A Phase 2b Diabetic Kidney Disease Study | NCT04170543 | Trialant
NCT04170543
Sponsor
AstraZeneca
Status
Completed
Last Update Posted
Jul 10, 2024Actual
Enrollment
609Actual
Phase
Phase 2
Conditions
Diabetic Kidney Disease
Interventions
MEDI3506
Placebo
Dapagliflozin
Countries
United States
Argentina
Canada
Chile
Japan
Peru
South Korea
Protocol Section
Identification Module
NCT ID
NCT04170543
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
D9183C00001
Secondary IDs
Not provided
Brief Title
A Phase 2b Diabetic Kidney Disease Study
Official Title
A Phase 2b Randomized, Double-blind, Placebo-controlled, Study to Evaluate the Efficacy and Safety of MEDI3506 in Subjects With Diabetic Kidney Disease
Acronym
Not provided
Organization
AstraZenecaINDUSTRY
Status Module
Record Verification Date
Jul 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
Nov 18, 2019Actual
Primary Completion Date
May 16, 2023Actual
Completion Date
May 16, 2023Actual
First Submitted Date
Nov 18, 2019
First Submission Date that Met QC Criteria
Nov 18, 2019
First Posted Date
Nov 20, 2019Actual
Results Waived
Not provided
Results First Submitted Date
May 14, 2024
Results First Submitted that Met QC Criteria
Jul 8, 2024
Results First Posted Date
Jul 10, 2024Actual
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
Jul 8, 2024
Last Update Posted Date
Jul 10, 2024Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
AstraZenecaINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
A Phase 2b Randomized, Double-blind, Placebo-controlled, Study to Evaluate the Efficacy and Safety of MEDI3506 in Subjects with Diabetic Kidney Disease
Detailed Description
This is a Phase 2b, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy, safety, PK, and immunogenicity of MEDI3506 on top of standard of care, including angiotensin-converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs) and dapagliflozin in adult subjects with diabetic kidney disease, defined as subjects with type 2 diabetes mellitus (T2DM) and an estimated glomerular filtration rate (eGFR) of 25-75 mL/min/1.73 m2 with a UACR in the range of 100-3000 mg/g, who meet all eligibility criteria. Approximately 565 subjects, among multiple countries will be randomized to MEDI3506 dose 1, 2, 3 or dose 4, or placebo during a treatment period of 24 weeks. All subjects will receive Dapagliflozin daily, as administered orally from Day 85 to Day 168. The primary objective is to evaluate the effect of MEDI3506 on albuminuria in subjects with DKD. Secondary objectives include evaluating safety, PK and the incidence of ADA during the treatment period.
Conditions Module
Conditions
Diabetic Kidney Disease
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
609Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Group 1
Experimental
MEDI3506 Dose 1 plus Dapagliflozin (Day 85 to Day 168).
Drug: MEDI3506
Drug: Dapagliflozin
Group 2
Experimental
MEDI3506 Dose 2 plus Dapagliflozin (Day 85 to Day 168).
Drug: MEDI3506
Drug: Dapagliflozin
Group 3
Experimental
MEDI3506 Dose 3 plus Dapagliflozin (Day 85 to Day 168).
Drug: MEDI3506
Drug: Dapagliflozin
Group 4
Experimental
MEDI3506 Dose 4 plus Dapagliflozin (Day 85 to Day 168).
Drug: MEDI3506
Drug: Dapagliflozin
Group 5
Placebo Comparator
Placebo (volume matched) plus Dapagliflozin (Day 85 to Day 168).
Drug: Placebo
Drug: Dapagliflozin
Interventions
Name
Type
Description
Arm Group Labels
Other Names
MEDI3506
Drug
Dose 1, Dose 2, Dose 3, Dose 4
Group 1
Group 2
Group 3
Group 4
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percent Change From Baseline to Day 169 (Week 24) in UACR - Per Protocol Population
UACR values are collected as triplicates at baseline and at each CSP planned visit. For each triplicate, the UACR are averaged with geometric mean.
Baseline is defined as the geometric mean of UACR measurements prior to first dose of study treatment.
For the intercurrent events, if a subject is lost to follow-up (EOT), discontinues treatment due to AE, or uses prohibited medication, the UACR data are treated as missing on or after the event and no imputation is performed.
The LS means of percent change and difference in percent change, corresponding 90% confidence intervals are calculated based on a mixed model with repeated measures (MMRM) of log (UACR post-baseline/UACR baseline) as the response, adjusting for fixed effects of treatment, visit, and treatment-by-visit interaction, SGLT2i, region (Japan or ROW), baseline log UACR, and baseline log UACR-by-visit interaction.
The MMRM includes UACR values at protocol specified visits from baseline up to Day 169.
From baseline to Day 169
Secondary Outcomes
Measure
Description
Time Frame
Percent Change From Baseline to Day 85 (Week 12) in UACR - Per Protocol Population
UACR values are collected as triplicates at baseline and at each CSP planned visit. For each triplicate, the UACR are averaged with geometric mean.
Baseline is defined as the geometric mean of UACR measurements prior to first dose of study treatment.
For the intercurrent events, if a subject is lost to follow-up (EOT), discontinues treatment due to AE, or uses prohibited medication, the UACR data are treated as missing on or after the event and no imputation is performed.
The LS means of percent change and difference in percent change, corresponding 90% confidence intervals are calculated based on a mixed model with repeated measures (MMRM) of log (UACR post-baseline/UACR baseline) as the response, adjusting for fixed effects of treatment, visit, and treatment-by-visit interaction, SGLT2i, region (Japan or ROW), baseline log UACR, and baseline log UACR-by-visit interaction.
The MMRM includes UACR values at protocol specified visits from baseline up to Day 169.
Other Outcomes
Measure
Description
Time Frame
Plasma Concentration of MEDI3506 - PK Analysis Population
MEDI3506/Tozorakimab serum concentrations were measured using a validated assay method.
Day 1, Day 29, Day 85 and Day 169
Eligibility Module
Eligibility Criteria
Key Inclusion Criteria
Adult men or women ≥ 18 years of age.
Diabetic kidney disease DKD defined as:
diagnosis of T2DM
eGFR 25-75 mL/min/1.73 m2
UACR 100-3000 mg albumin/g creatinine
BP ≤ 150/100 mmHg
Stable dose of ACEi or ARB Key Exclusion Criteria
1. Serum potassium > 5.5 mmol/L 2. Significant hepatic disease 3. Hemoglobin A1c > 10.5 % 4. B-type natriuretic peptide level > 200 pg/mL 5. History of clinically significant heart disease 6. Anticipated dialysis or renal transplantation within 1 year 7. History of underlying condition that predisposes the subject to infections 8. Significant infection (viral, bacterial, or fungal) 9. Amputation due to peripheral artery disease 10. Subjects with a positive diagnostic nucleic acid test for SARS-CoV-2 11. Pregnancy, breastfeeding or intention to become pregnant during the course of the study, 12. Any other medical condition or clinically relevant abnormal findings in physical examination, laboratory results, or electrocardiogram (ECG) during screening that, in the opinion of the investigator, may compromise the safety of the subject in the study, reduce the subject's ability to participate in the study, or interfere with evaluation of the investigational product
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared
When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access.For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
The following data were excluded from this analysis:
Data from patients enrolled in Phase 2a of the study: This phase was discontinued due to the COVID-19 pandemic.
Data from patients enrolled at a site that was discovered to not follow Good Clinical Practice (GCP) guidelines.
Data from patients not treated.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Placebo
Participants were randomized to receive Placebo
FG001
MEDI3506 30 mg
Participants were randomized to receive tozorakimab 30 mg
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
0
More Info Module
Limitations and Caveats
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Feb 14, 2022
May 14, 2024
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Mexico
Submission Tracking
Estimated Results First Submitted Date
Not provided
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Eligible subjects will be randomized to receive MEDI3506 or placebo as follows:
Group 1: MEDI3506 Dose 1. Group 2: MEDI3506 Dose 2. Group 3: MEDI3506 Dose 3 Group 4: MEDI3506 Dose 4 Group 5: Placebo (volume matched) All subjects will receive Dapa from Day 85 to Day 168.
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Quadruple
Masking Description
This is a double-blinded study in which MEDI3506 and placebo. Neither the subject nor any of the investigator or sponsor staff who are involved in the treatment or clinical evaluation of the subjects will be aware of the treatment received.
Percent Change From Day 85 (Week 12) to Day 169 (Week 24) in UACR - Per Protocol Population
UACR values are collected as triplicates at baseline and at each CSP planned visit. For each triplicate, the UACR are averaged with geometric mean.
Baseline is defined as the geometric mean of UACR measurements prior to first dose of study treatment.
For the intercurrent events, if a subject is lost to follow-up (EOT), discontinues treatment due to AE, or uses prohibited medication, the UACR data are treated as missing on or after the event and no imputation is performed.
The LS means of percent change and difference in percent change, corresponding 90% confidence intervals are calculated based on a mixed model with repeated measures (MMRM) of log (UACR post-baseline/UACR baseline) as the response, adjusting for fixed effects of treatment, visit, and treatment-by-visit interaction, SGLT2i, region (Japan or ROW), baseline log UACR, and baseline log UACR-by-visit interaction.
The MMRM includes UACR values at protocol specified visits from Day 85 up to Day 169.
From Day 85 to Day 169
Proportion of Subjects With Reduction in UACR at Day 169 (Week 24) - Per Protocol Population
UACR values are collected as triplicates at baseline and at each CSP planned visit. For each triplicate, the UACR are averaged with geometric mean.
Baseline is defined as the geometric mean of UACR measurements prior to first dose of study treatment.
Only participants with values at Baseline and Day 169 are included.
Baseline and Day 169
Percent Change From Baseline to Day 169 (Week 24) in UACR - Full Analysis Population
UACR values are collected as triplicates at baseline and at each CSP planned visit. For each triplicate, the UACR are averaged with geometric mean.
Baseline is defined as the geometric mean of UACR measurements prior to first dose of study treatment.
For the intercurrent events, if a subject is lost to follow-up (EOT), discontinues treatment due to AE, or uses prohibited medication, the UACR data are treated as missing on or after the event and no imputation is performed.
The LS means of percent change and difference in percent change, corresponding 90% confidence intervals are calculated based on a mixed model with repeated measures (MMRM) of log (UACR post-baseline/UACR baseline) as the response, adjusting for fixed effects of treatment, visit, and treatment-by-visit interaction, SGLT2i, region (Japan or ROW), baseline log UACR, and baseline log UACR-by-visit interaction.
The MMRM includes UACR values at protocol specified visits from baseline up to Day 169.
From baseline to Day 169
Percent Change From Baseline to Day 85 (Week 12) in UACR - Full Analysis Population
UACR values are collected as triplicates at baseline and at each CSP planned visit. For each triplicate, the UACR are averaged with geometric mean.
Baseline is defined as the geometric mean of UACR measurements prior to first dose of study treatment.
For the intercurrent events, if a subject is lost to follow-up (EOT), discontinues treatment due to AE, or uses prohibited medication, the UACR data are treated as missing on or after the event and no imputation is performed.
The LS means of percent change and difference in percent change, corresponding 90% confidence intervals are calculated based on a mixed model with repeated measures (MMRM) of log (UACR post-baseline/UACR baseline) as the response, adjusting for fixed effects of treatment, visit, and treatment-by-visit interaction, SGLT2i, region (Japan or ROW), baseline log UACR, and baseline log UACR-by-visit interaction.
The MMRM includes UACR values at protocol specified visits from baseline up to Day 169.
From baseline to Day 85
Proportion of Subjects With Reduction in UACR at Day 169 (Week 24) - Full Analysis Population
UACR values are collected as triplicates at baseline and at each CSP planned visit. For each triplicate, the UACR are averaged with geometric mean.
Baseline is defined as the geometric mean of UACR measurements prior to first dose of study treatment.
Only participants with values at Baseline and Day 169 are included.
Baseline and Day 169
Immunogenicity of MEDI3506 - PK Analysis Population
ADA prevalence: number of participants ADA positive (ADA+) at baseline and/or post-baseline.
Treatment-induced ADA+: ADA not detected or missing at baseline and at least one post-baseline ADA+.
Treatment-boosted ADA+: ADA+ at baseline and baseline titre is boosted by ≥ 4-fold increase at ≥ 1 post-baseline time point.
Treatment-emergent ADA+ (TE-ADA + or ADA incidence): Treatment-induced ADA+ OR and Treatment-boosted ADA+.
Day 1 to Day 230
Asymptomatic Participants Tested Positive for COVID-19 During the Study - Safety Analysis Population
Participants were tested for COVID-19 during the course of the study. Descriptive analysis of asymptomatic participants tested positive for COVID-19 during the study.
Day 1 to Day 230
Treatment-emergent Adverse Events and Treatment-emergent Serious Adverse Events Among COVID-19 Positive Participants - Safety Analysis Population
For participants tested positive for COVID-19 during the intervention and follow-up periods, this analysis provides:
the number and proportion of subjects with any treatment-emergent adverse event
the number and proportion of subjects with any treatment-emergent serious adverse event
Day 1 to Day 230
Huntsville
Alabama
35805
United States
Research Site
Mesa
Arizona
85210
United States
Research Site
Alhambra
California
91801
United States
Research Site
Glendale
California
91204
United States
Research Site
Granada Hills
California
91344
United States
Research Site
Huntington Park
California
90255
United States
Research Site
Northridge
California
91324
United States
Research Site
Sacramento
California
95821
United States
Research Site
San Diego
California
92123
United States
Research Site
San Dimas
California
91773
United States
Research Site
Vacaville
California
95687
United States
Research Site
Fleming Island
Florida
32003
United States
Research Site
Hialeah
Florida
33016
United States
Research Site
Jacksonville
Florida
32204
United States
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Miami
Florida
33015
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Atlanta
Georgia
30338
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Honolulu
Hawaii
96814
United States
Research Site
Chicago
Illinois
60607
United States
Research Site
Chicago
Illinois
60643
United States
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Iowa City
Iowa
52242
United States
Research Site
Manhattan
Kansas
66502
United States
Research Site
Topeka
Kansas
66606
United States
Research Site
Wichita
Kansas
67214
United States
Research Site
Flint
Michigan
48504
United States
Research Site
Henderson
Nevada
89014
United States
Research Site
Las Vegas
Nevada
89129
United States
Research Site
Berlin
New Jersey
08009
United States
Research Site
Charlotte
North Carolina
28204
United States
Research Site
Greensboro
North Carolina
27408
United States
Research Site
Greenville
North Carolina
27834
United States
Research Site
Morehead City
North Carolina
28557
United States
Research Site
Maumee
Ohio
43537
United States
Research Site
Oklahoma City
Oklahoma
73116
United States
Research Site
Bethlehem
Pennsylvania
18017
United States
Research Site
East Providence
Rhode Island
02915
United States
Research Site
Columbia
South Carolina
29203
United States
Research Site
Memphis
Tennessee
38119
United States
Research Site
Cypress
Texas
77429
United States
Research Site
Houston
Texas
77004
United States
Research Site
Houston
Texas
77079
United States
Research Site
Katy
Texas
77450
United States
Research Site
San Antonio
Texas
78212
United States
Research Site
San Antonio
Texas
78229
United States
Research Site
San Antonio
Texas
78251
United States
Research Site
St. George
Utah
84790
United States
Research Site
Burke
Virginia
22015
United States
Research Site
Tacoma
Washington
98405
United States
Research Site
Morgantown
West Virginia
26506
United States
Research Site
Buenos Aires
1425DES
Argentina
Research Site
Buenos Aires
C1056ABJ
Argentina
Research Site
Buenos Aires
C1429BWN
Argentina
Research Site
CABA
C1120AAC
Argentina
Research Site
Caba
C1128AAF
Argentina
Research Site
CABA
C1425AGC
Argentina
Research Site
Corrientes
W3400AMZ
Argentina
Research Site
Córdoba
X5000AAW
Argentina
Research Site
Mar del Plata
7600
Argentina
Research Site
Pergamino
B2700LDK
Argentina
Research Site
Ramos Mejía
B1704ETD
Argentina
Research Site
Rosario
S2000DNM
Argentina
Research Site
San Luis
D5700CTA
Argentina
Research Site
San Nicolás
B2900DMH
Argentina
Research Site
San Vicente
5006
Argentina
Research Site
Calgary
Alberta
T2H 2G4
Canada
Research Site
Red Deer
Alberta
T4N 6V7
Canada
Research Site
Brampton
Ontario
L6S 0S9
Canada
Research Site
Brampton
Ontario
L6T 0G1
Canada
Research Site
Concord
Ontario
L4K 4M2
Canada
Research Site
Etobicoke
Ontario
M9R 4E1
Canada
Research Site
Toronto
Ontario
M4G 3E8
Canada
Research Site
Concepción
Chile
Research Site
Ñuñoa
8520398
Chile
Research Site
Santiago
7500021
Chile
Research Site
Santiago
7500710
Chile
Research Site
Santiago
8320000
Chile
Research Site
Santiago
Chile
Research Site
Victoria
Chile
Research Site
Chūōku
103-0027
Japan
Research Site
Fukuoka
815-8555
Japan
Research Site
Ise-shi
516-8512
Japan
Research Site
Kisarazu-shi
292-8535
Japan
Research Site
Koshigaya-shi
343-8577
Japan
Research Site
Nagano
388-8004
Japan
Research Site
Nagoya
451-8511
Japan
Research Site
Nishinomiya-Shi
662-0918
Japan
Research Site
Osaka
530-0001
Japan
Research Site
Osaka
558-8558
Japan
Research Site
Sayama-Shi
Japan
Research Site
Piura
Peru
Research Site
Gangnam-Gu
6273
South Korea
Research Site
Goyang-si
10444
South Korea
Research Site
Jongno-gu
110-746
South Korea
Research Site
Seongbuk-Gu
02841
South Korea
Research Site
Seoul
06351
South Korea
Research Site
Suwon
16499
South Korea
Research Site
Wŏnju
26426
South Korea
Hofherr A, Liarte Marin E, Musial B, Seth A, Slidel T, Conway J, Baker D, Hansen PBL, Challis B, Bartesaghi S, Bhat M, Pecoits-Filho R, Tu X, Selvarajah V, Woollard K, Heerspink HJL. Inhibition of Interleukin-33 to Reduce Glomerular Endothelial Inflammation in Diabetic Kidney Disease. Kidney Int Rep. 2024 Mar 18;9(6):1876-1891. doi: 10.1016/j.ekir.2024.03.009. eCollection 2024 Jun.
Participants were randomized to receive tozorakimab 60 mg
FG003
MEDI3506 120 mg
Participants were randomized to receive tozorakimab 120 mg
FG004
MEDI3506 300 mg
Participants were randomized to receive tozorakimab 300 mg
FG000147 subjects
FG00196 subjects
FG002101 subjects
FG00395 subjects
FG004160 subjects
COMPLETED
FG00099 subjects
FG00170 subjects
FG00270 subjects
FG00368 subjects
FG004120 subjects
NOT COMPLETED
FG00048 subjects
FG00126 subjects
FG00231 subjects
FG00327 subjects
FG00440 subjects
Type
Comment
Reasons
Death
FG0001 subjects
FG0011 subjects
FG0021 subjects
FG0031 subjects
FG0041 subjects
Lost to Follow-up
FG0003 subjects
FG0013 subjects
FG0020 subjects
FG0033 subjects
FG004
Withdrawal by Subject
FG00013 subjects
FG0016 subjects
FG0025 subjects
FG0034 subjects
FG004
Not able to transition to phase 2b
FG0008 subjects
FG0010 subjects
FG00210 subjects
FG0030 subjects
FG004
Enrolled in Site with GCP Breach
FG0006 subjects
FG0011 subjects
FG0022 subjects
FG0032 subjects
FG004
Not Treated
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
(CRF)
FG00016 subjects
FG00115 subjects
FG00212 subjects
FG00317 subjects
FG004
Due to COVID-19 Pandemic
FG0001 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Placebo
Participants were randomized to receive Placebo
BG001
MEDI3506 30 mg
Participants were randomized to receive tozorakimab 30 mg
BG002
MEDI3506 60 mg
Participants were randomized to receive tozorakimab 60 mg
BG003
MEDI3506 120 mg
Participants were randomized to receive tozorakimab 120 mg
BG004
MEDI3506 300 mg
Participants were randomized to receive tozorakimab 300 mg
BG005
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000133
BG00195
BG00289
BG00393
BG004148
BG005558
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
The following patients are excluded from reporting:
patients not treated
patients included in Phase 2a who did not have the opportunity to switch to Phase 2b
patients enrolled in the site with GCP breach
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00066.7± 9.7
BG00167.1± 9.8
BG00267.2± 10.1
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Sex
Title
Measurements
Female
BG00046
BG00133
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Ethnicity
Title
Measurements
Hispanic or Latino
BG00061
BG00162
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Race
Title
Measurements
American Indian or Alaska Native
BG0002
BG0015
BG002
Region of Enrollment
The following patients are excluded from reporting:
patients not treated
patients included in Phase 2a who did not have the opportunity to switch to Phase 2b
patients enrolled in the site with GCP breach
Number
Participants
Title
Denominators
Categories
Argentina
Title
Measurements
BG00020
BG001
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
Percent Change From Baseline to Day 169 (Week 24) in UACR - Per Protocol Population
UACR values are collected as triplicates at baseline and at each CSP planned visit. For each triplicate, the UACR are averaged with geometric mean.
Baseline is defined as the geometric mean of UACR measurements prior to first dose of study treatment.
For the intercurrent events, if a subject is lost to follow-up (EOT), discontinues treatment due to AE, or uses prohibited medication, the UACR data are treated as missing on or after the event and no imputation is performed.
The LS means of percent change and difference in percent change, corresponding 90% confidence intervals are calculated based on a mixed model with repeated measures (MMRM) of log (UACR post-baseline/UACR baseline) as the response, adjusting for fixed effects of treatment, visit, and treatment-by-visit interaction, SGLT2i, region (Japan or ROW), baseline log UACR, and baseline log UACR-by-visit interaction.
The MMRM includes UACR values at protocol specified visits from baseline up to Day 169.
Per Protocol Population:
All randomized participants who received any study drug and did not violate any relevant important protocol deviations affecting the primary efficacy endpoint.
Posted
Least Squares Mean
90% Confidence Interval
Percentage change from baseline
From baseline to Day 169
ID
Title
Description
OG000
Placebo
Participants received Placebo
OG001
MEDI3506 30 mg
Participants received tozorakimab 30 mg
OG002
MEDI3506 60 mg
Participants received tozorakimab 60 mg
OG003
MEDI3506 120 mg
Participants received tozorakimab 120 mg
OG004
MEDI3506 300 mg
Participants received tozorakimab 300 mg
Units
Counts
Participants
OG000103
OG00181
OG00278
OG003
Title
Denominators
Categories
Title
Measurements
OG000-14.82(-27.05 to -0.53)
OG001-17.25(-30.69 to -1.19)
OG002-31.45(-42.54 to -18.21)
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
MMRM
0.8338
Unadjusted two-sided p-value
LS Mean Difference in Percent Change
-2.85
2-Sided
90
-22.61
21.94
MEDI3506 30 mg - Placebo
Other
OG000
OG002
MMRM
Secondary
Percent Change From Baseline to Day 85 (Week 12) in UACR - Per Protocol Population
UACR values are collected as triplicates at baseline and at each CSP planned visit. For each triplicate, the UACR are averaged with geometric mean.
Baseline is defined as the geometric mean of UACR measurements prior to first dose of study treatment.
For the intercurrent events, if a subject is lost to follow-up (EOT), discontinues treatment due to AE, or uses prohibited medication, the UACR data are treated as missing on or after the event and no imputation is performed.
The LS means of percent change and difference in percent change, corresponding 90% confidence intervals are calculated based on a mixed model with repeated measures (MMRM) of log (UACR post-baseline/UACR baseline) as the response, adjusting for fixed effects of treatment, visit, and treatment-by-visit interaction, SGLT2i, region (Japan or ROW), baseline log UACR, and baseline log UACR-by-visit interaction.
The MMRM includes UACR values at protocol specified visits from baseline up to Day 169.
Per Protocol Population:
All randomized participants who received any study drug and did not violate any relevant important protocol deviations affecting the primary efficacy endpoint.
Posted
Least Squares Mean
90% Confidence Interval
Percentage change from baseline
From baseline to Day 85
ID
Title
Description
OG000
Placebo
Participants received Placebo
OG001
MEDI3506 30 mg
Participants received tozorakimab 30 mg
Secondary
Percent Change From Day 85 (Week 12) to Day 169 (Week 24) in UACR - Per Protocol Population
UACR values are collected as triplicates at baseline and at each CSP planned visit. For each triplicate, the UACR are averaged with geometric mean.
Baseline is defined as the geometric mean of UACR measurements prior to first dose of study treatment.
For the intercurrent events, if a subject is lost to follow-up (EOT), discontinues treatment due to AE, or uses prohibited medication, the UACR data are treated as missing on or after the event and no imputation is performed.
The LS means of percent change and difference in percent change, corresponding 90% confidence intervals are calculated based on a mixed model with repeated measures (MMRM) of log (UACR post-baseline/UACR baseline) as the response, adjusting for fixed effects of treatment, visit, and treatment-by-visit interaction, SGLT2i, region (Japan or ROW), baseline log UACR, and baseline log UACR-by-visit interaction.
The MMRM includes UACR values at protocol specified visits from Day 85 up to Day 169.
Per Protocol Population:
All randomized participants who received any study drug and did not violate any relevant important protocol deviations affecting the primary efficacy endpoint.
Posted
Least Squares Mean
90% Confidence Interval
Percentage change from baseline
From Day 85 to Day 169
ID
Title
Description
OG000
Placebo
Participants received Placebo
OG001
MEDI3506 30 mg
Secondary
Proportion of Subjects With Reduction in UACR at Day 169 (Week 24) - Per Protocol Population
UACR values are collected as triplicates at baseline and at each CSP planned visit. For each triplicate, the UACR are averaged with geometric mean.
Baseline is defined as the geometric mean of UACR measurements prior to first dose of study treatment.
Only participants with values at Baseline and Day 169 are included.
Per Protocol Population:
All randomized participants who received any study drug and did not violate any relevant important protocol deviations affecting the primary efficacy endpoint.
Posted
Count of Participants
Participants
Baseline and Day 169
ID
Title
Description
OG000
Placebo
Participants received Placebo
OG001
MEDI3506 30 mg
Participants received tozorakimab 30 mg
OG002
MEDI3506 60 mg
Participants received tozorakimab 60 mg
OG003
MEDI3506 120 mg
Participants received tozorakimab 120 mg
Secondary
Percent Change From Baseline to Day 169 (Week 24) in UACR - Full Analysis Population
UACR values are collected as triplicates at baseline and at each CSP planned visit. For each triplicate, the UACR are averaged with geometric mean.
Baseline is defined as the geometric mean of UACR measurements prior to first dose of study treatment.
For the intercurrent events, if a subject is lost to follow-up (EOT), discontinues treatment due to AE, or uses prohibited medication, the UACR data are treated as missing on or after the event and no imputation is performed.
The LS means of percent change and difference in percent change, corresponding 90% confidence intervals are calculated based on a mixed model with repeated measures (MMRM) of log (UACR post-baseline/UACR baseline) as the response, adjusting for fixed effects of treatment, visit, and treatment-by-visit interaction, SGLT2i, region (Japan or ROW), baseline log UACR, and baseline log UACR-by-visit interaction.
The MMRM includes UACR values at protocol specified visits from baseline up to Day 169.
Full Analysis Population:
All randomized participants who received any study drug.
Posted
Least Squares Mean
90% Confidence Interval
Percentage change from baseline
From baseline to Day 169
ID
Title
Description
OG000
Placebo
Participants were randomized to receive Placebo
OG001
MEDI3506 30 mg
Participants were randomized to receive tozorakimab 30 mg
Secondary
Percent Change From Baseline to Day 85 (Week 12) in UACR - Full Analysis Population
UACR values are collected as triplicates at baseline and at each CSP planned visit. For each triplicate, the UACR are averaged with geometric mean.
Baseline is defined as the geometric mean of UACR measurements prior to first dose of study treatment.
For the intercurrent events, if a subject is lost to follow-up (EOT), discontinues treatment due to AE, or uses prohibited medication, the UACR data are treated as missing on or after the event and no imputation is performed.
The LS means of percent change and difference in percent change, corresponding 90% confidence intervals are calculated based on a mixed model with repeated measures (MMRM) of log (UACR post-baseline/UACR baseline) as the response, adjusting for fixed effects of treatment, visit, and treatment-by-visit interaction, SGLT2i, region (Japan or ROW), baseline log UACR, and baseline log UACR-by-visit interaction.
The MMRM includes UACR values at protocol specified visits from baseline up to Day 169.
Full Analysis Population:
All randomized participants who received any study drug.
Posted
Least Squares Mean
90% Confidence Interval
Percentage change from baseline
From baseline to Day 85
ID
Title
Description
OG000
Placebo
Participants were randomized to receive Placebo
OG001
MEDI3506 30 mg
Participants were randomized to receive tozorakimab 30 mg
Secondary
Proportion of Subjects With Reduction in UACR at Day 169 (Week 24) - Full Analysis Population
UACR values are collected as triplicates at baseline and at each CSP planned visit. For each triplicate, the UACR are averaged with geometric mean.
Baseline is defined as the geometric mean of UACR measurements prior to first dose of study treatment.
Only participants with values at Baseline and Day 169 are included.
Full Analysis Population:
All randomized participants who received any study drug.
Posted
Count of Participants
Participants
Baseline and Day 169
ID
Title
Description
OG000
Placebo
Participants were randomized to receive Placebo
OG001
MEDI3506 30 mg
Participants were randomized to receive tozorakimab 30 mg
OG002
MEDI3506 60 mg
Participants were randomized to receive tozorakimab 60 mg
OG003
MEDI3506 120 mg
Participants were randomized to receive tozorakimab 120 mg
Secondary
Immunogenicity of MEDI3506 - PK Analysis Population
ADA prevalence: number of participants ADA positive (ADA+) at baseline and/or post-baseline.
Treatment-induced ADA+: ADA not detected or missing at baseline and at least one post-baseline ADA+.
Treatment-boosted ADA+: ADA+ at baseline and baseline titre is boosted by ≥ 4-fold increase at ≥ 1 post-baseline time point.
Treatment-emergent ADA+ (TE-ADA + or ADA incidence): Treatment-induced ADA+ OR and Treatment-boosted ADA+.
PK Analysis Population:
All subjects who are randomized and receive any study drug who have at least one detectable MEDI3506 serum concentration measurement post-treatment.
Posted
Count of Participants
Participants
Day 1 to Day 230
ID
Title
Description
OG000
Placebo
Participants were randomized to receive Placebo
OG001
MEDI3506 30 mg
Participants were randomized to receive tozorakimab 30 mg
OG002
MEDI3506 60 mg
Participants were randomized to receive tozorakimab 60 mg
OG003
MEDI3506 120 mg
Other Pre-specified
Plasma Concentration of MEDI3506 - PK Analysis Population
MEDI3506/Tozorakimab serum concentrations were measured using a validated assay method.
PK Analysis Population:
All subjects who are randomized and receive any study drug who have at least one detectable MEDI3506 serum concentration measurement post-treatment.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
Day 1, Day 29, Day 85 and Day 169
ID
Title
Description
OG000
Placebo
Participants were randomized to receive Placebo
OG001
MEDI3506 30 mg
Participants were randomized to receive tozorakimab 30 mg
OG002
MEDI3506 60 mg
Participants were randomized to receive tozorakimab 60 mg
OG003
MEDI3506 120 mg
Participants were randomized to receive tozorakimab 120 mg
OG004
MEDI3506 300 mg
Secondary
Asymptomatic Participants Tested Positive for COVID-19 During the Study - Safety Analysis Population
Participants were tested for COVID-19 during the course of the study. Descriptive analysis of asymptomatic participants tested positive for COVID-19 during the study.
Safety Analysis Population:
All randomized participants who received any study drug.
Subset of participants tested positive for COVID-19 during the study.
Posted
Count of Participants
Participants
Day 1 to Day 230
ID
Title
Description
OG000
Placebo
Participants received Placebo
OG001
MEDI3506 30 mg
Participants received tozorakimab 30 mg
OG002
MEDI3506 60 mg
Participants received tozorakimab 60 mg
OG003
MEDI3506 120 mg
Participants received tozorakimab 120 mg
OG004
MEDI3506 300 mg
Secondary
Treatment-emergent Adverse Events and Treatment-emergent Serious Adverse Events Among COVID-19 Positive Participants - Safety Analysis Population
For participants tested positive for COVID-19 during the intervention and follow-up periods, this analysis provides:
the number and proportion of subjects with any treatment-emergent adverse event
the number and proportion of subjects with any treatment-emergent serious adverse event
Posted
Count of Participants
Participants
Day 1 to Day 230
ID
Title
Description
OG000
Placebo
Participants received Placebo
OG001
MEDI3506 30 mg
Participants received tozorakimab 30 mg
OG002
MEDI3506 60 mg
Participants received tozorakimab 60 mg
OG003
MEDI3506 120 mg
Participants received tozorakimab 120 mg
OG004
MEDI3506 300 mg
Time Frame
Day 1 to Day 230
Description
Not provided
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
Placebo
Participants received Placebo
1
133
15
133
62
133
EG001
MEDI3506 30 mg
Participants received tozorakimab 30 mg
1
95
14
95
55
95
EG002
MEDI3506 60 mg
Participants received tozorakimab 60 mg
1
89
5
89
39
89
EG003
MEDI3506 120 mg
Participants received tozorakimab 120 mg
1
93
12
93
48
93
EG004
MEDI3506 300 mg
Participants received tozorakimab 300 mg
1
148
11
148
74
148
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Atrial fibrillation
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected89 at risk
EG0032 events2 affected93 at risk
EG0040 events0 affected148 at risk
Covid-19
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected133 at risk
EG0010 events0 affected95 at risk
EG0021 events1 affected89 at risk
EG003
Covid-19 pneumonia
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0011 events1 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Gangrene
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Gastroenteritis salmonella
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0011 events1 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Influenza
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0011 events1 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Bradycardia
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected133 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Osteomyelitis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected133 at risk
EG0011 events1 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected133 at risk
EG0011 events1 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Pneumonia aspiration
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected133 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Pneumonia pseudomonal
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Septic shock
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected95 at risk
EG0021 events1 affected89 at risk
EG003
Cardiac arrest
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected133 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Urosepsis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected133 at risk
EG0011 events1 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Cardiac failure
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected133 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Cardiac failure congestive
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Traumatic intracranial haemorrhage
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0011 events1 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Cardio-respiratory arrest
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected95 at risk
EG0021 events1 affected89 at risk
EG003
Coronary artery disease
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0011 events1 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0011 events1 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Diabetes mellitus
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected133 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0012 events2 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Hypervolaemia
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected95 at risk
EG0021 events1 affected89 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0011 events1 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Ischaemic cardiomyopathy
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Hypovolaemia
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected95 at risk
EG0022 events1 affected89 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Intervertebral disc degeneration
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected95 at risk
EG0021 events1 affected89 at risk
EG003
Left ventricular failure
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0011 events1 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Bladder cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected133 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Lung adenocarcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Renal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Cerebral haemorrhage
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected133 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Nodal arrhythmia
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0011 events1 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Haemorrhagic stroke
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Lacunar infarction
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Transient ischaemic attack
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0011 events1 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 26.0
Systematic Assessment
EG0002 events2 affected133 at risk
EG0011 events1 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Chronic kidney disease
Renal and urinary disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Acute pulmonary oedema
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Acute respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected133 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected133 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected133 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Diabetic foot
Skin and subcutaneous tissue disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected133 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Hypertension
Vascular disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Hypotension
Vascular disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0011 events1 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Shock
Vascular disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected133 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected133 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Diabetic retinopathy
Eye disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Retinal detachment
Eye disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0011 events1 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Duodenal ulcer
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0011 events1 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Faecaloma
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected95 at risk
EG0021 events1 affected89 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected133 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Intestinal obstruction
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Pancreatitis
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected95 at risk
EG0021 events1 affected89 at risk
EG003
Acute myocardial infarction
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0011 events1 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Cholecystitis acute
Hepatobiliary disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected95 at risk
EG0021 events1 affected89 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected133 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Appendicitis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected133 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Atrial fibrillation
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0011 events1 affected95 at risk
EG0020 events0 affected89 at risk
EG0031 events1 affected93 at risk
EG0040 events0 affected148 at risk
Bacteriuria
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Covid-19
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0006 events6 affected133 at risk
EG0013 events3 affected95 at risk
EG0023 events3 affected89 at risk
EG003
Candida infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected133 at risk
EG0010 events0 affected95 at risk
EG0021 events1 affected89 at risk
EG003
Conjunctivitis bacterial
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0011 events1 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Conjunctivitis viral
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0011 events1 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Ear infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0011 events1 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Folliculitis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0011 events1 affected95 at risk
EG0021 events1 affected89 at risk
EG003
Fungal skin infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected95 at risk
EG0021 events1 affected89 at risk
EG003
Atrioventricular block first degree
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected133 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Gangrene
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0011 events1 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Genital infection fungal
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected133 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Helicobacter infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0011 events1 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0011 events1 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Infected dermal cyst
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected95 at risk
EG0021 events1 affected89 at risk
EG003
Influenza
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0011 events1 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0004 events4 affected133 at risk
EG0012 events1 affected95 at risk
EG0022 events2 affected89 at risk
EG003
Oesophageal candidiasis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected133 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Bradycardia
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected133 at risk
EG0011 events1 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Otitis externa
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0011 events1 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Otitis media
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0011 events1 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0011 events1 affected95 at risk
EG0021 events1 affected89 at risk
EG003
Pilonidal disease
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Pneumonia aspiration
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected95 at risk
EG0021 events1 affected89 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected133 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Soft tissue infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Tooth infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0011 events1 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Upper respiratory tract infection bacterial
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0011 events1 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0005 events5 affected133 at risk
EG0014 events3 affected95 at risk
EG0024 events4 affected89 at risk
EG003
Viral pharyngitis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Vulvovaginal mycotic infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0011 events1 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Arthropod bite
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected133 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Cardiac failure
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected95 at risk
EG0021 events1 affected89 at risk
EG003
Chemical burn
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Concussion
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0011 events1 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Epicondylitis
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0002 events2 affected133 at risk
EG0013 events2 affected95 at risk
EG0021 events1 affected89 at risk
EG003
Head injury
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected95 at risk
EG0021 events1 affected89 at risk
EG003
Humerus fracture
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0011 events1 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Iatrogenic injury
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Immunisation reaction
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0011 events1 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Injury
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Cardiac failure congestive
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0011 events1 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Ligament sprain
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0012 events2 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Limb injury
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected133 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Nail injury
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Road traffic accident
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected133 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Skin abrasion
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Skin laceration
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Traumatic haematoma
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Vaccination complication
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected133 at risk
EG0010 events0 affected95 at risk
EG0021 events1 affected89 at risk
EG003
Wrist fracture
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0011 events1 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 26.0
Systematic Assessment
EG0002 events2 affected133 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Blood glucose increased
Investigations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected95 at risk
EG0021 events1 affected89 at risk
EG003
Blood pressure decreased
Investigations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Blood pressure increased
Investigations
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected133 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Brain natriuretic peptide increased
Investigations
MedDRA 26.0
Systematic Assessment
EG0003 events3 affected133 at risk
EG0010 events0 affected95 at risk
EG0021 events1 affected89 at risk
EG003
C-reactive protein increased
Investigations
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected133 at risk
EG0010 events0 affected95 at risk
EG0021 events1 affected89 at risk
EG003
Coagulation test abnormal
Investigations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Glomerular filtration rate decreased
Investigations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0011 events1 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Glycosylated haemoglobin increased
Investigations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0011 events1 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Lipase increased
Investigations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0011 events1 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Coronary artery disease
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0011 events1 affected95 at risk
EG0021 events1 affected89 at risk
EG003
Occult blood positive
Investigations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Platelet count increased
Investigations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Pulse absent
Investigations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Sars-cov-2 test positive
Investigations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0011 events1 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Troponin increased
Investigations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected95 at risk
EG0021 events1 affected89 at risk
EG003
Urine albumin/creatinine ratio increased
Investigations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0011 events1 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Venous pressure jugular increased
Investigations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0011 events1 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Weight increased
Investigations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected95 at risk
EG0021 events1 affected89 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected133 at risk
EG0010 events0 affected95 at risk
EG0021 events1 affected89 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected133 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Diastolic dysfunction
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0011 events1 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Diabetes mellitus
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Dyslipidaemia
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected133 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Gout
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected133 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0002 events2 affected133 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0005 events5 affected133 at risk
EG0017 events4 affected95 at risk
EG0025 events5 affected89 at risk
EG003
Hyperlipidaemia
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected133 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Hypernatraemia
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected95 at risk
EG0021 events1 affected89 at risk
EG003
Hyperuricaemia
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0002 events2 affected133 at risk
EG0011 events1 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Hypervolaemia
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0011 events1 affected95 at risk
EG0021 events1 affected89 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG00112 events8 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Hypoglycaemia unawareness
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0012 events1 affected95 at risk
EG0021 events1 affected89 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0011 events1 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Hypovolaemia
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0011 events1 affected95 at risk
EG0021 events1 affected89 at risk
EG003
Iron deficiency
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0011 events1 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Metabolic acidosis
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0011 events1 affected95 at risk
EG0021 events1 affected89 at risk
EG003
Type 2 diabetes mellitus
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected133 at risk
EG0011 events1 affected95 at risk
EG0021 events1 affected89 at risk
EG003
Vitamin d deficiency
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected95 at risk
EG0021 events1 affected89 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0002 events2 affected133 at risk
EG0015 events4 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected133 at risk
EG0012 events2 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Left ventricular dysfunction
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0004 events4 affected133 at risk
EG0015 events5 affected95 at risk
EG0022 events2 affected89 at risk
EG003
Foot deformity
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected95 at risk
EG0021 events1 affected89 at risk
EG003
Haematoma muscle
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected133 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Joint effusion
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected95 at risk
EG0021 events1 affected89 at risk
EG003
Joint swelling
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0002 events1 affected133 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Lumbar spinal stenosis
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0011 events1 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Muscle fatigue
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected95 at risk
EG0021 events1 affected89 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected95 at risk
EG0023 events2 affected89 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected95 at risk
EG0021 events1 affected89 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0012 events2 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0003 events2 affected133 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Osteoporosis
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected133 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0004 events3 affected133 at risk
EG0011 events1 affected95 at risk
EG0021 events1 affected89 at risk
EG003
Periarthritis
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Rotator cuff syndrome
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Spinal stenosis
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected95 at risk
EG0021 events1 affected89 at risk
EG003
Trigger finger
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected133 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Left ventricular hypertrophy
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0002 events1 affected133 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Malignant melanoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Prostate cancer recurrent
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Renal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0011 events1 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Skin cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Diabetic neuropathy
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected133 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected133 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Headache
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0011 events1 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected133 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Restless legs syndrome
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected95 at risk
EG0021 events1 affected89 at risk
EG003
Sciatica
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Somnolence
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Syncope
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Delirium
Psychiatric disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0011 events1 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Palpitations
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected133 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 26.0
Systematic Assessment
EG0002 events2 affected133 at risk
EG0012 events2 affected95 at risk
EG0021 events1 affected89 at risk
EG003
Azotaemia
Renal and urinary disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected133 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Chronic kidney disease
Renal and urinary disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0011 events1 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected133 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Hypertonic bladder
Renal and urinary disorders
MedDRA 26.0
Systematic Assessment
EG0002 events2 affected133 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Polyuria
Renal and urinary disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0011 events1 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Renal cyst
Renal and urinary disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Renal impairment
Renal and urinary disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected95 at risk
EG0021 events1 affected89 at risk
EG003
Tricuspid valve incompetence
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected133 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Renal mass
Renal and urinary disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected133 at risk
EG0011 events1 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Urge incontinence
Renal and urinary disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0011 events1 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Cystocele
Reproductive system and breast disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected133 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Ejaculation failure
Reproductive system and breast disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Penile size reduced
Reproductive system and breast disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Allergic bronchitis
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0011 events1 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Bronchitis chronic
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected133 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Ventricular extrasystoles
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected133 at risk
EG0011 events1 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0003 events3 affected133 at risk
EG0011 events1 affected95 at risk
EG0021 events1 affected89 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected133 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Lung disorder
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected133 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Orthopnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected95 at risk
EG0021 events1 affected89 at risk
EG003
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected133 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Sleep apnoea syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected95 at risk
EG0021 events1 affected89 at risk
EG003
Phimosis
Congenital, familial and genetic disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Acne
Skin and subcutaneous tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0011 events1 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Dermatitis
Skin and subcutaneous tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Diabetic dermopathy
Skin and subcutaneous tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected95 at risk
EG0021 events1 affected89 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0011 events1 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Onychogryphosis
Skin and subcutaneous tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0011 events1 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0012 events2 affected95 at risk
EG0022 events2 affected89 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0011 events1 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Rash macular
Skin and subcutaneous tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected95 at risk
EG0021 events1 affected89 at risk
EG003
Ear discomfort
Ear and labyrinth disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Skin ulcer
Skin and subcutaneous tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0014 events2 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Urticarial vasculitis
Skin and subcutaneous tissue disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected133 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Bleeding varicose vein
Vascular disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected95 at risk
EG0021 events1 affected89 at risk
EG003
Flushing
Vascular disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0011 events1 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Haematoma
Vascular disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Hypertension
Vascular disorders
MedDRA 26.0
Systematic Assessment
EG0003 events3 affected133 at risk
EG0016 events6 affected95 at risk
EG0021 events1 affected89 at risk
EG003
Hypertensive urgency
Vascular disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Hypotension
Vascular disorders
MedDRA 26.0
Systematic Assessment
EG0002 events2 affected133 at risk
EG0011 events1 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Orthostatic hypotension
Vascular disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Tinnitus
Ear and labyrinth disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected133 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Peripheral arterial occlusive disease
Vascular disorders
MedDRA 26.0
Systematic Assessment
EG0002 events2 affected133 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Iron deficiency anaemia
Blood and lymphatic system disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0011 events1 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected133 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Hyperparathyroidism secondary
Endocrine disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0011 events1 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected95 at risk
EG0021 events1 affected89 at risk
EG003
Thyroid mass
Endocrine disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Cataract
Eye disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected133 at risk
EG0010 events0 affected95 at risk
EG0022 events1 affected89 at risk
EG003
Corneal disorder
Eye disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Dry eye
Eye disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Glaucoma
Eye disorders
MedDRA 26.0
Systematic Assessment
EG0002 events2 affected133 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Ocular hyperaemia
Eye disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0011 events1 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Leukocytosis
Blood and lymphatic system disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected133 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Retinal haemorrhage
Eye disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Vision blurred
Eye disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Vitreous floaters
Eye disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Vitreous haemorrhage
Eye disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Abdominal hernia
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected133 at risk
EG0011 events1 affected95 at risk
EG0021 events1 affected89 at risk
EG003
Abdominal pain lower
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected133 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Lymphopenia
Blood and lymphatic system disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0002 events2 affected133 at risk
EG0010 events0 affected95 at risk
EG0022 events2 affected89 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0002 events2 affected133 at risk
EG0011 events1 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Colitis microscopic
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected95 at risk
EG0021 events1 affected89 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected133 at risk
EG0011 events1 affected95 at risk
EG0022 events2 affected89 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0002 events2 affected133 at risk
EG0011 events1 affected95 at risk
EG0026 events4 affected89 at risk
EG003
Diverticulum intestinal
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected95 at risk
EG0021 events1 affected89 at risk
EG003
Duodenitis
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected133 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0002 events1 affected133 at risk
EG0011 events1 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Enterocolitis
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0011 events1 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected133 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Gastric polyps
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected95 at risk
EG0021 events1 affected89 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Gastritis erosive
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected95 at risk
EG0021 events1 affected89 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected133 at risk
EG0010 events0 affected95 at risk
EG0021 events1 affected89 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected133 at risk
EG0013 events2 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected133 at risk
EG0011 events1 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0011 events1 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected95 at risk
EG0021 events1 affected89 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected133 at risk
EG0010 events0 affected95 at risk
EG0021 events1 affected89 at risk
EG003
Asthenia
General disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected133 at risk
EG0010 events0 affected95 at risk
EG0021 events1 affected89 at risk
EG003
Chest pain
General disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Chills
General disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected133 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Fatigue
General disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0012 events2 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Granuloma
General disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected133 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Hunger
General disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0011 events1 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Angina pectoris
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected133 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Hypothermia
General disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected133 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Influenza like illness
General disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Injection site inflammation
General disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected95 at risk
EG0021 events1 affected89 at risk
EG003
Injection site pruritus
General disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0011 events1 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Injection site rash
General disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Injection site swelling
General disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0011 events1 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Malaise
General disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0011 events1 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Oedema peripheral
General disorders
MedDRA 26.0
Systematic Assessment
EG0004 events4 affected133 at risk
EG0014 events4 affected95 at risk
EG0021 events1 affected89 at risk
EG003
Pain
General disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected133 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Peripheral swelling
General disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected95 at risk
EG0023 events3 affected89 at risk
EG003
Arrhythmia supraventricular
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected133 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Pyrexia
General disorders
MedDRA 26.0
Systematic Assessment
EG0002 events2 affected133 at risk
EG0014 events4 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Swelling face
General disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Bile duct stone
Hepatobiliary disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected95 at risk
EG0021 events1 affected89 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Hepatic steatosis
Hepatobiliary disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Drug hypersensitivity
Immune system disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0011 events1 affected95 at risk
EG0021 events1 affected89 at risk
EG003
Seasonal allergy
Immune system disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected133 at risk
EG0011 events1 affected95 at risk
EG0020 events0 affected89 at risk
EG003
Acute sinusitis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected133 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected89 at risk
EG003
41 randomized participants were excluded from analysis populations in order to avoid heterogeneity in the data (bias, etc.) :
2 participants did not received any IP
24 participants were enrolled in phase 2a without having the possibility to be enrolled in phase 2b
15 participants were randomized in a site with GCP breach (inability to confirm the validity of the data reported)
These 41 participants are excluded from Baseline characteristics (558 participants).