A Study of LY3819253 (LY-CoV555) and LY3832479 (LY-CoV016... | NCT04427501 | Trialant
NCT04427501
Sponsor
Eli Lilly and Company
Status
Completed
Last Update Posted
Apr 11, 2024Actual
Enrollment
3,307Actual
Phase
Phase 2Phase 3
Conditions
COVID-19
Interventions
LY3819253
LY3832479
LY3853113
Placebo
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT04427501
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
17947
Secondary IDs
ID
Type
Description
Link
J2W-MC-PYAB
Other Identifier
Eli Lilly and Company
Brief Title
A Study of LY3819253 (LY-CoV555) and LY3832479 (LY-CoV016) in Participants With Mild to Moderate COVID-19 Illness
Official Title
A Randomized, Double-blind, Placebo-Controlled, Phase 2/3 Study to Evaluate the Efficacy and Safety of LY3819253 and LY3832479 in Participants With Mild to Moderate COVID-19 Illness
Acronym
BLAZE-1
Organization
Eli Lilly and CompanyINDUSTRY
Status Module
Record Verification Date
Apr 2024
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Jun 17, 2020Actual
Primary Completion Date
Feb 21, 2023Actual
Completion Date
Feb 21, 2023Actual
First Submitted Date
Jun 9, 2020
First Submission Date that Met QC Criteria
Jun 11, 2020
First Posted Date
Jun 11, 2020Actual
Results Waived
Not provided
Results First Submitted Date
Feb 14, 2022
Results First Submitted that Met QC Criteria
Feb 14, 2022
Results First Posted Date
Mar 7, 2022Actual
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
Apr 5, 2024
Last Update Posted Date
Apr 11, 2024Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Eli Lilly and CompanyINDUSTRY
Collaborators
Name
Class
AbCellera Biologics Inc.
INDUSTRY
Shanghai Junshi Bioscience Co., Ltd.
OTHER
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
Yes
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of this study is to measure how well LY3819253 and LY3832479 work against the virus that causes COVID-19. LY3819253 and LY3832479 will be given to participants with early symptoms of COVID-19. Samples will be taken from the back of the nose to determine how much virus is in the body at various times during the study. Participation could last about 12 weeks and includes one required visit to the study site, with the remainder of assessments performed in the home or by phone.
Pediatric participants, with mild to moderate COVID-19 illness, will enroll in a single-arm (Arm 22), open-label addendum to evaluate the pharmacokinetics and safety of LY3819253 and LY3832479. Enrollment began on March 31, 2021, and completed on September 24, 2021.
Pediatric participants, with mild to moderate COVID-19 illness, will enroll in a single-arm (Arm 23), open-label addendum to evaluate the pharmacokinetics and safety of LY3853113. Enrollment began on August 19, 2022, and completed on February 21, 2023.
350 mg, 700 mg, 2800 mg LY3819253 + 700 mg, 1400 mg, 2800 mg LY3832479 administered IV or subcutaneously (SQ)
Drug: LY3819253
Drug: LY3832479
LY3819253 + LY3832479 (Pediatric Addendum, Arm 22)
Experimental
LY3819253 dose based upon weight (weight Group: ≥40 kilogram (kg) = 700 mg dose, >20 kg to <40 kg = 350 mg dose, >12 kg to 20 kg = 175 mg dose and 1.5 kg to 12 kg = 15 mg/kg dose) and LY3832479 dose based upon weight (weight Group: ≥40 kg = 1400 mg dose, >20 kg to <40 kg = 700 mg dose, >12 kg to 20 kg = 350 mg dose and 1.5 kg to 12 kg = 30 mg/kg dose) administered IV.
Drug: LY3819253
Drug: LY3832479
LY3853113 (Pediatric Addendum, Arm 23)
Experimental
LY3853113 dose based upon weight (Weight Group: ≥3.3 to ≤12 kg = 3 mg/kg dose, >12 to ≤20 kg = 43.75 mg dose, >20 to <40 kg = 87.5 mg dose, ≥40 kg = 175 mg dose) administered IV.
Drug: LY3853113
Placebo
Placebo Comparator
Placebo administered IV
Interventions
Name
Type
Description
Arm Group Labels
Other Names
LY3819253
Drug
Administered IV
LY3819253
LY3819253 + LY3832479
LY3819253 + LY3832479 (Pediatric Addendum, Arm 22)
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Phase 3: Percentage of Participants Who Experience COVID-Related Hospitalization or Death From Any Cause in 2800 mg Bamlanivumab/2800 mg Etesevimab, 700 mg Bamlanivimab/1400mg Etesevimab and Their Placebo Groups
COVID-19 Related Deterioration (yes/no) was defined as a participant experiencing COVID-19-related hospitalization (defined as 24 hours of acute care) or death from any cause by Day 29.
Baseline through Day 29
Phase 3: Percentage of Participants With SARS-CoV-2 Viral Load Greater Than a Prespecified Threshold in Arms 350 mg Bamlanivimab/700 mg Etesevimab and Placebo
SARS-CoV-2 persistent high viral load (yes/no) was defined as ribonuclease P(RP) normalized viral load >=5.27 vs otherwise.
Day 7
Phase 2: Change From Baseline to Day 11 in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Viral Load
SARS-CoV-2 viral load was based on nasopharyngeal swab sampling for reverse transcription polymerase chain reaction (RT-PCR) testing for SARS-CoV-2. Least squares (LS) mean values were determined using a mixed-effects model repeated-measures (MMRM) that included log base 10 transformed baseline as a covariate, treatment, day, treatment-by-day interaction as fixed effects. If Day 11 SARS-CoV-2 viral load was missing, the earliest measurement closest to the Day 11 visit, but within 4 days (Day 7-Day 15), was used for the Day 11 value. If no measurements were available, the Day 11 viral load was treated as missing at random (MAR) in the analysis.
Viral load is reported as normalized viral load and is unitless.
Baseline, Day 11
Phase 2: Percentage of Participants Who Experience a Serious Adverse Event(s) SAE(s)
An SAE was defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect and other different situations will have medical or scientific judgment to determine if they are SAE. A summary of SAEs and other non-serious adverse events (AEs), regardless of causality are reported in the Adverse Events section.
Secondary Outcomes
Measure
Description
Time Frame
Phase 3: Percentage of Participants Demonstrating Symptom Resolution
Symptoms associated with COVID-19 were evaluated using a questionnaire that contains the following symptoms: cough, shortness of breath, feeling feverish, fatigue, body aches and pain, sore throat, chills, headache, loss of appetite, and changes in taste and smell. Each symptom was scored daily by the participant as experienced during the past 24 hours with following rating and score: None or absent (0), Mild (1), Moderate (2) and Severe (3). Symptom resolution (yes/no) is defined as a score of 0 for shortness of breath, feeling feverish, body aches and pains, sore throat, chills, and headache; and a score of 0 or 1 for cough and fatigue on the symptom questionnaire (excluding the loss of appetite and changes in taste and smell symptoms). Missing data were imputed using non-responder imputation (NRI) method.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Are currently not hospitalized. (Not applicable to participants in treatment arm 22.)
Have one or more mild or moderate COVID-19 symptoms: Fever, cough, sore throat, malaise, headache, muscle pain, gastrointestinal symptoms, or shortness of breath with exertion. (Not applicable to participants in treatment arm 22.)
Must have sample taken for test confirming viral infection no more than 3 days prior to starting the drug infusion
Are males or females, including pregnant females who agree to contraceptive requirements
Understand and agree to comply with planned study procedures
Agree to the collection of nasopharyngeal swabs and venous blood. (Not applicable to participants in treatment arms 20-21.)
The participant or legally authorized representative give signed informed consent and/or assent
Participants in treatment arms 7-9, 13-14, and 18-21 ONLY
Are greater than or equal to (≥)18 years of age and must satisfy at least one of the following at the time of screening
Are pregnant
Are ≥65 years of age
Have a body mass index (BMI) ≥35
Have chronic kidney disease (CKD)
Have type 1 or type 2 diabetes
Have immunosuppressive disease
Are currently receiving immunosuppressive treatment or
Are ≥55 years of age AND have:
cardiovascular disease (CVD), OR
hypertension, OR
chronic obstructive pulmonary disease (COPD) or other chronic respiratory disease
Are 12-17 years of age (inclusive) AND satisfy at least one of the following at the time of screening
Have neurodevelopmental disorders, for example, cerebral palsy
Have a medical-related technological dependence, for example, tracheostomy, gastrostomy, or positive pressure ventilation (not related to COVID-19)
Have asthma or reactive airway or other chronic respiratory disease that requires daily medication for control
Have type 1 or type 2 diabetes
Have chronic kidney disease
Have immunosuppressive disease, or
Are currently receiving immunosuppressive treatment
Participants in treatment arm 22 ONLY
- Are 0 (≥ 32 weeks gestational age AND ≥ 1.5 kilograms [kg]) to 17 years of age (inclusive) AND satisfy at least one of the following risk factors at the time of screening
Have neurodevelopmental disorders, for example, cerebral palsy, autism, or Down syndrome (FAIR Health 2020; Spreat et al. 2020)
Have a medical-related technological dependence, for example, tracheostomy, gastrostomy, or positive pressure ventilation (not related to COVID-19)
Have asthma, cystic fibrosis, reactive airways disease or other chronic respiratory disease that requires daily medication for control
Have type 1 or type 2 diabetes
Have chronic kidney disease
Have immunosuppressive disease, or
Are currently receiving immunosuppressive treatment, or
Are less than (<) one year of age.
Have one or more COVID-19 symptoms
Shortness of breath/difficulty breathing
Fever
Sore throat
Nausea
Diarrhea
Tiredness
Headache
New loss of taste
Nasal congestion/runny nose
Chills
Stomachache
Vomiting
Cough
Muscle/body aches and pain
New loss of smell
Poor appetite or poor feeding (in babies)
Participants in treatment arm 23 ONLY:
Must have first positive result sample of current SARS-CoV-2 viral infection ≤3 days prior to start of treatment administration.
Participant can have COVID previously and still meet criteria for this addendum. Positive result needs to be from a current infection.
Are 0 (≥ 38 weeks gestational age and ≥ 3.3 kg) to <12 years of age at the time of screening, or are 12 to 17 and weighing <40 kg; and
Have mild to moderate COVID-19 disease, including one or more COVID-19 symptoms within the last 7 days
Shortness of breath/difficulty breathing
Fever
Sore throat
Nausea
Diarrhea
Tiredness
Headache
New loss of taste
Nasal congestion/runny nose
Chills
Malaise
Vomiting
Cough
Muscle/body aches and pain
New loss of smell
Poor appetite or poor feeding (in babies under 1 year old)
Exclusion Criteria:
Have oxygen saturation (SpO2) less than or equal to (≤)93 percent (%) on room air at sea level or ratio of arterial oxygen partial pressure (PaO2 in millimeters of mercury) to fractional inspired oxygen (FiO2) less than (<)300, respiratory rate greater than or equal to (≥)30 per minute, heart rate ≥125 per minute due to COVID-19
Require mechanical ventilation or anticipated impending need for mechanical ventilation due to COVID-19
Have known allergies to any of the components used in the formulation of the interventions
Have hemodynamic instability requiring use of pressors within 24 hours of randomization
Suspected or proven serious, active bacterial, fungal, viral, or other infection (besides COVID-19) that in the opinion of the investigator could constitute a risk when taking intervention
Have any co-morbidity requiring surgery within <7 days, or that is considered life-threatening within 29 days
Have any serious concomitant systemic disease, condition or disorder that, in the opinion of the investigator, should preclude participation in this study
Have a history of a positive SARS-CoV-2 test prior to the one serving as eligibility for this study
Have received an investigational intervention for SARS-CoV-2 prophylaxis within 30 days before dosing
Have received treatment with a SARS-CoV-2 specific monoclonal antibody
Have received convalescent COVID-19 plasma treatment
Have participated in a previous SARS-CoV-2 vaccine study or have received a SARS-CoV-2 vaccine
Have participated, within the last 30 days, in a clinical study involving an investigational intervention. If the previous investigational intervention has a long half-life, 5 half-lives or 30 days, whichever is longer, should have passed
Are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
Mothers who are breast feeding
Participants in Treatment Arm 22 ONLY
Have a diagnosis of Multisystem Inflammatory Syndrome in Children (MIS-C) in the opinion of the investigator
Are currently hospitalized for treatment of COVID-19. Other reasons for hospitalization are acceptable.
Participants in treatment arm 23 ONLY
SpO2 ≤ 93% on room air at sea level, or while on chronic oxygen therapy and/or respiratory support due to underlying non-COVID-19 related comorbidity, respiratory rate ≥30 per minute, and heart rate ≥125 per minute due to COVID-19 (FDA February 2021)
Require mechanical ventilation or anticipated impending need for mechanical ventilation due to COVID-19
Have known allergies to any of the components used in the formulation of the interventions
Have hemodynamic instability requiring use of pressors within 24 hours of randomization
Suspected or proven serious, active bacterial, fungal, viral, or other infection (besides COVID-19) that in the opinion of the investigator could constitute a risk when taking intervention
Have any co-morbidity requiring surgery within 7 days, or that is considered life-threatening within 29 days
Have any serious concomitant systemic disease, condition or disorder that, in the opinion of the investigator, should preclude participation in this study.
Have received treatment with a SARS-CoV-2 specific monoclonal antibody or remdesivir within 90 days before dosing.
Have received convalescent COVID-19 plasma treatment within 90 days before dosing
Have participated, within the last 30 days, in a clinical study involving an investigational intervention. If the previous investigational intervention has a long half-life, 5 half-lives or 30 days, whichever is longer, should have passed
Are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
Are currently pregnant or breast feeding
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
0 Years
Maximum Age
Not provided
Standard Ages
ChildAdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting
Access Criteria
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting
This study has three parts: Phase 2, Phase 3 and pediatrics addendum. All participants in Placebo for Phase 3: 2800 mg Bamlanivimab + 2800 mg Etesevimab are also in Placebo For Phase 3: 700 mg Bamlanivimab + 1400 mg Etesevimab therefore the two arms are combined to avoid double counting.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Phase 2: Placebo
Participants received Placebo administered intravenously (IV).
FG001
Phase 2: 700 mg Bamlanivimab
Participants received 700 milligram (mg) bamlanivimab administered IV.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
0
More Info Module
Limitations and Caveats
Not provided
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: Protocol J2W-MC-PYAB (m)
Mar 2, 2021
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Puerto Rico
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Sequential Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Double
Masking Description
Some treatment arms are open label.
Who Masked
ParticipantInvestigator
Drug: Placebo
LY-CoV555
Bamlanivimab
LY3832479
Drug
Administered IV
LY3819253 + LY3832479
LY3819253 + LY3832479 (Pediatric Addendum, Arm 22)
LY-CoV016
Etesevimab
LY3853113
Drug
Administered IV
LY3853113 (Pediatric Addendum, Arm 23)
bebtelovimab
Placebo
Drug
Administered IV
Placebo
Baseline through Day 85
Phase 3 and Phase 2/3 [Arm 22], Pharmacokinetics (PK): Mean Concentrations of LY3819253 (Bamlanivimab)
Mean Concentration of Bamlanivimab in the presence of Etesevimab is reported. Due to the limited number of pediatric participants across all study arms in phase 3, PK concentration summary data was combined including phase 3 and phase 2/3 (Pediatric addendum, Arm 22) reporting arms. All pediatric participants from Phase 3 trial arms including Arm 22 who contributed data to the required outcome (PK concentration at Day 29) were included in the PK summary.
Day 29 Post-dose
Phase 3 and Phase 2/3 [Arm 22], Pharmacokinetics (PK): Mean Concentrations of LY3832479 (Etesevimab)
Mean Concentration of Etesevimab in the presence of Bamlanivimab is reported. Due to the limited number of pediatric participants across all study arms in phase 3, PK concentration summary data was combined including phase 3 and phase 2/3 (Pediatric addendum, Arm 22) reporting arms. All pediatric participants from Phase 3 trial arms including Arm 22 who contributed data to the required outcome (PK concentration at Day 29) were included in the PK summary.
Day 29 Post-dose
Phase 2/3, PK: Area Under the Concentration-time Curve From Time 0 to Infinity (AUC0-∞) for Bebtelovimab [Arm 23]
AUC0-∞ for Bebtelovimab was reported.
Day 60 Post-dose
Day 11
Phase 3: Percentage of Participants Demonstrating Symptom Improvement
Symptoms associated with COVID-19 were evaluated using a questionnaire that contains the following symptoms: cough, shortness of breath, feeling feverish, fatigue, body aches and pain, sore throat, chills, headache, loss of appetite, and changes in taste and smell. Each symptom will be scored daily by the participant as experienced during the past 24 hours with following rating and score: None or absent (0), Mild (1), Moderate (2) and Severe (3). Symptom improvement was defined as a participant experiencing both: Symptoms on the symptom questionnaire scored as moderate or severe at baseline are subsequently scored as mild or absent, and symptoms on the symptom questionnaire scored as mild or absent at baseline are subsequently scored as absent. Missing data were imputed using NRI method.
Day 11
Phase 3: Percentage of Participants Who Experience COVID-Related Hospitalization, COVID-Related Emergency Room (ER) Visit, or Death From Any Cause
COVID-19 Related Deterioration (yes/no) is defined as a patient experiencing COVID-19-related hospitalization, Emergency Room Visit, or Death from any causes vs otherwise.
Baseline through Day 85
Phase 3: Change From Baseline to Day 7 in SARS-CoV-2 Viral Load
Change from baseline to Day 7 (±2 days) in SARS-CoV-2 viral load was based on nasopharyngeal swab sampling for reverse transcription polymerase chain reaction (RT-PCR) testing for SARS-CoV-2. Least squares (LS) mean values were determined using a mixed-effects model repeated-measures (MMRM) that included log base 10 transformed baseline as a covariate, treatment, day, treatment-by-day interaction as fixed effects. If Day 7 SARS-CoV-2 viral load was missing, the earliest measurement closest to the Day 7 visit, but within 2 days (Day 5-Day 9), was used for the Day 7 value. If no measurements are available, the Day 7 viral load was treated as missing at random (MAR) in the analysis.
Viral load is reported as normalized viral and is unitless.
Baseline, Day 7
Phase 3: Time to Sustained Symptom Resolution
Sustained symptom resolution was defined as 2 consecutive assessments with a score of 0 for shortness of breath, feeling feverish, body aches and pains, sore throat, chills, and headache; and a score of 0 or 1 for cough and fatigue on the symptom questionnaire. Participants who did not experience sustained symptom resolution by completion or early discontinuation of study were censored at the date of their last visit during. Additionally, participants who were hospitalized were censored at their date of hospitalization.
Baseline through Day 29
Phase 3: Time to SARS-CoV-2 Viral Clearance
Participants who did not experience SARS-CoV-2 viral clearance by completion or early discontinuation of study were censored at the date of their last visit.
Baseline through Day 29
Phase 2: Change From Baseline to Day 11 in SARS-CoV-2 Viral Load Among Participants Enrolled With Recent Symptoms Prior to Randomization
SARS-CoV-2 viral load was based on nasopharyngeal swab sampling for reverse transcription polymerase chain reaction (RT-PCR) testing for SARS-CoV-2. This analysis included only participants whose symptoms developed no more than 8 days prior to randomization. Least squares (LS) mean values were determined using a mixed-effects model repeated-measures (MMRM) that included log base 10 transformed baseline as a covariate, treatment, day, treatment-by-day interaction as fixed effects. If Day 11 SARS-CoV-2 viral load is missing, the earliest measurement closest to the Day 11 visit, but within 4 days (Day 7-Day 15), will be used for the Day 11 value. If no measurements are available, the Day 11 viral load will be treated as MAR in the analysis.
Baseline, Day 11
Phase 2: Percentage of Participants Demonstrating Symptom Resolution
Symptoms associated with COVID-19 were evaluated using a questionnaire that contains the following symptoms: cough, shortness of breath, feeling feverish, fatigue, body aches and pain, sore throat, chills, headache, loss of appetite, and changes in taste and smell. Each symptom will be scored daily by the participant as experienced during the past 24 hours with following rating and score: None or absent (0), Mild (1), Moderate (2) and Severe (3). Symptom resolution was defined as all symptoms (those scored 0-3) on the symptom questionnaire scored as absent (0). Symptom Resolution (yes/no) was defined as all symptoms (excluding the loss of appetite and changes in taste and smell symptoms) on the symptom questionnaire scored as absent vs otherwise.
Missing data were imputed using non-responder imputation (NRI) method.
Day 11
Phase 2: Percentage of Participants Demonstrating Symptom Improvement
Symptoms associated with COVID-19 were evaluated using a questionnaire that contains the following symptoms: cough, shortness of breath, feeling feverish, fatigue, body aches and pain, sore throat, chills, headache, loss of appetite, and changes in taste and smell. Each symptom will be scored daily by the participant as experienced during the past 24 hours with following rating and score: None or absent (0), Mild (1), Moderate (2) and Severe (3). Symptom improvement was defined as a participant experiencing both: Symptoms on the symptom questionnaire scored as moderate or severe at baseline are subsequently scored as mild or absent, and Symptoms on the symptom questionnaire scored as mild or absent at baseline are subsequently scored as absent. Missing data were imputed using NRI method.
Day 11
Phase 2, Pharmacokinetics (PK): Mean Concentration of Bamlanivimab Alone and in the Presence of Etesevimab
(PK): Mean Concentration of Bamlanivimab alone and in the Presence of Etesevimab
Day 29 Post-dose
Phase 2, PK: Mean Concentration of Etesevimab in the Presence of Bamlanivimab
PK: Mean Concentration of Etesevimab in the Presence of Bamlanivimab
Day 29 Post-dose
Phase 2: Percentage of Participants Who Experience COVID-Related Hospitalization, COVID-Related Emergency Room (ER) Visit, or Death From Any Cause
Percentage of Participants Who Experience COVID-Related Hospitalization, COVID-Related ER Visit, or Death from Any Cause
Baseline through Day 85
Phase 2: Time to SARS-CoV-2 Viral Clearance
Participants who did not experience SARS-CoV-2 viral clearance by completion or early discontinuation of study were censored at the date of their last visit.
Baseline through Day 29
Phase 2/3: Percentage of Participants Who Experience COVID-19 Related Hospitalization, COVID-Related Emergency Room (ER) Visit, or Death From Any Cause [Arm 22]
Percentage of Participants Who Experience COVID-Related Hospitalization, COVID-Related ER Visit, or Death from Any Cause.
Baseline through Day 29
Phase 2/3: Change From Baseline to Day 7 in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Viral Load [Arm 22]
SARS-CoV-2 viral load was based on nasopharyngeal swab sampling for reverse transcription polymerase chain reaction (RT-PCR) testing for SARS-CoV-2.
Viral load is reported as normalized viral load and is unitless.
Baseline, Day 7
Phase 2/3: Percentage of Participants With SARS-CoV-2 Viral Load Greater Than a Prespecified Threshold [Arm 22]
SARS-CoV-2 persistent high viral load (yes/no) is defined as RP normalized viral load >5.27 vs otherwise. Percentage of response is calculated by n/Nx*100% (n = number of participants in the specified category, Nx = number of participants with non-missing values)
Day 7
Phase 2/3: Time to Complete Symptom Resolution [Arm 22]
Complete symptom resolution was defined as absence of all symptoms at a single timepoint.
Baseline through Day 29
Phase 2/3: Time to Sustained Complete Symptom Resolution [Arm 22]
Sustained complete symptom resolution is defined as the first of 2 consecutive days with complete symptom resolution.
Baseline through Day 29
Phase 2/3: Time to SARS-CoV-2 Viral Clearance [Arm 22]
Participants who did not experience SARS-CoV-2 viral clearance by completion or early discontinuation of study were censored at the date of their last visit.
Baseline through Day 29
Miami
Florida
33184
United States
Rophe Adult and Pediatric Medicine
Union City
Georgia
30291
United States
Massachusetts General Hospital
Boston
Massachusetts
02114
United States
U of MA Mem Med Ctr
Worcester
Massachusetts
01655
United States
Great Lakes Research Group, Inc.
Bay City
Michigan
48706
United States
Childrens Hospital of Michigan
Detroit
Michigan
48201
United States
Sky Clinical Prime and Health Wellness Clinic
Fayette
Mississippi
39069
United States
Sky Clin Resch - Quinn HC
Ridgeland
Mississippi
39157
United States
Monroe Biomed Research
Monroe
North Carolina
28112
United States
B S & W Med Center
Dallas
Texas
75246
United States
Sun Research Institute
San Antonio
Texas
78215
United States
Derived
Upadhyaya HP, Chien JY, Long AJ, Bohm MS, Kallewaard NL, Macpherson LF, Patel DR, Hufford MM, Krull CJ, Ang JY, Chen P, Muller WJ, Potts JA, Quinn T, Williams M; BLAZE-1 Investigators. Pharmacokinetics, Efficacy, and Safety of a SARS-CoV-2 Antibody Treatment in Pediatric Participants: An Open-Label Addendum of a Placebo-Controlled, Randomized Phase 2/3 Trial. Infect Dis Ther. 2023 Jul;12(7):1861-1873. doi: 10.1007/s40121-023-00832-y. Epub 2023 Jun 17.
Chen P, Behre G, Hebert C, Kumar P, Farmer Macpherson L, Graham-Clarke PL, De La Torre I, Nichols RM, Hufford MM, Patel DR, Naegeli AN. Bamlanivimab and Etesevimab Improve Symptoms and Associated Outcomes in Ambulatory Patients at Increased Risk for Severe Coronavirus Disease 2019: Results From the Placebo-Controlled Double-Blind Phase 3 BLAZE-1 Trial. Open Forum Infect Dis. 2022 Apr 7;9(5):ofac172. doi: 10.1093/ofid/ofac172. eCollection 2022 May.
Dougan M, Azizad M, Mocherla B, Gottlieb RL, Chen P, Hebert C, Perry R, Boscia J, Heller B, Morris J, Crystal C, Igbinadolor A, Huhn G, Cardona J, Shawa I, Kumar P, Blomkalns A, Adams AC, Van Naarden J, Custer KL, Knorr J, Oakley G, Schade AE, Holzer TR, Ebert PJ, Higgs RE, Sabo J, Patel DR, Dabora MC, Williams M, Klekotka P, Shen L, Skovronsky DM, Nirula A. A Randomized, Placebo-Controlled Clinical Trial of Bamlanivimab and Etesevimab Together in High-Risk Ambulatory Patients With COVID-19 and Validation of the Prognostic Value of Persistently High Viral Load. Clin Infect Dis. 2022 Aug 24;75(1):e440-e449. doi: 10.1093/cid/ciab912.
Nathan R, Shawa I, De La Torre I, Pustizzi JM, Haustrup N, Patel DR, Huhn G. A Narrative Review of the Clinical Practicalities of Bamlanivimab and Etesevimab Antibody Therapies for SARS-CoV-2. Infect Dis Ther. 2021 Dec;10(4):1933-1947. doi: 10.1007/s40121-021-00515-6. Epub 2021 Aug 10.
Meng X, Wang P, Xiong Y, Wu Y, Lin X, Lu S, Li R, Zhao B, Liu J, Zeng S, Zeng L, Wu Y, Lu Y, Zhang J, Liu D, Wang S, Lu H. Safety, tolerability, pharmacokinetic characteristics, and immunogenicity of MW33: a Phase 1 clinical study of the SARS-CoV-2 RBD-targeting monoclonal antibody. Emerg Microbes Infect. 2021 Dec;10(1):1638-1648. doi: 10.1080/22221751.2021.1960900.
Gottlieb RL, Nirula A, Chen P, Boscia J, Heller B, Morris J, Huhn G, Cardona J, Mocherla B, Stosor V, Shawa I, Kumar P, Adams AC, Van Naarden J, Custer KL, Durante M, Oakley G, Schade AE, Holzer TR, Ebert PJ, Higgs RE, Kallewaard NL, Sabo J, Patel DR, Klekotka P, Shen L, Skovronsky DM. Effect of Bamlanivimab as Monotherapy or in Combination With Etesevimab on Viral Load in Patients With Mild to Moderate COVID-19: A Randomized Clinical Trial. JAMA. 2021 Feb 16;325(7):632-644. doi: 10.1001/jama.2021.0202.
Participants received Placebo administered intravenously (IV).
FG009
Phase 3: 350 mg Bamlanivimab + 700 mg Etesevimab
Participants received 350 mg bamlanivimab and 700 mg etesevimab administered IV.
FG010
Phase 2/3: Bamlanivimab + Etesevimab (Pediatric Addendum, Arm 22)
Pediatric participants received a Bamlanivimab + Etesevimab dose based upon weight (Bamlanivimab dose: weight Group: ≥40 kg = 700 mg dose, >20 kg to <40 kg = 350 mg dose, >12 kg to 20 kg = 175 mg dose and 1.5 kg to 12 kg = 15 mg/kg dose) and Etesevimab dose: weight Group: ≥40 kg = 1400 mg dose, >20 kg to <40 kg = 700 mg dose, >12 kg to 20 kg = 350 mg dose and 1.5 kg to 12 kg = 30 mg/kg dose) administered IV.
FG011
Phase 2/3: Bebtelovimab (Pediatric Addendum, Arm 23)
Pediatric participants received Bebtelovimab dose based upon weight (Weight Group: ≥3.3 to ≤12 kg = 3 mg/kg dose, >12 to ≤20 kg = 43.75 mg dose, >20 to <40 kg = 87.5 mg dose, ≥40 kg = 175 mg dose) administered IV.
FG000156 subjects
FG001101 subjects
FG002107 subjects
FG003101 subjects
FG004112 subjects
FG005776 subjectsParticipants in Placebo for Phase 3: 2800 mg Bamlanivimab + 2800 mg Etesevimab and Phase 3: 700 mg Bamlanivimab + 1400 mg Etesevimab were combined to avoid double counting.
Participants received Placebo administered intravenously (IV).
BG009
Phase 3: 350 mg Bamlanivimab + 700 mg Etesevimab
Participants received 350 mg bamlanivimab and 700 mg etesevimab administered IV.
BG010
Phase 2/3: Bamlanivimab + Etesevimab (Pediatric Addendum, Arm 22)
Pediatric participants received a Bamlanivimab + Etesevimab dose based upon weight (Bamlanivimab dose: weight Group: ≥40 kg = 700 mg dose, >20 kg to <40 kg = 350 mg dose, >12 kg to 20 kg = 175 mg dose and 1.5 kg to 12 kg = 15 mg/kg dose) and Etesevimab dose: weight Group: ≥40 kg = 1400 mg dose, >20 kg to <40 kg = 700 mg dose, >12 kg to 20 kg = 350 mg dose and 1.5 kg to 12 kg = 30 mg/kg dose) administered IV.
BG011
Phase 2/3: Bebtelovimab (Pediatric Addendum, Arm 23)
Pediatric participants received Bebtelovimab dose based upon weight (Weight Group: ≥3.3 to ≤12 kg = 3 mg/kg dose, >12 to ≤20 kg = 43.75 mg dose, >20 to <40 kg = 87.5 mg dose, ≥40 kg = 175 mg dose) administered IV.
BG012
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000156
BG001101
BG002107
BG003101
BG004112
BG005776
BG006518
BG007513
BG008141
BG009213
BG01094
BG01117
BG0122849
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
ParticipantsBG000156
ParticipantsBG001101
ParticipantsBG002107
ParticipantsBG003
Sex: Female, Male
Count of Participants
Participants
No
Title
Denominators
Categories
ParticipantsBG000156
ParticipantsBG001101
ParticipantsBG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
No
Title
Denominators
Categories
ParticipantsBG000156
ParticipantsBG001101
ParticipantsBG002
Race (NIH/OMB)
Count of Participants
Participants
No
Title
Denominators
Categories
ParticipantsBG000156
ParticipantsBG001101
ParticipantsBG002
Region of Enrollment
Count of Participants
Participants
No
Title
Denominators
Categories
United States
ParticipantsBG000156
ParticipantsBG001101
ParticipantsBG002
SARS-CoV-2 Viral Load
All participants who received at least one dose of study drug and had at least 1 post-baseline viral load measurement. Cycle threshold (Ct) denotes how many PCR cycles are required before the SARS-CoV-2 viral RNA reached a detectable level. Higher Ct values correspond to a lower viral load.
Mean
Standard Deviation
Cycle threshold (Ct)
Title
Denominators
Categories
ParticipantsBG000152
ParticipantsBG001101
ParticipantsBG002
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
Phase 3: Percentage of Participants Who Experience COVID-Related Hospitalization or Death From Any Cause in 2800 mg Bamlanivumab/2800 mg Etesevimab, 700 mg Bamlanivimab/1400mg Etesevimab and Their Placebo Groups
COVID-19 Related Deterioration (yes/no) was defined as a participant experiencing COVID-19-related hospitalization (defined as 24 hours of acute care) or death from any cause by Day 29.
Phase 3: All randomized participants who received at least one dose of study drug and had COVID-related hospitalization or death from any cause data available in arms Placebo, 2800 mg Bamlanivimab + 2800 mg Etesevimab and 700 mg Bamlanivimab + 1400 mg Etesevimab.
Participants received Placebo administered intravenously (IV).
OG003
Phase 3: 700 mg Bamlanivimab + 1400 mg Etesevimab
Participants received 700 mg bamlanivimab and 1400 mg etesevimab administered IV.
Units
Counts
Participants
OG000517
OG001518
OG002776
OG003
Title
Denominators
Categories
Title
Measurements
OG0007.0(4.8 to 9.2)
OG0012.1(0.9 to 3.4)
OG0026.8(5.1 to 8.6)
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Odds Ratio (OR)
0.30
2-Sided
95
0.15
0.58
Superiority
OG002
OG003
Primary
Phase 3: Percentage of Participants With SARS-CoV-2 Viral Load Greater Than a Prespecified Threshold in Arms 350 mg Bamlanivimab/700 mg Etesevimab and Placebo
SARS-CoV-2 persistent high viral load (yes/no) was defined as ribonuclease P(RP) normalized viral load >=5.27 vs otherwise.
Phase 3: All randomized participants who received at least one dose of study drug and had non-missing viral load values in arms Placebo For 350 mg Bamlanivimab + 700 mg Etesevimab and 350 mg Bamlanivimab + 700 mg Etesevimab
Participants received Placebo administered intravenously (IV).
OG001
Phase 3: 350 mg Bamlanivimab + 700 mg Etesevimab
Participants received 350 mg bamlanivimab and 700 mg etesevimab administered IV.
Units
Counts
Participants
OG000
Primary
Phase 2: Change From Baseline to Day 11 in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Viral Load
SARS-CoV-2 viral load was based on nasopharyngeal swab sampling for reverse transcription polymerase chain reaction (RT-PCR) testing for SARS-CoV-2. Least squares (LS) mean values were determined using a mixed-effects model repeated-measures (MMRM) that included log base 10 transformed baseline as a covariate, treatment, day, treatment-by-day interaction as fixed effects. If Day 11 SARS-CoV-2 viral load was missing, the earliest measurement closest to the Day 11 visit, but within 4 days (Day 7-Day 15), was used for the Day 11 value. If no measurements were available, the Day 11 viral load was treated as missing at random (MAR) in the analysis.
Viral load is reported as normalized viral load and is unitless.
Phase 2: All randomized participants who received at least one dose of study drug and had a baseline and day 11 viral load value.
Posted
Least Squares Mean
Standard Error
unitless
Baseline, Day 11
ID
Title
Description
OG000
Part A: Placebo
Participants received Placebo administered intravenously (IV).
OG001
Phase 2: 700 mg Bamlanivimab
Participants received 700 mg bamlanivimab administered IV.
OG002
Phase 2: 2800 mg Bamlanivimab
Primary
Phase 2: Percentage of Participants Who Experience a Serious Adverse Event(s) SAE(s)
An SAE was defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect and other different situations will have medical or scientific judgment to determine if they are SAE. A summary of SAEs and other non-serious adverse events (AEs), regardless of causality are reported in the Adverse Events section.
Phase 2: All randomized participants who received at least one dose of study drug.
Posted
Number
percentage of participants
Baseline through Day 85
ID
Title
Description
OG000
Phase 2: Placebo
Participants received Placebo administered intravenously (IV).
OG001
Phase 2: 700 mg Bamlanivimab
Participants received 700 mg bamlanivimab administered IV.
OG002
Phase 2: 2800 mg Bamlanivimab
Participants received 2800 mg bamlanivimab administered IV.
OG003
Primary
Phase 3 and Phase 2/3 [Arm 22], Pharmacokinetics (PK): Mean Concentrations of LY3819253 (Bamlanivimab)
Mean Concentration of Bamlanivimab in the presence of Etesevimab is reported. Due to the limited number of pediatric participants across all study arms in phase 3, PK concentration summary data was combined including phase 3 and phase 2/3 (Pediatric addendum, Arm 22) reporting arms. All pediatric participants from Phase 3 trial arms including Arm 22 who contributed data to the required outcome (PK concentration at Day 29) were included in the PK summary.
Phase 2/3: All randomized participants who received a complete dose of Bamlanivimab and Etesevimab and had an evaluable PK sample on Day 29.
Posted
Geometric Mean
Geometric Coefficient of Variation
micrograms per milliliter (μg/mL)
Day 29 Post-dose
ID
Title
Description
OG000
Phase 3 and Phase 2/3 (Pediatric Addendum, Arm 22): Bamlanivimab + Etesevimab
Pediatric participants from Phase 3: 2800 mg Bamlanivimab + 2800 mg Etesevimab; Phase 3: 700 mg Bamlanivimab + 1400 mg Etesevimab; Phase 3: 350 mg Bamlanivimab + 700 mg Etesevimab reporting arms and Phase 2/3: Bamlanivimab + Etesevimab (Pediatric Addendum, Arm 22) received a single weight category-dependent dose of the combination Bamlanivimab + Etesevimab dose based upon weight (Bamlanivimab dose: weight Group: ≥40 kg = 700 mg dose, >20 kg to <40 kg = 350 mg dose, >12 kg to 20 kg = 175 mg dose and 1.5 kg to 12 kg = 15 mg/kg dose) and Etesevimab dose: weight Group: ≥40 kg = 1400 mg dose, >20 kg to <40 kg = 700 mg dose, >12 kg to 20 kg = 350 mg dose and 1.5 kg to 12 kg = 30 mg/kg dose) administered IV.
Primary
Phase 3 and Phase 2/3 [Arm 22], Pharmacokinetics (PK): Mean Concentrations of LY3832479 (Etesevimab)
Mean Concentration of Etesevimab in the presence of Bamlanivimab is reported. Due to the limited number of pediatric participants across all study arms in phase 3, PK concentration summary data was combined including phase 3 and phase 2/3 (Pediatric addendum, Arm 22) reporting arms. All pediatric participants from Phase 3 trial arms including Arm 22 who contributed data to the required outcome (PK concentration at Day 29) were included in the PK summary.
Phase 2/3: All randomized participants who received a complete dose of Bamlanivimab and Etesevimab and had an evaluable PK sample on Day 29.
Posted
Geometric Mean
Geometric Coefficient of Variation
micrograms per milliliter (μg/mL)
Day 29 Post-dose
ID
Title
Description
OG000
Phase 3 and Phase 2/3 (Pediatric Addendum, Arm 22): Bamlanivimab + Etesevimab
Pediatric participants from Phase 3: 2800 mg Bamlanivimab + 2800 mg Etesevimab; Phase 3: 700 mg Bamlanivimab + 1400 mg Etesevimab; Phase 3: 350 mg Bamlanivimab + 700 mg Etesevimab reporting arms and Phase 2/3: Bamlanivimab + Etesevimab (Pediatric Addendum, Arm 22) received a single weight category-dependent dose of the combination Bamlanivimab + Etesevimab dose based upon weight (Bamlanivimab dose: weight Group: ≥40 kg = 700 mg dose, >20 kg to <40 kg = 350 mg dose, >12 kg to 20 kg = 175 mg dose and 1.5 kg to 12 kg = 15 mg/kg dose) and Etesevimab dose: weight Group: ≥40 kg = 1400 mg dose, >20 kg to <40 kg = 700 mg dose, >12 kg to 20 kg = 350 mg dose and 1.5 kg to 12 kg = 30 mg/kg dose) administered IV.
Primary
Phase 2/3, PK: Area Under the Concentration-time Curve From Time 0 to Infinity (AUC0-∞) for Bebtelovimab [Arm 23]
AUC0-∞ for Bebtelovimab was reported.
Phase 2/3: All randomized participants who received a complete dose of Bebtelovimab and had at least 1 post-dose PK sample.
Posted
Geometric Mean
Geometric Coefficient of Variation
microgram*day per milliliter (μg*day/mL)
Day 60 Post-dose
ID
Title
Description
OG000
Phase 2/3: Bebtelovimab (Pediatric Addendum, Arm 23)
Pediatric participants received Bebtelovimab dose based upon weight (Weight Group: ≥3.3 to ≤12 kg = 3 mg/kg dose, >12 to ≤20 kg = 43.75 mg dose, >20 to <40 kg = 87.5 mg dose, ≥40 kg = 175 mg dose) administered IV.
Units
Counts
Participants
OG000
Secondary
Phase 3: Percentage of Participants Demonstrating Symptom Resolution
Symptoms associated with COVID-19 were evaluated using a questionnaire that contains the following symptoms: cough, shortness of breath, feeling feverish, fatigue, body aches and pain, sore throat, chills, headache, loss of appetite, and changes in taste and smell. Each symptom was scored daily by the participant as experienced during the past 24 hours with following rating and score: None or absent (0), Mild (1), Moderate (2) and Severe (3). Symptom resolution (yes/no) is defined as a score of 0 for shortness of breath, feeling feverish, body aches and pains, sore throat, chills, and headache; and a score of 0 or 1 for cough and fatigue on the symptom questionnaire (excluding the loss of appetite and changes in taste and smell symptoms). Missing data were imputed using non-responder imputation (NRI) method.
Phase 3: All randomized participants who received at least one dose of study drug and had non-missing Symptom Resolution values
Participants received 2800 mg bamlanivimab and 2800 mg etesevimab administered IV.
Secondary
Phase 3: Percentage of Participants Demonstrating Symptom Improvement
Symptoms associated with COVID-19 were evaluated using a questionnaire that contains the following symptoms: cough, shortness of breath, feeling feverish, fatigue, body aches and pain, sore throat, chills, headache, loss of appetite, and changes in taste and smell. Each symptom will be scored daily by the participant as experienced during the past 24 hours with following rating and score: None or absent (0), Mild (1), Moderate (2) and Severe (3). Symptom improvement was defined as a participant experiencing both: Symptoms on the symptom questionnaire scored as moderate or severe at baseline are subsequently scored as mild or absent, and symptoms on the symptom questionnaire scored as mild or absent at baseline are subsequently scored as absent. Missing data were imputed using NRI method.
Phase 3: All randomized participants who received at least one dose of study drug and had non-missing Symptom Improvement values
Participants received 2800 mg bamlanivimab and 2800 mg etesevimab administered IV.
Secondary
Phase 3: Percentage of Participants Who Experience COVID-Related Hospitalization, COVID-Related Emergency Room (ER) Visit, or Death From Any Cause
COVID-19 Related Deterioration (yes/no) is defined as a patient experiencing COVID-19-related hospitalization, Emergency Room Visit, or Death from any causes vs otherwise.
Phase 3: All randomized participants who received at least one dose of study drug and had COVID-related hospitalization, COVID-Related Emergency Room (ER) Visit, or death from any cause data available.
Participants received Placebo administered intravenously (IV).
OG003
Secondary
Phase 3: Change From Baseline to Day 7 in SARS-CoV-2 Viral Load
Change from baseline to Day 7 (±2 days) in SARS-CoV-2 viral load was based on nasopharyngeal swab sampling for reverse transcription polymerase chain reaction (RT-PCR) testing for SARS-CoV-2. Least squares (LS) mean values were determined using a mixed-effects model repeated-measures (MMRM) that included log base 10 transformed baseline as a covariate, treatment, day, treatment-by-day interaction as fixed effects. If Day 7 SARS-CoV-2 viral load was missing, the earliest measurement closest to the Day 7 visit, but within 2 days (Day 5-Day 9), was used for the Day 7 value. If no measurements are available, the Day 7 viral load was treated as missing at random (MAR) in the analysis.
Viral load is reported as normalized viral and is unitless.
Phase 3: All randomized participants who received at least one dose of study drug and had a baseline and day 7 viral load value.
Participants received 2800 mg bamlanivimab and 2800 mg etesevimab administered IV.
OG002
Secondary
Phase 3: Time to Sustained Symptom Resolution
Sustained symptom resolution was defined as 2 consecutive assessments with a score of 0 for shortness of breath, feeling feverish, body aches and pains, sore throat, chills, and headache; and a score of 0 or 1 for cough and fatigue on the symptom questionnaire. Participants who did not experience sustained symptom resolution by completion or early discontinuation of study were censored at the date of their last visit during. Additionally, participants who were hospitalized were censored at their date of hospitalization.
Phase 3: All randomized participants (including censored) who received at least one dose of study drug and who had at least one post-baseline symptom measurement. Participants censored: Placebo For 2800 mg Bamlanivimab + 2800 mg Etesevimab = 121, 2800 mg Bamlanivimab + 2800 mg Etesevimab = 88, Placebo For 700 mg Bamlanivimab + 1400 mg Etesevimab= 226, 700 mg Bamlanivimab + 1400 mg Etesevimab= 128, Placebo For 350 mg Bamlanivimab + 700 mg Etesevimab=44, 350 mg Bamlanivimab + 700 mg Etesevimab=43
Participants received 2800 mg bamlanivimab and 2800 mg etesevimab administered IV.
Secondary
Phase 3: Time to SARS-CoV-2 Viral Clearance
Participants who did not experience SARS-CoV-2 viral clearance by completion or early discontinuation of study were censored at the date of their last visit.
Phase 3: All randomized participants (Including censored) who received at least 1 dose of study drug and had at least 1 post-baseline viral load measurement. Censored participants: Placebo For 2800 mg Bamlanivimab + 2800 mg Etesevimab = 358, 2800 mg Bamlanivimab + 2800 mg Etesevimab = 325, Placebo For 700 mg Bamlanivimab + 1400 mg Etesevimab =530, 700 mg Bamlanivimab + 1400 mg Etesevimab= 326, Placebo For 350 mg Bamlanivimab + 700 mg Etesevimab=95, 350 mg Bamlanivimab + 700 mg Etesevimab=114
Participants received Placebo administered intravenously (IV).
Secondary
Phase 2: Change From Baseline to Day 11 in SARS-CoV-2 Viral Load Among Participants Enrolled With Recent Symptoms Prior to Randomization
SARS-CoV-2 viral load was based on nasopharyngeal swab sampling for reverse transcription polymerase chain reaction (RT-PCR) testing for SARS-CoV-2. This analysis included only participants whose symptoms developed no more than 8 days prior to randomization. Least squares (LS) mean values were determined using a mixed-effects model repeated-measures (MMRM) that included log base 10 transformed baseline as a covariate, treatment, day, treatment-by-day interaction as fixed effects. If Day 11 SARS-CoV-2 viral load is missing, the earliest measurement closest to the Day 11 visit, but within 4 days (Day 7-Day 15), will be used for the Day 11 value. If no measurements are available, the Day 11 viral load will be treated as MAR in the analysis.
Phase 2: All randomized participants who received at least one dose of study drug and had baseline and post-baseline viral load value. Participants enrolled with recent symptoms prior to randomization.
Posted
Least Squares Mean
Standard Error
unitless
Baseline, Day 11
ID
Title
Description
OG000
Phase 2: Placebo
Participants received Placebo administered intravenously (IV).
OG001
Phase 2: 700 mg Bamlanivimab
Participants received 700 mg bamlanivimab administered IV.
Secondary
Phase 2: Percentage of Participants Demonstrating Symptom Resolution
Symptoms associated with COVID-19 were evaluated using a questionnaire that contains the following symptoms: cough, shortness of breath, feeling feverish, fatigue, body aches and pain, sore throat, chills, headache, loss of appetite, and changes in taste and smell. Each symptom will be scored daily by the participant as experienced during the past 24 hours with following rating and score: None or absent (0), Mild (1), Moderate (2) and Severe (3). Symptom resolution was defined as all symptoms (those scored 0-3) on the symptom questionnaire scored as absent (0). Symptom Resolution (yes/no) was defined as all symptoms (excluding the loss of appetite and changes in taste and smell symptoms) on the symptom questionnaire scored as absent vs otherwise.
Missing data were imputed using non-responder imputation (NRI) method.
Phase 2: All randomized participants who received at least one dose of study drug and had non-missing Symptom Resolution values
Posted
Number
95% Confidence Interval
percentage of participants
Day 11
ID
Title
Description
OG000
Phase 2: Placebo
Participants received Placebo administered intravenously (IV).
OG001
Phase 2: 700 mg Bamlanivimab
Participants received 700 mg bamlanivimab administered IV.
OG002
Secondary
Phase 2: Percentage of Participants Demonstrating Symptom Improvement
Symptoms associated with COVID-19 were evaluated using a questionnaire that contains the following symptoms: cough, shortness of breath, feeling feverish, fatigue, body aches and pain, sore throat, chills, headache, loss of appetite, and changes in taste and smell. Each symptom will be scored daily by the participant as experienced during the past 24 hours with following rating and score: None or absent (0), Mild (1), Moderate (2) and Severe (3). Symptom improvement was defined as a participant experiencing both: Symptoms on the symptom questionnaire scored as moderate or severe at baseline are subsequently scored as mild or absent, and Symptoms on the symptom questionnaire scored as mild or absent at baseline are subsequently scored as absent. Missing data were imputed using NRI method.
Phase 2: All randomized participants who received at least one dose of study drug and had non-missing Symptom Improvement values
Posted
Number
95% Confidence Interval
percentage of participants
Day 11
ID
Title
Description
OG000
Phase 2: Placebo
Participants received Placebo administered intravenously (IV).
OG001
Phase 2: 700 mg Bamlanivimab
Participants received 700 mg bamlanivimab administered IV.
OG002
Phase 2: 2800 mg Bamlanivimab
Secondary
Phase 2, Pharmacokinetics (PK): Mean Concentration of Bamlanivimab Alone and in the Presence of Etesevimab
(PK): Mean Concentration of Bamlanivimab alone and in the Presence of Etesevimab
Phase 2: All randomized participants who received a complete dose of Bamlanivimab (for Bamlanivimab only arms) or Bamlanivimab in the Presence of Etesevimab (for Bamlanivimab + Etesevimab) and had at least 1 post-dose PK sample.
Posted
Geometric Mean
Geometric Coefficient of Variation
Microgram/milliliter (µg/mL)
Day 29 Post-dose
ID
Title
Description
OG000
Phase 2: 700 mg Bamlanivimab
Participants received 700 mg bamlanivimab (alone) administered IV.
OG001
Phase 2: 2800 mg Bamlanivimab
Participants received 2800 mg bamlanivimab (alone) administered IV.
OG002
Phase 2: 7000 mg Bamlanivimab
Participants received 7000 mg bamlanivimab (alone) administered IV..
Participants received 2800 mg bamlanivimab and 2800 mg etesevimab administered IV.
Secondary
Phase 2, PK: Mean Concentration of Etesevimab in the Presence of Bamlanivimab
PK: Mean Concentration of Etesevimab in the Presence of Bamlanivimab
Phase 2: All randomized participants who received a complete dose of Etesevimab in the Presence of Bamlanivimab and had at least 1 post-dose PK sample.
Participants received 2800 mg bamlanivimab and 2800 mg etesevimab administered IV.
Units
Counts
Participants
OG000
Secondary
Phase 2: Percentage of Participants Who Experience COVID-Related Hospitalization, COVID-Related Emergency Room (ER) Visit, or Death From Any Cause
Percentage of Participants Who Experience COVID-Related Hospitalization, COVID-Related ER Visit, or Death from Any Cause
Phase 2: All participants who received at least one dose of study drug.
Posted
Number
95% Confidence Interval
percentage of participants
Baseline through Day 85
ID
Title
Description
OG000
Part A: Placebo
Participants received Placebo administered intravenously (IV).
OG001
Phase 2: 700 mg Bamlanivimab
Participants received 700 mg bamlanivimab administered IV.
OG002
Phase 2: 2800 mg Bamlanivimab
Participants received 2800 mg bamlanivimab administered IV.
OG003
Phase 2: 7000 mg Bamlanivimab
Participants received 7000 mg bamlanivimab administered IV.
OG004
Secondary
Phase 2: Time to SARS-CoV-2 Viral Clearance
Participants who did not experience SARS-CoV-2 viral clearance by completion or early discontinuation of study were censored at the date of their last visit.
Phase 2: All randomized participants (including censored) who received at least one dose of study drug and had at least one post-baseline viral load measurement. Censored: Part A: Placebo= 68, Phase 2: 700 mg Bamlanivimab=39, Phase 2: 2800 mg Bamlanivimab=40, Phase 2: 7000 mg Bamlanivimab=42 and Phase 2: 2800 mg Bamlanivimab + 2800 mg Etesevimab=45
Posted
Median
95% Confidence Interval
Days
Baseline through Day 29
ID
Title
Description
OG000
Phase 2: Placebo
Participants received Placebo administered intravenously (IV).
OG001
Phase 2: 700 mg Bamlanivimab
Participants received 700 mg bamlanivimab administered IV.
OG002
Phase 2: 2800 mg Bamlanivimab
Participants received 2800 mg bamlanivimab administered IV.
OG003
Phase 2: 7000 mg Bamlanivimab
Secondary
Phase 2/3: Percentage of Participants Who Experience COVID-19 Related Hospitalization, COVID-Related Emergency Room (ER) Visit, or Death From Any Cause [Arm 22]
Percentage of Participants Who Experience COVID-Related Hospitalization, COVID-Related ER Visit, or Death from Any Cause.
Phase 2/3: All randomized participants who received at least one dose of study drug and had COVID-related hospitalization, COVID-Related Emergency Room (ER) Visit, or death from any cause data available.
Posted
Number
percentage of participants
Baseline through Day 29
ID
Title
Description
OG000
Phase 2/3: Bamlanivimab + Etesevimab (Pediatric Addendum, Arm 22)
Pediatric participants received a Bamlanivimab + Etesevimab dose based upon weight (Bamlanivimab dose: weight Group: ≥40 kg = 700 mg dose, >20 kg to <40 kg = 350 mg dose, >12 kg to 20 kg = 175 mg dose and 1.5 kg to 12 kg = 15 mg/kg dose) and Etesevimab dose: weight Group: ≥40 kg = 1400 mg dose, >20 kg to <40 kg = 700 mg dose, >12 kg to 20 kg = 350 mg dose and 1.5 kg to 12 kg = 30 mg/kg dose) administered IV.
Units
Counts
Participants
OG000
Secondary
Phase 2/3: Change From Baseline to Day 7 in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Viral Load [Arm 22]
SARS-CoV-2 viral load was based on nasopharyngeal swab sampling for reverse transcription polymerase chain reaction (RT-PCR) testing for SARS-CoV-2.
Viral load is reported as normalized viral load and is unitless.
Phase 2/3: All randomized participants who received at least one dose of study drug and had a baseline and day 7 viral load value.
Posted
Mean
Standard Deviation
unitless
Baseline, Day 7
ID
Title
Description
OG000
Phase 2/3: Bamlanivimab + Etesevimab (Pediatric Addendum, Arm 22)
Pediatric participants received a Bamlanivimab + Etesevimab dose based upon weight (Bamlanivimab dose: weight Group: ≥40 kg = 700 mg dose, >20 kg to <40 kg = 350 mg dose, >12 kg to 20 kg = 175 mg dose and 1.5 kg to 12 kg = 15 mg/kg dose) and Etesevimab dose: weight Group: ≥40 kg = 1400 mg dose, >20 kg to <40 kg = 700 mg dose, >12 kg to 20 kg = 350 mg dose and 1.5 kg to 12 kg = 30 mg/kg dose) administered IV.
Units
Counts
Participants
OG000
Secondary
Phase 2/3: Percentage of Participants With SARS-CoV-2 Viral Load Greater Than a Prespecified Threshold [Arm 22]
SARS-CoV-2 persistent high viral load (yes/no) is defined as RP normalized viral load >5.27 vs otherwise. Percentage of response is calculated by n/Nx*100% (n = number of participants in the specified category, Nx = number of participants with non-missing values)
Phase 2/3: All randomized participants who received at least one dose of study drug and had a day 7 viral load value.
Posted
Number
percentage of participants
Day 7
ID
Title
Description
OG000
Phase 2/3: Bamlanivimab + Etesevimab (Pediatric Addendum, Arm 22)
Pediatric participants received a Bamlanivimab + Etesevimab dose based upon weight (Bamlanivimab dose: weight Group: ≥40 kg = 700 mg dose, >20 kg to <40 kg = 350 mg dose, >12 kg to 20 kg = 175 mg dose and 1.5 kg to 12 kg = 15 mg/kg dose) and Etesevimab dose: weight Group: ≥40 kg = 1400 mg dose, >20 kg to <40 kg = 700 mg dose, >12 kg to 20 kg = 350 mg dose and 1.5 kg to 12 kg = 30 mg/kg dose) administered IV.
Units
Counts
Participants
OG000
Secondary
Phase 2/3: Time to Complete Symptom Resolution [Arm 22]
Complete symptom resolution was defined as absence of all symptoms at a single timepoint.
Phase 2/3: All randomized participants (including censored) who received at least one dose of study drug and had non-missing Symptom Resolution values. Censored participants = 7.
Posted
Median
95% Confidence Interval
days
Baseline through Day 29
ID
Title
Description
OG000
Phase 2/3: Bamlanivimab + Etesevimab (Pediatric Addendum, Arm 22)
Pediatric participants received a Bamlanivimab + Etesevimab dose based upon weight (Bamlanivimab dose: weight Group: ≥40 kg = 700 mg dose, >20 kg to <40 kg = 350 mg dose, >12 kg to 20 kg = 175 mg dose and 1.5 kg to 12 kg = 15 mg/kg dose) and Etesevimab dose: weight Group: ≥40 kg = 1400 mg dose, >20 kg to <40 kg = 700 mg dose, >12 kg to 20 kg = 350 mg dose and 1.5 kg to 12 kg = 30 mg/kg dose) administered IV.
Units
Counts
Participants
OG000
Secondary
Phase 2/3: Time to Sustained Complete Symptom Resolution [Arm 22]
Sustained complete symptom resolution is defined as the first of 2 consecutive days with complete symptom resolution.
Phase 2/3: All randomized participants (including censored) who received at least one dose of study drug and had non-missing Symptom Resolution values. Censored participants = 13.
Posted
Median
95% Confidence Interval
days
Baseline through Day 29
ID
Title
Description
OG000
Phase 2/3: Bamlanivimab + Etesevimab (Pediatric Addendum, Arm 22)
Pediatric participants received a Bamlanivimab + Etesevimab dose based upon weight (Bamlanivimab dose: weight Group: ≥40 kg = 700 mg dose, >20 kg to <40 kg = 350 mg dose, >12 kg to 20 kg = 175 mg dose and 1.5 kg to 12 kg = 15 mg/kg dose) and Etesevimab dose: weight Group: ≥40 kg = 1400 mg dose, >20 kg to <40 kg = 700 mg dose, >12 kg to 20 kg = 350 mg dose and 1.5 kg to 12 kg = 30 mg/kg dose) administered IV.
Units
Counts
Participants
OG000
Secondary
Phase 2/3: Time to SARS-CoV-2 Viral Clearance [Arm 22]
Participants who did not experience SARS-CoV-2 viral clearance by completion or early discontinuation of study were censored at the date of their last visit.
Phase 2/3: All randomized participants (Including censored) who received at least one dose of study drug and had at least one post-baseline viral load measurement. Censored participants = 34.
Posted
Median
95% Confidence Interval
days
Baseline through Day 29
ID
Title
Description
OG000
Phase 2/3: Bamlanivimab + Etesevimab (Pediatric Addendum, Arm 22)
Pediatric participants received a Bamlanivimab + Etesevimab dose based upon weight (Bamlanivimab dose: weight Group: ≥40 kg = 700 mg dose, >20 kg to <40 kg = 350 mg dose, >12 kg to 20 kg = 175 mg dose and 1.5 kg to 12 kg = 15 mg/kg dose) and Etesevimab dose: weight Group: ≥40 kg = 1400 mg dose, >20 kg to <40 kg = 700 mg dose, >12 kg to 20 kg = 350 mg dose and 1.5 kg to 12 kg = 30 mg/kg dose) administered IV.
Units
Counts
Participants
OG000
Time Frame
Baseline Up to 85 Days
Description
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Phase 2: Placebo
Participants received Placebo administered intravenously (IV).
0
156
1
156
44
156
EG001
Phase 2: 700 mg Bamlanivimab
Participants received 700 mg bamlanivimab administered IV.
0
101
2
101
29
101
EG002
Phase 2: 2800 mg Bamlanivimab
Participants received 2800 mg bamlanivimab administered IV.
0
107
0
107
26
107
EG003
Phase 2: 7000 mg Bamlanivimab
Participants received 7000 mg bamlanivimab administered IV.
Participants received 350 mg bamlanivimab and 700 mg etesevimab administered IV.
0
213
1
213
14
213
EG010
Phase 2/3: Bamlanivimab + Etesevimab (Pediatric Addendum, Arm 22)
Pediatric participants received a Bamlanivimab + Etesevimab dose based upon weight (Bamlanivimab dose: weight Group: ≥40 kg = 700 mg dose, >20 kg to <40 kg = 350 mg dose, >12 kg to 20 kg = 175 mg dose and 1.5 kg to 12 kg = 15 mg/kg dose) and Etesevimab dose: weight Group: ≥40 kg = 1400 mg dose, >20 kg to <40 kg = 700 mg dose, >12 kg to 20 kg = 350 mg dose and 1.5 kg to 12 kg = 30 mg/kg dose) administered IV.
0
94
1
94
16
94
EG011
Phase 2/3: Bebtelovimab (Pediatric Addendum, Arm 23)
Pediatric participants received Bebtelovimab dose based upon weight (Weight Group: ≥3.3 to ≤12 kg = 3 mg/kg dose, >12 to ≤20 kg = 43.75 mg dose, >20 to <40 kg = 87.5 mg dose, ≥40 kg = 175 mg dose) administered IV.
0
17
0
17
4
17
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Acute myocardial infarction
Cardiac disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG0030 events0 affected101 at risk
EG0040 events0 affected112 at risk
EG0051 events1 affected518 at risk
EG0060 events0 affected776 at risk
EG0070 events0 affected513 at risk
EG0080 events0 affected141 at risk
EG0090 events0 affected213 at risk
EG0100 events0 affected94 at risk
EG0110 events0 affected17 at risk
Angina pectoris
Cardiac disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Angina unstable
Cardiac disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Atrial flutter
Cardiac disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Cardiac arrest
Cardiac disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Coronary artery disease
Cardiac disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Ventricular extrasystoles
Cardiac disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Macular oedema
Eye disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Retinal vein occlusion
Eye disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Duodenitis
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Intestinal obstruction
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Intussusception
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Chest pain
General disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Sudden death
General disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Cholecystitis acute
Hepatobiliary disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Covid-19 pneumonia
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Localised infection
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Medical device site joint infection
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Perirectal abscess
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Sialoadenitis
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Bone contusion
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Concussion
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Femur fracture
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Foot fracture
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Hip fracture
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Injury
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Road traffic accident
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Toxicity to various agents
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Catheterisation cardiac
Investigations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Diabetic ketoacidosis
Metabolism and nutrition disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0011 events1 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Clear cell renal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0011 events1 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Lung neoplasm malignant
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Syncope
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Heavy menstrual bleeding
Reproductive system and breast disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected85 at risk
EG0010 events0 affected63 at risk
EG0020 events0 affected51 at risk
EG003
Uterine mass
Reproductive system and breast disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected85 at risk
EG0010 events0 affected63 at risk
EG0020 events0 affected51 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Respiratory arrest
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Arterial occlusive disease
Vascular disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG0030 events0 affected101 at risk
EG0040 events0 affected112 at risk
EG0050 events0 affected518 at risk
EG0061 events1 affected776 at risk
EG0074 events4 affected513 at risk
EG0080 events0 affected141 at risk
EG0092 events2 affected213 at risk
EG0100 events0 affected94 at risk
EG0110 events0 affected17 at risk
Leukopenia
Blood and lymphatic system disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Lymphopenia
Blood and lymphatic system disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Microcytic anaemia
Blood and lymphatic system disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Monocytopenia
Blood and lymphatic system disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Thrombocytosis
Blood and lymphatic system disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0011 events1 affected101 at risk
EG0021 events1 affected107 at risk
EG003
Acute myocardial infarction
Cardiac disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Angina pectoris
Cardiac disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Palpitations
Cardiac disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Ventricular extrasystoles
Cardiac disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Ventricular tachycardia
Cardiac disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Ear pain
Ear and labyrinth disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0011 events1 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Blepharitis
Eye disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Blepharospasm
Eye disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Cataract
Eye disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Cataract nuclear
Eye disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Diplopia
Eye disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Eye pain
Eye disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Eye paraesthesia
Eye disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0011 events1 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Eyelids pruritus
Eye disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Photophobia
Eye disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0011 events1 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Retinal vein occlusion
Eye disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Retinopathy hypertensive
Eye disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Vision blurred
Eye disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0011 events1 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Visual impairment
Eye disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Vitreous haemorrhage
Eye disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Xanthopsia
Eye disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0011 events1 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected156 at risk
EG0010 events0 affected101 at risk
EG0021 events1 affected107 at risk
EG003
Abdominal pain lower
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Aphthous ulcer
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0021 events1 affected107 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0002 events1 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0007 events7 affected156 at risk
EG0011 events1 affected101 at risk
EG0021 events1 affected107 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0021 events1 affected107 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0011 events1 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Frequent bowel movements
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Gastric ulcer
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Gastritis haemorrhagic
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Gastrointestinal motility disorder
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0012 events2 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Haematemesis
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Haemorrhoids thrombosed
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Hiatus hernia
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Hypoaesthesia oral
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Irritable bowel syndrome
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Melaena
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Mouth ulceration
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0008 events7 affected156 at risk
EG0013 events3 affected101 at risk
EG0024 events4 affected107 at risk
EG003
Oesophageal ulcer
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Oral disorder
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Paraesthesia oral
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Retching
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Swollen tongue
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Tongue ulceration
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0004 events4 affected156 at risk
EG0011 events1 affected101 at risk
EG0024 events3 affected107 at risk
EG003
Asthenia
General disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Chest discomfort
General disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected156 at risk
EG0010 events0 affected101 at risk
EG0021 events1 affected107 at risk
EG003
Chest pain
General disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0011 events1 affected101 at risk
EG0021 events1 affected107 at risk
EG003
Chills
General disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0021 events1 affected107 at risk
EG003
Extravasation
General disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Fatigue
General disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0021 events1 affected107 at risk
EG003
Feeling abnormal
General disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Infusion site pain
General disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Infusion site rash
General disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Injection site extravasation
General disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Nodule
General disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Oedema peripheral
General disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0011 events1 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Pain
General disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Pyrexia
General disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0011 events1 affected101 at risk
EG0022 events2 affected107 at risk
EG003
Swelling face
General disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0011 events1 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Thirst
General disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Xerosis
General disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Drug hypersensitivity
Immune system disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Hypersensitivity
Immune system disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected156 at risk
EG0011 events1 affected101 at risk
EG0021 events1 affected107 at risk
EG003
Seasonal allergy
Immune system disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Appendicitis
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Bacteraemia
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Candida infection
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Covid-19
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Ear infection
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Epididymitis
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected71 at risk
EG0010 events0 affected38 at risk
EG0020 events0 affected56 at risk
EG003
Eye infection
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Fungal infection
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Gangrene
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Herpes simplex
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Herpes virus infection
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0021 events1 affected107 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Localised infection
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Onychomycosis
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Otitis media
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0002 events2 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Pelvic inflammatory disease
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected85 at risk
EG0010 events0 affected63 at risk
EG0020 events0 affected51 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Pilonidal cyst
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Pneumonia bacterial
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Pneumonia viral
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Pyelonephritis
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Respiratory tract infection viral
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0003 events3 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Skin infection
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0011 events1 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Tonsillitis
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Tooth abscess
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Tooth infection
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Vaginal infection
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected85 at risk
EG0010 events0 affected63 at risk
EG0020 events0 affected51 at risk
EG003
Vulvovaginal mycotic infection
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected85 at risk
EG0010 events0 affected63 at risk
EG0020 events0 affected51 at risk
EG003
Animal bite
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0021 events1 affected107 at risk
EG003
Arthropod bite
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Arthropod sting
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Concussion
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Exposure during pregnancy
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Facial bones fracture
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Joint injury
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0011 events1 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Ligament rupture
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Ligament sprain
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Limb injury
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Lower limb fracture
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Maternal exposure during pregnancy
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected85 at risk
EG0010 events0 affected63 at risk
EG0021 events1 affected51 at risk
EG003
Nail avulsion
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Rib fracture
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Road traffic accident
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Skin abrasion
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Skin laceration
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Tibia fracture
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Upper limb fracture
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Vaccination complication
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Amylase increased
Investigations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Blood bicarbonate decreased
Investigations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0021 events1 affected107 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0021 events1 affected107 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Blood glucose increased
Investigations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Blood lactate dehydrogenase increased
Investigations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0011 events1 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Blood phosphorus decreased
Investigations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Blood pressure increased
Investigations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0014 events2 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Blood urea increased
Investigations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Blood uric acid increased
Investigations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Blood urine
Investigations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
C-reactive protein increased
Investigations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Electrocardiogram t wave abnormal
Investigations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Eosinophil count increased
Investigations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Epstein-barr virus antibody positive
Investigations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Fibrin d dimer increased
Investigations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Heart rate irregular
Investigations
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Hepatic enzyme increased
Investigations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0011 events1 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Lipase increased
Investigations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0011 events1 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Liver function test increased
Investigations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Lymphocyte morphology abnormal
Investigations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Neutrophil count increased
Investigations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Occult blood positive
Investigations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Platelet count decreased
Investigations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Platelet count increased
Investigations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Serum ferritin increased
Investigations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Transaminases increased
Investigations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0011 events1 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Weight decreased
Investigations
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
White blood cell count decreased
Investigations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Acidosis
Metabolism and nutrition disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 24.0
Systematic Assessment
EG0002 events2 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Diabetes mellitus
Metabolism and nutrition disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Diabetic ketoacidosis
Metabolism and nutrition disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Glucose tolerance impaired
Metabolism and nutrition disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Gout
Metabolism and nutrition disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Hypercholesterolaemia
Metabolism and nutrition disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0021 events1 affected107 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Hyperlipidaemia
Metabolism and nutrition disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0021 events1 affected107 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Hypovolaemia
Metabolism and nutrition disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Iron deficiency
Metabolism and nutrition disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Malnutrition
Metabolism and nutrition disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Type 2 diabetes mellitus
Metabolism and nutrition disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Vitamin b12 deficiency
Metabolism and nutrition disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Vitamin d deficiency
Metabolism and nutrition disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected156 at risk
EG0011 events1 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Coccydynia
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Extremity contracture
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Fibromyalgia
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Joint contracture
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Joint swelling
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Muscle twitching
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0021 events1 affected107 at risk
EG003
Musculoskeletal stiffness
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0012 events1 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Pain in jaw
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Periarthritis
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Rheumatoid arthritis
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0021 events1 affected107 at risk
EG003
Rotator cuff syndrome
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Spinal pain
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected156 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected107 at risk
EG003
Lipoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)