SARS-CoV-2 adjuvanted recombinant protein vaccine (monovalent B.1.351) (booster dose) >= 4 months after last vaccination
SARS-CoV-2 adjuvanted recombinant protein vaccine(monovalent D614)(primary series)& SARS-CoV-2 adjuvanted recombinant protein vaccine(monovalent B.1.351)(booster dose)>=4 months after last vaccination
Countries
United States
Colombia
Ghana
Honduras
India
Japan
Kenya
Mexico
Nepal
Uganda
Ukraine
Protocol Section
Identification Module
NCT ID
NCT04904549
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
VAT00008
Secondary IDs
ID
Type
Description
Link
U1111-1264-3238
Registry Identifier
ICTRP
VAT00008
Other Identifier
Sanofi Identifier
Brief Title
Study of Monovalent and Bivalent Recombinant Protein Vaccines Against COVID-19 in Adults 18 Years of Age and Older
Official Title
A Parallel-group, Phase III, Multi-stage, Modified Double-blind, Multi-armed Study to Assess the Efficacy, Safety, and Immunogenicity of Two SARS-CoV-2 Adjuvanted Recombinant Protein Vaccines (Monovalent and Bivalent) for Prevention Against COVID-19 in Adults 18 Years of Age and Older as a Primary Series and Open-label Extension to Assess Immunogenicity, Safety, Efficacy of a Monovalent Booster Dose of SARS-CoV2 Adjuvanted Recombinant Protein Vaccine
Acronym
VAT00008
Organization
SanofiINDUSTRY
Status Module
Record Verification Date
May 2026
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
The study was terminated as per Sponsor decision
Expanded Access Info
No
Start Date
May 26, 2021Actual
Primary Completion Date
Aug 31, 2024Actual
Completion Date
Aug 31, 2024Actual
First Submitted Date
May 26, 2021
First Submission Date that Met QC Criteria
May 26, 2021
First Posted Date
May 27, 2021Actual
Results Waived
Not provided
Results First Submitted Date
Aug 29, 2025
Results First Submitted that Met QC Criteria
May 6, 2026
Results First Posted Date
Jun 3, 2026Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
May 6, 2026
Last Update Posted Date
Jun 3, 2026Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Sanofi Pasteur, a Sanofi CompanyINDUSTRY
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
No
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of this Phase III study is to assess the efficacy, safety, and immunogenicity of two CoV2 preS dTM-AS03 vaccines (monovalent and bivalent) as part of primary series vaccinations in a multi-stage approach, as well as a booster injection of a CoV2 preS dTM-AS03 vaccine, in adults 18 years of age and older.
A total of approximately 21 046 participants are planned to be enrolled (5080 per study intervention group in Stage 1 and 5443 per study intervention group in Stage 2).
Initial, double-blind, primary series study design is planned for 365 days post-last Initial injection (ie, approximately 386 days total) for each participant.
Based on decisions of the Study Oversight Group, Stage 1 and Stage 2 participants will be invited to participate in an unblinded Crossover / Booster study design with duration as follows:
For participants who initially received vaccine: 12 months post-booster (ie, approximately 18 to 24 months)
For participants who initially received placebo: ≥ 4 months post-last dose of the primary series + 12 months post-booster (ie, approximately 28 to 34 months)
For participants who do not consent to continue in the unblinded Crossover / Booster part of the study, all study procedures will be stopped and participants will be discontinued from the study.
Detailed Description
The duration of participation in the initial, double-blind, primary series design of the study will be approximately 365 days post-last injection (ie, approximately 386 days total) for each participant.
Based on decisions of the Study OG, Stage 1 and Stage 2 participants will be invited to participate in an unblinded Crossover / Booster study design with duration as follows:
For participants who initially received vaccine: 12 months post-booster (ie, approximately 18 to 24 months)
For participants who initially received placebo: ≥ 4 months post-last dose of the primary series + 12 months post-booster (ie, approximately 28 to 34 months)
For participants who do not consent to continue in the unblinded Crossover / Booster part of the study, all study procedures will be stopped and participants will be discontinued from the study.
Conditions Module
Conditions
COVID-19
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
23,670Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Stage 1: SARS-CoV-2 vaccine
Experimental
2 injections of monovalent SARS-CoV-2 vaccine at Day 1 and Day 22
Biological: SARS-CoV-2 adjuvanted recombinant protein vaccine (monovalent D614) (primary series)
Biological: SARS-CoV-2 adjuvanted recombinant protein vaccine (monovalent B.1.351) (booster dose) >= 4 months after last vaccination
Stage 1: Placebo
Placebo Comparator
2 injections of placebo at Day 1 and Day 22
Biological: Placebo
Biological: SARS-CoV-2 adjuvanted recombinant protein vaccine(monovalent D614)(primary series)& SARS-CoV-2 adjuvanted recombinant protein vaccine(monovalent B.1.351)(booster dose)>=4 months after last vaccination
Stage 2: SARS-CoV-2 vaccine
Experimental
2 injections of bivalent SARS-CoV-2 vaccine at Day 1 and Day 22
Biological: SARS-CoV-2 adjuvanted recombinant protein vaccine (monovalent B.1.351) (booster dose) >= 4 months after last vaccination
Stage 2: Placebo
Placebo Comparator
2 injections of placebo at Day 1 and Day 22
Biological: Placebo
Biological: SARS-CoV-2 adjuvanted recombinant protein vaccine(monovalent D614)(primary series)& SARS-CoV-2 adjuvanted recombinant protein vaccine(monovalent B.1.351)(booster dose)>=4 months after last vaccination
Interventions
Name
Type
Description
Arm Group Labels
Other Names
SARS-CoV-2 adjuvanted recombinant protein vaccine (monovalent D614) (primary series)
Biological
Pharmaceutical form: emulsion for injection. Route of administration: intramuscular injection
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Stage 1 and Stage 2: Number of Participants With Onset of Symptomatic Coronavirus Disease 2019 (COVID-19) Episode
Symptomatic COVID-19 was defined as virologically-confirmed SARS-CoV-2 infection accompanied by protocol-defined COVID-19-like illness (CLI).
From Day 36 up to Day 387
Stage 1 and Stage 2: Number of Participants With Solicited Injection Site and Systemic Reactions
A solicited reaction was defined as an "expected" adverse reaction (AR) (sign or symptom) observed and reported under the conditions (nature and onset) pre-listed in the protocol and case report form (CRF) collected within 7 days after each injection and considered to be related to the corresponding study vaccine administered. An injection site reaction was an AR at and around the injection site of the study vaccine. Systemic AR were all ARs that were not injection site reactions and included systemic manifestations such as headache, fever, as well as localized or topical manifestations that are not associated with the injection site.
Up to 7 days after each vaccination (post-dose on Days 1 and 22)
Stage 1 and Stage 2: Number of Participants With Unsolicited Non-Serious Adverse Events (AEs)
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An unsolicited AE was an observed AE that did not fulfill the conditions of solicited reactions, that was pre-listed in the CRF in terms of diagnosis and onset window post-vaccination.
Up to 21 days after each vaccination (post-dose on Days 1 and 22)
Stage 1 and Stage 2: Number of Participants With Immediate Adverse Events
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Immediate events were recorded to capture medically relevant unsolicited injection site and systemic AEs which occurred within the first 30 minutes after vaccination.
Secondary Outcomes
Measure
Description
Time Frame
Stage 1 and Stage 2: Number of Participants With SARS-CoV-2 Infection
SARS-CoV-2 infection was defined as a serologically-confirmed SARS-CoV-2 infection or virologically-confirmed SARS-CoV-2 infection.
From Day 36 up to Day 387
Stage 1 and Stage 2: Number of Participants With Occurrence of Severe COVID-19
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Aged 18 years or older on the day of inclusion.
For persons living with human immunodeficiency virus (HIV), stable HIV infection determined by participant currently on antiretrovirals with CD4 count > 200/mm3.
SARS-CoV-2 rapid serodiagnostic test performed at the time of enrollment to detect presence of SARS-CoV-2 antibodies.
Does not intend to receive an authorized/approved COVID-19 vaccine despite encouragement by the Investigator to receive the authorized vaccine available to them at the time of enrollment.
Informed consent form has been signed and dated
Able to attend all visits and to comply with all study procedures
Covered by health insurance, only if required by local, regional or national regulations
A female participant is eligible to participate if she is not pregnant or breastfeeding and one of the following conditions applies:
is of non-childbearing potential. To be considered of non-childbearing potential, a female must be post-menopausal for at least 1 year or surgically sterile, or
is of childbearing potential and agrees to use an effective contraceptive method or abstinence from at least 4 weeks prior to the first study intervention administration until at least 12 weeks after the second study intervention administration.
A participant of childbearing potential must have a negative highly sensitive pregnancy test (urine or serum as required by local regulation) within 25 hours before any dose of study intervention.
Exclusion Criteria:
Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to a vaccine containing any of the same substances.
Dementia or any other cognitive condition at a stage that could interfere with following the study procedures based on Investigator?s judgment.
Self-reported thrombocytopenia, contraindicating intramuscular (IM) vaccination based on Investigator?s judgment
Bleeding disorder, or receipt of anticoagulants in the past 21 days preceding inclusion, contraindicating IM vaccination based on Investigator?s judgment.
Unstable acute or chronic illness that in the opinion of the Investigator or designee poses additional risk as a result of participation or that could interfere with the study procedures.
Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (temperature ? 38.0 C [? 100.4 F]). A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided.
Receipt of any vaccine in the 30 days preceding or on the day of the first study vaccination or planned receipt of any vaccine between the first study vaccination and in the 30 days following the second study vaccination except for influenza vaccination, which may be received at any time in relation to study intervention.
Prior administration of a coronavirus vaccine (SARS-CoV-2, SARS-CoV, Middle East Respiratory Syndrome).
Receipt of solid-organ or bone marrow transplants in the past 180 days.
Receipt of anti-cancer chemotherapy in the last 90 days.
Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily.
Identified as an Investigator or employee of the Investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (ie, parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study.
Participation at the time of study enrollment (or in the 30 days preceding the first study vaccination) or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure.
Accepts Healthy Volunteers
Yes
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Not provided
Locations
Facility
Status
City
State
ZIP
Country
Contacts
AES - DRS - Simon Williamson Clinic, PC - Birmingham- Site Number : 8400004
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Types
Not provided
Time Frame
Not provided
Access Criteria
Not provided
URL
Not provided
Results Section
Participant Flow Module
Pre-assignment Details
10139 participants were enrolled in Stage 1 and 13531 in Stage 2. A total of 23670 unique participants were enrolled in the study. Participants from the Original Cohort (Stage 1 and Stage 2) were included in the booster cohort because these assessed separate objectives. The study was terminated as per Sponsor decision.
Recruitment Details
The study was conducted at 87 centers in 11 countries from 26 May 2021 to 31 August 2024.
Participants received 0.5 milliliter (mL) severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) prefusion Spike delta TM with AS03 adjuvant, monovalent D614 (CoV2 preS dTM-AS03 [D614]) vaccine as an intramuscular (IM) injection once daily on Days 1 and 22 during Stage 1.
Periods
Title
Milestones
Reasons Not Completed
Stage 1 and 2 (Up to Day 387)
Type
Comment
Milestone Data
STARTED
Enrolled and randomized
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
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
Sep 8, 2022
Aug 29, 2025
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Nigeria
Sri Lanka
Submission Tracking
Estimated Results First Submitted Date
Not provided
Condition Browse Module
MeSH Terms
Intervention Browse Module
No data available
No data is available for this block.
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
The study is designed to demonstrate clinical efficacy of each of the two SARS-CoV-2 adjuvanted recombinant protein vaccines (monovalent and bivalent). In Stage 1, the monovalent vaccine will be evaluated against a placebo control. In Stage 2, the bivalent vaccine will be assessed against a placebo control.
Primary Purpose
Prevention
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Quadruple
Masking Description
For initial, double-blind, primary series design of study: participants, outcome assessors, Investigators, laboratory personnel, and sponsor trial staff are blinded to intervention group; and those preparing the study interventions are unblinded to vaccine assignment group.
For crossover / booster design of study (Stage 1 and Stage 2): unblinded
Pharmaceutical form: emulsion for injection. Route of administration: intramuscular injection.
Stage 2: SARS-CoV-2 vaccine
Placebo
Biological
Pharmaceutical form: liquid. Route of administration: intramuscular administration.
Stage 1: Placebo
Stage 2: Placebo
SARS-CoV-2 adjuvanted recombinant protein vaccine (monovalent B.1.351) (booster dose) >= 4 months after last vaccination
Biological
Pharmaceutical form: emulsion for injection. Route of administration: intramuscular injection.
Stage 1: SARS-CoV-2 vaccine
Stage 2: SARS-CoV-2 vaccine
SARS-CoV-2 adjuvanted recombinant protein vaccine(monovalent D614)(primary series)& SARS-CoV-2 adjuvanted recombinant protein vaccine(monovalent B.1.351)(booster dose)>=4 months after last vaccination
Biological
Pharmaceutical form: emulsion for injection. Route of administration: intramuscular injection.
Stage 1: Placebo
Stage 2: Placebo
Up to 30 minutes after each vaccination (post-dose on Days 1 and 22)
Stage 1 and Stage 2: Number of Participants With Medically Attended Adverse Events (MAAE), Serious Adverse Events (SAE), and Adverse Events of Special Interest (AESI)
An SAE was defined as any AE that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event. An AESI (serious or non-serious) was 1 of scientific and medical concern specific to the Sponsor's study intervention or program, for which ongoing monitoring and rapid communication by the Investigator to the Sponsor could be appropriate. An MAAE was a new onset or a worsening of a condition that prompted the participant or participant's parent/guardian to seek unplanned medical advice at a physician's office or Emergency Department.
From first dose of study vaccine administration (Day 1) up to 387 days
Stage 1 and Stage 2: Percentage of Participants With Virologically-Confirmed SARS-CoV-2 Infection and/or Symptomatic COVID-19
Virologically-confirmed SARS-CoV-2 infection was defined as a positive result for SARS CoV-2 by nucleic acid amplification test (NAAT) on at least 1 respiratory sample. This included positive results by any NAAT that included tests performed outside the trial protocol if confirmed by the adjudication committee. Symptomatic COVID-19 was defined as virologically-confirmed SARS-CoV-2 infection accompanied by protocol-defined COVID-19-like illness. Percentages are rounded off to the tenth decimal place. Here, percentage of participants with virologically-confirmed SARS-CoV-2 infection and/or symptomatic COVID-19 (regardless of adjudication) are reported.
From first dose of study vaccine administration (Day 1) up to 387 days
Severe COVID-19 was defined as COVID-19 with any 1 of the following: Any clinical signs of severe illness measured at least on 2 occasions separated by 30 minutes. Supplemental oxygen administration for > 1 hour. Use of invasive or non-invasive ventilation or extracorporeal membrane oxygenation. Clinical diagnosis of respiratory failure. Significant acute renal, hepatic, or neurologic dysfunction. Shock. Admission to an intensive care unit. Death.
From Day 36 up to Day 387
Stage 1 and Stage 2: Number of Participants With Asymptomatic SARS-CoV-2 Infection
Asymptomatic SARS-CoV-2 infection was defined as SARS-CoV-2 infection, with no reported COVID-19-like illness episodes between enrollment and 14 days after the timepoint at which SARS-CoV-2 infection was ascertained.
From first dose of study vaccine administration (Day 1) up to 387 days
Stage 1 and Stage 2: Number of Swabs With Positive Nucleic Acid Amplification Test (NAAT)
The viral copies were collected as protocol-defined respiratory swabs during participant's illness episode and reported as positive continuous values.
Here, duration between two consecutive positive NAAT results was calculated as: (the date of last swab tested positive) - (the date of first tested positive) + 1.
From first dose of study vaccine administration (Day 1) up to 387 days
Stage 1 and Stage 2: Number of Participants With Respective Number of Days Between Two Consecutive Positive Nucleic Acid Amplification Test
Duration between two consecutive positive NAAT results was calculated as: the date of last swab tested positive - the date of first swab tested positive + 1.
From first dose of study vaccine administration (Day 1) up to 387 days
Stage 1 and Stage 2: Number of Participants With Positive NAAT for SARS-CoV-2
Virologically-confirmed SARS-CoV-2 infection was defined as a positive result for SARS-CoV-2 by NAAT on at least 1 respiratory sample. Respiratory samples for NAAT testing were collected in participants with CLI through the study.
From first dose of study vaccine administration (Day 1) up to 387 days
Stage 1 and Stage 2: Number of Participants With Centers for Disease Control and Prevention (CDC)-Defined COVID-19
CDC-defined COVID-19 included virologically-confirmed SARS-CoV-2 infection with at least 1 of: fever or chills, cough, shortness of breath or difficulty breathing, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat, congestion or runny nose, nausea or vomiting, diarrhea.
From first dose of study vaccine administration (Day 1) up to 387 days
Stage 1 and Stage 2: Number of Participants With Occurrences of Hospitalized COVID-19
Hospitalized COVID-19 was defined as an episode of symptomatic COVID-19 that required inpatient hospitalization.
From first dose of study vaccine administration (Day 1) up to 387 days
Stage 1 and Stage 2: Number of Participants With Symptomatic COVID-19 With Severity of Moderate or Worse
Symptomatic COVID-19 was defined as virologically-confirmed SARS-CoV-2 infection accompanied by protocol-defined CLI. Moderate COVID-19 was defined as symptomatic COVID-19 with either shortness of breath that persisted for at least 12 hours or clinical signs of moderate illness measured at least on 2 occasions separated by 30 minutes and no clinical signs indicative of severe COVID-19.
From first dose of study vaccine administration (Day 1) up to 387 days
Stage 1 and Stage 2: Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 D614G Strain at Days 1, 22, and 43
Neutralizing antibodies activity against SARS-CoV-2 D614G strain was measured with the neutralization assay (monogram assay) and the results were expressed as geometric mean titers.
Pre-vaccination on Day 1 and post-vaccination on Days 22, and 43
Crossover: Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 D614G and B.1.351 Strains at Days 1, 43, 142, 163, and 322
Neutralizing antibodies activity against SARS-CoV-2 D614G strain and B.1.351 strain was measured with the neutralization assay (monogram assay) and the results were expressed as geometric mean titers.
Pre-vaccination on Day 1 and post-vaccination on Days 43, 142, 163 and 322
Booster: Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 D614G and B.1.351 Strains at Days 1, 22, and 202
Neutralizing antibodies activity against SARS-CoV-2 D614G strain and B.1.351 strain was measured with the neutralization assay (monogram assay) and the results were expressed as geometric mean titers.
Pre-vaccination on Day 1 and post-vaccination on Days 22, and 202
Stage 1 and Stage 2: Number of Responders as Determined by Neutralizing Antibody Titers Against SARS-CoV-2 D614G Strain at Days 22 and 43
Responders are participants who had baseline values below lower limit of quantification (LLOQ) with quantifiable neutralization titer above assay LLOQ at each pre-defined post-vaccination timepoint and participants with baseline values above LLOQ with a 4-fold increase in neutralizing antibody titers at each pre-defined post-vaccination timepoint.
Post-vaccination on Days 22 and 43
Crossover: Number of Responders as Determined by Neutralizing Antibody Titers Against SARS-CoV-2 D614G and B.1.351 Strains at Days 43, 142, 163, and 322
Responders are participants who had baseline values below LLOQ with quantifiable neutralization titer above assay LLOQ at each pre-defined post-vaccination timepoint and participants with baseline values above LLOQ with a 4-fold increase in neutralizing antibody titers at each pre-defined post-vaccination timepoint.
Post-vaccination on Days 43, 142, 163 and 322
Booster: Number of Responders as Determined by Neutralizing Antibody Titers Against SARS-CoV-2 D614G and B.1.351 Strains at Days 22 and 202
Responders are participants who had baseline values below LLOQ with quantifiable neutralization titer above assay LLOQ at each pre-defined post-vaccination timepoint and participants with baseline values above LLOQ with a 4-fold increase in neutralizing antibody titers at each pre-defined post-vaccination timepoint.
Post-vaccination on Days 22, and 202
Stage 1: Number of Participants With >=2-Fold and >=4-Fold Rise in Neutralizing Antibody Titers Against SARS-CoV-2 D614G Strain at Days 22 and 43
Neutralizing antibodies activity against SARS-CoV-2 D614G strain was measured with serum neutralization assay (monogram assay). Participants with neutralization antibody titers >=2-fold and >=4-fold increase from baseline (pre-vaccination) are reported.
Pre-vaccination on Day 1 and post-vaccination on Days 22 and 43
Crossover: Number of Participants With >=2-Fold and >=4-Fold Rise in Neutralizing Antibody Titers Against SARS-CoV-2 D614G and B.1.351 Strains at Days 43, 142, 163, and 322
Neutralizing antibodies activity against SARS-CoV-2 D614G strain and B.1.351 strain was measured with serum neutralization assay (monogram assay). Participants with neutralization antibody titers >=2-fold and >=4-fold increase from baseline (pre-vaccination) are reported.
Pre-vaccination on Day 1 and post-vaccination on Days 43, 142, 163, and 322
Booster: Number of Participants With >=2-Fold and >=4-Fold Rise in Neutralizing Antibody Titers Against SARS-CoV-2 D614G and B.1.351 Strains at Days 22 and 202
Neutralizing antibodies activity against SARS-CoV-2 D614G strain and B.1.351 strain was measured with serum neutralization assay (monogram assay). Participants with neutralization antibody titers >=2-fold and >=4-fold increase from baseline (pre-vaccination) are reported.
Pre-vaccination on Day 1 and post-vaccination on Days 22, and 202
Number of Participants With Symptomatic COVID-19 Episodes
Symptomatic COVID-19 is defined as virologically-confirmed SARS-CoV-2 infection accompanied by protocol-defined CLI. Grade 1: A type of AE that was usually transient and required only minimal treatment or therapeutic intervention and did not generally interfere with usual activities of daily living. Grade 2: A type of AE that was usually alleviated with additional therapeutic intervention and interfered with usual activities of daily living, causing discomfort but posed no significant or permanent risk of harm to the research participant. Grade 3: A type of AE that interrupted usual activities of daily living, or significantly affects clinical status, or required intensive therapeutic intervention.
Stages 1 and 2: From first dose of study vaccine administration (Day 1) up to Day 387. Crossover and Booster: From first dose of study vaccine administration (Day 1) up to Day 487
Number of Participants With COVID-19 Severity Using a 7-Point Ordinal Scale
The COVID-19 severity scale was based on the 7-point ordinal scale of clinical assessments: 1: death; 2: hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation; 3: hospitalized, on non-invasive ventilation or high flow oxygen devices; 4: hospitalized, that required supplemental oxygen; 5: hospitalized, that did not require supplemental oxygen- discharged but required ongoing medical care (COVID-19 related or otherwise); 6: hospitalized, that did not require supplemental oxygen discharged without ongoing medical care; 7: not hospitalized.
Stages 1 and 2: From first dose of study vaccine administration (Day 1) up to Day 387. Crossover and Booster: From first dose of study vaccine administration (Day 1) up to Day 487
Number of Deaths Associated With COVID-19
Death associated with COVID-19 was defined as death in a participant with COVID-19 who died within 28 days of the first positive specimen date or who died more than 28 days after the first specimen date and COVID-19 was mentioned as an immediate or underlying cause of death on the death certificate.
Stages 1 and 2: From first dose of study vaccine administration (Day 1) up to Day 387. Crossover and Booster: From first dose of study vaccine administration (Day 1) up to Day 487
Optimal Research Alabama- Site Number : 8400019
Huntsville
Alabama
35802
United States
Peninsula Research Associates, Inc.- Site Number : 8400021
Rolling Hills Estates
California
90274
United States
Synexus Clinical Research US, Inc. Site Number : 8400013
Centennial
Colorado
80112
United States
Optimal Research, LLC-Melbourne- Site Number : 8400002
Melbourne
Florida
32934
United States
Synexus Clinical Research US, Inc. - Orlando- Site Number : 8400020
Orlando
Florida
32806
United States
AES St. Petersburg- Site Number : 8400017
Pinellas Park
Florida
33781
United States
Synexus Clinical Research US, Inc. - Atlanta- Site Number : 8400005
Atlanta
Georgia
30328
United States
Synexus Clinical Research Chicago- Site Number : 8400012
Chicago
Illinois
60602
United States
Synexus Clinical Research Evansville- Site Number : 8400008
Evansville
Indiana
47714
United States
Synexus St. Louis- Site Number : 8400006
St Louis
Missouri
63141
United States
Synexus Clinical Research US, Inc. - Henderson- Site Number : 8400018
Henderson
Nevada
89052
United States
Rochester Clinical Research, Inc.- Site Number : 8400023
Rochester
New York
14609
United States
Synexus Akron- Site Number : 8400009
Akron
Ohio
44311
United States
Synexus Clinical Research US, Inc. - Cincinnati- Site Number : 8400010
Cincinnati
Ohio
45236
United States
Synexus US Columbus- Site Number : 8400011
Columbus
Ohio
43212
United States
Synexus Clinical Research Anderson- Site Number : 8400007
Anderson
South Carolina
29621
United States
Coastal Carolina Research Center - N Charleston- Site Number : 8400022
North Charleston
South Carolina
29405
United States
American Indian Clinical Trials Research Network Site Number : 8400025
Rapid City
South Dakota
57701
United States
AES Austin- Site Number : 8400003
Austin
Texas
78744
United States
Synexus Dallas- Site Number : 8400014
Dallas
Texas
75231
United States
Synexus Clinical Research US, Inc. - San Antonio- Site Number : 8400015
San Antonio
Texas
78229
United States
AES Salt Lake City- Site Number : 8400016
Murray
Utah
84123
United States
Investigational Site Number : 1700010
Aguazul
856018
Colombia
Investigational Site Number : 1700002
Barranquilla
080020
Colombia
Investigational Site Number : 1700008
Barranquilla
080020
Colombia
Investigational Site Number : 1700001
Bogotá
111611
Colombia
Investigational Site Number : 1700005
Cali
76001
Colombia
Investigational Site Number : 1700006
ChÃa
0000
Colombia
Investigational Site Number : 1700004
Floridablanca
681004
Colombia
Investigational Site Number : 1700007
Girardot
252431
Colombia
Investigational Site Number : 1700009
Meta
0000
Colombia
Investigational Site Number : 1700015
QuindÃo
630001
Colombia
Investigational Site Number : 1700003
Soledad
083001
Colombia
Investigational Site Number : 2880002
Kintampo
P. O. Box 200
Ghana
Investigational Site Number : 2880003
Kumasi
00000
Ghana
Investigational Site Number : 2880001
Navrongo
114
Ghana
Investigational Site Number : 3400001
Municipio Del Distrito Central
11101
Honduras
Investigational Site Number : 3400002
San Pedro Sula
21104
Honduras
Investigational Site Number : 3560010
Ajmer
305001
India
Investigational Site Number : 3560002
Ambawadi
380015
India
Investigational Site Number : 3560007
Belagavi
590002
India
Investigational Site Number : 3560001
Jaipur
302039
India
Investigational Site Number : 3560005
Kanpur
208002
India
Investigational Site Number : 3560009
Nagpur
440001
India
Investigational Site Number : 3560011
Odisha
751003
India
Investigational Site Number : 3560004
Patna
801507
India
Investigational Site Number : 3560003
Punjagutta
500082
India
Investigational Site Number : 3560006
Tamilnadu
603203
India
Investigational Site Number : 3920005
Chiyoda-ku,
Tokyo
101-0041
Japan
Investigational Site Number : 3920004
Haramachi,Shinjuku-ku
Tokyo
162-0053
Japan
Investigational Site Number : 3920003
Kouenji minami,Suginami-ku
Tokyo
166-0003
Japan
Investigational Site Number : 3920001
Kyobashi Chuo-ku
Tokyo
104-0031
Japan
Investigational Site Number : 3920002
Ohta-ku
Tokyo
143-0015
Japan
Investigational Site Number : 4040011
Butere
50101
Kenya
Investigational Site Number : 4040006
Eldoret
30100
Kenya
Investigational Site Number : 4040004
Kericho
00200
Kenya
Investigational Site Number : 4040002
Kisumu
40100
Kenya
Investigational Site Number : 4040003
Kisumu
40100
Kenya
Investigational Site Number : 4040012
Kisumu
40123 Kisumu
Kenya
Investigational Site Number : 4040008
Mombasa
80107 Ganjoni
Kenya
Investigational Site Number : 4040001
Nairobi
00100GPO
Kenya
Investigational Site Number : 4040007
Nairobi
00100
Kenya
Investigational Site Number : 4040009
Thika
00202 Kiambu
Kenya
Investigational Site Number : 4840005
León
Guanajuato
37000
Mexico
Investigational Site Number : 4840004
Acapulco de Juárez
Guerrero
39670
Mexico
Investigational Site Number : 4840003
Guadalajara
Jalisco
44280
Mexico
Investigational Site Number : 4840009
Mexico City
Mexico City
04530
Mexico
Investigational Site Number : 4840008
Cuernavaca
Morelos
62290
Mexico
Investigational Site Number : 4840006
Temixco
62587
Mexico
Investigational Site Number : 4840002
Veracruz
91910
Mexico
Investigational Site Number : 5240002
Dhulikhel
45200
Nepal
Investigational Site Number : 5240003
Kathmandu
44600
Nepal
Investigational Site Number : 5240001
Nepalgunj
21900
Nepal
Investigational Site Number : 8000002
Entebbe
0
Uganda
Investigational Site Number : 8000005
Entebbe
0
Uganda
Investigational Site Number : 8000001
Kampala
0
Uganda
Investigational Site Number : 8000013
Kampala
10101
Uganda
Investigational Site Number : 8000007
Kampala
23491
Uganda
Investigational Site Number : 8000003
Kampala
42 Nakasero Road
Uganda
Investigational Site Number : 8000004
Kampala
Plot 101, Lubowa
Uganda
Investigational Site Number : 8000014
Lira
10101
Uganda
Investigational Site Number : 8040002
Kiev
04210
Ukraine
Investigational Site Number : 8040004
Kyiv
01023
Ukraine
Investigational Site Number : 8040003
Kyiv
02002
Ukraine
Investigational Site Number : 8040001
Kyiv
03037
Ukraine
FG001
Stage 1: CoV2 preS dTM-AS03 Placebo
Participants received 0.5 mL placebo matching Cov2 preS dTM-AS03 (D614) vaccine as an IM injection once on Days 1 and 22 during Stage 1.
Participants received 0.5 mL SARS-CoV2 prefusion Spike delta TM with AS03 adjuvant, bivalent D614/B.1.351 (CoV2 preS dTM-AS03 [D614 + B.1.351]) vaccine as an IM injection once on Days 1 and 22 during Stage 2.
FG003
Stage 2: CoV2 preS dTM-AS03 Placebo
Participants received 0.5 mL placebo matching Cov2 preS dTM-AS03 (D614 + B.1.351) vaccine as an IM injection once daily on Days 1 and 22 during Stage 2.
Participants previously vaccinated for placebo during Stage 1 and 2 received 0.5 mL SARS-CoV2 preS dTM-AS03 (D614) vaccine as an IM injection once on Days 1 and 22 during crossover part of the study.
Participants previously vaccinated for either placebo or CoV2 preS dTM-AS03 (D614) vaccine (Stage 1) or CoV2 preS dTM-AS03 (D614+B.1.351) vaccine (Stage 2) received a single booster dose of 0.5mL SARS-CoV2 preS dTM B.1.351 vaccine as an IM injection >=4 months after last dose of priming vaccine during the booster part of the study.
FG0005061 subjects
FG0015078 subjects
FG0026776 subjects
FG0036755 subjects
FG0040 subjects
FG0050 subjects
COMPLETED
FG0004236 subjects
FG0013989 subjects
FG0025757 subjects
FG0035400 subjects
FG0040 subjects
FG0050 subjects
NOT COMPLETED
FG000825 subjects
FG0011089 subjects
FG0021019 subjects
FG0031355 subjects
FG0040 subjects
FG0050 subjects
Type
Comment
Reasons
Lost to Follow-up
FG000220 subjects
FG001275 subjects
FG002259 subjects
FG003298 subjects
FG0040 subjects
FG0050 subjects
Withdrawal by Subject
FG000509 subjects
FG001649 subjects
FG002616 subjects
FG003749 subjects
FG004
Protocol Violation
FG00079 subjects
FG001105 subjects
FG002102 subjects
FG003219 subjects
FG004
Adverse Event
FG00012 subjects
FG00133 subjects
FG00234 subjects
FG00348 subjects
FG004
Study Terminated by Sponsor
FG0001 subjects
FG00119 subjects
FG0020 subjects
FG00340 subjects
FG004
Other
FG0004 subjects
FG0018 subjects
FG0028 subjects
FG0031 subjects
FG004
Crossover (Up to Day 487)
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0046801 subjects
FG0050 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Booster (Up to Day 487)
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG00514237 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Stages 1 and 2: The full analysis set (FAS) consisted of all randomized participants who received at least 1 study injection.
Participants received 0.5 mL SARS-CoV2 preS dTM-AS03 (D614 + B.1.351) vaccine as an IM injection once on Days 1 and 22 during Stage 2.
BG003
Stage 2: CoV2 preS dTM-AS03 Placebo
Participants received 0.5 mL placebo matching Cov2 preS dTM-AS03 (D614 + B.1.351) vaccine as an IM injection once daily on Days 1 and 22 during Stage 2.
BG004
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0005049
BG0015065
BG0026734
BG0036716
BG00423564
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
year
Title
Denominators
Categories
Title
Measurements
BG00037.9± 13.8
BG00137.8± 13.9
BG00236.2± 13.0
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0002213
BG0012174
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
White
BG000114
BG001116
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
Stage 1 and Stage 2: Number of Participants With Onset of Symptomatic Coronavirus Disease 2019 (COVID-19) Episode
Symptomatic COVID-19 was defined as virologically-confirmed SARS-CoV-2 infection accompanied by protocol-defined COVID-19-like illness (CLI).
Stage 1: Modified full analysis set post-dose 2 (mFAS-PD2) Naïve-Day (D)01+D22 set is subset of FAS which consisted of all naïve participants who received at least 1 study injection on D01 and D22. Stage 2: mFAS-PD2 set is subset of FAS, which consisted of all participants who received at least 1 study injection. Only participants with data collected at specified timepoints are reported.
Participants received 0.5 mL SARS-CoV2 preS dTM-AS03 (D614 + B.1.351) vaccine as an IM injection once on Days 1 and 22 during Stage 2.
OG003
Stage 2: CoV2 preS dTM-AS03 Placebo
Participants received 0.5 mL placebo matching Cov2 preS dTM-AS03 (D614 + B.1.351) vaccine as an IM injection once daily on Days 1 and 22 during Stage 2.
Units
Counts
Participants
OG0001091
OG0011043
OG0025766
OG003
Title
Denominators
Categories
Title
Measurements
OG000120
OG001121
OG002151
OG003
Primary
Stage 1 and Stage 2: Number of Participants With Solicited Injection Site and Systemic Reactions
A solicited reaction was defined as an "expected" adverse reaction (AR) (sign or symptom) observed and reported under the conditions (nature and onset) pre-listed in the protocol and case report form (CRF) collected within 7 days after each injection and considered to be related to the corresponding study vaccine administered. An injection site reaction was an AR at and around the injection site of the study vaccine. Systemic AR were all ARs that were not injection site reactions and included systemic manifestations such as headache, fever, as well as localized or topical manifestations that are not associated with the injection site.
Reactogenicity safety analysis subset (RSafAS) consisted of all participants who received at least 1 study injection and are randomized into the reactogenicity subset. Only participants with data collected for specified categories are reported.
Posted
Count of Participants
Participants
Up to 7 days after each vaccination (post-dose on Days 1 and 22)
Participants received 0.5 mL SARS-CoV2 preS dTM with AS03 (D614) vaccine as an IM injection once daily on Days 1 and 22 during Stage 1.
OG001
Stage 1: CoV2 preS dTM-AS03 Placebo
Participants received 0.5 mL placebo matching Cov2 preS dTM-AS03 (D614) vaccine as an IM injection once on Days 1 and 22 during Stage 1.
Primary
Stage 1 and Stage 2: Number of Participants With Unsolicited Non-Serious Adverse Events (AEs)
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An unsolicited AE was an observed AE that did not fulfill the conditions of solicited reactions, that was pre-listed in the CRF in terms of diagnosis and onset window post-vaccination.
RSafAS consisted of all participants who received at least 1 study injection and are randomized into the reactogenicity subset. Only participants with data collected at specified timepoints are reported.
Posted
Count of Participants
Participants
Up to 21 days after each vaccination (post-dose on Days 1 and 22)
Stage 1 and Stage 2: Number of Participants With Immediate Adverse Events
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Immediate events were recorded to capture medically relevant unsolicited injection site and systemic AEs which occurred within the first 30 minutes after vaccination.
Safety analysis set (SafAS) consisted of all participants who had received at least 1 dose of the study vaccine or placebo.
Posted
Count of Participants
Participants
Up to 30 minutes after each vaccination (post-dose on Days 1 and 22)
Participants received 0.5 mL SARS-CoV2 preS dTM-AS03 (D614 + B.1.351) vaccine as an IM injection once on Days 1 and 22 during Stage 2.
Primary
Stage 1 and Stage 2: Number of Participants With Medically Attended Adverse Events (MAAE), Serious Adverse Events (SAE), and Adverse Events of Special Interest (AESI)
An SAE was defined as any AE that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event. An AESI (serious or non-serious) was 1 of scientific and medical concern specific to the Sponsor's study intervention or program, for which ongoing monitoring and rapid communication by the Investigator to the Sponsor could be appropriate. An MAAE was a new onset or a worsening of a condition that prompted the participant or participant's parent/guardian to seek unplanned medical advice at a physician's office or Emergency Department.
SafAS consisted of all participants who had received at least 1 dose of the study vaccine or placebo.
Posted
Count of Participants
Participants
From first dose of study vaccine administration (Day 1) up to 387 days
Participants received 0.5 mL SARS-CoV2 preS dTM with AS03 (D614) vaccine as an IM injection once daily on Days 1 and 22 during Stage 1.
OG001
Stage 1: CoV2 preS dTM-AS03 Placebo
Participants received 0.5 mL placebo matching Cov2 preS dTM-AS03 (D614) vaccine as an IM injection once on Days 1 and 22 during Stage 1.
Primary
Stage 1 and Stage 2: Percentage of Participants With Virologically-Confirmed SARS-CoV-2 Infection and/or Symptomatic COVID-19
Virologically-confirmed SARS-CoV-2 infection was defined as a positive result for SARS CoV-2 by nucleic acid amplification test (NAAT) on at least 1 respiratory sample. This included positive results by any NAAT that included tests performed outside the trial protocol if confirmed by the adjudication committee. Symptomatic COVID-19 was defined as virologically-confirmed SARS-CoV-2 infection accompanied by protocol-defined COVID-19-like illness. Percentages are rounded off to the tenth decimal place. Here, percentage of participants with virologically-confirmed SARS-CoV-2 infection and/or symptomatic COVID-19 (regardless of adjudication) are reported.
SafAS consisted of all participants who had received at least 1 dose of the study vaccine or placebo.
Posted
Number
95% Confidence Interval
percentage of participants
From first dose of study vaccine administration (Day 1) up to 387 days
Participants received 0.5 mL SARS-CoV2 preS dTM with AS03 (D614) vaccine as an IM injection once daily on Days 1 and 22 during Stage 1.
OG001
Stage 1: CoV2 preS dTM-AS03 Placebo
Participants received 0.5 mL placebo matching Cov2 preS dTM-AS03 (D614) vaccine as an IM injection once on Days 1 and 22 during Stage 1.
Secondary
Stage 1 and Stage 2: Number of Participants With SARS-CoV-2 Infection
SARS-CoV-2 infection was defined as a serologically-confirmed SARS-CoV-2 infection or virologically-confirmed SARS-CoV-2 infection.
mFAS-PD Naïve-D01+D22 set, is subset of FAS, which consisted of all naïve participants who received at least 1 study injection on D01 and D22. Only participants with data collected at specified timepoints are reported.
Participants received 0.5 mL SARS-CoV2 preS dTM-AS03 (D614 + B.1.351) vaccine as an IM injection once on Days 1 and 22 during Stage 2.
Secondary
Stage 1 and Stage 2: Number of Participants With Occurrence of Severe COVID-19
Severe COVID-19 was defined as COVID-19 with any 1 of the following: Any clinical signs of severe illness measured at least on 2 occasions separated by 30 minutes. Supplemental oxygen administration for > 1 hour. Use of invasive or non-invasive ventilation or extracorporeal membrane oxygenation. Clinical diagnosis of respiratory failure. Significant acute renal, hepatic, or neurologic dysfunction. Shock. Admission to an intensive care unit. Death.
mFAS-PD2 Naïve-D01+D22 set is a subset of FAS, which consisted of all naïve participants who received at least 1 study injection on D01 and D22. Only participants with data collected at specified timepoints are reported.
Stage 1 and Stage 2: Number of Participants With Asymptomatic SARS-CoV-2 Infection
Asymptomatic SARS-CoV-2 infection was defined as SARS-CoV-2 infection, with no reported COVID-19-like illness episodes between enrollment and 14 days after the timepoint at which SARS-CoV-2 infection was ascertained.
mFAS-PD2 Naïve-D01+D22 set is a subset of FAS, which consisted of all naïve participants who received at least 1 study injection on D01 and D22. Only participants with data collected at specified timepoints are reported.
Posted
Count of Participants
Participants
From first dose of study vaccine administration (Day 1) up to 387 days
Participants received 0.5 mL SARS-CoV2 preS dTM-AS03 (D614 + B.1.351) vaccine as an IM injection once on Days 1 and 22 during Stage 2.
Secondary
Stage 1 and Stage 2: Number of Swabs With Positive Nucleic Acid Amplification Test (NAAT)
The viral copies were collected as protocol-defined respiratory swabs during participant's illness episode and reported as positive continuous values.
Here, duration between two consecutive positive NAAT results was calculated as: (the date of last swab tested positive) - (the date of first tested positive) + 1.
mFAS-PD2 Naïve-D01+D22 set is a subset of FAS, which consisted of all naïve participants who received at least 1 study injection on D01 and D22.
Posted
Number
number of swabs
From first dose of study vaccine administration (Day 1) up to 387 days
Participants received 0.5 mL SARS-CoV2 preS dTM-AS03 (D614 + B.1.351) vaccine as an IM injection once on Days 1 and 22 during Stage 2.
Secondary
Stage 1 and Stage 2: Number of Participants With Respective Number of Days Between Two Consecutive Positive Nucleic Acid Amplification Test
Duration between two consecutive positive NAAT results was calculated as: the date of last swab tested positive - the date of first swab tested positive + 1.
mFAS-PD2 Naïve-D01+D22 set is a subset of FAS, which consisted of all naïve participants who received at least 1 study injection on D01 and D22.
Posted
Count of Participants
Participants
From first dose of study vaccine administration (Day 1) up to 387 days
Participants received 0.5 mL SARS-CoV2 preS dTM-AS03 (D614 + B.1.351) vaccine as an IM injection once on Days 1 and 22 during Stage 2.
Secondary
Stage 1 and Stage 2: Number of Participants With Positive NAAT for SARS-CoV-2
Virologically-confirmed SARS-CoV-2 infection was defined as a positive result for SARS-CoV-2 by NAAT on at least 1 respiratory sample. Respiratory samples for NAAT testing were collected in participants with CLI through the study.
Randomized population consisted of all participants with a randomized group that has been allocated by IRT. Only participants with data collected at specified timepoints are reported.
Posted
Count of Participants
Participants
From first dose of study vaccine administration (Day 1) up to 387 days
Participants received 0.5 mL SARS-CoV2 preS dTM-AS03 (D614 + B.1.351) vaccine as an IM injection once on Days 1 and 22 during Stage 2.
Secondary
Stage 1 and Stage 2: Number of Participants With Centers for Disease Control and Prevention (CDC)-Defined COVID-19
CDC-defined COVID-19 included virologically-confirmed SARS-CoV-2 infection with at least 1 of: fever or chills, cough, shortness of breath or difficulty breathing, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat, congestion or runny nose, nausea or vomiting, diarrhea.
mFAS-PD2 is a subset of FAS, which consisted of all participants who received at least 1 study injection. Only participants with data collected at specified timepoints are reported.
Posted
Count of Participants
Participants
From first dose of study vaccine administration (Day 1) up to 387 days
Participants received 0.5 mL SARS-CoV2 preS dTM-AS03 (D614 + B.1.351) vaccine as an IM injection once on Days 1 and 22 during Stage 2.
Secondary
Stage 1 and Stage 2: Number of Participants With Occurrences of Hospitalized COVID-19
Hospitalized COVID-19 was defined as an episode of symptomatic COVID-19 that required inpatient hospitalization.
mFAS-PD2 is a subset of FAS, which consisted of all participants who received at least 1 study injection. Only participants with data collected at specified timepoints are reported.
Posted
Count of Participants
Participants
From first dose of study vaccine administration (Day 1) up to 387 days
Participants received 0.5 mL SARS-CoV2 preS dTM-AS03 (D614 + B.1.351) vaccine as an IM injection once on Days 1 and 22 during Stage 2.
Secondary
Stage 1 and Stage 2: Number of Participants With Symptomatic COVID-19 With Severity of Moderate or Worse
Symptomatic COVID-19 was defined as virologically-confirmed SARS-CoV-2 infection accompanied by protocol-defined CLI. Moderate COVID-19 was defined as symptomatic COVID-19 with either shortness of breath that persisted for at least 12 hours or clinical signs of moderate illness measured at least on 2 occasions separated by 30 minutes and no clinical signs indicative of severe COVID-19.
mFAS-PD2 is a subset of FAS, which consisted of all participants who received at least 1 study injection. Only participants with data collected at specified timepoints are reported.
Posted
Count of Participants
Participants
From first dose of study vaccine administration (Day 1) up to 387 days
Stage 1 and Stage 2: Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 D614G Strain at Days 1, 22, and 43
Neutralizing antibodies activity against SARS-CoV-2 D614G strain was measured with the neutralization assay (monogram assay) and the results were expressed as geometric mean titers.
Immunogenicity analysis set (IAS) consisted of all randomized participants assigned to the random immunogenicity sub-cohort. Only participants analyzed for each parameter at specific timepoints are reported. For Stage 2, immunogenicity data was not collected, as it was extensively investigated in VAT00002 (NCT04762680), and thus Sponsor decided not to repeat the analysis in this study.
Posted
Geometric Mean
95% Confidence Interval
titers
Pre-vaccination on Day 1 and post-vaccination on Days 22, and 43
Crossover: Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 D614G and B.1.351 Strains at Days 1, 43, 142, 163, and 322
Neutralizing antibodies activity against SARS-CoV-2 D614G strain and B.1.351 strain was measured with the neutralization assay (monogram assay) and the results were expressed as geometric mean titers.
Crossover-IAS consisted of all randomized participants assigned to the random immunogenicity sub-cohort. Only participants analyzed for each parameter at specific timepoints are reported.
Posted
Geometric Mean
95% Confidence Interval
titers
Pre-vaccination on Day 1 and post-vaccination on Days 43, 142, 163 and 322
Participants previously vaccinated for placebo during Stage 1 and 2 received 0.5 mL SARS-CoV2 preS dTM-AS03 (D614) vaccine as an IM injection once on Days 1 and 22 during crossover part of the study.
Units
Counts
Participants
OG000
Secondary
Booster: Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 D614G and B.1.351 Strains at Days 1, 22, and 202
Neutralizing antibodies activity against SARS-CoV-2 D614G strain and B.1.351 strain was measured with the neutralization assay (monogram assay) and the results were expressed as geometric mean titers.
Booster-IAS consisted of all randomized participants assigned to the random immunogenicity sub-cohort. Only participants analyzed for each parameter at specific timepoints are reported.
Posted
Geometric Mean
95% Confidence Interval
titers
Pre-vaccination on Day 1 and post-vaccination on Days 22, and 202
Participants previously vaccinated for either placebo or CoV2 preS dTM-AS03 (D614) vaccine (Stage 1) or CoV2 preS dTM-AS03 (D614+B.1.351) vaccine (Stage 2) received a single booster dose of 0.5mL SARS-CoV2 preS dTM B.1.351 vaccine as an IM injection >=4 months after last dose of priming vaccine during the booster part of the study.
Units
Counts
Participants
OG000
Secondary
Stage 1 and Stage 2: Number of Responders as Determined by Neutralizing Antibody Titers Against SARS-CoV-2 D614G Strain at Days 22 and 43
Responders are participants who had baseline values below lower limit of quantification (LLOQ) with quantifiable neutralization titer above assay LLOQ at each pre-defined post-vaccination timepoint and participants with baseline values above LLOQ with a 4-fold increase in neutralizing antibody titers at each pre-defined post-vaccination timepoint.
IAS consisted of all randomized participants assigned to the random immunogenicity sub-cohort. Only participants analyzed for each parameter at specific timepoints are reported. For Stage 2, immunogenicity data was not collected, as it was extensively investigated in VAT00002 (NCT04762680), and thus Sponsor decided not to repeat the analysis in this study.
Participants received 0.5 mL SARS-CoV2 preS dTM with AS03 (D614) vaccine as an IM injection once daily on Days 1 and 22 during Stage 1.
OG001
Stage 1: CoV2 preS dTM-AS03 Placebo
Participants received 0.5 mL placebo matching Cov2 preS dTM-AS03 (D614) vaccine as an IM injection once on Days 1 and 22 during Stage 1.
OG002
Secondary
Crossover: Number of Responders as Determined by Neutralizing Antibody Titers Against SARS-CoV-2 D614G and B.1.351 Strains at Days 43, 142, 163, and 322
Responders are participants who had baseline values below LLOQ with quantifiable neutralization titer above assay LLOQ at each pre-defined post-vaccination timepoint and participants with baseline values above LLOQ with a 4-fold increase in neutralizing antibody titers at each pre-defined post-vaccination timepoint.
Crossover-IAS consisted of all randomized participants assigned to the random immunogenicity sub-cohort. Only participants analyzed for each parameter at specific timepoints are reported.
Participants previously vaccinated for placebo during Stage 1 and 2 received 0.5 mL SARS-CoV2 preS dTM-AS03 (D614) vaccine as an IM injection once on Days 1 and 22 during crossover part of the study.
Units
Counts
Participants
OG000
Secondary
Booster: Number of Responders as Determined by Neutralizing Antibody Titers Against SARS-CoV-2 D614G and B.1.351 Strains at Days 22 and 202
Responders are participants who had baseline values below LLOQ with quantifiable neutralization titer above assay LLOQ at each pre-defined post-vaccination timepoint and participants with baseline values above LLOQ with a 4-fold increase in neutralizing antibody titers at each pre-defined post-vaccination timepoint.
Booster-IAS consisted of all randomized participants assigned to the random immunogenicity sub-cohort. Only participants analyzed for each parameter at specific timepoints are reported.
Participants previously vaccinated for either placebo or CoV2 preS dTM-AS03 (D614) vaccine (Stage 1) or CoV2 preS dTM-AS03 (D614+B.1.351) vaccine (Stage 2) received a single booster dose of 0.5mL SARS-CoV2 preS dTM B.1.351 vaccine as an IM injection >=4 months after last dose of priming vaccine during the booster part of the study.
Units
Counts
Participants
OG000
Secondary
Stage 1: Number of Participants With >=2-Fold and >=4-Fold Rise in Neutralizing Antibody Titers Against SARS-CoV-2 D614G Strain at Days 22 and 43
Neutralizing antibodies activity against SARS-CoV-2 D614G strain was measured with serum neutralization assay (monogram assay). Participants with neutralization antibody titers >=2-fold and >=4-fold increase from baseline (pre-vaccination) are reported.
IAS consisted of all randomized participants assigned to the random immunogenicity sub-cohort. Only participants analyzed for each parameter at specific timepoints are reported.
Posted
Count of Participants
Participants
Pre-vaccination on Day 1 and post-vaccination on Days 22 and 43
Participants received 0.5 mL SARS-CoV2 preS dTM with AS03 (D614) vaccine as an IM injection once daily on Days 1 and 22 during Stage 1.
OG001
Stage 1: CoV2 preS dTM-AS03 Placebo
Participants received 0.5 mL placebo matching Cov2 preS dTM-AS03 (D614) vaccine as an IM injection once on Days 1 and 22 during Stage 1.
Units
Counts
Participants
Secondary
Crossover: Number of Participants With >=2-Fold and >=4-Fold Rise in Neutralizing Antibody Titers Against SARS-CoV-2 D614G and B.1.351 Strains at Days 43, 142, 163, and 322
Neutralizing antibodies activity against SARS-CoV-2 D614G strain and B.1.351 strain was measured with serum neutralization assay (monogram assay). Participants with neutralization antibody titers >=2-fold and >=4-fold increase from baseline (pre-vaccination) are reported.
Crossover-IAS consisted of all randomized participants assigned to the random immunogenicity sub-cohort. Only participants analyzed for each parameter at specific timepoints are reported.
Posted
Count of Participants
Participants
Pre-vaccination on Day 1 and post-vaccination on Days 43, 142, 163, and 322
Participants previously vaccinated for placebo during Stage 1 and 2 received 0.5 mL SARS-CoV2 preS dTM-AS03 (D614) vaccine as an IM injection once on Days 1 and 22 during crossover part of the study.
Units
Counts
Participants
OG000
Secondary
Booster: Number of Participants With >=2-Fold and >=4-Fold Rise in Neutralizing Antibody Titers Against SARS-CoV-2 D614G and B.1.351 Strains at Days 22 and 202
Neutralizing antibodies activity against SARS-CoV-2 D614G strain and B.1.351 strain was measured with serum neutralization assay (monogram assay). Participants with neutralization antibody titers >=2-fold and >=4-fold increase from baseline (pre-vaccination) are reported.
Booster-IAS consisted of all randomized participants assigned to the random immunogenicity sub-cohort. Only participants analyzed for each parameter at specific timepoints are reported.
Posted
Count of Participants
Participants
Pre-vaccination on Day 1 and post-vaccination on Days 22, and 202
Participants previously vaccinated for either placebo or CoV2 preS dTM-AS03 (D614) vaccine (Stage 1) or CoV2 preS dTM-AS03 (D614+B.1.351) vaccine (Stage 2) received a single booster dose of 0.5mL SARS-CoV2 preS dTM B.1.351 vaccine as an IM injection >=4 months after last dose of priming vaccine during the booster part of the study.
Units
Counts
Participants
Secondary
Number of Participants With Symptomatic COVID-19 Episodes
Symptomatic COVID-19 is defined as virologically-confirmed SARS-CoV-2 infection accompanied by protocol-defined CLI. Grade 1: A type of AE that was usually transient and required only minimal treatment or therapeutic intervention and did not generally interfere with usual activities of daily living. Grade 2: A type of AE that was usually alleviated with additional therapeutic intervention and interfered with usual activities of daily living, causing discomfort but posed no significant or permanent risk of harm to the research participant. Grade 3: A type of AE that interrupted usual activities of daily living, or significantly affects clinical status, or required intensive therapeutic intervention.
Stages 1 and 2: SafAS consisted of all randomized participants who have received at least 1 dose of the study vaccine or placebo. Crossover (CR-SafAS) and Booster (BS-SafAS) consisted of all participants who have received at least 1 dose of CoV2 preS dTM-AS03 vaccine during crossover and booster study phase respectively. Only participants with data collected at specified timepoints are reported.
Posted
Count of Participants
Participants
Stages 1 and 2: From first dose of study vaccine administration (Day 1) up to Day 387. Crossover and Booster: From first dose of study vaccine administration (Day 1) up to Day 487
Participants received 0.5 mL SARS-CoV2 preS dTM with AS03 (D614) vaccine as an IM injection once daily on Days 1 and 22 during Stage 1.
Secondary
Number of Participants With COVID-19 Severity Using a 7-Point Ordinal Scale
The COVID-19 severity scale was based on the 7-point ordinal scale of clinical assessments: 1: death; 2: hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation; 3: hospitalized, on non-invasive ventilation or high flow oxygen devices; 4: hospitalized, that required supplemental oxygen; 5: hospitalized, that did not require supplemental oxygen- discharged but required ongoing medical care (COVID-19 related or otherwise); 6: hospitalized, that did not require supplemental oxygen discharged without ongoing medical care; 7: not hospitalized.
Stage 1 and 2: SafAS Non-Naïve-D01 consisted of all randomized participants who have received at least 1 dose of the study vaccine or placebo on Day 01. CR-SafAS and BS-SafAS consisted of all participants who have received at least 1 dose of CoV2 preS dTM-AS03 vaccine during crossover and booster study phase respectively. Only participants with data collected for the specified categories are reported.
Posted
Count of Participants
Participants
Stages 1 and 2: From first dose of study vaccine administration (Day 1) up to Day 387. Crossover and Booster: From first dose of study vaccine administration (Day 1) up to Day 487
Participants received 0.5 mL SARS-CoV2 preS dTM with AS03 (D614) vaccine as an IM injection once daily on Days 1 and 22 during Stage 1.
OG001
Stage 1: CoV2 preS dTM-AS03 Placebo
Secondary
Number of Deaths Associated With COVID-19
Death associated with COVID-19 was defined as death in a participant with COVID-19 who died within 28 days of the first positive specimen date or who died more than 28 days after the first specimen date and COVID-19 was mentioned as an immediate or underlying cause of death on the death certificate.
Stage 1 and 2: SafAS Non-Naïve-D01 set consisted of all non-naïve participants who had received at least 1 dose of the study vaccine or placebo on D01.
CR-SafAS and BS-SafAS consisted of all participants who have received at least 1 dose of CoV2 preS dTM-AS03 vaccine during crossover and booster study phase respectively.
Posted
Count of Participants
Participants
Stages 1 and 2: From first dose of study vaccine administration (Day 1) up to Day 387. Crossover and Booster: From first dose of study vaccine administration (Day 1) up to Day 487
Stages 1 and 2: From first dose of study vaccine administration (Day 1) up to end of follow-up, 387 days. Crossover and Booster: From first dose of study vaccine administration (Day 1) up to end of follow-up 487 days.
Description
Analysis was performed on the SafAS. Safety analysis was performed according to the actual study vaccine received by the participants.
Participants received 0.5 mL SARS-CoV2 preS dTM-AS03 (D614 + B.1.351) vaccine as an IM injection once on Days 1 and 22 during Stage 2.
29
6,733
149
6,733
1,610
6,733
EG003
Stage 2: CoV2 preS dTM-AS03 Placebo
Participants received 0.5 mL placebo matching Cov2 preS dTM-AS03 (D614 + B.1.351) vaccine as an IM injection once daily on Days 1 and 22 during Stage 2.
Participants previously vaccinated for placebo during Stage 1 and 2 received 0.5 mL SARS-CoV2 preS dTM-AS03 (D614) vaccine as an IM injection once on Days 1 and 22 during crossover part of the study.
Participants previously vaccinated for either placebo or CoV2 preS dTM-AS03 (D614) vaccine (Stage 1) or CoV2 preS dTM-AS03 (D614+B.1.351) vaccine (Stage 2) received a single booster dose of 0.5mL SARS-CoV2 preS dTM B.1.351 vaccine as an IM injection >=4 months after last dose of priming vaccine during the booster part of the study.
21
14,237
125
14,237
261
14,237
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Abdominal Sepsis
Infections and infestations
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0021 events1 affected6,733 at risk
EG0030 events0 affected6,714 at risk
EG0040 events0 affected6,529 at risk
EG0050 events0 affected14,237 at risk
Abscess Limb
Infections and infestations
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0021 events1 affected6,733 at risk
EG003
Acquired Immunodeficiency Syndrome
Infections and infestations
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Acute Hiv Infection
Infections and infestations
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Acute Haemorrhagic Conjunctivitis
Infections and infestations
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Amoebiasis
Infections and infestations
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Appendicitis
Infections and infestations
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0011 events1 affected5,064 at risk
EG0022 events2 affected6,733 at risk
EG003
Appendicitis Perforated
Infections and infestations
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Arthritis Bacterial
Infections and infestations
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0011 events1 affected5,064 at risk
EG0021 events1 affected6,733 at risk
EG003
Arthritis Infective
Infections and infestations
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0012 events1 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Bacteraemia
Infections and infestations
MedDra 27.0
Systematic Assessment
EG0001 events1 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Bacterial Infection
Infections and infestations
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Bronchitis
Infections and infestations
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0011 events1 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Covid-19
Infections and infestations
MedDra 27.0
Systematic Assessment
EG0004 events4 affected5,049 at risk
EG00111 events11 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Covid-19 Pneumonia
Infections and infestations
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0016 events6 affected5,064 at risk
EG0021 events1 affected6,733 at risk
EG003
Cellulitis
Infections and infestations
MedDra 27.0
Systematic Assessment
EG0003 events3 affected5,049 at risk
EG0015 events4 affected5,064 at risk
EG0023 events2 affected6,733 at risk
EG003
Cerebral Toxoplasmosis
Infections and infestations
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Dengue Fever
Infections and infestations
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0013 events3 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Diarrhoea Infectious
Infections and infestations
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0011 events1 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Disseminated Tuberculosis
Infections and infestations
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0021 events1 affected6,733 at risk
EG003
Diverticulitis
Infections and infestations
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0021 events1 affected6,733 at risk
EG003
Encephalitis
Infections and infestations
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Enterococcal Bacteraemia
Infections and infestations
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0011 events1 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Escherichia Urinary Tract Infection
Infections and infestations
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Fournier's Gangrene
Infections and infestations
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0021 events1 affected6,733 at risk
EG003
Gangrene
Infections and infestations
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0021 events1 affected6,733 at risk
EG003
Gastroenteritis
Infections and infestations
MedDra 27.0
Systematic Assessment
EG0008 events8 affected5,049 at risk
EG0014 events4 affected5,064 at risk
EG0022 events2 affected6,733 at risk
EG003
Hiv Infection
Infections and infestations
MedDra 27.0
Systematic Assessment
EG0001 events1 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Hepatitis B
Infections and infestations
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0011 events1 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Intestinal Sepsis
Infections and infestations
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Localised Infection
Infections and infestations
MedDra 27.0
Systematic Assessment
EG0001 events1 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Malaria
Infections and infestations
MedDra 27.0
Systematic Assessment
EG0007 events7 affected5,049 at risk
EG0017 events7 affected5,064 at risk
EG00214 events13 affected6,733 at risk
EG003
Meningitis Bacterial
Infections and infestations
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0021 events1 affected6,733 at risk
EG003
Meningitis Cryptococcal
Infections and infestations
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Nasal Vestibulitis
Infections and infestations
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0011 events1 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Neurological Infection
Infections and infestations
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0011 events1 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Oropharyngeal Candidiasis
Infections and infestations
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Osteomyelitis
Infections and infestations
MedDra 27.0
Systematic Assessment
EG0001 events1 affected5,049 at risk
EG0011 events1 affected5,064 at risk
EG0021 events1 affected6,733 at risk
EG003
Otitis Media
Infections and infestations
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Otitis Media Chronic
Infections and infestations
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Parotitis
Infections and infestations
MedDra 27.0
Systematic Assessment
EG0001 events1 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Pelvic Inflammatory Disease
Infections and infestations
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0021 events1 affected6,733 at risk
EG003
Periorbital Cellulitis
Infections and infestations
MedDra 27.0
Systematic Assessment
EG0001 events1 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Peritonitis
Infections and infestations
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0011 events1 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Pharyngitis
Infections and infestations
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0022 events2 affected6,733 at risk
EG003
Pneumocystis Jirovecii Pneumonia
Infections and infestations
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0021 events1 affected6,733 at risk
EG003
Pneumonia
Infections and infestations
MedDra 27.0
Systematic Assessment
EG0008 events7 affected5,049 at risk
EG0014 events4 affected5,064 at risk
EG0023 events3 affected6,733 at risk
EG003
Pneumonia Aspiration
Infections and infestations
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0011 events1 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Pneumonia Bacterial
Infections and infestations
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0011 events1 affected5,064 at risk
EG0021 events1 affected6,733 at risk
EG003
Postoperative Wound Infection
Infections and infestations
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0011 events1 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Pulmonary Tuberculosis
Infections and infestations
MedDra 27.0
Systematic Assessment
EG0001 events1 affected5,049 at risk
EG0014 events3 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Pyelonephritis
Infections and infestations
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Pyelonephritis Acute
Infections and infestations
MedDra 27.0
Systematic Assessment
EG0001 events1 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Respiratory Tract Infection
Infections and infestations
MedDra 27.0
Systematic Assessment
EG0001 events1 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Retroviral Infection
Infections and infestations
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Sepsis
Infections and infestations
MedDra 27.0
Systematic Assessment
EG0001 events1 affected5,049 at risk
EG0013 events3 affected5,064 at risk
EG0022 events2 affected6,733 at risk
EG003
Sepsis Neonatal
Infections and infestations
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0021 events1 affected6,733 at risk
EG003
Septic Shock
Infections and infestations
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0012 events2 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Skin Infection
Infections and infestations
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Soft Tissue Infection
Infections and infestations
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0011 events1 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Staphylococcal Bacteraemia
Infections and infestations
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0011 events1 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Subcutaneous Abscess
Infections and infestations
MedDra 27.0
Systematic Assessment
EG0001 events1 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Suspected Covid-19
Infections and infestations
MedDra 27.0
Systematic Assessment
EG0001 events1 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Tonsillitis
Infections and infestations
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Tooth Abscess
Infections and infestations
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0021 events1 affected6,733 at risk
EG003
Toxoplasmosis
Infections and infestations
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0021 events1 affected6,733 at risk
EG003
Tropical Infectious Disease
Infections and infestations
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Tuberculosis
Infections and infestations
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0021 events1 affected6,733 at risk
EG003
Tungiasis
Infections and infestations
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0022 events1 affected6,733 at risk
EG003
Typhoid Fever
Infections and infestations
MedDra 27.0
Systematic Assessment
EG0003 events3 affected5,049 at risk
EG0015 events4 affected5,064 at risk
EG0023 events3 affected6,733 at risk
EG003
Upper Respiratory Tract Infection
Infections and infestations
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0021 events1 affected6,733 at risk
EG003
Urinary Tract Infection
Infections and infestations
MedDra 27.0
Systematic Assessment
EG0006 events6 affected5,049 at risk
EG00114 events11 affected5,064 at risk
EG0029 events8 affected6,733 at risk
EG003
Urosepsis
Infections and infestations
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Vulvovaginal Candidiasis
Infections and infestations
MedDra 27.0
Systematic Assessment
EG0001 events1 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Wound Sepsis
Infections and infestations
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0021 events1 affected6,733 at risk
EG003
Adenocarcinoma Of The Cervix
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Breast Cancer Metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0011 events1 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Desmoid Tumour
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Diffuse Large B-Cell Lymphoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0011 events1 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Endometrial Cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0011 events1 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Follicular Lymphoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDra 27.0
Systematic Assessment
EG0001 events1 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Gallbladder Cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0021 events1 affected6,733 at risk
EG003
Gastrointestinal Neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDra 27.0
Systematic Assessment
EG0001 events1 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Glioma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Haemangioblastoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDra 27.0
Systematic Assessment
EG0001 events1 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Hepatic Cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0011 events1 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Lung Adenocarcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDra 27.0
Systematic Assessment
EG0001 events1 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Lung Neoplasm Malignant
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Metastatic Gastric Cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Myelodysplastic Syndrome
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Nasopharyngeal Cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDra 27.0
Systematic Assessment
EG0001 events1 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Oesophageal Carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Ovarian Adenoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDra 27.0
Systematic Assessment
EG0001 events1 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Pancreatic Carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0011 events1 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Prostate Cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Serous Cystadenocarcinoma Ovary
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Squamous Cell Carcinoma Of The Oral Cavity
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Uterine Cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0011 events1 affected5,064 at risk
EG0021 events1 affected6,733 at risk
EG003
Uterine Leiomyoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDra 27.0
Systematic Assessment
EG0001 events1 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDra 27.0
Systematic Assessment
EG0002 events2 affected5,049 at risk
EG00111 events8 affected5,064 at risk
EG0024 events4 affected6,733 at risk
EG003
Blood Loss Anaemia
Blood and lymphatic system disorders
MedDra 27.0
Systematic Assessment
EG0001 events1 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0021 events1 affected6,733 at risk
EG003
Iron Deficiency Anaemia
Blood and lymphatic system disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Sickle Cell Anaemia With Crisis
Blood and lymphatic system disorders
MedDra 27.0
Systematic Assessment
EG0001 events1 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0011 events1 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Addison's Disease
Endocrine disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0021 events1 affected6,733 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0022 events2 affected6,733 at risk
EG003
Diabetes Mellitus
Metabolism and nutrition disorders
MedDra 27.0
Systematic Assessment
EG0001 events1 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Diabetes Mellitus Inadequate Control
Metabolism and nutrition disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Diabetic Ketoacidosis
Metabolism and nutrition disorders
MedDra 27.0
Systematic Assessment
EG0001 events1 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0021 events1 affected6,733 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Hyperlipidaemia
Metabolism and nutrition disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDra 27.0
Systematic Assessment
EG0001 events1 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0011 events1 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0021 events1 affected6,733 at risk
EG003
Metabolic Acidosis
Metabolism and nutrition disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0011 events1 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Obesity
Metabolism and nutrition disorders
MedDra 27.0
Systematic Assessment
EG0001 events1 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Tumour Lysis Syndrome
Metabolism and nutrition disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0011 events1 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Type 2 Diabetes Mellitus
Metabolism and nutrition disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0011 events1 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Acute Psychosis
Psychiatric disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Alcohol Use Disorder
Psychiatric disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0021 events1 affected6,733 at risk
EG003
Alcohol Withdrawal Syndrome
Psychiatric disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0011 events1 affected5,064 at risk
EG0022 events2 affected6,733 at risk
EG003
Anxiety
Psychiatric disorders
MedDra 27.0
Systematic Assessment
EG0001 events1 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Behaviour Disorder
Psychiatric disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0021 events1 affected6,733 at risk
EG003
Borderline Personality Disorder
Psychiatric disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0021 events1 affected6,733 at risk
EG003
Completed Suicide
Psychiatric disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0021 events1 affected6,733 at risk
EG003
Delirium Tremens
Psychiatric disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0021 events1 affected6,733 at risk
EG003
Depression
Psychiatric disorders
MedDra 27.0
Systematic Assessment
EG0002 events2 affected5,049 at risk
EG0011 events1 affected5,064 at risk
EG0023 events2 affected6,733 at risk
EG003
Dissociative Disorder
Psychiatric disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0011 events1 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Drug Dependence
Psychiatric disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Hallucination
Psychiatric disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Mental Disorder
Psychiatric disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0021 events1 affected6,733 at risk
EG003
Mixed Anxiety And Depressive Disorder
Psychiatric disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0021 events1 affected6,733 at risk
EG003
Psychotic Disorder
Psychiatric disorders
MedDra 27.0
Systematic Assessment
EG0002 events2 affected5,049 at risk
EG0011 events1 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Schizophrenia
Psychiatric disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0011 events1 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Substance-Induced Psychotic Disorder
Psychiatric disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Suicide Attempt
Psychiatric disorders
MedDra 27.0
Systematic Assessment
EG0001 events1 affected5,049 at risk
EG0012 events2 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Alcoholic Seizure
Nervous system disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Bell's Palsy
Nervous system disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0011 events1 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Benign Fasciculation Syndrome
Nervous system disorders
MedDra 27.0
Systematic Assessment
EG0001 events1 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Cerebral Haematoma
Nervous system disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Cerebral Infarction
Nervous system disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0011 events1 affected5,064 at risk
EG0021 events1 affected6,733 at risk
EG003
Cerebral Ischaemia
Nervous system disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Cerebrovascular Accident
Nervous system disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0012 events2 affected5,064 at risk
EG0024 events4 affected6,733 at risk
EG003
Cluster Headache
Nervous system disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Epilepsy
Nervous system disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0014 events3 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Headache
Nervous system disorders
MedDra 27.0
Systematic Assessment
EG0001 events1 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Hemiparesis
Nervous system disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0011 events1 affected5,064 at risk
EG0022 events2 affected6,733 at risk
EG003
Hypoglycaemic Unconsciousness
Nervous system disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Hyponatraemic Encephalopathy
Nervous system disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0011 events1 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Intracranial Mass
Nervous system disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Lumbar Radiculopathy
Nervous system disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Migraine
Nervous system disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0021 events1 affected6,733 at risk
EG003
Myelitis Transverse
Nervous system disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Neuropathy Peripheral
Nervous system disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Sacral Radiculopathy
Nervous system disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0011 events1 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Seizure
Nervous system disorders
MedDra 27.0
Systematic Assessment
EG0001 events1 affected5,049 at risk
EG0013 events3 affected5,064 at risk
EG0021 events1 affected6,733 at risk
EG003
Status Epilepticus
Nervous system disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0011 events1 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Status Migrainosus
Nervous system disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Syncope
Nervous system disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0011 events1 affected5,064 at risk
EG0021 events1 affected6,733 at risk
EG003
Transient Ischaemic Attack
Nervous system disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Vith Nerve Paralysis
Nervous system disorders
MedDra 27.0
Systematic Assessment
EG0001 events1 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Glaucoma
Eye disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Visual Acuity Reduced
Eye disorders
MedDra 27.0
Systematic Assessment
EG0001 events1 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Tympanic Membrane Perforation
Ear and labyrinth disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0011 events1 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDra 27.0
Systematic Assessment
EG0001 events1 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Acute Coronary Syndrome
Cardiac disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Acute Left Ventricular Failure
Cardiac disorders
MedDra 27.0
Systematic Assessment
EG0001 events1 affected5,049 at risk
EG0011 events1 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Acute Myocardial Infarction
Cardiac disorders
MedDra 27.0
Systematic Assessment
EG0001 events1 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0021 events1 affected6,733 at risk
EG003
Angina Pectoris
Cardiac disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0012 events2 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Angina Unstable
Cardiac disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0011 events1 affected5,064 at risk
EG0021 events1 affected6,733 at risk
EG003
Atrial Fibrillation
Cardiac disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Cardiac Arrest
Cardiac disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0021 events1 affected6,733 at risk
EG003
Cardiac Disorder
Cardiac disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Cardiac Failure
Cardiac disorders
MedDra 27.0
Systematic Assessment
EG0002 events2 affected5,049 at risk
EG0012 events2 affected5,064 at risk
EG0022 events2 affected6,733 at risk
EG003
Cardiac Failure Acute
Cardiac disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0021 events1 affected6,733 at risk
EG003
Cardiac Failure Chronic
Cardiac disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0021 events1 affected6,733 at risk
EG003
Cardiac Failure Congestive
Cardiac disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0011 events1 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Cardiac Valve Disease
Cardiac disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0011 events1 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Hypertensive Heart Disease
Cardiac disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0011 events1 affected5,064 at risk
EG0021 events1 affected6,733 at risk
EG003
Left Ventricular Failure
Cardiac disorders
MedDra 27.0
Systematic Assessment
EG0001 events1 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Myocardial Infarction
Cardiac disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0011 events1 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Myocardial Ischaemia
Cardiac disorders
MedDra 27.0
Systematic Assessment
EG0001 events1 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0021 events1 affected6,733 at risk
EG003
Pericarditis
Cardiac disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Rheumatic Heart Disease
Cardiac disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0021 events1 affected6,733 at risk
EG003
Aortic Aneurysm Rupture
Vascular disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Circulatory Collapse
Vascular disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Deep Vein Thrombosis
Vascular disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0011 events1 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Extremity Necrosis
Vascular disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0021 events1 affected6,733 at risk
EG003
Hypertension
Vascular disorders
MedDra 27.0
Systematic Assessment
EG0001 events1 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0021 events1 affected6,733 at risk
EG003
Hypertensive Crisis
Vascular disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0021 events1 affected6,733 at risk
EG003
Hypertensive Emergency
Vascular disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Hypertensive Urgency
Vascular disorders
MedDra 27.0
Systematic Assessment
EG0001 events1 affected5,049 at risk
EG0012 events2 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Hypotension
Vascular disorders
MedDra 27.0
Systematic Assessment
EG0001 events1 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Hypovolaemic Shock
Vascular disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Peripheral Venous Disease
Vascular disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Acute Respiratory Distress Syndrome
Respiratory, thoracic and mediastinal disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0021 events1 affected6,733 at risk
EG003
Acute Respiratory Failure
Respiratory, thoracic and mediastinal disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDra 27.0
Systematic Assessment
EG0002 events1 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Chronic Obstructive Pulmonary Disease
Respiratory, thoracic and mediastinal disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0022 events2 affected6,733 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDra 27.0
Systematic Assessment
EG0001 events1 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Hiccups
Respiratory, thoracic and mediastinal disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0021 events1 affected6,733 at risk
EG003
Laryngeal Stenosis
Respiratory, thoracic and mediastinal disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0022 events1 affected6,733 at risk
EG003
Pleural Effusion
Respiratory, thoracic and mediastinal disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Pneumonitis Aspiration
Respiratory, thoracic and mediastinal disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0021 events1 affected6,733 at risk
EG003
Pulmonary Embolism
Respiratory, thoracic and mediastinal disorders
MedDra 27.0
Systematic Assessment
EG0001 events1 affected5,049 at risk
EG0011 events1 affected5,064 at risk
EG0022 events2 affected6,733 at risk
EG003
Pulmonary Fibrosis
Respiratory, thoracic and mediastinal disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Pulmonary Infarction
Respiratory, thoracic and mediastinal disorders
MedDra 27.0
Systematic Assessment
EG0001 events1 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Pulmonary Oedema
Respiratory, thoracic and mediastinal disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Respiratory Failure
Respiratory, thoracic and mediastinal disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0021 events1 affected6,733 at risk
EG003
Abdominal Hernia
Gastrointestinal disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0021 events1 affected6,733 at risk
EG003
Abdominal Incarcerated Hernia
Gastrointestinal disorders
MedDra 27.0
Systematic Assessment
EG0001 events1 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Abdominal Pain
Gastrointestinal disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0012 events2 affected5,064 at risk
EG0021 events1 affected6,733 at risk
EG003
Acute Abdomen
Gastrointestinal disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Ascites
Gastrointestinal disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0021 events1 affected6,733 at risk
EG003
Chronic Gastritis
Gastrointestinal disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0021 events1 affected6,733 at risk
EG003
Colitis
Gastrointestinal disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0011 events1 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Duodenal Ulcer Perforation
Gastrointestinal disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0011 events1 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Enterocolitis Haemorrhagic
Gastrointestinal disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Enterocutaneous Fistula
Gastrointestinal disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Gastric Ulcer
Gastrointestinal disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0011 events1 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDra 27.0
Systematic Assessment
EG0003 events3 affected5,049 at risk
EG0014 events4 affected5,064 at risk
EG0021 events1 affected6,733 at risk
EG003
Gastritis Alcoholic
Gastrointestinal disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Gastrointestinal Haemorrhage
Gastrointestinal disorders
MedDra 27.0
Systematic Assessment
EG0001 events1 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Ileus
Gastrointestinal disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0021 events1 affected6,733 at risk
EG003
Inguinal Hernia
Gastrointestinal disorders
MedDra 27.0
Systematic Assessment
EG0001 events1 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0021 events1 affected6,733 at risk
EG003
Inguinal Hernia, Obstructive
Gastrointestinal disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Intestinal Fistula
Gastrointestinal disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Intestinal Obstruction
Gastrointestinal disorders
MedDra 27.0
Systematic Assessment
EG0001 events1 affected5,049 at risk
EG0011 events1 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Obstruction Gastric
Gastrointestinal disorders
MedDra 27.0
Systematic Assessment
EG0001 events1 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Obstructive Pancreatitis
Gastrointestinal disorders
MedDra 27.0
Systematic Assessment
EG0001 events1 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Pancreatitis Acute
Gastrointestinal disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0011 events1 affected5,064 at risk
EG0021 events1 affected6,733 at risk
EG003
Pancreatitis Necrotising
Gastrointestinal disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Peptic Ulcer
Gastrointestinal disorders
MedDra 27.0
Systematic Assessment
EG0002 events2 affected5,049 at risk
EG0018 events4 affected5,064 at risk
EG0027 events7 affected6,733 at risk
EG003
Peptic Ulcer Haemorrhage
Gastrointestinal disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0021 events1 affected6,733 at risk
EG003
Umbilical Hernia
Gastrointestinal disorders
MedDra 27.0
Systematic Assessment
EG0001 events1 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Upper Gastrointestinal Haemorrhage
Gastrointestinal disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0015 events2 affected5,064 at risk
EG0021 events1 affected6,733 at risk
EG003
Varices Oesophageal
Gastrointestinal disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0011 events1 affected5,064 at risk
EG0021 events1 affected6,733 at risk
EG003
Volvulus
Gastrointestinal disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0011 events1 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Alcoholic Liver Disease
Hepatobiliary disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0012 events2 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Bile Duct Stone
Hepatobiliary disorders
MedDra 27.0
Systematic Assessment
EG0001 events1 affected5,049 at risk
EG0011 events1 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Cholangitis
Hepatobiliary disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Cholecystitis
Hepatobiliary disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0011 events1 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Cholecystitis Acute
Hepatobiliary disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0011 events1 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Cholecystitis Chronic
Hepatobiliary disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDra 27.0
Systematic Assessment
EG0003 events2 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0023 events3 affected6,733 at risk
EG003
Chronic Hepatic Failure
Hepatobiliary disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0021 events1 affected6,733 at risk
EG003
Hepatic Cirrhosis
Hepatobiliary disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0021 events1 affected6,733 at risk
EG003
Hepatic Failure
Hepatobiliary disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0021 events1 affected6,733 at risk
EG003
Hepatitis
Hepatobiliary disorders
MedDra 27.0
Systematic Assessment
EG0001 events1 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Hepatitis Alcoholic
Hepatobiliary disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Liver Disorder
Hepatobiliary disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0021 events1 affected6,733 at risk
EG003
Angioedema
Skin and subcutaneous tissue disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0021 events1 affected6,733 at risk
EG003
Diabetic Foot
Skin and subcutaneous tissue disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0021 events1 affected6,733 at risk
EG003
Skin Ulcer
Skin and subcutaneous tissue disorders
MedDra 27.0
Systematic Assessment
EG0001 events1 affected5,049 at risk
EG0012 events2 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Vitiligo
Skin and subcutaneous tissue disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0011 events1 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDra 27.0
Systematic Assessment
EG0001 events1 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Back Pain
Musculoskeletal and connective tissue disorders
MedDra 27.0
Systematic Assessment
EG0001 events1 affected5,049 at risk
EG0011 events1 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Musculoskeletal Pain
Musculoskeletal and connective tissue disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0021 events1 affected6,733 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDra 27.0
Systematic Assessment
EG0001 events1 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0021 events1 affected6,733 at risk
EG003
Spinal Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0021 events1 affected6,733 at risk
EG003
Spondyloarthropathy
Musculoskeletal and connective tissue disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Acute Kidney Injury
Renal and urinary disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0013 events3 affected5,064 at risk
EG0021 events1 affected6,733 at risk
EG003
Azotaemia
Renal and urinary disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Calculus Bladder
Renal and urinary disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Calculus Urinary
Renal and urinary disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Chronic Kidney Disease
Renal and urinary disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0021 events1 affected6,733 at risk
EG003
Glomerulonephritis Rapidly Progressive
Renal and urinary disorders
MedDra 27.0
Systematic Assessment
EG0001 events1 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Hydronephrosis
Renal and urinary disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0011 events1 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Renal Colic
Renal and urinary disorders
MedDra 27.0
Systematic Assessment
EG0001 events1 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Renal Failure
Renal and urinary disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Ureterolithiasis
Renal and urinary disorders
MedDra 27.0
Systematic Assessment
EG0001 events1 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Urinary Retention
Renal and urinary disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Abortion Complete
Pregnancy, puerperium and perinatal conditions
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0011 events1 affected5,064 at risk
EG0022 events2 affected6,733 at risk
EG003
Abortion Incomplete
Pregnancy, puerperium and perinatal conditions
MedDra 27.0
Systematic Assessment
EG0001 events1 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0022 events2 affected6,733 at risk
EG003
Abortion Spontaneous
Pregnancy, puerperium and perinatal conditions
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0017 events7 affected5,064 at risk
EG0025 events5 affected6,733 at risk
EG003
Abortion Spontaneous Complete
Pregnancy, puerperium and perinatal conditions
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Abortion Threatened
Pregnancy, puerperium and perinatal conditions
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Ectopic Pregnancy
Pregnancy, puerperium and perinatal conditions
MedDra 27.0
Systematic Assessment
EG0001 events1 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Failed Induction Of Labour
Pregnancy, puerperium and perinatal conditions
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0011 events1 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Foetal Death
Pregnancy, puerperium and perinatal conditions
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0022 events2 affected6,733 at risk
EG003
Haemorrhage In Pregnancy
Pregnancy, puerperium and perinatal conditions
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Imminent Abortion
Pregnancy, puerperium and perinatal conditions
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0021 events1 affected6,733 at risk
EG003
Jaundice Neonatal
Pregnancy, puerperium and perinatal conditions
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0021 events1 affected6,733 at risk
EG003
Placenta Praevia
Pregnancy, puerperium and perinatal conditions
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0021 events1 affected6,733 at risk
EG003
Pre-Eclampsia
Pregnancy, puerperium and perinatal conditions
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0022 events2 affected6,733 at risk
EG003
Premature Delivery
Pregnancy, puerperium and perinatal conditions
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0022 events2 affected6,733 at risk
EG003
Premature Rupture Of Membranes
Pregnancy, puerperium and perinatal conditions
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0011 events1 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Ruptured Ectopic Pregnancy
Pregnancy, puerperium and perinatal conditions
MedDra 27.0
Systematic Assessment
EG0001 events1 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0021 events1 affected6,733 at risk
EG003
Stillbirth
Pregnancy, puerperium and perinatal conditions
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0021 events1 affected6,733 at risk
EG003
Threatened Labour
Pregnancy, puerperium and perinatal conditions
MedDra 27.0
Systematic Assessment
EG0001 events1 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Abnormal Uterine Bleeding
Reproductive system and breast disorders
MedDra 27.0
Systematic Assessment
EG0001 events1 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Adnexa Uteri Cyst
Reproductive system and breast disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0021 events1 affected6,733 at risk
EG003
Benign Prostatic Hyperplasia
Reproductive system and breast disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0021 events1 affected6,733 at risk
EG003
Cervical Dysplasia
Reproductive system and breast disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Endometrial Hyperplasia With Cellular Atypia
Reproductive system and breast disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Endometrial Metaplasia
Reproductive system and breast disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Female Genital Tract Fistula
Reproductive system and breast disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Genital Prolapse
Reproductive system and breast disorders
MedDra 27.0
Systematic Assessment
EG0001 events1 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Heavy Menstrual Bleeding
Reproductive system and breast disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Ovarian Cyst
Reproductive system and breast disorders
MedDra 27.0
Systematic Assessment
EG0001 events1 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Pelvic Pain
Reproductive system and breast disorders
MedDra 27.0
Systematic Assessment
EG0001 events1 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Congenital Pulmonary Airway Malformation
Congenital, familial and genetic disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0011 events1 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Retinitis Pigmentosa
Congenital, familial and genetic disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Chest Pain
General disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Death
General disorders
MedDra 27.0
Systematic Assessment
EG0002 events2 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0024 events4 affected6,733 at risk
EG003
Death Neonatal
General disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Electrocution
General disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Multiple Organ Dysfunction Syndrome
General disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0021 events1 affected6,733 at risk
EG003
Necrobiosis
General disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Non-Cardiac Chest Pain
General disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0012 events2 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Pyrexia
General disorders
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Abdominal Injury
Injury, poisoning and procedural complications
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Alcohol Poisoning
Injury, poisoning and procedural complications
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0011 events1 affected5,064 at risk
EG0022 events2 affected6,733 at risk
EG003
Anaesthetic Complication
Injury, poisoning and procedural complications
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Ankle Fracture
Injury, poisoning and procedural complications
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0012 events2 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Arthropod Sting
Injury, poisoning and procedural complications
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Burns Second Degree
Injury, poisoning and procedural complications
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0011 events1 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Chemical Poisoning
Injury, poisoning and procedural complications
MedDra 27.0
Systematic Assessment
EG0001 events1 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Chest Injury
Injury, poisoning and procedural complications
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0021 events1 affected6,733 at risk
EG003
Clavicle Fracture
Injury, poisoning and procedural complications
MedDra 27.0
Systematic Assessment
EG0001 events1 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Craniocerebral Injury
Injury, poisoning and procedural complications
MedDra 27.0
Systematic Assessment
EG0001 events1 affected5,049 at risk
EG0011 events1 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Craniofacial Fracture
Injury, poisoning and procedural complications
MedDra 27.0
Systematic Assessment
EG0001 events1 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Face Injury
Injury, poisoning and procedural complications
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0021 events1 affected6,733 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0024 events4 affected6,733 at risk
EG003
Femoral Neck Fracture
Injury, poisoning and procedural complications
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0021 events1 affected6,733 at risk
EG003
Femur Fracture
Injury, poisoning and procedural complications
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0012 events2 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Fibula Fracture
Injury, poisoning and procedural complications
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Foot Fracture
Injury, poisoning and procedural complications
MedDra 27.0
Systematic Assessment
EG0001 events1 affected5,049 at risk
EG0012 events2 affected5,064 at risk
EG0021 events1 affected6,733 at risk
EG003
Forearm Fracture
Injury, poisoning and procedural complications
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0021 events1 affected6,733 at risk
EG003
Foreign Body In Ear
Injury, poisoning and procedural complications
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0011 events1 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Gun Shot Wound
Injury, poisoning and procedural complications
MedDra 27.0
Systematic Assessment
EG0003 events3 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0024 events4 affected6,733 at risk
EG003
Hand Fracture
Injury, poisoning and procedural complications
MedDra 27.0
Systematic Assessment
EG0002 events2 affected5,049 at risk
EG0011 events1 affected5,064 at risk
EG0021 events1 affected6,733 at risk
EG003
Head Injury
Injury, poisoning and procedural complications
MedDra 27.0
Systematic Assessment
EG0002 events2 affected5,049 at risk
EG0013 events3 affected5,064 at risk
EG0023 events3 affected6,733 at risk
EG003
Humerus Fracture
Injury, poisoning and procedural complications
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0021 events1 affected6,733 at risk
EG003
Jaw Fracture
Injury, poisoning and procedural complications
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0021 events1 affected6,733 at risk
EG003
Joint Dislocation
Injury, poisoning and procedural complications
MedDra 27.0
Systematic Assessment
EG0001 events1 affected5,049 at risk
EG0012 events2 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Ligament Rupture
Injury, poisoning and procedural complications
MedDra 27.0
Systematic Assessment
EG0001 events1 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Ligament Sprain
Injury, poisoning and procedural complications
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0011 events1 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Limb Injury
Injury, poisoning and procedural complications
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Limb Traumatic Amputation
Injury, poisoning and procedural complications
MedDra 27.0
Systematic Assessment
EG0001 events1 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Lisfranc Fracture
Injury, poisoning and procedural complications
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0021 events1 affected6,733 at risk
EG003
Liver Contusion
Injury, poisoning and procedural complications
MedDra 27.0
Systematic Assessment
EG0001 events1 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Lower Limb Fracture
Injury, poisoning and procedural complications
MedDra 27.0
Systematic Assessment
EG0001 events1 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0021 events1 affected6,733 at risk
EG003
Lumbar Vertebral Fracture
Injury, poisoning and procedural complications
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Multiple Injuries
Injury, poisoning and procedural complications
MedDra 27.0
Systematic Assessment
EG0001 events1 affected5,049 at risk
EG0011 events1 affected5,064 at risk
EG0021 events1 affected6,733 at risk
EG003
Overdose
Injury, poisoning and procedural complications
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0021 events1 affected6,733 at risk
EG003
Pelvic Fracture
Injury, poisoning and procedural complications
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Penetrating Abdominal Trauma
Injury, poisoning and procedural complications
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Poisoning
Injury, poisoning and procedural complications
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Poisoning Deliberate
Injury, poisoning and procedural complications
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0021 events1 affected6,733 at risk
EG003
Post-Traumatic Pain
Injury, poisoning and procedural complications
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0011 events1 affected5,064 at risk
EG0021 events1 affected6,733 at risk
EG003
Radius Fracture
Injury, poisoning and procedural complications
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0022 events2 affected6,733 at risk
EG003
Rib Fracture
Injury, poisoning and procedural complications
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0021 events1 affected6,733 at risk
EG003
Road Traffic Accident
Injury, poisoning and procedural complications
MedDra 27.0
Systematic Assessment
EG0001 events1 affected5,049 at risk
EG0013 events3 affected5,064 at risk
EG0021 events1 affected6,733 at risk
EG003
Skin Laceration
Injury, poisoning and procedural complications
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0012 events2 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Soft Tissue Injury
Injury, poisoning and procedural complications
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0011 events1 affected5,064 at risk
EG0021 events1 affected6,733 at risk
EG003
Spinal Fracture
Injury, poisoning and procedural complications
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0011 events1 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Stab Wound
Injury, poisoning and procedural complications
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Tendon Injury
Injury, poisoning and procedural complications
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Tendon Rupture
Injury, poisoning and procedural complications
MedDra 27.0
Systematic Assessment
EG0001 events1 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Tibia Fracture
Injury, poisoning and procedural complications
MedDra 27.0
Systematic Assessment
EG0002 events2 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Toxicity To Various Agents
Injury, poisoning and procedural complications
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Traumatic Haemothorax
Injury, poisoning and procedural complications
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0021 events1 affected6,733 at risk
EG003
Traumatic Intracranial Haemorrhage
Injury, poisoning and procedural complications
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0021 events1 affected6,733 at risk
EG003
Ulna Fracture
Injury, poisoning and procedural complications
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0021 events1 affected6,733 at risk
EG003
Wound
Injury, poisoning and procedural complications
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Wound Necrosis
Injury, poisoning and procedural complications
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Wrist Fracture
Injury, poisoning and procedural complications
MedDra 27.0
Systematic Assessment
EG0001 events1 affected5,049 at risk
EG0011 events1 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Abortion Induced
Surgical and medical procedures
MedDra 27.0
Systematic Assessment
EG0001 events1 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Drug Abuser
Social circumstances
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0021 events1 affected6,733 at risk
EG003
Homicide
Social circumstances
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0020 events0 affected6,733 at risk
EG003
Physical Assault
Social circumstances
MedDra 27.0
Systematic Assessment
EG0000 events0 affected5,049 at risk
EG0010 events0 affected5,064 at risk
EG0022 events2 affected6,733 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Headache
Nervous system disorders
MedDra 27.0
Systematic Assessment
EG000921 events700 affected5,049 at risk
EG001595 events470 affected5,064 at risk
EG0021,296 events950 affected6,733 at risk
EG0031,019 events775 affected6,714 at risk
EG00456 events53 affected6,529 at risk
EG005156 events147 affected14,237 at risk
Arthralgia
Musculoskeletal and connective tissue disorders
MedDra 27.0
Systematic Assessment
EG000642 events492 affected5,049 at risk
EG001333 events273 affected5,064 at risk
EG002832 events631 affected6,733 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDra 27.0
Systematic Assessment
EG000858 events653 affected5,049 at risk
EG001406 events339 affected5,064 at risk
EG002897 events683 affected6,733 at risk
EG003
Chills
General disorders
MedDra 27.0
Systematic Assessment
EG000418 events354 affected5,049 at risk
EG001193 events164 affected5,064 at risk
EG002590 events470 affected6,733 at risk
EG003
Injection Site Pain
General disorders
MedDra 27.0
Systematic Assessment
EG0001,446 events1,018 affected5,049 at risk
EG001568 events483 affected5,064 at risk
EG0021,683 events1,206 affected6,733 at risk
EG003
Malaise
General disorders
MedDra 27.0
Systematic Assessment
EG000820 events624 affected5,049 at risk
EG001439 events354 affected5,064 at risk
EG002940 events713 affected6,733 at risk
EG003
Pyrexia
General disorders
MedDra 27.0
Systematic Assessment
EG000312 events279 affected5,049 at risk
EG001113 events100 affected5,064 at risk
EG002231 events209 affected6,733 at risk
EG003
The study was terminated as per Sponsor decision.
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
The Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications.
Participants received 0.5 mL SARS-CoV2 preS dTM-AS03 (D614 + B.1.351) vaccine as an IM injection once on Days 1 and 22 during Stage 2.
OG003
Stage 2: CoV2 preS dTM-AS03 Placebo
Participants received 0.5 mL placebo matching Cov2 preS dTM-AS03 (D614 + B.1.351) vaccine as an IM injection once daily on Days 1 and 22 during Stage 2.
Units
Counts
Participants
OG0002287
OG0012278
OG0022442
OG0032425
Title
Denominators
Categories
Solicited injection site reactions
Title
Measurements
OG0001020
OG001490
OG0021147
OG003661
Solicited systemic reactions
Title
Measurements
OG0001053
OG001663
OG0021117
OG003
Participants received 0.5 mL SARS-CoV2 preS dTM-AS03 (D614 + B.1.351) vaccine as an IM injection once on Days 1 and 22 during Stage 2.
OG003
Stage 2: CoV2 preS dTM-AS03 Placebo
Participants received 0.5 mL placebo matching Cov2 preS dTM-AS03 (D614 + B.1.351) vaccine as an IM injection once daily on Days 1 and 22 during Stage 2.
Units
Counts
Participants
OG0002294
OG0012294
OG0022458
OG0032443
Title
Denominators
Categories
Title
Measurements
OG000197
OG001259
OG002349
OG003470
OG003
Stage 2: CoV2 preS dTM-AS03 Placebo
Participants received 0.5 mL placebo matching Cov2 preS dTM-AS03 (D614 + B.1.351) vaccine as an IM injection once daily on Days 1 and 22 during Stage 2.
Participants received 0.5 mL SARS-CoV2 preS dTM-AS03 (D614 + B.1.351) vaccine as an IM injection once on Days 1 and 22 during Stage 2.
OG003
Stage 2: CoV2 preS dTM-AS03 Placebo
Participants received 0.5 mL placebo matching Cov2 preS dTM-AS03 (D614 + B.1.351) vaccine as an IM injection once daily on Days 1 and 22 during Stage 2.
Participants received 0.5 mL SARS-CoV2 preS dTM-AS03 (D614 + B.1.351) vaccine as an IM injection once on Days 1 and 22 during Stage 2.
OG003
Stage 2: CoV2 preS dTM-AS03 Placebo
Participants received 0.5 mL placebo matching Cov2 preS dTM-AS03 (D614 + B.1.351) vaccine as an IM injection once daily on Days 1 and 22 during Stage 2.
Units
Counts
Participants
OG0005049
OG0015064
OG0026733
OG0036714
Title
Denominators
Categories
Title
Measurements
OG0008.3(7.5 to 9.1)
OG00110.2(9.3 to 11.0)
OG00216.5(15.6 to 17.4)
OG00320.5(19.5 to 21.4)
OG003
Stage 2: CoV2 preS dTM-AS03 Placebo
Participants received 0.5 mL placebo matching Cov2 preS dTM-AS03 (D614 + B.1.351) vaccine as an IM injection once daily on Days 1 and 22 during Stage 2.
Units
Counts
Participants
OG0001083
OG0011031
OG002386
OG003405
Title
Denominators
Categories
Title
Measurements
OG000612
OG001615
OG002286
OG003346
Participants received 0.5 mL SARS-CoV2 preS dTM-AS03 (D614 + B.1.351) vaccine as an IM injection once on Days 1 and 22 during Stage 2.
OG003
Stage 2: CoV2 preS dTM-AS03 Placebo
Participants received 0.5 mL placebo matching Cov2 preS dTM-AS03 (D614 + B.1.351) vaccine as an IM injection once daily on Days 1 and 22 during Stage 2.
Units
Counts
Participants
OG0001083
OG0011031
OG002406
OG003423
Title
Denominators
Categories
Title
Measurements
OG0001
OG0016
OG00210
OG0036
OG003
Stage 2: CoV2 preS dTM-AS03 Placebo
Participants received 0.5 mL placebo matching Cov2 preS dTM-AS03 (D614 + B.1.351) vaccine as an IM injection once daily on Days 1 and 22 during Stage 2.
Units
Counts
Participants
OG0001083
OG0011031
OG002386
OG003405
Title
Denominators
Categories
Title
Measurements
OG000377
OG001427
OG002188
OG003222
OG003
Stage 2: CoV2 preS dTM-AS03 Placebo
Participants received 0.5 mL placebo matching Cov2 preS dTM-AS03 (D614 + B.1.351) vaccine as an IM injection once daily on Days 1 and 22 during Stage 2.
Units
Counts
Participants
OG0004691
OG0014644
OG0025766
OG0035641
Title
Denominators
Categories
Title
Measurements
OG000174
OG001154
OG00237
OG00361
OG003
Stage 2: CoV2 preS dTM-AS03 Placebo
Participants received 0.5 mL placebo matching Cov2 preS dTM-AS03 (D614 + B.1.351) vaccine as an IM injection once daily on Days 1 and 22 during Stage 2.
Units
Counts
Participants
OG0004691
OG0014644
OG0025766
OG0035641
Title
Denominators
Categories
1-3 days
Title
Measurements
OG00065
OG00153
OG0028
OG00310
4-6 days
Title
Measurements
OG00014
OG00112
OG0023
OG003
7-9 days
Title
Measurements
OG00038
OG00138
OG00210
OG003
10-30 days
Title
Measurements
OG00042
OG00138
OG00210
OG003
> 30 days
Title
Measurements
OG00015
OG00113
OG0026
OG003
OG003
Stage 2: CoV2 preS dTM-AS03 Placebo
Participants received 0.5 mL placebo matching Cov2 preS dTM-AS03 (D614 + B.1.351) vaccine as an IM injection once daily on Days 1 and 22 during Stage 2.
Units
Counts
Participants
OG0001427
OG0011256
OG0021677
OG0031644
Title
Denominators
Categories
Title
Measurements
OG000336
OG001405
OG002279
OG003411
OG003
Stage 2: CoV2 preS dTM-AS03 Placebo
Participants received 0.5 mL placebo matching Cov2 preS dTM-AS03 (D614 + B.1.351) vaccine as an IM injection once daily on Days 1 and 22 during Stage 2.
Units
Counts
Participants
OG0004675
OG0014617
OG0025762
OG0035638
Title
Denominators
Categories
Title
Measurements
OG000203
OG001256
OG002154
OG003210
OG003
Stage 2: CoV2 preS dTM-AS03 Placebo
Participants received 0.5 mL placebo matching Cov2 preS dTM-AS03 (D614 + B.1.351) vaccine as an IM injection once daily on Days 1 and 22 during Stage 2.
Units
Counts
Participants
OG0004675
OG0014617
OG0025765
OG0035638
Title
Denominators
Categories
Title
Measurements
OG0003
OG0017
OG0022
OG0033
Participants received 0.5 mL SARS-CoV2 preS dTM-AS03 (D614 + B.1.351) vaccine as an IM injection once on Days 1 and 22 during Stage 2.
OG003
Stage 2: CoV2 preS dTM-AS03 Placebo
Participants received 0.5 mL placebo matching Cov2 preS dTM-AS03 (D614 + B.1.351) vaccine as an IM injection once daily on Days 1 and 22 during Stage 2.
Units
Counts
Participants
OG0004675
OG0014617
OG0025765
OG0035638
Title
Denominators
Categories
Title
Measurements
OG00018
OG00131
OG00225
OG00324
Participants received 0.5 mL SARS-CoV2 preS dTM-AS03 (D614 + B.1.351) vaccine as an IM injection once on Days 1 and 22 during Stage 2.
OG003
Stage 2: CoV2 preS dTM-AS03 Placebo
Participants received 0.5 mL placebo matching Cov2 preS dTM-AS03 (D614 + B.1.351) vaccine as an IM injection once daily on Days 1 and 22 during Stage 2.
Participants received 0.5 mL SARS-CoV2 preS dTM-AS03 (D614 + B.1.351) vaccine as an IM injection once on Days 1 and 22 during Stage 2.
OG003
Stage 2: CoV2 preS dTM-AS03 Placebo
Participants received 0.5 mL placebo matching Cov2 preS dTM-AS03 (D614 + B.1.351) vaccine as an IM injection once daily on Days 1 and 22 during Stage 2.
Units
Counts
Participants
OG000395
OG001190
OG0020
OG0030
Title
Denominators
Categories
Day 22
ParticipantsOG000395
ParticipantsOG001190
ParticipantsOG0020
ParticipantsOG0030
Title
Measurements
OG000247
OG00126
Day 43
ParticipantsOG000379
ParticipantsOG001186
ParticipantsOG0020
ParticipantsOG0030
202
Title
Denominators
Categories
D614G: Day 43
ParticipantsOG000200
Title
Measurements
OG000113
D614G: Day 142
ParticipantsOG000194
Title
Measurements
OG00085
D614G: Day 163
ParticipantsOG000192
Title
Measurements
OG00094
D614G: Day 322
ParticipantsOG00050
Title
Measurements
OG00025
B.1.351: Day 43
ParticipantsOG000202
Title
Measurements
OG000124
B.1.351: Day 142
ParticipantsOG000197
Title
Measurements
OG00076
B.1.351: Day 163
ParticipantsOG000193
Title
Measurements
OG000103
B.1.351: Day 322
ParticipantsOG00050
Title
Measurements
OG00025
430
Title
Denominators
Categories
D614G: Day 22
ParticipantsOG000430
Title
Measurements
OG000129
D614G: Day 202
ParticipantsOG000278
Title
Measurements
OG00042
B.1.351: Day 22
ParticipantsOG000427
Title
Measurements
OG000153
B.1.351: Day 202
ParticipantsOG000276
Title
Measurements
OG00056
OG000395
OG001190
Title
Denominators
Categories
>=2 fold rise: Day 22
ParticipantsOG000395
ParticipantsOG001190
Title
Measurements
OG000260
OG00138
>=4 fold rise: Day 22
ParticipantsOG000395
ParticipantsOG001190
Title
Measurements
OG000240
OG001
>=2 fold rise: Day 43
ParticipantsOG000379
ParticipantsOG001186
Title
Measurements
OG000331
OG001
>=4 fold rise: Day 43
ParticipantsOG000379
ParticipantsOG001186
Title
Measurements
OG000315
OG001
202
Title
Denominators
Categories
D614G; >=2-fold rise: Day 43
ParticipantsOG000200
Title
Measurements
OG000149
D614G; >=4-fold rise: Day 43
ParticipantsOG000200
Title
Measurements
OG000113
D614G; >=2-fold rise: Day 142
ParticipantsOG000194
Title
Measurements
OG000111
D614G; >=4-fold rise: Day 142
ParticipantsOG000194
Title
Measurements
OG00085
D614G; >=2-fold rise: Day 163
ParticipantsOG000192
Title
Measurements
OG000116
D614G; >=4-fold rise: Day 163
ParticipantsOG000192
Title
Measurements
OG00094
D614G; >=2-fold rise: Day 322
ParticipantsOG00050
Title
Measurements
OG00032
D614G; >=4-fold rise: Day 322
ParticipantsOG00050
Title
Measurements
OG00025
B.1.351; >=2-fold rise: Day 43
ParticipantsOG000202
Title
Measurements
OG000147
B.1.351; >=4-fold rise: Day 43
ParticipantsOG000202
Title
Measurements
OG000124
B.1.351; >=2-fold rise: Day 142
ParticipantsOG000197
Title
Measurements
OG000112
B.1.351; >=4-fold rise: Day 142
ParticipantsOG000197
Title
Measurements
OG00076
B.1.351; >=2-fold rise: Day 163
ParticipantsOG000193
Title
Measurements
OG000127
B.1.351; >=4-fold rise: Day 163
ParticipantsOG000193
Title
Measurements
OG000103
B.1.351; >=2-fold rise: Day 322
ParticipantsOG00050
Title
Measurements
OG00035
B.1.351; >=4-fold rise: Day 322
ParticipantsOG00050
Title
Measurements
OG00025
OG000
430
Title
Denominators
Categories
D614G; >=2-fold rise: Day 22
ParticipantsOG000430
Title
Measurements
OG000207
D614G; >=4-fold rise: Day 22
ParticipantsOG000430
Title
Measurements
OG000127
D614G; >=2-fold rise: Day 202
ParticipantsOG000278
Title
Measurements
OG00087
D614G; >=4-fold rise: Day 202
ParticipantsOG000278
Title
Measurements
OG00042
B.1.351; >=2-fold rise: Day 22
ParticipantsOG000427
Title
Measurements
OG000228
B.1.351; >=4-fold rise: Day 22
ParticipantsOG000427
Title
Measurements
OG000152
B.1.351; >=2-fold rise: Day 202
ParticipantsOG000276
Title
Measurements
OG000105
B.1.351; >=4-fold rise: Day 202
ParticipantsOG000276
Title
Measurements
OG00054
OG001
Stage 1: CoV2 preS dTM-AS03 Placebo
Participants received 0.5 mL placebo matching Cov2 preS dTM-AS03 (D614) vaccine as an IM injection once on Days 1 and 22 during Stage 1.
Participants received 0.5 mL SARS-CoV2 preS dTM-AS03 (D614 + B.1.351) vaccine as an IM injection once on Days 1 and 22 during Stage 2.
OG003
Stage 2: CoV2 preS dTM-AS03 Placebo
Participants received 0.5 mL placebo matching Cov2 preS dTM-AS03 (D614 + B.1.351) vaccine as an IM injection once daily on Days 1 and 22 during Stage 2.
Participants previously vaccinated for placebo during Stage 1 and 2 received 0.5 mL SARS-CoV2 preS dTM-AS03 (D614) vaccine as an IM injection once on Days 1 and 22 during crossover part of the study.
Participants previously vaccinated for either placebo or CoV2 preS dTM-AS03 (D614) vaccine (Stage 1) or CoV2 preS dTM-AS03 (D614+B.1.351) vaccine (Stage 2) received a single booster dose of 0.5mL SARS-CoV2 preS dTM B.1.351 vaccine as an IM injection >=4 months after last dose of priming vaccine during the booster part of the study.
Units
Counts
Participants
OG000104
OG001164
OG002184
OG003272
OG00430
OG005119
Title
Denominators
Categories
Grade 1
Title
Measurements
OG00023
OG00141
OG00258
OG00380
OG00421
OG00562
Grade 2
Title
Measurements
OG00056
OG001100
OG00289
OG003
Grade 3
Title
Measurements
OG00025
OG00123
OG00237
OG003
Participants received 0.5 mL placebo matching Cov2 preS dTM-AS03 (D614) vaccine as an IM injection once on Days 1 and 22 during Stage 1.
Participants received 0.5 mL SARS-CoV2 preS dTM-AS03 (D614 + B.1.351) vaccine as an IM injection once on Days 1 and 22 during Stage 2.
OG003
Stage 2: CoV2 preS dTM-AS03 Placebo
Participants received 0.5 mL placebo matching Cov2 preS dTM-AS03 (D614 + B.1.351) vaccine as an IM injection once daily on Days 1 and 22 during Stage 2.
Participants previously vaccinated for placebo during Stage 1 and 2 received 0.5 mL SARS-CoV2 preS dTM-AS03 (D614) vaccine as an IM injection once on Days 1 and 22 during crossover part of the study.
Participants previously vaccinated for either placebo or CoV2 preS dTM-AS03 (D614) vaccine (Stage 1) or CoV2 preS dTM-AS03 (D614+B.1.351) vaccine (Stage 2) received a single booster dose of 0.5mL SARS-CoV2 preS dTM B.1.351 vaccine as an IM injection >=4 months after last dose of priming vaccine during the booster part of the study.
Units
Counts
Participants
OG00098
OG001158
OG002171
OG003264
OG00432
OG005126
Title
Denominators
Categories
Ordinal scale 1
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
Ordinal scale 2
Title
Measurements
OG0000
OG0010
OG0020
OG003
Ordinal scale 3
Title
Measurements
OG0000
OG0010
OG0020
OG003
Ordinal scale 4
Title
Measurements
OG0000
OG0010
OG0020
OG003
Ordinal scale 5
Title
Measurements
OG0000
OG0010
OG0021
OG003
Ordinal scale 6
Title
Measurements
OG0000
OG0011
OG0020
OG003
Ordinal scale 7
Title
Measurements
OG00086
OG001146
OG002150
OG003
Missing
Title
Measurements
OG00012
OG00111
OG00220
OG003
Participants received 0.5 mL SARS-CoV2 preS dTM-AS03 (D614 + B.1.351) vaccine as an IM injection once on Days 1 and 22 during Stage 2.
OG003
Stage 2: CoV2 preS dTM-AS03 Placebo
Participants received 0.5 mL placebo matching Cov2 preS dTM-AS03 (D614 + B.1.351) vaccine as an IM injection once daily on Days 1 and 22 during Stage 2.
Participants previously vaccinated for placebo during Stage 1 and 2 received 0.5 mL SARS-CoV2 preS dTM-AS03 (D614) vaccine as an IM injection once on Days 1 and 22 during crossover part of the study.
Participants previously vaccinated for either placebo or CoV2 preS dTM-AS03 (D614) vaccine (Stage 1) or CoV2 preS dTM-AS03 (D614+B.1.351) vaccine (Stage 2) received a single booster dose of 0.5mL SARS-CoV2 preS dTM B.1.351 vaccine as an IM injection >=4 months after last dose of priming vaccine during the booster part of the study.