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Clinical Trial Results:
A Phase 3, Randomized, Observer-blind, Active-controlled Study to Evaluate the Safety and Efficacy of mRNA-1010 Candidate Seasonal Influenza Vaccine in Adults 50 Years and Older

Summary
EudraCT number	2022-001638-12
Trial protocol	ES DE EE BG DK PL
Global end of trial date	05 Jan 2024

Results information
Results version number	v1(current)
This version publication date	05 Jan 2025
First version publication date	05 Jan 2025
Other versions

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

mRNA-1010-P302

ISRCTN number

US NCT number

NCT05566639

WHO universal trial number (UTN)

Sponsor organisation name

ModernaTX, Inc.

Sponsor organisation address

325 Binney Street, Cambridge, United States, 02142

Public contact

Moderna Clinical Trials Support Center, ModernaTX, Inc., +1 877-777-7187, clinicaltrials@modernatx.com

Scientific contact

Moderna Clinical Trials Support Center, ModernaTX, Inc., +1 877-777-7187, clinicaltrials@modernatx.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

16 Feb 2024

Is this the analysis of the primary completion data?

Yes

Primary completion date

05 Jan 2024

Global end of trial reached?

Yes

Global end of trial date

05 Jan 2024

Was the trial ended prematurely?

Main objective of the trial

The purpose of this study is to evaluate the safety and efficacy of mRNA-1010 in preventing seasonal influenza in adults 50 years and older.

Protection of trial subjects

This study was conducted in accordance with the protocol and consensus ethical principles derived from international guidelines including the Declaration of Helsinki, Council for International Organizations of Medical Sciences (CIOMS) International Ethical Guidelines, applicable International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Good Clinical Practice (GCP) Guidelines, and other applicable laws and regulations.

Background therapy

Evidence for comparator

Actual start date of recruitment

14 Sep 2022

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

Bulgaria: 1383

Country: Number of subjects enrolled

Canada: 1175

Country: Number of subjects enrolled

Denmark: 17

Country: Number of subjects enrolled

Estonia: 559

Country: Number of subjects enrolled

Germany: 782

Country: Number of subjects enrolled

Poland: 400

Country: Number of subjects enrolled

Spain: 129

Country: Number of subjects enrolled

Taiwan: 136

Country: Number of subjects enrolled

United Kingdom: 102

Country: Number of subjects enrolled

United States: 17819

Worldwide total number of subjects

22502

EEA total number of subjects

3270

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)

11501

From 65 to 84 years

10791

85 years and over

210

Subject disposition

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Recruitment details

Screening details

A total of 22502 participants were randomized in this study, including 11252 participants in the mRNA-1010 group and 11250 participants in the Fluarix Quadrivalent group.

Period 1 title

Overall Study (overall period)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator, Assessor

Are arms mutually exclusive

Yes

Fluarix Quadrivalent

Arm description

Participants received a single dose of Fluarix Quadrivalent by intramuscular (IM) injection on Day 1.

Arm type

Active comparator

Investigational medicinal product name

Fluarix Quadrivalent

Investigational medicinal product code

Other name

Licensed quadrivalent inactivated seasonal influenza vaccine

Pharmaceutical forms

Suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

Fluarix Quadrivalent was administered per schedule specified in the arm description.

mRNA-1010

Arm description

Participants received a single dose of mRNA-1010 by IM injection on Day 1.

Arm type

Experimental

Investigational medicinal product name

mRNA-1010

Investigational medicinal product code

Other name

Seasonal influenza vaccine

Pharmaceutical forms

Suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

mRNA-1010 was administered per schedule specified in the arm description.

Number of subjects in period 1	Fluarix Quadrivalent	mRNA-1010
Started	11250	11252
Full Analysis Set	11199	11211
Safety Set	11200	11210
Solicited Safety Set	11160	11168
Per-Protocol (PP) Set	11026	11055
PP Immunogenicity Set (PPIS)	408 ^[1]	444 ^[2]
Completed	10359	10359
Not completed	891	893
Adverse event, serious fatal	44	45
Physician decision	45	44
Consent withdrawn by subject	277	271
Other Than Specified	52	64
Adverse event, non-fatal	1	1
Protocol Deviation	4	4
Lost to follow-up	467	461
Serious Adverse Event	1	3

Notes
[1] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: These are the number of participants in the PPIS.
[2] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: These are the number of participants in the PPIS.

Baseline characteristics

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Reporting group title

Fluarix Quadrivalent

Reporting group description

Participants received a single dose of Fluarix Quadrivalent by intramuscular (IM) injection on Day 1.

Reporting group title

mRNA-1010

Reporting group description

Participants received a single dose of mRNA-1010 by IM injection on Day 1.

Reporting group values	Fluarix Quadrivalent	mRNA-1010	Total
Number of subjects	11250	11252	22502
Age categorical
Units: Subjects
Age Continuous
Units: years
arithmetic mean (standard deviation)	63.8 ( 8.41 )	63.9 ( 8.36 )	-
Sex: Female, Male
Units: participants
Female	6281	6256	12537
Male	4969	4996	9965
Race (NIH/OMB)
Units: Subjects
American Indian or Alaska Native	55	57	112
Asian	280	254	534
Native Hawaiian or Other Pacific Islander	15	11	26
Black or African American	1986	1950	3936
White	8790	8850	17640
More than one race	37	48	85
Unknown or Not Reported	87	82	169
Ethnicity (NIH/OMB)
Units: Subjects
Hispanic or Latino	1837	1859	3696
Not Hispanic or Latino	9289	9273	18562
Unknown or Not Reported	124	120	244

End points

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Reporting group title

Fluarix Quadrivalent

Reporting group description

Participants received a single dose of Fluarix Quadrivalent by intramuscular (IM) injection on Day 1.

Reporting group title

mRNA-1010

Reporting group description

Participants received a single dose of mRNA-1010 by IM injection on Day 1.

Primary: Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs)

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End point title

Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs) ^[1]

End point description

Solicited ARs (local and systemic) were collected in an electronic diary (eDiary). Local ARs: injection site pain, erythema, swelling/induration, and axillary (underarm) swelling or tenderness ipsilateral to the side of injection. Systemic ARs: fever, headache, fatigue, myalgia, arthralgia, nausea/vomiting, and chills. All solicited ARs considered causally related to injection were graded 0-4 (per Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials); lower score indicates lower severity, and a higher score indicates greater severity. Note, not all solicited ARs were considered adverse events (AEs). Investigator reviewed whether solicited AR was also to be recorded as an AE. A Summary of serious AEs (SAEs) and nonserious AEs, regardless of causality, is located in "Reported Adverse Events" section. Solicited Safety Set: all randomized participants who received any study intervention and contributed to any solicited AR data.

End point type

Primary

End point timeframe

7 days post-vaccination

Notes
[1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The endpoint is descriptive in nature.

End point values	Fluarix Quadrivalent	mRNA-1010
Number of subjects analysed	11160	11168
Units: participants
Any	5620	7989
Grade 1	3840	4433
Grade 2	1535	3050
Grade 3	245	500
Grade 4	0	6

No statistical analyses for this end point

Primary: Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Discontinuation

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End point title

Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Discontinuation ^[2]

End point description

An SAE was defined as any AE that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in disability/permanent damage, was a congenital anomaly/birth defect, or was an important medical event. AESIs included thrombocytopenia, new onset of or worsening of the protocol specified neurologic diseases, anaphylaxis, and myocarditis/pericarditis. An MAAE is an AE that lead to an unscheduled visit to an healthcare practitioner. This included visits to a study site for unscheduled assessments (for example, abnormal laboratory follow-up, and/or coronavirus disease 2019 [COVID-19] and visits to healthcare practitioners external to the study site (for example, urgent care, primary care physician). Safety Set included all randomized participants who received any study intervention. Participants were included in the vaccination group corresponding to the study intervention that they actually received.

End point type

Primary

End point timeframe

Day 1 through Day 361 (Month 12)

Notes
[2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The endpoint is descriptive in nature.

End point values	Fluarix Quadrivalent	mRNA-1010
Number of subjects analysed	11200	11210
Units: participants
SAEs	495	518
AESIs	13	10
MAAEs	3166	3126
AEs Leading to Discontinuation	47	49

No statistical analyses for this end point

Primary: Number of Participants With Unsolicited Adverse Events (AEs)

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End point title

Number of Participants With Unsolicited Adverse Events (AEs) ^[3]

End point description

An unsolicited AE was an AE that was not solicited using a participant diary and that was communicated by a participant who has signed informed consent. An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Any abnormal laboratory test result (hematology, clinical chemistry, or prothrombin time [PT]/partial thromboplastin time [PTT]) or other safety assessment, including one that worsened from baseline and was considered clinically significant in the medical and scientific judgment of the Investigator was recorded as an AE. Number of participants with unsolicited AEs (SAEs and non-serious AEs) up to 28 days post-vaccination are reported in this endpoint. Safety Set included all randomized participants who received any study intervention. Participants were included in the vaccination group corresponding to the study intervention that they actually received.

End point type

Primary

End point timeframe

Up to 28 days post-vaccination

Notes
[3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The endpoint is descriptive in nature.

End point values	Fluarix Quadrivalent	mRNA-1010
Number of subjects analysed	11200	11210
Units: participants	1495	1351

No statistical analyses for this end point

Primary: Number of Participants With First Episode of RT-PCR-Confirmed Protocol-Defined Influenza-Like Illness (ILI) Caused by Any Seasonal Influenza A or B Virus Strains Regardless of Antigenic Match to Strains Selected for the Seasonal Vaccine

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End point title

Number of Participants With First Episode of RT-PCR-Confirmed Protocol-Defined Influenza-Like Illness (ILI) Caused by Any Seasonal Influenza A or B Virus Strains Regardless of Antigenic Match to Strains Selected for the Seasonal Vaccine

End point description

Protocol-defined ILI: The presence of body temperature ≥37.5 degrees celsius (°C) (≥99.5 degrees fahrenheit [°F]), accompanied by at least one of the respiratory illness symptoms (sore throat, cough, sputum production, wheezing, or difficulty breathing) and a positive Reverse Transcription Polymerase Chain Reaction (RT-PCR) for influenza. PP Set included all participants in the Modified Intent-to-Treat (mITT) Set (all randomized participants who received any study intervention except those who discontinued from the study prior to 14 days following administration of study intervention) who did not have major protocol deviations that could adversely impact efficacy, for example, disease or therapeutic intervention that might cause suboptimal response to the study intervention.

End point type

Primary

End point timeframe

14 days post-vaccination through Day 181 (Month 6)

End point values	Fluarix Quadrivalent	mRNA-1010
Number of subjects analysed	11026	11055
Units: participants	142	140

Statistical Analysis 1

Statistical analysis description

rVE = 100 * (1 − HR) % was defined as the percent reduction in the hazard (mRNA-1010 vs active comparator), where HR was the hazard ratio between mRNA-1010 vs the active comparator.

Comparison groups

Fluarix Quadrivalent v mRNA-1010

Number of subjects included in analysis

22081

Analysis specification

Pre-specified

Analysis type

non-inferiority ^[4]

P-value

= 0.1715

Method

Stratified Cox proportional hazards

Parameter type

Relative vaccine efficacy (rVE)

Point estimate

1.7

Confidence interval

level

95%

sides

2-sided

lower limit

-24.1

upper limit

22.2

Notes
[4] - Noninferiority margin = 10%

Secondary: Number of Participants With First Episode of RT-PCR-Confirmed Protocol-Defined ILI Caused by Influenza A or B Strains With Similarity to Those Selected for the Seasonal Vaccine

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End point title

Number of Participants With First Episode of RT-PCR-Confirmed Protocol-Defined ILI Caused by Influenza A or B Strains With Similarity to Those Selected for the Seasonal Vaccine

End point description

End point type

Secondary

End point timeframe

14 days post-vaccination through Day 181 (Month 6)

End point values	Fluarix Quadrivalent	mRNA-1010
Number of subjects analysed	0 ^[5]	0 ^[6]
Units: participants

Notes
[5] - As pre-specified, the data for this endpoint was not collected and analyzed.
[6] - As pre-specified, the data for this endpoint was not collected and analyzed.

No statistical analyses for this end point

Secondary: Number of Participants With First Episode of RT-PCR-Confirmed Protocol-Defined ILI Caused by influenza A or B Strains Antigenically Matched to the Vaccine Strains Selected for the Seasonal Vaccine

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End point title

Number of Participants With First Episode of RT-PCR-Confirmed Protocol-Defined ILI Caused by influenza A or B Strains Antigenically Matched to the Vaccine Strains Selected for the Seasonal Vaccine

End point description

Protocol-defined ILI: The presence of body temperature ≥37.5°C (≥99.5°F), accompanied by at least one of the respiratory illness symptoms (sore throat, cough, sputum production, wheezing, or difficulty breathing) and a positive RT-PCR for influenza. PP Set included all participants in the mITT Set (all randomized participants who received any study intervention except those who discontinued from the study prior to 14 days following administration of study intervention) who did not have major protocol deviations that could adversely impact efficacy, for example, disease or therapeutic intervention that might cause suboptimal response to the study intervention.

End point type

Secondary

End point timeframe

14 days post-vaccination through Day 181 (Month 6)

End point values	Fluarix Quadrivalent	mRNA-1010
Number of subjects analysed	11026	11055
Units: participants	85	75

No statistical analyses for this end point

Secondary: Number of Participants With First Episode of Culture-Confirmed Protocol-Defined ILI Caused by Any Seasonal Influenza A or B Virus Strains Regardless of Antigenic Match to Strains Selected for the Seasonal Vaccine

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End point title

Number of Participants With First Episode of Culture-Confirmed Protocol-Defined ILI Caused by Any Seasonal Influenza A or B Virus Strains Regardless of Antigenic Match to Strains Selected for the Seasonal Vaccine

End point description

End point type

Secondary

End point timeframe

14 days post-vaccination through Day 181 (Month 6)

End point values	Fluarix Quadrivalent	mRNA-1010
Number of subjects analysed	11026	11055
Units: participants	91	81

No statistical analyses for this end point

Secondary: Number of Participants With First Episode of RT-PCR CDC-Defined ILI Caused by Influenza A or B Strains With Similarity to Vaccine Strains

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End point title

Number of Participants With First Episode of RT-PCR CDC-Defined ILI Caused by Influenza A or B Strains With Similarity to Vaccine Strains

End point description

CDC-defined ILI: The presence of temperature ≥37.8°C [≥100°F], accompanied by at least one of the respiratory illness symptoms (cough and/or sore throat) and a positive RT-PCR for influenza.

End point type

Secondary

End point timeframe

14 days post-vaccination through Day 181 (Month 6)

End point values	Fluarix Quadrivalent	mRNA-1010
Number of subjects analysed	0 ^[7]	0 ^[8]
Units: participants

Notes
[7] - As pre-specified, the data for this endpoint was not collected and analyzed.
[8] - As pre-specified, the data for this endpoint was not collected and analyzed.

No statistical analyses for this end point

Secondary: Number of Participants With First Episode of RT-PCR Confirmed United States (US) Centers for Disease Control and Prevention (CDC)-Defined ILI Caused by Any Influenza A or B Strains

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End point title

Number of Participants With First Episode of RT-PCR Confirmed United States (US) Centers for Disease Control and Prevention (CDC)-Defined ILI Caused by Any Influenza A or B Strains

End point description

CDC-defined ILI: The presence of temperature ≥37.8°C [≥100°F], accompanied by at least one of the respiratory illness symptoms (cough and/or sore throat) and a positive RT-PCR for influenza. PP Set included all participants in the mITT Set (all randomized participants who received any study intervention except those who discontinued from the study prior to 14 days following administration of study intervention) who did not have major protocol deviations that could adversely impact efficacy, for example, disease or therapeutic intervention that might cause suboptimal response to the study intervention.

End point type

Secondary

End point timeframe

14 days post-vaccination through Day 181 (Month 6)

End point values	Fluarix Quadrivalent	mRNA-1010
Number of subjects analysed	11026	11055
Units: participants	70	70

No statistical analyses for this end point

Secondary: Number of Participants With First Episode of RT-PCR CDC-Defined ILI Caused by Influenza A or B Strains That Were Antigenically Matched to Vaccine Strains

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End point title

Number of Participants With First Episode of RT-PCR CDC-Defined ILI Caused by Influenza A or B Strains That Were Antigenically Matched to Vaccine Strains

End point description

End point type

Secondary

End point timeframe

14 days post-vaccination through Day 181 (Month 6)

End point values	Fluarix Quadrivalent	mRNA-1010
Number of subjects analysed	11026	11055
Units: participants	44	38

No statistical analyses for this end point

Secondary: Number of Participants With Hospitalizations Associated With RT-PCR Confirmed Protocol-Defined ILI Caused by Any Seasonal Influenza A or B Virus Strains Regardless of Antigenic Match to Strains Selected for the Seasonal Vaccine

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End point title

Number of Participants With Hospitalizations Associated With RT-PCR Confirmed Protocol-Defined ILI Caused by Any Seasonal Influenza A or B Virus Strains Regardless of Antigenic Match to Strains Selected for the Seasonal Vaccine

End point description

End point type

Secondary

End point timeframe

14 days post-vaccination through Day 181 (Month 6)

End point values	Fluarix Quadrivalent	mRNA-1010
Number of subjects analysed	11026	11055
Units: participants	3	3

No statistical analyses for this end point

Secondary: Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies at Day 29, as Measured by Hemagglutination Inhibition (HAI) Assay for Vaccine-matched Influenza A and B Strains

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End point title

Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies at Day 29, as Measured by Hemagglutination Inhibition (HAI) Assay for Vaccine-matched Influenza A and B Strains

End point description

Seasonal influenza A strains included H1N1 and H3N2 and seasonal influenza B strains included Victoria-lineage and Yamagata-lineage. 95% confidence interval (CI) was calculated based on the t-distribution of log-transformed values for GM titer, then back transformed to original scale for presentation. PPIS included all randomized participants in the biomarker subset who received any study intervention; had baseline and Day 29 antibody assessment via HAI assay; complied with the immunogenicity testing schedule, and had no major protocol deviations that impacted the immunogenicity assessment.

End point type

Secondary

End point timeframe

Day 29

End point values	Fluarix Quadrivalent	mRNA-1010
Number of subjects analysed	408	444
Units: titer
geometric mean (confidence interval 95%)
Influenza A H1N1 Antibody	105.34 (95.71 to 115.93)	149.14 (135.47 to 164.19)
Influenza A H3N2 Antibody	85.99 (77.64 to 95.23)	104.06 (94.35 to 114.77)
Influenza B/Yamagata Lineage	140.50 (127.49 to 154.85)	132.24 (121.25 to 144.23)
Influenza B/Victoria Lineage	176.63 (162.42 to 192.08)	139.91 (129.71 to 150.91)

No statistical analyses for this end point

Secondary: Number of Participants With First Episode of Culture-Confirmed CDC-Defined ILI Caused by Any Seasonal Influenza A or B Virus Strains Regardless of Antigenic Match to Strains Selected for the Seasonal Vaccine

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End point title

Number of Participants With First Episode of Culture-Confirmed CDC-Defined ILI Caused by Any Seasonal Influenza A or B Virus Strains Regardless of Antigenic Match to Strains Selected for the Seasonal Vaccine

End point description

End point type

Secondary

End point timeframe

14 days post-vaccination through Day 181 (Month 6)

End point values	Fluarix Quadrivalent	mRNA-1010
Number of subjects analysed	11026	11055
Units: participants	45	40

No statistical analyses for this end point

Secondary: Percentage of Participants Reaching Seroconversion at Day 29, as Measured by HAI Assay for Vaccine-matched Influenza A and B Strains

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End point title

Percentage of Participants Reaching Seroconversion at Day 29, as Measured by HAI Assay for Vaccine-matched Influenza A and B Strains

End point description

Seroconversion was defined as either a Baseline HAI titer <1:10 and a post-Baseline titer ≥1:40 or a Baseline HAI titer ≥1:10 and a minimum 4-fold rise in post-Baseline HAI antibody titer. PPIS included all randomized participants in the biomarker subset who received any study intervention; had baseline and Day 29 antibody assessment via HAI assay; complied with the immunogenicity testing schedule, and had no major protocol deviations that impacted the immunogenicity assessment.

End point type

Secondary

End point timeframe

Day 29

End point values	Fluarix Quadrivalent	mRNA-1010
Number of subjects analysed	408	444
Units: percentage of participants
number (confidence interval 95%)
Influenza A H1N1 Antibody	29.4 (25.03 to 34.09)	44.8 (40.13 to 49.58)
Influenza A H3N2 Antibody	39.7 (34.93 to 44.64)	52.0 (47.27 to 56.76)
Influenza B/Yamagata Lineage	27.5 (23.18 to 32.06)	26.6 (22.52 to 30.95)
Influenza B/Victoria Lineage	22.8 (18.81 to 27.18)	13.1 (10.07 to 16.56)

No statistical analyses for this end point

Secondary: Percentage of Participants With HAI Titer ≥ 1:40 at Day 29

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End point title

Percentage of Participants With HAI Titer ≥ 1:40 at Day 29

End point description

PPIS included all randomized participants in the biomarker subset who received any study intervention; had baseline and Day 29 antibody assessment via HAI assay; complied with the immunogenicity testing schedule, and had no major protocol deviations that impacted the immunogenicity assessment.

End point type

Secondary

End point timeframe

Day 29

End point values	Fluarix Quadrivalent	mRNA-1010
Number of subjects analysed	408	444
Units: percentage of participants
number (confidence interval 95%)
Influenza A H1N1 Antibody	90.0 (86.61 to 92.69)	94.4 (91.80 to 96.32)
Influenza A H3N2 Antibody	85.5 (81.75 to 88.81)	89.6 (86.42 to 92.31)
Influenza B/Yamagata Lineage	94.6 (91.95 to 96.59)	94.8 (92.33 to 96.69)
Influenza B/Victoria Lineage	98.3 (96.50 to 99.31)	98.0 (96.19 to 99.07)

No statistical analyses for this end point

Secondary: Geometric Mean Fold Rise (GMFR) of Anti-HA Antibodies at Day 29, as Measured by HAI Assay for Vaccine-matched Influenza A and B Strains

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End point title

Geometric Mean Fold Rise (GMFR) of Anti-HA Antibodies at Day 29, as Measured by HAI Assay for Vaccine-matched Influenza A and B Strains

End point description

The GMFR measures the changes in immunogenicity titers or levels from Baseline within participants. Seasonal influenza A included H1N1 and H3N2 and seasonal influenza B strains included Victoria-lineage and Yamagata-lineage. Fold-rise was calculated by dividing post-vaccination results by the baseline value. 95% CI for GMFR was calculated based on the t distribution of the differences in the log-transformed values between analysis timepoint and baseline, then back transformed to the original scale for presentation. PPIS included all randomized participants in the biomarker subset who received any study intervention; had baseline and Day 29 antibody assessment via HAI assay; complied with the immunogenicity testing schedule, and had no major protocol deviations that impacted the immunogenicity assessment.

End point type

Secondary

End point timeframe

Baseline, Day 29

End point values	Fluarix Quadrivalent	mRNA-1010
Number of subjects analysed	408	444
Units: ratio
geometric mean (confidence interval 95%)
Influenza A H1N1 Antibody	2.42 (2.22 to 2.64)	3.42 (3.13 to 3.73)
Influenza A H3N2 Antibody	3.04 (2.79 to 3.30)	3.74 (3.44 to 4.07)
Influenza B/Yamagata Lineage	2.46 (2.26 to 2.69)	2.28 (2.14 to 2.43)
Influenza B/Victoria Lineage	2.07 (1.92 to 2.24)	1.75 (1.65 to 1.85)

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

Day 1 up to the end of the study (Day 361)

Adverse event reporting additional description

The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

25.0

Reporting group title

mRNA-1010

Reporting group description

Participants received a single dose of mRNA-1010 by IM injection on Day 1.

Reporting group title

Fluarix Quadrivalent

Reporting group description

Participants received a single dose of Fluarix Quadrivalent by IM injection on Day 1.

Serious adverse events	mRNA-1010	Fluarix Quadrivalent
Total subjects affected by serious adverse events
subjects affected / exposed	518 / 11210 (4.62%)	495 / 11200 (4.42%)
number of deaths (all causes)	45	44
number of deaths resulting from adverse events
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute leukaemia
subjects affected / exposed	0 / 11210 (0.00%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Adenocarcinoma gastric
subjects affected / exposed	1 / 11210 (0.01%)	0 / 11200 (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 / 11210 (0.01%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Adrenal adenoma
subjects affected / exposed	0 / 11210 (0.00%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Basal cell carcinoma
subjects affected / exposed	1 / 11210 (0.01%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Brain neoplasm malignant
subjects affected / exposed	0 / 11210 (0.00%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Benign neoplasm of testis
subjects affected / exposed	0 / 11210 (0.00%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Benign uterine neoplasm
subjects affected / exposed	1 / 11210 (0.01%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Bladder cancer
subjects affected / exposed	2 / 11210 (0.02%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Bladder transitional cell carcinoma
subjects affected / exposed	1 / 11210 (0.01%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Bone cancer
subjects affected / exposed	0 / 11210 (0.00%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Bowen's disease
subjects affected / exposed	1 / 11210 (0.01%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Benign laryngeal neoplasm
subjects affected / exposed	1 / 11210 (0.01%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Chronic myeloid leukaemia
subjects affected / exposed	1 / 11210 (0.01%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Colon cancer
subjects affected / exposed	3 / 11210 (0.03%)	4 / 11200 (0.04%)
occurrences causally related to treatment / all	0 / 4	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Colon cancer stage III
subjects affected / exposed	0 / 11210 (0.00%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Colon cancer stage IV
subjects affected / exposed	1 / 11210 (0.01%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Cutaneous T-cell lymphoma
subjects affected / exposed	0 / 11210 (0.00%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Endometrial adenocarcinoma
subjects affected / exposed	1 / 11210 (0.01%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Carcinoid tumour pulmonary
subjects affected / exposed	1 / 11210 (0.01%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Epiglottic cancer
subjects affected / exposed	0 / 11210 (0.00%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gallbladder cancer
subjects affected / exposed	0 / 11210 (0.00%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Breast cancer
subjects affected / exposed	6 / 11210 (0.05%)	8 / 11200 (0.07%)
occurrences causally related to treatment / all	0 / 6	0 / 8
deaths causally related to treatment / all	0 / 0	0 / 0
Breast cancer metastatic
subjects affected / exposed	2 / 11210 (0.02%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Breast cancer stage I
subjects affected / exposed	1 / 11210 (0.01%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Breast cancer stage II
subjects affected / exposed	0 / 11210 (0.00%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Endometrial cancer metastatic
subjects affected / exposed	0 / 11210 (0.00%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastric cancer
subjects affected / exposed	1 / 11210 (0.01%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Medullary thyroid cancer
subjects affected / exposed	1 / 11210 (0.01%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatocellular carcinoma
subjects affected / exposed	1 / 11210 (0.01%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Intraductal proliferative breast lesion
subjects affected / exposed	1 / 11210 (0.01%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Invasive breast carcinoma
subjects affected / exposed	1 / 11210 (0.01%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Invasive ductal breast carcinoma
subjects affected / exposed	1 / 11210 (0.01%)	5 / 11200 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Invasive lobular breast carcinoma
subjects affected / exposed	2 / 11210 (0.02%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Laryngeal cancer
subjects affected / exposed	0 / 11210 (0.00%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Lentigo maligna
subjects affected / exposed	1 / 11210 (0.01%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Lobular breast carcinoma in situ
subjects affected / exposed	1 / 11210 (0.01%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Lung adenocarcinoma
subjects affected / exposed	0 / 11210 (0.00%)	2 / 11200 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 1
Lung adenocarcinoma stage I
subjects affected / exposed	1 / 11210 (0.01%)	0 / 11200 (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	2 / 11210 (0.02%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 0
Malignant melanoma
subjects affected / exposed	0 / 11210 (0.00%)	1 / 11200 (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 / 11210 (0.00%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Metastases to central nervous system
subjects affected / exposed	1 / 11210 (0.01%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Prostate cancer metastatic
subjects affected / exposed	1 / 11210 (0.01%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Metastatic renal cell carcinoma
subjects affected / exposed	0 / 11210 (0.00%)	1 / 11200 (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	1 / 11210 (0.01%)	0 / 11200 (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 / 11210 (0.01%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Oesophageal squamous cell carcinoma
subjects affected / exposed	0 / 11210 (0.00%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Oropharyngeal cancer
subjects affected / exposed	1 / 11210 (0.01%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Osteosarcoma
subjects affected / exposed	1 / 11210 (0.01%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Ovarian adenoma
subjects affected / exposed	0 / 11210 (0.00%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Ovarian cancer metastatic
subjects affected / exposed	1 / 11210 (0.01%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Pancreatic carcinoma
subjects affected / exposed	1 / 11210 (0.01%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Pancreatic carcinoma metastatic
subjects affected / exposed	1 / 11210 (0.01%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Plasma cell myeloma
subjects affected / exposed	1 / 11210 (0.01%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Primary myelofibrosis
subjects affected / exposed	0 / 11210 (0.00%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Prostate cancer
subjects affected / exposed	4 / 11210 (0.04%)	12 / 11200 (0.11%)
occurrences causally related to treatment / all	0 / 4	0 / 12
deaths causally related to treatment / all	0 / 0	0 / 1
Metastases to liver
subjects affected / exposed	1 / 11210 (0.01%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Rectal adenocarcinoma
subjects affected / exposed	1 / 11210 (0.01%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Renal cell carcinoma
subjects affected / exposed	1 / 11210 (0.01%)	2 / 11200 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Small cell carcinoma of the cervix
subjects affected / exposed	0 / 11210 (0.00%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Small intestine adenocarcinoma
subjects affected / exposed	0 / 11210 (0.00%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Small intestine neuroendocrine tumour
subjects affected / exposed	1 / 11210 (0.01%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Squamous cell carcinoma of lung
subjects affected / exposed	0 / 11210 (0.00%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Transitional cell carcinoma
subjects affected / exposed	2 / 11210 (0.02%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Uterine leiomyoma
subjects affected / exposed	1 / 11210 (0.01%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Vulval cancer stage 0
subjects affected / exposed	1 / 11210 (0.01%)	0 / 11200 (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	0 / 11210 (0.00%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Vascular disorders
Aortic aneurysm
subjects affected / exposed	1 / 11210 (0.01%)	4 / 11200 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Giant cell arteritis
subjects affected / exposed	0 / 11210 (0.00%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hypertension
subjects affected / exposed	5 / 11210 (0.04%)	4 / 11200 (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	2 / 11210 (0.02%)	2 / 11200 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Hypertensive emergency
subjects affected / exposed	0 / 11210 (0.00%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Hypertensive urgency
subjects affected / exposed	1 / 11210 (0.01%)	3 / 11200 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Hypotension
subjects affected / exposed	1 / 11210 (0.01%)	4 / 11200 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Peripheral arterial occlusive disease
subjects affected / exposed	4 / 11210 (0.04%)	3 / 11200 (0.03%)
occurrences causally related to treatment / all	0 / 4	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Peripheral artery occlusion
subjects affected / exposed	1 / 11210 (0.01%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Aortic dissection
subjects affected / exposed	1 / 11210 (0.01%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Aortic stenosis
subjects affected / exposed	2 / 11210 (0.02%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Arteriosclerosis
subjects affected / exposed	1 / 11210 (0.01%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Deep vein thrombosis
subjects affected / exposed	4 / 11210 (0.04%)	5 / 11200 (0.04%)
occurrences causally related to treatment / all	0 / 4	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Dry gangrene
subjects affected / exposed	1 / 11210 (0.01%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Embolism
subjects affected / exposed	0 / 11210 (0.00%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Peripheral artery stenosis
subjects affected / exposed	2 / 11210 (0.02%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Peripheral ischaemia
subjects affected / exposed	1 / 11210 (0.01%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Peripheral vascular disorder
subjects affected / exposed	2 / 11210 (0.02%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Shock
subjects affected / exposed	0 / 11210 (0.00%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Vascular stenosis
subjects affected / exposed	1 / 11210 (0.01%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Peripheral artery thrombosis
subjects affected / exposed	1 / 11210 (0.01%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
General disorders and administration site conditions
Chest pain
subjects affected / exposed	2 / 11210 (0.02%)	4 / 11200 (0.04%)
occurrences causally related to treatment / all	0 / 2	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Asthenia
subjects affected / exposed	1 / 11210 (0.01%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Chest discomfort
subjects affected / exposed	1 / 11210 (0.01%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Death
subjects affected / exposed	8 / 11210 (0.07%)	4 / 11200 (0.04%)
occurrences causally related to treatment / all	0 / 8	0 / 4
deaths causally related to treatment / all	0 / 8	0 / 4
Generalised oedema
subjects affected / exposed	1 / 11210 (0.01%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Non-cardiac chest pain
subjects affected / exposed	5 / 11210 (0.04%)	4 / 11200 (0.04%)
occurrences causally related to treatment / all	0 / 5	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Oedema peripheral
subjects affected / exposed	1 / 11210 (0.01%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pain
subjects affected / exposed	1 / 11210 (0.01%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pyrexia
subjects affected / exposed	1 / 11210 (0.01%)	2 / 11200 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Stent-graft endoleak
subjects affected / exposed	1 / 11210 (0.01%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Strangulated hernia
subjects affected / exposed	0 / 11210 (0.00%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Sudden death
subjects affected / exposed	3 / 11210 (0.03%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 3	0 / 1
Drug withdrawal syndrome
subjects affected / exposed	1 / 11210 (0.01%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Immune system disorders
Anaphylactic reaction
subjects affected / exposed	0 / 11210 (0.00%)	3 / 11200 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Drug hypersensitivity
subjects affected / exposed	1 / 11210 (0.01%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Reproductive system and breast disorders
Benign prostatic hyperplasia
subjects affected / exposed	1 / 11210 (0.01%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Prostatomegaly
subjects affected / exposed	1 / 11210 (0.01%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Vaginal haemorrhage
subjects affected / exposed	1 / 11210 (0.01%)	0 / 11200 (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
Emphysema
subjects affected / exposed	1 / 11210 (0.01%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Acute pulmonary oedema
subjects affected / exposed	1 / 11210 (0.01%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Acute respiratory distress syndrome
subjects affected / exposed	0 / 11210 (0.00%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Acute respiratory failure
subjects affected / exposed	8 / 11210 (0.07%)	10 / 11200 (0.09%)
occurrences causally related to treatment / all	0 / 11	0 / 11
deaths causally related to treatment / all	0 / 1	0 / 2
Asthma
subjects affected / exposed	2 / 11210 (0.02%)	2 / 11200 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Bronchiectasis
subjects affected / exposed	1 / 11210 (0.01%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Chronic obstructive pulmonary disease
subjects affected / exposed	19 / 11210 (0.17%)	14 / 11200 (0.13%)
occurrences causally related to treatment / all	0 / 25	0 / 14
deaths causally related to treatment / all	0 / 0	0 / 0
Cough
subjects affected / exposed	0 / 11210 (0.00%)	2 / 11200 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 1
Dyspnoea
subjects affected / exposed	1 / 11210 (0.01%)	4 / 11200 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Haemothorax
subjects affected / exposed	1 / 11210 (0.01%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Respiratory failure
subjects affected / exposed	3 / 11210 (0.03%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hypoxia
subjects affected / exposed	0 / 11210 (0.00%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Interstitial lung disease
subjects affected / exposed	1 / 11210 (0.01%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Nasal septum deviation
subjects affected / exposed	0 / 11210 (0.00%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Organising pneumonia
subjects affected / exposed	0 / 11210 (0.00%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pleural effusion
subjects affected / exposed	1 / 11210 (0.01%)	2 / 11200 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumothorax
subjects affected / exposed	3 / 11210 (0.03%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumothorax spontaneous
subjects affected / exposed	0 / 11210 (0.00%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Productive cough
subjects affected / exposed	1 / 11210 (0.01%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pulmonary embolism
subjects affected / exposed	8 / 11210 (0.07%)	12 / 11200 (0.11%)
occurrences causally related to treatment / all	0 / 8	0 / 12
deaths causally related to treatment / all	0 / 0	0 / 3
Pulmonary fibrosis
subjects affected / exposed	0 / 11210 (0.00%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Pulmonary hypertension
subjects affected / exposed	2 / 11210 (0.02%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 0
Pulmonary mass
subjects affected / exposed	1 / 11210 (0.01%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pulmonary oedema
subjects affected / exposed	0 / 11210 (0.00%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hypercapnia
subjects affected / exposed	1 / 11210 (0.01%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Sleep apnoea syndrome
subjects affected / exposed	0 / 11210 (0.00%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Psychiatric disorders
Acute psychosis
subjects affected / exposed	0 / 11210 (0.00%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Mental status changes
subjects affected / exposed	1 / 11210 (0.01%)	0 / 11200 (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 / 11210 (0.00%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Alcohol use disorder
subjects affected / exposed	1 / 11210 (0.01%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Alcohol withdrawal syndrome
subjects affected / exposed	1 / 11210 (0.01%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Anxiety
subjects affected / exposed	0 / 11210 (0.00%)	2 / 11200 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Bipolar disorder
subjects affected / exposed	0 / 11210 (0.00%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Completed suicide
subjects affected / exposed	1 / 11210 (0.01%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Confusional state
subjects affected / exposed	0 / 11210 (0.00%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Delirium
subjects affected / exposed	1 / 11210 (0.01%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Depression
subjects affected / exposed	2 / 11210 (0.02%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Depression suicidal
subjects affected / exposed	1 / 11210 (0.01%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Drug dependence
subjects affected / exposed	1 / 11210 (0.01%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Major depression
subjects affected / exposed	1 / 11210 (0.01%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Affective disorder
subjects affected / exposed	0 / 11210 (0.00%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Mixed anxiety and depressive disorder
subjects affected / exposed	0 / 11210 (0.00%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Psychotic disorder
subjects affected / exposed	0 / 11210 (0.00%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Schizoaffective disorder
subjects affected / exposed	1 / 11210 (0.01%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Substance abuse
subjects affected / exposed	0 / 11210 (0.00%)	3 / 11200 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Suicidal ideation
subjects affected / exposed	1 / 11210 (0.01%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Post-traumatic stress disorder
subjects affected / exposed	0 / 11210 (0.00%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Investigations
Prostatic specific antigen increased
subjects affected / exposed	1 / 11210 (0.01%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Blood potassium decreased
subjects affected / exposed	0 / 11210 (0.00%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatic enzyme abnormal
subjects affected / exposed	1 / 11210 (0.01%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatic enzyme increased
subjects affected / exposed	0 / 11210 (0.00%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
International normalised ratio abnormal
subjects affected / exposed	1 / 11210 (0.01%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Liver function test abnormal
subjects affected / exposed	1 / 11210 (0.01%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Troponin increased
subjects affected / exposed	0 / 11210 (0.00%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
White blood cell count increased
subjects affected / exposed	0 / 11210 (0.00%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Weight increased
subjects affected / exposed	1 / 11210 (0.01%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Injury, poisoning and procedural complications
Facial bones fracture
subjects affected / exposed	1 / 11210 (0.01%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Accidental overdose
subjects affected / exposed	2 / 11210 (0.02%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Acetabulum fracture
subjects affected / exposed	0 / 11210 (0.00%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Alcohol poisoning
subjects affected / exposed	0 / 11210 (0.00%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Anastomotic ulcer
subjects affected / exposed	0 / 11210 (0.00%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Animal bite
subjects affected / exposed	0 / 11210 (0.00%)	1 / 11200 (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	4 / 11210 (0.04%)	3 / 11200 (0.03%)
occurrences causally related to treatment / all	0 / 4	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Bronchitis chemical
subjects affected / exposed	1 / 11210 (0.01%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cervical vertebral fracture
subjects affected / exposed	0 / 11210 (0.00%)	2 / 11200 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Concussion
subjects affected / exposed	0 / 11210 (0.00%)	2 / 11200 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Contusion
subjects affected / exposed	0 / 11210 (0.00%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Craniocerebral injury
subjects affected / exposed	1 / 11210 (0.01%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Fall
subjects affected / exposed	2 / 11210 (0.02%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Injury
subjects affected / exposed	0 / 11210 (0.00%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Femoral nerve injury
subjects affected / exposed	0 / 11210 (0.00%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Femur fracture
subjects affected / exposed	4 / 11210 (0.04%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 4	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Fibula fracture
subjects affected / exposed	1 / 11210 (0.01%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Foot fracture
subjects affected / exposed	0 / 11210 (0.00%)	2 / 11200 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Forearm fracture
subjects affected / exposed	1 / 11210 (0.01%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Fracture displacement
subjects affected / exposed	1 / 11210 (0.01%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal procedural complication
subjects affected / exposed	1 / 11210 (0.01%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gun shot wound
subjects affected / exposed	0 / 11210 (0.00%)	2 / 11200 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 2
Hand fracture
subjects affected / exposed	1 / 11210 (0.01%)	0 / 11200 (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	0 / 11210 (0.00%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Heat exhaustion
subjects affected / exposed	0 / 11210 (0.00%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hip fracture
subjects affected / exposed	4 / 11210 (0.04%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 4	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Humerus fracture
subjects affected / exposed	2 / 11210 (0.02%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Femoral neck fracture
subjects affected / exposed	1 / 11210 (0.01%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Joint dislocation
subjects affected / exposed	2 / 11210 (0.02%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Skin abrasion
subjects affected / exposed	0 / 11210 (0.00%)	1 / 11200 (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 / 11210 (0.00%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Lumbar vertebral fracture
subjects affected / exposed	1 / 11210 (0.01%)	2 / 11200 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Multiple injuries
subjects affected / exposed	0 / 11210 (0.00%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Overdose
subjects affected / exposed	2 / 11210 (0.02%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Patella fracture
subjects affected / exposed	0 / 11210 (0.00%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pelvic fracture
subjects affected / exposed	1 / 11210 (0.01%)	0 / 11200 (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	2 / 11210 (0.02%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Post procedural complication
subjects affected / exposed	1 / 11210 (0.01%)	2 / 11200 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Post procedural haemorrhage
subjects affected / exposed	1 / 11210 (0.01%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Procedural pain
subjects affected / exposed	3 / 11210 (0.03%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Rib fracture
subjects affected / exposed	3 / 11210 (0.03%)	5 / 11200 (0.04%)
occurrences causally related to treatment / all	0 / 3	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Road traffic accident
subjects affected / exposed	2 / 11210 (0.02%)	4 / 11200 (0.04%)
occurrences causally related to treatment / all	0 / 2	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Sacroiliac fracture
subjects affected / exposed	1 / 11210 (0.01%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Limb crushing injury
subjects affected / exposed	0 / 11210 (0.00%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Skin laceration
subjects affected / exposed	0 / 11210 (0.00%)	2 / 11200 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Traumatic liver injury
subjects affected / exposed	1 / 11210 (0.01%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Snake bite
subjects affected / exposed	0 / 11210 (0.00%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Spinal compression fracture
subjects affected / exposed	1 / 11210 (0.01%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Spinal cord injury
subjects affected / exposed	1 / 11210 (0.01%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Spinal fracture
subjects affected / exposed	0 / 11210 (0.00%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Splenic rupture
subjects affected / exposed	1 / 11210 (0.01%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Subdural haematoma
subjects affected / exposed	1 / 11210 (0.01%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Tendon rupture
subjects affected / exposed	0 / 11210 (0.00%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Thoracic vertebral fracture
subjects affected / exposed	1 / 11210 (0.01%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Tibia fracture
subjects affected / exposed	0 / 11210 (0.00%)	2 / 11200 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Toxicity to various agents
subjects affected / exposed	1 / 11210 (0.01%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Transplant failure
subjects affected / exposed	0 / 11210 (0.00%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Traumatic haemothorax
subjects affected / exposed	0 / 11210 (0.00%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Skull fracture
subjects affected / exposed	1 / 11210 (0.01%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Traumatic lung injury
subjects affected / exposed	0 / 11210 (0.00%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Ulna fracture
subjects affected / exposed	0 / 11210 (0.00%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Wrist fracture
subjects affected / exposed	0 / 11210 (0.00%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Vascular graft complication
subjects affected / exposed	1 / 11210 (0.01%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Upper limb fracture
subjects affected / exposed	2 / 11210 (0.02%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Congenital, familial and genetic disorders
Congenital cystic kidney disease
subjects affected / exposed	1 / 11210 (0.01%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac disorders
Cardiac disorder
subjects affected / exposed	1 / 11210 (0.01%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Acute myocardial infarction
subjects affected / exposed	12 / 11210 (0.11%)	11 / 11200 (0.10%)
occurrences causally related to treatment / all	0 / 12	0 / 12
deaths causally related to treatment / all	0 / 0	0 / 1
Angina pectoris
subjects affected / exposed	3 / 11210 (0.03%)	5 / 11200 (0.04%)
occurrences causally related to treatment / all	0 / 3	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Angina unstable
subjects affected / exposed	2 / 11210 (0.02%)	3 / 11200 (0.03%)
occurrences causally related to treatment / all	0 / 3	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Aortic valve incompetence
subjects affected / exposed	1 / 11210 (0.01%)	0 / 11200 (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	0 / 11210 (0.00%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Arrhythmia
subjects affected / exposed	0 / 11210 (0.00%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Arteriosclerosis coronary artery
subjects affected / exposed	1 / 11210 (0.01%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Atrial fibrillation
subjects affected / exposed	16 / 11210 (0.14%)	14 / 11200 (0.13%)
occurrences causally related to treatment / all	0 / 19	0 / 15
deaths causally related to treatment / all	0 / 0	0 / 0
Atrial flutter
subjects affected / exposed	1 / 11210 (0.01%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Atrioventricular block
subjects affected / exposed	0 / 11210 (0.00%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Bradycardia
subjects affected / exposed	3 / 11210 (0.03%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac arrest
subjects affected / exposed	3 / 11210 (0.03%)	3 / 11200 (0.03%)
occurrences causally related to treatment / all	0 / 3	0 / 3
deaths causally related to treatment / all	0 / 2	0 / 3
Acute left ventricular failure
subjects affected / exposed	2 / 11210 (0.02%)	2 / 11200 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 1
Mitral valve incompetence
subjects affected / exposed	1 / 11210 (0.01%)	2 / 11200 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Left ventricular failure
subjects affected / exposed	0 / 11210 (0.00%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac failure acute
subjects affected / exposed	2 / 11210 (0.02%)	5 / 11200 (0.04%)
occurrences causally related to treatment / all	0 / 3	0 / 5
deaths causally related to treatment / all	0 / 1	0 / 1
Cardiac failure chronic
subjects affected / exposed	1 / 11210 (0.01%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 1
Cardiac failure congestive
subjects affected / exposed	11 / 11210 (0.10%)	10 / 11200 (0.09%)
occurrences causally related to treatment / all	0 / 14	0 / 11
deaths causally related to treatment / all	0 / 0	0 / 0
Cardio-respiratory arrest
subjects affected / exposed	0 / 11210 (0.00%)	3 / 11200 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 3
Cardiogenic shock
subjects affected / exposed	1 / 11210 (0.01%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiomyopathy
subjects affected / exposed	1 / 11210 (0.01%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiopulmonary failure
subjects affected / exposed	1 / 11210 (0.01%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Coronary artery aneurysm
subjects affected / exposed	1 / 11210 (0.01%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Coronary artery disease
subjects affected / exposed	8 / 11210 (0.07%)	9 / 11200 (0.08%)
occurrences causally related to treatment / all	0 / 8	0 / 9
deaths causally related to treatment / all	0 / 0	0 / 0
Coronary artery dissection
subjects affected / exposed	0 / 11210 (0.00%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Coronary artery occlusion
subjects affected / exposed	0 / 11210 (0.00%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Coronary artery stenosis
subjects affected / exposed	1 / 11210 (0.01%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Intracardiac thrombus
subjects affected / exposed	0 / 11210 (0.00%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac failure
subjects affected / exposed	2 / 11210 (0.02%)	5 / 11200 (0.04%)
occurrences causally related to treatment / all	0 / 2	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 1
Mitral valve prolapse
subjects affected / exposed	2 / 11210 (0.02%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Myocardial infarction
subjects affected / exposed	12 / 11210 (0.11%)	9 / 11200 (0.08%)
occurrences causally related to treatment / all	0 / 12	0 / 9
deaths causally related to treatment / all	0 / 5	0 / 2
Myocardial ischaemia
subjects affected / exposed	0 / 11210 (0.00%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Myocarditis
subjects affected / exposed	0 / 11210 (0.00%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Myopericarditis
subjects affected / exposed	0 / 11210 (0.00%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pericardial effusion
subjects affected / exposed	0 / 11210 (0.00%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Sinus arrhythmia
subjects affected / exposed	0 / 11210 (0.00%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Sinus node dysfunction
subjects affected / exposed	0 / 11210 (0.00%)	3 / 11200 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Supraventricular tachycardia
subjects affected / exposed	2 / 11210 (0.02%)	2 / 11200 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Tachycardia
subjects affected / exposed	3 / 11210 (0.03%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Ventricular arrhythmia
subjects affected / exposed	1 / 11210 (0.01%)	0 / 11200 (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	2 / 11210 (0.02%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Pericarditis
subjects affected / exposed	4 / 11210 (0.04%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 4	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Nervous system disorders
Cerebral ventricle dilatation
subjects affected / exposed	1 / 11210 (0.01%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Amyotrophic lateral sclerosis
subjects affected / exposed	1 / 11210 (0.01%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Carotid artery disease
subjects affected / exposed	1 / 11210 (0.01%)	0 / 11200 (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 / 11210 (0.01%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Carotid artery stenosis
subjects affected / exposed	1 / 11210 (0.01%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cerebellar infarction
subjects affected / exposed	0 / 11210 (0.00%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cerebellar stroke
subjects affected / exposed	1 / 11210 (0.01%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cerebral artery embolism
subjects affected / exposed	0 / 11210 (0.00%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cerebral infarction
subjects affected / exposed	1 / 11210 (0.01%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cerebral venous sinus thrombosis
subjects affected / exposed	0 / 11210 (0.00%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hemiparesis
subjects affected / exposed	1 / 11210 (0.01%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Haemorrhagic stroke
subjects affected / exposed	1 / 11210 (0.01%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Ischaemic stroke
subjects affected / exposed	2 / 11210 (0.02%)	5 / 11200 (0.04%)
occurrences causally related to treatment / all	0 / 2	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 1
Lacunar infarction
subjects affected / exposed	1 / 11210 (0.01%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Lacunar stroke
subjects affected / exposed	0 / 11210 (0.00%)	2 / 11200 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Cerebrospinal fluid leakage
subjects affected / exposed	1 / 11210 (0.01%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cerebrovascular accident
subjects affected / exposed	16 / 11210 (0.14%)	14 / 11200 (0.13%)
occurrences causally related to treatment / all	0 / 16	0 / 14
deaths causally related to treatment / all	0 / 3	0 / 2
Cervical radiculopathy
subjects affected / exposed	0 / 11210 (0.00%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cranial nerve paralysis
subjects affected / exposed	1 / 11210 (0.01%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Dementia
subjects affected / exposed	0 / 11210 (0.00%)	2 / 11200 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Dementia Alzheimer's type
subjects affected / exposed	0 / 11210 (0.00%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Dizziness
subjects affected / exposed	1 / 11210 (0.01%)	4 / 11200 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Embolic stroke
subjects affected / exposed	0 / 11210 (0.00%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Encephalopathy
subjects affected / exposed	0 / 11210 (0.00%)	2 / 11200 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Generalised tonic-clonic seizure
subjects affected / exposed	1 / 11210 (0.01%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hypoaesthesia
subjects affected / exposed	0 / 11210 (0.00%)	1 / 11200 (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	1 / 11210 (0.01%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Spinal cord disorder
subjects affected / exposed	0 / 11210 (0.00%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Migraine with aura
subjects affected / exposed	1 / 11210 (0.01%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Multiple sclerosis
subjects affected / exposed	0 / 11210 (0.00%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Multiple sclerosis relapse
subjects affected / exposed	0 / 11210 (0.00%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Myelopathy
subjects affected / exposed	0 / 11210 (0.00%)	2 / 11200 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Nerve compression
subjects affected / exposed	1 / 11210 (0.01%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Paraesthesia
subjects affected / exposed	1 / 11210 (0.01%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Piriformis syndrome
subjects affected / exposed	0 / 11210 (0.00%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Post herpetic neuralgia
subjects affected / exposed	0 / 11210 (0.00%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Presyncope
subjects affected / exposed	0 / 11210 (0.00%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Radial nerve palsy
subjects affected / exposed	1 / 11210 (0.01%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Sciatica
subjects affected / exposed	0 / 11210 (0.00%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Seizure
subjects affected / exposed	3 / 11210 (0.03%)	2 / 11200 (0.02%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Metabolic encephalopathy
subjects affected / exposed	1 / 11210 (0.01%)	2 / 11200 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Spinal cord haematoma
subjects affected / exposed	1 / 11210 (0.01%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Spinal meningeal cyst
subjects affected / exposed	1 / 11210 (0.01%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Status epilepticus
subjects affected / exposed	1 / 11210 (0.01%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Subarachnoid haemorrhage
subjects affected / exposed	1 / 11210 (0.01%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Syncope
subjects affected / exposed	5 / 11210 (0.04%)	6 / 11200 (0.05%)
occurrences causally related to treatment / all	0 / 5	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
Transient global amnesia
subjects affected / exposed	1 / 11210 (0.01%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Tremor
subjects affected / exposed	1 / 11210 (0.01%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Vertebrobasilar stroke
subjects affected / exposed	0 / 11210 (0.00%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Transient ischaemic attack
subjects affected / exposed	2 / 11210 (0.02%)	6 / 11200 (0.05%)
occurrences causally related to treatment / all	0 / 2	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Blood and lymphatic system disorders
Leukocytosis
subjects affected / exposed	1 / 11210 (0.01%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Anaemia
subjects affected / exposed	3 / 11210 (0.03%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Blood loss anaemia
subjects affected / exposed	2 / 11210 (0.02%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hypochromic anaemia
subjects affected / exposed	1 / 11210 (0.01%)	0 / 11200 (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	2 / 11210 (0.02%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Iron deficiency anaemia
subjects affected / exposed	1 / 11210 (0.01%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Thrombocytosis
subjects affected / exposed	0 / 11210 (0.00%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Methaemoglobinaemia
subjects affected / exposed	1 / 11210 (0.01%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Ear and labyrinth disorders
Vertigo
subjects affected / exposed	0 / 11210 (0.00%)	5 / 11200 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Vertigo positional
subjects affected / exposed	1 / 11210 (0.01%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Eye disorders
Disorder of orbit
subjects affected / exposed	0 / 11210 (0.00%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Retinal artery occlusion
subjects affected / exposed	1 / 11210 (0.01%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Vision blurred
subjects affected / exposed	1 / 11210 (0.01%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Vitreous haemorrhage
subjects affected / exposed	1 / 11210 (0.01%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal disorders
Duodenitis
subjects affected / exposed	1 / 11210 (0.01%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Abdominal discomfort
subjects affected / exposed	0 / 11210 (0.00%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Abdominal hernia
subjects affected / exposed	0 / 11210 (0.00%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Abdominal pain
subjects affected / exposed	5 / 11210 (0.04%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 6	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Ascites
subjects affected / exposed	0 / 11210 (0.00%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Colitis
subjects affected / exposed	5 / 11210 (0.04%)	3 / 11200 (0.03%)
occurrences causally related to treatment / all	0 / 5	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Colitis ischaemic
subjects affected / exposed	1 / 11210 (0.01%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Colitis ulcerative
subjects affected / exposed	1 / 11210 (0.01%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Constipation
subjects affected / exposed	0 / 11210 (0.00%)	2 / 11200 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Diarrhoea
subjects affected / exposed	0 / 11210 (0.00%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Diverticular perforation
subjects affected / exposed	0 / 11210 (0.00%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Diverticulum intestinal
subjects affected / exposed	0 / 11210 (0.00%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Duodenal ulcer perforation
subjects affected / exposed	0 / 11210 (0.00%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Abdominal adhesions
subjects affected / exposed	0 / 11210 (0.00%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Enteritis
subjects affected / exposed	1 / 11210 (0.01%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Intestinal perforation
subjects affected / exposed	1 / 11210 (0.01%)	2 / 11200 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Gastritis
subjects affected / exposed	1 / 11210 (0.01%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastritis alcoholic
subjects affected / exposed	1 / 11210 (0.01%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal disorder
subjects affected / exposed	0 / 11210 (0.00%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal haemorrhage
subjects affected / exposed	0 / 11210 (0.00%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrooesophageal reflux disease
subjects affected / exposed	1 / 11210 (0.01%)	2 / 11200 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Hiatus hernia
subjects affected / exposed	3 / 11210 (0.03%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Ileus
subjects affected / exposed	1 / 11210 (0.01%)	2 / 11200 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Impaired gastric emptying
subjects affected / exposed	0 / 11210 (0.00%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Incarcerated inguinal hernia
subjects affected / exposed	1 / 11210 (0.01%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Inguinal hernia
subjects affected / exposed	0 / 11210 (0.00%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Intestinal ischaemia
subjects affected / exposed	1 / 11210 (0.01%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Intestinal mass
subjects affected / exposed	0 / 11210 (0.00%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Intestinal obstruction
subjects affected / exposed	4 / 11210 (0.04%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 4	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastric ulcer
subjects affected / exposed	2 / 11210 (0.02%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Intussusception
subjects affected / exposed	2 / 11210 (0.02%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Umbilical hernia perforation
subjects affected / exposed	1 / 11210 (0.01%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Large intestine polyp
subjects affected / exposed	0 / 11210 (0.00%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Lower gastrointestinal haemorrhage
subjects affected / exposed	1 / 11210 (0.01%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Melaena
subjects affected / exposed	0 / 11210 (0.00%)	1 / 11200 (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	1 / 11210 (0.01%)	2 / 11200 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Oesophagitis
subjects affected / exposed	1 / 11210 (0.01%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pancreatitis
subjects affected / exposed	3 / 11210 (0.03%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pancreatitis acute
subjects affected / exposed	2 / 11210 (0.02%)	3 / 11200 (0.03%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Pancreatitis chronic
subjects affected / exposed	1 / 11210 (0.01%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 0
Rectal haemorrhage
subjects affected / exposed	1 / 11210 (0.01%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Small intestinal obstruction
subjects affected / exposed	7 / 11210 (0.06%)	3 / 11200 (0.03%)
occurrences causally related to treatment / all	0 / 7	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Small intestinal perforation
subjects affected / exposed	2 / 11210 (0.02%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Umbilical hernia
subjects affected / exposed	0 / 11210 (0.00%)	2 / 11200 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Large intestine perforation
subjects affected / exposed	1 / 11210 (0.01%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Upper gastrointestinal haemorrhage
subjects affected / exposed	2 / 11210 (0.02%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Vomiting
subjects affected / exposed	2 / 11210 (0.02%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Volvulus
subjects affected / exposed	1 / 11210 (0.01%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatobiliary disorders
Bile duct stone
subjects affected / exposed	1 / 11210 (0.01%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Biliary colic
subjects affected / exposed	1 / 11210 (0.01%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cholangitis
subjects affected / exposed	0 / 11210 (0.00%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cholecystitis
subjects affected / exposed	1 / 11210 (0.01%)	2 / 11200 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Cholecystitis acute
subjects affected / exposed	3 / 11210 (0.03%)	3 / 11200 (0.03%)
occurrences causally related to treatment / all	0 / 3	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Cholelithiasis
subjects affected / exposed	4 / 11210 (0.04%)	5 / 11200 (0.04%)
occurrences causally related to treatment / all	0 / 4	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatic failure
subjects affected / exposed	0 / 11210 (0.00%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Hepatorenal failure
subjects affected / exposed	0 / 11210 (0.00%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Skin and subcutaneous tissue disorders
Skin lesion
subjects affected / exposed	0 / 11210 (0.00%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Angioedema
subjects affected / exposed	1 / 11210 (0.01%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Dermatitis allergic
subjects affected / exposed	1 / 11210 (0.01%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Excessive skin
subjects affected / exposed	1 / 11210 (0.01%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Renal and urinary disorders
Chronic kidney disease
subjects affected / exposed	0 / 11210 (0.00%)	2 / 11200 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Acute kidney injury
subjects affected / exposed	12 / 11210 (0.11%)	14 / 11200 (0.13%)
occurrences causally related to treatment / all	0 / 12	0 / 15
deaths causally related to treatment / all	0 / 1	0 / 0
Bladder stenosis
subjects affected / exposed	0 / 11210 (0.00%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Calculus urinary
subjects affected / exposed	1 / 11210 (0.01%)	0 / 11200 (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 / 11210 (0.01%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Renal cyst
subjects affected / exposed	0 / 11210 (0.00%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Renal failure
subjects affected / exposed	3 / 11210 (0.03%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Renal impairment
subjects affected / exposed	1 / 11210 (0.01%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Stress urinary incontinence
subjects affected / exposed	0 / 11210 (0.00%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Ureterolithiasis
subjects affected / exposed	0 / 11210 (0.00%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Urinary retention
subjects affected / exposed	0 / 11210 (0.00%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Nephrolithiasis
subjects affected / exposed	5 / 11210 (0.04%)	2 / 11200 (0.02%)
occurrences causally related to treatment / all	0 / 6	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Endocrine disorders
Primary hyperaldosteronism
subjects affected / exposed	1 / 11210 (0.01%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Inappropriate antidiuretic hormone secretion
subjects affected / exposed	1 / 11210 (0.01%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Goitre
subjects affected / exposed	0 / 11210 (0.00%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hyperparathyroidism
subjects affected / exposed	1 / 11210 (0.01%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hyperthyroidism
subjects affected / exposed	1 / 11210 (0.01%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Musculoskeletal and connective tissue disorders
Arthralgia
subjects affected / exposed	1 / 11210 (0.01%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Musculoskeletal chest pain
subjects affected / exposed	2 / 11210 (0.02%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Arthropathy
subjects affected / exposed	1 / 11210 (0.01%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Back pain
subjects affected / exposed	3 / 11210 (0.03%)	2 / 11200 (0.02%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Bone demineralisation
subjects affected / exposed	1 / 11210 (0.01%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cervical spinal stenosis
subjects affected / exposed	1 / 11210 (0.01%)	2 / 11200 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Exostosis
subjects affected / exposed	0 / 11210 (0.00%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Foot deformity
subjects affected / exposed	1 / 11210 (0.01%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Fracture nonunion
subjects affected / exposed	0 / 11210 (0.00%)	1 / 11200 (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	2 / 11210 (0.02%)	3 / 11200 (0.03%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Intervertebral disc disorder
subjects affected / exposed	2 / 11210 (0.02%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Intervertebral disc protrusion
subjects affected / exposed	2 / 11210 (0.02%)	2 / 11200 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Lumbar spinal stenosis
subjects affected / exposed	2 / 11210 (0.02%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Muscle spasms
subjects affected / exposed	0 / 11210 (0.00%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Muscular weakness
subjects affected / exposed	1 / 11210 (0.01%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Arthritis
subjects affected / exposed	3 / 11210 (0.03%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Neck pain
subjects affected / exposed	0 / 11210 (0.00%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Osteochondrosis
subjects affected / exposed	1 / 11210 (0.01%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Polyarthritis
subjects affected / exposed	1 / 11210 (0.01%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Polymyositis
subjects affected / exposed	1 / 11210 (0.01%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Rhabdomyolysis
subjects affected / exposed	1 / 11210 (0.01%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Rotator cuff syndrome
subjects affected / exposed	1 / 11210 (0.01%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Soft tissue necrosis
subjects affected / exposed	1 / 11210 (0.01%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Spinal osteoarthritis
subjects affected / exposed	0 / 11210 (0.00%)	4 / 11200 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Spinal stenosis
subjects affected / exposed	2 / 11210 (0.02%)	3 / 11200 (0.03%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Spondylolisthesis
subjects affected / exposed	0 / 11210 (0.00%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Vertebral foraminal stenosis
subjects affected / exposed	1 / 11210 (0.01%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Osteoarthritis
subjects affected / exposed	12 / 11210 (0.11%)	22 / 11200 (0.20%)
occurrences causally related to treatment / all	0 / 12	0 / 22
deaths causally related to treatment / all	0 / 0	0 / 0
Infections and infestations
Appendicitis
subjects affected / exposed	5 / 11210 (0.04%)	3 / 11200 (0.03%)
occurrences causally related to treatment / all	0 / 5	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Abscess limb
subjects affected / exposed	1 / 11210 (0.01%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Abdominal sepsis
subjects affected / exposed	1 / 11210 (0.01%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Abdominal abscess
subjects affected / exposed	1 / 11210 (0.01%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Appendicitis perforated
subjects affected / exposed	2 / 11210 (0.02%)	2 / 11200 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Arthritis bacterial
subjects affected / exposed	1 / 11210 (0.01%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Bacterial sepsis
subjects affected / exposed	0 / 11210 (0.00%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Bronchitis
subjects affected / exposed	2 / 11210 (0.02%)	3 / 11200 (0.03%)
occurrences causally related to treatment / all	0 / 2	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Cellulitis staphylococcal
subjects affected / exposed	2 / 11210 (0.02%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cellulitis
subjects affected / exposed	9 / 11210 (0.08%)	4 / 11200 (0.04%)
occurrences causally related to treatment / all	0 / 11	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
COVID-19 pneumonia
subjects affected / exposed	2 / 11210 (0.02%)	2 / 11200 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 1	0 / 0
COVID-19
subjects affected / exposed	8 / 11210 (0.07%)	8 / 11200 (0.07%)
occurrences causally related to treatment / all	0 / 8	0 / 8
deaths causally related to treatment / all	0 / 0	0 / 0
Cholecystitis infective
subjects affected / exposed	2 / 11210 (0.02%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Clostridium difficile colitis
subjects affected / exposed	0 / 11210 (0.00%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Clostridium difficile infection
subjects affected / exposed	0 / 11210 (0.00%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Colonic abscess
subjects affected / exposed	0 / 11210 (0.00%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Complicated appendicitis
subjects affected / exposed	2 / 11210 (0.02%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Device related bacteraemia
subjects affected / exposed	0 / 11210 (0.00%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Device related infection
subjects affected / exposed	1 / 11210 (0.01%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastroenteritis
subjects affected / exposed	0 / 11210 (0.00%)	2 / 11200 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Endocarditis
subjects affected / exposed	1 / 11210 (0.01%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Epstein-Barr virus infection
subjects affected / exposed	0 / 11210 (0.00%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Escherichia infection
subjects affected / exposed	0 / 11210 (0.00%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gangrene
subjects affected / exposed	0 / 11210 (0.00%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Diverticulitis
subjects affected / exposed	4 / 11210 (0.04%)	7 / 11200 (0.06%)
occurrences causally related to treatment / all	0 / 5	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
Gastroenteritis Escherichia coli
subjects affected / exposed	1 / 11210 (0.01%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gastroenteritis viral
subjects affected / exposed	0 / 11210 (0.00%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Human anaplasmosis
subjects affected / exposed	0 / 11210 (0.00%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Influenza
subjects affected / exposed	0 / 11210 (0.00%)	2 / 11200 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Intervertebral discitis
subjects affected / exposed	1 / 11210 (0.01%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Kidney infection
subjects affected / exposed	2 / 11210 (0.02%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Periorbital cellulitis
subjects affected / exposed	0 / 11210 (0.00%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Localised infection
subjects affected / exposed	2 / 11210 (0.02%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Meningitis
subjects affected / exposed	0 / 11210 (0.00%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Metapneumovirus infection
subjects affected / exposed	1 / 11210 (0.01%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Oral candidiasis
subjects affected / exposed	0 / 11210 (0.00%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Osteomyelitis
subjects affected / exposed	4 / 11210 (0.04%)	3 / 11200 (0.03%)
occurrences causally related to treatment / all	0 / 4	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Parainfluenzae viral bronchitis
subjects affected / exposed	1 / 11210 (0.01%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Klebsiella infection
subjects affected / exposed	0 / 11210 (0.00%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Perirectal abscess
subjects affected / exposed	2 / 11210 (0.02%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pyelonephritis acute
subjects affected / exposed	2 / 11210 (0.02%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pharyngitis streptococcal
subjects affected / exposed	0 / 11210 (0.00%)	2 / 11200 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Pharyngolaryngeal abscess
subjects affected / exposed	1 / 11210 (0.01%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pilonidal disease
subjects affected / exposed	0 / 11210 (0.00%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumonia
subjects affected / exposed	21 / 11210 (0.19%)	21 / 11200 (0.19%)
occurrences causally related to treatment / all	0 / 22	0 / 21
deaths causally related to treatment / all	0 / 0	0 / 5
Pneumonia aspiration
subjects affected / exposed	1 / 11210 (0.01%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumonia bacterial
subjects affected / exposed	2 / 11210 (0.02%)	2 / 11200 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumonia chlamydial
subjects affected / exposed	1 / 11210 (0.01%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Post procedural infection
subjects affected / exposed	0 / 11210 (0.00%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Post procedural sepsis
subjects affected / exposed	1 / 11210 (0.01%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Postoperative abscess
subjects affected / exposed	1 / 11210 (0.01%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Postoperative wound infection
subjects affected / exposed	0 / 11210 (0.00%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Prostatitis Escherichia coli
subjects affected / exposed	1 / 11210 (0.01%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pyelonephritis
subjects affected / exposed	0 / 11210 (0.00%)	1 / 11200 (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 / 11210 (0.00%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Rectal abscess
subjects affected / exposed	1 / 11210 (0.01%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Vulval cellulitis
subjects affected / exposed	1 / 11210 (0.01%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Respiratory tract infection
subjects affected / exposed	1 / 11210 (0.01%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Rhinovirus infection
subjects affected / exposed	3 / 11210 (0.03%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Scrotal abscess
subjects affected / exposed	1 / 11210 (0.01%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Sepsis
subjects affected / exposed	12 / 11210 (0.11%)	9 / 11200 (0.08%)
occurrences causally related to treatment / all	0 / 12	0 / 9
deaths causally related to treatment / all	0 / 0	0 / 2
Septic shock
subjects affected / exposed	1 / 11210 (0.01%)	2 / 11200 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Soft tissue infection
subjects affected / exposed	0 / 11210 (0.00%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Staphylococcal bacteraemia
subjects affected / exposed	1 / 11210 (0.01%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Staphylococcal skin infection
subjects affected / exposed	2 / 11210 (0.02%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Tularaemia
subjects affected / exposed	1 / 11210 (0.01%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Urinary tract infection
subjects affected / exposed	11 / 11210 (0.10%)	6 / 11200 (0.05%)
occurrences causally related to treatment / all	0 / 11	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Urosepsis
subjects affected / exposed	2 / 11210 (0.02%)	2 / 11200 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Viral infection
subjects affected / exposed	0 / 11210 (0.00%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Respiratory syncytial virus infection
subjects affected / exposed	0 / 11210 (0.00%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Wound infection
subjects affected / exposed	1 / 11210 (0.01%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Metabolism and nutrition disorders
Alcoholic ketoacidosis
subjects affected / exposed	1 / 11210 (0.01%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Dehydration
subjects affected / exposed	0 / 11210 (0.00%)	3 / 11200 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Diabetic complication
subjects affected / exposed	2 / 11210 (0.02%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 2	0 / 0
Diabetic ketoacidosis
subjects affected / exposed	1 / 11210 (0.01%)	2 / 11200 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 5
deaths causally related to treatment / all	0 / 1	0 / 0
Fluid retention
subjects affected / exposed	0 / 11210 (0.00%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hypercalcaemia
subjects affected / exposed	1 / 11210 (0.01%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hyperglycaemia
subjects affected / exposed	0 / 11210 (0.00%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hyperglycaemic hyperosmolar nonketotic syndrome
subjects affected / exposed	1 / 11210 (0.01%)	2 / 11200 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Hyperkalaemia
subjects affected / exposed	0 / 11210 (0.00%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hypervolaemia
subjects affected / exposed	0 / 11210 (0.00%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hypocalcaemia
subjects affected / exposed	1 / 11210 (0.01%)	0 / 11200 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hypoglycaemia
subjects affected / exposed	0 / 11210 (0.00%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hypokalaemia
subjects affected / exposed	1 / 11210 (0.01%)	2 / 11200 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Hypomagnesaemia
subjects affected / exposed	0 / 11210 (0.00%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hyponatraemia
subjects affected / exposed	4 / 11210 (0.04%)	2 / 11200 (0.02%)
occurrences causally related to treatment / all	0 / 4	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Hypovolaemia
subjects affected / exposed	0 / 11210 (0.00%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Lactic acidosis
subjects affected / exposed	0 / 11210 (0.00%)	1 / 11200 (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 / 11210 (0.00%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Obesity
subjects affected / exposed	2 / 11210 (0.02%)	3 / 11200 (0.03%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Steroid diabetes
subjects affected / exposed	0 / 11210 (0.00%)	1 / 11200 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Type 2 diabetes mellitus
subjects affected / exposed	2 / 11210 (0.02%)	2 / 11200 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0

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

Non-serious adverse events	mRNA-1010	Fluarix Quadrivalent
Total subjects affected by non serious adverse events
subjects affected / exposed	572 / 11210 (5.10%)	603 / 11200 (5.38%)
Infections and infestations
COVID-19
subjects affected / exposed	572 / 11210 (5.10%)	603 / 11200 (5.38%)
occurrences all number	581	621

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Were there any global substantial amendments to the protocol? Yes

02 Feb 2023

The main purpose of this amendment was to prespecify immunogenicity analysis for HAIs and alter the timing of the interim analysis (IA). The original plan was for 2 IAs at 45% and 75% of target cases. The first IA was removed because of the expected lower power and the timing of the second IA was set for February 2023 regardless of case accrual at the time. The planned statistical analyses were modified to accommodate the changes.

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 Phase 3, Randomized, Observer-blind, Active-controlled Study to Evaluate the Safety and Efficacy of mRNA-1010 Candidate Seasonal Influenza Vaccine in Adults 50 Years and Older

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs)

Primary: Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs)

Primary: Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Discontinuation

Primary: Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Discontinuation

Primary: Number of Participants With Unsolicited Adverse Events (AEs)

Primary: Number of Participants With Unsolicited Adverse Events (AEs)

Primary: Number of Participants With First Episode of RT-PCR-Confirmed Protocol-Defined Influenza-Like Illness (ILI) Caused by Any Seasonal Influenza A or B Virus Strains Regardless of Antigenic Match to Strains Selected for the Seasonal Vaccine

Primary: Number of Participants With First Episode of RT-PCR-Confirmed Protocol-Defined Influenza-Like Illness (ILI) Caused by Any Seasonal Influenza A or B Virus Strains Regardless of Antigenic Match to Strains Selected for the Seasonal Vaccine

Secondary: Number of Participants With First Episode of RT-PCR-Confirmed Protocol-Defined ILI Caused by Influenza A or B Strains With Similarity to Those Selected for the Seasonal Vaccine

Secondary: Number of Participants With First Episode of RT-PCR-Confirmed Protocol-Defined ILI Caused by Influenza A or B Strains With Similarity to Those Selected for the Seasonal Vaccine

Secondary: Number of Participants With First Episode of RT-PCR-Confirmed Protocol-Defined ILI Caused by influenza A or B Strains Antigenically Matched to the Vaccine Strains Selected for the Seasonal Vaccine

Secondary: Number of Participants With First Episode of RT-PCR-Confirmed Protocol-Defined ILI Caused by influenza A or B Strains Antigenically Matched to the Vaccine Strains Selected for the Seasonal Vaccine

Secondary: Number of Participants With First Episode of Culture-Confirmed Protocol-Defined ILI Caused by Any Seasonal Influenza A or B Virus Strains Regardless of Antigenic Match to Strains Selected for the Seasonal Vaccine

Secondary: Number of Participants With First Episode of Culture-Confirmed Protocol-Defined ILI Caused by Any Seasonal Influenza A or B Virus Strains Regardless of Antigenic Match to Strains Selected for the Seasonal Vaccine

Secondary: Number of Participants With First Episode of RT-PCR CDC-Defined ILI Caused by Influenza A or B Strains With Similarity to Vaccine Strains

Secondary: Number of Participants With First Episode of RT-PCR CDC-Defined ILI Caused by Influenza A or B Strains With Similarity to Vaccine Strains

Secondary: Number of Participants With First Episode of RT-PCR Confirmed United States (US) Centers for Disease Control and Prevention (CDC)-Defined ILI Caused by Any Influenza A or B Strains

Secondary: Number of Participants With First Episode of RT-PCR Confirmed United States (US) Centers for Disease Control and Prevention (CDC)-Defined ILI Caused by Any Influenza A or B Strains

Secondary: Number of Participants With First Episode of RT-PCR CDC-Defined ILI Caused by Influenza A or B Strains That Were Antigenically Matched to Vaccine Strains

Secondary: Number of Participants With First Episode of RT-PCR CDC-Defined ILI Caused by Influenza A or B Strains That Were Antigenically Matched to Vaccine Strains

Secondary: Number of Participants With Hospitalizations Associated With RT-PCR Confirmed Protocol-Defined ILI Caused by Any Seasonal Influenza A or B Virus Strains Regardless of Antigenic Match to Strains Selected for the Seasonal Vaccine

Secondary: Number of Participants With Hospitalizations Associated With RT-PCR Confirmed Protocol-Defined ILI Caused by Any Seasonal Influenza A or B Virus Strains Regardless of Antigenic Match to Strains Selected for the Seasonal Vaccine

Secondary: Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies at Day 29, as Measured by Hemagglutination Inhibition (HAI) Assay for Vaccine-matched Influenza A and B Strains

Secondary: Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies at Day 29, as Measured by Hemagglutination Inhibition (HAI) Assay for Vaccine-matched Influenza A and B Strains

Secondary: Number of Participants With First Episode of Culture-Confirmed CDC-Defined ILI Caused by Any Seasonal Influenza A or B Virus Strains Regardless of Antigenic Match to Strains Selected for the Seasonal Vaccine

Secondary: Number of Participants With First Episode of Culture-Confirmed CDC-Defined ILI Caused by Any Seasonal Influenza A or B Virus Strains Regardless of Antigenic Match to Strains Selected for the Seasonal Vaccine

Secondary: Percentage of Participants Reaching Seroconversion at Day 29, as Measured by HAI Assay for Vaccine-matched Influenza A and B Strains

Secondary: Percentage of Participants Reaching Seroconversion at Day 29, as Measured by HAI Assay for Vaccine-matched Influenza A and B Strains

Secondary: Percentage of Participants With HAI Titer ≥ 1:40 at Day 29

Secondary: Percentage of Participants With HAI Titer ≥ 1:40 at Day 29

Secondary: Geometric Mean Fold Rise (GMFR) of Anti-HA Antibodies at Day 29, as Measured by HAI Assay for Vaccine-matched Influenza A and B Strains

Secondary: Geometric Mean Fold Rise (GMFR) of Anti-HA Antibodies at Day 29, as Measured by HAI Assay for Vaccine-matched Influenza A and B Strains

Adverse events

Adverse events

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Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

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Clinical Trial Results:
A Phase 3, Randomized, Observer-blind, Active-controlled Study to Evaluate the Safety and Efficacy of mRNA-1010 Candidate Seasonal Influenza Vaccine in Adults 50 Years and Older