

362

Subject disposition

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Recruitment details

Screening details

A total of 18367 subjects were randomised, out of which 18348 were vaccinated.

Period 1 title

Disease surveillance over 1 year (overall period)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Investigator, Assessor, Subject

Are arms mutually exclusive

Yes

MVA-BN-RSV

Arm description

Single administration of MVA-BN-RSV vaccine with a titer of at least 3 x 10E8 infectious units (Inf.U)/0.5mL (intramuscular injection)

Arm type

Experimental

Investigational medicinal product name

MVA-BN-RSV

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

Single administration of MVA-BN-RSV vaccine with a titer of at least 3 x 10E8 infectious units (Inf.U)/0.5mL (intramuscular injection)

Placebo

Arm description

Single administration of Tris-buffered Saline (TBS) (intramuscular injection; 0.5mL)

Arm type

Placebo

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

Single administration of Tris-buffered Saline (TBS) (intramuscular injection; 0.5mL)

Number of subjects in period 1	MVA-BN-RSV	Placebo
Started	9160	9188
Completed	1530	1535
Not completed	7630	7653
Adverse event, serious fatal	38	32
Consent withdrawn by subject	203	222
Physician decision	20	8
Study terminated by Sponsor	6358	6358
Adverse event, non-fatal	2	2
Other reason	669	690
Lost to follow-up	334	339
Protocol deviation	6	2

Baseline characteristics

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Reporting group title

MVA-BN-RSV

Reporting group description

Single administration of MVA-BN-RSV vaccine with a titer of at least 3 x 10E8 infectious units (Inf.U)/0.5mL (intramuscular injection)

Reporting group title

Placebo

Reporting group description

Single administration of Tris-buffered Saline (TBS) (intramuscular injection; 0.5mL)

Reporting group values	MVA-BN-RSV	Placebo	Total
Number of subjects	9160	9188	18348
Age categorical
Baseline characteristics data are presented for the Full Analysis Set
Units: Subjects
60-64 years	931	933	1864
65-74 years	6166	6164	12330
75-84 years	1889	1903	3792
85 years and over	174	188	362
Age continuous
Units: years
arithmetic mean (standard deviation)	70.4 ( 5.78 )	70.5 ( 5.83 )	-
Gender categorical
Units: Subjects
Female	4606	4680	9286
Male	4554	4508	9062
Race
Units: Subjects
White	7786	7794	15580
Black or African American	1185	1202	2387
Asian	79	63	142
Native Hawaiian or Other Pacific Islander	9	15	24
American Indian or Alaska Native	34	26	60
Other	67	87	154
Not Reported	0	1	1
Ethnicity
Units: Subjects
Hispanic or Latino	2605	2659	5264
Not Hispanic or Latino	6464	6432	12896
Not Reported	76	87	163
Unknown	15	10	25

End points

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Reporting group title

MVA-BN-RSV

Reporting group description

Single administration of MVA-BN-RSV vaccine with a titer of at least 3 x 10E8 infectious units (Inf.U)/0.5mL (intramuscular injection)

Reporting group title

Placebo

Reporting group description

Single administration of Tris-buffered Saline (TBS) (intramuscular injection; 0.5mL)

Subject analysis set title

Full Analysis Set

Subject analysis set type

Full analysis

Subject analysis set description

Subjects who were randomised to any treatment arm and received study vaccine (MVA-BN-RSV or placebo). Subjects were analysed based on the treatment to which they were randomised. Subjects who received multiple doses of study vaccine ("multiple enrollers") were included once in this analysis set with group allocation based on their first randomisation and with data censored from the time of second randomisation.

Subject analysis set title

Safety Set

Subject analysis set type

Safety analysis

Subject analysis set description

Subjects who received study vaccine (MVA-BN-RSV or placebo). Subjects were analysed based on the treatment they actually received. Subjects who received multiple doses of study vaccine ("multiple enrollers") were analysed in the MVA-BN-RSV arm when having received the MVA-BN-RSV vaccine at least once; subjects were analysed in the placebo arm when having received placebo only.

Subject analysis set title

Immunogenicity Analysis Set

Subject analysis set type

Sub-group analysis

Subject analysis set description

A subset of the Full Analysis Set that includes those subjects at designated clinical trial sites who signed the informed consent form for the collection of serum samples and have at least one immunogenicity sample available

Primary: Occurrence of PCR Confirmed RSV-associated LRTD With at Least 3 Symptoms

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End point title

Occurrence of PCR Confirmed RSV-associated LRTD With at Least 3 Symptoms

End point description

RSV-associated lower respiratory tract disease (LRTD) is defined by the presence of clinical evidence of at least 1 sign or symptom of acute respiratory disease (ARD) and at least 3 LRTD signs or symptoms with onset ≥14 days following vaccination until the end of one RSV season (up to 12 months after vaccination), confirmed and documented by a medical professional, together with RSV disease confirmed by polymerase chain reaction (PCR). Population: Full Analysis Set.

End point type

Primary

End point timeframe

From 14 days post-vaccination up to the end of one RSV season

End point values	MVA-BN-RSV	Placebo
Number of subjects analysed	9160	9188
Units: Subjects	12	21

Vaccine Efficacy (%)

Statistical analysis description

Vaccine Efficacy (VE) is defined as 1 minus the hazard ratio resulting from a Cox proportional hazards regression model stratified by age group. It is demonstrated if the lower limit (LL) of the 2-sided 95% confidence interval (CI) for VE is above 20%

Comparison groups

MVA-BN-RSV v Placebo

Number of subjects included in analysis

18348

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Vaccine Efficacy

Point estimate

42.9

Confidence interval

level

95%

sides

2-sided

lower limit

-16.1

upper limit

71.9

Primary: Occurrence of PCR Confirmed RSV-associated LRTD With at Least 2 Symptoms

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End point title

Occurrence of PCR Confirmed RSV-associated LRTD With at Least 2 Symptoms

End point description

RSV-associated lower respiratory tract disease (LRTD) is defined by the presence of clinical evidence of at least 1 sign or symptom of acute respiratory disease (ARD) and at least 2 LRTD signs or symptoms with onset ≥14 days following vaccination until the end of one RSV season (up to 12 months after vaccination), confirmed and documented by a medical professional, together with RSV disease confirmed by polymerase chain reaction (PCR). Population: Full Analysis Set.

End point type

Primary

End point timeframe

From 14 days post-vaccination up to the end of one RSV season

End point values	MVA-BN-RSV	Placebo
Number of subjects analysed	9160	9188
Units: Subjects	25	61

Vaccine Efficacy (%)

Statistical analysis description

Vaccine Efficacy (VE) is defined as 1 minus the hazard ratio resulting from a Cox proportional hazards regression model stratified by age group. It is demonstrated if the first primary outcome is met and the lower limit (LL) of the 2-sided 95% confidence interval (CI) for VE is above 20%

Comparison groups

MVA-BN-RSV v Placebo

Number of subjects included in analysis

18348

Analysis specification

Pre-specified

Analysis type

other ^[1]

Method

Parameter type

Vaccine Efficacy

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

34.7

upper limit

74.3

Notes
[1] - Not formally tested, since the first primary outcome was not met

Secondary: Occurrence of PCR Confirmed RSV-associated ARD

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End point title

Occurrence of PCR Confirmed RSV-associated ARD

End point description

RSV-associated acute respiratory disease (ARD) is defined by the presence of either one ARD symptom lasting for at least 24 hours or two simultaneously occurring ARD symptoms (irrespective of duration), with onset ≥14 days following vaccination until the end of one RSV season (up to 12 months after vaccination), confirmed and documented by a medical professional, together with RSV disease confirmed by polymerase chain reaction (PCR). Population: Full Analysis Set.

End point type

Secondary

End point timeframe

From 14 days post-vaccination up to the end of one RSV season

End point values	MVA-BN-RSV	Placebo
Number of subjects analysed	9160	9188
Units: Subjects	42	82

Vaccine Efficacy (%)

Statistical analysis description

Vaccine Efficacy (VE) is defined as 1 minus the hazard ratio resulting from a Cox proportional hazards regression model stratified by age group. It is demonstrated if both primary outcomes are met and the lower limit (LL) of the 2-sided 95% confidence interval (CI) for VE is above 20%

Comparison groups

MVA-BN-RSV v Placebo

Number of subjects included in analysis

18348

Analysis specification

Pre-specified

Analysis type

other ^[2]

Method

Parameter type

Vaccine Efficacy

Point estimate

48.8

Confidence interval

level

95%

sides

2-sided

lower limit

25.8

upper limit

64.7

Notes
[2] - Not formally tested, since the first primary outcome was not met

Secondary: Occurrence of Complications Related to PCR-confirmed RSV Disease

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End point title

Occurrence of Complications Related to PCR-confirmed RSV Disease

End point description

RSV-specific complications include the presence of acute clinical consequences of RSV infection, such as pneumonia (incl. bacterial superinfection), sepsis, positive blood culture, and pneumothorax as well as longer term consequences of RSV-specific symptoms, such as persistent worsening of chronic conditions (e.g. COPD), new onset of persistent medical conditions (e.g. chronically impaired lung function, asthma) or a worsening of the functional status of the patient, e.g. new onset of nursing or assisted living need. RSV disease had to be confirmed by PCR testing. Population: Full Analysis Set.

End point type

Secondary

End point timeframe

From 14 days post-vaccination up to the end of one RSV season

End point values	MVA-BN-RSV	Placebo
Number of subjects analysed	9160	9188
Units: Subjects	0	1

No statistical analyses for this end point

Secondary: Occurrence of Hospitalization Due to Confirmed RSV Disease or Due to Any Complication Related to RSV-confirmed Respiratory Disease

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End point title

Occurrence of Hospitalization Due to Confirmed RSV Disease or Due to Any Complication Related to RSV-confirmed Respiratory Disease

End point description

Hospitalization due to PCR confirmed RSV disease and/or any complication related to PCR-confirmed RSV disease. RSV-specific complications include the presence of acute clinical consequences of RSV infection, such as pneumonia (incl. bacterial superinfection), sepsis, positive blood culture, and pneumothorax as well as longer term consequences of RSV-specific symptoms, such as persistent worsening of chronic conditions (e.g. COPD), new onset of persistent medical conditions (e.g. chronically impaired lung function, asthma) or a worsening of the functional status of the patient, e.g. new onset of nursing or assisted living need. RSV disease had to be confirmed by PCR testing. Population: Full Analysis Set.

End point type

Secondary

End point timeframe

From 14 days post-vaccination up to the end of one RSV season

End point values	MVA-BN-RSV	Placebo
Number of subjects analysed	9160	9188
Units: Subjects	0	1

No statistical analyses for this end point

Secondary: Occurrence of Severe PCR Confirmed RSV-associated LRTD

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End point title

Occurrence of Severe PCR Confirmed RSV-associated LRTD

End point description

Severe RSV-associated LRTD is defined by the presence of clinical evidence of at least 1 sign or symptom of ARD and at least 1 of the following signs or symptoms with onset ≥14 days following vaccination until the end of one RSV season (up to 12 months after vaccination), confirmed and documented by a medical professional, together with RSV disease confirmed by polymerase chain reaction (PCR): 1) hypoxemia (oxygen saturation <92% at rest in conjunction with an at least 3% decrease from baseline); 2) respiratory rate >25 breaths/Min; 3) imaging evidence of new onset of bronchitis, bronchiolitis, or pneumonia. Population: Full Analysis Set.

End point type

Secondary

End point timeframe

From 14 days post-vaccination up to the end of one RSV season

End point values	MVA-BN-RSV	Placebo
Number of subjects analysed	9160	9188
Units: Subjects	0	2

No statistical analyses for this end point

Secondary: RSV-specific Serum IgG Antibody Titers

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End point title

RSV-specific Serum IgG Antibody Titers

End point description

Geometric Mean Titers (GMTs) based on RSV-specific Immunoglobulin G (IgG) Enzyme-linked Immunosorbent Assay (ELISA). Population: Immunogenicity Analysis Set

End point type

Secondary

End point timeframe

2 weeks after vaccination

End point values	MVA-BN-RSV	Placebo
Number of subjects analysed	309	317
Units: titre
geometric mean (confidence interval 95%)
Baseline	1510.6 (1386.4 to 1646.0)	1590.1 (1468.3 to 1722.0)
Week 2	4335.5 (3963.7 to 4742.2)	1562.9 (1440.5 to 1695.6)

No statistical analyses for this end point

Secondary: RSV-specific Serum Neutralizing Antibody Titers (Subtype A)

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End point title

RSV-specific Serum Neutralizing Antibody Titers (Subtype A)

End point description

Geometric Mean Titers (GMTs) based on RSV-specific Plaque Reduction Neutralization Test (PRNT; against subtype A). Results below the lower limit of quantitation (LLOQ) are included with a value of 1/2 LLOQ. Population: Immunogenicity Analysis Set

End point type

Secondary

End point timeframe

2 weeks after vaccination

End point values	MVA-BN-RSV	Placebo
Number of subjects analysed	309	317
Units: titre
geometric mean (confidence interval 95%)
Baseline	275.1 (249.4 to 303.4)	310.6 (280.5 to 343.9)
Week 2	482.3 (436.9 to 532.5)	307.7 (276.5 to 342.4)

No statistical analyses for this end point

Secondary: RSV-specific Serum Neutralizing Antibody Titers (Subtype B)

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End point title

RSV-specific Serum Neutralizing Antibody Titers (Subtype B)

End point description

Geometric Mean Titers (GMTs) based on RSV-specific Plaque Reduction Neutralization Test (PRNT; against subtype B). Results below the lower limit of quantitation (LLOQ) are included with a value of 1/2 LLOQ. Population: Immunogenicity Analysis Set

End point type

Secondary

End point timeframe

2 weeks after vaccination

End point values	MVA-BN-RSV	Placebo
Number of subjects analysed	309	317
Units: titre
geometric mean (confidence interval 95%)
Baseline	289.5 (251.5 to 333.1)	336.5 (292.1 to 387.5)
Week 2	475.3 (419.7 to 538.3)	307.6 (265.4 to 356.5)

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

Up to 24 months (planned)

Adverse event reporting additional description

Serious adverse events were to be reported during the entire study, non-serious adverse events within 4 weeks after vaccination.

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

25.0

Reporting group title

MVA-BN-RSV

Reporting group description

Single administration of MVA-BN-RSV vaccine with a titer of at least 3 x 10E8 infectious units (Inf.U)/0.5mL (intramuscular injection)

Reporting group title

Placebo

Reporting group description

Single administration of Tris-buffered Saline (TBS) (intramuscular injection; 0.5mL)

Serious adverse events	MVA-BN-RSV	Placebo
Total subjects affected by serious adverse events
subjects affected / exposed	517 / 9389 (5.51%)	422 / 8959 (4.71%)
number of deaths (all causes)	41	34
number of deaths resulting from adverse events
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
subjects affected / exposed	3 / 9389 (0.03%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 3	0 / 0
Bladder cancer
subjects affected / exposed	2 / 9389 (0.02%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Brain neoplasm
subjects affected / exposed	2 / 9389 (0.02%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal stromal tumour
subjects affected / exposed	2 / 9389 (0.02%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Prostate cancer
subjects affected / exposed	2 / 9389 (0.02%)	2 / 8959 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Throat cancer
subjects affected / exposed	2 / 9389 (0.02%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Acute myeloid leukaemia
subjects affected / exposed	1 / 9389 (0.01%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Adenocarcinoma of colon
subjects affected / exposed	1 / 9389 (0.01%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Benign renal neoplasm
subjects affected / exposed	1 / 9389 (0.01%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Bladder cancer stage 0, with cancer in situ
subjects affected / exposed	1 / 9389 (0.01%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Bone cancer metastatic
subjects affected / exposed	1 / 9389 (0.01%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Breast cancer
subjects affected / exposed	1 / 9389 (0.01%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Chronic lymphocytic leukaemia
subjects affected / exposed	1 / 9389 (0.01%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Endometrial adenocarcinoma
subjects affected / exposed	1 / 9389 (0.01%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Endometrial cancer
subjects affected / exposed	1 / 9389 (0.01%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal adenocarcinoma
subjects affected / exposed	1 / 9389 (0.01%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Laryngeal cancer
subjects affected / exposed	1 / 9389 (0.01%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Lung carcinoma cell type unspecified recurrent
subjects affected / exposed	1 / 9389 (0.01%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Lung neoplasm malignant
subjects affected / exposed	1 / 9389 (0.01%)	3 / 8959 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 1	0 / 1
Malignant peritoneal neoplasm
subjects affected / exposed	1 / 9389 (0.01%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Mantle cell lymphoma
subjects affected / exposed	1 / 9389 (0.01%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Metastases to abdominal wall
subjects affected / exposed	1 / 9389 (0.01%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Myeloid leukaemia
subjects affected / exposed	1 / 9389 (0.01%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Oesophageal carcinoma
subjects affected / exposed	1 / 9389 (0.01%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pancreatic carcinoma
subjects affected / exposed	1 / 9389 (0.01%)	3 / 8959 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 1	0 / 0
Prostate cancer stage I
subjects affected / exposed	1 / 9389 (0.01%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Rectal cancer
subjects affected / exposed	1 / 9389 (0.01%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Schwannoma
subjects affected / exposed	1 / 9389 (0.01%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Tonsil cancer
subjects affected / exposed	1 / 9389 (0.01%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Transitional cell carcinoma
subjects affected / exposed	1 / 9389 (0.01%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Uterine cancer
subjects affected / exposed	1 / 9389 (0.01%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Adenocarcinoma pancreas
subjects affected / exposed	0 / 9389 (0.00%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Bladder neoplasm
subjects affected / exposed	0 / 9389 (0.00%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Bone cancer
subjects affected / exposed	0 / 9389 (0.00%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Brain cancer metastatic
subjects affected / exposed	0 / 9389 (0.00%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac myxoma
subjects affected / exposed	0 / 9389 (0.00%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Central nervous system lymphoma
subjects affected / exposed	0 / 9389 (0.00%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cholangiocarcinoma
subjects affected / exposed	0 / 9389 (0.00%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Chronic myeloid leukaemia
subjects affected / exposed	0 / 9389 (0.00%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Colon cancer
subjects affected / exposed	0 / 9389 (0.00%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatic cancer
subjects affected / exposed	0 / 9389 (0.00%)	2 / 8959 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 1
Intraductal proliferative breast lesion
subjects affected / exposed	0 / 9389 (0.00%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Invasive ductal breast carcinoma
subjects affected / exposed	0 / 9389 (0.00%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Lung carcinoma cell type unspecified stage IV
subjects affected / exposed	0 / 9389 (0.00%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Malignant melanoma
subjects affected / exposed	0 / 9389 (0.00%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Marginal zone lymphoma recurrent
subjects affected / exposed	0 / 9389 (0.00%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Meningioma
subjects affected / exposed	0 / 9389 (0.00%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Non-small cell lung cancer
subjects affected / exposed	0 / 9389 (0.00%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Oesophageal cancer metastatic
subjects affected / exposed	0 / 9389 (0.00%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Oncocytoma
subjects affected / exposed	0 / 9389 (0.00%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Plasma cell myeloma
subjects affected / exposed	0 / 9389 (0.00%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Salivary gland neoplasm
subjects affected / exposed	0 / 9389 (0.00%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Squamous cell carcinoma of skin
subjects affected / exposed	0 / 9389 (0.00%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Testis cancer
subjects affected / exposed	0 / 9389 (0.00%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Vascular disorders
Deep vein thrombosis
subjects affected / exposed	5 / 9389 (0.05%)	4 / 8959 (0.04%)
occurrences causally related to treatment / all	0 / 5	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Hypertensive crisis
subjects affected / exposed	4 / 9389 (0.04%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 4	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Aortic stenosis
subjects affected / exposed	2 / 9389 (0.02%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hypertension
subjects affected / exposed	2 / 9389 (0.02%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hypertensive emergency
subjects affected / exposed	2 / 9389 (0.02%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hypotension
subjects affected / exposed	2 / 9389 (0.02%)	6 / 8959 (0.07%)
occurrences causally related to treatment / all	0 / 2	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Thrombosis
subjects affected / exposed	2 / 9389 (0.02%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 2	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Arterial occlusive disease
subjects affected / exposed	1 / 9389 (0.01%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Arteriosclerosis
subjects affected / exposed	1 / 9389 (0.01%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Bleeding varicose vein
subjects affected / exposed	1 / 9389 (0.01%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Extremity necrosis
subjects affected / exposed	1 / 9389 (0.01%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Haematoma
subjects affected / exposed	1 / 9389 (0.01%)	2 / 8959 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Internal haemorrhage
subjects affected / exposed	1 / 9389 (0.01%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Ischaemia
subjects affected / exposed	1 / 9389 (0.01%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Malignant hypertension
subjects affected / exposed	1 / 9389 (0.01%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Peripheral arterial occlusive disease
subjects affected / exposed	1 / 9389 (0.01%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Peripheral artery occlusion
subjects affected / exposed	1 / 9389 (0.01%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Peripheral artery thrombosis
subjects affected / exposed	1 / 9389 (0.01%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Shock haemorrhagic
subjects affected / exposed	1 / 9389 (0.01%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Aortic aneurysm
subjects affected / exposed	0 / 9389 (0.00%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Aortic aneurysm rupture
subjects affected / exposed	0 / 9389 (0.00%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Aortic dissection
subjects affected / exposed	0 / 9389 (0.00%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Circulatory collapse
subjects affected / exposed	0 / 9389 (0.00%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pelvic venous thrombosis
subjects affected / exposed	0 / 9389 (0.00%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Peripheral artery stenosis
subjects affected / exposed	0 / 9389 (0.00%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Peripheral ischaemia
subjects affected / exposed	0 / 9389 (0.00%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Peripheral vascular disorder
subjects affected / exposed	0 / 9389 (0.00%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Venous thrombosis limb
subjects affected / exposed	0 / 9389 (0.00%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Surgical and medical procedures
Gallbladder operation
subjects affected / exposed	0 / 9389 (0.00%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hip surgery
subjects affected / exposed	0 / 9389 (0.00%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Inguinal hernia repair
subjects affected / exposed	0 / 9389 (0.00%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
General disorders and administration site conditions
Non-cardiac chest pain
subjects affected / exposed	11 / 9389 (0.12%)	3 / 8959 (0.03%)
occurrences causally related to treatment / all	0 / 11	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Death
subjects affected / exposed	9 / 9389 (0.10%)	7 / 8959 (0.08%)
occurrences causally related to treatment / all	0 / 9	0 / 7
deaths causally related to treatment / all	0 / 9	0 / 7
Chest discomfort
subjects affected / exposed	2 / 9389 (0.02%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Chest pain
subjects affected / exposed	2 / 9389 (0.02%)	3 / 8959 (0.03%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Gait disturbance
subjects affected / exposed	2 / 9389 (0.02%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Malaise
subjects affected / exposed	2 / 9389 (0.02%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Peripheral swelling
subjects affected / exposed	2 / 9389 (0.02%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pyrexia
subjects affected / exposed	2 / 9389 (0.02%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	1 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Asthenia
subjects affected / exposed	1 / 9389 (0.01%)	3 / 8959 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac death
subjects affected / exposed	1 / 9389 (0.01%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Cyst
subjects affected / exposed	1 / 9389 (0.01%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Drug withdrawal syndrome
subjects affected / exposed	1 / 9389 (0.01%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Injection site erythema
subjects affected / exposed	1 / 9389 (0.01%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Injection site pruritus
subjects affected / exposed	1 / 9389 (0.01%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Multiple organ dysfunction syndrome
subjects affected / exposed	1 / 9389 (0.01%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Oedema peripheral
subjects affected / exposed	1 / 9389 (0.01%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Sudden cardiac death
subjects affected / exposed	1 / 9389 (0.01%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Calcinosis
subjects affected / exposed	0 / 9389 (0.00%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Dysplasia
subjects affected / exposed	0 / 9389 (0.00%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Fatigue
subjects affected / exposed	0 / 9389 (0.00%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pain
subjects affected / exposed	0 / 9389 (0.00%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Reproductive system and breast disorders
Benign prostatic hyperplasia
subjects affected / exposed	1 / 9389 (0.01%)	2 / 8959 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Endometrial thickening
subjects affected / exposed	1 / 9389 (0.01%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Female genital tract fistula
subjects affected / exposed	1 / 9389 (0.01%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Ovarian cyst
subjects affected / exposed	1 / 9389 (0.01%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
subjects affected / exposed	13 / 9389 (0.14%)	18 / 8959 (0.20%)
occurrences causally related to treatment / all	0 / 16	0 / 23
deaths causally related to treatment / all	0 / 1	0 / 1
Dyspnoea
subjects affected / exposed	10 / 9389 (0.11%)	2 / 8959 (0.02%)
occurrences causally related to treatment / all	0 / 10	0 / 2
deaths causally related to treatment / all	0 / 1	0 / 0
Pulmonary embolism
subjects affected / exposed	9 / 9389 (0.10%)	8 / 8959 (0.09%)
occurrences causally related to treatment / all	0 / 9	0 / 9
deaths causally related to treatment / all	0 / 0	0 / 0
Acute respiratory failure
subjects affected / exposed	5 / 9389 (0.05%)	13 / 8959 (0.15%)
occurrences causally related to treatment / all	0 / 5	0 / 13
deaths causally related to treatment / all	0 / 1	0 / 2
Hypoxia
subjects affected / exposed	3 / 9389 (0.03%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pulmonary oedema
subjects affected / exposed	3 / 9389 (0.03%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Acute pulmonary oedema
subjects affected / exposed	2 / 9389 (0.02%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Asthma
subjects affected / exposed	2 / 9389 (0.02%)	2 / 8959 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Pleural effusion
subjects affected / exposed	2 / 9389 (0.02%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Dyspnoea exertional
subjects affected / exposed	1 / 9389 (0.01%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumothorax
subjects affected / exposed	1 / 9389 (0.01%)	2 / 8959 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Respiratory failure
subjects affected / exposed	1 / 9389 (0.01%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Asthma-chronic obstructive pulmonary disease overlap syndrome
subjects affected / exposed	0 / 9389 (0.00%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Bronchitis chronic
subjects affected / exposed	0 / 9389 (0.00%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Chronic respiratory failure
subjects affected / exposed	0 / 9389 (0.00%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Obstructive sleep apnoea syndrome
subjects affected / exposed	0 / 9389 (0.00%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Oropharyngeal pain
subjects affected / exposed	0 / 9389 (0.00%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumothorax spontaneous
subjects affected / exposed	0 / 9389 (0.00%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pulmonary artery occlusion
subjects affected / exposed	0 / 9389 (0.00%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pulmonary thrombosis
subjects affected / exposed	0 / 9389 (0.00%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Respiratory distress
subjects affected / exposed	0 / 9389 (0.00%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Wheezing
subjects affected / exposed	0 / 9389 (0.00%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Psychiatric disorders
Depression
subjects affected / exposed	5 / 9389 (0.05%)	3 / 8959 (0.03%)
occurrences causally related to treatment / all	0 / 5	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Mental status changes
subjects affected / exposed	4 / 9389 (0.04%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 4	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Anxiety
subjects affected / exposed	2 / 9389 (0.02%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Suicidal ideation
subjects affected / exposed	2 / 9389 (0.02%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Suicide attempt
subjects affected / exposed	2 / 9389 (0.02%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Alcohol use disorder
subjects affected / exposed	1 / 9389 (0.01%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Bipolar disorder
subjects affected / exposed	1 / 9389 (0.01%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Confusional state
subjects affected / exposed	1 / 9389 (0.01%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Delirium
subjects affected / exposed	1 / 9389 (0.01%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Depression suicidal
subjects affected / exposed	1 / 9389 (0.01%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Mental disorder
subjects affected / exposed	1 / 9389 (0.01%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Schizophrenia
subjects affected / exposed	1 / 9389 (0.01%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Substance use disorder
subjects affected / exposed	1 / 9389 (0.01%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Alcohol abuse
subjects affected / exposed	0 / 9389 (0.00%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Alcohol withdrawal syndrome
subjects affected / exposed	0 / 9389 (0.00%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Disorientation
subjects affected / exposed	0 / 9389 (0.00%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Product issues
Device dislocation
subjects affected / exposed	1 / 9389 (0.01%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Device failure
subjects affected / exposed	1 / 9389 (0.01%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Device loosening
subjects affected / exposed	0 / 9389 (0.00%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Investigations
Gastrointestinal stoma output increased
subjects affected / exposed	1 / 9389 (0.01%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
SARS-CoV-2 test positive
subjects affected / exposed	1 / 9389 (0.01%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Blood magnesium decreased
subjects affected / exposed	0 / 9389 (0.00%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Blood potassium increased
subjects affected / exposed	0 / 9389 (0.00%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac murmur
subjects affected / exposed	0 / 9389 (0.00%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Heart rate increased
subjects affected / exposed	0 / 9389 (0.00%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Heart rate irregular
subjects affected / exposed	0 / 9389 (0.00%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatic enzyme increased
subjects affected / exposed	0 / 9389 (0.00%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Injury, poisoning and procedural complications
Fall
subjects affected / exposed	5 / 9389 (0.05%)	4 / 8959 (0.04%)
occurrences causally related to treatment / all	0 / 5	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Femur fracture
subjects affected / exposed	5 / 9389 (0.05%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 5	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hip fracture
subjects affected / exposed	5 / 9389 (0.05%)	6 / 8959 (0.07%)
occurrences causally related to treatment / all	0 / 5	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Humerus fracture
subjects affected / exposed	3 / 9389 (0.03%)	2 / 8959 (0.02%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Multiple injuries
subjects affected / exposed	2 / 9389 (0.02%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pelvic fracture
subjects affected / exposed	2 / 9389 (0.02%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Spinal fracture
subjects affected / exposed	2 / 9389 (0.02%)	2 / 8959 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Cervical vertebral fracture
subjects affected / exposed	1 / 9389 (0.01%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Contusion
subjects affected / exposed	1 / 9389 (0.01%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Craniocerebral injury
subjects affected / exposed	1 / 9389 (0.01%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Facial bones fracture
subjects affected / exposed	1 / 9389 (0.01%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Fibula fracture
subjects affected / exposed	1 / 9389 (0.01%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hand fracture
subjects affected / exposed	1 / 9389 (0.01%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Head injury
subjects affected / exposed	1 / 9389 (0.01%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Lumbar vertebral fracture
subjects affected / exposed	1 / 9389 (0.01%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Neck injury
subjects affected / exposed	1 / 9389 (0.01%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Patella fracture
subjects affected / exposed	1 / 9389 (0.01%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Periprosthetic fracture
subjects affected / exposed	1 / 9389 (0.01%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Post procedural haematoma
subjects affected / exposed	1 / 9389 (0.01%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Postoperative ileus
subjects affected / exposed	1 / 9389 (0.01%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Radius fracture
subjects affected / exposed	1 / 9389 (0.01%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Rib fracture
subjects affected / exposed	1 / 9389 (0.01%)	5 / 8959 (0.06%)
occurrences causally related to treatment / all	0 / 1	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Seroma
subjects affected / exposed	1 / 9389 (0.01%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Splenic injury
subjects affected / exposed	1 / 9389 (0.01%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Subdural haematoma
subjects affected / exposed	1 / 9389 (0.01%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Tendon injury
subjects affected / exposed	1 / 9389 (0.01%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Tendon rupture
subjects affected / exposed	1 / 9389 (0.01%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Thoracic vertebral fracture
subjects affected / exposed	1 / 9389 (0.01%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Wrist fracture
subjects affected / exposed	1 / 9389 (0.01%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Acetabulum fracture
subjects affected / exposed	0 / 9389 (0.00%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Ankle fracture
subjects affected / exposed	0 / 9389 (0.00%)	3 / 8959 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Burns second degree
subjects affected / exposed	0 / 9389 (0.00%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Clavicle fracture
subjects affected / exposed	0 / 9389 (0.00%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Concussion
subjects affected / exposed	0 / 9389 (0.00%)	4 / 8959 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Extradural haematoma
subjects affected / exposed	0 / 9389 (0.00%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Femoral neck fracture
subjects affected / exposed	0 / 9389 (0.00%)	4 / 8959 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Foot fracture
subjects affected / exposed	0 / 9389 (0.00%)	2 / 8959 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal injury
subjects affected / exposed	0 / 9389 (0.00%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Incisional hernia
subjects affected / exposed	0 / 9389 (0.00%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Intentional overdose
subjects affected / exposed	0 / 9389 (0.00%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Ligament rupture
subjects affected / exposed	0 / 9389 (0.00%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Limb injury
subjects affected / exposed	0 / 9389 (0.00%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Post procedural haemorrhage
subjects affected / exposed	0 / 9389 (0.00%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Procedural haemorrhage
subjects affected / exposed	0 / 9389 (0.00%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Procedural intestinal perforation
subjects affected / exposed	0 / 9389 (0.00%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Procedural pain
subjects affected / exposed	0 / 9389 (0.00%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Road traffic accident
subjects affected / exposed	0 / 9389 (0.00%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Spinal column injury
subjects affected / exposed	0 / 9389 (0.00%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Stoma site haemorrhage
subjects affected / exposed	0 / 9389 (0.00%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Subdural haemorrhage
subjects affected / exposed	0 / 9389 (0.00%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Tibia fracture
subjects affected / exposed	0 / 9389 (0.00%)	2 / 8959 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Upper limb fracture
subjects affected / exposed	0 / 9389 (0.00%)	2 / 8959 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac disorders
Atrial fibrillation
subjects affected / exposed	21 / 9389 (0.22%)	14 / 8959 (0.16%)
occurrences causally related to treatment / all	1 / 21	1 / 14
deaths causally related to treatment / all	0 / 0	0 / 0
Acute myocardial infarction
subjects affected / exposed	15 / 9389 (0.16%)	6 / 8959 (0.07%)
occurrences causally related to treatment / all	0 / 15	0 / 6
deaths causally related to treatment / all	0 / 1	0 / 0
Myocardial infarction
subjects affected / exposed	11 / 9389 (0.12%)	13 / 8959 (0.15%)
occurrences causally related to treatment / all	0 / 11	0 / 13
deaths causally related to treatment / all	0 / 3	0 / 5
Angina pectoris
subjects affected / exposed	9 / 9389 (0.10%)	6 / 8959 (0.07%)
occurrences causally related to treatment / all	0 / 10	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac failure congestive
subjects affected / exposed	8 / 9389 (0.09%)	3 / 8959 (0.03%)
occurrences causally related to treatment / all	0 / 12	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac arrest
subjects affected / exposed	6 / 9389 (0.06%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 6	0 / 1
deaths causally related to treatment / all	0 / 5	0 / 1
Cardiac failure
subjects affected / exposed	6 / 9389 (0.06%)	2 / 8959 (0.02%)
occurrences causally related to treatment / all	0 / 6	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Coronary artery disease
subjects affected / exposed	6 / 9389 (0.06%)	6 / 8959 (0.07%)
occurrences causally related to treatment / all	0 / 6	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac failure acute
subjects affected / exposed	3 / 9389 (0.03%)	3 / 8959 (0.03%)
occurrences causally related to treatment / all	0 / 3	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Arrhythmia
subjects affected / exposed	2 / 9389 (0.02%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Atrioventricular block complete
subjects affected / exposed	2 / 9389 (0.02%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Acute coronary syndrome
subjects affected / exposed	1 / 9389 (0.01%)	2 / 8959 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Acute left ventricular failure
subjects affected / exposed	1 / 9389 (0.01%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Aortic valve stenosis
subjects affected / exposed	1 / 9389 (0.01%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Arrhythmic storm
subjects affected / exposed	1 / 9389 (0.01%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Arteriosclerosis coronary artery
subjects affected / exposed	1 / 9389 (0.01%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Atrioventricular block
subjects affected / exposed	1 / 9389 (0.01%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Bradycardia
subjects affected / exposed	1 / 9389 (0.01%)	2 / 8959 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Bundle branch block left
subjects affected / exposed	1 / 9389 (0.01%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cardio-respiratory arrest
subjects affected / exposed	1 / 9389 (0.01%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 1
Congestive cardiomyopathy
subjects affected / exposed	1 / 9389 (0.01%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Myocardial ischaemia
subjects affected / exposed	1 / 9389 (0.01%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Palpitations
subjects affected / exposed	1 / 9389 (0.01%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pericarditis
subjects affected / exposed	1 / 9389 (0.01%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Sinus arrest
subjects affected / exposed	1 / 9389 (0.01%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Sinus bradycardia
subjects affected / exposed	1 / 9389 (0.01%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Sinus node dysfunction
subjects affected / exposed	1 / 9389 (0.01%)	2 / 8959 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Stress cardiomyopathy
subjects affected / exposed	1 / 9389 (0.01%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Supraventricular tachycardia
subjects affected / exposed	1 / 9389 (0.01%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Ventricular tachycardia
subjects affected / exposed	1 / 9389 (0.01%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Angina unstable
subjects affected / exposed	0 / 9389 (0.00%)	4 / 8959 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac failure chronic
subjects affected / exposed	0 / 9389 (0.00%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiomyopathy
subjects affected / exposed	0 / 9389 (0.00%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiovascular disorder
subjects affected / exposed	0 / 9389 (0.00%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Pericardial effusion
subjects affected / exposed	0 / 9389 (0.00%)	3 / 8959 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Pulseless electrical activity
subjects affected / exposed	0 / 9389 (0.00%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Nervous system disorders
Cerebrovascular accident
subjects affected / exposed	15 / 9389 (0.16%)	11 / 8959 (0.12%)
occurrences causally related to treatment / all	2 / 15	0 / 11
deaths causally related to treatment / all	0 / 3	0 / 0
Transient ischaemic attack
subjects affected / exposed	12 / 9389 (0.13%)	6 / 8959 (0.07%)
occurrences causally related to treatment / all	0 / 12	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Syncope
subjects affected / exposed	9 / 9389 (0.10%)	8 / 8959 (0.09%)
occurrences causally related to treatment / all	2 / 9	0 / 8
deaths causally related to treatment / all	0 / 0	0 / 0
Encephalopathy
subjects affected / exposed	3 / 9389 (0.03%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Carotid artery stenosis
subjects affected / exposed	2 / 9389 (0.02%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cerebral haemorrhage
subjects affected / exposed	2 / 9389 (0.02%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Dizziness
subjects affected / exposed	2 / 9389 (0.02%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Ischaemic stroke
subjects affected / exposed	2 / 9389 (0.02%)	2 / 8959 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 1
Metabolic encephalopathy
subjects affected / exposed	2 / 9389 (0.02%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Myelopathy
subjects affected / exposed	2 / 9389 (0.02%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Presyncope
subjects affected / exposed	2 / 9389 (0.02%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Alcoholic seizure
subjects affected / exposed	1 / 9389 (0.01%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Altered state of consciousness
subjects affected / exposed	1 / 9389 (0.01%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Amnesia
subjects affected / exposed	1 / 9389 (0.01%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Ataxia
subjects affected / exposed	1 / 9389 (0.01%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Basal ganglia stroke
subjects affected / exposed	1 / 9389 (0.01%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Carotid artery occlusion
subjects affected / exposed	1 / 9389 (0.01%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cerebral ischaemia
subjects affected / exposed	1 / 9389 (0.01%)	2 / 8959 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Cerebrospinal fluid leakage
subjects affected / exposed	1 / 9389 (0.01%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cervical radiculopathy
subjects affected / exposed	1 / 9389 (0.01%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Embolic stroke
subjects affected / exposed	1 / 9389 (0.01%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Epilepsy
subjects affected / exposed	1 / 9389 (0.01%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Facial paresis
subjects affected / exposed	1 / 9389 (0.01%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Headache
subjects affected / exposed	1 / 9389 (0.01%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatic encephalopathy
subjects affected / exposed	1 / 9389 (0.01%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Loss of consciousness
subjects affected / exposed	1 / 9389 (0.01%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Monoplegia
subjects affected / exposed	1 / 9389 (0.01%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Paralysis
subjects affected / exposed	1 / 9389 (0.01%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Seizure
subjects affected / exposed	1 / 9389 (0.01%)	3 / 8959 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Speech disorder
subjects affected / exposed	1 / 9389 (0.01%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Bell's palsy
subjects affected / exposed	0 / 9389 (0.00%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cervical spinal cord paralysis
subjects affected / exposed	0 / 9389 (0.00%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Dysarthria
subjects affected / exposed	0 / 9389 (0.00%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Facial paralysis
subjects affected / exposed	0 / 9389 (0.00%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Haemorrhage intracranial
subjects affected / exposed	0 / 9389 (0.00%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Haemorrhagic stroke
subjects affected / exposed	0 / 9389 (0.00%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Lacunar stroke
subjects affected / exposed	0 / 9389 (0.00%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Lumbar radiculopathy
subjects affected / exposed	0 / 9389 (0.00%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Migraine
subjects affected / exposed	0 / 9389 (0.00%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Mononeuropathy
subjects affected / exposed	0 / 9389 (0.00%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Normal pressure hydrocephalus
subjects affected / exposed	0 / 9389 (0.00%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Paraesthesia
subjects affected / exposed	0 / 9389 (0.00%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Partial seizures
subjects affected / exposed	0 / 9389 (0.00%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Sciatica
subjects affected / exposed	0 / 9389 (0.00%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Spinal claudication
subjects affected / exposed	0 / 9389 (0.00%)	2 / 8959 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Toxic encephalopathy
subjects affected / exposed	0 / 9389 (0.00%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Blood and lymphatic system disorders
Anaemia
subjects affected / exposed	2 / 9389 (0.02%)	4 / 8959 (0.04%)
occurrences causally related to treatment / all	0 / 2	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Blood loss anaemia
subjects affected / exposed	1 / 9389 (0.01%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Febrile neutropenia
subjects affected / exposed	1 / 9389 (0.01%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Immune thrombocytopenia
subjects affected / exposed	1 / 9389 (0.01%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Iron deficiency anaemia
subjects affected / exposed	0 / 9389 (0.00%)	2 / 8959 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Leukocytosis
subjects affected / exposed	0 / 9389 (0.00%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Ear and labyrinth disorders
Vertigo
subjects affected / exposed	1 / 9389 (0.01%)	2 / 8959 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Vertigo positional
subjects affected / exposed	1 / 9389 (0.01%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Eye disorders
Diplopia
subjects affected / exposed	1 / 9389 (0.01%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Lens dislocation
subjects affected / exposed	1 / 9389 (0.01%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Macular oedema
subjects affected / exposed	1 / 9389 (0.01%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Glaucoma
subjects affected / exposed	0 / 9389 (0.00%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Visual impairment
subjects affected / exposed	0 / 9389 (0.00%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal disorders
Small intestinal obstruction
subjects affected / exposed	5 / 9389 (0.05%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 5	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Abdominal pain
subjects affected / exposed	4 / 9389 (0.04%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 4	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Colitis
subjects affected / exposed	4 / 9389 (0.04%)	2 / 8959 (0.02%)
occurrences causally related to treatment / all	0 / 4	1 / 3
deaths causally related to treatment / all	0 / 1	0 / 0
Gastrointestinal haemorrhage
subjects affected / exposed	4 / 9389 (0.04%)	2 / 8959 (0.02%)
occurrences causally related to treatment / all	0 / 4	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Colitis ischaemic
subjects affected / exposed	2 / 9389 (0.02%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Diarrhoea
subjects affected / exposed	2 / 9389 (0.02%)	2 / 8959 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Duodenal ulcer haemorrhage
subjects affected / exposed	2 / 9389 (0.02%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Dysphagia
subjects affected / exposed	2 / 9389 (0.02%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Inguinal hernia
subjects affected / exposed	2 / 9389 (0.02%)	2 / 8959 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Pancreatitis
subjects affected / exposed	2 / 9389 (0.02%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pancreatitis acute
subjects affected / exposed	2 / 9389 (0.02%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Rectal haemorrhage
subjects affected / exposed	2 / 9389 (0.02%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Upper gastrointestinal haemorrhage
subjects affected / exposed	2 / 9389 (0.02%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Abdominal hernia
subjects affected / exposed	1 / 9389 (0.01%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Abdominal incarcerated hernia
subjects affected / exposed	1 / 9389 (0.01%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Abdominal pain lower
subjects affected / exposed	1 / 9389 (0.01%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Abdominal pain upper
subjects affected / exposed	1 / 9389 (0.01%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Constipation
subjects affected / exposed	1 / 9389 (0.01%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Diaphragmatic hernia
subjects affected / exposed	1 / 9389 (0.01%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Diverticulum intestinal haemorrhagic
subjects affected / exposed	1 / 9389 (0.01%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Dyspepsia
subjects affected / exposed	1 / 9389 (0.01%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Enteritis
subjects affected / exposed	1 / 9389 (0.01%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gastric ulcer haemorrhage
subjects affected / exposed	1 / 9389 (0.01%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastritis
subjects affected / exposed	1 / 9389 (0.01%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal obstruction
subjects affected / exposed	1 / 9389 (0.01%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Haematemesis
subjects affected / exposed	1 / 9389 (0.01%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Haematochezia
subjects affected / exposed	1 / 9389 (0.01%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Intestinal obstruction
subjects affected / exposed	1 / 9389 (0.01%)	2 / 8959 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Lower gastrointestinal haemorrhage
subjects affected / exposed	1 / 9389 (0.01%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Oesophageal ulcer haemorrhage
subjects affected / exposed	1 / 9389 (0.01%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Oesophagitis
subjects affected / exposed	1 / 9389 (0.01%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Proctitis ulcerative
subjects affected / exposed	1 / 9389 (0.01%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Umbilical hernia
subjects affected / exposed	1 / 9389 (0.01%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Vomiting
subjects affected / exposed	1 / 9389 (0.01%)	3 / 8959 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Abdominal wall haematoma
subjects affected / exposed	0 / 9389 (0.00%)	2 / 8959 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Diverticular perforation
subjects affected / exposed	0 / 9389 (0.00%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Enterovesical fistula
subjects affected / exposed	0 / 9389 (0.00%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastric ulcer
subjects affected / exposed	0 / 9389 (0.00%)	3 / 8959 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Hiatus hernia
subjects affected / exposed	0 / 9389 (0.00%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Ileus
subjects affected / exposed	0 / 9389 (0.00%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Intestinal perforation
subjects affected / exposed	0 / 9389 (0.00%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Large intestine polyp
subjects affected / exposed	0 / 9389 (0.00%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Nausea
subjects affected / exposed	0 / 9389 (0.00%)	2 / 8959 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Obstructive pancreatitis
subjects affected / exposed	0 / 9389 (0.00%)	2 / 8959 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Volvulus of small bowel
subjects affected / exposed	0 / 9389 (0.00%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatobiliary disorders
Cholecystitis acute
subjects affected / exposed	5 / 9389 (0.05%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 5	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cholelithiasis
subjects affected / exposed	3 / 9389 (0.03%)	2 / 8959 (0.02%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Biliary colic
subjects affected / exposed	1 / 9389 (0.01%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cholecystitis
subjects affected / exposed	1 / 9389 (0.01%)	3 / 8959 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatic cirrhosis
subjects affected / exposed	1 / 9389 (0.01%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatotoxicity
subjects affected / exposed	1 / 9389 (0.01%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Bile duct stenosis
subjects affected / exposed	0 / 9389 (0.00%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Biliary obstruction
subjects affected / exposed	0 / 9389 (0.00%)	2 / 8959 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatic lesion
subjects affected / exposed	0 / 9389 (0.00%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatitis alcoholic
subjects affected / exposed	0 / 9389 (0.00%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Skin and subcutaneous tissue disorders
Dermatitis
subjects affected / exposed	1 / 9389 (0.01%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Diabetic foot
subjects affected / exposed	1 / 9389 (0.01%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Decubitus ulcer
subjects affected / exposed	0 / 9389 (0.00%)	2 / 8959 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Transient acantholytic dermatosis
subjects affected / exposed	0 / 9389 (0.00%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Renal and urinary disorders
Acute kidney injury
subjects affected / exposed	7 / 9389 (0.07%)	2 / 8959 (0.02%)
occurrences causally related to treatment / all	0 / 8	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Nephrolithiasis
subjects affected / exposed	4 / 9389 (0.04%)	6 / 8959 (0.07%)
occurrences causally related to treatment / all	0 / 4	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Chronic kidney disease
subjects affected / exposed	1 / 9389 (0.01%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
End stage renal disease
subjects affected / exposed	1 / 9389 (0.01%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hydronephrosis
subjects affected / exposed	1 / 9389 (0.01%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Mixed incontinence
subjects affected / exposed	1 / 9389 (0.01%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Renal failure
subjects affected / exposed	1 / 9389 (0.01%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Ureterolithiasis
subjects affected / exposed	1 / 9389 (0.01%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Urinary retention
subjects affected / exposed	1 / 9389 (0.01%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Urinary tract obstruction
subjects affected / exposed	1 / 9389 (0.01%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Bladder spasm
subjects affected / exposed	0 / 9389 (0.00%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Ureteric obstruction
subjects affected / exposed	0 / 9389 (0.00%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Urinary bladder polyp
subjects affected / exposed	0 / 9389 (0.00%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Endocrine disorders
Goitre
subjects affected / exposed	1 / 9389 (0.01%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Musculoskeletal and connective tissue disorders
Osteoarthritis
subjects affected / exposed	14 / 9389 (0.15%)	24 / 8959 (0.27%)
occurrences causally related to treatment / all	0 / 14	0 / 24
deaths causally related to treatment / all	0 / 0	0 / 0
Arthralgia
subjects affected / exposed	4 / 9389 (0.04%)	2 / 8959 (0.02%)
occurrences causally related to treatment / all	0 / 4	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Lumbar spinal stenosis
subjects affected / exposed	4 / 9389 (0.04%)	2 / 8959 (0.02%)
occurrences causally related to treatment / all	0 / 4	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Arthritis
subjects affected / exposed	2 / 9389 (0.02%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Back pain
subjects affected / exposed	2 / 9389 (0.02%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cervical spinal stenosis
subjects affected / exposed	2 / 9389 (0.02%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Intervertebral disc protrusion
subjects affected / exposed	2 / 9389 (0.02%)	2 / 8959 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Joint swelling
subjects affected / exposed	2 / 9389 (0.02%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Spinal retrolisthesis
subjects affected / exposed	2 / 9389 (0.02%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Spinal stenosis
subjects affected / exposed	2 / 9389 (0.02%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Spondylolisthesis
subjects affected / exposed	2 / 9389 (0.02%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Foot deformity
subjects affected / exposed	1 / 9389 (0.01%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Fracture pain
subjects affected / exposed	1 / 9389 (0.01%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Intervertebral disc compression
subjects affected / exposed	1 / 9389 (0.01%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Musculoskeletal stiffness
subjects affected / exposed	1 / 9389 (0.01%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Neck pain
subjects affected / exposed	1 / 9389 (0.01%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Osteochondrosis
subjects affected / exposed	1 / 9389 (0.01%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Scoliosis
subjects affected / exposed	1 / 9389 (0.01%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Soft tissue swelling
subjects affected / exposed	1 / 9389 (0.01%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Haemarthrosis
subjects affected / exposed	0 / 9389 (0.00%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Intervertebral disc degeneration
subjects affected / exposed	0 / 9389 (0.00%)	2 / 8959 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Joint range of motion decreased
subjects affected / exposed	0 / 9389 (0.00%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Muscle spasms
subjects affected / exposed	0 / 9389 (0.00%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Rhabdomyolysis
subjects affected / exposed	0 / 9389 (0.00%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Rotator cuff syndrome
subjects affected / exposed	0 / 9389 (0.00%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Spinal osteoarthritis
subjects affected / exposed	0 / 9389 (0.00%)	2 / 8959 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Synovial cyst
subjects affected / exposed	0 / 9389 (0.00%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Vertebral osteophyte
subjects affected / exposed	0 / 9389 (0.00%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Infections and infestations
Pneumonia
subjects affected / exposed	37 / 9389 (0.39%)	23 / 8959 (0.26%)
occurrences causally related to treatment / all	1 / 38	1 / 24
deaths causally related to treatment / all	0 / 1	0 / 0
Sepsis
subjects affected / exposed	12 / 9389 (0.13%)	9 / 8959 (0.10%)
occurrences causally related to treatment / all	0 / 12	0 / 9
deaths causally related to treatment / all	0 / 1	0 / 0
Cellulitis
subjects affected / exposed	10 / 9389 (0.11%)	6 / 8959 (0.07%)
occurrences causally related to treatment / all	0 / 11	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
COVID-19
subjects affected / exposed	9 / 9389 (0.10%)	5 / 8959 (0.06%)
occurrences causally related to treatment / all	0 / 9	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Urinary tract infection
subjects affected / exposed	9 / 9389 (0.10%)	7 / 8959 (0.08%)
occurrences causally related to treatment / all	0 / 9	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
Diverticulitis
subjects affected / exposed	6 / 9389 (0.06%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 6	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Arthritis infective
subjects affected / exposed	5 / 9389 (0.05%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 7	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Appendicitis
subjects affected / exposed	4 / 9389 (0.04%)	3 / 8959 (0.03%)
occurrences causally related to treatment / all	0 / 4	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
COVID-19 pneumonia
subjects affected / exposed	4 / 9389 (0.04%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 4	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Influenza
subjects affected / exposed	3 / 9389 (0.03%)	2 / 8959 (0.02%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Pyelonephritis
subjects affected / exposed	3 / 9389 (0.03%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Septic shock
subjects affected / exposed	3 / 9389 (0.03%)	4 / 8959 (0.04%)
occurrences causally related to treatment / all	0 / 3	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 1
Abscess limb
subjects affected / exposed	2 / 9389 (0.02%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Atypical pneumonia
subjects affected / exposed	2 / 9389 (0.02%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cystitis
subjects affected / exposed	2 / 9389 (0.02%)	2 / 8959 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Localised infection
subjects affected / exposed	2 / 9389 (0.02%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Metapneumovirus pneumonia
subjects affected / exposed	2 / 9389 (0.02%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Osteomyelitis
subjects affected / exposed	2 / 9389 (0.02%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Sinusitis
subjects affected / exposed	2 / 9389 (0.02%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Abdominal wall abscess
subjects affected / exposed	1 / 9389 (0.01%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Abscess intestinal
subjects affected / exposed	1 / 9389 (0.01%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Arthritis bacterial
subjects affected / exposed	1 / 9389 (0.01%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Bacterial infection
subjects affected / exposed	1 / 9389 (0.01%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Campylobacter infection
subjects affected / exposed	1 / 9389 (0.01%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cellulitis staphylococcal
subjects affected / exposed	1 / 9389 (0.01%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Clostridium difficile infection
subjects affected / exposed	1 / 9389 (0.01%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Complicated appendicitis
subjects affected / exposed	1 / 9389 (0.01%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Endocarditis
subjects affected / exposed	1 / 9389 (0.01%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Epididymitis
subjects affected / exposed	1 / 9389 (0.01%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Escherichia bacteraemia
subjects affected / exposed	1 / 9389 (0.01%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Fournier's gangrene
subjects affected / exposed	1 / 9389 (0.01%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gangrene
subjects affected / exposed	1 / 9389 (0.01%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatitis A
subjects affected / exposed	1 / 9389 (0.01%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Infective exacerbation of chronic obstructive airways disease
subjects affected / exposed	1 / 9389 (0.01%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Large intestine infection
subjects affected / exposed	1 / 9389 (0.01%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Lower respiratory tract infection
subjects affected / exposed	1 / 9389 (0.01%)	2 / 8959 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Norovirus infection
subjects affected / exposed	1 / 9389 (0.01%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumonia influenzal
subjects affected / exposed	1 / 9389 (0.01%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumonia respiratory syncytial viral
subjects affected / exposed	1 / 9389 (0.01%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Postoperative wound infection
subjects affected / exposed	1 / 9389 (0.01%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Staphylococcal infection
subjects affected / exposed	1 / 9389 (0.01%)	2 / 8959 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Urosepsis
subjects affected / exposed	1 / 9389 (0.01%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Wound infection
subjects affected / exposed	1 / 9389 (0.01%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Bronchitis
subjects affected / exposed	0 / 9389 (0.00%)	3 / 8959 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Cholecystitis infective
subjects affected / exposed	0 / 9389 (0.00%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Erysipelas
subjects affected / exposed	0 / 9389 (0.00%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
External ear cellulitis
subjects affected / exposed	0 / 9389 (0.00%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Fungaemia
subjects affected / exposed	0 / 9389 (0.00%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastroenteritis
subjects affected / exposed	0 / 9389 (0.00%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Incision site abscess
subjects affected / exposed	0 / 9389 (0.00%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Infected bite
subjects affected / exposed	0 / 9389 (0.00%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Kidney infection
subjects affected / exposed	0 / 9389 (0.00%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Oesophageal candidiasis
subjects affected / exposed	0 / 9389 (0.00%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pelvic abscess
subjects affected / exposed	0 / 9389 (0.00%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Peritonitis
subjects affected / exposed	0 / 9389 (0.00%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumococcal bacteraemia
subjects affected / exposed	0 / 9389 (0.00%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Post procedural infection
subjects affected / exposed	0 / 9389 (0.00%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pyelonephritis acute
subjects affected / exposed	0 / 9389 (0.00%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Rhinovirus infection
subjects affected / exposed	0 / 9389 (0.00%)	2 / 8959 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Scrotal cellulitis
subjects affected / exposed	0 / 9389 (0.00%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Skin bacterial infection
subjects affected / exposed	0 / 9389 (0.00%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Streptococcal sepsis
subjects affected / exposed	0 / 9389 (0.00%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Vestibular neuronitis
subjects affected / exposed	0 / 9389 (0.00%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Vulval abscess
subjects affected / exposed	0 / 9389 (0.00%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Metabolism and nutrition disorders
Dehydration
subjects affected / exposed	6 / 9389 (0.06%)	3 / 8959 (0.03%)
occurrences causally related to treatment / all	0 / 6	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Hypoglycaemia
subjects affected / exposed	4 / 9389 (0.04%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 4	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hypokalaemia
subjects affected / exposed	4 / 9389 (0.04%)	2 / 8959 (0.02%)
occurrences causally related to treatment / all	0 / 4	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Hyponatraemia
subjects affected / exposed	3 / 9389 (0.03%)	2 / 8959 (0.02%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Diabetic ketoacidosis
subjects affected / exposed	2 / 9389 (0.02%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hyperglycaemia
subjects affected / exposed	2 / 9389 (0.02%)	3 / 8959 (0.03%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Hyperglycaemic hyperosmolar nonketotic syndrome
subjects affected / exposed	2 / 9389 (0.02%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hyperkalaemia
subjects affected / exposed	2 / 9389 (0.02%)	2 / 8959 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Hypervolaemia
subjects affected / exposed	2 / 9389 (0.02%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 4	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hypovolaemia
subjects affected / exposed	2 / 9389 (0.02%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Electrolyte imbalance
subjects affected / exposed	1 / 9389 (0.01%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Failure to thrive
subjects affected / exposed	1 / 9389 (0.01%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Hypomagnesaemia
subjects affected / exposed	1 / 9389 (0.01%)	0 / 8959 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cachexia
subjects affected / exposed	0 / 9389 (0.00%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Gout
subjects affected / exposed	0 / 9389 (0.00%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Malnutrition
subjects affected / exposed	0 / 9389 (0.00%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Metabolic acidosis
subjects affected / exposed	0 / 9389 (0.00%)	1 / 8959 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 0.5%

Non-serious adverse events	MVA-BN-RSV	Placebo
Total subjects affected by non serious adverse events
subjects affected / exposed	82 / 9389 (0.87%)	82 / 8959 (0.92%)
Infections and infestations
COVID-19
subjects affected / exposed	82 / 9389 (0.87%)	82 / 8959 (0.92%)
occurrences all number	83	84

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Were there any global substantial amendments to the protocol? No

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None reported

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Clinical trials

Clinical Trial Results:
A Randomized, Double-blind, Phase 3 Trial to Assess Clinical Efficacy, Safety and Reactogenicity of the Recombinant MVA-BN®-RSV Vaccine in Adults ≥60 Years of Age

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Occurrence of PCR Confirmed RSV-associated LRTD With at Least 3 Symptoms

Primary: Occurrence of PCR Confirmed RSV-associated LRTD With at Least 3 Symptoms

Primary: Occurrence of PCR Confirmed RSV-associated LRTD With at Least 2 Symptoms

Primary: Occurrence of PCR Confirmed RSV-associated LRTD With at Least 2 Symptoms

Secondary: Occurrence of PCR Confirmed RSV-associated ARD

Secondary: Occurrence of PCR Confirmed RSV-associated ARD

Secondary: Occurrence of Complications Related to PCR-confirmed RSV Disease

Secondary: Occurrence of Complications Related to PCR-confirmed RSV Disease

Secondary: Occurrence of Hospitalization Due to Confirmed RSV Disease or Due to Any Complication Related to RSV-confirmed Respiratory Disease

Secondary: Occurrence of Hospitalization Due to Confirmed RSV Disease or Due to Any Complication Related to RSV-confirmed Respiratory Disease

Secondary: Occurrence of Severe PCR Confirmed RSV-associated LRTD

Secondary: Occurrence of Severe PCR Confirmed RSV-associated LRTD

Secondary: RSV-specific Serum IgG Antibody Titers

Secondary: RSV-specific Serum IgG Antibody Titers

Secondary: RSV-specific Serum Neutralizing Antibody Titers (Subtype A)

Secondary: RSV-specific Serum Neutralizing Antibody Titers (Subtype A)

Secondary: RSV-specific Serum Neutralizing Antibody Titers (Subtype B)

Secondary: RSV-specific Serum Neutralizing Antibody Titers (Subtype B)

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA

Clinical trials

Clinical Trial Results: A Randomized, Double-blind, Phase 3 Trial to Assess Clinical Efficacy, Safety and Reactogenicity of the Recombinant MVA-BN®-RSV Vaccine in Adults ≥60 Years of Age

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Occurrence of PCR Confirmed RSV-associated LRTD With at Least 3 Symptoms

Primary: Occurrence of PCR Confirmed RSV-associated LRTD With at Least 3 Symptoms

Primary: Occurrence of PCR Confirmed RSV-associated LRTD With at Least 2 Symptoms

Primary: Occurrence of PCR Confirmed RSV-associated LRTD With at Least 2 Symptoms

Secondary: Occurrence of PCR Confirmed RSV-associated ARD

Secondary: Occurrence of PCR Confirmed RSV-associated ARD

Secondary: Occurrence of Complications Related to PCR-confirmed RSV Disease

Secondary: Occurrence of Complications Related to PCR-confirmed RSV Disease

Secondary: Occurrence of Hospitalization Due to Confirmed RSV Disease or Due to Any Complication Related to RSV-confirmed Respiratory Disease

Secondary: Occurrence of Hospitalization Due to Confirmed RSV Disease or Due to Any Complication Related to RSV-confirmed Respiratory Disease

Secondary: Occurrence of Severe PCR Confirmed RSV-associated LRTD

Secondary: Occurrence of Severe PCR Confirmed RSV-associated LRTD

Secondary: RSV-specific Serum IgG Antibody Titers

Secondary: RSV-specific Serum IgG Antibody Titers

Secondary: RSV-specific Serum Neutralizing Antibody Titers (Subtype A)

Secondary: RSV-specific Serum Neutralizing Antibody Titers (Subtype A)

Secondary: RSV-specific Serum Neutralizing Antibody Titers (Subtype B)

Secondary: RSV-specific Serum Neutralizing Antibody Titers (Subtype B)

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

Clinical Trial Results:
A Randomized, Double-blind, Phase 3 Trial to Assess Clinical Efficacy, Safety and Reactogenicity of the Recombinant MVA-BN®-RSV Vaccine in Adults ≥60 Years of Age