Parent Study: Study Understanding Pre-Exposure pRophylaxis of NOvel Anitbodies (SUPERNOVA) Sub-study: Study Understanding Pre-Exposure pRophylaxis of NOvel Anitbodies (SUPERNOVA Sub-study)
Official Title
A Phase I/III Randomized, Double-blind Study to Evaluate the Safety, Efficacy and Neutralizing Activity of AZD5156/AZD3152 for Pre-exposure Prophylaxis of COVID-19 in Participants With Conditions Causing Immune Impairment. Sub-study: Phase II Open Label Sub-study to Evaluate the Safety, PK, and Neutralizing Activity of AZD3152 for Pre-exposure Prophylaxis of COVID-19
Acronym
SUPERNOVA
Organization
AstraZenecaINDUSTRY
Status Module
Record Verification Date
May 2026
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Dec 16, 2022Actual
Primary Completion Date
Mar 29, 2024Actual
Completion Date
Feb 11, 2025Actual
First Submitted Date
Nov 30, 2022
First Submission Date that Met QC Criteria
Dec 12, 2022
First Posted Date
Dec 13, 2022Actual
Results Waived
Not provided
Results First Submitted Date
Sep 25, 2025
Results First Submitted that Met QC Criteria
May 21, 2026
Results First Posted Date
Jun 18, 2026Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Jan 20, 2025
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Jun 18, 2026Actual
Last Update Submitted Date
May 21, 2026
Last Update Posted Date
Jun 18, 2026Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
AstraZenecaINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
AZD3152, a single mAb, is being developed to have broad neutralizing activity across known SARS-CoV-2 variants of concern for pre-exposure prophylaxis of COVID-19.
The aim of the Phase I/III study (Parent Study) will be to evaluate the safety, efficacy and neutralizing activity of AZD3152 compared with comparator for pre exposure prophylaxis of COVID-19, and separately evaluate the safety and PK of AZD5156, a combination of AZD3152 and AZD1061.
Sub-study:
This Phase II sub-study of SUPERNOVA will assess the safety, PK, and predicted neutralizing activity of AZD3152 compared with EVUSHELD for pre-exposure prophylaxis of COVID-19.
Detailed Description
In the Parent study, the Phase I Sentinel Safety Cohort will assess the safety of AZD5156 (a combination of 2 mAbs, AZD1061 [cilgavimab, a component of AZD7442 (EVUSHELD)] and AZD3152) in healthy adults and the Phase III Main Cohort will assess the safety, efficacy, PK, and neutralizing activity of two doses of AZD3152 compared with two doses of comparator given at a 6-month interval in adults and adolescents 12 years of age or older (weighing at least 40 kg) with conditions causing immune impairment, who are less likely to mount an adequate protective immune response after vaccination and thus are at higher risk of developing severe COVID-19 in 18 countries.
Sub-study:
This Phase II sub-study of SUPERNOVA is operating in USA only, and it will assess the safety, PK, and predicted neutralizing activity of AZD3152 in adults 18 years of age or older (weighing at least 40 kg) with conditions causing immune impairment who are less likely to mount an adequate protective immune response after vaccination as well as individuals who are immunocompetent (including healthy participants) with all degrees of SARS-CoV-2 infection risk.
The Sentinel Safety Cohort of the Parent Study will enroll 56 healthy adults, 18 to 55 years of age, who will be randomized to receive AZD5156 (40 participants) or placebo (16 participants). Participants will be randomized to receive study intervention IM either in the gluteal or the anterolateral thigh. Dosing within the Sentinel Safety Cohort will be staggered, with participants allocated sequentially to 4 subcohorts (1a, 1b, 2a, and 2b).
Biological: AZD5156 (Parent study Sentinel Safety Cohort)
The Sentinel Safety Cohort of the Parent study will enroll 56 healthy adults, 18 to 55 years of age, who will be randomized to receive AZD5156 (40 participants) or placebo (16 participants). Participants will be randomized to receive study intervention IM either in the gluteal or the anterolateral thigh. Dosing within the Sentinel Safety Cohort will be staggered, with participants allocated sequentially to 4 subcohorts (1a, 1b, 2a, and 2b).
Biological: Placebo (Parent study Sentinel Safety Cohort)
The Sentinel Safety Cohort of the Parent study will enroll 56 healthy adults, 18 to 55 years of age, who will be randomized to receive AZD5156 (40 participants) or placebo (16 participants). Participants will be randomized to receive study intervention IM either in the gluteal or the anterolateral thigh. Dosing within the Sentinel Safety Cohort will be staggered, with participants allocated sequentially to 4 subcohorts (1a, 1b, 2a, and 2b).
Biological: AZD5156 (Parent study Sentinel Safety Cohort)
Interventions
Name
Type
Description
Arm Group Labels
Other Names
AZD5156 (Parent study Sentinel Safety Cohort)
Biological
600 mg AZD5156 consisting of 300 mg AZD1061 at 100 mg/mL and 300 mg AZD3152 at 150 mg/mL
3 mL of AZD1061 2 mL of AZD3152 IM on Visit 1 Day 1
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
(Main Cohort) Occurrence of AEs Collected Through Approximately 90 Days After Each IMP Administration; SAEs, MAAEs, and AESIs Collected Through Day 451
Primary: (Main Cohort) Occurrence of AEs collected through approximately 90 days after each IMP administration; SAEs, MAAEs, and AESIs collected through Day 451
AEs: through 90 days post each IMP administration; SAEs, MAAEs, and AESIs: through Day 451
(Sub-study) Occurrence of AEs Collected Through 29 Days After IMP Administration. SAEs, MAAEs, and AESIs Collected Through Day 451.
(Sub-study) Occurrence of AEs collected through 29 days after IMP administration. SAEs, MAAEs, and AESIs collected through Day 451 (ie, end of study).
through 29 days post IMP administration (AEs); through Day 451 (SAEs, MAAEs, and AESIs)
(Sub-study) Predicted SARS-CoV-2 nAb Titers Derived From Serum PK and in Vitro IC50 for SARS-CoV-2 Variants BA.2.86 Following AZD3152 Administration and Alpha Variant Following EVUSHELD Administration.
AZD3152 Day 29 predicted nAb titer for BA.2.86 variant = AZD3152 serum PK conc. (ng/mL)/(3.8 ng/mL), where 3.8 ng/mL is AZD3152 BA.2.86 IC50. AZD7442 Day 29 predicted nAb titer for Alpha variant = AZD7442 serum PK conc. (ng/mL)/(2.1 ng/mL), where 2.1 ng/mL is AZD7442 Alpha IC50. This table only shows AZD3152 and AZD7442 concentration at Day 29.
at Day 29
(Sub-study) Predicted SARS-CoV-2 nAb Titers Derived From Serum PK and in Vitro IC50 for SARS-CoV-2 Variants BA.2.86 Following AZD3152 Administration and Alpha Variant Following EVUSHELD Administration.
AZD3152 Day 29 predicted nAb titer for BA.2.86 variant = AZD3152 serum PK conc. (ng/mL)/(3.8 ng/mL), where 3.8 ng/mL is AZD3152 BA.2.86 IC50. AZD7442 Day 29 predicted nAb titer for Alpha variant = AZD7442 serum PK conc. (ng/mL)/(2.1 ng/mL), where 2.1 ng/mL is AZD7442 Alpha IC50. This table shows the predicted nAb titer at Day 29 (please see the previous table for AZD3152 and AZD7442 concentration at Day 29).
Secondary Outcomes
Measure
Description
Time Frame
(Sub-study) AZD3152 and EVUSHELD (ie, AZD7442) Concentrations in Serum, Over Time
Secondary: (Sub-study) AZD3152 and EVUSHELD (ie, AZD7442) concentrations in serum, over time.
Day 29, Day 91, Day 181
(Sub-study) Incidence of ADA to AZD3152 and EVUSHELD
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Parent study - Sentinel Safety Cohort Participants (Phase I):
Parent study - Sentinel Cohort Inclusion Criteria:
Healthy participants according to medical history, physical examination, baseline safety laboratory tests, and screening parameters, according to the judgment of the investigator, with no concomitant disease or concomitant medication (except for medication specifically permitted by the protocol).
Age 18 to 55 years at the time of signing the informed consent.
Negative rapid antigen test at Visit 1.
Weight ≥ 45 kg and ≤ 110 kg at screening.
Parent study - Sentinel Cohort Exclusion Criteria:
Women who are pregnant, lactating, or of childbearing potential and not using a highly effective method of contraception or abstinence from at least 4 weeks prior to study intervention administration and until at least 6 months after study intervention administration.
Known hypersensitivity to any component of the study intervention.
Previous hypersensitivity or severe adverse reaction following administration of a mAb.
Acute (time-limited) or febrile (temperature ≥ 38.0°C [100.4ºF]) illness/infection on day prior to or day of planned dosing; participants excluded for transient acute illness may be dosed if illness resolves within the screening period or may be rescreened once.
Blood drawn in excess of a total of 450 mL (1 unit) for any reason within 30 days prior to Visit 1.
Clinically significant bleeding disorder (eg, factor deficiency, coagulopathy, or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venipuncture.
Receipt of immunoglobulin (non-COVID related) or blood products within 6 months prior to Visit 1.
Previous receipt of a mAb against SARS-CoV-2.
Receipt of a COVID-19 vaccine within 3 months prior to Visit 1.
Receipt of a COVID-19 antiviral for prophylaxis within 3 months prior to Visit 1
COVID-19 within 3 months prior to Visit 1 (confirmed either by laboratory testing or a rapid test [including at home testing]).
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.
Known or suspected congenital or acquired immunodeficiency, or receipt of immunosuppressive therapy, including any course of glucocorticoid therapy exceeding 2 weeks of prednisone or equivalent at a dose of 20 mg daily or every other day within 6 months prior to screening.
Active infection with hepatitis B or C.
Serum creatinine, AST, or ALT above 1.5 × ULN at screening
History of malignancy other than treated non-melanoma skin cancers or locally-treated cervical cancer in previous 5 years.
Parent study - Main Cohort Participants (Phase III):
Parent study - Main Cohort Inclusion Criteria:
Participant must be 12 years of age or older at the time of signing the informed consent.
Negative rapid antigen test prior to dosing at Visit 1.
Weight ≥ 40 kg at screening.
Participants must satisfy at least 1 of the following risk factors at enrollment:
Have solid tumor cancer and be on active immunosuppressive treatment
Have hematologic malignancy
Transplant participants must satisfy at least one of the following:
Have had a solid organ transplant within 2 years and / or
Had a hematopoietic stem cell transplant within 2 years and / or
Who have chronic graft-versus-host disease
Participants who previously had a solid organ transplant or hematopoietic stem cell transplant more than 2 years prior to Visit 1 may also be eligible based on the inclusion criterion for immunosuppressive treatment
Are actively taking immunosuppressive medicines (eg, are using corticosteroids [ie, ≥ 20 mg prednisone or equivalent per day when administered for ≥ 2 weeks], high dose alkylating agents, antimetabolites, transplant-related immunosuppressive drugs, cancer chemotherapeutic agents classified as severely immunosuppressive [eg, Bruton's tyrosine kinase inhibitors], tumor-necrosis blockers, or other immunosuppressive or immunomodulatory biologic agents (eg, for rheumatic diseases)
Received chimeric antigen receptor T cell therapy
Within 1 year of receiving B-cell depleting therapies (eg, rituximab, ocrelizumab, ofatumumab, alemtuzumab)
Have a moderate or severe primary (eg, DiGeorge syndrome) or secondary (eg, hemodialysis) immunodeficiency
Advanced or untreated HIV infection (people with HIV and CD4 cell counts < 200/mm3 within 6 months of Visit 1, history of an AIDS-defining illness without immune reconstitution, or clinical manifestations of symptomatic HIV)
Medically stable defined as disease not requiring significant change in maintenance therapy or hospitalization for worsening disease or any recent CV event (eg, acute myocardial infarction, thromboembolic event) during the 1 month prior to enrollment, with no acute change in condition at the time of study enrollment as judged by the Investigator and no expected changes at the time of the enrollment.
Able to understand and comply with all study requirements/procedures (if applicable, with assistance by caregiver, surrogate, or legally authorized representative or equivalent representative as locally defined), including those at Illness Visits, based on the assessment of the Investigator.
Parent study - Main Cohort Exclusion Criteria:
Women who are pregnant, lactating, or of childbearing potential and not using a highly effective method of contraception or abstinence from at least 4 weeks prior to study intervention administration and until at least 6 months after study intervention administration. Note: female participants aged > 12 years will be considered to be a woman of childbearing potential.
Known hypersensitivity to any component of the study intervention.
Previous hypersensitivity or severe adverse reaction following administration of a mAb.
Acute (time-limited) or febrile (temperature ≥ 38.0°C [100.4ºF]) illness/infection on day prior to or day of planned dosing; participants excluded for transient acute illness may be dosed if illness resolves and may be rescreened for enrollment once.
Blood drawn in excess of a total of 450 mL (1 unit) for any reason within 30 days prior to Visit 1.
Clinically significant bleeding disorder (eg, factor deficiency, coagulopathy, or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venipuncture.
Receipt of IV or SC immunoglobulin within 6 months prior to Visit 1 or expected to receive IV or SC immunoglobulin 6 months after dosing.
Receipt of convalescent COVID-19 plasma treatment within 6 months prior to Visit 1.
Previous receipt of a mAb against SARS-CoV-2 within 6 months prior to Visit 1.
Receipt of a COVID-19 vaccine within 3 months prior to Visit 1.
Receipt of a COVID-19 antiviral for prophylaxis within at least 2 weeks prior to Visit 1.
COVID-19 within 3 months prior to Visit 1 (confirmed either by laboratory testing or a rapid test [including at home testing]).
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 except where the participant ceased IMP treatment >90 days and is in the follow-up period of the study and not expected to receive further IMP).
Healthy, defined according to medical history, physical examination, baseline safety laboratory tests, and screening parameters, according to the judgment of the Investigator.
Participants must be 18 to 55 years at the time of signing the informed consent.
Weight ≥ 45 kg and ≤ 110 kg at screening.
Sub-study - Full Sub-study Cohort Inclusion Criteria:
Immunocompromised or immunocompetent, including healthy participants, with all degrees of SARS-CoV-2 infection risk, will be enrolled following completion of Sentinel Safety Cohort enrolment.
Participants must be 18 years of age or older at the time of signing the informed consent.
Weight ≥ 40 kg at screening.
Sub-study - Sub-study Sentinel Safety Cohort and Full Sub-study Cohort Inclusion Criteria:
Written informed consent and any locally required authorization (eg, HIPAA in the US) obtained from the participant prior to performing any protocol-related procedures, including screening evaluations.
Negative rapid antigen test for SARS-CoV-2 prior to dosing at Visit 1.
Medically stable defined as disease not requiring significant change in maintenance therapy or hospitalization for worsening disease or any recent cardiovascular event (eg, acute myocardial infarction, thromboembolic event) during the 1 month prior to enrollment, with no acute change in condition at the time of study enrollment as judged by the Investigator and no expected changes at the time of the enrollment.
Able to understand and comply with all study requirements/procedures (if applicable, with assistance by caregiver, surrogate, or legally authorized representative or equivalent representative as locally defined), based on the assessment of the Investigator.
Serum creatinine, AST, or ALT above 1.5 × ULN at screening.
History of malignancy other than treated non-melanoma skin cancers or locally-treated cervical cancer in previous 5 years.
Sub-study - Sentinel Safety Cohort and Full Sub-study Cohort Exclusion Criteria:
Receipt of EVUSHELD (AZD7442) within 12 months prior to Visit 1.
Women who are pregnant, lactating, or of childbearing potential and not using a highly effective method of contraception or abstinence from at least 4 weeks prior to study intervention administration and until at least 6 months after study intervention administration. Note: female participants aged > 12 years will be considered to be a woman of childbearing potential.
Known hypersensitivity to any component of the study intervention.
Previous hypersensitivity or severe adverse reaction following administration of a mAb.
Acute (time-limited) or febrile (temperature ≥ 38.0°C [100.4ºF]) illness/infection on day prior to or day of planned dosing; participants excluded for transient acute illness may be dosed if illness resolves and may be rescreened for enrollment once.
Blood drawn in excess of a total of 450 mL (1 unit) for any reason within 30 days prior to Visit 1.
Clinically significant bleeding disorder (eg, factor deficiency, coagulopathy, or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venipuncture.
Has human immunodeficiency virus infection.
Receipt of IV or SC immunoglobulin or blood products within 6 months prior to Visit 1 and expected to receive IV or SC immunoglobulin or blood products 6 months after dosing.
Receipt of a COVID-19 vaccine within 3 months prior to Visit 1.
Receipt of a COVID-19 antiviral for prophylaxis within at least 2 weeks prior to Visit 1.
COVID-19 within 3 months prior to Visit 1 (confirmed either by laboratory RT-PCR testing or a rapid antigen test [including at-home testing]).
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 (except where the participant ceased IMP treatment > 90 days and is in the follow-up period of the study and not expected to receive further IMP).
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.
All request will be evaluated as per the AZ disclosure commitment:
When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Overall 3713 participants were screened in the Main Study; 87 screened for the Sentinel Cohort; 576 participants were screened in the Sub-study.
Recruitment Details
In Main Cohort, 3348 participants 12 years of age or older were randomized 1:1 to receive AZD3152 or comparator. In Sentinel Cohort, 57 participants were randomized 5:2 to receive AZD5156 (41 participants) or Placebo (16 participants). In Sub-study, 476 participants, 18 years of age or older, were randomized 2:1 to receive AZD3152 or AZD7442.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
AZD3152 - Main Cohort
Planned treatment assignments are AZD3152 300mg IM at Day 1 and AZD3152 300mg IM at Day 181.
FG001
AZD7442 - Main Cohort
Planned treatment assignments are AZD7442 600mg IM on Day 1 and placebo on Day 181.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
2
More Info Module
Limitations and Caveats
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Jun 14, 2023
Dec 15, 2025
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Argentina
China
Mexico
South Africa
Turkey (Türkiye)
Submission Tracking
Estimated Results First Submitted Date
Not provided
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
D7000C00001 is a Phase I/III study (Parent study) being conducted in conjunction with a Phase II sub study that will be conducted in approximately 3706 participants (approximately 3256 in the Parent study and 450 in the sub study) to evaluate the safety, efficacy, PK, and neutralizing activity of AZD3152 compared with comparator for pre exposure prophylaxis of COVID-19, and separately evaluate the safety and PK of AZD5156, a combination of AZD3152 and AZD1061.
The Parent study will consist of 2 cohorts: a Sentinel Safety Cohort and a Main Cohort. The Sentinel Safety Cohort will compare AZD5156 with placebo, while the Main Cohort will compare AZD3152 with placebo.
The sub-study will have an initial Sentinel Safety Cohort that will include 12 healthy volunteers; all other participants in the study will be either immunocompromised or immunocompetent with all degrees of SARS-CoV-2 infection risk. Participants will be randomized 2:1 to receive AZD3152 or AZD7442 (EVUSHELD).
Primary Purpose
Prevention
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Quadruple
Masking Description
For the Sentinel Safety Cohort and Main Cohort, neither the participant nor any of the Investigators or Sponsor staff who are involved in the treatment or clinical evaluation and monitoring of the participants will be aware of the study intervention received. Since AZD5156, AZD3152, and placebo are visually distinct prior to dose preparation (due to differences in vial volumes and container closure), study intervention will be handled by an unblinded pharmacist and administered by an unblinded administrator (or designee, in accordance with local and institutional regulations) at the study site who will be independent of safety evaluations and other trial evaluations. Personnel preparing and administering study intervention may be the same individual. Syringe masking will be required in order to maintain the blind.
The Sentinel Safety Cohort of the Parent study will enroll 56 healthy adults, 18 to 55 years of age, who will be randomized to receive AZD5156 (40 participants) or placebo (16 participants). Participants will be randomized to receive study intervention IM either in the gluteal or the anterolateral thigh. Dosing within the Sentinel Safety Cohort will be staggered, with participants allocated sequentially to 4 subcohorts (1a, 1b, 2a, and 2b).
Biological: Placebo (Parent study Sentinel Safety Cohort)
Parent study Sentinel Safety Cohort - Subcohort 2a Gluteal- AZD5156
Experimental
The Sentinel Safety Cohort of the Parent study will enroll 56 healthy adults, 18 to 55 years of age, who will be randomized to receive AZD5156 (40 participants) or placebo (16 participants). Participants will be randomized to receive study intervention IM either in the gluteal or the anterolateral thigh. Dosing within the Sentinel Safety Cohort will be staggered, with participants allocated sequentially to 4 subcohorts (1a, 1b, 2a, and 2b).
Biological: AZD5156 (Parent study Sentinel Safety Cohort)
The Sentinel Safety Cohort of the Parent study will enroll 56 healthy adults, 18 to 55 years of age, who will be randomized to receive AZD5156 (40 participants) or placebo (16 participants). Participants will be randomized to receive study intervention IM either in the gluteal or the anterolateral thigh. Dosing within the Sentinel Safety Cohort will be staggered, with participants allocated sequentially to 4 subcohorts (1a, 1b, 2a, and 2b).
Biological: Placebo (Parent study Sentinel Safety Cohort)
The Sentinel Safety Cohort of the Parent study will enroll 56 healthy adults, 18 to 55 years of age, who will be randomized to receive AZD5156 (40 participants) or placebo (16 participants). Participants will be randomized to receive study intervention IM either in the gluteal or the anterolateral thigh. Dosing within the Sentinel Safety Cohort will be staggered, with participants allocated sequentially to 4 subcohorts (1a, 1b, 2a, and 2b).
Biological: AZD5156 (Parent study Sentinel Safety Cohort)
The Sentinel Safety Cohort of the Parent study will enroll 56 healthy adults, 18 to 55 years of age, who will be randomized to receive AZD5156 (40 participants) or placebo (16 participants). Participants will be randomized to receive study intervention IM either in the gluteal or the anterolateral thigh. Dosing within the Sentinel Safety Cohort will be staggered, with participants allocated sequentially to 4 subcohorts (1a, 1b, 2a, and 2b).
Biological: Placebo (Parent study Sentinel Safety Cohort)
Parent study Main Cohort - AZD3152
Experimental
The Main Cohort of the Parent study will enroll approximately 3200 participants. Dosing in the Main Cohort will be staggered, so that it starts with adult participants aged 18 years and older, with no adolescent participants dosed in the Main Cohort until safety data from Visit 2a (Day 8) and Visit 2b (Day 15) have been reviewed by the DSMB for at least 80 adult Main Cohort participants (which will include at least 40 participants who have received AZD3152). Participants in the Main Cohort will be randomized 1:1 to receive AZD3152 300 mg or comparator administered IM in the anterolateral thigh on Day 1. Participants will receive a second dose of their original randomized study intervention (ie, active treatment or comparator) 6 months after Visit 1.
Biological: Placebo (Parent study Sentinel Safety Cohort)
Biological: AZD3152 (Parent study Main Cohort)
Parent study Main Cohort - EVUSHELD™
Active Comparator
Participants in the Main Cohort of the Parent study will be randomized 1:1 to receive AZD3152 300 mg or comparator administered IM in the anterolateral thigh on Day 1. Participants will receive a second dose of their original randomized study intervention (ie, active treatment or comparator) 6 months after Visit 1.
At the request of regulatory authorities the active comparator will be changed to placebo. As the comparator is given on two occasions, this means that a participant randomized to the comparator arm may receive (a) two doses of EVUSHELD, (b) a dose of EVUSHELD and a dose of placebo, or (c) two doses of placebo.
Biological: EVUSHELD™ (Parent study Main Cohort)
Parent study Main Cohort - Placebo
Placebo Comparator
Participants in the Main Cohort of the Parent study will be randomized 1:1 to receive AZD3152 300 mg or comparator administered IM in the anterolateral thigh on Day 1. Participants will receive a second dose of their original randomized study intervention (ie, active treatment or comparator) 6 months after Visit 1.
At the request of regulatory authorities the active comparator will be changed to placebo. As the comparator is given on two occasions, this means that a participant randomized to the comparator arm may receive (a) two doses of EVUSHELD, (b) a dose of EVUSHELD and a dose of placebo, or (c) two doses of placebo.
Biological: Placebo (Parent study Main Cohort)
Sub-study - AZD3152
Experimental
This sub-study will enroll approximately 450 participants, ≥ 18 years of age with a minimum weight of 40 kg. An initial Sentinel Safety Cohort will include 12 healthy volunteers; all other participants in the study will be either immunocompromised or immunocompetent (including healthy participants) with all degrees of SARS-CoV-2 infection risk.
Biological: AZD3152 (Sub-study)
Sub-study - AZD7442 (EVUSHELD™)
Active Comparator
This sub-study will enroll approximately 450 participants, ≥ 18 years of age with a minimum weight of 40 kg. An initial Sentinel Safety Cohort will include 12 healthy volunteers; all other participants in the study will be either immunocompromised or immunocompetent (including healthy participants) with all degrees of SARS-CoV-2 infection risk.
Biological: AZD7442 - EVUSHELD™ (Sub-study)
Sub-study - AZD7442 (EVUSHELD™) Immunocompromised participants offered AZD3152 1200mg IV
Experimental
This sub-study will enroll approximately 450 participants, ≥ 18 years of age with a minimum weight of 40 kg. An initial Sentinel Safety Cohort will include 12 healthy volunteers; all other participants in the study will be either immunocompromised or immunocompetent (including healthy participants) with all degrees of SARS-CoV-2 infection risk.
Sub-study - AZD7442 (EVUSHELD™) Immunocompromised participants offered AZD3152 1200mg IV
at Day 29
(Main Cohort) Confirmed Symptomatic COVID-19 Case
(Main Cohort) Confirmed symptomatic COVID-19 case at Primary Analysis.
at Primary Analysis: average follow-up time of 170 days
(Main Cohort) Confirmed Symptomatic COVID-19 Case Attributable to Matched Variants
(Main Cohort) Confirmed symptomatic COVID-19 case attributable to matched variants at Primary Analysis.
at Primary Analysis: average follow-up time of 170 days
(Sentinel Cohort) Occurrence of AEs, SAEs, MAAEs, and AESIs Collected Through Day 461
Primary: (Sentinel Cohort) Occurrence of AEs, SAEs, MAAEs, and AESIs collected through Day 461
through Day 461
AZD3152 recipients were tested for ADA to AZD3152; EVUSHELD recipients were tested for ADA to EVUSHELD.
through Day 181
(Sub-study) Cilgavimab and Tixagevimab Concentrations in Serum, Over Time
AZD7442 (ie EVUSHELD) is composed of cilgavimab and tixagevimab. This summary is only applicable to AZD7442 group.
Day 29, Day 91, Day 181
(Sub-study) ADA Titers
ADA titers were only available for ADA positive samples.
Day 1, Day 29, Day 91, Day 181
(Main Cohort) Symptomatic COVID-19 Case (Negative RT-PCR at Baseline to Positive at Any Time up 12 Months With All Observed Events at Final Readout) Caused by Any SARS-CoV-2 Matched Variant
(Main Cohort) Symptomatic COVID-19 case (negative RT-PCR at baseline to positive at any time up 12 months with all observed events at final readout) caused by any SARS-CoV-2 matched variant. First secondary endpoint to be tested in hierarchical testing after dual-primary endpoint efficacy was demonstrated in hierarchical testing
through Day 361
(Main Cohort) Symptomatic COVID-19 Case (Negative RT-PCR at Baseline to Positive at Any Time up to 12 Months With All Observed Events at Final Readout) Caused by Any SARS-CoV-2 Variants
Secondary: (Main Cohort) Symptomatic COVID-19 case (negative RT-PCR at baseline to positive at any time up to 12 months with all observed events at final readout) caused by any SARS-CoV-2 variants. Second secondary endpoint to be tested in hierarchical testing after dual-primary endpoint efficacy was demonstrated in hierarchical testing
through Day 361
(Main Cohort) Severe COVID-19 Caused by Any SARS-CoV-2 Variant Any Time up to 12 Months
third secondary endpoint to be tested in hierarchical testing after dual-primary endpoint efficacy was demonstrated in hierarchical testing
through Day 361
(Main Cohort) Severe COVID-19 Caused by Any SARS-CoV-2 Matched Variants at Any Time up to 12 Months
Secondary: (Main Cohort) Severe COVID-19 caused by any SARS-CoV-2 matched variants at any time up to 12 months through Day 361.
through Day 361
(Main Cohort) Composite of COVID-19-related Hospitalization and/or COVID-19-related Death (WHO COVID-19 Clinical Progression Scale Score ≥ 4) Any Time up to 12 Months
Secondary: (Main Cohort) Composite of COVID-19-related hospitalization and/or COVID-19-related death (WHO COVID-19 Clinical Progression Scale score ≥ 4) any time up to 12 months.
through Day 361
(Main Cohort) COVID-19-related Hospitalization Any Time up to 12 Months
Secondary: (Main Cohort) COVID-19-related hospitalization any time up to 12 months.
through Day 361
(Main Cohort) COVID-19 Related Death
(Main Cohort) COVID-19 related death - through Day 361
through Day 361
(Main Cohort) GMT of SARS-CoV-2 nAbs at Baseline and Day 29
Secondary: (Main Cohort) GMT of SARS-CoV-2 nAbs at baseline and Day 29
at Day 29
(Main Cohort) GMFR of SARS-CoV-2 nAbs at Day 29
Secondary: (Main Cohort) GMFR of SARS-CoV-2 nAbs at Day 29
at Day 29
(Main Cohort) AZD3152 and AZD7442 (EVUSHELD) Concentrations Over Time
(Main Cohort) AZD3152 and AZD7442 (EVUSHELD) concentrations over time - through Day 361
through Day 361
(Main Cohort) Incidence of ADA to AZD3152 and AZD7442 (EVUSHELD)
AZD3152 recipients were tested for ADA to AZD3152; AZD7442 recipients were tested for ADA to AZD7442.
through Day 361
(Sentinel Cohort) AZD5156, AZD1061, and AZD3152 Concentrations Over Time
AZD5156 is a combination of AZD3152 and AZD1061. This summary is only eligible for AZD5156 group.
Day 29, Day 181, Day 361
(Sentinel Cohort) Incidence of ADA to AZD5156, AZD3152, and AZD1061
(Sentinel Cohort) Incidence of ADA to AZD5156, AZD3152, and AZD1061 - through Day 361
through Day 361
(Main Cohort) ADA Titers
ADA titers were only available for ADA positive samples.
through Day 361
(Main Cohort) AZD1061 and AZD8895 Concentrations Over Time
AZD7442 (ie EVUSHELD) is composed of AZD1061 (ie, cilgavimab) and AZD8895 (ie, tixagevimab). This summary is only applicable to AZD7442 group.
through Day 361
Birmingham
Alabama
35215
United States
Research Site
Mobile
Alabama
36608
United States
Research Site
Glendale
Arizona
85306
United States
Research Site
Mesa
Arizona
85206
United States
Research Site
Mesa
Arizona
85210
United States
Research Site
Tucson
Arizona
85712
United States
Research Site
Little Rock
Arkansas
72205
United States
Research Site
Colton
California
92324
United States
Research Site
La Mesa
California
91942
United States
Research Site
Long Beach
California
90815
United States
Research Site
Los Angeles
California
90027
United States
Research Site
Modesto
California
95350
United States
Research Site
Sacramento
California
95817
United States
Research Site
Tustin
California
92780
United States
Research Site
Westminster
California
92683
United States
Research Site
Aurora
Colorado
80014
United States
Research Site
Denver
Colorado
80209
United States
Research Site
Denver
Colorado
80246
United States
Research Site
Fort Collins
Colorado
80525
United States
Research Site
New Haven
Connecticut
06519
United States
Research Site
Washington D.C.
District of Columbia
20007
United States
Research Site
Coral Gables
Florida
33134
United States
Research Site
Fleming Island
Florida
32003
United States
Research Site
Fort Myers
Florida
33912
United States
Research Site
Hollywood
Florida
33024
United States
Research Site
Jacksonville
Florida
32216
United States
Research Site
Jacksonville
Florida
32256
United States
Research Site
Lake Worth
Florida
33462
United States
Research Site
Largo
Florida
33777
United States
Research Site
Lauderdale Lakes
Florida
33313
United States
Research Site
Leesburg
Florida
34748
United States
Research Site
Medley
Florida
33166
United States
Research Site
Miami
Florida
33125
United States
Research Site
Miami
Florida
33126
United States
Research Site
Miami
Florida
33135
United States
Research Site
Miami
Florida
33186
United States
Research Site
Miami Lakes
Florida
33014
United States
Research Site
Miami Springs
Florida
33166
United States
Research Site
North Miami Beach
Florida
33162
United States
Research Site
Orlando
Florida
32806
United States
Research Site
Ormond Beach
Florida
32174
United States
Research Site
Port Orange
Florida
32127
United States
Research Site
St. Petersburg
Florida
33713
United States
Research Site
Winter Park
Florida
32789
United States
Research Site
Atlanta
Georgia
30342
United States
Research Site
Columbus
Georgia
31904
United States
Research Site
Boise
Idaho
83712
United States
Research Site
Burr Ridge
Illinois
60527
United States
Research Site
Chicago
Illinois
60612
United States
Research Site
Chicago
Illinois
60640
United States
Research Site
Gurnee
Illinois
60031
United States
Research Site
Evansville
Indiana
47712
United States
Research Site
Evansville
Indiana
47715
United States
Research Site
South Bend
Indiana
46617
United States
Research Site
West Des Moines
Iowa
50266
United States
Research Site
Overland Park
Kansas
66204
United States
Research Site
Wichita
Kansas
67214
United States
Research Site
Bowling Green
Kentucky
42101
United States
Research Site
Lexington
Kentucky
40503
United States
Research Site
Lexington
Kentucky
40509
United States
Research Site
Lake Charles
Louisiana
70605
United States
Research Site
Metairie
Louisiana
70006
United States
Research Site
New Orleans
Louisiana
70119
United States
Research Site
Baltimore
Maryland
21287
United States
Research Site
Boston
Massachusetts
02115
United States
Research Site
Boston
Massachusetts
02215
United States
Research Site
Methuen
Massachusetts
01844
United States
Research Site
Springfield
Massachusetts
01107
United States
Research Site
Worcester
Massachusetts
01655
United States
Research Site
Detroit
Michigan
48202
United States
Research Site
Farmington Hills
Michigan
48334
United States
Research Site
Grand Rapids
Michigan
49525
United States
Research Site
Novi
Michigan
48377
United States
Research Site
Saint Clair Shores
Michigan
48081
United States
Research Site
Minneapolis
Minnesota
55446
United States
Research Site
Jefferson City
Missouri
65109
United States
Research Site
Kansas City
Missouri
64114
United States
Research Site
St Louis
Missouri
63110
United States
Research Site
St Louis
Missouri
63131
United States
Research Site
Missoula
Montana
59808
United States
Research Site
Lincoln
Nebraska
68516
United States
Research Site
Las Vegas
Nevada
89119
United States
Research Site
Portsmouth
New Hampshire
03801
United States
Research Site
Hackensack
New Jersey
07601
United States
Research Site
Albuquerque
New Mexico
87109
United States
Research Site
Buffalo
New York
14202
United States
Research Site
Ridgewood
New York
11385
United States
Research Site
Rochester
New York
14607
United States
Research Site
Rochester
New York
14642
United States
Research Site
Charlotte
North Carolina
28208
United States
Research Site
Durham
North Carolina
27710
United States
Research Site
Monroe
North Carolina
28112
United States
Research Site
Morehead City
North Carolina
28557
United States
Research Site
Wilmington
North Carolina
28403
United States
Research Site
Cincinnati
Ohio
45267
United States
Research Site
Westlake
Ohio
44145
United States
Research Site
Allentown
Pennsylvania
18103
United States
Research Site
Duncansville
Pennsylvania
16635
United States
Research Site
Harrisburg
Pennsylvania
17110
United States
Research Site
Philadelphia
Pennsylvania
19104
United States
Research Site
Philadelphia
Pennsylvania
19107
United States
Research Site
Pittsburgh
Pennsylvania
15232
United States
Research Site
Providence
Rhode Island
02903
United States
Research Site
Myrtle Beach
South Carolina
29572
United States
Research Site
North Charleston
South Carolina
29405
United States
Research Site
Rock Hill
South Carolina
29732
United States
Research Site
Spartanburg
South Carolina
29303
United States
Research Site
Knoxville
Tennessee
37909
United States
Research Site
Austin
Texas
78745
United States
Research Site
Dallas
Texas
75246
United States
Research Site
El Paso
Texas
79925
United States
Research Site
Houston
Texas
77054
United States
Research Site
Houston
Texas
77065
United States
Research Site
Houston
Texas
77070
United States
Research Site
Houston
Texas
77081
United States
Research Site
Houston
Texas
77089
United States
Research Site
Kingwood
Texas
77339
United States
Research Site
Mesquite
Texas
75150
United States
Research Site
San Angelo
Texas
76904
United States
Research Site
San Antonio
Texas
78229
United States
Research Site
Shenandoah
Texas
77384
United States
Research Site
Layton
Utah
84041
United States
Research Site
Salt Lake City
Utah
84115
United States
Research Site
Annandale
Virginia
22003
United States
Research Site
Norfolk
Virginia
23502
United States
Research Site
Norfolk
Virginia
23507
United States
Research Site
Olympia
Washington
98506
United States
Research Site
Seattle
Washington
98109
United States
Research Site
Madison
Wisconsin
53715
United States
Research Site
Melbourne
3000
Australia
Research Site
Melbourne
3004
Australia
Research Site
Murdoch
6150
Australia
Research Site
Parkville
3050
Australia
Research Site
Raymond Terrace
4101
Australia
Research Site
Sippy Downs
4556
Australia
Research Site
West Perth
6005
Australia
Research Site
Alken
3570
Belgium
Research Site
Liège
4000
Belgium
Research Site
Montreal
Quebec
H2X 0A9
Canada
Research Site
Montreal
Quebec
H4A 3J1
Canada
Research Site
Aalborg
9100
Denmark
Research Site
Aarhus
8200
Denmark
Research Site
Hvidovre
2650
Denmark
Research Site
Roskilde
4000
Denmark
Research Site
Svendborg
DK-5700
Denmark
Research Site
Dijon
21079
France
Research Site
La Roche-sur-Yon
85925
France
Research Site
Lille
59037
France
Research Site
Nantes
44093
France
Research Site
Nîmes
30029
France
Research Site
Paris
75014
France
Research Site
Paris
75475
France
Research Site
Poitiers
86000
France
Research Site
Saint-Etienne
42055
France
Research Site
Strasbourg
67091
France
Research Site
Toulouse
31059
France
Research Site
Tours
37000
France
Research Site
Cologne
50924
Germany
Research Site
Essen
45147
Germany
Research Site
Hamburg
20095
Germany
Research Site
Hanover
30625
Germany
Research Site
Mainz
55131
Germany
Research Site
Petah Tikva
49100
Israel
Research Site
Ramat Gan
52621
Israel
Research Site
Kuala Lumpur
56000
Malaysia
Research Site
Kuala Lumpur
59100
Malaysia
Research Site
Kuching
93586
Malaysia
Research Site
Seberang Jaya
13700
Malaysia
Research Site
Sunway City
47500
Malaysia
Research Site
Krakow
30-727
Poland
Research Site
Skórzewo
60-185
Poland
Research Site
Singapore
117599
Singapore
Research Site
Singapore
169608
Singapore
Research Site
Singapore
308442
Singapore
Research Site
Gyeonggi-do
13620
South Korea
Research Site
Seoul
03080
South Korea
Research Site
Seoul
08308
South Korea
Research Site
Seoul
5505
South Korea
Research Site
Badalona
08916
Spain
Research Site
Barcelona
08035
Spain
Research Site
Barcelona
08036
Spain
Research Site
Barcelona
08041
Spain
Research Site
Córdoba
14004
Spain
Research Site
Madrid
28007
Spain
Research Site
Madrid
28031
Spain
Research Site
Madrid
28040
Spain
Research Site
Marbella (Málaga)
29603
Spain
Research Site
Mérida
06800
Spain
Research Site
Pozuelo de Alarcón
28223
Spain
Research Site
Valladolid
47003
Spain
Research Site
Vigo
36312
Spain
Research Site
Taichung
40447
Taiwan
Research Site
Taipei
11490
Taiwan
Research Site
Bangkok
10400
Thailand
Research Site
Bangkok
10700
Thailand
Research Site
Khon Kaen
40002
Thailand
Research Site
Muang
11000
Thailand
Research Site
Muang
50200
Thailand
Research Site
Abu Dhabi
2951
United Arab Emirates
Research Site
Abu Dhabi
34555
United Arab Emirates
Research Site
Bristol
BS2 8DX
United Kingdom
Research Site
Edinburgh
EH4 2XU
United Kingdom
Research Site
Harrow
HA1 3UJ
United Kingdom
Research Site
Leeds
LS9 7TF
United Kingdom
Research Site
Liverpool
L7 8XP
United Kingdom
Research Site
London
SE1 7EH
United Kingdom
Research Site
London
W1T 7HA
United Kingdom
Research Site
Manchester
M8 5RB
United Kingdom
Research Site
Oxford
OX3 7LA
United Kingdom
Research Site
Sheffield
S10 2JF
United Kingdom
Research Site
Torpoint
PL11 2TB
United Kingdom
Research Site
Truro
TR1 3LJ
United Kingdom
Research Site
Hanoi
100000
Vietnam
Research Site
Hochiminh City
700000
Vietnam
Background
Bosch BJ, van der Zee R, de Haan CA, Rottier PJ. The coronavirus spike protein is a class I virus fusion protein: structural and functional characterization of the fusion core complex. J Virol. 2003 Aug;77(16):8801-11. doi: 10.1128/jvi.77.16.8801-8811.2003.
Background
CDC 2021 CDC (Centers for Disease Control and Prevention). General Best Practice Guidelines for Immunization: Altered Immunocompetence. Available from: https://www.cdc.gov/vaccines/hcp/acip-recs/general-recs/immunocompetence.html. Accessed 23 May 2022.
Dall'Acqua WF, Kiener PA, Wu H. Properties of human IgG1s engineered for enhanced binding to the neonatal Fc receptor (FcRn). J Biol Chem. 2006 Aug 18;281(33):23514-24. doi: 10.1074/jbc.M604292200. Epub 2006 Jun 21.
Background
Fact Sheet EUA Bebtelovimab 2022 US Food and Drug Administration. Fact Sheet For Healthcare Providers: Emergency Use Authorization for Bebtelovimab, March 2022. Available at: https://www.fda.gov/media/156152/download. Accessed 23 May 2022.
Gupta A, Gonzalez-Rojas Y, Juarez E, Crespo Casal M, Moya J, Falci DR, Sarkis E, Solis J, Zheng H, Scott N, Cathcart AL, Hebner CM, Sager J, Mogalian E, Tipple C, Peppercorn A, Alexander E, Pang PS, Free A, Brinson C, Aldinger M, Shapiro AE; COMET-ICE Investigators. Early Treatment for Covid-19 with SARS-CoV-2 Neutralizing Antibody Sotrovimab. N Engl J Med. 2021 Nov 18;385(21):1941-1950. doi: 10.1056/NEJMoa2107934. Epub 2021 Oct 27.
Harpaz R, Dahl RM, Dooling KL. Prevalence of Immunosuppression Among US Adults, 2013. JAMA. 2016 Dec 20;316(23):2547-2548. doi: 10.1001/jama.2016.16477. No abstract available.
Hoffmann M, Kleine-Weber H, Schroeder S, Kruger N, Herrler T, Erichsen S, Schiergens TS, Herrler G, Wu NH, Nitsche A, Muller MA, Drosten C, Pohlmann S. SARS-CoV-2 Cell Entry Depends on ACE2 and TMPRSS2 and Is Blocked by a Clinically Proven Protease Inhibitor. Cell. 2020 Apr 16;181(2):271-280.e8. doi: 10.1016/j.cell.2020.02.052. Epub 2020 Mar 5.
Levin MJ, Ustianowski A, De Wit S, Launay O, Avila M, Templeton A, Yuan Y, Seegobin S, Ellery A, Levinson DJ, Ambery P, Arends RH, Beavon R, Dey K, Garbes P, Kelly EJ, Koh GCKW, Near KA, Padilla KW, Psachoulia K, Sharbaugh A, Streicher K, Pangalos MN, Esser MT; PROVENT Study Group. Intramuscular AZD7442 (Tixagevimab-Cilgavimab) for Prevention of Covid-19. N Engl J Med. 2022 Jun 9;386(23):2188-2200. doi: 10.1056/NEJMoa2116620. Epub 2022 Apr 20.
Li F. Structure, Function, and Evolution of Coronavirus Spike Proteins. Annu Rev Virol. 2016 Sep 29;3(1):237-261. doi: 10.1146/annurev-virology-110615-042301. Epub 2016 Aug 25.
Maltezou HC, Anastassopoulou C, Hatziantoniou S, Poland GA, Tsakris A. Anaphylaxis rates associated with COVID-19 vaccines are comparable to those of other vaccines. Vaccine. 2022 Jan 21;40(2):183-186. doi: 10.1016/j.vaccine.2021.11.066. Epub 2021 Nov 27.
Background
NIH 2017 NIH. Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Available at: https://ctep.cancer.gov/protocolDevelopment/electronic_applications/ctc.htm#ctc_50. Published 2017. Accessed 23 May 2022.
Oganesyan V, Gao C, Shirinian L, Wu H, Dall'Acqua WF. Structural characterization of a human Fc fragment engineered for lack of effector functions. Acta Crystallogr D Biol Crystallogr. 2008 Jun;64(Pt 6):700-4. doi: 10.1107/S0907444908007877. Epub 2008 May 14.
Parker EPK, Desai S, Marti M, Nohynek H, Kaslow DC, Kochhar S, O'Brien KL, Hombach J, Wilder-Smith A. Response to additional COVID-19 vaccine doses in people who are immunocompromised: a rapid review. Lancet Glob Health. 2022 Mar;10(3):e326-e328. doi: 10.1016/S2214-109X(21)00593-3. No abstract available.
Sampson HA, Munoz-Furlong A, Campbell RL, Adkinson NF Jr, Bock SA, Branum A, Brown SG, Camargo CA Jr, Cydulka R, Galli SJ, Gidudu J, Gruchalla RS, Harlor AD Jr, Hepner DL, Lewis LM, Lieberman PL, Metcalfe DD, O'Connor R, Muraro A, Rudman A, Schmitt C, Scherrer D, Simons FE, Thomas S, Wood JP, Decker WW. Second symposium on the definition and management of anaphylaxis: summary report--Second National Institute of Allergy and Infectious Disease/Food Allergy and Anaphylaxis Network symposium. J Allergy Clin Immunol. 2006 Feb;117(2):391-7. doi: 10.1016/j.jaci.2005.12.1303.
Tuekprakhon A, Nutalai R, Dijokaite-Guraliuc A, Zhou D, Ginn HM, Selvaraj M, Liu C, Mentzer AJ, Supasa P, Duyvesteyn HME, Das R, Skelly D, Ritter TG, Amini A, Bibi S, Adele S, Johnson SA, Constantinides B, Webster H, Temperton N, Klenerman P, Barnes E, Dunachie SJ, Crook D, Pollard AJ, Lambe T, Goulder P, Paterson NG, Williams MA, Hall DR; OPTIC Consortium; ISARIC4C Consortium; Fry EE, Huo J, Mongkolsapaya J, Ren J, Stuart DI, Screaton GR. Antibody escape of SARS-CoV-2 Omicron BA.4 and BA.5 from vaccine and BA.1 serum. Cell. 2022 Jul 7;185(14):2422-2433.e13. doi: 10.1016/j.cell.2022.06.005. Epub 2022 Jun 9.
Walls AC, Tortorici MA, Snijder J, Xiong X, Bosch BJ, Rey FA, Veesler D. Tectonic conformational changes of a coronavirus spike glycoprotein promote membrane fusion. Proc Natl Acad Sci U S A. 2017 Oct 17;114(42):11157-11162. doi: 10.1073/pnas.1708727114. Epub 2017 Oct 3.
Weinreich DM, Sivapalasingam S, Norton T, Ali S, Gao H, Bhore R, Musser BJ, Soo Y, Rofail D, Im J, Perry C, Pan C, Hosain R, Mahmood A, Davis JD, Turner KC, Hooper AT, Hamilton JD, Baum A, Kyratsous CA, Kim Y, Cook A, Kampman W, Kohli A, Sachdeva Y, Graber X, Kowal B, DiCioccio T, Stahl N, Lipsich L, Braunstein N, Herman G, Yancopoulos GD; Trial Investigators. REGN-COV2, a Neutralizing Antibody Cocktail, in Outpatients with Covid-19. N Engl J Med. 2021 Jan 21;384(3):238-251. doi: 10.1056/NEJMoa2035002. Epub 2020 Dec 17.
Background
WHO 2022 World Health Organization. WHO COVID-19 Case definition, July 2022. Available at: https://www.who.int/publications/i/item/WHO-2019-nCoV-Surveillance_Case_Definition 2022.1. Accessed 05 May 2023.
Background
WHO 2023 WHO Coronavirus disease (COVID-19) dashboard. Available at: https://covid19.who.int. Accessed 05 June 2023.
Kelly JD, Leonard S, Hoggatt KJ, Boscardin WJ, Lum EN, Moss-Vazquez TA, Andino R, Wong JK, Byers A, Bravata DM, Tien PC, Keyhani S. Incidence of Severe COVID-19 Illness Following Vaccination and Booster With BNT162b2, mRNA-1273, and Ad26.COV2.S Vaccines. JAMA. 2022 Oct 11;328(14):1427-1437. doi: 10.1001/jama.2022.17985.
Haidar G, Thomas S, Loubet P, Baker RI, Benfield T, Boonyaratanakornkit J, Kiertiburanakul S, Kim AHJ, Longbrake EE, Molina JM, Paredes R, Tucker D, Uriel A, Weinmann-Menke J, Aksyuk AA, Clegg LE, Currie A, Yang H, Flyrin K, Gibbs M, Shroff M, Perez JL, Chang LJ, Cohen TS; SUPERNOVA study group. Efficacy and safety of sipavibart for prevention of COVID-19 in individuals who are immunocompromised (SUPERNOVA): a randomised, controlled, double-blind, phase 3 trial. Lancet Infect Dis. 2025 Jul;25(7):813-826. doi: 10.1016/S1473-3099(24)00804-1. Epub 2025 Feb 24.
Cai Y, Diallo S, Rosenthal K, Ren K, Flores DJ, Dippel A, Oganesyan V, van Dyk N, Chen X, Cantu E, Choudhary R, Sulikowski M, Adissu H, Chawla B, Kar S, Liu C, Dijokaite-Guraliuc A, Mongkolsapaya J, Rajan S, Loo YM, Beavon R, Webber C, Chang LJ, Thomas S, Clegg L, Zhang H, Screaton GR, Philbin N, Harre M, Selim A, Martinez-Alier N, Uriel A, Cohen TS, Perez JL, Esser MT, Blair W, Francica JR. AZD3152 neutralizes SARS-CoV-2 historical and contemporary variants and is protective in hamsters and well tolerated in adults. Sci Transl Med. 2024 Jun 26;16(753):eado2817. doi: 10.1126/scitranslmed.ado2817. Epub 2024 Jun 26.
Planned treatment assignments are placebo on Day 1 and placebo on Day 181.
FG003
AZD5156, Gluteal - Sentinel Cohort
(Planned treatment assignment is AZD5156 600 mg IM in gluteal area)
FG004
AZD5156, Anterolateral Thigh - Sentinel Cohort
(Planned treatment assignment is AZD5156 600 mg IM in anterolateral thigh area)
FG005
Placebo, Gluteal - Sentinel Cohort
(Planned treatment assignment is placebo 600 mg in gluteal area)
FG006
Placebo, Anterolateral Thigh - Sentinel Cohort
(Planned treatment is placebo 600 mg IM in anterolateral thigh area)
FG007
AZD3152 - Sub Study
Planned treatment assignment is ADZ3152 1200mg IV at Day 1.
FG008
AZD7442 - Sub Study
Planned treatment is AZD7442 300mg IM at Day 1.
FG0001671 subjects5 participants who were randomized to this arm but not treated are excluded from summary.
FG0011102 subjects6 participants who were randomized to this arm but not treated are excluded from summary. 1 participant was randomized to AZD3152 group then re-randomized to AZD7442 group under a different subject ID was excluded from AZD7442 group.
FG002561 subjects3 participants who were randomized to this arm but not treated are excluded from summary.
FG00320 subjects
FG00421 subjects
FG0058 subjects
FG0068 subjects
FG007310 subjects7 participants who were randomized to this arm but not treated are excluded from summary.
FG008158 subjects1 participant who was randomized to this arm but not treated is excluded from summary. 2 immunocompromised participants who received AZD7442 at Day 1 and received the optional dose AZD3152 at Day 29 are included.
COMPLETED
FG0001469 subjects
FG001962 subjects
FG002513 subjects
FG00319 subjects
FG00418 subjects
FG0057 subjects
FG0066 subjects
FG007277 subjects
FG008142 subjects
NOT COMPLETED
FG000202 subjects
FG001140 subjects
FG00248 subjects
FG0031 subjects
FG0043 subjects
FG0051 subjects
FG0062 subjects
FG00733 subjects
FG00816 subjects
Type
Comment
Reasons
Adverse Event
FG0003 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0081 subjects
Death
FG00040 subjects
FG00124 subjects
FG0026 subjects
FG0031 subjects
FG004
Lost to Follow-up
FG00047 subjects
FG00129 subjects
FG00214 subjects
FG0030 subjects
FG004
Physician Decision
FG00018 subjects
FG00115 subjects
FG0023 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG00090 subjects
FG00171 subjects
FG00223 subjects
FG0030 subjects
FG004
Missing reason
FG0004 subjects
FG0010 subjects
FG0022 subjects
FG0030 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
AZD3152 - Main Cohort
(AZD3152 Experimental treatment)
BG001
AZD7442 - Main Cohort
(AZD7442 Active Comparator treatment)
BG002
Placebo - Main Cohort
(Placebo comparator treatment)
BG003
AZD5156 - Sentinel Cohort
(AZD5156 Experimental treatment)
BG004
Placebo - Sentinel Cohort
(Placebo comparator treatment)
BG005
AZD3152 - Sub Study
(AZD3152 Experimental treatment)
BG006
AZD7442 - Sub Study
(AZD7442 Active Comparator treatment)
BG007
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0001671
BG0011102
BG002561
BG00341
BG00416
BG005310
BG006158
BG0073859
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00058.1± 13.9
BG00158.6± 13.7
BG00257.7± 13.2
BG003
Age, Customized
Number
Participants
Title
Denominators
Categories
In utero
Title
Measurements
BG0000
BG0010
BG002
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG000954
BG001610
BG002
Race/Ethnicity, Customized
Number
Participants
Title
Denominators
Categories
Black or African American
Title
Measurements
BG000202
BG001122
BG002
Ethnicity
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG000356
BG001235
BG002
Race
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Black or African American
BG000202
BG001122
BG002
SARS-CoV-2 vaccination status within 6 months prior to randomization
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Yes SARS-CoV-2 vaccination
BG000199
BG001147
BG002
Prior SARS-CoV-2 infection within 6 months prior to randomization
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Yes prior SARS-CoV-2 infection
BG00066
BG00158
BG002
EVUSHELD use within 12 months prior to randomization
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Yes EVUSHELD use
BG000191
BG001148
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
(Main Cohort) Occurrence of AEs Collected Through Approximately 90 Days After Each IMP Administration; SAEs, MAAEs, and AESIs Collected Through Day 451
Primary: (Main Cohort) Occurrence of AEs collected through approximately 90 days after each IMP administration; SAEs, MAAEs, and AESIs collected through Day 451
Safety analysis set: all randomized participants who received part or all of the study intervention.
Posted
Count of Participants
Participants
AEs: through 90 days post each IMP administration; SAEs, MAAEs, and AESIs: through Day 451
ID
Title
Description
OG000
AZD3152 - Main Cohort
(AZD3152 Experimental treatment)
OG001
AZD7442 - Main Cohort
(AZD7442 Active Comparator treatment)
OG002
Placebo - Main Cohort
(Placebo comparator treatment)
Units
Counts
Participants
OG0001671
OG0011102
OG002561
Title
Denominators
Categories
AEs
Title
Measurements
OG000846
OG001591
OG002273
SAEs
Primary
(Sub-study) Occurrence of AEs Collected Through 29 Days After IMP Administration. SAEs, MAAEs, and AESIs Collected Through Day 451.
(Sub-study) Occurrence of AEs collected through 29 days after IMP administration. SAEs, MAAEs, and AESIs collected through Day 451 (ie, end of study).
Safety analysis set: all randomized participants who received part or all of the study intervention.
Posted
Count of Participants
Participants
through 29 days post IMP administration (AEs); through Day 451 (SAEs, MAAEs, and AESIs)
ID
Title
Description
OG000
AZD3152 - Sub Study
(AZD3152 experimental treatment)
OG001
AZD7442 - Sub Study
(AZD7442 active comparator treatment)
OG002
Crossover - Sub Study
(including 2 immunocompromised participants who received AZD7442 at Day 1 and AZD3152 at Day 29)
Units
Counts
Participants
Primary
(Sub-study) Predicted SARS-CoV-2 nAb Titers Derived From Serum PK and in Vitro IC50 for SARS-CoV-2 Variants BA.2.86 Following AZD3152 Administration and Alpha Variant Following EVUSHELD Administration.
AZD3152 Day 29 predicted nAb titer for BA.2.86 variant = AZD3152 serum PK conc. (ng/mL)/(3.8 ng/mL), where 3.8 ng/mL is AZD3152 BA.2.86 IC50. AZD7442 Day 29 predicted nAb titer for Alpha variant = AZD7442 serum PK conc. (ng/mL)/(2.1 ng/mL), where 2.1 ng/mL is AZD7442 Alpha IC50. This table only shows AZD3152 and AZD7442 concentration at Day 29.
Pharmacokinetic analysis set: all randomized participants who received a full dose of IMP per protocol, with sufficient information to estimate at least 1 postdose quantifiable serum concentration for any mAb component. Participants with protocol deviations that may interfere with the serum concentrations may be excluded or have data collected after the protocol deviations set to missing. Participants without valid serum concentration at Day 29 were excluded from this table.
Posted
Geometric Mean
Geometric Coefficient of Variation
ug/mL
at Day 29
ID
Title
Description
OG000
AZD3152 - Sub Study
(AZD3152 experimental treatment)
OG001
AZD7442 - Sub Study
(AZD7442 active comparator treatment)
Primary
(Sub-study) Predicted SARS-CoV-2 nAb Titers Derived From Serum PK and in Vitro IC50 for SARS-CoV-2 Variants BA.2.86 Following AZD3152 Administration and Alpha Variant Following EVUSHELD Administration.
AZD3152 Day 29 predicted nAb titer for BA.2.86 variant = AZD3152 serum PK conc. (ng/mL)/(3.8 ng/mL), where 3.8 ng/mL is AZD3152 BA.2.86 IC50. AZD7442 Day 29 predicted nAb titer for Alpha variant = AZD7442 serum PK conc. (ng/mL)/(2.1 ng/mL), where 2.1 ng/mL is AZD7442 Alpha IC50. This table shows the predicted nAb titer at Day 29 (please see the previous table for AZD3152 and AZD7442 concentration at Day 29).
Pharmacokinetic analysis set: all randomized participants who received a full dose of IMP per protocol, with sufficient information to estimate at least 1 postdose quantifiable serum concentration for any mAb component. Participants with protocol deviations that may interfere with the serum concentrations may be excluded or have data collected after the protocol deviations set to missing. Participants without valid serum concentration at Day 29 were excluded from this table.
Posted
Geometric Mean
Geometric Coefficient of Variation
1/Dilution
at Day 29
ID
Title
Description
OG000
AZD3152 - Sub Study
(AZD3152 experimental treatment)
OG001
AZD7442 - Sub Study
(AZD7442 active comparator treatment)
Primary
(Main Cohort) Confirmed Symptomatic COVID-19 Case
(Main Cohort) Confirmed symptomatic COVID-19 case at Primary Analysis.
SARS-CoV-2-Negative Set: all randomized participants who received part or all of the study intervention and did not have evidence of a current SARS-CoV-2 infection at baseline. Participants with positive RT-PCR test results at baseline were excluded from this analysis set.
Posted
Count of Participants
Participants
at Primary Analysis: average follow-up time of 170 days
ID
Title
Description
OG000
AZD3152 - Main Cohort
(AZD3152 Experimental treatment)
OG001
AZD7442 - Main Cohort
(AZD7442 active comparator treatment)
OG002
Placebo - Main Cohort
(Placebo comparator treatment)
Units
Counts
Participants
Primary
(Main Cohort) Confirmed Symptomatic COVID-19 Case Attributable to Matched Variants
(Main Cohort) Confirmed symptomatic COVID-19 case attributable to matched variants at Primary Analysis.
SARS-CoV-2-Negative Set: all randomized participants who received part or all of the study intervention and did not have evidence of a current SARS-CoV-2 infection at baseline. Participants with positive RT-PCR test results at baseline were excluded from this analysis set.
Posted
Count of Participants
Participants
at Primary Analysis: average follow-up time of 170 days
ID
Title
Description
OG000
AZD3152 - Main Cohort
(AZD3152 Experimental treatment)
OG001
AZD7442 - Main Cohort
(AZD7442 active comparator treatment)
OG002
Placebo - Main Cohort
(Placebo comparator treatment)
Units
Counts
Participants
Primary
(Sentinel Cohort) Occurrence of AEs, SAEs, MAAEs, and AESIs Collected Through Day 461
Primary: (Sentinel Cohort) Occurrence of AEs, SAEs, MAAEs, and AESIs collected through Day 461
Safety analysis set: all randomized participants who received part or all of the study intervention.
Posted
Count of Participants
Participants
through Day 461
ID
Title
Description
OG000
AZD5156 - Sentinel Cohort
(AZD5156 experimental treatment)
OG001
Placebo - Sentinel Cohort
(Placebo comparator treatment)
Units
Counts
Participants
OG000
Secondary
(Sub-study) AZD3152 and EVUSHELD (ie, AZD7442) Concentrations in Serum, Over Time
Secondary: (Sub-study) AZD3152 and EVUSHELD (ie, AZD7442) concentrations in serum, over time.
Pharmacokinetic analysis set: all randomized participants who received a full dose of IMP per protocol, with sufficient information to estimate at least 1 postdose quantifiable serum concentration for any mAb component. Participants with protocol deviations that may interfere with the serum concentrations may be excluded or have data collected after the protocol deviations set to missing.
Posted
Geometric Mean
Geometric Coefficient of Variation
ug/mL
Day 29, Day 91, Day 181
ID
Title
Description
OG000
AZD3152 - Sub Study
(AZD3152 experimental treatment)
OG001
AZD7442 - Sub Study
(AZD7442 active comparator treatment)
Units
Counts
Participants
OG000
Secondary
(Sub-study) Incidence of ADA to AZD3152 and EVUSHELD
AZD3152 recipients were tested for ADA to AZD3152; EVUSHELD recipients were tested for ADA to EVUSHELD.
The ADA analysis sets: all participants who received part or all of study intervention and had a non-missing baseline and at least one non-missing post-baseline ADA result of the same mAb component.
Posted
Count of Participants
Participants
through Day 181
ID
Title
Description
OG000
AZD3152 - Sub Study
(AZD3152 experimental treatment)
OG001
AZD7442 - Sub Study
(AZD7442 active comparator treatment)
Units
Counts
Participants
OG000
Secondary
(Sub-study) Cilgavimab and Tixagevimab Concentrations in Serum, Over Time
AZD7442 (ie EVUSHELD) is composed of cilgavimab and tixagevimab. This summary is only applicable to AZD7442 group.
Only AZD7442 group of Pharmacokinetic analysis set is eligible for the summary.
Posted
Geometric Mean
Geometric Coefficient of Variation
ug/mL
Day 29, Day 91, Day 181
ID
Title
Description
OG000
AZD7442 - Sub Study
(AZD7442 active comparator treatment)
Units
Counts
Participants
OG000154
Secondary
(Sub-study) ADA Titers
ADA titers were only available for ADA positive samples.
The ADA analysis sets: all participants who received part or all of study intervention and had a non-missing baseline and at least one non-missing post-baseline ADA result of the same mAb component.
Posted
Median
Full Range
ADA titers
Day 1, Day 29, Day 91, Day 181
ID
Title
Description
OG000
AZD3152 - Sub Study
(AZD3152 experimental treatment)
OG001
AZD7442 - Sub Study
(AZD7442 active comparator treatment)
Units
Counts
Participants
OG000
Secondary
(Main Cohort) Symptomatic COVID-19 Case (Negative RT-PCR at Baseline to Positive at Any Time up 12 Months With All Observed Events at Final Readout) Caused by Any SARS-CoV-2 Matched Variant
(Main Cohort) Symptomatic COVID-19 case (negative RT-PCR at baseline to positive at any time up 12 months with all observed events at final readout) caused by any SARS-CoV-2 matched variant. First secondary endpoint to be tested in hierarchical testing after dual-primary endpoint efficacy was demonstrated in hierarchical testing
SARS-CoV-2-Negative Set: all randomized participants who received part or all of the study intervention and did not have evidence of a current SARS-CoV-2 infection at baseline. Participants with positive RT-PCR test results at baseline were excluded from this analysis set.
Posted
Count of Participants
Participants
through Day 361
ID
Title
Description
OG000
AZD3152 - Main Cohort
(AZD3152 experimental treatment)
OG001
AZD7442 - Main Study
(AZD7442 active comparator treatment)
OG002
Placebo - Main Cohort
(Placebo comparator treatment)
Secondary
(Main Cohort) Symptomatic COVID-19 Case (Negative RT-PCR at Baseline to Positive at Any Time up to 12 Months With All Observed Events at Final Readout) Caused by Any SARS-CoV-2 Variants
Secondary: (Main Cohort) Symptomatic COVID-19 case (negative RT-PCR at baseline to positive at any time up to 12 months with all observed events at final readout) caused by any SARS-CoV-2 variants. Second secondary endpoint to be tested in hierarchical testing after dual-primary endpoint efficacy was demonstrated in hierarchical testing
SARS-CoV-2-Negative Set: all randomized participants who received part or all of the study intervention and did not have evidence of a current SARS-CoV-2 infection at baseline. Participants with positive RT-PCR test results at baseline were excluded from this analysis set.
Posted
Count of Participants
Participants
through Day 361
ID
Title
Description
OG000
AZD3152 - Main Cohort
(AZD3152 experimental treatment)
OG001
AZD7442 - Main Cohort
(AZD7442 active comparator treatment)
OG002
Placebo - Main Cohort
(Placebo comparator treatment)
Secondary
(Main Cohort) Severe COVID-19 Caused by Any SARS-CoV-2 Variant Any Time up to 12 Months
third secondary endpoint to be tested in hierarchical testing after dual-primary endpoint efficacy was demonstrated in hierarchical testing
SARS-CoV-2-Negative Set: all randomized participants who received part or all of the study intervention and did not have evidence of a current SARS-CoV-2 infection at baseline. Participants with positive RT-PCR test results at baseline were excluded from this analysis set.
Posted
Count of Participants
Participants
through Day 361
ID
Title
Description
OG000
AZD3152 - Main Cohort
(AZD3152 experimental treatment)
OG001
AZD7442 - Main Cohort
(AZD7442 active comparator treatment)
OG002
Placebo - Main Cohort
(Placebo comparator treatment)
Units
Counts
Participants
Secondary
(Main Cohort) Severe COVID-19 Caused by Any SARS-CoV-2 Matched Variants at Any Time up to 12 Months
Secondary: (Main Cohort) Severe COVID-19 caused by any SARS-CoV-2 matched variants at any time up to 12 months through Day 361.
SARS-CoV-2-Negative Set: all randomized participants who received part or all of the study intervention and did not have evidence of a current SARS-CoV-2 infection at baseline. Participants with positive RT-PCR test results at baseline were excluded from this analysis set.
Posted
Count of Participants
Participants
through Day 361
ID
Title
Description
OG000
AZD3152 - Main Cohort
(AZD3152 experimental treatment)
OG001
AZD7442 - Main Cohort
(AZD7442 active comparator treatment)
OG002
Placebo - Main Cohort
(Placebo comparator treatment)
Units
Counts
Participants
Secondary
(Main Cohort) Composite of COVID-19-related Hospitalization and/or COVID-19-related Death (WHO COVID-19 Clinical Progression Scale Score ≥ 4) Any Time up to 12 Months
Secondary: (Main Cohort) Composite of COVID-19-related hospitalization and/or COVID-19-related death (WHO COVID-19 Clinical Progression Scale score ≥ 4) any time up to 12 months.
SARS-CoV-2-Negative Set: all randomized participants who received part or all of the study intervention and did not have evidence of a current SARS-CoV-2 infection at baseline. Participants with positive RT-PCR test results at baseline were excluded from this analysis set.
Posted
Count of Participants
Participants
through Day 361
ID
Title
Description
OG000
AZD3152 - Main Cohort
(AZD3152 experimental treatment)
OG001
AZD7442 - Main Cohort
(AZD7442 active comparator treatment)
OG002
Placebo - Main Cohort
(Placebo comparator treatment)
Units
Counts
Secondary
(Main Cohort) COVID-19-related Hospitalization Any Time up to 12 Months
Secondary: (Main Cohort) COVID-19-related hospitalization any time up to 12 months.
SARS-CoV-2-Negative Set: all randomized participants who received part or all of the study intervention and did not have evidence of a current SARS-CoV-2 infection at baseline. Participants with positive RT-PCR test results at baseline were excluded from this analysis set.
Posted
Count of Participants
Participants
through Day 361
ID
Title
Description
OG000
AZD3152 - Main Cohort
(AZD3152 experimental treatment)
OG001
AZD7442 - Main Cohort
(AZD7442 active comparator treatment)
OG002
Placebo - Main Cohort
(Placebo comparator treatment)
Units
Counts
Participants
Secondary
(Main Cohort) COVID-19 Related Death
(Main Cohort) COVID-19 related death - through Day 361
SARS-CoV-2-Negative Set: all randomized participants who received part or all of the study intervention and did not have evidence of a current SARS-CoV-2 infection at baseline. Participants with positive RT-PCR test results at baseline were excluded from this analysis set.
Posted
Count of Participants
Participants
through Day 361
ID
Title
Description
OG000
AZD3152 - Main Cohort
(AZD3152 experimental treatment)
OG001
AZD7442 - Main Cohort
(AZD7442 active comparator treatment)
OG002
Placebo - Main Cohort
(Placebo comparator treatment)
Units
Counts
Participants
Secondary
(Main Cohort) GMT of SARS-CoV-2 nAbs at Baseline and Day 29
Secondary: (Main Cohort) GMT of SARS-CoV-2 nAbs at baseline and Day 29
SARS-CoV-2 nAb Set: all participants who received part or all of the study intervention and had baseline and at least one post-dose antibody measurement. Participants with protocol deviations that may interfere with serum SARS-CoV-2 nAb titers or interpretation of nAb responses may be excluded or have data collected on or after the protocol deviations be set to missing. Participants with a positive baseline central SARS-CoV-2 RT-PCR test were excluded from this analysis set.
Posted
Geometric Mean
95% Confidence Interval
1/dilution
at Day 29
ID
Title
Description
OG000
AZD3152 - Main Cohort
(AZD3152 experimental treatment)
OG001
AZD7442 - Main Cohort
(AZD7442 active comparator treatment)
OG002
Placebo - Main Cohort
(Placebo comparator treatment)
Units
Counts
Secondary
(Main Cohort) GMFR of SARS-CoV-2 nAbs at Day 29
Secondary: (Main Cohort) GMFR of SARS-CoV-2 nAbs at Day 29
SARS-CoV-2 nAb Set: all participants who received part or all of the study intervention and had baseline and at least one post-dose antibody measurement. Participants with protocol deviations that may interfere with serum SARS-CoV-2 nAb titers or interpretation of nAb responses may be excluded or have data collected on or after the protocol deviations be set to missing. Participants with a positive baseline central SARS-CoV-2 RT-PCR test were excluded from this analysis set.
Posted
Geometric Mean
95% Confidence Interval
ratio
at Day 29
ID
Title
Description
OG000
AZD3152 - Main Cohort
(AZD3152 experimental treatment)
OG001
AZD7442 - Main Cohort
(AZD7442 active comparator treatment)
OG002
Placebo - Main Cohort
(Placebo comparator treatment)
Units
Counts
Secondary
(Main Cohort) AZD3152 and AZD7442 (EVUSHELD) Concentrations Over Time
(Main Cohort) AZD3152 and AZD7442 (EVUSHELD) concentrations over time - through Day 361
Pharmacokinetic analysis set: all randomized participants who received a full dose of IMP per protocol, with sufficient information to estimate at least 1 postdose quantifiable serum concentration for any mAb component. Participants with protocol deviations that may interfere with the serum concentrations may be excluded or have data collected after the protocol deviations set to missing.
Posted
Geometric Mean
Geometric Coefficient of Variation
mg/L
through Day 361
ID
Title
Description
OG000
AZD3152 - Main Cohort
(AZD3152 experimental treatment)
OG001
AZD7442 - Main Cohort
(AZD7442 active comparator treatment)
Units
Counts
Participants
OG000
Secondary
(Main Cohort) Incidence of ADA to AZD3152 and AZD7442 (EVUSHELD)
AZD3152 recipients were tested for ADA to AZD3152; AZD7442 recipients were tested for ADA to AZD7442.
The ADA analysis sets: all participants who received part or all of study intervention and had a non-missing baseline and at least one non-missing post-baseline ADA result of the same mAb component.
Posted
Count of Participants
Participants
through Day 361
ID
Title
Description
OG000
AZD3152 - Main Cohort
(AZD3152 experimental treatment)
OG001
AZD7442 - Main Cohort
(AZD7442 active comparator treatment)
Units
Counts
Participants
OG000
Secondary
(Sentinel Cohort) AZD5156, AZD1061, and AZD3152 Concentrations Over Time
AZD5156 is a combination of AZD3152 and AZD1061. This summary is only eligible for AZD5156 group.
Pharmacokinetic analysis set: all randomized participants who received a full dose of IMP per protocol, with sufficient information to estimate at least 1 postdose quantifiable serum concentration for any mAb component. Participants with protocol deviations that may interfere with the serum concentrations may be excluded or have data collected after the protocol deviations set to missing.
Posted
Geometric Mean
Geometric Coefficient of Variation
mg/L
Day 29, Day 181, Day 361
ID
Title
Description
OG000
AZD5156 - Sentinel Cohort
(AZD5156 experimental treatment)
Units
Counts
Participants
OG000
Secondary
(Sentinel Cohort) Incidence of ADA to AZD5156, AZD3152, and AZD1061
(Sentinel Cohort) Incidence of ADA to AZD5156, AZD3152, and AZD1061 - through Day 361
The ADA analysis sets: all participants who received part or all of study intervention and had a non-missing baseline and at least one non-missing post-baseline ADA result of the same mAb component.
Posted
Count of Participants
Participants
through Day 361
ID
Title
Description
OG000
AZD5156 - Sentinel Cohort
(AZD5156 experimental treatment)
Units
Counts
Participants
OG00040
Secondary
(Main Cohort) ADA Titers
ADA titers were only available for ADA positive samples.
The ADA analysis sets: all participants who received part or all of study intervention and had a non-missing baseline and at least one non-missing post-baseline ADA result of the same mAb component.
Posted
Median
Full Range
ADA titers
through Day 361
ID
Title
Description
OG000
AZD3152 - Main Cohort
(AZD3152 experimental treatment)
OG001
AZD7442 - Main Cohort
(AZD7442 active comparator treatment)
Units
Counts
Participants
OG000
Secondary
(Main Cohort) AZD1061 and AZD8895 Concentrations Over Time
AZD7442 (ie EVUSHELD) is composed of AZD1061 (ie, cilgavimab) and AZD8895 (ie, tixagevimab). This summary is only applicable to AZD7442 group.
Only AZD7442 group of Pharmacokinetic analysis set is eligible for the summary.
Posted
Geometric Mean
Geometric Coefficient of Variation
mg/L
through Day 361
ID
Title
Description
OG000
AZD7442 - Main Cohort
(AZD7442 active comparator treatment)
Units
Counts
Participants
OG000780
Time Frame
through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
Description
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
AZD3152 - Main Cohort
(Including participants who received AZD3152 on Day 1 and either AZD3152 or no dose on Day 181)
40
1,671
315
1,671
892
1,671
EG001
AZD7442 - Main Cohort
(Including participants who received AZD7442 on Day 1 and either placebo or no dose on Day 181)
24
1,102
222
1,102
624
1,102
EG002
Placebo - Main Cohort
(Including participants who received placebo on Day 1 and either placebo or no dose on Day 181)
6
561
90
561
292
561
EG003
AZD5156 - Sentinel Cohort
(AZD5156 experimental treatment)
1
41
2
41
19
41
EG004
Placebo - Sentinel Cohort
(Placebo comparator treatment)
0
16
0
16
12
16
EG005
AZD3152 - Sub Study
(AZD3152 experimental treatment)
2
310
15
310
38
310
EG006
AZD7442 - Sub Study
(AZD7442 active comparator treatment)
0
156
11
156
17
156
EG007
Crossover - Sub Study
(Including 2 immunocompromised participants who received AZD7442 at Day 1 then AZD3152 at Day 29)
Infective exacerbation of chronic obstructive airways disease
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Influenza
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0006 events6 affected1,671 at risk
EG0013 events3 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Jc virus infection
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0021 events1 affected561 at risk
EG003
Kidney infection
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0021 events1 affected561 at risk
EG003
Klebsiella bacteraemia
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 27.1
Systematic Assessment
EG00013 events12 affected1,671 at risk
EG0018 events7 affected1,102 at risk
EG0022 events2 affected561 at risk
EG003
Klebsiella sepsis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0021 events1 affected561 at risk
EG003
Large intestine infection
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Liver abscess
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Localised infection
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Measles
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0021 events1 affected561 at risk
EG003
Medical device site joint infection
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Metapneumovirus pneumonia
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Necrotising soft tissue infection
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0021 events1 affected561 at risk
EG003
Atrial flutter
Cardiac disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0012 events2 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Neutropenic sepsis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0014 events4 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Norovirus infection
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Oesophageal candidiasis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Osteomyelitis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0003 events3 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0021 events1 affected561 at risk
EG003
Otitis media
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Parainfluenzae virus infection
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0021 events1 affected561 at risk
EG003
Pelvic abscess
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0021 events1 affected561 at risk
EG003
Peritonitis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0003 events3 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0021 events1 affected561 at risk
EG003
Peritonitis bacterial
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Pilonidal disease
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Atrioventricular block complete
Cardiac disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Pneumococcal infection
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Pneumocystis jirovecii pneumonia
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0021 events1 affected561 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG00034 events32 affected1,671 at risk
EG00115 events15 affected1,102 at risk
EG0026 events6 affected561 at risk
EG003
Pneumonia bacterial
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0003 events3 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0022 events2 affected561 at risk
EG003
Pneumonia haemophilus
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0002 events2 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Pneumonia influenzal
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Pneumonia mycoplasmal
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0002 events2 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Pneumonia necrotising
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Pneumonia pneumococcal
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0021 events1 affected561 at risk
EG003
Pneumonia respiratory syncytial viral
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Atrioventricular block second degree
Cardiac disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Pneumonia serratia
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Pneumonia staphylococcal
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Pneumonia viral
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0012 events2 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Post procedural infection
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0021 events1 affected561 at risk
EG003
Postoperative wound infection
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0021 events1 affected561 at risk
EG003
Progressive multifocal leukoencephalopathy
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0021 events1 affected561 at risk
EG003
Pulmonary sepsis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Pulmonary tuberculosis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Pyelonephritis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0002 events2 affected1,671 at risk
EG0012 events2 affected1,102 at risk
EG0021 events1 affected561 at risk
EG003
Pyelonephritis acute
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0002 events2 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Bradycardia
Cardiac disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Pyomyositis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Renal graft infection
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Respiratory syncytial virus bronchitis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0022 events1 affected561 at risk
EG003
Respiratory syncytial virus infection
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0021 events1 affected561 at risk
EG003
Respiratory tract infection bacterial
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Respiratory tract infection viral
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Rhinovirus infection
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0021 events1 affected561 at risk
EG003
Rickettsiosis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Sepsis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG00012 events12 affected1,671 at risk
EG0019 events9 affected1,102 at risk
EG0024 events4 affected561 at risk
EG003
Cardiac arrest
Cardiac disorders
MedDRA 27.1
Systematic Assessment
EG0007 events7 affected1,671 at risk
EG0012 events2 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Septic pulmonary embolism
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Septic shock
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG00015 events14 affected1,671 at risk
EG0014 events4 affected1,102 at risk
EG0023 events3 affected561 at risk
EG003
Staphylococcal bacteraemia
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0004 events4 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0022 events2 affected561 at risk
EG003
Staphylococcal infection
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0012 events2 affected1,102 at risk
EG0021 events1 affected561 at risk
EG003
Staphylococcal sepsis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0002 events2 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Stenotrophomonas infection
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0012 events1 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Stenotrophomonas maltophilia pneumonia
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Streptococcal infection
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0021 events1 affected561 at risk
EG003
Streptococcal sepsis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0002 events2 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Cardiac failure
Cardiac disorders
MedDRA 27.1
Systematic Assessment
EG0002 events1 affected1,671 at risk
EG0012 events2 affected1,102 at risk
EG0022 events2 affected561 at risk
EG003
Superinfection bacterial
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0021 events1 affected561 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0009 events8 affected1,671 at risk
EG0016 events6 affected1,102 at risk
EG0021 events1 affected561 at risk
EG003
Urinary tract infection bacterial
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0012 events2 affected1,102 at risk
EG0021 events1 affected561 at risk
EG003
Urinary tract infection fungal
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Urinary tract infection pseudomonal
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Urosepsis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0004 events4 affected1,671 at risk
EG0013 events3 affected1,102 at risk
EG0021 events1 affected561 at risk
EG003
Varicella
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Vascular access site cellulitis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Cardiac failure acute
Cardiac disorders
MedDRA 27.1
Systematic Assessment
EG0009 events8 affected1,671 at risk
EG0014 events4 affected1,102 at risk
EG0021 events1 affected561 at risk
EG003
Viral sepsis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0012 events2 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Wound cellulitis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Wound infection
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Wound infection staphylococcal
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Accidental overdose
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0021 events1 affected561 at risk
EG003
Acetabulum fracture
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Anaemia postoperative
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Anastomotic ulcer
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Ankle fracture
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0002 events2 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA 27.1
Systematic Assessment
EG0004 events3 affected1,671 at risk
EG0016 events6 affected1,102 at risk
EG0022 events2 affected561 at risk
EG003
Cardiac failure congestive
Cardiac disorders
MedDRA 27.1
Systematic Assessment
EG00012 events11 affected1,671 at risk
EG00111 events10 affected1,102 at risk
EG0022 events2 affected561 at risk
EG003
Arteriovenous fistula occlusion
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Arteriovenous fistula site complication
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0002 events2 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Arteriovenous fistula thrombosis
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0021 events1 affected561 at risk
EG003
Arteriovenous graft thrombosis
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0012 events2 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Burns second degree
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0021 events1 affected561 at risk
EG003
Cervical vertebral fracture
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Comminuted fracture
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Complications of transplanted kidney
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Cystitis radiation
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Cardiac valve disease
Cardiac disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Deep vein thrombosis postoperative
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Femoral neck fracture
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0002 events2 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Femur fracture
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0021 events1 affected561 at risk
EG003
Fibula fracture
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Foot fracture
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Gastrointestinal stoma complication
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Gastrostomy tube site complication
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Graft haemorrhage
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Hip fracture
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0002 events2 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Cardio-respiratory arrest
Cardiac disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Humerus fracture
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Hyphaema
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Incisional hernia, obstructive
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Intentional overdose
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Limb injury
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Lower limb fracture
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0021 events1 affected561 at risk
EG003
Multiple fractures
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Pelvic fracture
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Post procedural bile leak
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Post procedural complication
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Cardiogenic shock
Cardiac disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Post procedural fever
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Post procedural haemorrhage
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0002 events2 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Postoperative respiratory failure
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Procedural haemorrhage
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Radius fracture
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0002 events2 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Renal transplant failure
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Rib fracture
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Spinal compression fracture
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Spinal fracture
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Spleen contusion
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Coronary artery disease
Cardiac disorders
MedDRA 27.1
Systematic Assessment
EG0003 events3 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Subcutaneous haematoma
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Subdural haemorrhage
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Tendon injury
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Tendon rupture
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Tibia fracture
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Ulna fracture
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Upper limb fracture
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0021 events1 affected561 at risk
EG003
Vascular access site thrombosis
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Vascular graft complication
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Vascular graft occlusion
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Heart failure with preserved ejection fraction
Cardiac disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Wound dehiscence
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Anticoagulation drug level above therapeutic
Investigations
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Influenza a virus test positive
Investigations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
International normalised ratio increased
Investigations
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Troponin increased
Investigations
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
White blood cell count decreased
Investigations
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0012 events2 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Diabetic ketoacidosis
Metabolism and nutrition disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0021 events1 affected561 at risk
EG003
Heart failure with reduced ejection fraction
Cardiac disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0023 events3 affected561 at risk
EG003
Electrolyte imbalance
Metabolism and nutrition disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Gout
Metabolism and nutrition disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0012 events2 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 27.1
Systematic Assessment
EG0008 events8 affected1,671 at risk
EG00112 events8 affected1,102 at risk
EG0021 events1 affected561 at risk
EG003
Hypernatraemia
Metabolism and nutrition disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Hypervolaemia
Metabolism and nutrition disorders
MedDRA 27.1
Systematic Assessment
EG00013 events11 affected1,671 at risk
EG00114 events10 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0014 events3 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Hypovolaemia
Metabolism and nutrition disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Hypertensive heart disease
Cardiac disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Type 2 diabetes mellitus
Metabolism and nutrition disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0012 events2 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Chondrocalcinosis
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Fracture nonunion
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Immunoglobulin g4 related disease
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0021 events1 affected561 at risk
EG003
Intervertebral disc protrusion
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Joint destruction
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Lumbar spinal stenosis
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Left ventricular dysfunction
Cardiac disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0021 events1 affected561 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Osteonecrosis
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Psoriatic arthropathy
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Rhabdomyolysis
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0003 events3 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0021 events1 affected561 at risk
EG003
Rheumatoid arthritis
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0013 events1 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Sacroiliitis
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Mitral valve incompetence
Cardiac disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Spinal osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0021 events1 affected561 at risk
EG003
Spinal stenosis
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Systemic lupus erythematosus
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0002 events2 affected1,671 at risk
EG0012 events2 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Acute myeloid leukaemia
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Acute myeloid leukaemia refractory
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Adenocarcinoma gastric
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0021 events1 affected561 at risk
EG003
Adenocarcinoma of colon
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.1
Systematic Assessment
EG0002 events2 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0021 events1 affected561 at risk
EG003
Anaplastic large cell lymphoma t- and null-cell types
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
B-cell lymphoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
B-cell small lymphocytic lymphoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0021 events1 affected561 at risk
EG003
Autoimmune neutropenia
Blood and lymphatic system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA 27.1
Systematic Assessment
EG0004 events4 affected1,671 at risk
EG0012 events2 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Bladder cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0021 events1 affected561 at risk
EG003
Brain neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Bronchial carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Central nervous system lymphoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0013 events3 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Cholangiocarcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Chronic lymphocytic leukaemia
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.1
Systematic Assessment
EG0002 events2 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0021 events1 affected561 at risk
EG003
Clear cell renal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Colon cancer metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Colorectal cancer metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Diffuse large b-cell lymphoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.1
Systematic Assessment
EG0002 events2 affected1,671 at risk
EG0012 events2 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Pericardial effusion
Cardiac disorders
MedDRA 27.1
Systematic Assessment
EG0002 events2 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Endometrial cancer metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Follicular lymphoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0021 events1 affected561 at risk
EG003
Follicular lymphoma stage iv
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Glioma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Hepatocellular carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
High-grade b-cell lymphoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Hormone receptor positive breast cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Intestinal adenocarcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Invasive ductal breast carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Lung adenocarcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0012 events2 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Pericarditis
Cardiac disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Lymphoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Malignant melanoma in situ
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Malignant neoplasm progression
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.1
Systematic Assessment
EG0002 events2 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Mantle cell lymphoma recurrent
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Marginal zone lymphoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Myelodysplastic syndrome
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Non-hodgkin's lymphoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0012 events2 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Non-small cell lung cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.1
Systematic Assessment
EG0002 events2 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0021 events1 affected561 at risk
EG003
Non-small cell lung cancer metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Oesophageal adenocarcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Supraventricular tachycardia
Cardiac disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0021 events1 affected561 at risk
EG003
Ovarian cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Pancreatic carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0021 events1 affected561 at risk
EG003
Papillary thyroid cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Plasma cell myeloma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0021 events1 affected561 at risk
EG003
Plasma cell myeloma recurrent
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Post transplant lymphoproliferative disorder
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0021 events1 affected561 at risk
EG003
Prostate cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.1
Systematic Assessment
EG0002 events2 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Prostate cancer metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Prostate cancer stage iv
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0021 events1 affected561 at risk
EG003
Rectal cancer stage iv
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Renal cancer metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Renal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Renal neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Skin squamous cell carcinoma metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Squamous cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Squamous cell carcinoma of skin
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0021 events1 affected561 at risk
EG003
T-cell lymphoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Throat cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Transitional cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Transitional cell carcinoma metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Ventricular extrasystoles
Cardiac disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Uterine leiomyoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Altered state of consciousness
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0021 events1 affected561 at risk
EG003
Aphasia
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Ataxia
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Brain injury
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0012 events2 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Brain stem haemorrhage
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Brain stem infarction
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Brain stem stroke
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Carotid arteriosclerosis
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Carotid artery disease
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Ventricular fibrillation
Cardiac disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Cauda equina syndrome
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0021 events1 affected561 at risk
EG003
Central nervous system lupus
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Cerebral haemorrhage
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Cerebral infarction
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0021 events1 affected561 at risk
EG003
Cerebral microinfarction
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0006 events6 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Cervical radiculopathy
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Diabetic neuropathy
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Embolic stroke
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Encephalopathy
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0002 events2 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Ventricular tachyarrhythmia
Cardiac disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Epilepsy
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Facial paralysis
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Focal dyscognitive seizures
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Haemorrhage intracranial
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Haemorrhagic stroke
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Headache
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0022 events2 affected561 at risk
EG003
Idiopathic intracranial hypertension
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Intracranial aneurysm
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Ischaemic stroke
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0002 events2 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Metabolic encephalopathy
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0004 events3 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Ventricular tachycardia
Cardiac disorders
MedDRA 27.1
Systematic Assessment
EG0003 events3 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Migraine
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Multiple sclerosis
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Multiple sclerosis relapse
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0002 events2 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Myasthenia gravis
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0021 events1 affected561 at risk
EG003
Myasthenia gravis crisis
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Myelopathy
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Nerve compression
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Neurotoxicity
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Partial seizures
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Phrenic nerve paralysis
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Haemorrhagic arteriovenous malformation
Congenital, familial and genetic disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Sciatica
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0012 events2 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Seizure
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0003 events3 affected1,671 at risk
EG0012 events2 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Syncope
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0007 events7 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0021 events1 affected561 at risk
EG003
Tension headache
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Toxic encephalopathy
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Transient ischaemic attack
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0012 events2 affected1,102 at risk
EG0021 events1 affected561 at risk
EG003
Trigeminal neuralgia
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Vith nerve paralysis
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Device malfunction
Product Issues
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Alcohol withdrawal syndrome
Psychiatric disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Bicytopenia
Blood and lymphatic system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Bipolar disorder
Psychiatric disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Mental status changes
Psychiatric disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0013 events3 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Post-traumatic stress disorder
Psychiatric disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Psychotic disorder
Psychiatric disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Suicide attempt
Psychiatric disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 27.1
Systematic Assessment
EG00011 events11 affected1,671 at risk
EG00110 events8 affected1,102 at risk
EG0025 events4 affected561 at risk
EG003
Azotaemia
Renal and urinary disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Bladder perforation
Renal and urinary disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Chronic kidney disease
Renal and urinary disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0021 events1 affected561 at risk
EG003
Cystitis haemorrhagic
Renal and urinary disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Thyroid disorder
Endocrine disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0021 events1 affected561 at risk
EG003
End stage renal disease
Renal and urinary disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Hydronephrosis
Renal and urinary disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0021 events1 affected561 at risk
EG003
Lupus nephritis
Renal and urinary disorders
MedDRA 27.1
Systematic Assessment
EG0002 events2 affected1,671 at risk
EG0012 events1 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Nephrotic syndrome
Renal and urinary disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Renal artery stenosis
Renal and urinary disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Renal failure
Renal and urinary disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Renal infarct
Renal and urinary disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Renal injury
Renal and urinary disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Cataract
Eye disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Renal mass
Renal and urinary disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Subcapsular renal haematoma
Renal and urinary disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Ureterolithiasis
Renal and urinary disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Urinary retention
Renal and urinary disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Cervical dysplasia
Reproductive system and breast disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Cystocele
Reproductive system and breast disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Endometrial hyperplasia
Reproductive system and breast disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Ovarian cyst
Reproductive system and breast disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Pelvic pain
Reproductive system and breast disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Diabetic retinal oedema
Eye disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Prostatitis
Reproductive system and breast disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Acute pulmonary oedema
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0002 events2 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Acute respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0007 events7 affected1,671 at risk
EG00111 events9 affected1,102 at risk
EG0023 events3 affected561 at risk
EG003
Aspiration
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0022 events1 affected561 at risk
EG003
Bronchial hyperreactivity
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Bronchiectasis
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0021 events1 affected561 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0005 events5 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0021 events1 affected561 at risk
EG003
Chronic rhinosinusitis with nasal polyps
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Glaucoma
Eye disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0005 events5 affected1,671 at risk
EG0013 events3 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0002 events2 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Haemothorax
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Interstitial lung disease
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0021 events1 affected561 at risk
EG003
Lupus pleurisy
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Malignant pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Organising pneumonia
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0022 events2 affected561 at risk
EG003
Retinal vein occlusion
Eye disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0005 events3 affected1,671 at risk
EG0013 events3 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0008 events8 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0021 events1 affected561 at risk
EG003
Pulmonary fibrosis
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Pulmonary haemorrhage
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Pulmonary hypertension
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0012 events2 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Pulmonary infarction
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0021 events1 affected561 at risk
EG003
Pulmonary oedema
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0007 events7 affected1,671 at risk
EG0014 events4 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Respiratory arrest
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0002 events2 affected1,671 at risk
EG0013 events3 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Abdominal adhesions
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Diabetic foot
Skin and subcutaneous tissue disorders
MedDRA 27.1
Systematic Assessment
EG0002 events2 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Erythema nodosum
Skin and subcutaneous tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Skin mass
Skin and subcutaneous tissue disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Abdominal hernia
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Toe amputation
Surgical and medical procedures
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0021 events1 affected561 at risk
EG003
Aneurysm ruptured
Vascular disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Aortic dissection
Vascular disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Aortic stenosis
Vascular disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0021 events1 affected561 at risk
EG003
Aortitis
Vascular disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Arterial thrombosis
Vascular disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Brachiocephalic vein thrombosis
Vascular disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA 27.1
Systematic Assessment
EG0003 events1 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0023 events2 affected561 at risk
EG003
Dialysis hypotension
Vascular disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0021 events1 affected561 at risk
EG003
Haematoma
Vascular disorders
MedDRA 27.1
Systematic Assessment
EG0002 events1 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0002 events2 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0021 events1 affected561 at risk
EG003
Hypertension
Vascular disorders
MedDRA 27.1
Systematic Assessment
EG0004 events4 affected1,671 at risk
EG0012 events2 affected1,102 at risk
EG0021 events1 affected561 at risk
EG003
Hypertensive crisis
Vascular disorders
MedDRA 27.1
Systematic Assessment
EG0004 events4 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Hypertensive emergency
Vascular disorders
MedDRA 27.1
Systematic Assessment
EG0005 events5 affected1,671 at risk
EG0017 events6 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Hypertensive urgency
Vascular disorders
MedDRA 27.1
Systematic Assessment
EG0002 events1 affected1,671 at risk
EG0014 events4 affected1,102 at risk
EG0022 events2 affected561 at risk
EG003
Hypotension
Vascular disorders
MedDRA 27.1
Systematic Assessment
EG0009 events8 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0021 events1 affected561 at risk
EG003
Hypovolaemic shock
Vascular disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Jugular vein thrombosis
Vascular disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Orthostatic hypotension
Vascular disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Peripheral arterial occlusive disease
Vascular disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Peripheral ischaemia
Vascular disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Peripheral venous disease
Vascular disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Raynaud's phenomenon
Vascular disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Shock haemorrhagic
Vascular disorders
MedDRA 27.1
Systematic Assessment
EG0002 events2 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Superficial vein thrombosis
Vascular disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Venous stenosis
Vascular disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Blood loss anaemia
Blood and lymphatic system disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0021 events1 affected561 at risk
EG003
Abdominal wall cyst
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0003 events3 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0024 events2 affected561 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0005 events5 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Colitis ischaemic
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Colitis ulcerative
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0012 events1 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0002 events2 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Diverticulum intestinal
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0021 events1 affected561 at risk
EG003
Diverticulum intestinal haemorrhagic
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Duodenal stenosis
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0021 events1 affected561 at risk
EG003
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA 27.1
Systematic Assessment
EG0007 events6 affected1,671 at risk
EG0017 events5 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Duodenal ulcer haemorrhage
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0021 events1 affected561 at risk
EG003
Faecaloma
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Femoral hernia
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Fistula of small intestine
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0023 events1 affected561 at risk
EG003
Food poisoning
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Gastritis haemorrhagic
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0021 events1 affected561 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0003 events3 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Gastrointestinal pain
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Gastrointestinal polyp haemorrhage
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Immune-mediated pancytopenia
Blood and lymphatic system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0021 events1 affected561 at risk
EG003
Haematemesis
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Hiatus hernia
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Ileus
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Impaired gastric emptying
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0012 events1 affected1,102 at risk
EG0021 events1 affected561 at risk
EG003
Inguinal hernia
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0002 events2 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Internal hernia
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Intestinal obstruction
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Intestinal perforation
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Intra-abdominal haemorrhage
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Iron deficiency anaemia
Blood and lymphatic system disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Large intestinal ulcer perforation
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Large intestine perforation
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Lower gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Obstructive pancreatitis
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Oedematous pancreatitis
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0022 events1 affected561 at risk
EG003
Oesophageal stenosis
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Oesophagitis
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0012 events2 affected1,102 at risk
EG0021 events1 affected561 at risk
EG003
Oral macule
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Vomiting
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG00038 events34 affected1,671 at risk
EG00117 events17 affected1,102 at risk
EG00211 events11 affected561 at risk
EG0030 events0 affected41 at risk
EG0040 events0 affected16 at risk
EG0051 events1 affected310 at risk
EG0061 events1 affected156 at risk
EG0070 events0 affected2 at risk
Asthenia
General disorders
MedDRA 27.1
Systematic Assessment
EG00040 events39 affected1,671 at risk
EG00129 events26 affected1,102 at risk
EG0028 events8 affected561 at risk
EG003
Fatigue
General disorders
MedDRA 27.1
Systematic Assessment
EG000109 events98 affected1,671 at risk
EG00177 events69 affected1,102 at risk
EG00239 events35 affected561 at risk
EG003
Injection site pain
General disorders
MedDRA 27.1
Systematic Assessment
EG00034 events33 affected1,671 at risk
EG00133 events29 affected1,102 at risk
EG0028 events7 affected561 at risk
EG003
Injection site pruritus
General disorders
MedDRA 27.1
Systematic Assessment
EG0003 events3 affected1,671 at risk
EG0012 events2 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 27.1
Systematic Assessment
EG0004 events4 affected1,671 at risk
EG0014 events4 affected1,102 at risk
EG0022 events2 affected561 at risk
EG003
Peripheral swelling
General disorders
MedDRA 27.1
Systematic Assessment
EG0004 events4 affected1,671 at risk
EG0012 events2 affected1,102 at risk
EG0022 events2 affected561 at risk
EG003
Pyrexia
General disorders
MedDRA 27.1
Systematic Assessment
EG00062 events53 affected1,671 at risk
EG00145 events43 affected1,102 at risk
EG00220 events15 affected561 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG00056 events49 affected1,671 at risk
EG00133 events30 affected1,102 at risk
EG0028 events7 affected561 at risk
EG003
Covid-19
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG000293 events273 affected1,671 at risk
EG001218 events205 affected1,102 at risk
EG002116 events112 affected561 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG00017 events17 affected1,671 at risk
EG00112 events12 affected1,102 at risk
EG0023 events3 affected561 at risk
EG003
Gastritis viral
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Gastroenteritis viral
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0003 events3 affected1,671 at risk
EG0012 events2 affected1,102 at risk
EG0022 events2 affected561 at risk
EG003
Influenza
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG00038 events37 affected1,671 at risk
EG00114 events14 affected1,102 at risk
EG0028 events8 affected561 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG00085 events77 affected1,671 at risk
EG00145 events41 affected1,102 at risk
EG00227 events24 affected561 at risk
EG003
Respiratory tract infection viral
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0002 events2 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0021 events1 affected561 at risk
EG003
Rhinitis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG00047 events41 affected1,671 at risk
EG00132 events27 affected1,102 at risk
EG00211 events10 affected561 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG00062 events50 affected1,671 at risk
EG00142 events34 affected1,102 at risk
EG00221 events18 affected561 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG000150 events121 affected1,671 at risk
EG00169 events63 affected1,102 at risk
EG00250 events44 affected561 at risk
EG003
Ureaplasma infection
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG000125 events87 affected1,671 at risk
EG00185 events60 affected1,102 at risk
EG00231 events27 affected561 at risk
EG003
Viral upper respiratory tract infection
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG00025 events19 affected1,671 at risk
EG00115 events11 affected1,102 at risk
EG00210 events9 affected561 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG00011 events10 affected1,671 at risk
EG00113 events11 affected1,102 at risk
EG0029 events7 affected561 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG00041 events39 affected1,671 at risk
EG00126 events25 affected1,102 at risk
EG00214 events14 affected561 at risk
EG003
Sars-cov-2 test positive
Investigations
MedDRA 27.1
Systematic Assessment
EG00029 events29 affected1,671 at risk
EG00123 events23 affected1,102 at risk
EG0023 events3 affected561 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG00039 events34 affected1,671 at risk
EG00124 events22 affected1,102 at risk
EG00210 events9 affected561 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG00020 events20 affected1,671 at risk
EG00125 events25 affected1,102 at risk
EG00220 events18 affected561 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG00039 events37 affected1,671 at risk
EG00136 events32 affected1,102 at risk
EG00219 events17 affected561 at risk
EG003
Rheumatoid arthritis
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG00035 events24 affected1,671 at risk
EG00133 events25 affected1,102 at risk
EG00217 events12 affected561 at risk
EG003
Headache
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG000154 events128 affected1,671 at risk
EG00197 events83 affected1,102 at risk
EG00246 events36 affected561 at risk
EG003
Migraine
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0005 events5 affected1,671 at risk
EG0016 events5 affected1,102 at risk
EG0025 events5 affected561 at risk
EG003
Syncope
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0009 events8 affected1,671 at risk
EG0013 events3 affected1,102 at risk
EG0022 events2 affected561 at risk
EG003
Motion sickness
Ear and labyrinth disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA 27.1
Systematic Assessment
EG0004 events3 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0022 events2 affected561 at risk
EG003
Dysmenorrhoea
Reproductive system and breast disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG000170 events144 affected1,671 at risk
EG001135 events111 affected1,102 at risk
EG00233 events25 affected561 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG00062 events58 affected1,671 at risk
EG00133 events27 affected1,102 at risk
EG00213 events13 affected561 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG000119 events96 affected1,671 at risk
EG00170 events58 affected1,102 at risk
EG00224 events22 affected561 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG00085 events70 affected1,671 at risk
EG00168 events59 affected1,102 at risk
EG00220 events18 affected561 at risk
EG003
Wheezing
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0021 events1 affected561 at risk
EG003
Acne
Skin and subcutaneous tissue disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Dermatitis
Skin and subcutaneous tissue disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0021 events1 affected561 at risk
EG003
Dermatitis atopic
Skin and subcutaneous tissue disorders
MedDRA 27.1
Systematic Assessment
EG0005 events5 affected1,671 at risk
EG0011 events1 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
Ingrowing nail
Skin and subcutaneous tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0012 events2 affected1,102 at risk
EG0021 events1 affected561 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG00022 events22 affected1,671 at risk
EG00111 events8 affected1,102 at risk
EG00210 events6 affected561 at risk
EG003
Hypertension
Vascular disorders
MedDRA 27.1
Systematic Assessment
EG00054 events51 affected1,671 at risk
EG00141 events40 affected1,102 at risk
EG00222 events21 affected561 at risk
EG003
Abdominal pain lower
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0005 events5 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0021 events1 affected561 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG00078 events72 affected1,671 at risk
EG00165 events53 affected1,102 at risk
EG00227 events23 affected561 at risk
EG003
Food poisoning
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0004 events4 affected1,671 at risk
EG0010 events0 affected1,102 at risk
EG0023 events3 affected561 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG00014 events14 affected1,671 at risk
EG00111 events10 affected1,102 at risk
EG0024 events4 affected561 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG00057 events54 affected1,671 at risk
EG00135 events34 affected1,102 at risk
EG00219 events17 affected561 at risk
EG003
Oral pain
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected1,671 at risk
EG0012 events2 affected1,102 at risk
EG0020 events0 affected561 at risk
EG003
In Adverse Event reporting section, 2 immunocompromised participants who received AZD7442 on Day 1 and received the optional AZD3152 dose at Day 29 visit are included in Crossover - Sub Study group. For non-serious AE summary, only preferred terms with > 2% frequency at least 1 arm are included.
Preterm newborn infants (gestational age < 37 wks)
Title
Measurements
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
Newborns (0-27 days)
Title
Measurements
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
Infants and toddlers (28 days-23 months)
Title
Measurements
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
Children (2-11 years)
Title
Measurements
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
Adolescents (12-17 years)
Title
Measurements
BG0008
BG0017
BG0020
BG0030
BG0040
BG0050
BG0060
BG00715
Adults (18-64 years)
Title
Measurements
BG0001057
BG001678
BG002375
BG00341
BG00416
BG005250
BG006126
BG0072543
From 65-84 years
Title
Measurements
BG000597
BG001403
BG002181
BG0030
BG0040
BG00560
BG00631
BG0071272
85 years and over
Title
Measurements
BG0009
BG00114
BG0025
BG0030
BG0040
BG0050
BG0061
BG00729
329
BG00323
BG00411
BG005169
BG00694
BG0072190
Male
BG000717
BG001492
BG002232
BG00318
BG0045
BG005141
BG00664
BG0071669
78
BG00311
BG0044
BG00566
BG00633
BG007516
White
Title
Measurements
BG0001241
BG001814
BG002416
BG00327
BG0049
BG005233
BG006118
BG0072858
Asian
Title
Measurements
BG000111
BG00194
BG00213
BG0031
BG0041
BG0054
BG0064
BG007228
Other
Title
Measurements
BG00028
BG00133
BG00211
BG0032
BG0042
BG0054
BG0062
BG00782
More than one race
Title
Measurements
BG00042
BG00131
BG0022
BG0030
BG0040
BG0052
BG0061
BG00778
Unknown or Not Reported
Title
Measurements
BG00047
BG0018
BG00241
BG0030
BG0040
BG0051
BG0060
BG00797
125
BG0032
BG0040
BG00586
BG00640
BG007844
Not Hispanic or Latino
BG0001240
BG001841
BG002386
BG00337
BG00414
BG005222
BG006116
BG0072856
Not reported
BG00075
BG00126
BG00250
BG0032
BG0042
BG0052
BG0062
BG007159
78
BG00311
BG0044
BG00566
BG00633
BG007516
White
BG0001241
BG001814
BG002416
BG00327
BG0049
BG005233
BG006118
BG0072858
Asian
BG000111
BG00194
BG00213
BG0031
BG0041
BG0054
BG0064
BG007228
Other
BG00028
BG00133
BG00211
BG0032
BG0042
BG0054
BG0062
BG00782
Multiple
BG00042
BG00131
BG0022
BG0030
BG0040
BG0052
BG0061
BG00778
Not reported
BG00038
BG0018
BG00229
BG0030
BG0040
BG0051
BG0060
BG00776
Missing
BG0009
BG0010
BG00212
BG0030
BG0040
BG0050
BG0060
BG00721
50
BG0033
BG0042
BG00513
BG0065
BG007419
No SARS-CoV-2 vaccination
BG0001472
BG001955
BG002511
BG00338
BG00414
BG005297
BG006153
BG0073440
7
BG0031
BG0040
BG0052
BG0061
BG007135
No prior SARS-CoV-2 infection
BG0001605
BG0011044
BG002554
BG00340
BG00416
BG005308
BG006157
BG0073724
39
BG0030
BG0040
BG0050
BG0060
BG007378
No EVUSHELD use
BG0001480
BG001954
BG002522
BG00341
BG00416
BG0050
BG0060
BG0073013
Missing
BG0000
BG0010
BG0020
BG0030
BG0040
BG005310
BG006158
BG007468
Title
Measurements
OG000315
OG001222
OG00290
MAAEs
Title
Measurements
OG000976
OG001651
OG002297
AESIs
Title
Measurements
OG00045
OG00118
OG0029
OG000310
OG001156
OG0022
Title
Denominators
Categories
AEs
Title
Measurements
OG00081
OG00132
OG0021
SAEs
Title
Measurements
OG00015
OG00111
OG0021
MAAEs
Title
Measurements
OG00089
OG00165
OG0022
AESIs
Title
Measurements
OG0009
OG0011
OG0020
Units
Counts
Participants
OG000281
OG001141
Title
Denominators
Categories
Title
Measurements
OG000137.3± 0.56
OG00118.7± 0.61
Units
Counts
Participants
OG000281
OG001141
Title
Denominators
Categories
Title
Measurements
OG00036127.1± 0.56
OG0018882.5± 0.61
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
The geometric mean titer ratio (GMTR) and its confidence intervals are estimated from an Analysis of Variance Model that includes the log10-transformed predicted nAb titers at Day 29 as the response variable and treatment arm as the primary explanatory variable.
ANOVA
GMTR
4.07
2-Sided
90
3.71
4.46
Non-Inferiority
Pre-specified non-inferiority
OG000
OG001
The GMTR and its confidence intervals are estimated from an Analysis of Variance Model that includes the log10-transformed predicted nAb titers at Day 29 as the response variable and treatment arm as the primary explanatory variable.
ANOVA
GMTR
4.07
2-Sided
95
3.65
4.53
Superiority
OG0001649
OG0011082
OG002549
Title
Denominators
Categories
Title
Measurements
OG000122
OG001117
OG00261
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
OG002
Comparator group combined AZD7442/Placebo groups. Relative risk reduction was defined as 1-relative risk of AZD3152/AZD3152 versus Comparator, where relative risk was evaluated with a Poisson regression with robust variance, which includes study intervention and the randomization stratification factors as covariates and adjusts follow-up time.
Poisson regression
< 0.001
first-ranked p-value in Holm procedure
relative risk reduction, %
34.9
2-Sided
97.5
15.0
50.1
Superiority
OG0001649
OG0011082
OG002549
Title
Denominators
Categories
Title
Measurements
OG00054
OG00155
OG00235
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
OG002
Comparator group combined AZD7442/Placebo groups. Relative risk reduction was defined as 1-relative risk of AZD3152/AZD3152 versus Comparator, where relative risk was evaluated with a Poisson regression with robust variance, which includes study intervention and the randomization stratification factors as covariates and adjusts follow-up time.
Poisson regression
= 0.001
second-ranked p-value in Holm procedure
relative risk reduction, %
42.9
2-Sided
95
19.9
59.3
Superiority
41
OG00116
Title
Denominators
Categories
AEs
Title
Measurements
OG00019
OG00112
SAEs
Title
Measurements
OG0002
OG0010
MAAEs
Title
Measurements
OG0009
OG0013
AESIs
Title
Measurements
OG0000
OG0010
299
OG001154
Title
Denominators
Categories
Day 29
ParticipantsOG000295
ParticipantsOG001151
Title
Measurements
OG000133.4± 0.72
OG00121.2± 0.62
Day 91
ParticipantsOG000281
ParticipantsOG001154
Title
Measurements
OG00069.6± 0.82
OG001
Day 181
ParticipantsOG000285
ParticipantsOG001139
Title
Measurements
OG00030.3± 1.64
OG001
297
OG001151
Title
Denominators
Categories
Title
Measurements
OG0002
OG0010
Title
Denominators
Categories
Cilgavimab: Day 29
ParticipantsOG000151
Title
Measurements
OG0008.9± 0.65
Cilgavimab: Day 91
ParticipantsOG000143
Title
Measurements
OG0007.0± 0.68
Cilgavimab: Day 181
ParticipantsOG000139
Title
Measurements
OG0003.2± 0.84
Tixagevimab: Day 29
ParticipantsOG000151
Title
Measurements
OG0009.4± 0.64
Tixagevimab: Day 91
ParticipantsOG000143
Title
Measurements
OG0007.6± 0.66
Tixagevimab: Day 181
ParticipantsOG000139
Title
Measurements
OG0003.5± 0.89
297
OG001151
Title
Denominators
Categories
Day 1
ParticipantsOG000297
ParticipantsOG001151
Title
Measurements
OG000200(100 to 800)
OG00180(40 to 640)
Day 29
ParticipantsOG000296
ParticipantsOG001149
Title
Measurements
OG000NA(NA to NA)All ADA results were negative, and their ADA titers were below the level of detection, so the values are NAs.
OG001
Day 91
ParticipantsOG000280
ParticipantsOG001140
Title
Measurements
OG000100(100 to 100)
OG001
Day 181
ParticipantsOG000279
ParticipantsOG001135
Title
Measurements
OG000100(100 to 400)
OG001
Units
Counts
Participants
OG0001649
OG0011082
OG002549
Title
Denominators
Categories
Title
Measurements
OG00059
OG00156
OG00237
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
OG002
Comparator group combined AZD7442/Placebo groups. Relative risk reduction was defined as 1-relative risk of AZD3152/AZD3152 versus Comparator, where relative risk was evaluated with a Poisson regression with robust variance, which includes study intervention and the randomization stratification factors as covariates and adjusts follow-up time.
Poisson regression
= 0.003
relative risk reduction, %
39.8
2-Sided
95
16.2
56.7
Superiority
Units
Counts
Participants
OG0001649
OG0011082
OG002549
Title
Denominators
Categories
Title
Measurements
OG000175
OG001147
OG00279
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
OG002
Comparator group combined AZD7442/Placebo groups. Relative risk reduction was defined as 1-relative risk of AZD3152/AZD3152 versus Comparator, where relative risk was evaluated with a Poisson regression with robust variance, which includes study intervention and the randomization stratification factors as covariates and adjusts follow-up time.
Poisson regression
= 0.002
relative risk reduction, %
26.9
2-Sided
95
10.7
40.2
Superiority
OG0001649
OG0011082
OG002549
Title
Denominators
Categories
Title
Measurements
OG0003
OG0013
OG0023
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
OG002
Relative risk reduction was defined as 1-relative risk of AZD3152/AZD3152 versus Comparator, where relative risk was evaluated with a Poisson regression with robust variance, which includes study intervention and the randomization stratification factors as covariates and adjusts for follow-up time. Only participants with non-missing covariates are included in the analysis. If there is 0 event at any level of a stratification factor, then the stratification factor is dropped from the model.
Poisson regression
= 0.308
relative risk reduction, %
51.5
2-Sided
95
-95.1
87.9
Superiority
The test result was not significant, hierarchical testing procedure stopped.