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Clinical Trial Results:
A Phase III Randomized, Double-blind, Placebo-controlled, Multicenter Study to Determine the Safety and Efficacy of AZD7442 for the Treatment of COVID-19 in Non-hospitalized Adults

Summary
EudraCT number	2020-005315-44
Trial protocol	DE IT HU PL BG
Global end of trial date	19 Oct 2022

Results information
Results version number	v2(current)
This version publication date	02 Aug 2023
First version publication date	02 Jun 2023
Other versions	v1
Version creation reason

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

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Trial information

Top of page

Sponsor protocol code

D8851C00001

ISRCTN number

-

US NCT number

NCT04723394

WHO universal trial number (UTN)

-

Sponsor organisation name

AstraZeneca

Sponsor organisation address

S-151, Sodertalje, Sweden,

Public contact

Global Clinical Lead, AstraZeneca, 1 8772409479, information.center@astrazeneca.com

Scientific contact

Global Clinical Lead, AstraZeneca, 1 8772409479, information.center@astrazeneca.com

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

No

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

No

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

No

Analysis stage

Final

Date of interim/final analysis

02 Dec 2022

Is this the analysis of the primary completion data?

No

Global end of trial reached?

Yes

Global end of trial date

19 Oct 2022

Was the trial ended prematurely?

No

Main objective of the trial

To estimate the efficacy of AZD7442 in the prevention of the composite endpoint of either severe COVID-19 or death from any cause through study Day 29

Protection of trial subjects

This study is conducted in accordance with the protocol and with the following: Consensus ethical principles derived from international guidelines including the Declaration of Helsinki and Council for International Organizations of Medical Sciences International Ethical Guidelines; Applicable International Conference on Harmonisation (ICH)/Good Clinical Practice (GCP) Guidelines; Applicable laws and regulations. The protocol, protocol amendments, Informed Consent Form (ICF), Investigator Brochure, and other relevant documents (e.g. advertisements) must be submitted to an Institutional Review Board/Independent Ethics Committee (IRB/IEC) by the Investigator and reviewed and approved by the IRB/IEC before the study is initiated. Any amendments to the protocol will require IRB/IEC approval before implementation of changes made to the study design, except for changes necessary to eliminate an immediate hazard to study patients. Where applicable as per relevant laws and regulations, amendments will also be submitted to, reviewed and approved by regulatory authorities/national competent authorities.

Background therapy

-

Evidence for comparator

-

Actual start date of recruitment

28 Jan 2021

Long term follow-up planned

No

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

Argentina: 60

Country: Number of subjects enrolled

Brazil: 27

Country: Number of subjects enrolled

Czechia: 7

Country: Number of subjects enrolled

Germany: 92

Country: Number of subjects enrolled

Hungary: 3

Country: Number of subjects enrolled

Italy: 73

Country: Number of subjects enrolled

Japan: 42

Country: Number of subjects enrolled

Mexico: 310

Country: Number of subjects enrolled

Poland: 2

Country: Number of subjects enrolled

Russian Federation: 119

Country: Number of subjects enrolled

Spain: 70

Country: Number of subjects enrolled

Ukraine: 16

Country: Number of subjects enrolled

United Kingdom: 44

Country: Number of subjects enrolled

United States: 149

Worldwide total number of subjects

1014

EEA total number of subjects

247

Number of subjects enrolled per age group

In utero

0

Preterm newborn - gestational age < 37 wk

0

Newborns (0-27 days)

0

Infants and toddlers (28 days-23 months)

0

Children (2-11 years)

0

Adolescents (12-17 years)

0

Adults (18-64 years)

890

From 65 to 84 years

123

85 years and over

1

Subject disposition

Top of page

Recruitment details

910 participants were randomized to receive treatment in study D8851C00001 (TACKLE) with AZD7442 (AZD8895 + AZD1061) or placebo. Of the 910 participants randomized, 903 (99.2%) received treatment with study drug. Of the 903 dosed, 452 (50.1%) participants received AZD7442 and 451 (49.9%) participants received placebo.

Screening details

In TACKLE, at the first visit, ie, the enrollment visit 1, participants were evaluated regarding the protocol mandated inclusion and exclusion criteria. After enrolment, eligible participants were randomized at a 1: 1 ratio to receive a single dose of study provided AZD7442 (AZD8895 + AZD1061) or placebo.

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, Data analyst, Carer, Assessor

Are arms mutually exclusive

Yes

AZD7442

Arm description

Single dose of 600 mg of AZD7442 (2 separate IM injections) on Day 1

Arm type

Experimental

Investigational medicinal product name

Combination of 2 mAbs (AZD8895 and AZD1061)

Investigational medicinal product code

Other name

tixagevimab–cilgavimab

Pharmaceutical forms

Solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

Single dose (× 2 separate IM injections) of 600 mg of AZD7442 on Day 1.

Placebo

Arm description

Single dose of Placebo (2 separate IM injections) on Day 1

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

Single dose (× 2 separate IM injections) of saline placebo on Day 1.

Number of subjects in period 1 ^[1]	AZD7442	Placebo
Started	452	451
Modified Full Analysis Set	413	421
Primary Analysis Population	410	419
Key Secondary Analysis Population	404 ^[2]	411
Completed	407	390
Not completed	45	61
Adverse event, serious fatal	8	8
Consent withdrawn by subject	17	33
Adverse event, non-fatal	-	3
Lost to follow-up	20	17

Notes
[1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
Justification: These participants are those who have non-missing results of key secondary endpoint.
[2] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: 1014 total participants enrolled in the study but only 903 dosed, and we report results of these dosed participants (Full Analysis Set).

Baseline characteristics

Top of page

Reporting group title

AZD7442

Reporting group description

Single dose of 600 mg of AZD7442 (2 separate IM injections) on Day 1

Reporting group title

Placebo

Reporting group description

Single dose of Placebo (2 separate IM injections) on Day 1

Reporting group values	AZD7442	Placebo	Total
Number of subjects	452	451	903
Age categorical
Units: Subjects
In utero	0	0	0
Preterm newborn infants (gestational age < 37 wks)	0	0	0
Newborns (0-27 days)	0	0	0
Infants and toddlers (28 days-23 months)	0	0	0
Children (2-11 years)	0	0	0
Adolescents (12-17 years)	0	0	0
Adults (18-64 years)	393	394	787
From 65-84 years	59	56	115
85 years and over	0	1	1
Age Continuous
Full Analysis Set
Units: years
median (full range (min-max))	46.0 (18.0 to 83.0)	46.0 (18.0 to 86.0)	-
Sex: Female, Male
Units: Participants
Female	239	216	455
Male	213	235	448
Ethnicity (NIH/OMB)
Units: Subjects
Hispanic or Latino	230	238	468
Not Hispanic or Latino	222	213	435
Race (NIH/OMB)
Units: Subjects
American Indian or Alaska Native	100	115	215
Asian	30	21	51
Black or African American	16	20	36
Multiple	0	0	0
Native Hawaiian or Other Pacific Islander	0	0	0
Not reported	21	21	42
White	285	274	559
Risk of Progression to Severe COVID-19
Risk of Progression to Severe COVID-19 is assessed based on participant's medical history - based on FDA/CDC guidelines. Summarized in the Full Analysis Set
Units: Subjects
High	405	406	811
Low	47	45	92
Country
Units: Subjects
Argentina	29	28	57
Brazil	7	12	19
Czech Republic	3	2	5
Germany	33	38	71
Hungary	2	1	3
Italy	37	33	70
Japan	26	14	40
Mexico	139	166	305
Poland	1	1	2
Russian Federation	55	51	106
Spain	31	37	68
Ukraine	5	10	15
United Kingdom	20	18	38
United States	64	40	104
BMI (kg/m^2)
Full Analysis Set
Units: kg/m^2
arithmetic mean (standard deviation)	28.9 ( 5.46 )	29.2 ( 6.56 )	-
Age Continuous
Full Analysis Set
Units: Years
arithmetic mean (standard deviation)	46.3 ( 15.42 )	45.9 ( 14.99 )	-

Subject analysis set title

AZD7442 modified Full Analysis Set

Subject analysis set type

Full analysis

Subject analysis set description

All participants in the full analysis set who received AZD7442 ≤ 7 days from symptom onset and were not hospitalized at baseline (≤ Day 1) for isolation purpose.

Subject analysis set title

Placebo modified Full Analysis Set

Subject analysis set type

Full analysis

Subject analysis set description

All participants in the full analysis set who received placebo ≤ 7 days from symptom onset and were not hospitalized at baseline (≤ Day 1) for isolation purpose.

Subject analysis sets values	AZD7442 modified Full Analysis Set	Placebo modified Full Analysis Set
Number of subjects	413	421
Age categorical
Units: Subjects
In utero
Preterm newborn infants (gestational age < 37 wks)
Newborns (0-27 days)
Infants and toddlers (28 days-23 months)
Children (2-11 years)
Adolescents (12-17 years)
Adults (18-64 years)
From 65-84 years
85 years and over
Age Continuous
Full Analysis Set
Units: years
median (full range (min-max))
Sex: Female, Male
Units: Participants
Female	226	206
Male	187	215
Ethnicity (NIH/OMB)
Units: Subjects
Hispanic or Latino
Not Hispanic or Latino
Race (NIH/OMB)
Units: Subjects
American Indian or Alaska Native
Asian
Black or African American
Multiple
Native Hawaiian or Other Pacific Islander
Not reported
White
Risk of Progression to Severe COVID-19
Risk of Progression to Severe COVID-19 is assessed based on participant's medical history - based on FDA/CDC guidelines. Summarized in the Full Analysis Set
Units: Subjects
High
Low
Country
Units: Subjects
Argentina
Brazil
Czech Republic
Germany
Hungary
Italy
Japan
Mexico
Poland
Russian Federation
Spain
Ukraine
United Kingdom
United States
BMI (kg/m^2)
Full Analysis Set
Units: kg/m^2
arithmetic mean (standard deviation)	( )	( )
Age Continuous
Full Analysis Set
Units: Years
arithmetic mean (standard deviation)	( )	( )

End points

Top of page

Reporting group title

AZD7442

Reporting group description

Single dose of 600 mg of AZD7442 (2 separate IM injections) on Day 1

Reporting group title

Placebo

Reporting group description

Single dose of Placebo (2 separate IM injections) on Day 1

Subject analysis set title

AZD7442 modified Full Analysis Set

Subject analysis set type

Full analysis

Subject analysis set description

All participants in the full analysis set who received AZD7442 ≤ 7 days from symptom onset and were not hospitalized at baseline (≤ Day 1) for isolation purpose.

Subject analysis set title

Placebo modified Full Analysis Set

Subject analysis set type

Full analysis

Subject analysis set description

All participants in the full analysis set who received placebo ≤ 7 days from symptom onset and were not hospitalized at baseline (≤ Day 1) for isolation purpose.

Primary: A Composite of Either Severe COVID-19 or Death From Any Cause Through Day 29

Top of page

End point title

A Composite of Either Severe COVID-19 or Death From Any Cause Through Day 29

End point description

Severe COVID-19 is characterized by a minimum of either pneumonia (fever, cough, tachypnea, or dyspnea, and lung infiltrates) or hypoxemia (SpO2 < 90% in room air and/or severe respiratory distress) and a WHO Clinical Progression Scale score of 5 or higher.

End point type

Primary

End point timeframe

Baseline (Day 1) and Day 29

End point values	AZD7442 modified Full Analysis Set	Placebo modified Full Analysis Set
Number of subjects analysed	410	419
Units: Participants	18	37

relative risk reduction

Statistical analysis description

AZD7442 vs Placebo

Comparison groups

AZD7442 modified Full Analysis Set v Placebo modified Full Analysis Set

Number of subjects included in analysis

829

Analysis specification

Pre-specified

Analysis type

superiority ^[1]

P-value

= 0.01

Method

Cochran-Mantel-Haenszel

Parameter type

Relative Risk Reduction (100*[1-RR])

Point estimate

50.38

Confidence interval

level

95%

sides

2-sided

lower limit

14.38

upper limit

71.25

Notes
[1] - The relative risk reduction RRR represents the percent reduction in incidence of severe COVID-19 or death from any cause in the AZD7442 group relative to placebo. A RRR > 0 represents favorable efficacy in the AZD7442 group. A p-value <0.05 indicates a statistically significant result.

Secondary: A Composite of Death From Any Cause or Hospitalization for COVID-19 Complications or Sequelae Through Day 169

Top of page

End point title

A Composite of Death From Any Cause or Hospitalization for COVID-19 Complications or Sequelae Through Day 169

End point description

Death from Any Cause or Hospitalization for COVID-19 Complications or Sequelae through Day 169

End point type

Secondary

End point timeframe

Baseline (Day 1) and Day 169

End point values	AZD7442 modified Full Analysis Set	Placebo modified Full Analysis Set
Number of subjects analysed	404	411
Units: Participants	20	40

relative risk reduction

Statistical analysis description

AZD7442 vs Placebo

Comparison groups

AZD7442 modified Full Analysis Set v Placebo modified Full Analysis Set

Number of subjects included in analysis

815

Analysis specification

Pre-specified

Analysis type

superiority ^[2]

P-value

= 0.009

Method

Cochran-Mantel-Haenszel

Parameter type

Relative Risk Reduction (100*[1-RR])

Point estimate

49.24

Confidence interval

level

95%

sides

2-sided

lower limit

14.72

upper limit

69.79

Notes
[2] - The relative risk reduction RRR represents the percent reduction in incidence of death from any cause or hospitalization for COVID-19 complications or sequelae in the AZD7442 group relative to placebo. A RRR > 0 represents favorable efficacy in the AZD7442 group. A p-value <0.05 indicates a statistically significant result. Participants who discontinued or were lost to follow up prior to Day 169 are considered missing.

Adverse events

Top of page

Timeframe for reporting adverse events

From first dose of study drug until end of study, with an average of 436 days.

Adverse event reporting additional description

AEs are reported for the Safety Analysis Set, defined as all participants randomized and dosed with IMP.

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

24.0

Reporting group title

Placebo

Reporting group description

Single dose of Placebo (2 separate IM injections) on Day 1

Reporting group title

AZD7442

Reporting group description

Single dose of 600 mg of AZD7442 (2 separate IM injections) on Day 1

Serious adverse events	Placebo	AZD7442
Total subjects affected by serious adverse events
subjects affected / exposed	65 / 451 (14.41%)	46 / 452 (10.18%)
number of deaths (all causes)	8	8
number of deaths resulting from adverse events	0	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
subjects affected / exposed	0 / 451 (0.00%)	1 / 452 (0.22%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Colorectal cancer metastatic
subjects affected / exposed	0 / 451 (0.00%)	1 / 452 (0.22%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Vascular disorders
Hypertensive emergency
subjects affected / exposed	1 / 451 (0.22%)	0 / 452 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Peripheral artery thrombosis
subjects affected / exposed	0 / 451 (0.00%)	1 / 452 (0.22%)
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 / 451 (0.00%)	1 / 452 (0.22%)
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
Abortion spontaneous
subjects affected / exposed	2 / 451 (0.44%)	0 / 452 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
General disorders and administration site conditions
Sudden cardiac death
subjects affected / exposed	0 / 451 (0.00%)	1 / 452 (0.22%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Death
subjects affected / exposed	1 / 451 (0.22%)	0 / 452 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Reproductive system and breast disorders
Adenomyosis
subjects affected / exposed	1 / 451 (0.22%)	0 / 452 (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
Acute pulmonary oedema
subjects affected / exposed	1 / 451 (0.22%)	0 / 452 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumothorax
subjects affected / exposed	1 / 451 (0.22%)	0 / 452 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pulmonary embolism
subjects affected / exposed	0 / 451 (0.00%)	1 / 452 (0.22%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Psychiatric disorders
Bipolar disorder
subjects affected / exposed	0 / 451 (0.00%)	1 / 452 (0.22%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Disorientation
subjects affected / exposed	1 / 451 (0.22%)	0 / 452 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Injury, poisoning and procedural complications
Forearm fracture
subjects affected / exposed	1 / 451 (0.22%)	0 / 452 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hip fracture
subjects affected / exposed	0 / 451 (0.00%)	1 / 452 (0.22%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Foreign body in gastrointestinal tract
subjects affected / exposed	1 / 451 (0.22%)	0 / 452 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Jaw fracture
subjects affected / exposed	1 / 451 (0.22%)	0 / 452 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Road traffic accident
subjects affected / exposed	0 / 451 (0.00%)	1 / 452 (0.22%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Cardiac disorders
Acute left ventricular failure
subjects affected / exposed	0 / 451 (0.00%)	1 / 452 (0.22%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Acute myocardial infarction
subjects affected / exposed	1 / 451 (0.22%)	2 / 452 (0.44%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 1
Arrhythmia
subjects affected / exposed	2 / 451 (0.44%)	0 / 452 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Acute coronary syndrome
subjects affected / exposed	0 / 451 (0.00%)	1 / 452 (0.22%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac failure
subjects affected / exposed	1 / 451 (0.22%)	0 / 452 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac arrest
subjects affected / exposed	1 / 451 (0.22%)	0 / 452 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Atrial fibrillation
subjects affected / exposed	0 / 451 (0.00%)	1 / 452 (0.22%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Supraventricular extrasystoles
subjects affected / exposed	0 / 451 (0.00%)	1 / 452 (0.22%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Myocardial ischaemia
subjects affected / exposed	0 / 451 (0.00%)	1 / 452 (0.22%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Nervous system disorders
Loss of consciousness
subjects affected / exposed	1 / 451 (0.22%)	0 / 452 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Optic neuritis
subjects affected / exposed	1 / 451 (0.22%)	0 / 452 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Presyncope
subjects affected / exposed	0 / 451 (0.00%)	1 / 452 (0.22%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Superior sagittal sinus thrombosis
subjects affected / exposed	1 / 451 (0.22%)	0 / 452 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Syncope
subjects affected / exposed	0 / 451 (0.00%)	1 / 452 (0.22%)
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 of malignant disease
subjects affected / exposed	0 / 451 (0.00%)	1 / 452 (0.22%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Blood loss anaemia
subjects affected / exposed	1 / 451 (0.22%)	0 / 452 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Eye disorders
Diabetic retinopathy
subjects affected / exposed	1 / 451 (0.22%)	0 / 452 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal disorders
Oesophageal varices haemorrhage
subjects affected / exposed	1 / 451 (0.22%)	0 / 452 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gastritis erosive
subjects affected / exposed	1 / 451 (0.22%)	0 / 452 (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	1 / 451 (0.22%)	0 / 452 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Varices oesophageal
subjects affected / exposed	1 / 451 (0.22%)	0 / 452 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatobiliary disorders
Cholecystitis
subjects affected / exposed	0 / 451 (0.00%)	1 / 452 (0.22%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cholecystitis chronic
subjects affected / exposed	0 / 451 (0.00%)	2 / 452 (0.44%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Portal vein thrombosis
subjects affected / exposed	1 / 451 (0.22%)	0 / 452 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Biliary colic
subjects affected / exposed	1 / 451 (0.22%)	0 / 452 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Skin and subcutaneous tissue disorders
Actinic keratosis
subjects affected / exposed	1 / 451 (0.22%)	0 / 452 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Renal and urinary disorders
Chronic kidney disease
subjects affected / exposed	0 / 451 (0.00%)	1 / 452 (0.22%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Nephrolithiasis
subjects affected / exposed	1 / 451 (0.22%)	1 / 452 (0.22%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Ureteric obstruction
subjects affected / exposed	1 / 451 (0.22%)	0 / 452 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
subjects affected / exposed	1 / 451 (0.22%)	0 / 452 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Immobilisation syndrome
subjects affected / exposed	0 / 451 (0.00%)	1 / 452 (0.22%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Infections and infestations
Pneumonia bacterial
subjects affected / exposed	0 / 451 (0.00%)	1 / 452 (0.22%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Superinfection bacterial
subjects affected / exposed	1 / 451 (0.22%)	0 / 452 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Sinusitis
subjects affected / exposed	1 / 451 (0.22%)	0 / 452 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Appendicitis
subjects affected / exposed	0 / 451 (0.00%)	1 / 452 (0.22%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Bacterial diarrhoea
subjects affected / exposed	1 / 451 (0.22%)	0 / 452 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
COVID-19
subjects affected / exposed	9 / 451 (2.00%)	2 / 452 (0.44%)
occurrences causally related to treatment / all	0 / 9	0 / 2
deaths causally related to treatment / all	0 / 1	0 / 1
COVID-19 pneumonia
subjects affected / exposed	37 / 451 (8.20%)	23 / 452 (5.09%)
occurrences causally related to treatment / all	0 / 37	0 / 23
deaths causally related to treatment / all	0 / 5	0 / 2
Cellulitis
subjects affected / exposed	0 / 451 (0.00%)	1 / 452 (0.22%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Disseminated tuberculosis
subjects affected / exposed	1 / 451 (0.22%)	0 / 452 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Septic shock
subjects affected / exposed	1 / 451 (0.22%)	0 / 452 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Sepsis
subjects affected / exposed	0 / 451 (0.00%)	1 / 452 (0.22%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pseudomonas infection
subjects affected / exposed	1 / 451 (0.22%)	0 / 452 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Post-acute COVID-19 syndrome
subjects affected / exposed	1 / 451 (0.22%)	0 / 452 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gastroenteritis viral
subjects affected / exposed	0 / 451 (0.00%)	1 / 452 (0.22%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 0%

Non-serious adverse events	Placebo	AZD7442
Total subjects affected by non serious adverse events
subjects affected / exposed	224 / 451 (49.67%)	230 / 452 (50.88%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
subjects affected / exposed	1 / 451 (0.22%)	0 / 452 (0.00%)
occurrences all number	1	0
Plasma cell myeloma
subjects affected / exposed	0 / 451 (0.00%)	1 / 452 (0.22%)
occurrences all number	0	1
Bladder cancer
subjects affected / exposed	0 / 451 (0.00%)	1 / 452 (0.22%)
occurrences all number	0	1
Anogenital warts
subjects affected / exposed	0 / 451 (0.00%)	1 / 452 (0.22%)
occurrences all number	0	1
Acrochordon
subjects affected / exposed	1 / 451 (0.22%)	0 / 452 (0.00%)
occurrences all number	1	0
Seborrhoeic keratosis
subjects affected / exposed	1 / 451 (0.22%)	0 / 452 (0.00%)
occurrences all number	1	0
Uterine leiomyoma
subjects affected / exposed	1 / 451 (0.22%)	0 / 452 (0.00%)
occurrences all number	1	0
Vascular disorders
Aortic arteriosclerosis
subjects affected / exposed	1 / 451 (0.22%)	0 / 452 (0.00%)
occurrences all number	1	0
Brachiocephalic arteriosclerosis
subjects affected / exposed	0 / 451 (0.00%)	1 / 452 (0.22%)
occurrences all number	0	1
Deep vein thrombosis
subjects affected / exposed	0 / 451 (0.00%)	1 / 452 (0.22%)
occurrences all number	0	1
Essential hypertension
subjects affected / exposed	1 / 451 (0.22%)	0 / 452 (0.00%)
occurrences all number	1	0
Hot flush
subjects affected / exposed	0 / 451 (0.00%)	1 / 452 (0.22%)
occurrences all number	0	1
Hypertension
subjects affected / exposed	18 / 451 (3.99%)	16 / 452 (3.54%)
occurrences all number	18	16
Hypertensive crisis
subjects affected / exposed	1 / 451 (0.22%)	0 / 452 (0.00%)
occurrences all number	1	0
Hypertensive urgency
subjects affected / exposed	0 / 451 (0.00%)	1 / 452 (0.22%)
occurrences all number	0	1
Hypotension
subjects affected / exposed	1 / 451 (0.22%)	1 / 452 (0.22%)
occurrences all number	1	1
Lymphostasis
subjects affected / exposed	1 / 451 (0.22%)	0 / 452 (0.00%)
occurrences all number	1	0
Peripheral artery aneurysm
subjects affected / exposed	1 / 451 (0.22%)	0 / 452 (0.00%)
occurrences all number	1	0
Thrombophlebitis
subjects affected / exposed	1 / 451 (0.22%)	0 / 452 (0.00%)
occurrences all number	1	0
Venous thrombosis limb
subjects affected / exposed	0 / 451 (0.00%)	1 / 452 (0.22%)
occurrences all number	0	1
Surgical and medical procedures
Abdominal wall operation
subjects affected / exposed	0 / 451 (0.00%)	1 / 452 (0.22%)
occurrences all number	0	1
General disorders and administration site conditions
Asthenia
subjects affected / exposed	9 / 451 (2.00%)	8 / 452 (1.77%)
occurrences all number	9	10
Chest discomfort
subjects affected / exposed	0 / 451 (0.00%)	1 / 452 (0.22%)
occurrences all number	0	1
Decreased activity
subjects affected / exposed	0 / 451 (0.00%)	1 / 452 (0.22%)
occurrences all number	0	1
Energy increased
subjects affected / exposed	2 / 451 (0.44%)	1 / 452 (0.22%)
occurrences all number	2	1
Injection site haematoma
subjects affected / exposed	1 / 451 (0.22%)	1 / 452 (0.22%)
occurrences all number	1	1
Fatigue
subjects affected / exposed	15 / 451 (3.33%)	16 / 452 (3.54%)
occurrences all number	17	16
Feeling hot
subjects affected / exposed	0 / 451 (0.00%)	1 / 452 (0.22%)
occurrences all number	0	1
Gait disturbance
subjects affected / exposed	0 / 451 (0.00%)	1 / 452 (0.22%)
occurrences all number	0	1
Injection site bruising
subjects affected / exposed	1 / 451 (0.22%)	1 / 452 (0.22%)
occurrences all number	1	1
Injection site erythema
subjects affected / exposed	2 / 451 (0.44%)	2 / 452 (0.44%)
occurrences all number	2	2
Face oedema
subjects affected / exposed	1 / 451 (0.22%)	0 / 452 (0.00%)
occurrences all number	1	0
Injection site induration
subjects affected / exposed	0 / 451 (0.00%)	1 / 452 (0.22%)
occurrences all number	0	1
Injection site nodule
subjects affected / exposed	0 / 451 (0.00%)	1 / 452 (0.22%)
occurrences all number	0	2
Injection site pain
subjects affected / exposed	11 / 451 (2.44%)	8 / 452 (1.77%)
occurrences all number	15	12
Injection site swelling
subjects affected / exposed	0 / 451 (0.00%)	1 / 452 (0.22%)
occurrences all number	0	2
Injection site warmth
subjects affected / exposed	1 / 451 (0.22%)	0 / 452 (0.00%)
occurrences all number	2	0
Malaise
subjects affected / exposed	1 / 451 (0.22%)	2 / 452 (0.44%)
occurrences all number	1	2
Pain
subjects affected / exposed	1 / 451 (0.22%)	1 / 452 (0.22%)
occurrences all number	1	1
Pyrexia
subjects affected / exposed	0 / 451 (0.00%)	3 / 452 (0.66%)
occurrences all number	0	4
Suprapubic pain
subjects affected / exposed	1 / 451 (0.22%)	0 / 452 (0.00%)
occurrences all number	1	0
Vaccination site pain
subjects affected / exposed	2 / 451 (0.44%)	3 / 452 (0.66%)
occurrences all number	3	6
Vaccination site reaction
subjects affected / exposed	1 / 451 (0.22%)	0 / 452 (0.00%)
occurrences all number	1	0
Injection site inflammation
subjects affected / exposed	0 / 451 (0.00%)	1 / 452 (0.22%)
occurrences all number	0	1
Influenza like illness
subjects affected / exposed	0 / 451 (0.00%)	1 / 452 (0.22%)
occurrences all number	0	1
Adverse drug reaction
subjects affected / exposed	1 / 451 (0.22%)	1 / 452 (0.22%)
occurrences all number	1	1
Application site haematoma
subjects affected / exposed	0 / 451 (0.00%)	1 / 452 (0.22%)
occurrences all number	0	1
Oedema peripheral
subjects affected / exposed	2 / 451 (0.44%)	0 / 452 (0.00%)
occurrences all number	2	0
Non-cardiac chest pain
subjects affected / exposed	2 / 451 (0.44%)	1 / 452 (0.22%)
occurrences all number	2	1
Injection site discomfort
subjects affected / exposed	1 / 451 (0.22%)	2 / 452 (0.44%)
occurrences all number	1	3
Immune system disorders
Allergy to arthropod sting
subjects affected / exposed	0 / 451 (0.00%)	1 / 452 (0.22%)
occurrences all number	0	1
Hypersensitivity
subjects affected / exposed	0 / 451 (0.00%)	1 / 452 (0.22%)
occurrences all number	0	1
Seasonal allergy
subjects affected / exposed	1 / 451 (0.22%)	2 / 452 (0.44%)
occurrences all number	1	2
Drug hypersensitivity
subjects affected / exposed	1 / 451 (0.22%)	0 / 452 (0.00%)
occurrences all number	2	0
Social circumstances
Unhealthy diet
subjects affected / exposed	0 / 451 (0.00%)	1 / 452 (0.22%)
occurrences all number	0	1
Reproductive system and breast disorders
Bartholin's cyst
subjects affected / exposed	0 / 451 (0.00%)	1 / 452 (0.22%)
occurrences all number	0	1
Benign prostatic hyperplasia
subjects affected / exposed	1 / 451 (0.22%)	1 / 452 (0.22%)
occurrences all number	1	1
Breast discharge
subjects affected / exposed	0 / 451 (0.00%)	1 / 452 (0.22%)
occurrences all number	0	1
Endometrial thickening
subjects affected / exposed	1 / 451 (0.22%)	0 / 452 (0.00%)
occurrences all number	1	0
Erectile dysfunction
subjects affected / exposed	4 / 451 (0.89%)	0 / 452 (0.00%)
occurrences all number	4	0
Hypomenorrhoea
subjects affected / exposed	1 / 451 (0.22%)	0 / 452 (0.00%)
occurrences all number	1	0
Menopausal symptoms
subjects affected / exposed	1 / 451 (0.22%)	1 / 452 (0.22%)
occurrences all number	1	1
Menstruation irregular
subjects affected / exposed	0 / 451 (0.00%)	1 / 452 (0.22%)
occurrences all number	0	1
Nipple pain
subjects affected / exposed	0 / 451 (0.00%)	1 / 452 (0.22%)
occurrences all number	0	1
Ovarian cyst
subjects affected / exposed	1 / 451 (0.22%)	0 / 452 (0.00%)
occurrences all number	1	0
Polycystic ovaries
subjects affected / exposed	0 / 451 (0.00%)	1 / 452 (0.22%)
occurrences all number	0	1
Prostatitis
subjects affected / exposed	2 / 451 (0.44%)	1 / 452 (0.22%)
occurrences all number	2	1
Prostatomegaly
subjects affected / exposed	1 / 451 (0.22%)	0 / 452 (0.00%)
occurrences all number	1	0
Vaginal haemorrhage
subjects affected / exposed	0 / 451 (0.00%)	1 / 452 (0.22%)
occurrences all number	0	1
Vulvovaginal erythema
subjects affected / exposed	1 / 451 (0.22%)	0 / 452 (0.00%)
occurrences all number	1	0
Dysmenorrhoea
subjects affected / exposed	1 / 451 (0.22%)	0 / 452 (0.00%)
occurrences all number	1	0
Respiratory, thoracic and mediastinal disorders
Organising pneumonia
subjects affected / exposed	0 / 451 (0.00%)	1 / 452 (0.22%)
occurrences all number	0	1
Asthma
subjects affected / exposed	2 / 451 (0.44%)	2 / 452 (0.44%)
occurrences all number	2	2
Bronchial hyperreactivity
subjects affected / exposed	1 / 451 (0.22%)	0 / 452 (0.00%)
occurrences all number	1	0
Bronchitis chronic
subjects affected / exposed	1 / 451 (0.22%)	0 / 452 (0.00%)
occurrences all number	1	0
Bronchospasm
subjects affected / exposed	1 / 451 (0.22%)	0 / 452 (0.00%)
occurrences all number	1	0
Chronic obstructive pulmonary disease
subjects affected / exposed	2 / 451 (0.44%)	1 / 452 (0.22%)
occurrences all number	2	1
Cough
subjects affected / exposed	4 / 451 (0.89%)	8 / 452 (1.77%)
occurrences all number	4	8
Dyspnoea
subjects affected / exposed	11 / 451 (2.44%)	3 / 452 (0.66%)
occurrences all number	12	3
Dyspnoea exertional
subjects affected / exposed	3 / 451 (0.67%)	4 / 452 (0.88%)
occurrences all number	3	5
Epistaxis
subjects affected / exposed	2 / 451 (0.44%)	0 / 452 (0.00%)
occurrences all number	4	0
Hiccups
subjects affected / exposed	1 / 451 (0.22%)	1 / 452 (0.22%)
occurrences all number	1	1
Interstitial lung disease
subjects affected / exposed	0 / 451 (0.00%)	1 / 452 (0.22%)
occurrences all number	0	2
Nasal congestion
subjects affected / exposed	3 / 451 (0.67%)	1 / 452 (0.22%)
occurrences all number	3	1
Nasal obstruction
subjects affected / exposed	0 / 451 (0.00%)	1 / 452 (0.22%)
occurrences all number	0	1
Oropharyngeal pain
subjects affected / exposed	3 / 451 (0.67%)	0 / 452 (0.00%)
occurrences all number	4	0
Pleurisy
subjects affected / exposed	1 / 451 (0.22%)	0 / 452 (0.00%)
occurrences all number	1	0
Productive cough
subjects affected / exposed	1 / 451 (0.22%)	1 / 452 (0.22%)
occurrences all number	1	1
Pulmonary fibrosis
subjects affected / exposed	1 / 451 (0.22%)	1 / 452 (0.22%)
occurrences all number	1	1
Rales
subjects affected / exposed	1 / 451 (0.22%)	1 / 452 (0.22%)
occurrences all number	1	1
Respiratory failure
subjects affected / exposed	0 / 451 (0.00%)	1 / 452 (0.22%)
occurrences all number	0	1
Rhinitis allergic
subjects affected / exposed	3 / 451 (0.67%)	1 / 452 (0.22%)
occurrences all number	3	1
Rhinorrhoea
subjects affected / exposed	4 / 451 (0.89%)	0 / 452 (0.00%)
occurrences all number	5	0
Sleep apnoea syndrome
subjects affected / exposed	0 / 451 (0.00%)	1 / 452 (0.22%)
occurrences all number	0	1
Throat irritation
subjects affected / exposed	1 / 451 (0.22%)	0 / 452 (0.00%)
occurrences all number	1	0
Vocal cord polyp
subjects affected / exposed	1 / 451 (0.22%)	0 / 452 (0.00%)
occurrences all number	1	0
Wheezing
subjects affected / exposed	0 / 451 (0.00%)	1 / 452 (0.22%)
occurrences all number	0	1
Psychiatric disorders
Alcohol abuse
subjects affected / exposed	1 / 451 (0.22%)	0 / 452 (0.00%)
occurrences all number	1	0
Alcoholism
subjects affected / exposed	1 / 451 (0.22%)	0 / 452 (0.00%)
occurrences all number	1	0
Anxiety
subjects affected / exposed	4 / 451 (0.89%)	3 / 452 (0.66%)
occurrences all number	4	3
Anxiety disorder
subjects affected / exposed	1 / 451 (0.22%)	0 / 452 (0.00%)
occurrences all number	1	0
Attention deficit hyperactivity disorder
subjects affected / exposed	0 / 451 (0.00%)	1 / 452 (0.22%)
occurrences all number	0	1
Bruxism
subjects affected / exposed	0 / 451 (0.00%)	1 / 452 (0.22%)
occurrences all number	0	1
Burnout syndrome
subjects affected / exposed	1 / 451 (0.22%)	0 / 452 (0.00%)
occurrences all number	1	0
Confusional state
subjects affected / exposed	1 / 451 (0.22%)	1 / 452 (0.22%)
occurrences all number	2	1
Depression
subjects affected / exposed	5 / 451 (1.11%)	5 / 452 (1.11%)
occurrences all number	5	5
Insomnia
subjects affected / exposed	2 / 451 (0.44%)	7 / 452 (1.55%)
occurrences all number	2	7
Mixed anxiety and depressive disorder
subjects affected / exposed	0 / 451 (0.00%)	1 / 452 (0.22%)
occurrences all number	0	1
Sleep disorder
subjects affected / exposed	1 / 451 (0.22%)	2 / 452 (0.44%)
occurrences all number	1	2
Stress
subjects affected / exposed	1 / 451 (0.22%)	0 / 452 (0.00%)
occurrences all number	1	0
Acute stress disorder
subjects affected / exposed	2 / 451 (0.44%)	0 / 452 (0.00%)
occurrences all number	2	0
Hepatobiliary disorders
Non-alcoholic steatohepatitis
subjects affected / exposed	0 / 451 (0.00%)	1 / 452 (0.22%)
occurrences all number	0	1
Biliary colic
subjects affected / exposed	1 / 451 (0.22%)	2 / 452 (0.44%)
occurrences all number	1	2
Cholecystitis
subjects affected / exposed	1 / 451 (0.22%)	0 / 452 (0.00%)
occurrences all number	1	0
Cholecystitis chronic
subjects affected / exposed	0 / 451 (0.00%)	1 / 452 (0.22%)
occurrences all number	0	1
Cholelithiasis
subjects affected / exposed	0 / 451 (0.00%)	2 / 452 (0.44%)
occurrences all number	0	2
Cholestasis
subjects affected / exposed	1 / 451 (0.22%)	0 / 452 (0.00%)
occurrences all number	1	0
Drug-induced liver injury
subjects affected / exposed	0 / 451 (0.00%)	1 / 452 (0.22%)
occurrences all number	0	1
Hepatic failure
subjects affected / exposed	1 / 451 (0.22%)	0 / 452 (0.00%)
occurrences all number	1	0
Hepatic steatosis
subjects affected / exposed	2 / 451 (0.44%)	2 / 452 (0.44%)
occurrences all number	2	2
Hepatitis toxic
subjects affected / exposed	0 / 451 (0.00%)	1 / 452 (0.22%)
occurrences all number	0	1
Investigations
Alanine aminotransferase increased
subjects affected / exposed	1 / 451 (0.22%)	0 / 452 (0.00%)
occurrences all number	1	0
Blood alkaline phosphatase increased
subjects affected / exposed	1 / 451 (0.22%)	0 / 452 (0.00%)
occurrences all number	1	0
Blood creatine phosphokinase increased
subjects affected / exposed	1 / 451 (0.22%)	0 / 452 (0.00%)
occurrences all number	1	0
Blood urine present
subjects affected / exposed	0 / 451 (0.00%)	1 / 452 (0.22%)
occurrences all number	0	1
Body temperature increased
subjects affected / exposed	0 / 451 (0.00%)	2 / 452 (0.44%)
occurrences all number	0	2
Cardiac murmur
subjects affected / exposed	0 / 451 (0.00%)	1 / 452 (0.22%)
occurrences all number	0	1
White blood cell count decreased
subjects affected / exposed	0 / 451 (0.00%)	1 / 452 (0.22%)
occurrences all number	0	1
Transaminases increased
subjects affected / exposed	0 / 451 (0.00%)	1 / 452 (0.22%)
occurrences all number	0	1
Platelet count increased
subjects affected / exposed	0 / 451 (0.00%)	1 / 452 (0.22%)
occurrences all number	0	1
Oxygen saturation decreased
subjects affected / exposed	2 / 451 (0.44%)	1 / 452 (0.22%)
occurrences all number	2	1
Neutrophil count decreased
subjects affected / exposed	0 / 451 (0.00%)	1 / 452 (0.22%)
occurrences all number	0	1
Lipids abnormal
subjects affected / exposed	1 / 451 (0.22%)	0 / 452 (0.00%)
occurrences all number	1	0
Hepatitis A antibody
subjects affected / exposed	1 / 451 (0.22%)	0 / 452 (0.00%)
occurrences all number	1	0
Hepatic enzyme increased
subjects affected / exposed	1 / 451 (0.22%)	1 / 452 (0.22%)
occurrences all number	1	1
C-reactive protein increased
subjects affected / exposed	0 / 451 (0.00%)	1 / 452 (0.22%)
occurrences all number	0	1
Aspartate aminotransferase increased
subjects affected / exposed	1 / 451 (0.22%)	0 / 452 (0.00%)
occurrences all number	1	0
Injury, poisoning and procedural complications
Post-traumatic neck syndrome
subjects affected / exposed	0 / 451 (0.00%)	1 / 452 (0.22%)
occurrences all number	0	1
Post procedural swelling
subjects affected / exposed	1 / 451 (0.22%)	0 / 452 (0.00%)
occurrences all number	1	0
Anaemia postoperative
subjects affected / exposed	0 / 451 (0.00%)	1 / 452 (0.22%)
occurrences all number	0	1
Ankle fracture
subjects affected / exposed	0 / 451 (0.00%)	1 / 452 (0.22%)
occurrences all number	0	1
Complications of transplanted kidney
subjects affected / exposed	1 / 451 (0.22%)	0 / 452 (0.00%)
occurrences all number	1	0
Contusion
subjects affected / exposed	0 / 451 (0.00%)	1 / 452 (0.22%)
occurrences all number	0	1
Head injury
subjects affected / exposed	0 / 451 (0.00%)	1 / 452 (0.22%)
occurrences all number	0	1
Incision site haemorrhage
subjects affected / exposed	1 / 451 (0.22%)	0 / 452 (0.00%)
occurrences all number	1	0
Joint injury
subjects affected / exposed	1 / 451 (0.22%)	0 / 452 (0.00%)
occurrences all number	1	0
Ligament injury
subjects affected / exposed	1 / 451 (0.22%)	0 / 452 (0.00%)
occurrences all number	1	0
Ligament sprain
subjects affected / exposed	5 / 451 (1.11%)	1 / 452 (0.22%)
occurrences all number	5	1
Limb injury
subjects affected / exposed	2 / 451 (0.44%)	0 / 452 (0.00%)
occurrences all number	2	0
Meniscus injury
subjects affected / exposed	0 / 451 (0.00%)	1 / 452 (0.22%)
occurrences all number	0	1
Muscle injury
subjects affected / exposed	1 / 451 (0.22%)	0 / 452 (0.00%)
occurrences all number	1	0
Muscle strain
subjects affected / exposed	1 / 451 (0.22%)	0 / 452 (0.00%)
occurrences all number	1	0
Post-traumatic pain
subjects affected / exposed	0 / 451 (0.00%)	1 / 452 (0.22%)
occurrences all number	0	1
Road traffic accident
subjects affected / exposed	0 / 451 (0.00%)	1 / 452 (0.22%)
occurrences all number	0	1
Skin abrasion
subjects affected / exposed	0 / 451 (0.00%)	1 / 452 (0.22%)
occurrences all number	0	1
Thermal burn
subjects affected / exposed	0 / 451 (0.00%)	1 / 452 (0.22%)
occurrences all number	0	1
Vaccination complication
subjects affected / exposed	13 / 451 (2.88%)	13 / 452 (2.88%)
occurrences all number	33	29
Procedural haemorrhage
subjects affected / exposed	1 / 451 (0.22%)	0 / 452 (0.00%)
occurrences all number	1	0
Fall
subjects affected / exposed	0 / 451 (0.00%)	1 / 452 (0.22%)
occurrences all number	0	1
Congenital, familial and genetic disorders
Azygos lobe
subjects affected / exposed	0 / 451 (0.00%)	1 / 452 (0.22%)
occurrences all number	0	1
Cardiac disorders
Angina pectoris
subjects affected / exposed	0 / 451 (0.00%)	1 / 452 (0.22%)
occurrences all number	0	1
Atrial fibrillation
subjects affected / exposed	2 / 451 (0.44%)	1 / 452 (0.22%)
occurrences all number	2	1
Atrioventricular block first degree
subjects affected / exposed	0 / 451 (0.00%)	1 / 452 (0.22%)
occurrences all number	0	1
Bradycardia
subjects affected / exposed	1 / 451 (0.22%)	0 / 452 (0.00%)
occurrences all number	1	0
Cardiac failure acute
subjects affected / exposed	1 / 451 (0.22%)	1 / 452 (0.22%)
occurrences all number	1	1
Cardiac failure chronic
subjects affected / exposed	1 / 451 (0.22%)	0 / 452 (0.00%)
occurrences all number	1	0
Cardiac flutter
subjects affected / exposed	1 / 451 (0.22%)	0 / 452 (0.00%)
occurrences all number	1	0
Coronary artery disease
subjects affected / exposed	1 / 451 (0.22%)	0 / 452 (0.00%)
occurrences all number	1	0
Mitral valve disease
subjects affected / exposed	1 / 451 (0.22%)	0 / 452 (0.00%)
occurrences all number	1	0
Myocardial ischaemia
subjects affected / exposed	1 / 451 (0.22%)	0 / 452 (0.00%)
occurrences all number	2	0
Nodal rhythm
subjects affected / exposed	0 / 451 (0.00%)	1 / 452 (0.22%)
occurrences all number	0	1
Palpitations
subjects affected / exposed	2 / 451 (0.44%)	3 / 452 (0.66%)
occurrences all number	2	3
Sinus arrhythmia
subjects affected / exposed	0 / 451 (0.00%)	1 / 452 (0.22%)
occurrences all number	0	1
Sinus bradycardia
subjects affected / exposed	0 / 451 (0.00%)	1 / 452 (0.22%)
occurrences all number	0	1
Sinus tachycardia
subjects affected / exposed	0 / 451 (0.00%)	1 / 452 (0.22%)
occurrences all number	0	1
Ventricular extrasystoles
subjects affected / exposed	1 / 451 (0.22%)	0 / 452 (0.00%)
occurrences all number	1	0
Nervous system disorders
Lumbar radiculopathy
subjects affected / exposed	1 / 451 (0.22%)	0 / 452 (0.00%)
occurrences all number	1	0
Loss of consciousness
subjects affected / exposed	0 / 451 (0.00%)	1 / 452 (0.22%)
occurrences all number	0	1
Intercostal neuralgia
subjects affected / exposed	2 / 451 (0.44%)	0 / 452 (0.00%)
occurrences all number	2	0
Hyposmia
subjects affected / exposed	1 / 451 (0.22%)	0 / 452 (0.00%)
occurrences all number	1	0
Hypoaesthesia
subjects affected / exposed	0 / 451 (0.00%)	1 / 452 (0.22%)
occurrences all number	0	1
Hypersomnia
subjects affected / exposed	0 / 451 (0.00%)	1 / 452 (0.22%)
occurrences all number	0	1
Hypergeusia
subjects affected / exposed	0 / 451 (0.00%)	1 / 452 (0.22%)
occurrences all number	0	1
Hemiparaesthesia
subjects affected / exposed	0 / 451 (0.00%)	1 / 452 (0.22%)
occurrences all number	0	1
Headache
subjects affected / exposed	11 / 451 (2.44%)	13 / 452 (2.88%)
occurrences all number	15	14
Head discomfort
subjects affected / exposed	0 / 451 (0.00%)	1 / 452 (0.22%)
occurrences all number	0	1
Facial paralysis
subjects affected / exposed	0 / 451 (0.00%)	1 / 452 (0.22%)
occurrences all number	0	1
Encephalopathy
subjects affected / exposed	1 / 451 (0.22%)	1 / 452 (0.22%)
occurrences all number	1	1
Dysgeusia
subjects affected / exposed	1 / 451 (0.22%)	2 / 452 (0.44%)
occurrences all number	1	2
Dysaesthesia
subjects affected / exposed	1 / 451 (0.22%)	0 / 452 (0.00%)
occurrences all number	1	0
Dizziness
subjects affected / exposed	1 / 451 (0.22%)	8 / 452 (1.77%)
occurrences all number	1	8
Disturbance in attention
subjects affected / exposed	2 / 451 (0.44%)	1 / 452 (0.22%)
occurrences all number	2	1
Cervicobrachial syndrome
subjects affected / exposed	0 / 451 (0.00%)	1 / 452 (0.22%)
occurrences all number	0	1
Cerebrovascular disorder
subjects affected / exposed	0 / 451 (0.00%)	1 / 452 (0.22%)
occurrences all number	0	1
Cerebral hypoperfusion
subjects affected / exposed	0 / 451 (0.00%)	1 / 452 (0.22%)
occurrences all number	0	1
Cerebral arteriosclerosis
subjects affected / exposed	0 / 451 (0.00%)	1 / 452 (0.22%)
occurrences all number	0	1
Carpal tunnel syndrome
subjects affected / exposed	1 / 451 (0.22%)	0 / 452 (0.00%)
occurrences all number	1	0
Aphasia
subjects affected / exposed	1 / 451 (0.22%)	0 / 452 (0.00%)
occurrences all number	1	0
Apallic syndrome
subjects affected / exposed	1 / 451 (0.22%)	0 / 452 (0.00%)
occurrences all number	1	0
Anosmia
subjects affected / exposed	3 / 451 (0.67%)	8 / 452 (1.77%)
occurrences all number	3	9
Amnesia
subjects affected / exposed	1 / 451 (0.22%)	2 / 452 (0.44%)
occurrences all number	1	2
Ageusia
subjects affected / exposed	2 / 451 (0.44%)	2 / 452 (0.44%)
occurrences all number	2	2
Memory impairment
subjects affected / exposed	1 / 451 (0.22%)	0 / 452 (0.00%)
occurrences all number	2	0
Migraine
subjects affected / exposed	1 / 451 (0.22%)	1 / 452 (0.22%)
occurrences all number	1	1
Neuralgia
subjects affected / exposed	1 / 451 (0.22%)	0 / 452 (0.00%)
occurrences all number	1	0
Paraesthesia
subjects affected / exposed	4 / 451 (0.89%)	0 / 452 (0.00%)
occurrences all number	4	0
Parosmia
subjects affected / exposed	3 / 451 (0.67%)	2 / 452 (0.44%)
occurrences all number	3	2
Restless legs syndrome
subjects affected / exposed	0 / 451 (0.00%)	1 / 452 (0.22%)
occurrences all number	0	1
Syncope
subjects affected / exposed	1 / 451 (0.22%)	1 / 452 (0.22%)
occurrences all number	1	1
Tarsal tunnel syndrome
subjects affected / exposed	1 / 451 (0.22%)	0 / 452 (0.00%)
occurrences all number	1	0
Taste disorder
subjects affected / exposed	1 / 451 (0.22%)	1 / 452 (0.22%)
occurrences all number	1	1
Blood and lymphatic system disorders
Normochromic normocytic anaemia
subjects affected / exposed	1 / 451 (0.22%)	0 / 452 (0.00%)
occurrences all number	1	0
Anaemia
subjects affected / exposed	1 / 451 (0.22%)	1 / 452 (0.22%)
occurrences all number	1	1
Bicytopenia
subjects affected / exposed	1 / 451 (0.22%)	0 / 452 (0.00%)
occurrences all number	1	0
Anaemia of malignant disease
subjects affected / exposed	0 / 451 (0.00%)	1 / 452 (0.22%)
occurrences all number	0	1
Iron deficiency anaemia
subjects affected / exposed	2 / 451 (0.44%)	1 / 452 (0.22%)
occurrences all number	2	1
Nephrogenic anaemia
subjects affected / exposed	0 / 451 (0.00%)	1 / 452 (0.22%)
occurrences all number	0	1
Lymphadenopathy
subjects affected / exposed	1 / 451 (0.22%)	1 / 452 (0.22%)
occurrences all number	1	1
Leukopenia
subjects affected / exposed	1 / 451 (0.22%)	0 / 452 (0.00%)
occurrences all number	1	0
Thrombocytosis
subjects affected / exposed	1 / 451 (0.22%)	0 / 452 (0.00%)
occurrences all number	1	0
Thrombocytopenia
subjects affected / exposed	1 / 451 (0.22%)	1 / 452 (0.22%)
occurrences all number	1	1
Ear and labyrinth disorders
Deafness
subjects affected / exposed	0 / 451 (0.00%)	1 / 452 (0.22%)
occurrences all number	0	1
Ear pain
subjects affected / exposed	0 / 451 (0.00%)	1 / 452 (0.22%)
occurrences all number	0	1
Vertigo
subjects affected / exposed	3 / 451 (0.67%)	1 / 452 (0.22%)
occurrences all number	3	1
Vertigo positional
subjects affected / exposed	1 / 451 (0.22%)	0 / 452 (0.00%)
occurrences all number	1	0
Eye disorders
Cataract
subjects affected / exposed	1 / 451 (0.22%)	0 / 452 (0.00%)
occurrences all number	1	0
Conjunctival haemorrhage
subjects affected / exposed	0 / 451 (0.00%)	1 / 452 (0.22%)
occurrences all number	0	1
Conjunctivitis allergic
subjects affected / exposed	2 / 451 (0.44%)	1 / 452 (0.22%)
occurrences all number	2	1
Diabetic retinal oedema
subjects affected / exposed	0 / 451 (0.00%)	1 / 452 (0.22%)
occurrences all number	0	1
Diabetic retinopathy
subjects affected / exposed	0 / 451 (0.00%)	1 / 452 (0.22%)
occurrences all number	0	1
Diplopia
subjects affected / exposed	0 / 451 (0.00%)	1 / 452 (0.22%)
occurrences all number	0	1
Eyelid oedema
subjects affected / exposed	0 / 451 (0.00%)	1 / 452 (0.22%)
occurrences all number	0	1
Glaucoma
subjects affected / exposed	1 / 451 (0.22%)	0 / 452 (0.00%)
occurrences all number	1	0
Ocular hyperaemia
subjects affected / exposed	0 / 451 (0.00%)	1 / 452 (0.22%)
occurrences all number	0	1
Retinal detachment
subjects affected / exposed	0 / 451 (0.00%)	1 / 452 (0.22%)
occurrences all number	0	1
Visual impairment
subjects affected / exposed	0 / 451 (0.00%)	1 / 452 (0.22%)
occurrences all number	0	1
Conjunctival disorder
subjects affected / exposed	1 / 451 (0.22%)	0 / 452 (0.00%)
occurrences all number	1	0
Gastrointestinal disorders
Abdominal discomfort
subjects affected / exposed	1 / 451 (0.22%)	0 / 452 (0.00%)
occurrences all number	1	0
Abdominal pain
subjects affected / exposed	3 / 451 (0.67%)	2 / 452 (0.44%)
occurrences all number	3	2
Abdominal pain lower
subjects affected / exposed	1 / 451 (0.22%)	1 / 452 (0.22%)
occurrences all number	1	1
Abdominal pain upper
subjects affected / exposed	2 / 451 (0.44%)	2 / 452 (0.44%)
occurrences all number	2	2
Anal fissure
subjects affected / exposed	1 / 451 (0.22%)	0 / 452 (0.00%)
occurrences all number	1	0
Anal pruritus
subjects affected / exposed	0 / 451 (0.00%)	1 / 452 (0.22%)
occurrences all number	0	1
Chronic gastritis
subjects affected / exposed	2 / 451 (0.44%)	2 / 452 (0.44%)
occurrences all number	2	2
Coeliac disease
subjects affected / exposed	1 / 451 (0.22%)	0 / 452 (0.00%)
occurrences all number	1	0
Colitis ulcerative
subjects affected / exposed	0 / 451 (0.00%)	1 / 452 (0.22%)
occurrences all number	0	1
Constipation
subjects affected / exposed	1 / 451 (0.22%)	4 / 452 (0.88%)
occurrences all number	1	4
Diarrhoea
subjects affected / exposed	6 / 451 (1.33%)	11 / 452 (2.43%)
occurrences all number	6	12
Diverticulum intestinal
subjects affected / exposed	1 / 451 (0.22%)	0 / 452 (0.00%)
occurrences all number	1	0
Vomiting
subjects affected / exposed	0 / 451 (0.00%)	1 / 452 (0.22%)
occurrences all number	0	1
Toothache
subjects affected / exposed	2 / 451 (0.44%)	0 / 452 (0.00%)
occurrences all number	2	0
Reflux gastritis
subjects affected / exposed	0 / 451 (0.00%)	1 / 452 (0.22%)
occurrences all number	0	1
Pancreatitis chronic
subjects affected / exposed	0 / 451 (0.00%)	1 / 452 (0.22%)
occurrences all number	0	1
Oesophagitis
subjects affected / exposed	1 / 451 (0.22%)	0 / 452 (0.00%)
occurrences all number	1	0
Oesophageal spasm
subjects affected / exposed	2 / 451 (0.44%)	0 / 452 (0.00%)
occurrences all number	2	0
Nausea
subjects affected / exposed	3 / 451 (0.67%)	5 / 452 (1.11%)
occurrences all number	3	5
Irritable bowel syndrome
subjects affected / exposed	2 / 451 (0.44%)	0 / 452 (0.00%)
occurrences all number	2	0
Intra-abdominal haematoma
subjects affected / exposed	1 / 451 (0.22%)	0 / 452 (0.00%)
occurrences all number	1	0
Hiatus hernia
subjects affected / exposed	1 / 451 (0.22%)	0 / 452 (0.00%)
occurrences all number	1	0
Haemorrhoids
subjects affected / exposed	2 / 451 (0.44%)	1 / 452 (0.22%)
occurrences all number	2	1
Haematochezia
subjects affected / exposed	1 / 451 (0.22%)	0 / 452 (0.00%)
occurrences all number	1	0
Gastrooesophageal reflux disease
subjects affected / exposed	4 / 451 (0.89%)	3 / 452 (0.66%)
occurrences all number	4	3
Gastrointestinal haemorrhage
subjects affected / exposed	0 / 451 (0.00%)	1 / 452 (0.22%)
occurrences all number	0	1
Gastrointestinal disorder
subjects affected / exposed	0 / 451 (0.00%)	1 / 452 (0.22%)
occurrences all number	0	1
Gastritis
subjects affected / exposed	4 / 451 (0.89%)	3 / 452 (0.66%)
occurrences all number	5	3
Functional gastrointestinal disorder
subjects affected / exposed	0 / 451 (0.00%)	1 / 452 (0.22%)
occurrences all number	0	1
Food poisoning
subjects affected / exposed	1 / 451 (0.22%)	0 / 452 (0.00%)
occurrences all number	1	0
Flatulence
subjects affected / exposed	1 / 451 (0.22%)	0 / 452 (0.00%)
occurrences all number	1	0
Duodenitis
subjects affected / exposed	1 / 451 (0.22%)	0 / 452 (0.00%)
occurrences all number	1	0
Diverticulum oesophageal
subjects affected / exposed	1 / 451 (0.22%)	0 / 452 (0.00%)
occurrences all number	1	0
Stomatitis
subjects affected / exposed	1 / 451 (0.22%)	0 / 452 (0.00%)
occurrences all number	1	0
Dyspepsia
subjects affected / exposed	1 / 451 (0.22%)	0 / 452 (0.00%)
occurrences all number	1	0
Glossodynia
subjects affected / exposed	0 / 451 (0.00%)	1 / 452 (0.22%)
occurrences all number	0	1
Inguinal hernia
subjects affected / exposed	1 / 451 (0.22%)	1 / 452 (0.22%)
occurrences all number	1	1
Odynophagia
subjects affected / exposed	0 / 451 (0.00%)	1 / 452 (0.22%)
occurrences all number	0	1
Skin and subcutaneous tissue disorders
Dermatitis allergic
subjects affected / exposed	1 / 451 (0.22%)	0 / 452 (0.00%)
occurrences all number	1	0
Dermatitis
subjects affected / exposed	2 / 451 (0.44%)	0 / 452 (0.00%)
occurrences all number	2	0
Drug eruption
subjects affected / exposed	1 / 451 (0.22%)	0 / 452 (0.00%)
occurrences all number	1	0
Dry skin
subjects affected / exposed	1 / 451 (0.22%)	1 / 452 (0.22%)
occurrences all number	1	1
Eczema
subjects affected / exposed	0 / 451 (0.00%)	1 / 452 (0.22%)
occurrences all number	0	1
Erythema
subjects affected / exposed	1 / 451 (0.22%)	1 / 452 (0.22%)
occurrences all number	1	1
Hyperhidrosis
subjects affected / exposed	0 / 451 (0.00%)	1 / 452 (0.22%)
occurrences all number	0	1
Macule
subjects affected / exposed	0 / 451 (0.00%)	1 / 452 (0.22%)
occurrences all number	0	1
Neurodermatitis
subjects affected / exposed	1 / 451 (0.22%)	0 / 452 (0.00%)
occurrences all number	1	0
Prurigo
subjects affected / exposed	1 / 451 (0.22%)	0 / 452 (0.00%)
occurrences all number	2	0
Pruritus
subjects affected / exposed	4 / 451 (0.89%)	3 / 452 (0.66%)
occurrences all number	4	3
Psoriasis
subjects affected / exposed	1 / 451 (0.22%)	0 / 452 (0.00%)
occurrences all number	1	0
Rash
subjects affected / exposed	4 / 451 (0.89%)	4 / 452 (0.88%)
occurrences all number	4	4
Alopecia
subjects affected / exposed	7 / 451 (1.55%)	5 / 452 (1.11%)
occurrences all number	8	5
Blister
subjects affected / exposed	1 / 451 (0.22%)	1 / 452 (0.22%)
occurrences all number	1	1
Decubitus ulcer
subjects affected / exposed	1 / 451 (0.22%)	1 / 452 (0.22%)
occurrences all number	1	1
Dermatitis contact
subjects affected / exposed	1 / 451 (0.22%)	0 / 452 (0.00%)
occurrences all number	1	0
Rash pruritic
subjects affected / exposed	1 / 451 (0.22%)	0 / 452 (0.00%)
occurrences all number	1	0
Skin ulcer
subjects affected / exposed	0 / 451 (0.00%)	1 / 452 (0.22%)
occurrences all number	0	1
Urticaria
subjects affected / exposed	0 / 451 (0.00%)	1 / 452 (0.22%)
occurrences all number	0	1
Xeroderma
subjects affected / exposed	1 / 451 (0.22%)	0 / 452 (0.00%)
occurrences all number	1	0
Skin reaction
subjects affected / exposed	0 / 451 (0.00%)	1 / 452 (0.22%)
occurrences all number	0	1
Renal and urinary disorders
Acute kidney injury
subjects affected / exposed	2 / 451 (0.44%)	1 / 452 (0.22%)
occurrences all number	2	1
Dysuria
subjects affected / exposed	0 / 451 (0.00%)	1 / 452 (0.22%)
occurrences all number	0	1
Haematuria
subjects affected / exposed	0 / 451 (0.00%)	1 / 452 (0.22%)
occurrences all number	0	1
Oliguria
subjects affected / exposed	1 / 451 (0.22%)	0 / 452 (0.00%)
occurrences all number	1	0
Pollakiuria
subjects affected / exposed	1 / 451 (0.22%)	0 / 452 (0.00%)
occurrences all number	1	0
Endocrine disorders
Goitre
subjects affected / exposed	0 / 451 (0.00%)	1 / 452 (0.22%)
occurrences all number	0	1
Hyperthyroidism
subjects affected / exposed	0 / 451 (0.00%)	1 / 452 (0.22%)
occurrences all number	0	1
Hypothyroidism
subjects affected / exposed	0 / 451 (0.00%)	2 / 452 (0.44%)
occurrences all number	0	2
Thyroid mass
subjects affected / exposed	0 / 451 (0.00%)	1 / 452 (0.22%)
occurrences all number	0	1
Musculoskeletal and connective tissue disorders
Arthralgia
subjects affected / exposed	8 / 451 (1.77%)	9 / 452 (1.99%)
occurrences all number	8	10
Arthritis
subjects affected / exposed	1 / 451 (0.22%)	1 / 452 (0.22%)
occurrences all number	1	1
Arthritis enteropathic
subjects affected / exposed	0 / 451 (0.00%)	1 / 452 (0.22%)
occurrences all number	0	1
Arthropathy
subjects affected / exposed	1 / 451 (0.22%)	0 / 452 (0.00%)
occurrences all number	1	0
Back pain
subjects affected / exposed	10 / 451 (2.22%)	10 / 452 (2.21%)
occurrences all number	10	11
Costochondritis
subjects affected / exposed	1 / 451 (0.22%)	0 / 452 (0.00%)
occurrences all number	1	0
Fibromyalgia
subjects affected / exposed	2 / 451 (0.44%)	0 / 452 (0.00%)
occurrences all number	2	0
Intervertebral disc protrusion
subjects affected / exposed	1 / 451 (0.22%)	2 / 452 (0.44%)
occurrences all number	1	2
Tendonitis
subjects affected / exposed	1 / 451 (0.22%)	0 / 452 (0.00%)
occurrences all number	1	0
Tendon pain
subjects affected / exposed	1 / 451 (0.22%)	0 / 452 (0.00%)
occurrences all number	1	0
Synovitis
subjects affected / exposed	0 / 451 (0.00%)	1 / 452 (0.22%)
occurrences all number	0	1
Spinal osteoarthritis
subjects affected / exposed	1 / 451 (0.22%)	1 / 452 (0.22%)
occurrences all number	1	1
Sjogren's syndrome
subjects affected / exposed	1 / 451 (0.22%)	0 / 452 (0.00%)
occurrences all number	1	0
Rhabdomyolysis
subjects affected / exposed	0 / 451 (0.00%)	1 / 452 (0.22%)
occurrences all number	0	1
Plantar fasciitis
subjects affected / exposed	0 / 451 (0.00%)	1 / 452 (0.22%)
occurrences all number	0	1
Pain in extremity
subjects affected / exposed	3 / 451 (0.67%)	1 / 452 (0.22%)
occurrences all number	4	1
Osteoporosis
subjects affected / exposed	0 / 451 (0.00%)	2 / 452 (0.44%)
occurrences all number	0	2
Osteochondrosis
subjects affected / exposed	0 / 451 (0.00%)	1 / 452 (0.22%)
occurrences all number	0	1
Osteoarthritis
subjects affected / exposed	1 / 451 (0.22%)	3 / 452 (0.66%)
occurrences all number	2	3
Neck pain
subjects affected / exposed	0 / 451 (0.00%)	2 / 452 (0.44%)
occurrences all number	0	2
Myositis
subjects affected / exposed	1 / 451 (0.22%)	0 / 452 (0.00%)
occurrences all number	1	0
Myalgia
subjects affected / exposed	4 / 451 (0.89%)	7 / 452 (1.55%)
occurrences all number	5	7
Musculoskeletal discomfort
subjects affected / exposed	0 / 451 (0.00%)	1 / 452 (0.22%)
occurrences all number	0	1
Musculoskeletal chest pain
subjects affected / exposed	2 / 451 (0.44%)	3 / 452 (0.66%)
occurrences all number	2	3
Muscle spasms
subjects affected / exposed	1 / 451 (0.22%)	2 / 452 (0.44%)
occurrences all number	1	2
Muscle contracture
subjects affected / exposed	0 / 451 (0.00%)	1 / 452 (0.22%)
occurrences all number	0	1
Mastication disorder
subjects affected / exposed	1 / 451 (0.22%)	0 / 452 (0.00%)
occurrences all number	1	0
Joint stiffness
subjects affected / exposed	0 / 451 (0.00%)	1 / 452 (0.22%)
occurrences all number	0	1
Infections and infestations
Gastroenteritis viral
subjects affected / exposed	1 / 451 (0.22%)	0 / 452 (0.00%)
occurrences all number	1	0
Acute sinusitis
subjects affected / exposed	1 / 451 (0.22%)	1 / 452 (0.22%)
occurrences all number	1	2
Asymptomatic COVID-19
subjects affected / exposed	0 / 451 (0.00%)	1 / 452 (0.22%)
occurrences all number	0	1
Bed bug infestation
subjects affected / exposed	0 / 451 (0.00%)	1 / 452 (0.22%)
occurrences all number	0	1
Bronchiolitis
subjects affected / exposed	1 / 451 (0.22%)	0 / 452 (0.00%)
occurrences all number	1	0
Bronchitis
subjects affected / exposed	2 / 451 (0.44%)	1 / 452 (0.22%)
occurrences all number	2	1
Bronchitis bacterial
subjects affected / exposed	1 / 451 (0.22%)	0 / 452 (0.00%)
occurrences all number	1	0
Bronchitis viral
subjects affected / exposed	0 / 451 (0.00%)	2 / 452 (0.44%)
occurrences all number	0	2
COVID-19
subjects affected / exposed	43 / 451 (9.53%)	49 / 452 (10.84%)
occurrences all number	44	49
COVID-19 pneumonia
subjects affected / exposed	12 / 451 (2.66%)	4 / 452 (0.88%)
occurrences all number	12	4
Cellulitis
subjects affected / exposed	0 / 451 (0.00%)	2 / 452 (0.44%)
occurrences all number	0	2
Cervicitis
subjects affected / exposed	0 / 451 (0.00%)	1 / 452 (0.22%)
occurrences all number	0	1
Chlamydial infection
subjects affected / exposed	2 / 451 (0.44%)	0 / 452 (0.00%)
occurrences all number	2	0
Clostridium difficile colitis
subjects affected / exposed	1 / 451 (0.22%)	0 / 452 (0.00%)
occurrences all number	1	0
Conjunctivitis
subjects affected / exposed	1 / 451 (0.22%)	0 / 452 (0.00%)
occurrences all number	1	0
Cystitis
subjects affected / exposed	2 / 451 (0.44%)	2 / 452 (0.44%)
occurrences all number	2	2
Diarrhoea infectious
subjects affected / exposed	0 / 451 (0.00%)	1 / 452 (0.22%)
occurrences all number	0	1
Ear infection
subjects affected / exposed	0 / 451 (0.00%)	1 / 452 (0.22%)
occurrences all number	0	1
Enterobacter pneumonia
subjects affected / exposed	1 / 451 (0.22%)	0 / 452 (0.00%)
occurrences all number	1	0
Epididymitis
subjects affected / exposed	1 / 451 (0.22%)	0 / 452 (0.00%)
occurrences all number	1	0
Fungal skin infection
subjects affected / exposed	0 / 451 (0.00%)	1 / 452 (0.22%)
occurrences all number	0	1
Furuncle
subjects affected / exposed	0 / 451 (0.00%)	1 / 452 (0.22%)
occurrences all number	0	1
Gastroenteritis
subjects affected / exposed	2 / 451 (0.44%)	6 / 452 (1.33%)
occurrences all number	2	6
Gingivitis
subjects affected / exposed	1 / 451 (0.22%)	0 / 452 (0.00%)
occurrences all number	1	0
Sinusitis bacterial
subjects affected / exposed	1 / 451 (0.22%)	1 / 452 (0.22%)
occurrences all number	1	1
Gonorrhoea
subjects affected / exposed	3 / 451 (0.67%)	0 / 452 (0.00%)
occurrences all number	3	0
H3N2 influenza
subjects affected / exposed	0 / 451 (0.00%)	1 / 452 (0.22%)
occurrences all number	0	1
Helicobacter gastritis
subjects affected / exposed	1 / 451 (0.22%)	0 / 452 (0.00%)
occurrences all number	1	0
Helicobacter infection
subjects affected / exposed	2 / 451 (0.44%)	0 / 452 (0.00%)
occurrences all number	2	0
Herpes zoster
subjects affected / exposed	0 / 451 (0.00%)	4 / 452 (0.88%)
occurrences all number	0	4
Influenza
subjects affected / exposed	2 / 451 (0.44%)	4 / 452 (0.88%)
occurrences all number	3	5
Lower respiratory tract infection
subjects affected / exposed	0 / 451 (0.00%)	2 / 452 (0.44%)
occurrences all number	0	2
Mastitis
subjects affected / exposed	1 / 451 (0.22%)	0 / 452 (0.00%)
occurrences all number	1	0
Nasopharyngitis
subjects affected / exposed	8 / 451 (1.77%)	4 / 452 (0.88%)
occurrences all number	10	4
Onychomycosis
subjects affected / exposed	0 / 451 (0.00%)	1 / 452 (0.22%)
occurrences all number	0	1
Otitis externa
subjects affected / exposed	1 / 451 (0.22%)	1 / 452 (0.22%)
occurrences all number	1	2
Otitis media
subjects affected / exposed	1 / 451 (0.22%)	1 / 452 (0.22%)
occurrences all number	1	1
Pharyngitis
subjects affected / exposed	2 / 451 (0.44%)	0 / 452 (0.00%)
occurrences all number	2	0
Pharyngotonsillitis
subjects affected / exposed	2 / 451 (0.44%)	1 / 452 (0.22%)
occurrences all number	3	1
Pneumonia bacterial
subjects affected / exposed	2 / 451 (0.44%)	1 / 452 (0.22%)
occurrences all number	2	1
Post-acute COVID-19 syndrome
subjects affected / exposed	29 / 451 (6.43%)	38 / 452 (8.41%)
occurrences all number	30	39
Pyelonephritis
subjects affected / exposed	1 / 451 (0.22%)	0 / 452 (0.00%)
occurrences all number	1	0
Pyelonephritis chronic
subjects affected / exposed	0 / 451 (0.00%)	1 / 452 (0.22%)
occurrences all number	0	1
Respiratory tract infection
subjects affected / exposed	0 / 451 (0.00%)	1 / 452 (0.22%)
occurrences all number	0	1
Respiratory tract infection viral
subjects affected / exposed	3 / 451 (0.67%)	1 / 452 (0.22%)
occurrences all number	3	1
Gonococcal infection
subjects affected / exposed	0 / 451 (0.00%)	1 / 452 (0.22%)
occurrences all number	0	1
Tinea pedis
subjects affected / exposed	0 / 451 (0.00%)	2 / 452 (0.44%)
occurrences all number	0	2
Tonsillitis
subjects affected / exposed	1 / 451 (0.22%)	2 / 452 (0.44%)
occurrences all number	1	2
Tooth infection
subjects affected / exposed	1 / 451 (0.22%)	0 / 452 (0.00%)
occurrences all number	1	0
Upper respiratory tract infection
subjects affected / exposed	4 / 451 (0.89%)	4 / 452 (0.88%)
occurrences all number	4	4
Upper respiratory tract infection bacterial
subjects affected / exposed	0 / 451 (0.00%)	1 / 452 (0.22%)
occurrences all number	0	1
Urinary tract infection
subjects affected / exposed	9 / 451 (2.00%)	10 / 452 (2.21%)
occurrences all number	11	11
Vaginal infection
subjects affected / exposed	0 / 451 (0.00%)	1 / 452 (0.22%)
occurrences all number	0	1
Vestibular neuronitis
subjects affected / exposed	1 / 451 (0.22%)	0 / 452 (0.00%)
occurrences all number	1	0
Viral infection
subjects affected / exposed	0 / 451 (0.00%)	1 / 452 (0.22%)
occurrences all number	0	1
Viral rhinitis
subjects affected / exposed	1 / 451 (0.22%)	2 / 452 (0.44%)
occurrences all number	1	2
Viral upper respiratory tract infection
subjects affected / exposed	0 / 451 (0.00%)	3 / 452 (0.66%)
occurrences all number	0	3
Vulvovaginal candidiasis
subjects affected / exposed	1 / 451 (0.22%)	1 / 452 (0.22%)
occurrences all number	2	1
Suspected COVID-19
subjects affected / exposed	0 / 451 (0.00%)	1 / 452 (0.22%)
occurrences all number	0	1
Syphilis
subjects affected / exposed	1 / 451 (0.22%)	0 / 452 (0.00%)
occurrences all number	1	0
Sinusitis
subjects affected / exposed	5 / 451 (1.11%)	1 / 452 (0.22%)
occurrences all number	7	1
Pneumonia
subjects affected / exposed	1 / 451 (0.22%)	0 / 452 (0.00%)
occurrences all number	1	0
Periodontitis
subjects affected / exposed	1 / 451 (0.22%)	0 / 452 (0.00%)
occurrences all number	1	0
Oral herpes
subjects affected / exposed	1 / 451 (0.22%)	1 / 452 (0.22%)
occurrences all number	1	1
Genitourinary chlamydia infection
subjects affected / exposed	0 / 451 (0.00%)	1 / 452 (0.22%)
occurrences all number	0	1
Chronic sinusitis
subjects affected / exposed	1 / 451 (0.22%)	0 / 452 (0.00%)
occurrences all number	2	0
Metabolism and nutrition disorders
Glucose tolerance impaired
subjects affected / exposed	1 / 451 (0.22%)	1 / 452 (0.22%)
occurrences all number	1	1
Dyslipidaemia
subjects affected / exposed	5 / 451 (1.11%)	3 / 452 (0.66%)
occurrences all number	5	3
Diabetes mellitus inadequate control
subjects affected / exposed	4 / 451 (0.89%)	7 / 452 (1.55%)
occurrences all number	5	10
Diabetes mellitus
subjects affected / exposed	3 / 451 (0.67%)	2 / 452 (0.44%)
occurrences all number	3	2
Dehydration
subjects affected / exposed	0 / 451 (0.00%)	1 / 452 (0.22%)
occurrences all number	0	1
Gout
subjects affected / exposed	0 / 451 (0.00%)	1 / 452 (0.22%)
occurrences all number	0	1
Hypocalcaemia
subjects affected / exposed	1 / 451 (0.22%)	0 / 452 (0.00%)
occurrences all number	1	0
Hypokalaemia
subjects affected / exposed	1 / 451 (0.22%)	1 / 452 (0.22%)
occurrences all number	1	1
Type 2 diabetes mellitus
subjects affected / exposed	7 / 451 (1.55%)	9 / 452 (1.99%)
occurrences all number	7	9
Vitamin B12 deficiency
subjects affected / exposed	1 / 451 (0.22%)	0 / 452 (0.00%)
occurrences all number	1	0
Vitamin D deficiency
subjects affected / exposed	2 / 451 (0.44%)	1 / 452 (0.22%)
occurrences all number	2	1
Weight gain poor
subjects affected / exposed	1 / 451 (0.22%)	0 / 452 (0.00%)
occurrences all number	1	0
Hypercholesterolaemia
subjects affected / exposed	0 / 451 (0.00%)	1 / 452 (0.22%)
occurrences all number	0	1
Hyperglycaemia
subjects affected / exposed	1 / 451 (0.22%)	0 / 452 (0.00%)
occurrences all number	1	0
Hyperkalaemia
subjects affected / exposed	1 / 451 (0.22%)	1 / 452 (0.22%)
occurrences all number	1	1
Hyperlipidaemia
subjects affected / exposed	0 / 451 (0.00%)	2 / 452 (0.44%)
occurrences all number	0	2
Hypernatraemia
subjects affected / exposed	2 / 451 (0.44%)	0 / 452 (0.00%)
occurrences all number	2	0
Hypertriglyceridaemia
subjects affected / exposed	1 / 451 (0.22%)	0 / 452 (0.00%)
occurrences all number	1	0
Hyperuricaemia
subjects affected / exposed	1 / 451 (0.22%)	0 / 452 (0.00%)
occurrences all number	1	0

More information

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Were there any global substantial amendments to the protocol? Yes

22 Dec 2020

Update to the key secondary objective and associated analysis estimand to include as intercurrent events, participants who are unblinded to be considered for COVID-19 vaccination. Consequential consistency change to Section 9.4.2.1 (Primary Endpoint).

26 Feb 2021

COVID places pregnant women at increased risk of poor outcomes and poor pregnancy outcomes (CDC, 2021). A fetal TCR study showed no binding of AZD7442 mAbs to any fetal tissues tested. Prior experience with antibody therapy against infectious diseases and with other mAbs suggests low risk in pregnancy. Therefore, the exclusion of pregnant or breast feeding women has been removed from the CSP.

10 Mar 2021

Pregnant women and breastfeeding mothers are excluded from the trial (Criterion 16) as there is insufficient data on the drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes or effects of the drug on the breastfed infant, or on milk production. All women of child bearing potential must have a negative pregnancy test result at Visit 1 (Criterion 8b). AstraZeneca acknowledges the risk for severe COVID-19 in pregnant women but would like to establish the risk/benefit profile in adults before including pregnant women in the clinical trial.

31 Mar 2021

Highly efficacious vaccines against SARS-CoV-2 are being deployed on a mass scale in the participating countries, leading to substantially decreasing attack rates for COVID-19 and reduced potential for study enrollment. Therefore, the interim analysis has been removed and the primary analysis adjusted so that it is completed 30 days after the 52nd event has occurred. This period, of 30 days, allows sufficient time for the 52nd event to be monitored, and any other events occurring during this time interval will also be evaluated. Enrollment will stop after the 52nd event has occurred.

21 Apr 2021

Amid a rising number of coronavirus disease 2019 (COVID-19) hospitalizations across the world, leading to a shortage of hospital beds, temporary facilities are being utilized increasingly to manage severe COVID-19 patients who would have usually been treated in a traditional hospital setting. As hospitalizations are an integral component of both the primary and key secondary endpoints in the study, further guidance is provided regarding what constitutes these temporary facility or alternate care sites used for managing participants with severe COVID-19.

05 Jul 2021

Due to regional differences in medical practice for COVID-19, the primary analysis population has been clarified to ensure that the efficacy of AZD7442 for the treatment of COVID-19 is assessed only in non-hospitalized adults.

18 Mar 2022

Cardiovascular & thrombotic events were added as AESIs which are described as potential risks in the latest IB version. A Cardiovascular Event Adjudication Committee was added to provide an independent, external, systematic, and unbiased assessment of de-identified blinded data to systematically evaluate CV events.

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

http://www.ncbi.nlm.nih.gov/pubmed/36411267
http://www.ncbi.nlm.nih.gov/pubmed/35688164

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