Phase III Double-blind, Placebo-controlled Study of AZD7442 for Post- exposure Prophylaxis of COVID-19 in Adults - STORM CHASER

Study identifier:D8850C00003

ClinicalTrials.gov identifier:NCT04625972

EudraCT identifier:2020-004719-28

CTIS identifier:N/A

Study Complete

Official Title

A Phase III Randomized, Double-blind, Placebo-controlled, Multi-center Study in Adults to Determine the Safety and Efficacy of AZD7442, a Combination Product of Two Monoclonal Antibodies (AZD8895 and AZD1061), for Post-exposure Prophylaxis of COVID-19

Medical condition

COVID-19

Phase

Phase 3

Healthy volunteers

Study drug

AZD7442, Placebo

Sex

All

Actual Enrollment

1131

Study type

Interventional

Age

18 Years - 120 Years

Date

Study Start Date: 02 Dec 2020

Primary Completion Date: 07 Apr 2021

Study Completion Date: 25 Jul 2022

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Prevention

Verification:

Verified 01 Nov 2023 by AstraZeneca

Collaborators

IQVIA

Inclusion and exclusion criteria

Inclusion Criteria

1. ≥ 18 years of age at the time of signing the informed consent
2. Adults with potential exposure, within 8 days, to a specific identified individual with laboratory-confirmed SARS-COV-2 infection, symptomatic or asymptomatic
3. Participants must not have had COVID-19 symptoms within 10 days of dosing
4. Negative result from point of care SARS-CoV-2 serology test at screening
5. Contraception used by women of childbearing potential, condom by men
6. Able to understand and comply with study requirements/procedures based on the assessment of the investigator

Exclusion Criteria

1. History of laboratory-confirmed SARS-CoV-2 infection or SARS-CoV-2 seropositivity at screening.
2. History of infection with severe acute respiratory syndrome (SARS) or Middle East respiratory syndrome (MERS).
3. Known history of allergy or reaction to any component of the study drug formulation.
4. Previous hypersensitivity, infusion-related reaction, or severe adverse reaction following administration of a mAb.
5. Any prior receipt of investigational or licensed vaccine or other mAb/biologic indicated for the prevention of SARS-CoV-2 or COVID-19 or expected receipt during the period of study follow up.
6. Clinically significant bleeding disorder or prior history of significant bleeding or bruising following IM injections or venipuncture.
7. Any other significant disease, disorder, or finding that, in the judgement of the investigator, may significantly increase the risk to the participant because of participation in the study, affect the ability of the participant to participate in the study, or impair interpretation of the study data.
8. Receipt of any IMP in the preceding 90 days or expected receipt of IMP during the period of study follow-up, or concurrent participation in another interventional study.
9. Currently pregnant or breast feeding.
10. Blood drawn in excess of a total of 450 mL (1 unit) for any reason within 30 days prior to randomization.
11. Employees of the Sponsor involved in planning, executing, supervising, or reviewing the AZD7442 program, clinical study site staff, or any other individuals involved with the conduct of the study, or immediate family members of such individuals.
12. In nations, states, or other jurisdictions that for legal or ethical reasons bar the enrollment of participants who lack capacity to provide their own informed consent, such subjects are excluded.

Location

Research Site

Modesto, CA, United States, 95350

Location

Research Site

Conyers, GA, United States, 30094

Location

Research Site

San Antonio, TX, United States, 78215

Location

Research Site

Coral Springs, FL, United States, 33071

Location

Research Site

Huntington Beach, CA, United States, 92647

Location

Research Site

Chicago, IL, United States, 60640

Location

Research Site

Chicago, IL, United States, 60607

Location

Research Site

Pembroke Pines, FL, United States, 33024

Arms	Assigned Interventions
Experimental: AZD7442 Participants will be randomized in a 2:1 ratio to receive a single dose (× 2 IM injections) of either 300 mg of AZD7442 (n = approximately 750) or saline placebo (n = approximately 375) on Day 1.	Drug: AZD7442 Single dose (× 2 IM injections) of 300 mg of AZD7442 on Day 1. Other Name: A combination of 2 mAbs (AZD8895 and AZD1061)
Placebo Comparator: Placebo Participants will be randomized in a 2:1 ratio to receive a single dose (× 2 IM injections) of either 300 mg of AZD7442 (n = approximately 750) or saline placebo (n = approximately 375) on Day 1.	Drug: Placebo Single dose (× 2 IM injections) of saline placebo on Day 1.

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Target sample size was 1125. As this was a multi-site study there was a lag on the information of the number of participants recruited, hence we ended up with a population slightly over 1125 (N=1131).

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
AZD7442	Single dose 300 mg IM (AZD8895 and AZD1061)
Placebo	Saline Placebo

Participant Flow: Overall Study

	AZD7442	Placebo
STARTED	756	375
Dosed (Full Analysis Set)	749	372
COMPLETED	624	304
NOT COMPLETED	132	71
Death	3	2
Lost to Follow-up	82	38
Physician Decision	2	0
Protocol Violation	0	1
Withdrawal by Subject	37	24
Not specified elsewhere	8	6

Baseline Characteristics

Analysis Population Description -- Explanation of how the number of participants for analysis was determined.

Full Analysis Set

Reporting Groups

	Description
AZD7442	Single dose 300 mg IM (AZD8895 and AZD1061)
Placebo	Saline Placebo

Baseline Measures

	AZD7442	Placebo	Total
Number of Participants [units: Participants]	749	372	1121
Sex: Female, Male [units: Participants]
Female	375	182	557
Male	374	190	564
Race (NIH/OMB) [units: Participants]
American Indian or Alaska Native	6	1	7
Asian	15	13	28
Black or African American	76	36	112
Multiple	4	4	8
Native Hawaiian or Other Pacific Islander	2	1	3
Not reported	15	3	18
Unknown	3	0	3
White	628	314	942
Ethnicity (NIH/OMB) [units: Participants]
Hispanic or Latino	435	210	645
Not Hispanic or Latino	299	159	458
Not reported	11	1	12
Unknown	4	2	6
Age Continuous [units: Years] Mean ± Standard Deviation	46.62 ± 15.74	45.97 ± 16.20	46.40 ± 15.89
Age, Customized [units: Years] Median ( Inter-Quartile Range )	48.00 (18 to 92)	47.00 (18 to 89)	48.0 (18 to 92)
Any COVID-19 comorbidities at baseline [units: Participants]
Yes	418	210	628
MISSING	331	162	493
Any high risk for severe COVID-19 at baseline [units: Participants]
Yes	486	243	729
MISSING	263	129	392
SARS-CoV-2 status at baseline [units: Participants]
Negative	651	327	978
Positive	34	14	48
MISSING	64	31	95
Baseline BMI (kg/m^2) [units: kg/m^2] Mean ± Standard Deviation	29.60 ± 6.67	29.80 ± 6.68	29.67 ± 6.67
Height [units: cm] Mean ± Standard Deviation	168.43 ± 10.56	168.57 ± 10.32	168.5 ± 10.48

Outcome Measures

1. Primary Outcome Measure: Number of Participants with First Case of SARS-CoV-2 RT-PCR Positive Symptomatic Illness [ Time Frame: Planned to be evaluated through Day 183, however, the number of participants required was achieved 127 days after the study start date ]

Measure Type	Primary
Measure Name	Number of Participants with First Case of SARS-CoV-2 RT-PCR Positive Symptomatic Illness
Measure Description	To estimate the efficacy of a single IM dose of AZD7442 compared to placebo for the prevention of COVID-19
Time Frame	Planned to be evaluated through Day 183, however, the number of participants required was achieved 127 days after the study start date
Safety Issue?

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All randomized participants who received at least one dose of IMP.

Reporting Groups

	Description
AZD7442	Single dose 300 mg IM (AZD8895 and AZD1061)
Placebo	Saline Placebo

Measured Values

	AZD7442	Placebo
Number of Participants Analyzed [units:participants]	749	372
Number of Participants with First Case of SARS-CoV-2 RT-PCR Positive Symptomatic Illness [units: Participants]
Primary Analysis	23	17
Final analysis	28	24

Statistical Analysis 1 for Number of Participants with First Case of SARS-CoV-2 RT-PCR Positive Symptomatic Illness

Groups^[1]	All groups
Method^[3]	Other [Poisson regression]
P-Value^[4]	0.212
Other^[5]	33.31
95% Confidence Interval	( -25.92 to 64.68 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[5]	Other relevant estimation information:
	Primary Analysis Estimates are based on Poisson regression with robust variance. The model includes covariate for treatment and the log of follow-up time as an offset. Estimated RRR greater than 0% provides evidence in favor of AZD7442.

Statistical Analysis 2 for Number of Participants with First Case of SARS-CoV-2 RT-PCR Positive Symptomatic Illness

Groups^[1]	All groups
Method^[3]	Other [Poisson regression]
P-Value^[4]	0.044
Other^[5]	43.28
95% Confidence Interval	( 1.40 to 67.37 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[5]	Other relevant estimation information:
	Final Analysis Estimates are based on Poisson regression with robust variance. The model includes covariate for treatment and the log of follow-up time as an offset. Estimated RRR greater than 0% provides evidence in favor of AZD7442.

2. Primary Outcome Measure: AEs, SAEs, MAAEs, and AESIs post dose of IMP [ Time Frame: 457 Days ]

Measure Type	Primary
Measure Name	AEs, SAEs, MAAEs, and AESIs post dose of IMP
Measure Description
Time Frame	457 Days
Safety Issue?

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

Reporting Groups

	Description
AZD7442	Single dose 300 mg IM (AZD8895 and AZD1061)
Placebo	Saline Placebo

Measured Values

	AZD7442	Placebo
Number of Participants Analyzed [units:participants]	749	372
AEs, SAEs, MAAEs, and AESIs post dose of IMP [units: Participants]
Any Adverse Event	348	193
Non-serious Adverse Event	345	191
Serious Adverse Events	20	16
Medically Attended Adverse Events	95	52
Adverse Events of Special Interest	4	4

No statistical analysis provided for AEs, SAEs, MAAEs, and AESIs post dose of IMP

3. Secondary Outcome Measure: The incidence of SARS-CoV-2 RT-PCR-positive severe or critical symptomatic illness occurring after dosing with IMP [ Time Frame: 183 Days ]

Measure Type	Secondary
Measure Name	The incidence of SARS-CoV-2 RT-PCR-positive severe or critical symptomatic illness occurring after dosing with IMP
Measure Description
Time Frame	183 Days
Safety Issue?

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

Reporting Groups

	Description
AZD7442	Single dose 300 mg IM (AZD8895 and AZD1061)
Placebo	Saline Placebo

Measured Values

	AZD7442	Placebo
Number of Participants Analyzed [units:participants]	749	372
The incidence of SARS-CoV-2 RT-PCR-positive severe or critical symptomatic illness occurring after dosing with IMP [units: Participants]
Primary analysis	0	1
Final Analysis	0	1

Statistical Analysis 1 for The incidence of SARS-CoV-2 RT-PCR-positive severe or critical symptomatic illness occurring after dosing with IMP

Groups^[1]	All groups
Method^[3]	Other [Poisson regression]
P-Value^[4]	0.664
Other^[5]	100
97.5% Confidence Interval	( -1836.98 to --- )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[5]	Other relevant estimation information:
	No text entered.

4. Secondary Outcome Measure: The incidence of participants who have a post-treatment response (negative at baseline to positive at any time post-baseline) for SARSCoV- 2 nucleocapsid antibodies [ Time Frame: 366 Days ]

Measure Type	Secondary
Measure Name	The incidence of participants who have a post-treatment response (negative at baseline to positive at any time post-baseline) for SARSCoV- 2 nucleocapsid antibodies
Measure Description
Time Frame	366 Days
Safety Issue?

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

Reporting Groups

	Description
AZD7442	Single dose 300 mg IM (AZD8895 and AZD1061)
Placebo	Saline Placebo

Measured Values

	AZD7442	Placebo
Number of Participants Analyzed [units:participants]	570	281
The incidence of participants who have a post-treatment response (negative at baseline to positive at any time post-baseline) for SARSCoV- 2 nucleocapsid antibodies [units: Participants]	173	98

Statistical Analysis 1 for The incidence of participants who have a post-treatment response (negative at baseline to positive at any time post-baseline) for SARSCoV- 2 nucleocapsid antibodies

Groups^[1]	All groups
Method^[3]	Other [Poisson regression]
P-Value^[4]	0.163
Other^[5]	13.90
95% Confidence Interval	( -6.23 to 30.21 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[5]	Other relevant estimation information:
	No text entered.

5. Secondary Outcome Measure: The incidence of COVID-19-related death occurring after dosing with IMP [ Time Frame: 366 Days ]

Measure Type	Secondary
Measure Name	The incidence of COVID-19-related death occurring after dosing with IMP
Measure Description
Time Frame	366 Days
Safety Issue?

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

Reporting Groups

	Description
AZD7442	Single dose 300 mg IM (AZD8895 and AZD1061)
Placebo	Saline Placebo

Measured Values

	AZD7442	Placebo
Number of Participants Analyzed [units:participants]	749	372
The incidence of COVID-19-related death occurring after dosing with IMP [units: Participants]	0	0

No statistical analysis provided for The incidence of COVID-19-related death occurring after dosing with IMP

6. Secondary Outcome Measure: The incidence of all-cause mortality occurring after dosing with IMP [ Time Frame: 366 Days ]

Measure Type	Secondary
Measure Name	The incidence of all-cause mortality occurring after dosing with IMP
Measure Description
Time Frame	366 Days
Safety Issue?

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

Reporting Groups

	Description
AZD7442	Single dose 300 mg IM (AZD8895 and AZD1061)
Placebo	Saline Placebo

Measured Values

	AZD7442	Placebo
Number of Participants Analyzed [units:participants]	749	372
The incidence of all-cause mortality occurring after dosing with IMP [units: Participants]	3	2

Statistical Analysis 1 for The incidence of all-cause mortality occurring after dosing with IMP

Groups^[1]	All groups
Method^[3]	Other [Poisson regression]
P-Value^[4]	0.744
Other^[5]	25.75
95% Confidence Interval	( -343.53 to 87.57 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[5]	Other relevant estimation information:
	No text entered.

7. Secondary Outcome Measure: Serum AZD7442 concentrations, PK parameters [ Time Frame: 457 Days ]

Measure Type	Secondary
Measure Name	Serum AZD7442 concentrations, PK parameters
Measure Description
Time Frame	457 Days
Safety Issue?

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Only AZD7442 arm samples have been analysed for PK concentrations. Baseline and Day 457 were not calculated due to lot of missing samples or concentrations < LLOQ

Reporting Groups

	Description
AZD7442	Single dose 300 mg IM (AZD8895 and AZD1061)
Placebo	Saline Placebo

Measured Values

	AZD7442	Placebo
Number of Participants Analyzed [units:participants]	722	0
Serum AZD7442 concentrations, PK parameters [units: µg/mL] Geometric Mean (Geometric Coefficient of Variation)
Day 8	10.028 (110.166%)
Day 29	11.718 (72.721%)
Day 58	9.420 (75.160%)
Day 92	7.183 (81.706%)
Day 183	2.975 (79.694%)
Day 366	0.696 (63.725%)

No statistical analysis provided for Serum AZD7442 concentrations, PK parameters

8. Secondary Outcome Measure: Incidence of ADA to AZD7442 in serum [ Time Frame: 457 Days ]

Measure Type	Secondary
Measure Name	Incidence of ADA to AZD7442 in serum
Measure Description
Time Frame	457 Days
Safety Issue?

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

Reporting Groups

	Description
AZD7442	Single dose 300 mg IM (AZD8895 and AZD1061)
Placebo	Saline Placebo

Measured Values

	AZD7442	Placebo
Number of Participants Analyzed [units:participants]	629	326
Incidence of ADA to AZD7442 in serum [units: Participants]	110	6

No statistical analysis provided for Incidence of ADA to AZD7442 in serum

Serious Adverse Events

Time Frame	15 months
Additional Description	No text entered.

Reporting Groups

	Description
AZD7442	Single dose 300 mg IM (AZD8895 and AZD1061)
Placebo	Saline Placebo

Serious Adverse Events

AZD7442

Placebo

Total, serious adverse events

# participants affected / at risk

20/749 (2.67%)

16/372 (4.30%)

Infections and infestations

Covid-19¹,^†

# participants affected / at risk

1/749 (0.13%)

0/372 (0.00%)

# events

Infections and infestations

Covid-19 pneumonia¹,^†

# participants affected / at risk

0/749 (0.00%)

3/372 (0.81%)

# events

Infections and infestations

Cellulitis¹,^†

# participants affected / at risk

2/749 (0.27%)

0/372 (0.00%)

# events

Cardiac disorders

Acute myocardial infarction¹,^†

# participants affected / at risk

0/749 (0.00%)

1/372 (0.27%)

# events

Infections and infestations

Osteomyelitis¹,^†

# participants affected / at risk

1/749 (0.13%)

0/372 (0.00%)

# events

Infections and infestations

Pneumonia¹,^†

# participants affected / at risk

3/749 (0.40%)

0/372 (0.00%)

# events

Infections and infestations

Pyelonephritis acute¹,^†

# participants affected / at risk

1/749 (0.13%)

0/372 (0.00%)

# events

Cardiac disorders

Cardiac arrest¹,^†

# participants affected / at risk

1/749 (0.13%)

0/372 (0.00%)

# events

Infections and infestations

Urinary tract infection¹,^†

# participants affected / at risk

1/749 (0.13%)

0/372 (0.00%)

# events

Cardiac disorders

Cardiac failure¹,^†

# participants affected / at risk

1/749 (0.13%)

0/372 (0.00%)

# events

Injury, poisoning and procedural complications

Burns second degree¹,^†

# participants affected / at risk

0/749 (0.00%)

1/372 (0.27%)

# events

Injury, poisoning and procedural complications

Lumbar vertebral fracture¹,^†

# participants affected / at risk

1/749 (0.13%)

0/372 (0.00%)

# events

Injury, poisoning and procedural complications

Near drowning¹,^†

# participants affected / at risk

1/749 (0.13%)

0/372 (0.00%)

# events

Injury, poisoning and procedural complications

Overdose¹,^†

# participants affected / at risk

1/749 (0.13%)

0/372 (0.00%)

# events

Injury, poisoning and procedural complications

Subdural haematoma¹,^†

# participants affected / at risk

1/749 (0.13%)

0/372 (0.00%)

# events

Cardiac disorders

Coronary artery disease¹,^†

# participants affected / at risk

0/749 (0.00%)

1/372 (0.27%)

# events

Injury, poisoning and procedural complications

Thermal burn¹,^†

# participants affected / at risk

1/749 (0.13%)

0/372 (0.00%)

# events

Injury, poisoning and procedural complications

Tibia fracture¹,^†

# participants affected / at risk

1/749 (0.13%)

0/372 (0.00%)

# events

Injury, poisoning and procedural complications

Toxicity to various agents¹,^†

# participants affected / at risk

0/749 (0.00%)

1/372 (0.27%)

# events

Cardiac disorders

Myocardial infarction¹,^†

# participants affected / at risk

1/749 (0.13%)

0/372 (0.00%)

# events

Metabolism and nutrition disorders

Diabetic ketoacidosis¹,^†

# participants affected / at risk

0/749 (0.00%)

2/372 (0.54%)

# events

Metabolism and nutrition disorders

Hypoglycaemia¹,^†

# participants affected / at risk

1/749 (0.13%)

1/372 (0.27%)

# events

Congenital, familial and genetic disorders

Trisomy 21¹,^†

# participants affected / at risk

0/749 (0.00%)

1/372 (0.27%)

# events

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Adrenal adenoma¹,^†

# participants affected / at risk

1/749 (0.13%)

0/372 (0.00%)

# events

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Lung cancer metastatic¹,^†

# participants affected / at risk

1/749 (0.13%)

0/372 (0.00%)

# events

Nervous system disorders

Basal ganglia haemorrhage¹,^†

# participants affected / at risk

1/749 (0.13%)

0/372 (0.00%)

# events

Nervous system disorders

Cerebral ischaemia¹,^†

# participants affected / at risk

1/749 (0.13%)

0/372 (0.00%)

# events

Nervous system disorders

Hepatic encephalopathy¹,^†

# participants affected / at risk

1/749 (0.13%)

0/372 (0.00%)

# events

Nervous system disorders

Ischaemic stroke¹,^†

# participants affected / at risk

0/749 (0.00%)

1/372 (0.27%)

# events

Nervous system disorders

Multiple sclerosis¹,^†

# participants affected / at risk

0/749 (0.00%)

1/372 (0.27%)

# events

Nervous system disorders

Syncope¹,^†

# participants affected / at risk

1/749 (0.13%)

0/372 (0.00%)

# events

Pregnancy, puerperium and perinatal conditions

Abortion spontaneous¹,^†

# participants affected / at risk

0/749 (0.00%)

1/372 (0.27%)

# events

Psychiatric disorders

Bipolar i disorder¹,^†

# participants affected / at risk

1/749 (0.13%)

0/372 (0.00%)

# events

Psychiatric disorders

Suicide attempt¹,^†

# participants affected / at risk

1/749 (0.13%)

0/372 (0.00%)

# events

Renal and urinary disorders

Chronic kidney disease¹,^†

# participants affected / at risk

1/749 (0.13%)

0/372 (0.00%)

# events

Renal and urinary disorders

Nephrolithiasis¹,^†

# participants affected / at risk

0/749 (0.00%)

1/372 (0.27%)

# events

Renal and urinary disorders

Renal infarct¹,^†

# participants affected / at risk

0/749 (0.00%)

1/372 (0.27%)

# events

Respiratory, thoracic and mediastinal disorders

Acute respiratory failure¹,^†

# participants affected / at risk

0/749 (0.00%)

1/372 (0.27%)

# events

Respiratory, thoracic and mediastinal disorders

Chronic obstructive pulmonary disease¹,^†

# participants affected / at risk

0/749 (0.00%)

1/372 (0.27%)

# events

Gastrointestinal disorders

Enteritis¹,^†

# participants affected / at risk

1/749 (0.13%)

0/372 (0.00%)

# events

General disorders and administration site conditions

Unevaluable event¹,^†

# participants affected / at risk

0/749 (0.00%)

1/372 (0.27%)

# events

Hepatobiliary disorders

Cholecystitis¹,^†

# participants affected / at risk

1/749 (0.13%)

0/372 (0.00%)

# events

Hepatobiliary disorders

Cholecystitis acute¹,^†

# participants affected / at risk

0/749 (0.00%)

1/372 (0.27%)

# events

†	Events were collected by systematic assessment
1	Term from vocabulary, MedDRA 24.0

Other Adverse Events

Time Frame	15 months
Additional Description	No text entered.

Frequency Threshold

Threshold above which other adverse events are reported	0%

Reporting Groups

	Description
AZD7442	Single dose 300 mg IM (AZD8895 and AZD1061)
Placebo	Saline Placebo

Other Adverse Events

AZD7442

Placebo

Total, other (not including serious) adverse events

# participants affected / at risk

345/749 (46.06%)

191/372 (51.34%)

Blood and lymphatic system disorders

Neutropenia¹,^†

# participants affected / at risk

2/749 (0.27%)

0/372 (0.00%)

# events

Hepatobiliary disorders

Hepatic steatosis¹,^†

# participants affected / at risk

1/749 (0.13%)

0/372 (0.00%)

# events

Hepatobiliary disorders

Hyperbilirubinaemia¹,^†

# participants affected / at risk

1/749 (0.13%)

0/372 (0.00%)

# events

Immune system disorders

Allergy to arthropod sting¹,^†

# participants affected / at risk

1/749 (0.13%)

0/372 (0.00%)

# events

Immune system disorders

Drug hypersensitivity¹,^†

# participants affected / at risk

1/749 (0.13%)

0/372 (0.00%)

# events

Immune system disorders

Hypersensitivity¹,^†

# participants affected / at risk

1/749 (0.13%)

0/372 (0.00%)

# events

Immune system disorders

Mycotic allergy¹,^†

# participants affected / at risk

0/749 (0.00%)

1/372 (0.27%)

# events

Immune system disorders

Seasonal allergy¹,^†

# participants affected / at risk

2/749 (0.27%)

2/372 (0.54%)

# events

Infections and infestations

Abscess¹,^†

# participants affected / at risk

1/749 (0.13%)

0/372 (0.00%)

# events

Infections and infestations

Abscess limb¹,^†

# participants affected / at risk

0/749 (0.00%)

1/372 (0.27%)

# events

Infections and infestations

Acute sinusitis¹,^†

# participants affected / at risk

3/749 (0.40%)

0/372 (0.00%)

# events

Blood and lymphatic system disorders

Normocytic anaemia¹,^†

# participants affected / at risk

1/749 (0.13%)

0/372 (0.00%)

# events

Infections and infestations

Appendicitis¹,^†

# participants affected / at risk

0/749 (0.00%)

1/372 (0.27%)

# events

Infections and infestations

Asymptomatic covid-19¹,^†

# participants affected / at risk

7/749 (0.93%)

5/372 (1.34%)

# events

Infections and infestations

Atypical pneumonia¹,^†

# participants affected / at risk

0/749 (0.00%)

1/372 (0.27%)

# events

Infections and infestations

Bacterial infection¹,^†

# participants affected / at risk

0/749 (0.00%)

1/372 (0.27%)

# events

Infections and infestations

Bacterial vaginosis¹,^†

# participants affected / at risk

1/749 (0.13%)

0/372 (0.00%)

# events

Infections and infestations

Bacterial vulvovaginitis¹,^†

# participants affected / at risk

1/749 (0.13%)

0/372 (0.00%)

# events

Infections and infestations

Bacteriuria¹,^†

# participants affected / at risk

1/749 (0.13%)

0/372 (0.00%)

# events

Infections and infestations

Bronchitis¹,^†

# participants affected / at risk

6/749 (0.80%)

3/372 (0.81%)

# events

Infections and infestations

Covid-19¹,^†

# participants affected / at risk

117/749 (15.62%)

53/372 (14.25%)

# events

125

Blood and lymphatic system disorders

Pancytopenia¹,^†

# participants affected / at risk

1/749 (0.13%)

0/372 (0.00%)

# events

Infections and infestations

Cellulitis¹,^†

# participants affected / at risk

3/749 (0.40%)

1/372 (0.27%)

# events

Infections and infestations

Conjunctivitis¹,^†

# participants affected / at risk

0/749 (0.00%)

1/372 (0.27%)

# events

Infections and infestations

Diarrhoea infectious¹,^†

# participants affected / at risk

0/749 (0.00%)

1/372 (0.27%)

# events

Infections and infestations

Diverticulitis¹,^†

# participants affected / at risk

1/749 (0.13%)

0/372 (0.00%)

# events

Infections and infestations

Ear infection¹,^†

# participants affected / at risk

2/749 (0.27%)

2/372 (0.54%)

# events

Infections and infestations

Epstein-barr virus infection¹,^†

# participants affected / at risk

1/749 (0.13%)

0/372 (0.00%)

# events

Infections and infestations

Eye infection¹,^†

# participants affected / at risk

1/749 (0.13%)

0/372 (0.00%)

# events

Infections and infestations

Fungal skin infection¹,^†

# participants affected / at risk

1/749 (0.13%)

0/372 (0.00%)

# events

Infections and infestations

Furuncle¹,^†

# participants affected / at risk

1/749 (0.13%)

1/372 (0.27%)

# events

Infections and infestations

Gastroenteritis¹,^†

# participants affected / at risk

2/749 (0.27%)

2/372 (0.54%)

# events

Infections and infestations

Gastroenteritis viral¹,^†

# participants affected / at risk

1/749 (0.13%)

0/372 (0.00%)

# events

Infections and infestations

Hand-foot-and-mouth disease¹,^†

# participants affected / at risk

2/749 (0.27%)

0/372 (0.00%)

# events

Infections and infestations

Herpes zoster¹,^†

# participants affected / at risk

1/749 (0.13%)

1/372 (0.27%)

# events

Infections and infestations

Hordeolum¹,^†

# participants affected / at risk

1/749 (0.13%)

0/372 (0.00%)

# events

Infections and infestations

Influenza¹,^†

# participants affected / at risk

1/749 (0.13%)

1/372 (0.27%)

# events

Infections and infestations

Labyrinthitis¹,^†

# participants affected / at risk

0/749 (0.00%)

1/372 (0.27%)

# events

Infections and infestations

Localised infection¹,^†

# participants affected / at risk

0/749 (0.00%)

1/372 (0.27%)

# events

Infections and infestations

Lower respiratory tract infection¹,^†

# participants affected / at risk

1/749 (0.13%)

0/372 (0.00%)

# events

Infections and infestations

Myringitis¹,^†

# participants affected / at risk

0/749 (0.00%)

1/372 (0.27%)

# events

Infections and infestations

Nasopharyngitis¹,^†

# participants affected / at risk

16/749 (2.14%)

4/372 (1.08%)

# events

Cardiac disorders

Angina pectoris¹,^†

# participants affected / at risk

1/749 (0.13%)

0/372 (0.00%)

# events

Infections and infestations

Onychomycosis¹,^†

# participants affected / at risk

1/749 (0.13%)

0/372 (0.00%)

# events

Infections and infestations

Oral herpes¹,^†

# participants affected / at risk

0/749 (0.00%)

1/372 (0.27%)

# events

Infections and infestations

Otitis externa¹,^†

# participants affected / at risk

0/749 (0.00%)

1/372 (0.27%)

# events

Infections and infestations

Otitis media¹,^†

# participants affected / at risk

4/749 (0.53%)

1/372 (0.27%)

# events

Infections and infestations

Periorbital cellulitis¹,^†

# participants affected / at risk

1/749 (0.13%)

0/372 (0.00%)

# events

Infections and infestations

Pharyngitis¹,^†

# participants affected / at risk

2/749 (0.27%)

2/372 (0.54%)

# events

Infections and infestations

Pharyngitis streptococcal¹,^†

# participants affected / at risk

3/749 (0.40%)

2/372 (0.54%)

# events

Infections and infestations

Pilonidal cyst¹,^†

# participants affected / at risk

1/749 (0.13%)

0/372 (0.00%)

# events

Infections and infestations

Pneumonia¹,^†

# participants affected / at risk

0/749 (0.00%)

1/372 (0.27%)

# events

Cardiac disorders

Atrioventricular block complete¹,^†

# participants affected / at risk

1/749 (0.13%)

0/372 (0.00%)

# events

Infections and infestations

Post procedural infection¹,^†

# participants affected / at risk

1/749 (0.13%)

0/372 (0.00%)

# events

Infections and infestations

Pyelonephritis¹,^†

# participants affected / at risk

1/749 (0.13%)

0/372 (0.00%)

# events

Infections and infestations

Respiratory syncytial virus infection¹,^†

# participants affected / at risk

2/749 (0.27%)

0/372 (0.00%)

# events

Infections and infestations

Respiratory tract infection¹,^†

# participants affected / at risk

1/749 (0.13%)

0/372 (0.00%)

# events

Infections and infestations

Rhinitis¹,^†

# participants affected / at risk

1/749 (0.13%)

2/372 (0.54%)

# events

Infections and infestations

Sepsis¹,^†

# participants affected / at risk

1/749 (0.13%)

0/372 (0.00%)

# events

Infections and infestations

Sinusitis¹,^†

# participants affected / at risk

7/749 (0.93%)

4/372 (1.08%)

# events

Infections and infestations

Sinusitis bacterial¹,^†

# participants affected / at risk

0/749 (0.00%)

1/372 (0.27%)

# events

Infections and infestations

Skin infection¹,^†

# participants affected / at risk

0/749 (0.00%)

1/372 (0.27%)

# events

Infections and infestations

Superinfection bacterial¹,^†

# participants affected / at risk

1/749 (0.13%)

0/372 (0.00%)

# events

Infections and infestations

Suspected covid-19¹,^†

# participants affected / at risk

0/749 (0.00%)

1/372 (0.27%)

# events

Infections and infestations

Tonsillitis¹,^†

# participants affected / at risk

2/749 (0.27%)

0/372 (0.00%)

# events

Infections and infestations

Tooth abscess¹,^†

# participants affected / at risk

1/749 (0.13%)

1/372 (0.27%)

# events

Infections and infestations

Tooth infection¹,^†

# participants affected / at risk

1/749 (0.13%)

0/372 (0.00%)

# events

Infections and infestations

Upper respiratory tract infection¹,^†

# participants affected / at risk

14/749 (1.87%)

3/372 (0.81%)

# events

Infections and infestations

Urinary tract infection¹,^†

# participants affected / at risk

22/749 (2.94%)

13/372 (3.49%)

# events

Infections and infestations

Vaginal infection¹,^†

# participants affected / at risk

1/749 (0.13%)

0/372 (0.00%)

# events

Infections and infestations

Viral infection¹,^†

# participants affected / at risk

2/749 (0.27%)

0/372 (0.00%)

# events

Infections and infestations

Wound infection¹,^†

# participants affected / at risk

1/749 (0.13%)

0/372 (0.00%)

# events

Injury, poisoning and procedural complications

Ankle fracture¹,^†

# participants affected / at risk

0/749 (0.00%)

1/372 (0.27%)

# events

Injury, poisoning and procedural complications

Arthropod bite¹,^†

# participants affected / at risk

0/749 (0.00%)

2/372 (0.54%)

# events

Injury, poisoning and procedural complications

Arthropod sting¹,^†

# participants affected / at risk

0/749 (0.00%)

1/372 (0.27%)

# events

Injury, poisoning and procedural complications

Back injury¹,^†

# participants affected / at risk

1/749 (0.13%)

0/372 (0.00%)

# events

Injury, poisoning and procedural complications

Bone contusion¹,^†

# participants affected / at risk

0/749 (0.00%)

1/372 (0.27%)

# events

Injury, poisoning and procedural complications

Concussion¹,^†

# participants affected / at risk

1/749 (0.13%)

0/372 (0.00%)

# events

Injury, poisoning and procedural complications

Contusion¹,^†

# participants affected / at risk

1/749 (0.13%)

3/372 (0.81%)

# events

Injury, poisoning and procedural complications

Exposure to toxic agent¹,^†

# participants affected / at risk

0/749 (0.00%)

1/372 (0.27%)

# events

Injury, poisoning and procedural complications

Face injury¹,^†

# participants affected / at risk

0/749 (0.00%)

1/372 (0.27%)

# events

Cardiac disorders

Cardiac failure chronic¹,^†

# participants affected / at risk

1/749 (0.13%)

0/372 (0.00%)

# events

Injury, poisoning and procedural complications

Fall¹,^†

# participants affected / at risk

5/749 (0.67%)

1/372 (0.27%)

# events

Injury, poisoning and procedural complications

Fibula fracture¹,^†

# participants affected / at risk

0/749 (0.00%)

2/372 (0.54%)

# events

Injury, poisoning and procedural complications

Joint injury¹,^†

# participants affected / at risk

1/749 (0.13%)

0/372 (0.00%)

# events

Injury, poisoning and procedural complications

Ligament rupture¹,^†

# participants affected / at risk

1/749 (0.13%)

0/372 (0.00%)

# events

Injury, poisoning and procedural complications

Ligament sprain¹,^†

# participants affected / at risk

2/749 (0.27%)

2/372 (0.54%)

# events

Injury, poisoning and procedural complications

Meniscus injury¹,^†

# participants affected / at risk

0/749 (0.00%)

1/372 (0.27%)

# events

Injury, poisoning and procedural complications

Muscle strain¹,^†

# participants affected / at risk

1/749 (0.13%)

1/372 (0.27%)

# events

Injury, poisoning and procedural complications

Neck injury¹,^†

# participants affected / at risk

0/749 (0.00%)

1/372 (0.27%)

# events

Cardiac disorders

Chronic left ventricular failure¹,^†

# participants affected / at risk

0/749 (0.00%)

1/372 (0.27%)

# events

Injury, poisoning and procedural complications

Post procedural haematoma¹,^†

# participants affected / at risk

0/749 (0.00%)

1/372 (0.27%)

# events

Injury, poisoning and procedural complications

Post-traumatic pain¹,^†

# participants affected / at risk

1/749 (0.13%)

0/372 (0.00%)

# events

Injury, poisoning and procedural complications

Procedural pain¹,^†

# participants affected / at risk

1/749 (0.13%)

0/372 (0.00%)

# events

Injury, poisoning and procedural complications

Radius fracture¹,^†

# participants affected / at risk

2/749 (0.27%)

0/372 (0.00%)

# events

Injury, poisoning and procedural complications

Rib fracture¹,^†

# participants affected / at risk

1/749 (0.13%)

0/372 (0.00%)

# events

Injury, poisoning and procedural complications

Road traffic accident¹,^†

# participants affected / at risk

1/749 (0.13%)

0/372 (0.00%)

# events

Injury, poisoning and procedural complications

Skin laceration¹,^†

# participants affected / at risk

1/749 (0.13%)

2/372 (0.54%)

# events

Injury, poisoning and procedural complications

Soft tissue injury¹,^†

# participants affected / at risk

1/749 (0.13%)

0/372 (0.00%)

# events

Blood and lymphatic system disorders

Anaemia¹,^†

# participants affected / at risk

5/749 (0.67%)

1/372 (0.27%)

# events

Injury, poisoning and procedural complications

Tendon injury¹,^†

# participants affected / at risk

1/749 (0.13%)

0/372 (0.00%)

# events

Injury, poisoning and procedural complications

Tooth fracture¹,^†

# participants affected / at risk

1/749 (0.13%)

0/372 (0.00%)

# events

Injury, poisoning and procedural complications

Traumatic haemorrhage¹,^†

# participants affected / at risk

1/749 (0.13%)

0/372 (0.00%)

# events

Injury, poisoning and procedural complications

Upper limb fracture¹,^†

# participants affected / at risk

2/749 (0.27%)

0/372 (0.00%)

# events

Injury, poisoning and procedural complications

Vaccination complication¹,^†

# participants affected / at risk

4/749 (0.53%)

5/372 (1.34%)

# events

Investigations

Alanine aminotransferase abnormal¹,^†

# participants affected / at risk

0/749 (0.00%)

1/372 (0.27%)

# events

Investigations

Alanine aminotransferase increased¹,^†

# participants affected / at risk

1/749 (0.13%)

5/372 (1.34%)

# events

Investigations

Aspartate aminotransferase abnormal¹,^†

# participants affected / at risk

0/749 (0.00%)

1/372 (0.27%)

# events

Investigations

Aspartate aminotransferase increased¹,^†

# participants affected / at risk

5/749 (0.67%)

4/372 (1.08%)

# events

Investigations

Blood cholesterol increased¹,^†

# participants affected / at risk

1/749 (0.13%)

0/372 (0.00%)

# events

Investigations

Blood creatine increased¹,^†

# participants affected / at risk

0/749 (0.00%)

1/372 (0.27%)

# events

Investigations

Blood creatine phosphokinase increased¹,^†

# participants affected / at risk

12/749 (1.60%)

4/372 (1.08%)

# events

Investigations

Blood creatinine increased¹,^†

# participants affected / at risk

2/749 (0.27%)

1/372 (0.27%)

# events

Investigations

Blood glucose increased¹,^†

# participants affected / at risk

5/749 (0.67%)

1/372 (0.27%)

# events

Investigations

Blood iron decreased¹,^†

# participants affected / at risk

0/749 (0.00%)

1/372 (0.27%)

# events

Investigations

Blood phosphorus decreased¹,^†

# participants affected / at risk

1/749 (0.13%)

0/372 (0.00%)

# events

Investigations

Blood potassium decreased¹,^†

# participants affected / at risk

0/749 (0.00%)

1/372 (0.27%)

# events

Cardiac disorders

Palpitations¹,^†

# participants affected / at risk

0/749 (0.00%)

1/372 (0.27%)

# events

Investigations

Blood potassium increased¹,^†

# participants affected / at risk

1/749 (0.13%)

0/372 (0.00%)

# events

Investigations

Blood pressure diastolic increased¹,^†

# participants affected / at risk

1/749 (0.13%)

0/372 (0.00%)

# events

Investigations

Blood pressure increased¹,^†

# participants affected / at risk

3/749 (0.40%)

2/372 (0.54%)

# events

Investigations

Blood uric acid increased¹,^†

# participants affected / at risk

0/749 (0.00%)

1/372 (0.27%)

# events

Investigations

Body temperature increased¹,^†

# participants affected / at risk

1/749 (0.13%)

0/372 (0.00%)

# events

Investigations

C-reactive protein increased¹,^†

# participants affected / at risk

9/749 (1.20%)

3/372 (0.81%)

# events

Investigations

Electrocardiogram t wave inversion¹,^†

# participants affected / at risk

0/749 (0.00%)

1/372 (0.27%)

# events

Investigations

Gamma-glutamyltransferase increased¹,^†

# participants affected / at risk

8/749 (1.07%)

4/372 (1.08%)

# events

Investigations

Glomerular filtration rate decreased¹,^†

# participants affected / at risk

2/749 (0.27%)

2/372 (0.54%)

# events

Investigations

Haematocrit decreased¹,^†

# participants affected / at risk

1/749 (0.13%)

1/372 (0.27%)

# events

Cardiac disorders

Sinus tachycardia¹,^†

# participants affected / at risk

0/749 (0.00%)

1/372 (0.27%)

# events

Investigations

Haemoglobin decreased¹,^†

# participants affected / at risk

2/749 (0.27%)

1/372 (0.27%)

# events

Investigations

Hepatic enzyme increased¹,^†

# participants affected / at risk

2/749 (0.27%)

0/372 (0.00%)

# events

Investigations

Influenza a virus test positive¹,^†

# participants affected / at risk

0/749 (0.00%)

1/372 (0.27%)

# events

Investigations

Liver function test abnormal¹,^†

# participants affected / at risk

0/749 (0.00%)

1/372 (0.27%)

# events

Investigations

Liver function test increased¹,^†

# participants affected / at risk

2/749 (0.27%)

0/372 (0.00%)

# events

Investigations

Lymph node palpable¹,^†

# participants affected / at risk

1/749 (0.13%)

0/372 (0.00%)

# events

Investigations

Neutrophil count increased¹,^†

# participants affected / at risk

1/749 (0.13%)

0/372 (0.00%)

# events

Investigations

Platelet count decreased¹,^†

# participants affected / at risk

1/749 (0.13%)

1/372 (0.27%)

# events

Investigations

Red blood cell count decreased¹,^†

# participants affected / at risk

1/749 (0.13%)

1/372 (0.27%)

# events

Investigations

Red blood cells urine¹,^†

# participants affected / at risk

0/749 (0.00%)

1/372 (0.27%)

# events

Cardiac disorders

Tachycardia¹,^†

# participants affected / at risk

0/749 (0.00%)

3/372 (0.81%)

# events

Investigations

Red blood cells urine positive¹,^†

# participants affected / at risk

1/749 (0.13%)

0/372 (0.00%)

# events

Investigations

Urine analysis abnormal¹,^†

# participants affected / at risk

0/749 (0.00%)

1/372 (0.27%)

# events

Investigations

Weight decreased¹,^†

# participants affected / at risk

1/749 (0.13%)

0/372 (0.00%)

# events

Investigations

White blood cell count increased¹,^†

# participants affected / at risk

3/749 (0.40%)

0/372 (0.00%)

# events

Investigations

White blood cells urine positive¹,^†

# participants affected / at risk

4/749 (0.53%)

1/372 (0.27%)

# events

Metabolism and nutrition disorders

Decreased appetite¹,^†

# participants affected / at risk

4/749 (0.53%)

5/372 (1.34%)

# events

Metabolism and nutrition disorders

Dehydration¹,^†

# participants affected / at risk

4/749 (0.53%)

1/372 (0.27%)

# events

Metabolism and nutrition disorders

Diabetes mellitus¹,^†

# participants affected / at risk

3/749 (0.40%)

3/372 (0.81%)

# events

Metabolism and nutrition disorders

Glucose tolerance impaired¹,^†

# participants affected / at risk

0/749 (0.00%)

1/372 (0.27%)

# events

Cardiac disorders

Ventricular hypokinesia¹,^†

# participants affected / at risk

0/749 (0.00%)

1/372 (0.27%)

# events

Metabolism and nutrition disorders

Gout¹,^†

# participants affected / at risk

0/749 (0.00%)

2/372 (0.54%)

# events

Metabolism and nutrition disorders

Hypercholesterolaemia¹,^†

# participants affected / at risk

2/749 (0.27%)

0/372 (0.00%)

# events

Metabolism and nutrition disorders

Hyperglycaemia¹,^†

# participants affected / at risk

3/749 (0.40%)

4/372 (1.08%)

# events

Metabolism and nutrition disorders

Hyperkalaemia¹,^†

# participants affected / at risk

2/749 (0.27%)

2/372 (0.54%)

# events

Metabolism and nutrition disorders

Hyperlipidaemia¹,^†

# participants affected / at risk

1/749 (0.13%)

0/372 (0.00%)

# events

Metabolism and nutrition disorders

Hypoglycaemia¹,^†

# participants affected / at risk

2/749 (0.27%)

2/372 (0.54%)

# events

Metabolism and nutrition disorders

Hypokalaemia¹,^†

# participants affected / at risk

3/749 (0.40%)

1/372 (0.27%)

# events

Metabolism and nutrition disorders

Hypomagnesaemia¹,^†

# participants affected / at risk

0/749 (0.00%)

1/372 (0.27%)

# events

Metabolism and nutrition disorders

Hyponatraemia¹,^†

# participants affected / at risk

1/749 (0.13%)

1/372 (0.27%)

# events

Metabolism and nutrition disorders

Hypophosphataemia¹,^†

# participants affected / at risk

1/749 (0.13%)

2/372 (0.54%)

# events

Metabolism and nutrition disorders

Lactic acidosis¹,^†

# participants affected / at risk

0/749 (0.00%)

1/372 (0.27%)

# events

Metabolism and nutrition disorders

Metabolic acidosis¹,^†

# participants affected / at risk

1/749 (0.13%)

0/372 (0.00%)

# events

Metabolism and nutrition disorders

Type 2 diabetes mellitus¹,^†

# participants affected / at risk

4/749 (0.53%)

2/372 (0.54%)

# events

Metabolism and nutrition disorders

Vitamin b12 deficiency¹,^†

# participants affected / at risk

1/749 (0.13%)

0/372 (0.00%)

# events

Musculoskeletal and connective tissue disorders

Arthralgia¹,^†

# participants affected / at risk

12/749 (1.60%)

2/372 (0.54%)

# events

Musculoskeletal and connective tissue disorders

Arthritis¹,^†

# participants affected / at risk

1/749 (0.13%)

1/372 (0.27%)

# events

Musculoskeletal and connective tissue disorders

Back pain¹,^†

# participants affected / at risk

10/749 (1.34%)

7/372 (1.88%)

# events

Musculoskeletal and connective tissue disorders

Costochondritis¹,^†

# participants affected / at risk

0/749 (0.00%)

1/372 (0.27%)

# events

Musculoskeletal and connective tissue disorders

Exostosis¹,^†

# participants affected / at risk

1/749 (0.13%)

0/372 (0.00%)

# events

Musculoskeletal and connective tissue disorders

Fibromyalgia¹,^†

# participants affected / at risk

2/749 (0.27%)

0/372 (0.00%)

# events

Ear and labyrinth disorders

Cerumen impaction¹,^†

# participants affected / at risk

1/749 (0.13%)

0/372 (0.00%)

# events

Musculoskeletal and connective tissue disorders

Foot deformity¹,^†

# participants affected / at risk

1/749 (0.13%)

0/372 (0.00%)

# events

Musculoskeletal and connective tissue disorders

Intervertebral disc protrusion¹,^†

# participants affected / at risk

0/749 (0.00%)

1/372 (0.27%)

# events

Musculoskeletal and connective tissue disorders

Muscle spasms¹,^†

# participants affected / at risk

4/749 (0.53%)

0/372 (0.00%)

# events

Musculoskeletal and connective tissue disorders

Musculoskeletal stiffness¹,^†

# participants affected / at risk

1/749 (0.13%)

2/372 (0.54%)

# events

Musculoskeletal and connective tissue disorders

Myalgia¹,^†

# participants affected / at risk

25/749 (3.34%)

27/372 (7.26%)

# events

Musculoskeletal and connective tissue disorders

Myositis¹,^†

# participants affected / at risk

0/749 (0.00%)

1/372 (0.27%)

# events

Musculoskeletal and connective tissue disorders

Neck pain¹,^†

# participants affected / at risk

1/749 (0.13%)

2/372 (0.54%)

# events

Musculoskeletal and connective tissue disorders

Osteoarthritis¹,^†

# participants affected / at risk

1/749 (0.13%)

0/372 (0.00%)

# events

Musculoskeletal and connective tissue disorders

Pain in extremity¹,^†

# participants affected / at risk

5/749 (0.67%)

5/372 (1.34%)

# events

Musculoskeletal and connective tissue disorders

Plantar fasciitis¹,^†

# participants affected / at risk

0/749 (0.00%)

1/372 (0.27%)

# events

Ear and labyrinth disorders

Ear pain¹,^†

# participants affected / at risk

3/749 (0.40%)

1/372 (0.27%)

# events

Musculoskeletal and connective tissue disorders

Rhabdomyolysis¹,^†

# participants affected / at risk

2/749 (0.27%)

0/372 (0.00%)

# events

Musculoskeletal and connective tissue disorders

Rheumatoid arthritis¹,^†

# participants affected / at risk

1/749 (0.13%)

0/372 (0.00%)

# events

Musculoskeletal and connective tissue disorders

Rotator cuff syndrome¹,^†

# participants affected / at risk

1/749 (0.13%)

0/372 (0.00%)

# events

Musculoskeletal and connective tissue disorders

Seronegative arthritis¹,^†

# participants affected / at risk

1/749 (0.13%)

0/372 (0.00%)

# events

Musculoskeletal and connective tissue disorders

Spinal osteoarthritis¹,^†

# participants affected / at risk

1/749 (0.13%)

0/372 (0.00%)

# events

Musculoskeletal and connective tissue disorders

Tendonitis¹,^†

# participants affected / at risk

1/749 (0.13%)

0/372 (0.00%)

# events

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Basal cell carcinoma¹,^†

# participants affected / at risk

1/749 (0.13%)

0/372 (0.00%)

# events

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Fibrous histiocytoma¹,^†

# participants affected / at risk

0/749 (0.00%)

1/372 (0.27%)

# events

Ear and labyrinth disorders

Middle ear effusion¹,^†

# participants affected / at risk

1/749 (0.13%)

0/372 (0.00%)

# events

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Skin papilloma¹,^†

# participants affected / at risk

1/749 (0.13%)

0/372 (0.00%)

# events

Nervous system disorders

Ageusia¹,^†

# participants affected / at risk

18/749 (2.40%)

14/372 (3.76%)

# events

Nervous system disorders

Anosmia¹,^†

# participants affected / at risk

18/749 (2.40%)

13/372 (3.49%)

# events

Nervous system disorders

Balance disorder¹,^†

# participants affected / at risk

0/749 (0.00%)

1/372 (0.27%)

# events

Nervous system disorders

Bell's palsy¹,^†

# participants affected / at risk

1/749 (0.13%)

0/372 (0.00%)

# events

Nervous system disorders

Central pain syndrome¹,^†

# participants affected / at risk

0/749 (0.00%)

1/372 (0.27%)

# events

Nervous system disorders

Cerebral small vessel ischaemic disease¹,^†

# participants affected / at risk

1/749 (0.13%)

0/372 (0.00%)

# events

Nervous system disorders

Disturbance in attention¹,^†

# participants affected / at risk

0/749 (0.00%)

1/372 (0.27%)

# events

Blood and lymphatic system disorders

Blood loss anaemia¹,^†

# participants affected / at risk

1/749 (0.13%)

0/372 (0.00%)

# events

Ear and labyrinth disorders

Tympanic membrane disorder¹,^†

# participants affected / at risk

0/749 (0.00%)

1/372 (0.27%)

# events

Nervous system disorders

Dizziness¹,^†

# participants affected / at risk

4/749 (0.53%)

3/372 (0.81%)

# events

Nervous system disorders

Dizziness exertional¹,^†

# participants affected / at risk

1/749 (0.13%)

0/372 (0.00%)

# events

Nervous system disorders

Dysgeusia¹,^†

# participants affected / at risk

1/749 (0.13%)

0/372 (0.00%)

# events

Nervous system disorders

Encephalopathy¹,^†

# participants affected / at risk

0/749 (0.00%)

1/372 (0.27%)

# events

Nervous system disorders

Headache¹,^†

# participants affected / at risk

86/749 (11.48%)

52/372 (13.98%)

# events

109

Nervous system disorders

Hypoaesthesia¹,^†

# participants affected / at risk

0/749 (0.00%)

1/372 (0.27%)

# events

Nervous system disorders

Lacunar infarction¹,^†

# participants affected / at risk

1/749 (0.13%)

0/372 (0.00%)

# events

Nervous system disorders

Lethargy¹,^†

# participants affected / at risk

1/749 (0.13%)

0/372 (0.00%)

# events

Ear and labyrinth disorders

Tympanic membrane hyperaemia¹,^†

# participants affected / at risk

0/749 (0.00%)

1/372 (0.27%)

# events

Nervous system disorders

Migraine¹,^†

# participants affected / at risk

1/749 (0.13%)

0/372 (0.00%)

# events

Nervous system disorders

Neuropathy peripheral¹,^†

# participants affected / at risk

1/749 (0.13%)

1/372 (0.27%)

# events

Nervous system disorders

Paraesthesia¹,^†

# participants affected / at risk

0/749 (0.00%)

1/372 (0.27%)

# events

Nervous system disorders

Presyncope¹,^†

# participants affected / at risk

0/749 (0.00%)

1/372 (0.27%)

# events

Nervous system disorders

Restless legs syndrome¹,^†

# participants affected / at risk

2/749 (0.27%)

0/372 (0.00%)

# events

Nervous system disorders

Sciatica¹,^†

# participants affected / at risk

1/749 (0.13%)

1/372 (0.27%)

# events

Nervous system disorders

Seizure¹,^†

# participants affected / at risk

0/749 (0.00%)

1/372 (0.27%)

# events

Nervous system disorders

Sinus headache¹,^†

# participants affected / at risk

0/749 (0.00%)

1/372 (0.27%)

# events

Nervous system disorders

Somnolence¹,^†

# participants affected / at risk

1/749 (0.13%)

1/372 (0.27%)

# events

Ear and labyrinth disorders

Vertigo¹,^†

# participants affected / at risk

3/749 (0.40%)

2/372 (0.54%)

# events

Nervous system disorders

Syncope¹,^†

# participants affected / at risk

2/749 (0.27%)

2/372 (0.54%)

# events

Nervous system disorders

Tremor¹,^†

# participants affected / at risk

1/749 (0.13%)

0/372 (0.00%)

# events

Psychiatric disorders

Adjustment disorder¹,^†

# participants affected / at risk

1/749 (0.13%)

0/372 (0.00%)

# events

Psychiatric disorders

Adjustment disorder with depressed mood¹,^†

# participants affected / at risk

1/749 (0.13%)

0/372 (0.00%)

# events

Psychiatric disorders

Anxiety¹,^†

# participants affected / at risk

6/749 (0.80%)

2/372 (0.54%)

# events

Psychiatric disorders

Attention deficit hyperactivity disorder¹,^†

# participants affected / at risk

3/749 (0.40%)

0/372 (0.00%)

# events

Psychiatric disorders

Confusional state¹,^†

# participants affected / at risk

1/749 (0.13%)

0/372 (0.00%)

# events

Psychiatric disorders

Depressed mood¹,^†

# participants affected / at risk

2/749 (0.27%)

0/372 (0.00%)

# events

Ear and labyrinth disorders

Vertigo positional¹,^†

# participants affected / at risk

1/749 (0.13%)

0/372 (0.00%)

# events

Psychiatric disorders

Depression¹,^†

# participants affected / at risk

1/749 (0.13%)

4/372 (1.08%)

# events

Psychiatric disorders

Insomnia¹,^†

# participants affected / at risk

2/749 (0.27%)

0/372 (0.00%)

# events

Psychiatric disorders

Panic attack¹,^†

# participants affected / at risk

2/749 (0.27%)

1/372 (0.27%)

# events

Psychiatric disorders

Panic disorder¹,^†

# participants affected / at risk

1/749 (0.13%)

0/372 (0.00%)

# events

Renal and urinary disorders

Acute kidney injury¹,^†

# participants affected / at risk

2/749 (0.27%)

2/372 (0.54%)

# events

Renal and urinary disorders

Dysuria¹,^†

# participants affected / at risk

1/749 (0.13%)

2/372 (0.54%)

# events

Renal and urinary disorders

Glycosuria¹,^†

# participants affected / at risk

1/749 (0.13%)

2/372 (0.54%)

# events

Renal and urinary disorders

Haematuria¹,^†

# participants affected / at risk

3/749 (0.40%)

2/372 (0.54%)

# events

Endocrine disorders

Hyperplasia adrenal¹,^†

# participants affected / at risk

1/749 (0.13%)

0/372 (0.00%)

# events

Renal and urinary disorders

Leukocyturia¹,^†

# participants affected / at risk

1/749 (0.13%)

0/372 (0.00%)

# events

Renal and urinary disorders

Micturition urgency¹,^†

# participants affected / at risk

0/749 (0.00%)

1/372 (0.27%)

# events

Renal and urinary disorders

Nephrolithiasis¹,^†

# participants affected / at risk

1/749 (0.13%)

3/372 (0.81%)

# events

Renal and urinary disorders

Pollakiuria¹,^†

# participants affected / at risk

1/749 (0.13%)

0/372 (0.00%)

# events

Renal and urinary disorders

Proteinuria¹,^†

# participants affected / at risk

5/749 (0.67%)

0/372 (0.00%)

# events

Renal and urinary disorders

Renal cyst¹,^†

# participants affected / at risk

0/749 (0.00%)

1/372 (0.27%)

# events

Renal and urinary disorders

Urethral stenosis¹,^†

# participants affected / at risk

0/749 (0.00%)

1/372 (0.27%)

# events

Renal and urinary disorders

Urinary bladder polyp¹,^†

# participants affected / at risk

0/749 (0.00%)

1/372 (0.27%)

# events

Reproductive system and breast disorders

Benign prostatic hyperplasia¹,^†

# participants affected / at risk

1/749 (0.13%)

0/372 (0.00%)

# events

Endocrine disorders

Hypothyroidism¹,^†

# participants affected / at risk

1/749 (0.13%)

0/372 (0.00%)

# events

Reproductive system and breast disorders

Dysmenorrhoea¹,^†

# participants affected / at risk

1/749 (0.13%)

0/372 (0.00%)

# events

Reproductive system and breast disorders

Heavy menstrual bleeding¹,^†

# participants affected / at risk

1/749 (0.13%)

0/372 (0.00%)

# events

Reproductive system and breast disorders

Menstruation irregular¹,^†

# participants affected / at risk

1/749 (0.13%)

1/372 (0.27%)

# events

Reproductive system and breast disorders

Pelvic congestion¹,^†

# participants affected / at risk

0/749 (0.00%)

1/372 (0.27%)

# events

Reproductive system and breast disorders

Vaginal haemorrhage¹,^†

# participants affected / at risk

1/749 (0.13%)

1/372 (0.27%)

# events

Respiratory, thoracic and mediastinal disorders

Acute respiratory failure¹,^†

# participants affected / at risk

0/749 (0.00%)

1/372 (0.27%)

# events

Respiratory, thoracic and mediastinal disorders

Aphonia¹,^†

# participants affected / at risk

1/749 (0.13%)

0/372 (0.00%)

# events

Respiratory, thoracic and mediastinal disorders

Asthma¹,^†

# participants affected / at risk

1/749 (0.13%)

1/372 (0.27%)

# events

Respiratory, thoracic and mediastinal disorders

Chronic obstructive pulmonary disease¹,^†

# participants affected / at risk

0/749 (0.00%)

1/372 (0.27%)

# events

Respiratory, thoracic and mediastinal disorders

Cough¹,^†

# participants affected / at risk

80/749 (10.68%)

46/372 (12.37%)

# events

Eye disorders

Eye movement disorder¹,^†

# participants affected / at risk

1/749 (0.13%)

0/372 (0.00%)

# events

Respiratory, thoracic and mediastinal disorders

Dyspnoea¹,^†

# participants affected / at risk

29/749 (3.87%)

14/372 (3.76%)

# events

Respiratory, thoracic and mediastinal disorders

Epistaxis¹,^†

# participants affected / at risk

4/749 (0.53%)

1/372 (0.27%)

# events

Respiratory, thoracic and mediastinal disorders

Hypoxia¹,^†

# participants affected / at risk

0/749 (0.00%)

1/372 (0.27%)

# events

Respiratory, thoracic and mediastinal disorders

Nasal congestion¹,^†

# participants affected / at risk

50/749 (6.68%)

34/372 (9.14%)

# events

Respiratory, thoracic and mediastinal disorders

Nasal obstruction¹,^†

# participants affected / at risk

1/749 (0.13%)

0/372 (0.00%)

# events

Respiratory, thoracic and mediastinal disorders

Oropharyngeal pain¹,^†

# participants affected / at risk

59/749 (7.88%)

28/372 (7.53%)

# events

Respiratory, thoracic and mediastinal disorders

Paranasal sinus discomfort¹,^†

# participants affected / at risk

1/749 (0.13%)

0/372 (0.00%)

# events

Respiratory, thoracic and mediastinal disorders

Paranasal sinus inflammation¹,^†

# participants affected / at risk

1/749 (0.13%)

0/372 (0.00%)

# events

Respiratory, thoracic and mediastinal disorders

Pharyngeal erythema¹,^†

# participants affected / at risk

2/749 (0.27%)

2/372 (0.54%)

# events

Respiratory, thoracic and mediastinal disorders

Pharyngeal ulceration¹,^†

# participants affected / at risk

1/749 (0.13%)

0/372 (0.00%)

# events

Eye disorders

Eye pain¹,^†

# participants affected / at risk

1/749 (0.13%)

1/372 (0.27%)

# events

Respiratory, thoracic and mediastinal disorders

Productive cough¹,^†

# participants affected / at risk

1/749 (0.13%)

0/372 (0.00%)

# events

Respiratory, thoracic and mediastinal disorders

Pulmonary congestion¹,^†

# participants affected / at risk

2/749 (0.27%)

2/372 (0.54%)

# events

Respiratory, thoracic and mediastinal disorders

Rales¹,^†

# participants affected / at risk

0/749 (0.00%)

1/372 (0.27%)

# events

Respiratory, thoracic and mediastinal disorders

Respiratory depression¹,^†

# participants affected / at risk

1/749 (0.13%)

0/372 (0.00%)

# events

Respiratory, thoracic and mediastinal disorders

Respiratory disorder¹,^†

# participants affected / at risk

2/749 (0.27%)

1/372 (0.27%)

# events

Respiratory, thoracic and mediastinal disorders

Respiratory failure¹,^†

# participants affected / at risk

1/749 (0.13%)

0/372 (0.00%)

# events

Respiratory, thoracic and mediastinal disorders

Respiratory tract congestion¹,^†

# participants affected / at risk

3/749 (0.40%)

0/372 (0.00%)

# events

Respiratory, thoracic and mediastinal disorders

Rhinitis allergic¹,^†

# participants affected / at risk

3/749 (0.40%)

0/372 (0.00%)

# events

Respiratory, thoracic and mediastinal disorders

Rhinorrhoea¹,^†

# participants affected / at risk

61/749 (8.14%)

27/372 (7.26%)

# events

Respiratory, thoracic and mediastinal disorders

Sinus congestion¹,^†

# participants affected / at risk

13/749 (1.74%)

3/372 (0.81%)

# events

Eye disorders

Eye pruritus¹,^†

# participants affected / at risk

0/749 (0.00%)

1/372 (0.27%)

# events

Respiratory, thoracic and mediastinal disorders

Sinus pain¹,^†

# participants affected / at risk

1/749 (0.13%)

1/372 (0.27%)

# events

Respiratory, thoracic and mediastinal disorders

Sneezing¹,^†

# participants affected / at risk

3/749 (0.40%)

1/372 (0.27%)

# events

Respiratory, thoracic and mediastinal disorders

Throat irritation¹,^†

# participants affected / at risk

0/749 (0.00%)

1/372 (0.27%)

# events

Respiratory, thoracic and mediastinal disorders

Tonsillar hypertrophy¹,^†

# participants affected / at risk

1/749 (0.13%)

1/372 (0.27%)

# events

Respiratory, thoracic and mediastinal disorders

Tonsillar inflammation¹,^†

# participants affected / at risk

1/749 (0.13%)

0/372 (0.00%)

# events

Respiratory, thoracic and mediastinal disorders

Upper respiratory tract congestion¹,^†

# participants affected / at risk

1/749 (0.13%)

0/372 (0.00%)

# events

Respiratory, thoracic and mediastinal disorders

Upper-airway cough syndrome¹,^†

# participants affected / at risk

2/749 (0.27%)

0/372 (0.00%)

# events

Respiratory, thoracic and mediastinal disorders

Wheezing¹,^†

# participants affected / at risk

1/749 (0.13%)

1/372 (0.27%)

# events

Skin and subcutaneous tissue disorders

Alopecia¹,^†

# participants affected / at risk

0/749 (0.00%)

1/372 (0.27%)

# events

Skin and subcutaneous tissue disorders

Blister¹,^†

# participants affected / at risk

1/749 (0.13%)

1/372 (0.27%)

# events

Eye disorders

Eye swelling¹,^†

# participants affected / at risk

0/749 (0.00%)

1/372 (0.27%)

# events

Skin and subcutaneous tissue disorders

Cullen's sign¹,^†

# participants affected / at risk

1/749 (0.13%)

0/372 (0.00%)

# events

Skin and subcutaneous tissue disorders

Dermatitis¹,^†

# participants affected / at risk

0/749 (0.00%)

1/372 (0.27%)

# events

Skin and subcutaneous tissue disorders

Dermatitis allergic¹,^†

# participants affected / at risk

0/749 (0.00%)

1/372 (0.27%)

# events

Skin and subcutaneous tissue disorders

Eczema¹,^†

# participants affected / at risk

1/749 (0.13%)

2/372 (0.54%)

# events

Skin and subcutaneous tissue disorders

Hyperhidrosis¹,^†

# participants affected / at risk

1/749 (0.13%)

1/372 (0.27%)

# events

Skin and subcutaneous tissue disorders

Pruritus¹,^†

# participants affected / at risk

1/749 (0.13%)

4/372 (1.08%)

# events

Skin and subcutaneous tissue disorders

Rash¹,^†

# participants affected / at risk

3/749 (0.40%)

1/372 (0.27%)

# events

Skin and subcutaneous tissue disorders

Rosacea¹,^†

# participants affected / at risk

0/749 (0.00%)

1/372 (0.27%)

# events

Skin and subcutaneous tissue disorders

Urticaria¹,^†

# participants affected / at risk

2/749 (0.27%)

1/372 (0.27%)

# events

Vascular disorders

Accelerated hypertension¹,^†

# participants affected / at risk

0/749 (0.00%)

1/372 (0.27%)

# events

Blood and lymphatic system disorders

Increased tendency to bruise¹,^†

# participants affected / at risk

1/749 (0.13%)

0/372 (0.00%)

# events

Eye disorders

Lacrimation increased¹,^†

# participants affected / at risk

1/749 (0.13%)

0/372 (0.00%)

# events

Vascular disorders

Behcet's syndrome¹,^†

# participants affected / at risk

1/749 (0.13%)

0/372 (0.00%)

# events

Vascular disorders

Deep vein thrombosis¹,^†

# participants affected / at risk

1/749 (0.13%)

0/372 (0.00%)

# events

Vascular disorders

Flushing¹,^†

# participants affected / at risk

0/749 (0.00%)

1/372 (0.27%)

# events

Vascular disorders

Haematoma¹,^†

# participants affected / at risk

0/749 (0.00%)

2/372 (0.54%)

# events

Vascular disorders

Hot flush¹,^†

# participants affected / at risk

1/749 (0.13%)

3/372 (0.81%)

# events

Vascular disorders

Hypertension¹,^†

# participants affected / at risk

11/749 (1.47%)

5/372 (1.34%)

# events

Vascular disorders

Hypotension¹,^†

# participants affected / at risk

2/749 (0.27%)

0/372 (0.00%)

# events

Vascular disorders

Pallor¹,^†

# participants affected / at risk

0/749 (0.00%)

1/372 (0.27%)

# events

Vascular disorders

Thrombophlebitis superficial¹,^†

# participants affected / at risk

0/749 (0.00%)

1/372 (0.27%)

# events

Vascular disorders

Visceral congestion¹,^†

# participants affected / at risk

0/749 (0.00%)

2/372 (0.54%)

# events

Eye disorders

Vision blurred¹,^†

# participants affected / at risk

1/749 (0.13%)

0/372 (0.00%)

# events

Eye disorders

Visual impairment¹,^†

# participants affected / at risk

0/749 (0.00%)

1/372 (0.27%)

# events

Gastrointestinal disorders

Abdominal distension¹,^†

# participants affected / at risk

0/749 (0.00%)

1/372 (0.27%)

# events

Gastrointestinal disorders

Abdominal pain¹,^†

# participants affected / at risk

2/749 (0.27%)

2/372 (0.54%)

# events

Gastrointestinal disorders

Abdominal pain upper¹,^†

# participants affected / at risk

2/749 (0.27%)

2/372 (0.54%)

# events

Gastrointestinal disorders

Chronic gastritis¹,^†

# participants affected / at risk

1/749 (0.13%)

0/372 (0.00%)

# events

Gastrointestinal disorders

Constipation¹,^†

# participants affected / at risk

2/749 (0.27%)

2/372 (0.54%)

# events

Gastrointestinal disorders

Diarrhoea¹,^†

# participants affected / at risk

19/749 (2.54%)

23/372 (6.18%)

# events

Gastrointestinal disorders

Diverticulum¹,^†

# participants affected / at risk

2/749 (0.27%)

0/372 (0.00%)

# events

Blood and lymphatic system disorders

Leukocytosis¹,^†

# participants affected / at risk

2/749 (0.27%)

0/372 (0.00%)

# events

Gastrointestinal disorders

Dyspepsia¹,^†

# participants affected / at risk

4/749 (0.53%)

1/372 (0.27%)

# events

Gastrointestinal disorders

Dysphagia¹,^†

# participants affected / at risk

1/749 (0.13%)

0/372 (0.00%)

# events

Gastrointestinal disorders

Erosive oesophagitis¹,^†

# participants affected / at risk

0/749 (0.00%)

1/372 (0.27%)

# events

Gastrointestinal disorders

Food poisoning¹,^†

# participants affected / at risk

0/749 (0.00%)

1/372 (0.27%)

# events

Gastrointestinal disorders

Gastritis¹,^†

# participants affected / at risk

1/749 (0.13%)

0/372 (0.00%)

# events

Gastrointestinal disorders

Gastrointestinal pain¹,^†

# participants affected / at risk

0/749 (0.00%)

1/372 (0.27%)

# events

Gastrointestinal disorders

Gastrooesophageal reflux disease¹,^†

# participants affected / at risk

2/749 (0.27%)

0/372 (0.00%)

# events

Gastrointestinal disorders

Gingival swelling¹,^†

# participants affected / at risk

1/749 (0.13%)

0/372 (0.00%)

# events

Gastrointestinal disorders

Haemorrhoids¹,^†

# participants affected / at risk

2/749 (0.27%)

0/372 (0.00%)

# events

Blood and lymphatic system disorders

Leukopenia¹,^†

# participants affected / at risk

2/749 (0.27%)

0/372 (0.00%)

# events

Gastrointestinal disorders

Hiatus hernia¹,^†

# participants affected / at risk

1/749 (0.13%)

0/372 (0.00%)

# events

Gastrointestinal disorders

Impaired gastric emptying¹,^†

# participants affected / at risk

0/749 (0.00%)

1/372 (0.27%)

# events

Gastrointestinal disorders

Inguinal hernia¹,^†

# participants affected / at risk

1/749 (0.13%)

0/372 (0.00%)

# events

Gastrointestinal disorders

Large intestine polyp¹,^†

# participants affected / at risk

1/749 (0.13%)

0/372 (0.00%)

# events

Gastrointestinal disorders

Mouth ulceration¹,^†

# participants affected / at risk

1/749 (0.13%)

0/372 (0.00%)

# events

Gastrointestinal disorders

Nausea¹,^†

# participants affected / at risk

22/749 (2.94%)

23/372 (6.18%)

# events

Gastrointestinal disorders

Oesophagitis¹,^†

# participants affected / at risk

1/749 (0.13%)

0/372 (0.00%)

# events

Gastrointestinal disorders

Pancreatitis acute¹,^†

# participants affected / at risk

1/749 (0.13%)

0/372 (0.00%)

# events

Gastrointestinal disorders

Periodontal disease¹,^†

# participants affected / at risk

0/749 (0.00%)

1/372 (0.27%)

# events

Gastrointestinal disorders

Stomach mass¹,^†

# participants affected / at risk

0/749 (0.00%)

1/372 (0.27%)

# events

Blood and lymphatic system disorders

Lymphadenopathy¹,^†

# participants affected / at risk

2/749 (0.27%)

1/372 (0.27%)

# events

Gastrointestinal disorders

Toothache¹,^†

# participants affected / at risk

4/749 (0.53%)

0/372 (0.00%)

# events

Gastrointestinal disorders

Umbilical hernia¹,^†

# participants affected / at risk

0/749 (0.00%)

1/372 (0.27%)

# events

Gastrointestinal disorders

Upper gastrointestinal haemorrhage¹,^†

# participants affected / at risk

1/749 (0.13%)

0/372 (0.00%)

# events

Gastrointestinal disorders

Vomiting¹,^†

# participants affected / at risk

8/749 (1.07%)

7/372 (1.88%)

# events

General disorders and administration site conditions

Asthenia¹,^†

# participants affected / at risk

2/749 (0.27%)

0/372 (0.00%)

# events

General disorders and administration site conditions

Chest discomfort¹,^†

# participants affected / at risk

2/749 (0.27%)

0/372 (0.00%)

# events

General disorders and administration site conditions

Chills¹,^†

# participants affected / at risk

32/749 (4.27%)

23/372 (6.18%)

# events

General disorders and administration site conditions

Drug withdrawal syndrome¹,^†

# participants affected / at risk

0/749 (0.00%)

1/372 (0.27%)

# events

General disorders and administration site conditions

Energy increased¹,^†

# participants affected / at risk

1/749 (0.13%)

0/372 (0.00%)

# events

General disorders and administration site conditions

Fatigue¹,^†

# participants affected / at risk

57/749 (7.61%)

39/372 (10.48%)

# events

Blood and lymphatic system disorders

Lymphocytosis¹,^†

# participants affected / at risk

1/749 (0.13%)

0/372 (0.00%)

# events

General disorders and administration site conditions

Feeling abnormal¹,^†

# participants affected / at risk

1/749 (0.13%)

0/372 (0.00%)

# events

General disorders and administration site conditions

Feeling cold¹,^†

# participants affected / at risk

0/749 (0.00%)

1/372 (0.27%)

# events

General disorders and administration site conditions

Generalised oedema¹,^†

# participants affected / at risk

1/749 (0.13%)

0/372 (0.00%)

# events

General disorders and administration site conditions

Impaired healing¹,^†

# participants affected / at risk

0/749 (0.00%)

1/372 (0.27%)

# events

General disorders and administration site conditions

Influenza like illness¹,^†

# participants affected / at risk

4/749 (0.53%)

2/372 (0.54%)

# events

General disorders and administration site conditions

Injection site pain¹,^†

# participants affected / at risk

3/749 (0.40%)

1/372 (0.27%)

# events

General disorders and administration site conditions

Injection site pruritus¹,^†

# participants affected / at risk

1/749 (0.13%)

2/372 (0.54%)

# events

General disorders and administration site conditions

Injection site reaction¹,^†

# participants affected / at risk

0/749 (0.00%)

1/372 (0.27%)

# events

General disorders and administration site conditions

Localised oedema¹,^†

# participants affected / at risk

0/749 (0.00%)

1/372 (0.27%)

# events

General disorders and administration site conditions

Malaise¹,^†

# participants affected / at risk

7/749 (0.93%)

1/372 (0.27%)

# events

Blood and lymphatic system disorders

Monocytosis¹,^†

# participants affected / at risk

1/749 (0.13%)

0/372 (0.00%)

# events

General disorders and administration site conditions

Non-cardiac chest pain¹,^†

# participants affected / at risk

1/749 (0.13%)

0/372 (0.00%)

# events

General disorders and administration site conditions

Pain¹,^†

# participants affected / at risk

39/749 (5.21%)

35/372 (9.41%)

# events

General disorders and administration site conditions

Pyrexia¹,^†

# participants affected / at risk

46/749 (6.14%)

32/372 (8.60%)

# events

General disorders and administration site conditions

Swelling¹,^†

# participants affected / at risk

0/749 (0.00%)

1/372 (0.27%)

# events

General disorders and administration site conditions

Thirst¹,^†

# participants affected / at risk

0/749 (0.00%)

1/372 (0.27%)

# events

General disorders and administration site conditions

Vaccination site pain¹,^†

# participants affected / at risk

1/749 (0.13%)

2/372 (0.54%)

# events

Hepatobiliary disorders

Cholecystitis¹,^†

# participants affected / at risk

0/749 (0.00%)

1/372 (0.27%)

# events

Hepatobiliary disorders

Gallbladder polyp¹,^†

# participants affected / at risk

0/749 (0.00%)

1/372 (0.27%)

# events

†	Events were collected by systematic assessment
1	Term from vocabulary, MedDRA 24.0

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Results are reported for the Primary analysis conducted during the study.

Results Point of Contact

Name/Title:	Global Clinical Lead
Organization:	AstraZeneca
Phone	1-877-240-9479
E-mail:	[email protected]

Documents available

redacted CSR Synopsis
Download
redacted CSP
Download
redacted SAP
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

information.center@astrazeneca.com

Investigators

Principal Investigator

Myron Levin

AstraZeneca AB

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

redacted CSR Synopsis

redacted CSP

redacted SAP

Trial Results Summaries