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Clinical Trial Results:
A Phase III Randomized, Double-blind, Placebo-controlled Multicenter Study in Adults to Determine the Safety, Efficacy, and Immunogenicity of AZD1222, a Non-replicating ChAdOx1 Vector Vaccine, for the Prevention of COVID-19

Summary
EudraCT number	2020-005226-28
Trial protocol	FR DE IT
Global end of trial date	21 Mar 2023

Results information
Results version number	v1(current)
This version publication date	23 Nov 2023
First version publication date	23 Nov 2023
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

D8110C00001

ISRCTN number

US NCT number

NCT04516746

WHO universal trial number (UTN)

Sponsor organisation name

AstraZeneca AB

Sponsor organisation address

Karlebyhusentren, B674 Astraallen, Södertälje, Sweden, SE-151 85

Public contact

Global Clinical Lead, AstraZeneca, +1 877-240-9479, information.center@astrazeneca.com

Scientific contact

Global Clinical Lead, AstraZeneca, +1 877-240-9479, information.center@astrazeneca.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

21 Mar 2023

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

21 Mar 2023

Was the trial ended prematurely?

Main objective of the trial

To estimate the efficacy and assess the safety, tolerability and reactogenicity (for substudy only) of 2 intramuscular (IM) doses of AZD1222 compared to saline placebo for the prevention of coronavirus disease-2019 (COVID-19).

Protection of trial subjects

This study was performed in accordance with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with International Council for Harmonisation/Good Clinical Practice, applicable regulatory requirements, and the AstraZeneca policy on Bioethics.

Background therapy

Evidence for comparator

Actual start date of recruitment

28 Aug 2020

Long term follow-up planned

Yes

Long term follow-up rationale

Safety

Long term follow-up duration

2 Years

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

Chile: 2206

Country: Number of subjects enrolled

Peru: 1470

Country: Number of subjects enrolled

United States: 28774

Worldwide total number of subjects

32450

EEA total number of subjects

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)

25195

From 65 to 84 years

7136

85 years and over

119

Subject disposition

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Recruitment details

This Phase III randomized study was conducted in adult participants who were healthy or had medically stable chronic diseases and were at increased risk for severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2) acquisition and coronavirus disease-2019 (COVID-19). One participant was enrolled at 2 sites and excluded from all analysis sets.

Screening details

Study had a screening period (14 days), followed by a treatment and follow-up period (up to 760 days). A total of 32450 participants were randomized in a 2:1 ratio to receive AZD1222 or placebo. The first participants randomized in each age group in the United States of America participated in a substudy to assess immunogenicity and reactogenicity.

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, Monitor, Carer

Are arms mutually exclusive

Yes

AZD1222

Arm description

Participants were randomized to receive 2 IM doses of 5*10^10 viral particles (vp) (nominal, ± 1.5*10^10 vp) AZD1222 on Days 1 and 29.

Arm type

Experimental

Investigational medicinal product name

AZD1222

Investigational medicinal product code

ChAdOx1 nCoV-19

Other name

Vaxzevria

Pharmaceutical forms

Solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

AZD1222 5*10^10 vp was administered on Days 1 and 29.

Placebo

Arm description

Participants were randomized to receive 2 IM doses of placebo matching with AZD1222 on Days 1 and 29.

Arm type

Placebo

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

Placebo matching with AZD1222 was administered on Days 1 and 29.

Number of subjects in period 1	AZD1222	Placebo
Started	21634	10816
Participants who received first dose	21583	10797
Participants who received second dose	20770	9954
Completed	16099	7213
Not completed	5535	3603
Consent withdrawn by subject	1946	1696
Physician decision	10	8
Adverse event, non-fatal	-	1
Death	62	32
Randomized but not Treated	51	19
Unspecified	35	16
Lost to follow-up	3431	1831

Baseline characteristics

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Reporting group title

AZD1222

Reporting group description

Participants were randomized to receive 2 IM doses of 5*10^10 viral particles (vp) (nominal, ± 1.5*10^10 vp) AZD1222 on Days 1 and 29.

Reporting group title

Placebo

Reporting group description

Participants were randomized to receive 2 IM doses of placebo matching with AZD1222 on Days 1 and 29.

Reporting group values	AZD1222	Placebo	Total
Number of subjects	21634	10816	32450
Age Categorical
Units: Subjects
Age Continuous
Units: years
arithmetic mean (standard deviation)	50.2 ( 15.92 )	50.2 ( 15.86 )	-
Gender Categorical
Units: Subjects
Female	9603	4797	14400
Male	12031	6019	18050
Ethnicity
Units: Subjects
Hispanic or Latino	4787	2456	7243
Not Hispanic or Latino	16506	8217	24723
Not reported	293	127	420
Unknown	48	16	64
Race
Units: Subjects
Multiple	513	258	771
White	17100	8534	25634
Black or African American	1798	899	2697
Asian	947	483	1430
American Indian or Alaska Native	855	430	1285
Native Hawaiian or Other Pacific Islander	60	21	81
Not reported	260	138	398
Unknown	101	53	154

End points

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Reporting group title

AZD1222

Reporting group description

Participants were randomized to receive 2 IM doses of 5*10^10 viral particles (vp) (nominal, ± 1.5*10^10 vp) AZD1222 on Days 1 and 29.

Reporting group title

Placebo

Reporting group description

Participants were randomized to receive 2 IM doses of placebo matching with AZD1222 on Days 1 and 29.

Primary: Number of Participants With Binary Response

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End point title

Number of Participants With Binary Response

End point description

A binary response, whereby a participant with negative serostatus at baseline is defined as a COVID-19 case if their first case of SARS-CoV-2 RT-PCR-positive symptomatic illness occurs ≥ 15 days post second dose of study intervention. Otherwise, a participant is not defined as a COVID-19 case. The primary efficacy analysis was performed once approximately 150 events meeting the primary efficacy outcome measure definition had occurred across the AZD1222 and placebo groups. The fully vaccinated analysis set (FVS) included all participants in the full analysis set (FAS) who were seronegative at baseline, received 2 doses of study intervention, and who remained on-study 15 days after their second dose without having had a prior SARS-CoV-2 RT-PCR-positive confirmed COVID-19 infection.

End point type

Primary

End point timeframe

From 15 days post second dose up to data cut-off date (DCO) of 05 March 2021 or study discontinuation or unblinding or receipt of non-study COVID-19 vaccination, up to a maximum of 17 weeks

End point values	AZD1222	Placebo
Number of subjects analysed	17662	8550
Units: participants	73	130

Treatment ratio in binary response

Statistical analysis description

The 95% confidence interval (CI) and p-value were estimated based on Poisson regression with robust variance (including study arm and stratification factor [age group at informed consent] as covariates, and log of the follow up time as an offset).

Comparison groups

AZD1222 v Placebo

Number of subjects included in analysis

26212

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Poisson regression with robust variance

Parameter type

Vaccine efficacy

Point estimate

73.98

Confidence interval

level

95%

sides

2-sided

lower limit

65.34

upper limit

80.47

Primary: Number of Participants With Adverse Events (AEs) Post Each Dose of Study Intervention

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End point title

Number of Participants With Adverse Events (AEs) Post Each Dose of Study Intervention ^[1]

End point description

An AE is the development of any untoward medical occurrence in a clinical study participant administered medicinal product and which does not necessarily have a causal relationship with this medicinal product. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. The safety analysis set included all participants who received at least 1 dose of study intervention. Here, 'n' is number of participants analyzed at specific time point.

End point type

Primary

End point timeframe

From Day 1 up to 28 days post second dose of study intervention, approximately 57 days

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: Only descriptive statistical analysis was performed for the primary endpoint.

End point values	AZD1222	Placebo
Number of subjects analysed	21587	10792
Units: participants
After first dose (n= 21587, 10792)	5736	1926
After second dose (n= 20773, 9947)	5074	1797
After any dose (n= 21587, 10792)	8771	3201

No statistical analyses for this end point

Primary: Number of Participants With Serious Adverse Events (SAE), Medically Attended Adverse Events (MAAE), and Adverse Event of Special Interest (AESI) Throughout the Study

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End point title

Number of Participants With Serious Adverse Events (SAE), Medically Attended Adverse Events (MAAE), and Adverse Event of Special Interest (AESI) Throughout the Study ^[2]

End point description

An SAE is an AE occurring during any study phase that fulfils 1 or more of the following criteria: death; immediately life-threatening; in-participant hospitalization or prolongation of existing hospitalization; persistent or significant disability or incapacity; congenital abnormality or birth defect; an important medical event. AESIs were events of scientific and medical interest specific to the further understanding of the study intervention safety profile and required close monitoring and rapid communication by the investigators to the sponsor. MAAEs are defined as AEs leading to medically-attended visits that were not routine visits for physical examination or vaccination, such as an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. Different follow-up time between AZD1222 and Placebo groups (20223 versus 3893 participant years). The safety analysis set.

End point type

Primary

End point timeframe

From Day 1 up to 2 years of follow-up post first dose or study discontinuation or receipt of non-study COVID-19 vaccination, a maximum of approximately 760 days

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: Only descriptive statistical analysis was performed for the primary endpoint.

End point values	AZD1222	Placebo
Number of subjects analysed	21587	10793
Units: participants
SAEs	621	136
MAAEs	4750	1256
AESIs	2516	591

No statistical analyses for this end point

Primary: Number of Participants With Local and Systemic Solicited AEs in the Substudy Only

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End point title

Number of Participants With Local and Systemic Solicited AEs in the Substudy Only ^[3]

End point description

Solicited AEs are local or systemic predefined events for assessment of reactogenicity. Solicited AEs were collected in a e-Diary only for participants in the substudy. The safety analysis set included all participants who received at least 1 dose of study intervention. Only participants included in the substudy were analyzed. Here, 'n' is number of participants analyzed at specific time point.

End point type

Primary

End point timeframe

From Day 1 up to 7 days post each dose of study intervention, approximately 14 days

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: Only descriptive statistical analysis was performed for the primary endpoint.

End point values	AZD1222	Placebo
Number of subjects analysed	2037	1013
Units: participants
Solicited local AEs: After 1st dose(n=1830,920)	1250	173
Solicited local AEs: After 2nd dose(n=1829,908)	977	120
Solicited local AEs: After any dose(n=1944,979)	1440	239
Solicited systemic AEs: After 1st dose(n=1842,924)	1191	415
Solicited systemic AEs: After 2nd dose(n=1821,905)	862	314
Solicited systemic AEs: After any dose(n=1947,980)	1395	519

No statistical analyses for this end point

Secondary: Number of Participants With First COVID-19 Symptomatic Illness Using Centers for Disease Control and Prevention (CDC) Criteria Post Second Dose of Study Intervention

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End point title

Number of Participants With First COVID-19 Symptomatic Illness Using Centers for Disease Control and Prevention (CDC) Criteria Post Second Dose of Study Intervention

End point description

The incidence of the first case of SARS-CoV-2 RT-PCR-positive symptomatic illness occurring ≥ 15 days post second dose of study intervention using CDC criteria. Participant must present with at least 1 of the following symptoms per CDC criteria: fever, shortness of breath, difficulty breathing, chills, cough, fatigue, muscle aches, body aches, headache, new loss of taste, new loss of smell, sore throat, congestion, runny nose, nausea, vomiting, or diarrhea. The FVS included all participants in the full analysis set who were seronegative at baseline, received 2 doses of study intervention, and who remained on-study 15 days after their second dose without having had a prior SARS-CoV-2 RT-PCR-positive confirmed COVID-19 infection.

End point type

Secondary

End point timeframe

From 15 days post second dose up to DCO of 05 March 2021 or study discontinuation or unblinding or receipt of non-study COVID-19 vaccination, up to a maximum of 17 weeks

End point values	AZD1222	Placebo
Number of subjects analysed	17662	8550
Units: participants	95	145

Treatment difference: COVID-19 symptomatic illness

Statistical analysis description

The 95% CI and p-value were estimated based on Poisson regression with robust variance (including study arm and stratification factor [age group at informed consent] as covariates, and log of the follow up time as an offset).

Comparison groups

AZD1222 v Placebo

Number of subjects included in analysis

26212

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Poisson regression with robust variance

Parameter type

Vaccine efficacy

Point estimate

69.65

Confidence interval

level

95%

sides

2-sided

lower limit

60.68

upper limit

76.57

Secondary: Number of Participants With First Post-intervention Response for SARS-CoV-2 Nucleocapsid Antibodies Post Second Dose of Study

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End point title

Number of Participants With First Post-intervention Response for SARS-CoV-2 Nucleocapsid Antibodies Post Second Dose of Study

End point description

The incidence of the first post-intervention response (negative at baseline to positive post intervention with study intervention) for SARS-CoV-2 nucleocapsid antibodies occurring ≥ 15 days post second dose of study intervention (key secondary endpoint). The FVS included all participants in the FAS who were seronegative at baseline, received 2 doses of study intervention, and who remained on-study 15 days after their second dose without having had a prior SARS-CoV-2 RT-PCR-positive confirmed COVID-19 infection.

End point type

Secondary

End point timeframe

From 15 days post second dose up to DCO of 05 March 2021 or study discontinuation or unblinding or receipt of non-study COVID-19 vaccination, up to a maximum of 17 weeks

End point values	AZD1222	Placebo
Number of subjects analysed	17662	8550
Units: participants	156	202

Treatment difference: Nucleocapsid antibodies

Statistical analysis description

Comparison groups

AZD1222 v Placebo

Number of subjects included in analysis

26212

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Poisson regression with robust variance

Parameter type

Vaccine efficacy

Point estimate

64.32

Confidence interval

level

95%

sides

2-sided

lower limit

56.05

upper limit

71.03

Secondary: Number of Participants With First COVID-19 Symptomatic Illness Using University of Oxford-Defined Symptom Criteria Post Second Dose of Study Intervention

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End point title

Number of Participants With First COVID-19 Symptomatic Illness Using University of Oxford-Defined Symptom Criteria Post Second Dose of Study Intervention

End point description

The incidence of the first case of SARS-CoV-2 RT-PCR-positive symptomatic illness occurring ≥ 15 days post second dose of study intervention using University of Oxford-defined symptom criteria: new onset of fever (> 100 °Fahrenheit [> 37.8 °Celsius]), cough, shortness of breath, or anosmia/ageusia. The FVS included all participants in the FAS who were seronegative at baseline, received 2 doses of study intervention, and who remained on-study 15 days after their second dose without having had a prior SARS-CoV-2 RT-PCR-positive confirmed COVID-19 infection.

End point type

Secondary

End point timeframe

From 15 days post second dose up to DCO of 05 March 2021 or study discontinuation or unblinding or receipt of non-study COVID-19 vaccination, up to a maximum of 17 weeks

End point values	AZD1222	Placebo
Number of subjects analysed	17662	8550
Units: participants	86	136

Treatment difference: COVID-19 symptomatic illness

Statistical analysis description

Comparison groups

AZD1222 v Placebo

Number of subjects included in analysis

26212

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Poisson regression with robust variance

Parameter type

Vaccine efficacy

Point estimate

70.7

Confidence interval

level

95%

sides

2-sided

lower limit

61.62

upper limit

77.64

Secondary: Number of Participants With First Symptomatic COVID-19 Regardless of Evidence of Prior SARS-CoV-2 Infection Post Second Dose of Study Intervention

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End point title

Number of Participants With First Symptomatic COVID-19 Regardless of Evidence of Prior SARS-CoV-2 Infection Post Second Dose of Study Intervention

End point description

The incidence of the first case of SARS-CoV-2 RT-PCR-positive symptomatic illness occurring ≥ 15 days post second dose of study intervention regardless of evidence of prior SARS-CoV-2 infection (key secondary endpoint). The FVS regardless of prior SARS-COV-2 infection included all participants in the FAS who were seronegative at baseline, received 2 doses of study intervention, and who remained on-study 15 days after their second dose.

End point type

Secondary

End point timeframe

From 15 days post second dose up to DCO of 05 March 2021 or study discontinuation or unblinding or receipt of non-study COVID-19 vaccination, up to a maximum of 17 weeks

End point values	AZD1222	Placebo
Number of subjects analysed	18563	9031
Units: participants	76	135

Treatment difference: First symptomatic COVID-19

Statistical analysis description

Comparison groups

AZD1222 v Placebo

Number of subjects included in analysis

27594

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Poisson regression with robust variance

Parameter type

Vaccine efficacy

Point estimate

73.68

Confidence interval

level

95%

sides

2-sided

lower limit

65.13

upper limit

80.13

Secondary: Number of Participants With COVID-19 Severe or Critical Symptomatic Illness Post Second Dose of Study Intervention

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End point title

Number of Participants With COVID-19 Severe or Critical Symptomatic Illness Post Second Dose of Study Intervention

End point description

The incidence of SARS-CoV-2 RT-PCR-positive severe or critical symptomatic illness occurring ≥ 15 days post second dose of study intervention. The severity of COVID-19 was evaluated in participants with symptoms of COVID-19. Following are the findings regarding severe of critical symptomatic COVID-19: clinical signs at rest indicative of severe systemic illness; respiratory failure; evidence of shock; significant acute renal, hepatic, or neurologic dysfunction; admission to an intensive care unit; and death (key secondary endpoint). The FVS included all participants in the FAS who were seronegative at baseline, received 2 doses of study intervention, and who remained on-study 15 days after their second dose without having had a prior SARS-CoV-2 RT-PCR-positive confirmed COVID-19 infection.

End point type

Secondary

End point timeframe

From 15 days post second dose up to DCO of 05 March 2021 or study discontinuation or unblinding or receipt of non-study COVID-19 vaccination, up to a maximum of 17 weeks

End point values	AZD1222	Placebo
Number of subjects analysed	17662	8550
Units: participants	0	8

Treatment difference: COVID-19 symptomatic illness

Statistical analysis description

The exact 1-sided 97.5% CI and p-value were estimated based on stratified Poisson regression with exact conditional method (including study arm and stratification factor [age group at informed consent] as strata factor and log of total number of participants for each combination of study arm and strata as an offset).

Comparison groups

AZD1222 v Placebo

Number of subjects included in analysis

26212

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Poisson regression exact conditional

Parameter type

Vaccine efficacy

Point estimate

100

Confidence interval

level

97.5%

sides

1-sided

lower limit

71.62

upper limit

Secondary: Number of Participants With COVID-19-Related Emergency Department Visits Post Second Dose of Study Intervention

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End point title

Number of Participants With COVID-19-Related Emergency Department Visits Post Second Dose of Study Intervention

End point description

The incidence of COVID-19-related emergency department visits occurring ≥ 15 days post second dose of study intervention (key secondary endpoint). The FVS included all participants in the FAS who were seronegative at baseline, received 2 doses of study intervention, and who remained on-study 15 days after their second dose without having had a prior SARS-CoV-2 RT-PCR-positive confirmed COVID-19 infection.

End point type

Secondary

End point timeframe

From 15 days post second dose up to DCO of 05 March 2021 or study discontinuation or unblinding or receipt of non-study COVID-19 vaccination, up to a maximum of 17 weeks

End point values	AZD1222	Placebo
Number of subjects analysed	17662	8550
Units: participants	1	9

Treatment difference: Emergency department visits

Statistical analysis description

Comparison groups

AZD1222 v Placebo

Number of subjects included in analysis

26212

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.005

Method

Poisson regression with robust variance

Parameter type

Vaccine efficacy

Point estimate

94.8

Confidence interval

level

95%

sides

2-sided

lower limit

58.98

upper limit

99.34

Secondary: Number of Participants With COVID-19 Severe or Critical Symptomatic Illness Post First Dose of Study Intervention

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End point title

Number of Participants With COVID-19 Severe or Critical Symptomatic Illness Post First Dose of Study Intervention

End point description

The incidence of SARS-CoV-2 RT-PCR-positive severe or critical symptomatic illness occurring post first dose of study intervention. The severity of COVID-19 was evaluated in participants with symptoms of COVID-19. Following are the findings regarding severe of critical symptomatic COVID-19: clinical signs at rest indicative of severe systemic illness; respiratory failure; evidence of shock; significant acute renal, hepatic, or neurologic dysfunction; admission to an intensive care unit; and death. The FAS included all randomized participants who received at least 1 dose of study intervention, irrespective of their protocol adherence and continued participation in the study. Only participants who are seronegative at baseline were analyzed.

End point type

Secondary

End point timeframe

From 15 days post second dose up to DCO of 05 March 2021 or study discontinuation or unblinding or receipt of non-study COVID-19 vaccination, up to a maximum of 17 weeks

End point values	AZD1222	Placebo
Number of subjects analysed	20589	10300
Units: participants	5	16

Treatment difference: COVID-19 symptomatic illness

Statistical analysis description

The 95% CI were estimated based on Poisson regression with robust variance (including study arm and age group at screening (18-65 years, ≥ 65 years) as covariates and log of the follow-up time as an offset).

Comparison groups

AZD1222 v Placebo

Number of subjects included in analysis

30889

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Poisson regression with robust variance

Parameter type

Vaccine efficacy

Point estimate

84.97

Confidence interval

level

95%

sides

2-sided

lower limit

58.97

upper limit

94.5

Secondary: Geometric Mean Titers (GMTs) for SARS-CoV-2 Spike (S) and Receptor Binding Domain (RBD) Antibodies as Measured by Meso Scale Discovery (MSD) Serology Assay

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End point title

Geometric Mean Titers (GMTs) for SARS-CoV-2 Spike (S) and Receptor Binding Domain (RBD) Antibodies as Measured by Meso Scale Discovery (MSD) Serology Assay

End point description

The GMT was calculated as the antilogarithm of Σ(log base 2 transformed titer/n), i.e. as the anti-logarithm transformation of the mean of the log-transformed titer, where 'n' is the number of participants with titer information. The immunogenicity analysis population included all participants in the safety analysis set who had no protocol deviations judged to have the potential to interfere with the generation or interpretation of an immune response. Only participants included in the substudy were analyzed. Here, 'n' is number of participants analyzed at specific time point.

End point type

Secondary

End point timeframe

Baseline (Day 1) and Days 15, 29, 43, 57, 90, 180, 360, and 730

End point values	AZD1222	Placebo
Number of subjects analysed	2008	1002
Units: arbitrary units per milliliter (AU/mL)
geometric mean (confidence interval 95%)
S Antibody Titer: Day 1 (n=2008, 1002)	53.18 (50.37 to 56.14)	54.68 (50.10 to 59.69)
S Antibody Titer: Day 15 (n=1897, 949)	1820.10 (1696.48 to 1952.72)	53.47 (48.88 to 58.50)
S Antibody Titer: Day 29 (n=1428, 708)	5782.09 (5389.88 to 6202.84)	53.64 (47.98 to 59.97)
S Antibody Titer: Day 43 (n=1809, 899)	24105.87 (22945.04 to 25325.44)	58.15 (52.68 to 64.18)
S Antibody Titer: Day 57 (n=1760, 829)	19488.64 (18521.81 to 20505.92)	58.30 (52.35 to 64.94)
S Antibody Titer: Day 90 (n=1675, 643)	14583.30 (13839.22 to 15367.38)	87.51 (74.78 to 102.42)
S Antibody Titer: Day 180 (n=1217, 147)	7483.04 (6911.35 to 8102.02)	266.47 (161.19 to 440.49)
S Antibody Titer: Day 360 (n=874, 47)	6686.81 (5779.74 to 7736.24)	1268.45 (489.80 to 3284.98)
S Antibody Titer: Day 730 (n=276, 22)	186727.78 (154395.93 to 225830.20)	19093.94 (5685.04 to 64129.44)
RBD Antibody Titer: Day 1 (n=2008, 1002)	133.6 (129.1 to 138.4)	138.9 (130.9 to 147.3)
RBD Antibody Titer: Day 15 (n=1897, 949)	965.0 (897.0 to 1038.1)	138.6 (130.5 to 147.1)
RBD Antibody Titer: Day 29 (n=1427, 708)	5176.6 (4794.8 to 5588.9)	143.0 (132.4 to 154.3)
RBD Antibody Titer: Day 43 (n=1809, 899)	29351.9 (27875.6 to 30906.4)	145.7 (136.0 to 156.1)
RBD Antibody Titer: Day 57 (n=1760, 829)	23840.6 (22614.3 to 25133.3)	151.6 (140.3 to 163.8)
RBD Antibody Titer: Day 90 (n=1675, 643)	17499.9 (16559.1 to 18494.1)	192.6 (171.0 to 217.0)
RBD Antibody Titer: Day 180 (n=1217, 147)	8333.1 (7647.9 to 9079.7)	481.6 (314.8 to 736.7)
RBD Antibody Titer: Day 360 (n=874, 47)	7499.2 (6417.7 to 8763.1)	1912.3 (839.0 to 4358.5)
RBD Antibody Titer: Day 730 (n=276, 22)	276381.8 (227665.9 to 335521.9)	19319.4 (5290.3 to 70551.9)

No statistical analyses for this end point

Secondary: Geometric Mean Fold Rise (GMFR) for SARS-CoV-2 S and RBD Antibodies as Measured by MSD Serology Assay

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End point title

Geometric Mean Fold Rise (GMFR) for SARS-CoV-2 S and RBD Antibodies as Measured by MSD Serology Assay

End point description

The fold rise was calculated as the ratio of the post-vaccination titer level to the pre-vaccination titer level. GMFR was calculated as anti-logarithm of Σ (log base 2 transformed (post-vaccination titer/ pre-vaccination titer)/n). Where 'n' is the number of participants with titer information. The immunogenicity analysis population included all participants in the safety analysis set who had no protocol deviations judged to have the potential to interfere with the generation or interpretation of an immune response. Only participants included in the substudy were analyzed. Here, 'n' is number of participants analyzed at specific time point.

End point type

Secondary

End point timeframe

Days 15, 29, 43, 57, 90, 180, 360, and 730

End point values	AZD1222	Placebo
Number of subjects analysed	1885	943
Units: ratio
geometric mean (confidence interval 95%)
S Antibody Titer: Day 15 (n=1885, 943)	34.28 (31.87 to 36.86)	0.97 (0.94 to 1.00)
S Antibody Titer: Day 29 (n=1420, 706)	108.35 (99.95 to 117.45)	0.92 (0.87 to 0.96)
S Antibody Titer: Day 43 (n=1797, 894)	455.38 (425.71 to 487.12)	1.08 (1.02 to 1.14)
S Antibody Titer: Day 57 (n=1746, 823)	373.44 (348.12 to 400.60)	1.10 (1.02 to 1.19)
S Antibody Titer: Day 90 (n=1664, 638)	274.05 (255.01 to 294.50)	1.61 (1.41 to 1.85)
S Antibody Titer: Day 180 (n=1207, 146)	138.44 (125.37 to 152.88)	3.33 (2.07 to 5.37)
S Antibody Titer: Day 360 (n=866, 46)	121.12 (102.89 to 142.58)	17.44 (6.75 to 45.07)
S Antibody Titer: Day 730 (n=273, 22)	3506.74 (2808.52 to 4378.55)	295.66 (89.07 to 981.35)
RBD Antibody Titer: Day 15 (n=1885, 943)	7.24 (6.76 to 7.76)	1.00 (0.98 to 1.02)
RBD Antibody Titer: Day 29 (n=1419, 706)	39.01 (36.10 to 42.17)	1.01 (0.98 to 1.03)
RBD Antibody Titer: Day 43 (n=1797, 894)	219.94 (207.28 to 233.37)	1.05 (1.01 to 1.09)
RBD Antibody Titer: Day 57 (n=1746, 823)	178.61 (167.97 to 189.92)	1.10 (1.04 to 1.16)
RBD Antibody Titer: Day 90 (n=1664, 638)	130.46 (122.53 to 138.89)	1.41 (1.27 to 1.57)
RBD Antibody Titer: Day 180 (n=1207, 146)	61.69 (56.27 to 67.62)	3.13 (2.11 to 4.65)
RBD Antibody Titer: Day 360 (n=866, 46)	53.91 (45.86 to 63.37)	11.18 (4.91 to 25.45)
RBD Antibody Titer: Day 730 (n=273, 22)	2103.65 (1706.88 to 2592.64)	106.35 (29.93 to 377.87)

No statistical analyses for this end point

Secondary: Percentage of Participants With Seroresponse to the S and RBD Antigens of AZD1222 as Measured by MSD Serology Assay

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End point title

Percentage of Participants With Seroresponse to the S and RBD Antigens of AZD1222 as Measured by MSD Serology Assay

End point description

The fold rise was calculated as the ratio of the post-vaccination titer level to the pre-vaccination titer level. The percentage of participants with a post-intervention seroresponse (≥ 4-fold rise in titers from baseline value to 28 days post each dose) to the S and RBD antigens of AZD1222 as measured by MSD serology assay is reported. The immunogenicity analysis population included all participants in the safety analysis set who had no protocol deviations judged to have the potential to interfere with the generation or interpretation of an immune response. Only participants included in the substudy were analyzed. Here, 'n' is number of participants analyzed at specific time point.

End point type

Secondary

End point timeframe

Days 15, 29, 43, 57, 90, 180, 360, and 730

End point values	AZD1222	Placebo
Number of subjects analysed	1885	943
Units: percentage of participants
number (not applicable)
S Antibody Titer: Day 15 (n=1885, 943)	89.8	1.1
S Antibody Titer: Day 29 (n=1420, 706)	97.1	1.6
S Antibody Titer: Day 43 (n=1797, 894)	99.4	2.5
S Antibody Titer: Day 57 (n=1746, 823)	99.3	3.2
S Antibody Titer: Day 90 (n=1664, 638)	99.3	8.9
S Antibody Titer: Day 180 (n=1207, 146)	98.3	23.3
S Antibody Titer: Day 360 (n=866, 46)	96.1	54.3
S Antibody Titer: Day 730 (n=273, 22)	100.0	90.9
RBD Antibody Titer: Day 15 (n=1885, 943)	61.3	0.4
RBD Antibody Titer: Day 29 (n=1419, 706)	92.2	1.0
RBD Antibody Titer: Day 43 (n=1797, 894)	98.8	2.0
RBD Antibody Titer: Day 57 (n=1746, 823)	98.7	2.6
RBD Antibody Titer: Day 90 (n=1664, 638)	98.6	7.7
RBD Antibody Titer: Day 180 (n=1207, 146)	96.3	22.6
RBD Antibody Titer: Day 360 (n=866, 46)	89.8	50.0
RBD Antibody Titer: Day 730 (n=273, 22)	99.3	86.4

No statistical analyses for this end point

Secondary: GMTs for SARS-CoV-2 Neutralizing Antibodies as Measured by Pseudo-neutralization Assay

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End point title

GMTs for SARS-CoV-2 Neutralizing Antibodies as Measured by Pseudo-neutralization Assay

End point description

End point type

Secondary

End point timeframe

Baseline (Day 1) and Days 15, 29, 43, 57, 90, 180, and 360

End point values	AZD1222	Placebo
Number of subjects analysed	1943	973
Units: AU/mL
geometric mean (confidence interval 95%)
Day 1 (n=1943, 973)	20.6 (20.3 to 20.9)	21.4 (20.7 to 22.0)
Day 15 (n=1747, 920)	41.7 (39.3 to 44.2)	21.7 (20.9 to 22.4)
Day 29 (n=1227, 682)	65.9 (60.8 to 71.4)	23.0 (21.8 to 24.3)
Day 43 (n=1642, 876)	221.3 (208.4 to 235.0)	22.6 (21.6 to 23.5)
Day 57 (n=1469, 777)	251.8 (235.7 to 269.0)	23.3 (22.1 to 24.6)
Day 90 (n=60, 21)	206.1 (150.3 to 282.6)	37.5 (15.0 to 94.1)
Day 180 (n=283, 127)	112.9 (90.4 to 141.0)	51.3 (37.4 to 70.4)
Day 360 (n=27, 14)	265.7 (94.0 to 751.1)	46.3 (20.1 to 106.4)

No statistical analyses for this end point

Secondary: GMFR for SARS-CoV-2 Neutralizing Antibodies as Measured by Pseudo-neutralization Assay

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End point title

GMFR for SARS-CoV-2 Neutralizing Antibodies as Measured by Pseudo-neutralization Assay

End point description

End point type

Secondary

End point timeframe

Days 15, 29, 43, 57, 90, 180, and 360

End point values	AZD1222	Placebo
Number of subjects analysed	1705	896
Units: ratio
geometric mean (confidence interval 95%)
Day 15 (n=1705, 896)	2.03 (1.92 to 2.15)	1.01 (0.99 to 1.03)
Day 29 (n=1200, 670)	3.24 (2.99 to 3.50)	1.07 (1.02 to 1.11)
Day 43 (n=1597, 854)	10.91 (10.27 to 11.58)	1.05 (1.01 to 1.08)
Day 57 (n=1432, 759)	12.32 (11.54 to 13.16)	1.08 (1.03 to 1.14)
Day 90 (n=60, 20)	9.95 (7.33 to 13.51)	1.94 (0.74 to 5.09)
Day 180 (n=274, 123)	5.37 (4.30 to 6.71)	2.22 (1.65 to 3.00)
Day 360 (n=26, 14)	12.64 (4.31 to 37.11)	2.31 (1.01 to 5.32)

No statistical analyses for this end point

Secondary: Percentage of Participants With Seroresponse to SARS-CoV-2 Neutralizing Antibodies of AZD1222 as Measured by Pseudo-neutralization Assay

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End point title

Percentage of Participants With Seroresponse to SARS-CoV-2 Neutralizing Antibodies of AZD1222 as Measured by Pseudo-neutralization Assay

End point description

The fold rise was calculated as the ratio of the post-vaccination titer level to the pre-vaccination titer level. The percentage of participants with a post-intervention seroresponse (≥ 4-fold rise in titers from baseline value to 28 days post each dose) to SARS-CoV-2 neutralizing antibodies of AZD1222 as measured by pseudo-neutralization assay is reported. The immunogenicity analysis population included all participants in the safety analysis set who had no protocol deviations judged to have the potential to interfere with the generation or interpretation of an immune response. Only participants included in the substudy were analyzed. Here, 'n' is number of participants analyzed at specific time point.

End point type

Secondary

End point timeframe

Days 15, 29, 43, 57, 90, 180, and 360

End point values	AZD1222	Placebo
Number of subjects analysed	1705	896
Units: percentage of participants
number (not applicable)
Day 15 (n=1705, 896)	24.8	0.3
Day 29 (n=1200, 670)	41.1	1.8
Day 43 (n=1597, 854)	84.4	1.9
Day 57 (n=1432, 759)	84.4	2.2
Day 90 (n=60, 20)	83.3	10.0
Day 180 (n=274, 123)	51.5	22.0
Day 360 (n=26, 14)	53.8	28.6

No statistical analyses for this end point

Secondary: Number of Participants With COVID-19 Symptomatic Illness Post First Dose of Study Intervention

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End point title

Number of Participants With COVID-19 Symptomatic Illness Post First Dose of Study Intervention

End point description

The incidence of SARS-CoV-2 RT-PCR-positive symptomatic illness occurring post first dose of study intervention. The FAS included all randomized participants who received at least 1 dose of study intervention, irrespective of their protocol adherence and continued participation in the study. Only participants who are seronegative at baseline were analyzed.

End point type

Secondary

End point timeframe

From Day 1 up to DCO of 05 March 2021 or study discontinuation or unblinding or receipt of non-study COVID-19 vaccination, up to a maximum of approximately 27 weeks

End point values	AZD1222	Placebo
Number of subjects analysed	20589	10300
Units: participants	287	303

Treatment difference: COVID-19 symptomatic illness

Statistical analysis description

Comparison groups

AZD1222 v Placebo

Number of subjects included in analysis

30889

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

Vaccine efficacy

Point estimate

54.47

Confidence interval

level

95%

sides

2-sided

lower limit

46.48

upper limit

61.26

Adverse events

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Timeframe for reporting adverse events

For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days.

Adverse event reporting additional description

The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

23.1

Reporting group title

Placebo

Reporting group description

Participants received 2 IM doses of placebo matching with AZD1222 on Days 1 and 29.

Reporting group title

AZD1222

Reporting group description

Participants received 2 IM doses of 5*10^10 vp (nominal, ± 1.5*10^10 vp) AZD1222 on Days 1 and 29.

Serious adverse events	Placebo	AZD1222
Total subjects affected by serious adverse events
subjects affected / exposed	467 / 10793 (4.33%)	1039 / 21587 (4.81%)
number of deaths (all causes)	33	62
number of deaths resulting from adverse events	33	62
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
subjects affected / exposed	2 / 10793 (0.02%)	2 / 21587 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Acral lentiginous melanoma
subjects affected / exposed	1 / 10793 (0.01%)	0 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Acute monocytic leukaemia
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Acute myeloid leukaemia
subjects affected / exposed	1 / 10793 (0.01%)	2 / 21587 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Adenocarcinoma of colon
subjects affected / exposed	3 / 10793 (0.03%)	7 / 21587 (0.03%)
occurrences causally related to treatment / all	0 / 3	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
Adenocarcinoma pancreas
subjects affected / exposed	0 / 10793 (0.00%)	2 / 21587 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Astrocytoma
subjects affected / exposed	2 / 10793 (0.02%)	0 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
B-cell lymphoma
subjects affected / exposed	1 / 10793 (0.01%)	3 / 21587 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Basal cell carcinoma
subjects affected / exposed	1 / 10793 (0.01%)	3 / 21587 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Benign neoplasm of bladder
subjects affected / exposed	1 / 10793 (0.01%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Benign salivary gland neoplasm
subjects affected / exposed	1 / 10793 (0.01%)	0 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Chronic lymphocytic leukaemia
subjects affected / exposed	0 / 10793 (0.00%)	2 / 21587 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Bladder neoplasm
subjects affected / exposed	1 / 10793 (0.01%)	0 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Bladder transitional cell carcinoma
subjects affected / exposed	0 / 10793 (0.00%)	2 / 21587 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 1
Borderline mucinous tumour of ovary
subjects affected / exposed	1 / 10793 (0.01%)	0 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Brain neoplasm
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
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	7 / 10793 (0.06%)	11 / 21587 (0.05%)
occurrences causally related to treatment / all	0 / 7	0 / 11
deaths causally related to treatment / all	0 / 0	0 / 0
Breast cancer female
subjects affected / exposed	0 / 10793 (0.00%)	2 / 21587 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Breast cancer male
subjects affected / exposed	1 / 10793 (0.01%)	0 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Breast cancer metastatic
subjects affected / exposed	1 / 10793 (0.01%)	2 / 21587 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Breast cancer recurrent
subjects affected / exposed	1 / 10793 (0.01%)	0 / 21587 (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 I
subjects affected / exposed	0 / 10793 (0.00%)	2 / 21587 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Breast cancer stage II
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cerebral haemangioma
subjects affected / exposed	1 / 10793 (0.01%)	0 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cervix carcinoma
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cervix carcinoma stage IV
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cholangiocarcinoma
subjects affected / exposed	2 / 10793 (0.02%)	3 / 21587 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 1
Choroid melanoma
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Colorectal cancer metastatic
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Glioblastoma
subjects affected / exposed	0 / 10793 (0.00%)	2 / 21587 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Colorectal adenocarcinoma
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Colon cancer stage IV
subjects affected / exposed	2 / 10793 (0.02%)	0 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Colon cancer stage III
subjects affected / exposed	0 / 10793 (0.00%)	2 / 21587 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Colon cancer metastatic
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Colon cancer
subjects affected / exposed	0 / 10793 (0.00%)	2 / 21587 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Colon adenoma
subjects affected / exposed	1 / 10793 (0.01%)	2 / 21587 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Clear cell renal cell carcinoma
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Diffuse large B-cell lymphoma
subjects affected / exposed	1 / 10793 (0.01%)	0 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Ductal adenocarcinoma of pancreas
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Endometrial cancer
subjects affected / exposed	0 / 10793 (0.00%)	2 / 21587 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Ependymoma
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Follicular thyroid cancer
subjects affected / exposed	1 / 10793 (0.01%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal tract adenoma
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Colorectal cancer
subjects affected / exposed	1 / 10793 (0.01%)	0 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Invasive ductal breast carcinoma
subjects affected / exposed	7 / 10793 (0.06%)	13 / 21587 (0.06%)
occurrences causally related to treatment / all	0 / 7	0 / 13
deaths causally related to treatment / all	0 / 0	0 / 0
Invasive breast carcinoma
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Intraductal proliferative breast lesion
subjects affected / exposed	2 / 10793 (0.02%)	7 / 21587 (0.03%)
occurrences causally related to treatment / all	0 / 2	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
Intraductal papillary breast neoplasm
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Huerthle cell carcinoma
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hormone receptor positive breast cancer
subjects affected / exposed	1 / 10793 (0.01%)	0 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Haemangioma of bone
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Glioma
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Glioblastoma multiforme
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Invasive lobular breast carcinoma
subjects affected / exposed	0 / 10793 (0.00%)	2 / 21587 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Lung adenocarcinoma stage III
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Lung adenocarcinoma
subjects affected / exposed	1 / 10793 (0.01%)	2 / 21587 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 1	0 / 0
Lipoma
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Lip squamous cell carcinoma
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Lip and/or oral cavity cancer
subjects affected / exposed	1 / 10793 (0.01%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Lentigo maligna
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Laryngeal squamous cell carcinoma
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Lung carcinoma cell type unspecified stage IV
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Mucoepidermoid carcinoma
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Lymphoma
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Malignant anorectal neoplasm
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Malignant melanoma
subjects affected / exposed	2 / 10793 (0.02%)	9 / 21587 (0.04%)
occurrences causally related to treatment / all	0 / 3	0 / 9
deaths causally related to treatment / all	0 / 0	0 / 0
Malignant neoplasm of ampulla of Vater
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Malignant neoplasm of pleura
subjects affected / exposed	1 / 10793 (0.01%)	0 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Malignant neoplasm of thymus
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Malignant splenic neoplasm
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Mantle cell lymphoma
subjects affected / exposed	1 / 10793 (0.01%)	0 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Metastatic squamous cell carcinoma
subjects affected / exposed	1 / 10793 (0.01%)	0 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Metastatic carcinoma of the bladder
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Metastases to peritoneum
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Metastases to liver
subjects affected / exposed	0 / 10793 (0.00%)	2 / 21587 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Metastases to bone
subjects affected / exposed	1 / 10793 (0.01%)	0 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Meningioma benign
subjects affected / exposed	0 / 10793 (0.00%)	2 / 21587 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Meningioma
subjects affected / exposed	1 / 10793 (0.01%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Lung neoplasm malignant
subjects affected / exposed	2 / 10793 (0.02%)	0 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Myelodysplastic syndrome
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pancreatic carcinoma metastatic
subjects affected / exposed	1 / 10793 (0.01%)	3 / 21587 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 2
Neuroendocrine carcinoma of the skin
subjects affected / exposed	1 / 10793 (0.01%)	0 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Neuroendocrine tumour
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Non-Hodgkin's lymphoma
subjects affected / exposed	2 / 10793 (0.02%)	4 / 21587 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Non-Hodgkin's lymphoma stage III
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Non-small cell lung cancer
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Oesophageal adenocarcinoma
subjects affected / exposed	1 / 10793 (0.01%)	0 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Oesophageal adenocarcinoma stage III
subjects affected / exposed	1 / 10793 (0.01%)	0 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Oesophageal cancer metastatic
subjects affected / exposed	1 / 10793 (0.01%)	0 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Oesophageal carcinoma
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Oesophageal squamous cell carcinoma stage II
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Oligodendroglioma
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Ovarian cancer
subjects affected / exposed	1 / 10793 (0.01%)	0 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Ovarian cancer metastatic
subjects affected / exposed	1 / 10793 (0.01%)	0 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Ovarian cancer stage III
subjects affected / exposed	2 / 10793 (0.02%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Neuroendocrine carcinoma
subjects affected / exposed	0 / 10793 (0.00%)	2 / 21587 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 1
Pancreatic carcinoma stage IV
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Renal cell carcinoma
subjects affected / exposed	0 / 10793 (0.00%)	2 / 21587 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Parathyroid tumour benign
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pituitary tumour benign
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Plasma cell myeloma
subjects affected / exposed	1 / 10793 (0.01%)	3 / 21587 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Plasmacytoma
subjects affected / exposed	1 / 10793 (0.01%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Polycythaemia vera
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
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	22 / 10793 (0.20%)	32 / 21587 (0.15%)
occurrences causally related to treatment / all	0 / 22	0 / 34
deaths causally related to treatment / all	0 / 0	0 / 0
Prostate cancer metastatic
subjects affected / exposed	1 / 10793 (0.01%)	4 / 21587 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Prostate cancer recurrent
subjects affected / exposed	0 / 10793 (0.00%)	2 / 21587 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Prostate cancer stage I
subjects affected / exposed	1 / 10793 (0.01%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Prostate cancer stage II
subjects affected / exposed	0 / 10793 (0.00%)	2 / 21587 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Prostate cancer stage III
subjects affected / exposed	2 / 10793 (0.02%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Prostate cancer stage IV
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Rectal adenocarcinoma
subjects affected / exposed	1 / 10793 (0.01%)	3 / 21587 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Renal cancer
subjects affected / exposed	1 / 10793 (0.01%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Papillary thyroid cancer
subjects affected / exposed	0 / 10793 (0.00%)	7 / 21587 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
Renal cell carcinoma stage IV
subjects affected / exposed	0 / 10793 (0.00%)	2 / 21587 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Triple negative breast cancer
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Sarcoma uterus
subjects affected / exposed	1 / 10793 (0.01%)	0 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Seminoma
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Signet-ring cell carcinoma
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Sinonasal papilloma
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Small cell lung cancer
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Spinal cord neoplasm
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Squamous cell carcinoma
subjects affected / exposed	1 / 10793 (0.01%)	2 / 21587 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 1
Squamous cell carcinoma of skin
subjects affected / exposed	0 / 10793 (0.00%)	6 / 21587 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Squamous cell carcinoma of the oral cavity
subjects affected / exposed	1 / 10793 (0.01%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 0
T-cell lymphoma
subjects affected / exposed	1 / 10793 (0.01%)	0 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Testicular seminoma (pure)
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Testis cancer
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Throat cancer
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Tonsil cancer
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Transitional cell carcinoma
subjects affected / exposed	1 / 10793 (0.01%)	3 / 21587 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Retinal melanocytoma
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Tumour associated fever
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Uterine leiomyoma
subjects affected / exposed	0 / 10793 (0.00%)	2 / 21587 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Vascular disorders
Haematoma
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Granulomatosis with polyangiitis
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hypertensive crisis
subjects affected / exposed	0 / 10793 (0.00%)	2 / 21587 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Hypertensive emergency
subjects affected / exposed	2 / 10793 (0.02%)	0 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hypotension
subjects affected / exposed	4 / 10793 (0.04%)	3 / 21587 (0.01%)
occurrences causally related to treatment / all	0 / 4	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Aortic aneurysm
subjects affected / exposed	1 / 10793 (0.01%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Aortic aneurysm rupture
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Aortic dilatation
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Aortic dissection
subjects affected / exposed	1 / 10793 (0.01%)	1 / 21587 (0.00%)
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	1 / 10793 (0.01%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Arterial haemorrhage
subjects affected / exposed	1 / 10793 (0.01%)	0 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Arteriosclerosis
subjects affected / exposed	0 / 10793 (0.00%)	2 / 21587 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Deep vein thrombosis
subjects affected / exposed	3 / 10793 (0.03%)	13 / 21587 (0.06%)
occurrences causally related to treatment / all	0 / 3	0 / 14
deaths causally related to treatment / all	0 / 0	0 / 1
Embolism
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hypertension
subjects affected / exposed	0 / 10793 (0.00%)	2 / 21587 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Hypovolaemic shock
subjects affected / exposed	0 / 10793 (0.00%)	2 / 21587 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Pelvic venous thrombosis
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Peripheral arterial occlusive disease
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Peripheral artery haematoma
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Peripheral artery occlusion
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Shock haemorrhagic
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Venous thrombosis limb
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pregnancy, puerperium and perinatal conditions
Ruptured ectopic pregnancy
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Abortion spontaneous
subjects affected / exposed	3 / 10793 (0.03%)	15 / 21587 (0.07%)
occurrences causally related to treatment / all	0 / 3	1 / 17
deaths causally related to treatment / all	0 / 0	0 / 0
Cervical incompetence
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Ectopic pregnancy
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gestational hypertension
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Postpartum haemorrhage
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pre-eclampsia
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Premature delivery
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Premature labour
subjects affected / exposed	1 / 10793 (0.01%)	0 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Stillbirth
subjects affected / exposed	1 / 10793 (0.01%)	0 / 21587 (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
Asthenia
subjects affected / exposed	1 / 10793 (0.01%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Catheter site haematoma
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Catheter site haemorrhage
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Chest discomfort
subjects affected / exposed	0 / 10793 (0.00%)	2 / 21587 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Chest pain
subjects affected / exposed	2 / 10793 (0.02%)	7 / 21587 (0.03%)
occurrences causally related to treatment / all	0 / 2	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
Death
subjects affected / exposed	4 / 10793 (0.04%)	7 / 21587 (0.03%)
occurrences causally related to treatment / all	0 / 4	0 / 7
deaths causally related to treatment / all	0 / 4	0 / 7
Drowning
subjects affected / exposed	1 / 10793 (0.01%)	0 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Hernia
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hypothermia
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Incarcerated hernia
subjects affected / exposed	1 / 10793 (0.01%)	0 / 21587 (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	0 / 10793 (0.00%)	2 / 21587 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Oedema peripheral
subjects affected / exposed	0 / 10793 (0.00%)	2 / 21587 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Procedural failure
subjects affected / exposed	1 / 10793 (0.01%)	0 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pyrexia
subjects affected / exposed	0 / 10793 (0.00%)	2 / 21587 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Sudden cardiac death
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Swelling face
subjects affected / exposed	1 / 10793 (0.01%)	0 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Multiple organ dysfunction syndrome
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Immune system disorders
Drug hypersensitivity
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hypersensitivity
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Anaphylactic reaction
subjects affected / exposed	2 / 10793 (0.02%)	4 / 21587 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Reproductive system and breast disorders
Adenomyosis
subjects affected / exposed	2 / 10793 (0.02%)	0 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Rectocele
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Prostatitis
subjects affected / exposed	1 / 10793 (0.01%)	2 / 21587 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Benign prostatic hyperplasia
subjects affected / exposed	2 / 10793 (0.02%)	4 / 21587 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Breast haematoma
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cervical dysplasia
subjects affected / exposed	0 / 10793 (0.00%)	2 / 21587 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Endometriosis
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Female genital tract fistula
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Menorrhagia
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Ovarian cyst
subjects affected / exposed	1 / 10793 (0.01%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Ovarian cyst ruptured
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Vaginal haemorrhage
subjects affected / exposed	1 / 10793 (0.01%)	0 / 21587 (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
Asthmatic crisis
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Chronic obstructive pulmonary disease
subjects affected / exposed	1 / 10793 (0.01%)	6 / 21587 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 2
Chronic respiratory failure
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Diaphragmatic paralysis
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Dyspnoea
subjects affected / exposed	0 / 10793 (0.00%)	2 / 21587 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Dyspnoea exertional
subjects affected / exposed	1 / 10793 (0.01%)	0 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Epistaxis
subjects affected / exposed	1 / 10793 (0.01%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Acute pulmonary oedema
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Acute respiratory distress syndrome
subjects affected / exposed	0 / 10793 (0.00%)	3 / 21587 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 1
Acute respiratory failure
subjects affected / exposed	3 / 10793 (0.03%)	11 / 21587 (0.05%)
occurrences causally related to treatment / all	0 / 3	0 / 11
deaths causally related to treatment / all	0 / 1	0 / 2
Asphyxia
subjects affected / exposed	1 / 10793 (0.01%)	0 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Aspiration
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Asthma
subjects affected / exposed	2 / 10793 (0.02%)	3 / 21587 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Haemoptysis
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pulmonary mass
subjects affected / exposed	0 / 10793 (0.00%)	2 / 21587 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Hypoxia
subjects affected / exposed	0 / 10793 (0.00%)	2 / 21587 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Idiopathic pulmonary fibrosis
subjects affected / exposed	0 / 10793 (0.00%)	2 / 21587 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 1
Laryngeal leukoplakia
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Laryngeal obstruction
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
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	0 / 10793 (0.00%)	4 / 21587 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Pleuritic pain
subjects affected / exposed	1 / 10793 (0.01%)	0 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumonia aspiration
subjects affected / exposed	1 / 10793 (0.01%)	2 / 21587 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumothorax
subjects affected / exposed	1 / 10793 (0.01%)	2 / 21587 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Pulmonary embolism
subjects affected / exposed	7 / 10793 (0.06%)	29 / 21587 (0.13%)
occurrences causally related to treatment / all	0 / 7	0 / 32
deaths causally related to treatment / all	0 / 1	0 / 3
Pulmonary fibrosis
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pulmonary granuloma
subjects affected / exposed	1 / 10793 (0.01%)	0 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pulmonary haemorrhage
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pulmonary hypertension
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pulmonary infarction
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Haemothorax
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pulmonary oedema
subjects affected / exposed	0 / 10793 (0.00%)	2 / 21587 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Respiratory failure
subjects affected / exposed	0 / 10793 (0.00%)	4 / 21587 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 2
Sleep apnoea syndrome
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Respiratory arrest
subjects affected / exposed	1 / 10793 (0.01%)	0 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Psychiatric disorders
Acute psychosis
subjects affected / exposed	1 / 10793 (0.01%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Adjustment disorder with depressed mood
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Affective disorder
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Alcohol withdrawal syndrome
subjects affected / exposed	1 / 10793 (0.01%)	0 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Alcoholism
subjects affected / exposed	1 / 10793 (0.01%)	0 / 21587 (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	2 / 10793 (0.02%)	0 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Bipolar I disorder
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Bipolar II disorder
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Suicidal ideation
subjects affected / exposed	5 / 10793 (0.05%)	5 / 21587 (0.02%)
occurrences causally related to treatment / all	0 / 6	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Completed suicide
subjects affected / exposed	0 / 10793 (0.00%)	2 / 21587 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 2
Delirium
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Delirium tremens
subjects affected / exposed	1 / 10793 (0.01%)	0 / 21587 (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	1 / 10793 (0.01%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Depression suicidal
subjects affected / exposed	0 / 10793 (0.00%)	2 / 21587 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Major depression
subjects affected / exposed	1 / 10793 (0.01%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Mania
subjects affected / exposed	1 / 10793 (0.01%)	0 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Mental status changes
subjects affected / exposed	1 / 10793 (0.01%)	2 / 21587 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Post-traumatic stress disorder
subjects affected / exposed	1 / 10793 (0.01%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Schizoaffective disorder
subjects affected / exposed	2 / 10793 (0.02%)	0 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 4	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Schizophrenia
subjects affected / exposed	2 / 10793 (0.02%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Substance abuse
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Substance-induced psychotic disorder
subjects affected / exposed	0 / 10793 (0.00%)	3 / 21587 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Bipolar disorder
subjects affected / exposed	3 / 10793 (0.03%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Suicide attempt
subjects affected / exposed	3 / 10793 (0.03%)	7 / 21587 (0.03%)
occurrences causally related to treatment / all	0 / 3	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
Product issues
Device breakage
subjects affected / exposed	1 / 10793 (0.01%)	0 / 21587 (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 stenosis
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Bile duct stone
subjects affected / exposed	1 / 10793 (0.01%)	2 / 21587 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Cholangitis
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cholecystitis
subjects affected / exposed	2 / 10793 (0.02%)	8 / 21587 (0.04%)
occurrences causally related to treatment / all	0 / 2	0 / 8
deaths causally related to treatment / all	0 / 0	0 / 0
Cholecystitis acute
subjects affected / exposed	3 / 10793 (0.03%)	9 / 21587 (0.04%)
occurrences causally related to treatment / all	0 / 3	0 / 9
deaths causally related to treatment / all	0 / 0	0 / 0
Cholelithiasis
subjects affected / exposed	3 / 10793 (0.03%)	8 / 21587 (0.04%)
occurrences causally related to treatment / all	0 / 3	0 / 8
deaths causally related to treatment / all	0 / 0	0 / 0
Gallbladder polyp
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatitis alcoholic
subjects affected / exposed	1 / 10793 (0.01%)	0 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Ischaemic hepatitis
subjects affected / exposed	1 / 10793 (0.01%)	0 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Jaundice
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Jaundice cholestatic
subjects affected / exposed	2 / 10793 (0.02%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Portal vein thrombosis
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Investigations
Anticoagulation drug level above therapeutic
subjects affected / exposed	0 / 10793 (0.00%)	2 / 21587 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Catheterisation cardiac
subjects affected / exposed	1 / 10793 (0.01%)	0 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Precancerous cells present
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Oxygen saturation decreased
subjects affected / exposed	0 / 10793 (0.00%)	2 / 21587 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatic enzyme increased
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Heart rate increased
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Fibrin D dimer increased
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Injury, poisoning and procedural complications
Accident
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Accidental overdose
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Acetabulum fracture
subjects affected / exposed	1 / 10793 (0.01%)	0 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Acquired encephalocele
subjects affected / exposed	1 / 10793 (0.01%)	0 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Alcohol poisoning
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
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	3 / 10793 (0.03%)	6 / 21587 (0.03%)
occurrences causally related to treatment / all	0 / 3	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Aortic injury
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Bladder injury
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Burns second degree
subjects affected / exposed	0 / 10793 (0.00%)	2 / 21587 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Cartilage injury
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cervical vertebral fracture
subjects affected / exposed	1 / 10793 (0.01%)	2 / 21587 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Chemical peritonitis
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Head injury
subjects affected / exposed	1 / 10793 (0.01%)	2 / 21587 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 1	0 / 0
Comminuted fracture
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Concussion
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Contusion
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
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	2 / 10793 (0.02%)	0 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Facial bones fracture
subjects affected / exposed	0 / 10793 (0.00%)	2 / 21587 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Fall
subjects affected / exposed	0 / 10793 (0.00%)	3 / 21587 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Femoral neck fracture
subjects affected / exposed	2 / 10793 (0.02%)	2 / 21587 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Femur fracture
subjects affected / exposed	6 / 10793 (0.06%)	3 / 21587 (0.01%)
occurrences causally related to treatment / all	0 / 6	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Fibula fracture
subjects affected / exposed	1 / 10793 (0.01%)	2 / 21587 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Foot fracture
subjects affected / exposed	2 / 10793 (0.02%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Forearm fracture
subjects affected / exposed	1 / 10793 (0.01%)	1 / 21587 (0.00%)
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	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Gun shot wound
subjects affected / exposed	0 / 10793 (0.00%)	2 / 21587 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 1
Hand fracture
subjects affected / exposed	0 / 10793 (0.00%)	2 / 21587 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Colon injury
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
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 / 10793 (0.04%)	6 / 21587 (0.03%)
occurrences causally related to treatment / all	0 / 4	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
Medication error
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hypobarism
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Ilium fracture
subjects affected / exposed	0 / 10793 (0.00%)	2 / 21587 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Incarcerated incisional hernia
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Incision site haematoma
subjects affected / exposed	1 / 10793 (0.01%)	0 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Incisional hernia
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Injury
subjects affected / exposed	1 / 10793 (0.01%)	0 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Intentional overdose
subjects affected / exposed	1 / 10793 (0.01%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Joint dislocation
subjects affected / exposed	1 / 10793 (0.01%)	3 / 21587 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Ligament rupture
subjects affected / exposed	1 / 10793 (0.01%)	0 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Ligament sprain
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Limb crushing injury
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Lower limb fracture
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
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 / 10793 (0.01%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Humerus fracture
subjects affected / exposed	1 / 10793 (0.01%)	2 / 21587 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Multiple injuries
subjects affected / exposed	0 / 10793 (0.00%)	2 / 21587 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Multiple fractures
subjects affected / exposed	1 / 10793 (0.01%)	0 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Overdose
subjects affected / exposed	1 / 10793 (0.01%)	5 / 21587 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 3
Patella fracture
subjects affected / exposed	0 / 10793 (0.00%)	2 / 21587 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Pelvic fracture
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Periprosthetic fracture
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumothorax traumatic
subjects affected / exposed	0 / 10793 (0.00%)	3 / 21587 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Post procedural haematuria
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Post procedural swelling
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Post-traumatic pain
subjects affected / exposed	1 / 10793 (0.01%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Postoperative ileus
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Procedural complication
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Procedural intestinal perforation
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Radius fracture
subjects affected / exposed	1 / 10793 (0.01%)	0 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Reactive gastropathy
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Rib fracture
subjects affected / exposed	1 / 10793 (0.01%)	6 / 21587 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Osteochondral fracture
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Road traffic accident
subjects affected / exposed	2 / 10793 (0.02%)	3 / 21587 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 2
Toxicity to various agents
subjects affected / exposed	2 / 10793 (0.02%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 2	0 / 1
Soft tissue injury
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
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	2 / 10793 (0.02%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Spinal cord injury
subjects affected / exposed	1 / 10793 (0.01%)	0 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Spinal fracture
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
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 / 10793 (0.01%)	0 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Stab wound
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Sternal fracture
subjects affected / exposed	0 / 10793 (0.00%)	2 / 21587 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Subdural haematoma
subjects affected / exposed	1 / 10793 (0.01%)	3 / 21587 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Subdural haemorrhage
subjects affected / exposed	1 / 10793 (0.01%)	0 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Tendon injury
subjects affected / exposed	1 / 10793 (0.01%)	0 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Tendon rupture
subjects affected / exposed	2 / 10793 (0.02%)	4 / 21587 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Thermal burn
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Tibia fracture
subjects affected / exposed	2 / 10793 (0.02%)	4 / 21587 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Skin laceration
subjects affected / exposed	1 / 10793 (0.01%)	0 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Traumatic haemothorax
subjects affected / exposed	0 / 10793 (0.00%)	2 / 21587 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Traumatic intracranial haemorrhage
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Traumatic liver injury
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
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 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Traumatic intracranial haematoma
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Congenital, familial and genetic disorders
Thalassaemia minor
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cerebral arteriovenous malformation haemorrhagic
subjects affected / exposed	1 / 10793 (0.01%)	0 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cerebral cavernous malformation
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cerebral palsy
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Haemorrhagic arteriovenous malformation
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hamartoma
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hypertrophic cardiomyopathy
subjects affected / exposed	1 / 10793 (0.01%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Multiple congenital abnormalities
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Renal aplasia
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac disorders
Atrial flutter
subjects affected / exposed	2 / 10793 (0.02%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Atrial fibrillation
subjects affected / exposed	13 / 10793 (0.12%)	21 / 21587 (0.10%)
occurrences causally related to treatment / all	0 / 13	0 / 22
deaths causally related to treatment / all	0 / 0	0 / 0
Arteriosclerosis coronary artery
subjects affected / exposed	1 / 10793 (0.01%)	0 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Arrhythmia
subjects affected / exposed	2 / 10793 (0.02%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Aortic valve stenosis
subjects affected / exposed	0 / 10793 (0.00%)	2 / 21587 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Angina unstable
subjects affected / exposed	0 / 10793 (0.00%)	2 / 21587 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Angina pectoris
subjects affected / exposed	1 / 10793 (0.01%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Acute myocardial infarction
subjects affected / exposed	7 / 10793 (0.06%)	27 / 21587 (0.13%)
occurrences causally related to treatment / all	0 / 7	0 / 27
deaths causally related to treatment / all	0 / 1	0 / 1
Acute left ventricular failure
subjects affected / exposed	1 / 10793 (0.01%)	0 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Acute coronary syndrome
subjects affected / exposed	2 / 10793 (0.02%)	0 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Atrial tachycardia
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Chronic left ventricular failure
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiomyopathy
subjects affected / exposed	1 / 10793 (0.01%)	0 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cardio-respiratory arrest
subjects affected / exposed	0 / 10793 (0.00%)	2 / 21587 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 2
Cardiac tamponade
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac failure congestive
subjects affected / exposed	6 / 10793 (0.06%)	9 / 21587 (0.04%)
occurrences causally related to treatment / all	0 / 9	0 / 11
deaths causally related to treatment / all	0 / 1	0 / 1
Cardiac failure acute
subjects affected / exposed	0 / 10793 (0.00%)	4 / 21587 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac failure
subjects affected / exposed	0 / 10793 (0.00%)	3 / 21587 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac disorder
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Cardiac arrest
subjects affected / exposed	4 / 10793 (0.04%)	5 / 21587 (0.02%)
occurrences causally related to treatment / all	0 / 4	0 / 5
deaths causally related to treatment / all	0 / 3	0 / 3
Bundle branch block right
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Brugada syndrome
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Bradycardia
subjects affected / exposed	2 / 10793 (0.02%)	0 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Atrioventricular block second degree
subjects affected / exposed	0 / 10793 (0.00%)	2 / 21587 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Atrioventricular block complete
subjects affected / exposed	3 / 10793 (0.03%)	0 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Atrioventricular block
subjects affected / exposed	2 / 10793 (0.02%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiopulmonary failure
subjects affected / exposed	1 / 10793 (0.01%)	0 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Congestive cardiomyopathy
subjects affected / exposed	1 / 10793 (0.01%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Pericardial effusion
subjects affected / exposed	0 / 10793 (0.00%)	3 / 21587 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Coronary artery dissection
subjects affected / exposed	1 / 10793 (0.01%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Coronary artery occlusion
subjects affected / exposed	0 / 10793 (0.00%)	2 / 21587 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Coronary artery stenosis
subjects affected / exposed	1 / 10793 (0.01%)	2 / 21587 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Hypertensive heart disease
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Ischaemic cardiomyopathy
subjects affected / exposed	1 / 10793 (0.01%)	0 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Mitral valve incompetence
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Mitral valve prolapse
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Myocardial infarction
subjects affected / exposed	10 / 10793 (0.09%)	12 / 21587 (0.06%)
occurrences causally related to treatment / all	0 / 10	1 / 12
deaths causally related to treatment / all	0 / 2	0 / 3
Myocardial ischaemia
subjects affected / exposed	2 / 10793 (0.02%)	0 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Myocarditis
subjects affected / exposed	1 / 10793 (0.01%)	0 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Myxomatous mitral valve degeneration
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Non-obstructive cardiomyopathy
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Palpitations
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Coronary artery disease
subjects affected / exposed	5 / 10793 (0.05%)	25 / 21587 (0.12%)
occurrences causally related to treatment / all	0 / 7	0 / 26
deaths causally related to treatment / all	0 / 0	0 / 1
Pericarditis
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Sinus bradycardia
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
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	1 / 10793 (0.01%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Supraventricular tachycardia
subjects affected / exposed	2 / 10793 (0.02%)	4 / 21587 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Tachycardia
subjects affected / exposed	1 / 10793 (0.01%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Torsade de pointes
subjects affected / exposed	1 / 10793 (0.01%)	0 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Ventricular fibrillation
subjects affected / exposed	0 / 10793 (0.00%)	3 / 21587 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Ventricular tachycardia
subjects affected / exposed	1 / 10793 (0.01%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Right ventricular failure
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Nervous system disorders
Cerebral haemorrhage
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Alcoholic seizure
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Amnesia
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Bulbar palsy
subjects affected / exposed	1 / 10793 (0.01%)	0 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Carotid artery dissection
subjects affected / exposed	2 / 10793 (0.02%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Carotid artery stenosis
subjects affected / exposed	3 / 10793 (0.03%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cerebellar stroke
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cerebral artery occlusion
subjects affected / exposed	1 / 10793 (0.01%)	0 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Focal dyscognitive seizures
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Embolic stroke
subjects affected / exposed	1 / 10793 (0.01%)	0 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cerebral infarction
subjects affected / exposed	1 / 10793 (0.01%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cerebral venous thrombosis
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cerebrovascular accident
subjects affected / exposed	3 / 10793 (0.03%)	6 / 21587 (0.03%)
occurrences causally related to treatment / all	0 / 3	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Chronic inflammatory demyelinating polyradiculoneuropathy
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cognitive disorder
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Corticobasal degeneration
subjects affected / exposed	1 / 10793 (0.01%)	0 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Delayed myelination
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Dementia
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Dementia Alzheimer's type
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Demyelinating polyneuropathy
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Dizziness
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Dysarthria
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Generalised tonic-clonic seizure
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Haemorrhage intracranial
subjects affected / exposed	1 / 10793 (0.01%)	3 / 21587 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 1	0 / 0
Metabolic encephalopathy
subjects affected / exposed	1 / 10793 (0.01%)	0 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Headache
subjects affected / exposed	0 / 10793 (0.00%)	2 / 21587 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Hemianopia
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hemianopia homonymous
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hemiparesis
subjects affected / exposed	0 / 10793 (0.00%)	3 / 21587 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Hydrocephalus
subjects affected / exposed	1 / 10793 (0.01%)	0 / 21587 (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 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hypoxic-ischaemic encephalopathy
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Internal capsule infarction
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Intracranial aneurysm
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Intraventricular haemorrhage
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Ischaemic cerebral infarction
subjects affected / exposed	1 / 10793 (0.01%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Ischaemic stroke
subjects affected / exposed	7 / 10793 (0.06%)	15 / 21587 (0.07%)
occurrences causally related to treatment / all	0 / 8	0 / 15
deaths causally related to treatment / all	0 / 0	0 / 0
Loss of consciousness
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Lumbar radiculopathy
subjects affected / exposed	0 / 10793 (0.00%)	2 / 21587 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Lumbosacral radiculopathy
subjects affected / exposed	1 / 10793 (0.01%)	0 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Haemorrhagic transformation stroke
subjects affected / exposed	1 / 10793 (0.01%)	0 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Migraine
subjects affected / exposed	1 / 10793 (0.01%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Seizure
subjects affected / exposed	0 / 10793 (0.00%)	2 / 21587 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Myasthenia gravis
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Myelomalacia
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Myelopathy
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Myoclonic epilepsy
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Neurodegenerative disorder
subjects affected / exposed	1 / 10793 (0.01%)	0 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Neuropathy peripheral
subjects affected / exposed	1 / 10793 (0.01%)	0 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Normal pressure hydrocephalus
subjects affected / exposed	1 / 10793 (0.01%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Paraesthesia
subjects affected / exposed	0 / 10793 (0.00%)	2 / 21587 (0.01%)
occurrences causally related to treatment / all	0 / 0	1 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Parkinson's disease
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Peripheral sensory neuropathy
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Post stroke seizure
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Presyncope
subjects affected / exposed	1 / 10793 (0.01%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Radiculopathy
subjects affected / exposed	1 / 10793 (0.01%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Sciatica
subjects affected / exposed	0 / 10793 (0.00%)	2 / 21587 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Multiple sclerosis
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Sensory loss
subjects affected / exposed	1 / 10793 (0.01%)	0 / 21587 (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 / 10793 (0.01%)	3 / 21587 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Syncope
subjects affected / exposed	4 / 10793 (0.04%)	8 / 21587 (0.04%)
occurrences causally related to treatment / all	0 / 4	0 / 8
deaths causally related to treatment / all	0 / 0	0 / 0
Thalamic infarction
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Thrombotic stroke
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Toxic encephalopathy
subjects affected / exposed	1 / 10793 (0.01%)	0 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Transient global amnesia
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
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	8 / 10793 (0.07%)	10 / 21587 (0.05%)
occurrences causally related to treatment / all	0 / 8	0 / 10
deaths causally related to treatment / all	0 / 0	0 / 0
Spinal cord compression
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Blood and lymphatic system disorders
Anaemia
subjects affected / exposed	0 / 10793 (0.00%)	6 / 21587 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Hypercoagulation
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Iron deficiency anaemia
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Neutropenia
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Splenic cyst
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Splenic haematoma
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Splenic infarction
subjects affected / exposed	1 / 10793 (0.01%)	0 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Thrombocytopenia
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Blood loss anaemia
subjects affected / exposed	3 / 10793 (0.03%)	2 / 21587 (0.01%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Ear and labyrinth disorders
Deafness bilateral
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Deafness
subjects affected / exposed	1 / 10793 (0.01%)	0 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Deafness unilateral
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Neurosensory hypoacusis
subjects affected / exposed	1 / 10793 (0.01%)	0 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Vertigo
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Vertigo positional
subjects affected / exposed	0 / 10793 (0.00%)	3 / 21587 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Eye disorders
Amaurosis fugax
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Endocrine ophthalmopathy
subjects affected / exposed	1 / 10793 (0.01%)	0 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Optic ischaemic neuropathy
subjects affected / exposed	1 / 10793 (0.01%)	0 / 21587 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Retinal artery occlusion
subjects affected / exposed	0 / 10793 (0.00%)	2 / 21587 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Retinal detachment
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Retinal vein occlusion
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal disorders
Diverticular perforation
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
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 / 10793 (0.00%)	3 / 21587 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Abdominal pain lower
subjects affected / exposed	1 / 10793 (0.01%)	0 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Abdominal pain upper
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Abdominal strangulated hernia
subjects affected / exposed	1 / 10793 (0.01%)	0 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Abdominal wall haematoma
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Aphthous ulcer
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Chronic gastritis
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Colitis
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Colitis ischaemic
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Constipation
subjects affected / exposed	0 / 10793 (0.00%)	2 / 21587 (0.01%)
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 / 10793 (0.00%)	2 / 21587 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Diverticulum intestinal
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
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	2 / 10793 (0.02%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Duodenal perforation
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Duodenal ulcer haemorrhage
subjects affected / exposed	1 / 10793 (0.01%)	0 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Erosive oesophagitis
subjects affected / exposed	0 / 10793 (0.00%)	2 / 21587 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Femoral hernia incarcerated
subjects affected / exposed	1 / 10793 (0.01%)	0 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Food poisoning
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastric fistula
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastric ulcer haemorrhage
subjects affected / exposed	0 / 10793 (0.00%)	2 / 21587 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Gastric ulcer perforation
subjects affected / exposed	1 / 10793 (0.01%)	0 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal haemorrhage
subjects affected / exposed	2 / 10793 (0.02%)	5 / 21587 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal necrosis
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
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 / 10793 (0.01%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Haemorrhoids thrombosed
subjects affected / exposed	0 / 10793 (0.00%)	2 / 21587 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Hiatus hernia
subjects affected / exposed	0 / 10793 (0.00%)	4 / 21587 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Ileus
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Diverticulum intestinal haemorrhagic
subjects affected / exposed	0 / 10793 (0.00%)	3 / 21587 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Mesenteric vein thrombosis
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Lower gastrointestinal haemorrhage
subjects affected / exposed	1 / 10793 (0.01%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Oesophageal ulcer haemorrhage
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Oesophageal varices haemorrhage
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Oesophagitis
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Oesophagitis haemorrhagic
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pancreatic failure
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Pancreatitis
subjects affected / exposed	2 / 10793 (0.02%)	2 / 21587 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 1	0 / 0
Pancreatitis acute
subjects affected / exposed	1 / 10793 (0.01%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pancreatitis necrotising
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Inguinal hernia
subjects affected / exposed	1 / 10793 (0.01%)	3 / 21587 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Internal hernia
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
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	0 / 10793 (0.00%)	1 / 21587 (0.00%)
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	1 / 10793 (0.01%)	9 / 21587 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 9
deaths causally related to treatment / all	0 / 0	0 / 0
Intestinal perforation
subjects affected / exposed	1 / 10793 (0.01%)	0 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Large intestine perforation
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Obstructive pancreatitis
subjects affected / exposed	1 / 10793 (0.01%)	2 / 21587 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Pancreatolithiasis
subjects affected / exposed	1 / 10793 (0.01%)	0 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pharyngo-oesophageal diverticulum
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Rectal haemorrhage
subjects affected / exposed	0 / 10793 (0.00%)	2 / 21587 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Small intestinal obstruction
subjects affected / exposed	5 / 10793 (0.05%)	12 / 21587 (0.06%)
occurrences causally related to treatment / all	0 / 5	0 / 13
deaths causally related to treatment / all	0 / 0	0 / 0
Small intestinal perforation
subjects affected / exposed	0 / 10793 (0.00%)	2 / 21587 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Umbilical hernia
subjects affected / exposed	1 / 10793 (0.01%)	0 / 21587 (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	1 / 10793 (0.01%)	3 / 21587 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Volvulus
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Vomiting
subjects affected / exposed	0 / 10793 (0.00%)	2 / 21587 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Peptic ulcer haemorrhage
subjects affected / exposed	1 / 10793 (0.01%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Skin and subcutaneous tissue disorders
Petechiae
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Angioedema
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Dermatitis
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Diabetic foot
subjects affected / exposed	1 / 10793 (0.01%)	0 / 21587 (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
Nephrolithiasis
subjects affected / exposed	4 / 10793 (0.04%)	6 / 21587 (0.03%)
occurrences causally related to treatment / all	0 / 4	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Acute kidney injury
subjects affected / exposed	6 / 10793 (0.06%)	13 / 21587 (0.06%)
occurrences causally related to treatment / all	0 / 7	0 / 13
deaths causally related to treatment / all	0 / 0	0 / 0
Bladder outlet obstruction
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Bladder perforation
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Chronic kidney disease
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Haematuria
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hydronephrosis
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Nephropathy toxic
subjects affected / exposed	0 / 10793 (0.00%)	2 / 21587 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Pelvi-ureteric obstruction
subjects affected / exposed	1 / 10793 (0.01%)	0 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Renal aneurysm
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
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	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Renal mass
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Renal tubular necrosis
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
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 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Urethral caruncle
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
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	2 / 10793 (0.02%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Urinary tract obstruction
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Nephrotic syndrome
subjects affected / exposed	1 / 10793 (0.01%)	0 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Endocrine disorders
Goitre
subjects affected / exposed	2 / 10793 (0.02%)	0 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hypothyroidism
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Secondary adrenocortical insufficiency
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Thyroid mass
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Thyroiditis subacute
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Thyrotoxic crisis
subjects affected / exposed	2 / 10793 (0.02%)	0 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Musculoskeletal and connective tissue disorders
Arthralgia
subjects affected / exposed	0 / 10793 (0.00%)	2 / 21587 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Rhabdomyolysis
subjects affected / exposed	2 / 10793 (0.02%)	5 / 21587 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Back pain
subjects affected / exposed	1 / 10793 (0.01%)	4 / 21587 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Cervical spinal stenosis
subjects affected / exposed	2 / 10793 (0.02%)	2 / 21587 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Costochondritis
subjects affected / exposed	0 / 10793 (0.00%)	2 / 21587 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Haemarthrosis
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Haematoma muscle
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Intervertebral disc degeneration
subjects affected / exposed	0 / 10793 (0.00%)	3 / 21587 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Intervertebral disc protrusion
subjects affected / exposed	4 / 10793 (0.04%)	5 / 21587 (0.02%)
occurrences causally related to treatment / all	0 / 5	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
Limb mass
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Lumbar spinal stenosis
subjects affected / exposed	2 / 10793 (0.02%)	6 / 21587 (0.03%)
occurrences causally related to treatment / all	0 / 2	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Muscle spasms
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Musculoskeletal chest pain
subjects affected / exposed	1 / 10793 (0.01%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Neck pain
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Osteoarthritis
subjects affected / exposed	10 / 10793 (0.09%)	14 / 21587 (0.06%)
occurrences causally related to treatment / all	0 / 13	0 / 16
deaths causally related to treatment / all	0 / 0	0 / 0
Pain in extremity
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Arthritis
subjects affected / exposed	0 / 10793 (0.00%)	5 / 21587 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
Spinal stenosis
subjects affected / exposed	3 / 10793 (0.03%)	2 / 21587 (0.01%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Spinal pain
subjects affected / exposed	1 / 10793 (0.01%)	0 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Spondylolisthesis
subjects affected / exposed	0 / 10793 (0.00%)	2 / 21587 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Vertebral foraminal stenosis
subjects affected / exposed	1 / 10793 (0.01%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Rheumatoid arthritis
subjects affected / exposed	1 / 10793 (0.01%)	0 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Rotator cuff syndrome
subjects affected / exposed	2 / 10793 (0.02%)	0 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Scoliosis
subjects affected / exposed	1 / 10793 (0.01%)	0 / 21587 (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 / 10793 (0.00%)	2 / 21587 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Spinal synovial cyst
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Infections and infestations
Abdominal sepsis
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Abdominal abscess
subjects affected / exposed	0 / 10793 (0.00%)	2 / 21587 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Abdominal wall abscess
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Abscess limb
subjects affected / exposed	0 / 10793 (0.00%)	4 / 21587 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Chronic sinusitis
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cholecystitis infective
subjects affected / exposed	0 / 10793 (0.00%)	2 / 21587 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Cellulitis
subjects affected / exposed	7 / 10793 (0.06%)	11 / 21587 (0.05%)
occurrences causally related to treatment / all	0 / 8	0 / 12
deaths causally related to treatment / all	0 / 0	0 / 0
Campylobacter colitis
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
COVID-19 pneumonia
subjects affected / exposed	21 / 10793 (0.19%)	29 / 21587 (0.13%)
occurrences causally related to treatment / all	0 / 23	0 / 34
deaths causally related to treatment / all	0 / 3	0 / 2
COVID-19
subjects affected / exposed	16 / 10793 (0.15%)	20 / 21587 (0.09%)
occurrences causally related to treatment / all	0 / 17	0 / 23
deaths causally related to treatment / all	0 / 2	0 / 1
Bursitis infective
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Balanitis candida
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Bacterial pyelonephritis
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Bacteraemia
subjects affected / exposed	0 / 10793 (0.00%)	2 / 21587 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Arthritis bacterial
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Appendicitis perforated
subjects affected / exposed	2 / 10793 (0.02%)	4 / 21587 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Appendicitis
subjects affected / exposed	11 / 10793 (0.10%)	29 / 21587 (0.13%)
occurrences causally related to treatment / all	0 / 11	0 / 31
deaths causally related to treatment / all	0 / 0	0 / 0
Anal abscess
subjects affected / exposed	1 / 10793 (0.01%)	0 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Encephalitis
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Diverticulitis intestinal perforated
subjects affected / exposed	0 / 10793 (0.00%)	3 / 21587 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Diverticulitis
subjects affected / exposed	1 / 10793 (0.01%)	7 / 21587 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 9
deaths causally related to treatment / all	0 / 0	0 / 0
Device related sepsis
subjects affected / exposed	0 / 10793 (0.00%)	3 / 21587 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Device related infection
subjects affected / exposed	3 / 10793 (0.03%)	2 / 21587 (0.01%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Cystitis
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Enterococcal bacteraemia
subjects affected / exposed	0 / 10793 (0.00%)	3 / 21587 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Complicated appendicitis
subjects affected / exposed	2 / 10793 (0.02%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Colonic abscess
subjects affected / exposed	0 / 10793 (0.00%)	2 / 21587 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Coccidioidomycosis
subjects affected / exposed	0 / 10793 (0.00%)	2 / 21587 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Clostridium difficile infection
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Clostridium difficile colitis
subjects affected / exposed	2 / 10793 (0.02%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 0
Enterobacter sepsis
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Coronavirus infection
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Enterococcal sepsis
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Influenza
subjects affected / exposed	1 / 10793 (0.01%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Infective tenosynovitis
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Infected skin ulcer
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Giardiasis
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal infection
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastroenteritis viral
subjects affected / exposed	1 / 10793 (0.01%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastroenteritis shigella
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastroenteritis
subjects affected / exposed	2 / 10793 (0.02%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gangrene
subjects affected / exposed	1 / 10793 (0.01%)	0 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Focal peritonitis
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Extradural abscess
subjects affected / exposed	0 / 10793 (0.00%)	3 / 21587 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Escherichia urinary tract infection
subjects affected / exposed	1 / 10793 (0.01%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Escherichia pyelonephritis
subjects affected / exposed	1 / 10793 (0.01%)	0 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Escherichia bacteraemia
subjects affected / exposed	1 / 10793 (0.01%)	0 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Epididymitis
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
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 / 10793 (0.00%)	2 / 21587 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Peritonsillar abscess
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Periorbital cellulitis
subjects affected / exposed	1 / 10793 (0.01%)	0 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pelvic abscess
subjects affected / exposed	1 / 10793 (0.01%)	0 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Parainfluenzae virus infection
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Otitis externa
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Osteomyelitis
subjects affected / exposed	5 / 10793 (0.05%)	5 / 21587 (0.02%)
occurrences causally related to treatment / all	0 / 5	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Oropharyngeal candidiasis
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Orchitis
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Monkeypox
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
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	0 / 10793 (0.00%)	2 / 21587 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Large intestine infection
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Labyrinthitis
subjects affected / exposed	0 / 10793 (0.00%)	2 / 21587 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Kidney infection
subjects affected / exposed	1 / 10793 (0.01%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Intervertebral discitis
subjects affected / exposed	1 / 10793 (0.01%)	0 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Perirectal abscess
subjects affected / exposed	1 / 10793 (0.01%)	0 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumonia bacterial
subjects affected / exposed	0 / 10793 (0.00%)	5 / 21587 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumonia klebsiella
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumonia legionella
subjects affected / exposed	1 / 10793 (0.01%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumonia streptococcal
subjects affected / exposed	0 / 10793 (0.00%)	2 / 21587 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Post procedural infection
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Postoperative abscess
subjects affected / exposed	1 / 10793 (0.01%)	0 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Postoperative wound infection
subjects affected / exposed	1 / 10793 (0.01%)	3 / 21587 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Pseudomonal sepsis
subjects affected / exposed	1 / 10793 (0.01%)	0 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Psoas abscess
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pyelonephritis
subjects affected / exposed	0 / 10793 (0.00%)	5 / 21587 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Pyelonephritis acute
subjects affected / exposed	1 / 10793 (0.01%)	0 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Renal cyst infection
subjects affected / exposed	1 / 10793 (0.01%)	0 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Respiratory syncytial virus infection
subjects affected / exposed	1 / 10793 (0.01%)	0 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
SARS-CoV-2 sepsis
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Salmonellosis
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pharyngitis
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumonia
subjects affected / exposed	8 / 10793 (0.07%)	32 / 21587 (0.15%)
occurrences causally related to treatment / all	0 / 9	0 / 36
deaths causally related to treatment / all	0 / 0	0 / 1
Scrotal cellulitis
subjects affected / exposed	1 / 10793 (0.01%)	0 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Vascular device infection
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Sepsis syndrome
subjects affected / exposed	1 / 10793 (0.01%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Septic shock
subjects affected / exposed	2 / 10793 (0.02%)	5 / 21587 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 5
deaths causally related to treatment / all	0 / 1	0 / 0
Sinusitis bacterial
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
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	0 / 10793 (0.00%)	2 / 21587 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Staphylococcal infection
subjects affected / exposed	2 / 10793 (0.02%)	2 / 21587 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Staphylococcal sepsis
subjects affected / exposed	0 / 10793 (0.00%)	2 / 21587 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Streptococcal bacteraemia
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Suspected COVID-19
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Toxic shock syndrome staphylococcal
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Tubo-ovarian abscess
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Urinary tract infection
subjects affected / exposed	2 / 10793 (0.02%)	8 / 21587 (0.04%)
occurrences causally related to treatment / all	0 / 2	0 / 9
deaths causally related to treatment / all	0 / 0	0 / 0
Urinary tract infection bacterial
subjects affected / exposed	0 / 10793 (0.00%)	2 / 21587 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 1
Urinary tract infection enterococcal
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Urosepsis
subjects affected / exposed	0 / 10793 (0.00%)	3 / 21587 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Sepsis
subjects affected / exposed	3 / 10793 (0.03%)	11 / 21587 (0.05%)
occurrences causally related to treatment / all	0 / 3	0 / 11
deaths causally related to treatment / all	0 / 0	0 / 0
Viral infection
subjects affected / exposed	1 / 10793 (0.01%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Viral pericarditis
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
West Nile viral infection
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Metabolism and nutrition disorders
Dehydration
subjects affected / exposed	1 / 10793 (0.01%)	2 / 21587 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Failure to thrive
subjects affected / exposed	0 / 10793 (0.00%)	2 / 21587 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Gout
subjects affected / exposed	1 / 10793 (0.01%)	0 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hypercalcaemia
subjects affected / exposed	0 / 10793 (0.00%)	4 / 21587 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Hyperglycaemia
subjects affected / exposed	2 / 10793 (0.02%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hyperglycaemic hyperosmolar nonketotic syndrome
subjects affected / exposed	1 / 10793 (0.01%)	0 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hyperkalaemia
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hypoglycaemia
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hypokalaemia
subjects affected / exposed	2 / 10793 (0.02%)	2 / 21587 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Hypomagnesaemia
subjects affected / exposed	1 / 10793 (0.01%)	0 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hyponatraemia
subjects affected / exposed	4 / 10793 (0.04%)	3 / 21587 (0.01%)
occurrences causally related to treatment / all	0 / 4	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Hypovolaemia
subjects affected / exposed	1 / 10793 (0.01%)	0 / 21587 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Obesity
subjects affected / exposed	0 / 10793 (0.00%)	1 / 21587 (0.00%)
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	1 / 10793 (0.01%)	3 / 21587 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Diabetic ketoacidosis
subjects affected / exposed	4 / 10793 (0.04%)	7 / 21587 (0.03%)
occurrences causally related to treatment / all	0 / 4	0 / 8
deaths causally related to treatment / all	0 / 1	0 / 0

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

Non-serious adverse events	Placebo	AZD1222
Total subjects affected by non serious adverse events
subjects affected / exposed	4234 / 10793 (39.23%)	11846 / 21587 (54.88%)
Nervous system disorders
Headache
subjects affected / exposed	996 / 10793 (9.23%)	3511 / 21587 (16.26%)
occurrences all number	1125	4106
General disorders and administration site conditions
Pyrexia
subjects affected / exposed	73 / 10793 (0.68%)	1174 / 21587 (5.44%)
occurrences all number	78	1209
Fatigue
subjects affected / exposed	853 / 10793 (7.90%)	2836 / 21587 (13.14%)
occurrences all number	942	3250
Injection site pain
subjects affected / exposed	532 / 10793 (4.93%)	3624 / 21587 (16.79%)
occurrences all number	595	4363
Pain
subjects affected / exposed	264 / 10793 (2.45%)	1857 / 21587 (8.60%)
occurrences all number	283	2023
Chills
subjects affected / exposed	248 / 10793 (2.30%)	2208 / 21587 (10.23%)
occurrences all number	264	2366
Musculoskeletal and connective tissue disorders
Myalgia
subjects affected / exposed	278 / 10793 (2.58%)	1622 / 21587 (7.51%)
occurrences all number	296	1736
Infections and infestations
COVID-19
subjects affected / exposed	2715 / 10793 (25.16%)	6207 / 21587 (28.75%)
occurrences all number	2921	6717

More information

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Were there any global substantial amendments to the protocol? Yes

26 Oct 2020

Revised important potential risks. Increased the sample size from 30000 to 40000 participants. Added a description of the independent neurological AESI Expert Committee. Expanded the AESI list and specified that AESIs were reported to the Sponsor within one day of becoming aware of the event. New section for evaluation of potential neurological AESIs.

14 Dec 2020

Revised the first secondary endpoint. Identified the 4 key secondary endpoints. Added an immunogenicity cohort of approximately 300 participants. Reduced the sample size from 40000 back to the original number of 30000. Added text to indicate that experimental vaccinations, other than AZD1222, for prevention of SARS-CoV-2 or COVID-19 are prohibited. Also, noted that participants who choose to receive an authorized COVID-19 vaccine should inform the Investigator so it can be properly documented, and they should be encouraged to continue study conduct. Specified the procedures for unblinding in the event a study participant is contacted about receiving an authorized COVID-19 vaccine. Specified that if the primary endpoint results of the interim or primary analysis are statistically significant, an additional analysis with 5% alpha was performed once all participants had completed the first year of follow up. Revised to indicate how the primary efficacy endpoints and 4 key secondary endpoints were assessed.

19 Feb 2021

Removed “and Adolescents” from the title and removed text from the study rationale regarding adolescents. Upgraded exploratory endpoint "To estimate the efficacy of AZD1222 compared to saline placebo for the prevention of COVID-19 following the first dose" to secondary endpoint. Removed all references to Part 1 and Part 2 (Parts 1 and 2 were introduced in Amendment 5; an amendment which was not implemented).

29 Mar 2021

Revised to reflect the addition of an unblinded phase with an open-label dosing option (Part B). The original randomized, double-blind part of the study was labeled as Part A. Added additional exploratory objectives to assess the long-term safety and tolerability of 2 IM doses of AZD1222.

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 III Randomized, Double-blind, Placebo-controlled Multicenter Study in Adults to Determine the Safety, Efficacy, and Immunogenicity of AZD1222, a Non-replicating ChAdOx1 Vector Vaccine, for the Prevention of COVID-19

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Number of Participants With Binary Response

Primary: Number of Participants With Binary Response

Primary: Number of Participants With Adverse Events (AEs) Post Each Dose of Study Intervention

Primary: Number of Participants With Adverse Events (AEs) Post Each Dose of Study Intervention

Primary: Number of Participants With Serious Adverse Events (SAE), Medically Attended Adverse Events (MAAE), and Adverse Event of Special Interest (AESI) Throughout the Study

Primary: Number of Participants With Serious Adverse Events (SAE), Medically Attended Adverse Events (MAAE), and Adverse Event of Special Interest (AESI) Throughout the Study

Primary: Number of Participants With Local and Systemic Solicited AEs in the Substudy Only

Primary: Number of Participants With Local and Systemic Solicited AEs in the Substudy Only

Secondary: Number of Participants With First COVID-19 Symptomatic Illness Using Centers for Disease Control and Prevention (CDC) Criteria Post Second Dose of Study Intervention

Secondary: Number of Participants With First COVID-19 Symptomatic Illness Using Centers for Disease Control and Prevention (CDC) Criteria Post Second Dose of Study Intervention

Secondary: Number of Participants With First Post-intervention Response for SARS-CoV-2 Nucleocapsid Antibodies Post Second Dose of Study

Secondary: Number of Participants With First Post-intervention Response for SARS-CoV-2 Nucleocapsid Antibodies Post Second Dose of Study

Secondary: Number of Participants With First COVID-19 Symptomatic Illness Using University of Oxford-Defined Symptom Criteria Post Second Dose of Study Intervention

Secondary: Number of Participants With First COVID-19 Symptomatic Illness Using University of Oxford-Defined Symptom Criteria Post Second Dose of Study Intervention

Secondary: Number of Participants With First Symptomatic COVID-19 Regardless of Evidence of Prior SARS-CoV-2 Infection Post Second Dose of Study Intervention

Secondary: Number of Participants With First Symptomatic COVID-19 Regardless of Evidence of Prior SARS-CoV-2 Infection Post Second Dose of Study Intervention

Secondary: Number of Participants With COVID-19 Severe or Critical Symptomatic Illness Post Second Dose of Study Intervention

Secondary: Number of Participants With COVID-19 Severe or Critical Symptomatic Illness Post Second Dose of Study Intervention

Secondary: Number of Participants With COVID-19-Related Emergency Department Visits Post Second Dose of Study Intervention

Secondary: Number of Participants With COVID-19-Related Emergency Department Visits Post Second Dose of Study Intervention

Secondary: Number of Participants With COVID-19 Severe or Critical Symptomatic Illness Post First Dose of Study Intervention

Secondary: Number of Participants With COVID-19 Severe or Critical Symptomatic Illness Post First Dose of Study Intervention

Secondary: Geometric Mean Titers (GMTs) for SARS-CoV-2 Spike (S) and Receptor Binding Domain (RBD) Antibodies as Measured by Meso Scale Discovery (MSD) Serology Assay

Secondary: Geometric Mean Titers (GMTs) for SARS-CoV-2 Spike (S) and Receptor Binding Domain (RBD) Antibodies as Measured by Meso Scale Discovery (MSD) Serology Assay

Secondary: Geometric Mean Fold Rise (GMFR) for SARS-CoV-2 S and RBD Antibodies as Measured by MSD Serology Assay

Secondary: Geometric Mean Fold Rise (GMFR) for SARS-CoV-2 S and RBD Antibodies as Measured by MSD Serology Assay

Secondary: Percentage of Participants With Seroresponse to the S and RBD Antigens of AZD1222 as Measured by MSD Serology Assay

Secondary: Percentage of Participants With Seroresponse to the S and RBD Antigens of AZD1222 as Measured by MSD Serology Assay

Secondary: GMTs for SARS-CoV-2 Neutralizing Antibodies as Measured by Pseudo-neutralization Assay

Secondary: GMTs for SARS-CoV-2 Neutralizing Antibodies as Measured by Pseudo-neutralization Assay

Secondary: GMFR for SARS-CoV-2 Neutralizing Antibodies as Measured by Pseudo-neutralization Assay

Secondary: GMFR for SARS-CoV-2 Neutralizing Antibodies as Measured by Pseudo-neutralization Assay

Secondary: Percentage of Participants With Seroresponse to SARS-CoV-2 Neutralizing Antibodies of AZD1222 as Measured by Pseudo-neutralization Assay

Secondary: Percentage of Participants With Seroresponse to SARS-CoV-2 Neutralizing Antibodies of AZD1222 as Measured by Pseudo-neutralization Assay

Secondary: Number of Participants With COVID-19 Symptomatic Illness Post First Dose of Study Intervention

Secondary: Number of Participants With COVID-19 Symptomatic Illness Post First Dose of Study Intervention

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

Clinical Trial Results:
A Phase III Randomized, Double-blind, Placebo-controlled Multicenter Study in Adults to Determine the Safety, Efficacy, and Immunogenicity of AZD1222, a Non-replicating ChAdOx1 Vector Vaccine, for the Prevention of COVID-19