Placebo-Controlled Study of Brazikumab in Participants Wi... | NCT03616821 | Trialant
NCT03616821
Sponsor
AstraZeneca
Status
Terminated
Last Update Posted
Jun 23, 2026Actual
Enrollment
242Actual
Phase
Phase 2
Conditions
Ulcerative Colitis
IBD
Interventions
Brazikumab
Placebo
Countries
United States
Canada
Czechia
Germany
Hungary
India
Israel
Italy
Japan
Poland
Puerto Rico
Russia
Slovakia
South Africa
South Korea
Spain
Taiwan
Ukraine
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT03616821
Obsolete or Duplicate NCT IDs
NCT04718818
Organization Study
D5272C00001
Secondary IDs
ID
Type
Description
Link
Legacy #3151-201-008
Other Identifier
Allergan
2018-001605-93
EudraCT Number
Brief Title
Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Ulcerative Colitis
Official Title
A 54-Week, Multicenter, Randomized, Double-blind, Placebo Controlled, Parallel-group Phase 2 Study to Assess the Efficacy and Safety of Brazikumab in Participants With Moderately to Severely Active Ulcerative Colitis (Expedition Lead-in)
Acronym
Expedition
Organization
AstraZenecaINDUSTRY
Status Module
Record Verification Date
May 2026
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Strategic decision to discontinue the development of brazikumab in inflammatory bowel disease.
Expanded Access Info
No
Start Date
Aug 7, 2018Actual
Primary Completion Date
Oct 23, 2023Actual
Completion Date
Oct 23, 2023Actual
First Submitted Date
Aug 1, 2018
First Submission Date that Met QC Criteria
Aug 1, 2018
First Posted Date
Aug 6, 2018Actual
Results Waived
Not provided
Results First Submitted Date
Oct 18, 2024
Results First Submitted that Met QC Criteria
May 27, 2026
Results First Posted Date
Jun 23, 2026Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
May 27, 2026
Last Update Posted Date
Jun 23, 2026Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
AstraZenecaINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Yes
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The present study (D5272C00001/Legacy #3151-201-008) aims to evaluate the efficacy and safety of brazikumab in patients with moderately to severely active UC and will include assessments of clinical responses as demonstrated by improvement of symptoms and of colonic mucosal appearance as observed on endoscopy
Detailed Description
Not provided
Conditions Module
Conditions
Ulcerative Colitis
IBD
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
242Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Brazikumab Dose 1
Experimental
Intravenous brazikumab on day 1, day 15, and day 43 followed by Subcutaneous brazikumab every 4 weeks beginning on day 71 through week 50
Drug: Brazikumab
Brazikumab Dose 2
Experimental
Intravenous brazikumab on day 1, day 15, and day 43 followed by Subcutaneous brazikumab every 4 weeks beginning on day 71 through Week 50
Drug: Brazikumab
Placebo
Placebo Comparator
Intravenous placebo on day 1, day 15, and day 43 followed by Subcutaneous every 4 weeks beginning on day 71 through Week 50.
Drug: Placebo
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Brazikumab
Drug
Intravenous brazikumab on day 1, day 15, and day 43 followed by Subcutaneous brazikumab every 4 weeks beginning on day 71 through Week 50
Brazikumab Dose 1
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Clinical Remission
Efficacy was assessed using the Mayo Scoring System for assessment of Ulcerative Colitis. The Mayo score assesses
stool frequency,
rectal bleeding,
endoscopic findings, and
physician's assessment of disease activity. Each of these four subscores can be scored as 0, 1, 2, or 3, where 0 is a normal finding and 3 corresponds to severe disease.
The Mayo score has been modified (modified Mayo Score, mMS) to specify no friability in the endoscopy subscore of 1 (mild disease).
Clinical Remission is defined by the mMS at Week 10:
Endoscopy subscore = 0 or 1, AND
Rectal bleeding subscore = 0, AND
Stool frequency subscore = 0 or 1, AND at least a 1-point decrease from baseline
Further, if the patient
discontinue treatment prematurely for any reason
takes rescue treatment or meet the rescue criteria
uses prohibited medication the patient is considered as unsuccessfully treated and imputed as non-responder
at Week 10
Secondary Outcomes
Measure
Description
Time Frame
Sustained Clinical Remission
Sustained clinical remission defined as Modified Mayo Score (mMS): Endoscopy subscore = 0 or 1, AND Rectal bleeding subscore = 0, AND Stool frequency subscore = 0 or 1 AND at least a 1 point decrease from baseline
Further, if the patient
discontinue treatment prematurely for any reason
takes rescue treatment or meet the rescue criteria
uses prohibited medication the patient is considered as unsuccessfully treated and imputed as non-responder
Other Outcomes
Measure
Description
Time Frame
Physical Examination
Physical examination as safety assessment, to facilitate the evaluation of the safety objective (Adverse Events).
through week 68
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Ability to provide informed consent
Aged 18 to 80 years of age
Diagnosis of UC with an onset of symptoms for a minimum of 3 months prior to Screening
Evidence of UC extending proximal to the rectum (≥ 15 cm of involved colon)
Moderately to severely active UC as defined by:
Average daily mMS Stool Frequency subscore ≥ 1 AND Average daily mMS Rectal Bleeding subscore ≥ 1
Modified Mayo endoscopic subscore of ≥ 2 based on a full colonoscopy within 14 days prior to randomization.
Participant had an inadequate response or intolerance to intervention with conventional treatment or prior biological treatment or demonstrated CS dependence for the treatment of UC. For participants who have previously used biological treatment, a participant may have failed up to 3 biologics that include up to 2 different mechanisms of action.
Participants taking 5-aminosalicylates, oral prednisone (or equivalent), oral budesonide, or immunomodulators must be at a stable dose or discontinued. Topical (rectal) aminosalicylic acid or topical (rectal) steroids should be discontinued.
Female participants of childbearing potential must have a negative urine pregnancy test prior to administration of study intervention and must agree to use a highly effective method of birth control throughout the study and for at least 18 weeks after the last dose of study intervention.
Women not of childbearing potential are defined as women who are either permanently sterilized (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy), or who are postmenopausal.
Non sterilized males who are sexually active with a female partner of childbearing potential should use condoms during treatment and until the end of relevant systemic exposure in the male participant, plus a further 18 weeks.
No known history of active TB or latent TB without completion of appropriate intervention and negative QFT-TB during Screening.
Complete inclusion criteria are in the Clinical Study Protocol
Exclusion Criteria:
Participant has UC limited to the rectum (ie, not beyond 15 cm of the anal verge).
Current diagnosis of fulminant colitis, a diagnosis of CD or indeterminate colitis, presence or history of a fistula consistent with CD, primary sclerosing cholangitis, celiac disease, or untreated bile acid malabsorption. Participants with a history of toxic megacolon within 12 months of screening are excluded.
History of subtotal colectomy with ileorectostomy or colectomy with ileoanal pouch, Koch pouch, ileostomy, or other prior colonic resection, or need for surgical intervention for control of UC anticipated within 6 months.
Participant has received the following treatment:
Infliximab: within 8 weeks prior to randomization.
Adalimumab, certolizumab pegol, or golimumab: within 8 weeks prior to randomization.
Vedolizumab or ustekinumab within 12 weeks of randomization.
Other prohibited medication, biologic or small molecule treatment within 5 half-lives prior to randomization.
Fecal microbiota transplantation: within 8 weeks prior to randomization.
Criterion deleted as part of Amendment 5 v6.0
Except for ustekinumab, prior exposure to any biologic agent targeting IL-12 or IL-23.
Known history of allergy to the study intervention formulation or any of its excipients or components of the delivery device, or to any other biologic therapy.
Participant received cyclosporine, mycophenolate mofetil, sirolimus (rapamycin), thalidomide, tacrolimus (FK-506), or tofacitinib within 2 weeks prior to Screening.
Participants who received IV or intramuscular steroids within 2 weeks prior to Screening.
Participant is currently enrolled in another investigational device or drug study, or is within 35 days or 5 half-lives, whichever is longer, since ending another investigational device or drug study(s), or receiving other investigational agent(s).
Participant received a transfusion of blood, plasma, or platelets within 30 days prior to Screening.
Participant received a Bacille Calmette-Guérin vaccination within 12 months of randomization or any other live vaccine less than 4 weeks prior to randomization.
Participant has any of the following criteria related to infections:
Evidence of a recent systemic fungal infection, requiring inpatient hospitalization, and/or antifungal treatment.
Any infection requiring hospitalization or treatment with IV anti-infectives within 4 weeks of Screening.
Cytomegalovirus or Epstein-Barr virus infection that has not resolved within 8 weeks prior to Screening.
Clinically significant chronic infection that has not resolved within 8 weeks of Screening.
Nonserious infection requiring oral anti-infectives within 2 weeks prior to randomization must be further discussed with study medical monitor.
Clinical evidence of or suspected to have an abscess during Screening.
Any underlying condition that predisposes the participant to infections.
Participant had previous allogenic bone marrow transplant or history of organ or cell-based transplantation.
Clinically significant active infection or signs/symptoms of infection that has the potential to worsen with immunosuppressive therapy.
Signs or symptoms of ongoing infection due to intestinal pathogens.
Participant has known or suspected history of chronic use of NSAIDs and/or opiates, drug, or alcohol abuse.
History of cancer with the following exceptions: history of basal cell carcinoma and/or squamous cell carcinoma of the skin OR carcinoma in situ of the cervix; with apparent successful curative therapy, greater than 12 months prior to Screening.
Clinically significant cardiovascular conditions.
Prolonged QTcF interval or conditions leading to additional risk for QT prolongation.
Clinically significant kidney disease
Abnormal laboratory results at Screening as defined in the study protocol
Participant is pregnant or breastfeeding or plans to become pregnant during the study.
Participant has other known, pre-existing, clinically significant medical conditions that are not associated with UC and are uncontrolled with standard treatment.
Participant has any disorder that may compromise the ability of the participant to give written informed consent and/or to comply with all required study procedures.
Employees of the clinical study site or any other individuals involved with the conduct of the study, or immediate family members of such individuals.
Complete exclusion criteria are in the Clinical Study Protocol
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.
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.
As of 1 June 2023, AstraZeneca discontinued the development of brazikumab. All study related dosing was immediately stopped. Because of study early termination, site data cleaning engagement proved challenging and as a result databases were locked with unclean data. A patient centric approach was taken to focus data cleaning on key safety variables (adverse events). Please be aware that the data submitted needs to be considered with the data quality in mind.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Brazikumab 720 mg
IV brazikumab 720 mg during induction period
FG001
Brazikumab 1440 mg
IV brazikumab 1440 mg during induction period
Periods
Title
Milestones
Reasons Not Completed
Induction Period
Type
Comment
Milestone Data
STARTED
Subjects who started Induction Period treatment
Baseline Characteristics Module
Baseline Analysis Population Description
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
Mar 10, 2022
May 27, 2026
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Australia
Austria
Belgium
Bulgaria
France
Romania
Submission Tracking
Estimated Results First Submitted Date
Not provided
Condition Browse Module
MeSH Terms
Intervention Browse Module
No data available
No data is available for this block.
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Global, multicenter, randomized, double-blind, placebo-controlled, parallel-group, Phase 2 study
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Triple
Masking Description
Not provided
Who Masked
ParticipantCare ProviderInvestigator
Brazikumab Dose 2
Placebo
Drug
Intravenous placebo on day 1, day 15, and day 43 followed by Subcutaneous placebo every 4 weeks beginning on Day 71 through Week 50.
Placebo
Week 10 and 54
CS-free Clinical Remission
CS-free clinical remission defined as mMS: Endoscopy subscore = 0 or 1, AND Rectal bleeding subscore = 0, AND Stool frequency subscore = 0 or 1 AND at least a 1 point decrease from baseline
Further, if the patient
discontinue treatment prematurely for any reason
takes rescue treatment or meet the rescue criteria
uses prohibited medication the patient is considered as unsuccessfully treated and imputed as non-responder
Week 54
Clinical Response
Efficacy was assessed using the Mayo Scoring System for assessment of Ulcerative Colitis. The Mayo score assesses
stool frequency,
rectal bleeding,
endoscopic findings, and
physician's assessment of disease activity. Each of these four subscores can be scored as 0, 1, 2, or 3, where 0 is a normal finding and 3 corresponds to severe disease.
The Mayo score is the sum of the four subscores. The Mayo score has been modified (modified Mayo Score, mMS) to specify no friability in the endoscopy subscore of 1 (mild disease).
Clinical response is defined as Reduction in mMS ≥ 2 points from baseline AND ≥ 30% from baseline AND a decrease in the rectal bleeding score ≥ 1 point from baseline or a score of 0 or 1
Further, if the patient
discontinue treatment prematurely for any reason
takes rescue treatment or meet the rescue criteria
uses prohibited medication the patient is considered as unsuccessfully treated and imputed as non-responder
Week 10
Endoscopic Improvement
Efficacy was assessed using the Mayo Scoring System for assessment of Ulcerative Colitis. The Mayo score assesses
stool frequency,
rectal bleeding,
endoscopic findings, and
physician's assessment of disease activity. Each of these four subscores can be scored as 0, 1, 2, or 3, where 0 is a normal finding and 3 corresponds to severe disease.
Endoscopic improvement is defined as Endoscopy subscore ≤ 1.
Further, if the patient
discontinue treatment prematurely for any reason
takes rescue treatment or meet the rescue criteria
uses prohibited medication the patient is considered as unsuccessfully treated and imputed as non-responder
Week 10
Serum Concentrations of Brazikumab (Induction)
Pharmacokinetics: concentration of brazikumab in serum
through week 10
Exposure-response
Participants with Clinical Remission by Quartile of Brazikumab concentration
through week 68
Incidence of Anti-drug Antibodies (Induction)
Immunogenicity: incidence of brazikumab anti-drug antibodies in serum
through week 10
Adverse Events
Number and percentage of patients with reported adverse events.
Through week 68: Induction: AE with onset on or after first IV dose up to SC dose, or early term trt date + 18 wks after last dose. Maintenance: AE with onset on or after first SC dose up to and including 18 weeks after date of last SC dose.
Laboratory Values
Percentage of patients with potentially clinically significant changes in hematology, clinical chemistry, urinalysis.
through week 68
Vital Signs
Percentage of patients with potentially clinically significant changes in systolic and diastolic blood pressure, and pulse rate.
through week 68
Abnormal ECG Results Through Week 68
Percentage of patients with potentially clinically significant changes in 12-lead ECG recordings
through week 68
Serum Concentrations of Brazikumab (Maintenance)
Pharmacokinetics: concentration of brazikumab in serum
Week 30 through week 68
Incidence of Anti-drug Antibodies (Maintenance)
Immunogenicity: incidence of brazikumab anti-drug antibodies in serum
Week 30 through week 68
mMS Total Score (Induction)
mMS total score at baseline and Week 10
through Week 10
mMS Component Score: Endoscopy (Induction)
Number of participants in each score category for Endoscopy score
through Week 10
mMS Component Score: Stool Frequency (Induction)
Number of participants in each score category for Stool frequency
through Week 10
mMS Component Score: Rectal Bleeding (Induction)
Number of participants in each score category for Rectal bleeding
through Week 10
Total mMS (Maintenance)
mMS total score at baseline and Week 54
Week 54
mMS Component Score: Endoscopy (Maintenance)
Number of participants in each score category for Endoscopy score
through Week 54
mMS Component Score: Stool Frequency (Maintenance)
Number of participants in each score category for Stool frequency score
IV vedolizumab 300 mg during induction period and maintenance
FG004
Placebo
IV placebo during induction period
FG00073 subjects
FG00173 subjects
FG00210 subjects
FG00310 subjects
FG00471 subjects
COMPLETED
Subjects who completed Induction Period treatment
FG00054 subjects
FG00158 subjects
FG0029 subjects
FG0039 subjects
FG00441 subjects
NOT COMPLETED
FG00019 subjects
FG00115 subjects
FG0021 subjects
FG0031 subjects
FG00430 subjects
Type
Comment
Reasons
Adverse Event
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0041 subjects
Lack of Efficacy
FG0004 subjects
FG0012 subjects
FG0021 subjects
FG0030 subjects
FG004
Physician Decision
FG0002 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Protocol Violation
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Study terminated by sponsor, Site terminated by sponsor, or Other
FG00012 subjects
FG00112 subjects
FG0020 subjects
FG0030 subjects
Maintenance Period
Type
Comment
Milestone Data
STARTED
Subjects who started Maintenance Period treatment
FG00048 subjects
FG00153 subjects
FG0029 subjects
FG0039 subjects
FG00432 subjects
COMPLETED
Subjects who completed Maintenance Period treatment
FG00011 subjects
FG00115 subjects
FG0027 subjects
FG003
NOT COMPLETED
FG00037 subjects
FG00138 subjects
FG0022 subjects
FG0034 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG003
The efficacy analysis set includes subjects who had completed the induction period at time of study termination, or who would have had the opportunity to complete the induction period at the time of the termination if not prematurely discontinuing IP. The reason for excluding subjects was to avoid bias in the analysis.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Brazikumab 720 mg
IV brazikumab 720 mg during induction period
BG001
Brazikumab 1440 mg
IV brazikumab 1440 mg during induction period
BG002
Brazikumab 2100 mg
IV brazikumab 2100 mg during induction period
BG003
Vedolizumab 300 mg
IV vedolizumab 300 mg during induction period
BG004
Placebo
IV placebo during induction period
BG005
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00065
BG00165
BG00210
BG00310
BG00465
BG005215
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00039.4± 13.82
BG00143.7± 13.59
BG00251.2± 14.95
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00034
BG00128
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0004
BG0014
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Clinical Remission
Efficacy was assessed using the Mayo Scoring System for assessment of Ulcerative Colitis. The Mayo score assesses
stool frequency,
rectal bleeding,
endoscopic findings, and
physician's assessment of disease activity. Each of these four subscores can be scored as 0, 1, 2, or 3, where 0 is a normal finding and 3 corresponds to severe disease.
The Mayo score has been modified (modified Mayo Score, mMS) to specify no friability in the endoscopy subscore of 1 (mild disease).
Clinical Remission is defined by the mMS at Week 10:
Endoscopy subscore = 0 or 1, AND
Rectal bleeding subscore = 0, AND
Stool frequency subscore = 0 or 1, AND at least a 1-point decrease from baseline
Further, if the patient
discontinue treatment prematurely for any reason
takes rescue treatment or meet the rescue criteria
uses prohibited medication the patient is considered as unsuccessfully treated and imputed as non-responder
The efficacy analysis set includes subjects who had completed the induction period at time of study termination, or who would have had the opportunity to complete the induction period at the time of the termination if not prematurely discontinuing IP. The reason for excluding subjects was to avoid bias in the analysis.
Posted
Count of Participants
Participants
at Week 10
ID
Title
Description
OG000
Brazikumab 720 mg
IV brazikumab 720 mg during induction period
OG001
Brazikumab 1440 mg
IV brazikumab 1440 mg during induction period
OG002
Brazikumab 2100 mg
IV brazikumab 2100 mg during induction period
OG003
Vedolizumab
IV vedolizumab 300 mg during induction period
OG004
Placebo
IV placebo during induction period
Units
Counts
Participants
OG00065
OG00165
OG00210
OG003
Title
Denominators
Categories
Title
Measurements
OG00013
OG00116
OG0022
OG003
Secondary
Sustained Clinical Remission
Sustained clinical remission defined as Modified Mayo Score (mMS): Endoscopy subscore = 0 or 1, AND Rectal bleeding subscore = 0, AND Stool frequency subscore = 0 or 1 AND at least a 1 point decrease from baseline
Further, if the patient
discontinue treatment prematurely for any reason
takes rescue treatment or meet the rescue criteria
uses prohibited medication the patient is considered as unsuccessfully treated and imputed as non-responder
Outcome measure 2 is not available since the component based on rescue and prohibited medication is defined by adjudication of blinded data. The adjudication was not performed for the maintenance period, and adjudicated data is not available. Thus, this outcome measure cannot be derived due to lack of this component. What can be derived is descriptive statistics for the mMS total score and components. These are provided in outcome measures 16 - 19 for induction, and 20 - 23 for maintenance.
Posted
Week 10 and 54
ID
Title
Description
OG000
Brazikumab 720 mg
IV brazikumab 720 mg during induction period
OG001
Brazikumab 1440 mg
IV brazikumab 1440 mg during induction period
OG002
Brazikumab 2100 mg
IV brazikumab 2100 mg during induction period
Secondary
CS-free Clinical Remission
CS-free clinical remission defined as mMS: Endoscopy subscore = 0 or 1, AND Rectal bleeding subscore = 0, AND Stool frequency subscore = 0 or 1 AND at least a 1 point decrease from baseline
Further, if the patient
discontinue treatment prematurely for any reason
takes rescue treatment or meet the rescue criteria
uses prohibited medication the patient is considered as unsuccessfully treated and imputed as non-responder
Outcome measure 3 is not available since the component based on rescue and prohibited medication is defined by adjudication of blinded data. The adjudication was not performed for the maintenance period, and the adjudicated data is not available. Thus, this outcome measure cannot be derived due to lack of this component. What can be derived is descriptive statistics for the Endoscopy, Rectal bleeding and Stool frequency subscores at week 54. These are provided in outcome measures 21 - 23.
Posted
Week 54
ID
Title
Description
OG000
Brazikumab 720 mg
IV brazikumab 720 mg during induction period
OG001
Brazikumab 1440 mg
IV brazikumab 1440 mg during induction period
OG002
Brazikumab 2100 mg
IV brazikumab 2100 mg during induction period
Secondary
Clinical Response
Efficacy was assessed using the Mayo Scoring System for assessment of Ulcerative Colitis. The Mayo score assesses
stool frequency,
rectal bleeding,
endoscopic findings, and
physician's assessment of disease activity. Each of these four subscores can be scored as 0, 1, 2, or 3, where 0 is a normal finding and 3 corresponds to severe disease.
The Mayo score is the sum of the four subscores. The Mayo score has been modified (modified Mayo Score, mMS) to specify no friability in the endoscopy subscore of 1 (mild disease).
Clinical response is defined as Reduction in mMS ≥ 2 points from baseline AND ≥ 30% from baseline AND a decrease in the rectal bleeding score ≥ 1 point from baseline or a score of 0 or 1
Further, if the patient
discontinue treatment prematurely for any reason
takes rescue treatment or meet the rescue criteria
uses prohibited medication the patient is considered as unsuccessfully treated and imputed as non-responder
The efficacy analysis set includes subjects who had completed the induction period at time of study termination, or who would have had the opportunity to complete the induction period at the time of the termination if not prematurely discontinuing IP. The reason for excluding subjects was to avoid bias in the analysis.
Posted
Count of Participants
Participants
Week 10
ID
Title
Description
OG000
Brazikumab 720 mg
IV brazikumab 720 mg during induction period
OG001
Brazikumab 1440 mg
Secondary
Endoscopic Improvement
Efficacy was assessed using the Mayo Scoring System for assessment of Ulcerative Colitis. The Mayo score assesses
stool frequency,
rectal bleeding,
endoscopic findings, and
physician's assessment of disease activity. Each of these four subscores can be scored as 0, 1, 2, or 3, where 0 is a normal finding and 3 corresponds to severe disease.
Endoscopic improvement is defined as Endoscopy subscore ≤ 1.
Further, if the patient
discontinue treatment prematurely for any reason
takes rescue treatment or meet the rescue criteria
uses prohibited medication the patient is considered as unsuccessfully treated and imputed as non-responder
The efficacy analysis set includes subjects who had completed the induction period at time of study termination, or who would have had the opportunity to complete the induction period at the time of the termination if not prematurely discontinuing IP. The reason for excluding subjects was to avoid bias in the analysis.
Posted
Count of Participants
Participants
Week 10
ID
Title
Description
OG000
Brazikumab 720 mg
IV brazikumab 720 mg during induction period
OG001
Brazikumab 1440 mg
IV brazikumab 1440 mg during induction period
OG002
Brazikumab 2100 mg
Secondary
Serum Concentrations of Brazikumab (Induction)
Pharmacokinetics: concentration of brazikumab in serum
The PK population includes all participants who receive at least 1 dose of study intervention and have at least 1 PK sample containing detectable brazikumab concentrations.
Posted
Mean
Standard Deviation
ng/mL
through week 10
ID
Title
Description
OG000
Brazikumab 720 mg
IV brazikumab 720 mg during induction period
OG001
Brazikumab 1440 mg
IV brazikumab 1440 mg during induction period
OG002
Brazikumab 2100 mg
IV brazikumab 2100 mg during induction period
Units
Counts
Participants
OG000
Secondary
Exposure-response
Participants with Clinical Remission by Quartile of Brazikumab concentration
All participants who receive at least 1 dose of study intervention and have at least 1 PK sample containing detectable brazikumab concentrations, and who are part of the Efficacy Analysis Set.
Posted
Count of Participants
Participants
through week 68
ID
Title
Description
OG000
Brazikumab 1st Quartile
Participants who have braziumab concentration in the 1st quartile
OG001
Brazikumab 2nd Quartile
Participants who have braziumab concentration in the 2nd quartile
OG002
Brazikumab 3rd Quartile
Participants who have braziumab concentration in the 3rd quartile
OG003
Brazikumab 4th Quartile
Participants who have braziumab concentration in the 4th quartile
Secondary
Incidence of Anti-drug Antibodies (Induction)
Immunogenicity: incidence of brazikumab anti-drug antibodies in serum
The data is reported for the PK population including all participants who receive at least 1 dose of study intervention and have at least 1 PK sample containing detectable brazikumab concentrations.
Posted
Count of Participants
Participants
through week 10
ID
Title
Description
OG000
Brazikumab 720 mg
IV brazikumab 720 mg during induction period
OG001
Brazikumab 1440 mg
IV brazikumab 1440 mg during induction period
OG002
Brazikumab 2100 mg
IV brazikumab 2100 mg during induction period
Units
Counts
Participants
OG000
Secondary
Adverse Events
Number and percentage of patients with reported adverse events.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
Posted
Count of Participants
Participants
Through week 68: Induction: AE with onset on or after first IV dose up to SC dose, or early term trt date + 18 wks after last dose. Maintenance: AE with onset on or after first SC dose up to and including 18 weeks after date of last SC dose.
ID
Title
Description
OG000
Brazikumab 720 mg
IV brazikumab 720 mg during induction period
OG001
Brazikumab 1440 mg
IV brazikumab 1440 mg during induction period
OG002
Brazikumab 2100 mg
IV brazikumab 2100 mg during induction period
Secondary
Laboratory Values
Percentage of patients with potentially clinically significant changes in hematology, clinical chemistry, urinalysis.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
Posted
Count of Participants
Participants
through week 68
ID
Title
Description
OG000
Brazikumab 720 mg
IV brazikumab 720 mg during induction period
OG001
Brazikumab 1440 mg
IV brazikumab 1440 mg during induction period
OG002
Brazikumab 2100 mg
IV brazikumab 2100 mg during induction period
OG003
Vedolizumab 300 mg
Secondary
Vital Signs
Percentage of patients with potentially clinically significant changes in systolic and diastolic blood pressure, and pulse rate.
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
Posted
Count of Participants
Participants
through week 68
ID
Title
Description
OG000
Brazikumab 720 mg
IV brazikumab 720 mg during induction period
OG001
Brazikumab 1440 mg
IV brazikumab 1440 mg during induction period
OG002
Brazikumab 2100 mg
IV brazikumab 2100 mg during induction period
OG003
Vedolizumab 300 mg
Other Pre-specified
Physical Examination
Physical examination as safety assessment, to facilitate the evaluation of the safety objective (Adverse Events).
Any new or aggravated clinically relevant abnormal medical finding occurring at a physical examination (PE) as compared with the Baseline assessment was considered as a treatment emergent adverse event and is reported in the Adverse Event section. No data related to the PE was captured and it was not captured for the adverse events if it was related to a PE. Since it was never collected it is not possible to report either any PE data or the AEs related to a PE separately.
Posted
through week 68
ID
Title
Description
OG000
Brazikumab 720 mg
IV brazikumab 720 mg during induction period
OG001
Brazikumab 1440 mg
IV brazikumab 1440 mg during induction period
OG002
Brazikumab 2100 mg
IV brazikumab 2100 mg during induction period
OG003
Vedolizumab 300 mg
IV vedolizumab 300 mg during induction period
Secondary
Abnormal ECG Results Through Week 68
Percentage of patients with potentially clinically significant changes in 12-lead ECG recordings
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
Posted
Count of Participants
Participants
through week 68
ID
Title
Description
OG000
Brazikumab 720 mg
IV brazikumab 720 mg during induction period
OG001
Brazikumab 1440 mg
IV brazikumab 1440 mg during induction period
OG002
Brazikumab 2100 mg
IV brazikumab 2100 mg during induction period
OG003
Vedolizumab 300 mg
Secondary
Serum Concentrations of Brazikumab (Maintenance)
Pharmacokinetics: concentration of brazikumab in serum
The PK population includes all participants who receive at least 1 dose of study intervention and have at least 1 PK sample containing detectable brazikumab concentrations.
Posted
Mean
Standard Deviation
ng/mL
Week 30 through week 68
ID
Title
Description
OG000
Brazikumab IV 720 mg/SC 120 mg
IV brazikumab 720 mg during induction period then SC brazikumab 120 mg during maintenance
OG001
Brazikumab IV 720 mg/SC 240 mg
IV brazikumab during induction period then SC 240 mg brazikumab during maintenance
OG002
Brazikumab IV 1440 mg/SC 120 mg
IV brazikumab 1440 mg during induction period then SC 120 mg during maintenance
OG003
Brazikumab IV 1440 mg/SC 240 mg
IV brazikumab 1440 mg during induction period then SC 240 mg brazikumab during maintenance
Secondary
Incidence of Anti-drug Antibodies (Maintenance)
Immunogenicity: incidence of brazikumab anti-drug antibodies in serum
The data is reported for the PK population including all participants who receive at least 1 dose of study intervention and have at least 1 PK sample containing detectable brazikumab concentrations.
Posted
Count of Participants
Participants
Week 30 through week 68
ID
Title
Description
OG000
Brazikumab IV 720 mg/SC 120 mg
IV brazikumab 720 mg during induction period then SC 120 mg brazikumab during maintenance
OG001
Brazikumab IV 720 mg/SC 240 mg
IV brazikumab 720 mg during induction period then SC 240 mg brazikumab during maintenance
OG002
Brazikumab IV 1440 mg/SC 120 mg
IV brazikumab 1440 mg during induction period then SC 120 mg during maintenance
OG003
Brazikumab IV 1440 mg/SC 240 mg
IV brazikumab 1440 mg during induction period then SC 240 mg brazikumab during maintenance
Secondary
mMS Total Score (Induction)
mMS total score at baseline and Week 10
The efficacy analysis set includes subjects who had completed the induction period at time of study termination, or who would have had the opportunity to complete the induction period at the time of the termination if not prematurely discontinuing IP. The reason for excluding subjects was to avoid bias in the analysis.
Posted
Mean
Standard Deviation
score
through Week 10
ID
Title
Description
OG000
Brazikumab 720 mg
IV brazikumab 720 mg during induction period
OG001
Brazikumab 1440 mg
IV brazikumab 1440 mg during induction period
OG002
Brazikumab 2100 mg
IV brazikumab 2100 mg during induction period
OG003
Vedolizumab
IV vedolizumab 300 mg during induction period
OG004
Placebo
Secondary
mMS Component Score: Endoscopy (Induction)
Number of participants in each score category for Endoscopy score
The efficacy analysis set includes subjects who had completed the induction period at time of study termination, or who would have had the opportunity to complete the induction period at the time of the termination if not prematurely discontinuing IP. The reason for excluding subjects was to avoid bias in the analysis.
Posted
Count of Participants
Participants
through Week 10
ID
Title
Description
OG000
Brazikumab 720 mg
IV brazikumab 720 mg during induction period
OG001
Brazikumab 1440 mg
IV brazikumab 1440 mg during induction period
OG002
Brazikumab 2100 mg
IV brazikumab 2100 mg during induction period
OG003
Vedolizumab
IV vedolizumab 300 mg during induction period
OG004
Secondary
mMS Component Score: Stool Frequency (Induction)
Number of participants in each score category for Stool frequency
The efficacy analysis set includes subjects who had completed the induction period at time of study termination, or who would have had the opportunity to complete the induction period at the time of the termination if not prematurely discontinuing IP. The reason for excluding subjects was to avoid bias in the analysis.
Posted
Count of Participants
Participants
through Week 10
ID
Title
Description
OG000
Brazikumab 720 mg
IV brazikumab 720 mg during induction period
OG001
Brazikumab 1440 mg
IV brazikumab 1440 mg during induction period
OG002
Brazikumab 2100 mg
IV brazikumab 2100 mg during induction period
OG003
Vedolizumab
IV vedolizumab 300 mg during induction period
OG004
Secondary
mMS Component Score: Rectal Bleeding (Induction)
Number of participants in each score category for Rectal bleeding
The efficacy analysis set includes subjects who had completed the induction period at time of study termination, or who would have had the opportunity to complete the induction period at the time of the termination if not prematurely discontinuing IP. The reason for excluding subjects was to avoid bias in the analysis.
Posted
Count of Participants
Participants
through Week 10
ID
Title
Description
OG000
Brazikumab 720 mg
IV brazikumab 720 mg during induction period
OG001
Brazikumab 1440 mg
IV brazikumab 1440 mg during induction period
OG002
Brazikumab 2100 mg
IV brazikumab 2100 mg during induction period
OG003
Vedolizumab
IV vedolizumab 300 mg during induction period
OG004
Secondary
Total mMS (Maintenance)
mMS total score at baseline and Week 54
The efficacy analysis set includes subjects who had completed the induction period at time of study termination, or who would have had the opportunity to complete the induction period at the time of the termination if not prematurely discontinuing IP. The reason for excluding subjects was to avoid bias in the analysis.
Posted
Mean
Standard Deviation
points
Week 54
ID
Title
Description
OG000
Brazikumab IV 720 mg/SC 120 mg (Maintenance Period)
IV brazikumab 720 mg during induction period, SC 120 mg during maintenance period
OG001
Brazikumab IV 720 mg/SC 240 mg (Maintenance Period)
IV brazikumab 720 mg during induction period, SC 240 mg during maintenance period
OG002
Brazikumab IV 1440 mg/SC 120 mg (Maintenance Period)
IV brazikumab 1440 mg during induction period, SC 120 mg during maintenance period
OG003
Brazikumab IV 1440 mg/SC 240 mg (Maintenance Period)
Secondary
mMS Component Score: Endoscopy (Maintenance)
Number of participants in each score category for Endoscopy score
The efficacy analysis set includes subjects who had completed the induction period at time of study termination, or who would have had the opportunity to complete the induction period at the time of the termination if not prematurely discontinuing IP. The reason for excluding subjects was to avoid bias in the analysis.
Posted
Count of Participants
Participants
through Week 54
ID
Title
Description
OG000
Brazikumab IV 720 mg/SC 120 mg (Maintenance Period))
IV brazikumab 720 mg during induction period, SC 120 mg during maintenance
OG001
Brazikumab IV 720 mg/SC 240 mg (Maintenance Period)
IV brazikumab 720 mg during induction period, SC 240 mg during maintenance
OG002
Brazikumab IV 1440 mg/SC 120 mg (Maintenance Period)
IV brazikumab 1440 mg during induction period, SC 120 mg during maintenance
OG003
Brazikumab IV 1440 mg/ SC 240 mg (Maintenance Period)
Secondary
mMS Component Score: Stool Frequency (Maintenance)
Number of participants in each score category for Stool frequency score
The efficacy analysis set includes subjects who had completed the induction period at time of study termination, or who would have had the opportunity to complete the induction period at the time of the termination if not prematurely discontinuing IP. The reason for excluding subjects was to avoid bias in the analysis.
Posted
Count of Participants
Participants
through Week 54
ID
Title
Description
OG000
Brazikumab IV 720 mg/SC 120 mg (Maintenance Period)
IV brazikumab 720 mg during induction period, SC 120 mg during maintenance
OG001
Brazikumab IV 720 mg/SC 240 mg (Maintenance Period)
IV brazikumab 720 mg during induction period, SC 240 mg during maintenance
OG002
Brazikumab IV 1440 mg/SC 120 mg (Maintenance Period)
IV brazikumab 1440 mg during induction period, SC 120 mg during maintenance
OG003
Brazikumab IV 1440 mg/ SC 240 mg (Maintenance Period)
Number of participants in each score category for Rectal bleeding score
The efficacy analysis set includes subjects who had completed the induction period at time of study termination, or who would have had the opportunity to complete the induction period at the time of the termination if not prematurely discontinuing IP. The reason for excluding subjects was to avoid bias in the analysis.
Posted
Count of Participants
Participants
through Week 54
ID
Title
Description
OG000
Brazikumab IV 720 mg/SC 120 mg (Maintenance Period)
IV brazikumab 720 mg during induction period, SC 120 mg during maintenance
OG001
Brazikumab IV 720 mg/SC 240 mg (Maintenance Period)
IV brazikumab 720 mg during induction period, SC 240 mg during maintenance
OG002
Brazikumab IV 1440 mg/SC 120 mg (Maintenance Period)
IV brazikumab 1440 mg during induction period, SC 120 mg during maintenance
OG003
Brazikumab IV 1440 mg/ SC 240 mg (Maintenance Period)
Time Frame
Through week 68: Induction period includes AE with an onset date on or after the date of first IV dose of IP up to the first dose of SC, or early termination treatment date + 18 weeks after the date of last dose. Maintenance period includes AE with an onset date on or after the date of first dose of SC up to and including 18 weeks after the date of last SC dose.
Description
Induction period is followed by maintenance. Patients were re-randomized after induction. Reporting is separate for periods and displayed side-by-side. Induction uses the Safety Population (patients who received ≥1 dose). Maintenance uses the Maintenance Period Population (MPP, patients who received ≥1 dose at or after Week 10). Thus, patients who receive the Week 10 dose (last induction visit) but discontinue treatment before first maintenance dose (but continue the study) are included in MPP.
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
Brazikumab 720 mg (Induction Period)
IV brazikumab 720 mg during induction period
0
73
3
73
31
73
EG001
Brazikumab 1440 mg (Induction Period))
IV brazikumab 1440 mg during induction period
0
73
2
73
33
73
EG002
Brazikumab 2100 mg (Induction Period)
IV brazikumab 2100 mg during induction period
0
10
0
10
7
10
EG003
Vedolizumab 300 mg (Induction Period)
IV Vedolizumab 300 mg during Induction period
0
10
0
10
5
10
EG004
Placebo (Induction Period)
IV placebo during induction period
0
71
4
71
24
71
EG005
Brazikumab 720 mg/120 mg (Maintenance Period)
IV brazikumab 720 mg during induction, SC brazikumab 120 mg during maintenance
0
31
0
31
16
31
EG006
Brazikumab 720 mg/240 mg (Maintenance Period)
IV brazikumab 720 mg during induction, SC brazikumab 240 mg during maintenance
0
28
0
28
5
28
EG007
Brazikumab 1440 mg/120 mg (Maintenance Period)
IV brazikumab 1440 mg during induction, SC brazikumab 120 mg during maintenance
0
31
1
31
16
31
EG008
Brazikumab 1440 mg/240 mg (Maintenance Period)
IV brazikumab 1440 mg during induction, SC brazikumab 240 mg during maintenance
0
31
0
31
15
31
EG009
Brazikumab 2100mg/140 mg (Maintenance Period)
IV brazikumab 2100 mg during induction period, SC brazikumab 120 mg during maintenance
0
6
0
6
5
6
EG010
Brazikumab 2100 mg/240 mg (Maintenance Period)
IV brazikumab 2100 mg during induction, SC brazikumab 240 mg during maintenance
0
4
0
4
3
4
EG011
Vedolizumab 300 mg (Maintenance Period)
IV vedolizumab 300 mg during induction and maintenance
0
9
0
9
5
9
EG012
Placebo (Maintenance Period)
Placebo during maintenance period
0
58
2
58
23
58
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Perirectal abscess
Infections and infestations
Systematic Assessment
EG0000 affected73 at risk
EG0011 affected73 at risk
EG0020 affected10 at risk
EG0030 affected10 at risk
EG0040 affected71 at risk
EG0050 affected31 at risk
EG0060 affected28 at risk
EG0070 affected31 at risk
EG0080 affected31 at risk
EG0090 affected6 at risk
EG0100 affected4 at risk
EG0110 affected9 at risk
EG0120 affected58 at risk
COVID-19
Infections and infestations
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected10 at risk
EG003
Anaemia
Blood and lymphatic system disorders
Systematic Assessment
EG0001 affected73 at risk
EG0010 affected73 at risk
EG0020 affected10 at risk
EG003
Microcytic anaemia
Blood and lymphatic system disorders
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected10 at risk
EG003
Cerebral artery stenosis
Nervous system disorders
Systematic Assessment
EG0001 affected73 at risk
EG0010 affected73 at risk
EG0020 affected10 at risk
EG003
Cerebrovascular accident
Nervous system disorders
Systematic Assessment
EG0001 affected73 at risk
EG0010 affected73 at risk
EG0020 affected10 at risk
EG003
Acute myocardial infarction
Cardiac disorders
Systematic Assessment
EG0000 affected73 at risk
EG0011 affected73 at risk
EG0020 affected10 at risk
EG003
Colitis ulcerative
Gastrointestinal disorders
Systematic Assessment
EG0001 affected73 at risk
EG0010 affected73 at risk
EG0020 affected10 at risk
EG003
Pancreatitis acute
Gastrointestinal disorders
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected10 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected10 at risk
EG003
Acetabulum fracture
Injury, poisoning and procedural complications
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected10 at risk
EG003
Fall
Injury, poisoning and procedural complications
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected10 at risk
EG003
Pelvic fracture
Injury, poisoning and procedural complications
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected10 at risk
EG003
Skull fracture
Injury, poisoning and procedural complications
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected10 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anal abscess
Infections and infestations
Systematic Assessment
EG0000 affected73 at risk
EG0011 affected73 at risk
EG0020 affected10 at risk
EG0030 affected10 at risk
EG0040 affected71 at risk
EG0050 affected31 at risk
EG0060 affected28 at risk
EG0070 affected31 at risk
EG0080 affected31 at risk
EG0090 affected6 at risk
EG0100 affected4 at risk
EG0110 affected9 at risk
EG0120 affected58 at risk
Bronchitis
Infections and infestations
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected10 at risk
EG003
COVID-19
Infections and infestations
Systematic Assessment
EG0008 affected73 at risk
EG0012 affected73 at risk
EG0020 affected10 at risk
EG003
Clostridium difficile infection
Infections and infestations
Systematic Assessment
EG0001 affected73 at risk
EG0010 affected73 at risk
EG0020 affected10 at risk
EG003
Diverticulitis
Infections and infestations
Systematic Assessment
EG0000 affected73 at risk
EG0011 affected73 at risk
EG0020 affected10 at risk
EG003
Folliculitis
Infections and infestations
Systematic Assessment
EG0000 affected73 at risk
EG0011 affected73 at risk
EG0020 affected10 at risk
EG003
Gastrointestinal infection
Infections and infestations
Systematic Assessment
EG0000 affected73 at risk
EG0011 affected73 at risk
EG0020 affected10 at risk
EG003
Herpes zoster
Infections and infestations
Systematic Assessment
EG0000 affected73 at risk
EG0011 affected73 at risk
EG0020 affected10 at risk
EG003
Impetigo
Infections and infestations
Systematic Assessment
EG0000 affected73 at risk
EG0011 affected73 at risk
EG0020 affected10 at risk
EG003
Nasopharyngitis
Infections and infestations
Systematic Assessment
EG0001 affected73 at risk
EG0013 affected73 at risk
EG0020 affected10 at risk
EG003
Oral herpes
Infections and infestations
Systematic Assessment
EG0002 affected73 at risk
EG0010 affected73 at risk
EG0020 affected10 at risk
EG003
Perirectal abscess
Infections and infestations
Systematic Assessment
EG0000 affected73 at risk
EG0011 affected73 at risk
EG0020 affected10 at risk
EG003
Pharyngitis
Infections and infestations
Systematic Assessment
EG0001 affected73 at risk
EG0010 affected73 at risk
EG0021 affected10 at risk
EG003
Pustule
Infections and infestations
Systematic Assessment
EG0000 affected73 at risk
EG0011 affected73 at risk
EG0020 affected10 at risk
EG003
Scarlet fever
Infections and infestations
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected10 at risk
EG003
Sinusitis
Infections and infestations
Systematic Assessment
EG0001 affected73 at risk
EG0011 affected73 at risk
EG0020 affected10 at risk
EG003
Upper respiratory tract infection
Infections and infestations
Systematic Assessment
EG0002 affected73 at risk
EG0014 affected73 at risk
EG0020 affected10 at risk
EG003
Urinary tract infection
Infections and infestations
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0021 affected10 at risk
EG003
Viral upper respiratory tract infection
Infections and infestations
Systematic Assessment
EG0002 affected73 at risk
EG0010 affected73 at risk
EG0020 affected10 at risk
EG003
Candida urethritis
Infections and infestations
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected10 at risk
EG003
Ear infection
Infections and infestations
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected10 at risk
EG003
Eye infection bacterial
Infections and infestations
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected10 at risk
EG003
Fungal infection
Infections and infestations
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected10 at risk
EG003
Cellulitis
Infections and infestations
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected10 at risk
EG003
Furuncle
Infections and infestations
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected10 at risk
EG003
Gastroenteritis
Infections and infestations
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected10 at risk
EG003
Influenza
Infections and infestations
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected10 at risk
EG003
Laryngopharyngitis
Infections and infestations
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected10 at risk
EG003
Onychomycosis
Infections and infestations
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected10 at risk
EG003
Periodontitis
Infections and infestations
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected10 at risk
EG003
Rhinitis
Infections and infestations
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected10 at risk
EG003
Skin infection
Infections and infestations
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected10 at risk
EG003
Tonsillitis
Infections and infestations
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected10 at risk
EG003
Upper respiratory tract infection bacterial
Infections and infestations
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected10 at risk
EG003
Viral infection
Infections and infestations
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected10 at risk
EG003
Uterine leiomyoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected10 at risk
EG003
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0001 affected73 at risk
EG0010 affected73 at risk
EG0020 affected10 at risk
EG003
Anaemia
Blood and lymphatic system disorders
Systematic Assessment
EG0001 affected73 at risk
EG0010 affected73 at risk
EG0020 affected10 at risk
EG003
Iron deficiency anaemia
Blood and lymphatic system disorders
Systematic Assessment
EG0000 affected73 at risk
EG0011 affected73 at risk
EG0020 affected10 at risk
EG003
Leukocytosis
Blood and lymphatic system disorders
Systematic Assessment
EG0000 affected73 at risk
EG0011 affected73 at risk
EG0020 affected10 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
Systematic Assessment
EG0001 affected73 at risk
EG0011 affected73 at risk
EG0020 affected10 at risk
EG003
Microcytic anaemia
Blood and lymphatic system disorders
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0021 affected10 at risk
EG003
Thrombocytosis
Blood and lymphatic system disorders
Systematic Assessment
EG0000 affected73 at risk
EG0011 affected73 at risk
EG0020 affected10 at risk
EG003
Lymphadenopathy
Blood and lymphatic system disorders
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected10 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected10 at risk
EG003
Drug hypersensitivity
Immune system disorders
Systematic Assessment
EG0000 affected73 at risk
EG0011 affected73 at risk
EG0021 affected10 at risk
EG003
Hypersensitivity
Immune system disorders
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected10 at risk
EG003
Adrenal insufficiency
Endocrine disorders
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected10 at risk
EG003
Secondary adrenocortical insufficiency
Endocrine disorders
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected10 at risk
EG003
Gout
Metabolism and nutrition disorders
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected10 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
Systematic Assessment
EG0000 affected73 at risk
EG0011 affected73 at risk
EG0020 affected10 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
Systematic Assessment
EG0000 affected73 at risk
EG0011 affected73 at risk
EG0020 affected10 at risk
EG003
Type 2 diabetes mellitus
Metabolism and nutrition disorders
Systematic Assessment
EG0000 affected73 at risk
EG0011 affected73 at risk
EG0020 affected10 at risk
EG003
Abnormal weight gain
Metabolism and nutrition disorders
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected10 at risk
EG003
Folate deficiency
Metabolism and nutrition disorders
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected10 at risk
EG003
Vitamin D deficiency
Metabolism and nutrition disorders
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected10 at risk
EG003
Anxiety disorder
Psychiatric disorders
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected10 at risk
EG003
Depressive symptom
Psychiatric disorders
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected10 at risk
EG003
Sleep disorder
Psychiatric disorders
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected10 at risk
EG003
Cerebral artery stenosis
Nervous system disorders
Systematic Assessment
EG0001 affected73 at risk
EG0010 affected73 at risk
EG0020 affected10 at risk
EG003
Cerebrovascular accident
Nervous system disorders
Systematic Assessment
EG0001 affected73 at risk
EG0010 affected73 at risk
EG0020 affected10 at risk
EG003
Disturbance in attention
Nervous system disorders
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0021 affected10 at risk
EG003
Dizziness
Nervous system disorders
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected10 at risk
EG003
Headache
Nervous system disorders
Systematic Assessment
EG0002 affected73 at risk
EG0012 affected73 at risk
EG0020 affected10 at risk
EG003
Loss of consciouness
Nervous system disorders
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0021 affected10 at risk
EG003
Migraine
Nervous system disorders
Systematic Assessment
EG0001 affected73 at risk
EG0011 affected73 at risk
EG0020 affected10 at risk
EG003
Neuropathy peripheral
Nervous system disorders
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected10 at risk
EG003
Sinus headache
Nervous system disorders
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected10 at risk
EG003
Tension headache
Nervous system disorders
Systematic Assessment
EG0001 affected73 at risk
EG0010 affected73 at risk
EG0020 affected10 at risk
EG003
Nerve compression
Nervous system disorders
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected10 at risk
EG003
Cataract
Eye disorders
Systematic Assessment
EG0000 affected73 at risk
EG0011 affected73 at risk
EG0020 affected10 at risk
EG003
Conjunctival hyperaemia
Eye disorders
Systematic Assessment
EG0000 affected73 at risk
EG0011 affected73 at risk
EG0020 affected10 at risk
EG003
Eye allergy
Eye disorders
Systematic Assessment
EG0001 affected73 at risk
EG0010 affected73 at risk
EG0020 affected10 at risk
EG003
Vision blurred
Eye disorders
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected10 at risk
EG003
Vitreous floaters
Eye disorders
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0021 affected10 at risk
EG003
Blepharospasm
Eye disorders
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected10 at risk
EG003
Dry eye
Eye disorders
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected10 at risk
EG003
Iritis
Eye disorders
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected10 at risk
EG003
Photopsia
Eye disorders
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected10 at risk
EG003
Vitreous detachment
Eye disorders
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected10 at risk
EG003
Acute myocardial infarction
Cardiac disorders
Systematic Assessment
EG0000 affected73 at risk
EG0011 affected73 at risk
EG0020 affected10 at risk
EG003
Sinus tachycardia
Cardiac disorders
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected10 at risk
EG003
Tachycardia paroxysmal
Cardiac disorders
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected10 at risk
EG003
Ventricular arrhythmia
Cardiac disorders
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected10 at risk
EG003
Catarrh
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0001 affected73 at risk
EG0010 affected73 at risk
EG0020 affected10 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected10 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0001 affected73 at risk
EG0010 affected73 at risk
EG0020 affected10 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 affected73 at risk
EG0011 affected73 at risk
EG0020 affected10 at risk
EG003
Upper respiratory tract congestion
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0021 affected10 at risk
EG003
Hypertension
Vascular disorders
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected10 at risk
EG003
Allergic bronchitis
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected10 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected10 at risk
EG003
Abdominal pain
Gastrointestinal disorders
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected10 at risk
EG003
Anorectal discomfort
Gastrointestinal disorders
Systematic Assessment
EG0000 affected73 at risk
EG0011 affected73 at risk
EG0020 affected10 at risk
EG003
Aphthous ulcer
Gastrointestinal disorders
Systematic Assessment
EG0001 affected73 at risk
EG0010 affected73 at risk
EG0020 affected10 at risk
EG003
Colitis ulcerative
Gastrointestinal disorders
Systematic Assessment
EG0001 affected73 at risk
EG0011 affected73 at risk
EG0021 affected10 at risk
EG003
Constipation
Gastrointestinal disorders
Systematic Assessment
EG0001 affected73 at risk
EG0011 affected73 at risk
EG0021 affected10 at risk
EG003
Dental caries
Gastrointestinal disorders
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected10 at risk
EG003
Diarrhoea
Gastrointestinal disorders
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0021 affected10 at risk
EG003
Diverticulum intestinal
Gastrointestinal disorders
Systematic Assessment
EG0000 affected73 at risk
EG0011 affected73 at risk
EG0020 affected10 at risk
EG003
Flatulence
Gastrointestinal disorders
Systematic Assessment
EG0001 affected73 at risk
EG0010 affected73 at risk
EG0020 affected10 at risk
EG003
Gastritis
Gastrointestinal disorders
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected10 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
Systematic Assessment
EG0001 affected73 at risk
EG0010 affected73 at risk
EG0020 affected10 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
Systematic Assessment
EG0003 affected73 at risk
EG0010 affected73 at risk
EG0020 affected10 at risk
EG003
Nausea
Gastrointestinal disorders
Systematic Assessment
EG0000 affected73 at risk
EG0011 affected73 at risk
EG0020 affected10 at risk
EG003
Pancreatitis
Gastrointestinal disorders
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected10 at risk
EG003
Pancreatitis acute
Gastrointestinal disorders
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected10 at risk
EG003
Peptic ulcer
Gastrointestinal disorders
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0021 affected10 at risk
EG003
Rectal haemorrhage
Gastrointestinal disorders
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected10 at risk
EG003
Vomiting
Gastrointestinal disorders
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected10 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected10 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected10 at risk
EG003
Anal fissure
Gastrointestinal disorders
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected10 at risk
EG003
Anal haemorrhage
Gastrointestinal disorders
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected10 at risk
EG003
Dyspepsia
Gastrointestinal disorders
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected10 at risk
EG003
Food poisoning
Gastrointestinal disorders
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected10 at risk
EG003
Glossodynia
Gastrointestinal disorders
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected10 at risk
EG003
Pancreatic duct dilation
Gastrointestinal disorders
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected10 at risk
EG003
Rectal tenesmus
Gastrointestinal disorders
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected10 at risk
EG003
Toothache
Gastrointestinal disorders
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected10 at risk
EG003
Hepatic steatosis
Hepatobiliary disorders
Systematic Assessment
EG0000 affected73 at risk
EG0011 affected73 at risk
EG0020 affected10 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected10 at risk
EG003
Drug-induced liver injury
Hepatobiliary disorders
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected10 at risk
EG003
Hepatic steatosis
Hepatobiliary disorders
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected10 at risk
EG003
Acne
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0002 affected73 at risk
EG0010 affected73 at risk
EG0020 affected10 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0001 affected73 at risk
EG0012 affected73 at risk
EG0020 affected10 at risk
EG003
Dermatitis allergic
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0001 affected73 at risk
EG0010 affected73 at risk
EG0020 affected10 at risk
EG003
Dermatitis atopic
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0000 affected73 at risk
EG0011 affected73 at risk
EG0020 affected10 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected10 at risk
EG003
Miliaria
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected10 at risk
EG003
Purpura
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0021 affected10 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0001 affected73 at risk
EG0010 affected73 at risk
EG0020 affected10 at risk
EG003
Rosacea
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0000 affected73 at risk
EG0011 affected73 at risk
EG0020 affected10 at risk
EG003
Dermatitis contact
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected10 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected10 at risk
EG003
Rash pruritic
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected10 at risk
EG003
Seborrhoeic dermatitis
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected10 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0002 affected73 at risk
EG0010 affected73 at risk
EG0021 affected10 at risk
EG003
Arthropathy
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0000 affected73 at risk
EG0011 affected73 at risk
EG0021 affected10 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0001 affected73 at risk
EG0010 affected73 at risk
EG0020 affected10 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0000 affected73 at risk
EG0011 affected73 at risk
EG0020 affected10 at risk
EG003
Sacral pain
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0001 affected73 at risk
EG0010 affected73 at risk
EG0020 affected10 at risk
EG003
Torticollis
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0001 affected73 at risk
EG0010 affected73 at risk
EG0020 affected10 at risk
EG003
Muscoskeletal stiffness
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected10 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected10 at risk
EG003
Plantar fasciitis
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected10 at risk
EG003
Spinal pain
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected10 at risk
EG003
Tendonitis
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected10 at risk
EG003
Acute kidney injury
Renal and urinary disorders
Systematic Assessment
EG0000 affected73 at risk
EG0011 affected73 at risk
EG0020 affected10 at risk
EG003
Micturition urgency
Renal and urinary disorders
Systematic Assessment
EG0001 affected73 at risk
EG0010 affected73 at risk
EG0020 affected10 at risk
EG003
Haematuria
Renal and urinary disorders
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected10 at risk
EG003
Proteinuria
Renal and urinary disorders
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected10 at risk
EG003
Prostatitis
Reproductive system and breast disorders
Systematic Assessment
EG0001 affected73 at risk
EG0010 affected73 at risk
EG0020 affected10 at risk
EG003
Amenorrhoea
Reproductive system and breast disorders
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected10 at risk
EG003
Asthenia
General disorders
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected10 at risk
EG003
Catheter site inflammation
General disorders
Systematic Assessment
EG0001 affected73 at risk
EG0010 affected73 at risk
EG0020 affected10 at risk
EG003
Fatigue
General disorders
Systematic Assessment
EG0001 affected73 at risk
EG0013 affected73 at risk
EG0022 affected10 at risk
EG003
Impaired healing
General disorders
Systematic Assessment
EG0000 affected73 at risk
EG0011 affected73 at risk
EG0020 affected10 at risk
EG003
Influenza like illness
General disorders
Systematic Assessment
EG0001 affected73 at risk
EG0010 affected73 at risk
EG0020 affected10 at risk
EG003
Infusion site phlebitis
General disorders
Systematic Assessment
EG0001 affected73 at risk
EG0010 affected73 at risk
EG0020 affected10 at risk
EG003
Infusion site swelling
General disorders
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected10 at risk
EG003
Malaise
General disorders
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected10 at risk
EG003
Pyrexia
General disorders
Systematic Assessment
EG0000 affected73 at risk
EG0011 affected73 at risk
EG0020 affected10 at risk
EG003
Tissue infiltration
General disorders
Systematic Assessment
EG0001 affected73 at risk
EG0010 affected73 at risk
EG0020 affected10 at risk
EG003
Vessel puncture site thrombosis
General disorders
Systematic Assessment
EG0001 affected73 at risk
EG0010 affected73 at risk
EG0020 affected10 at risk
EG003
Administration site reaction
General disorders
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected10 at risk
EG003
Injection site erythema
General disorders
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected10 at risk
EG003
Injection site pruritus
General disorders
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected10 at risk
EG003
Injection site reaction
General disorders
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected10 at risk
EG003
Injection site swelling
General disorders
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected10 at risk
EG003
Oedema peripheral
General disorders
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected10 at risk
EG003
Peripheral swelling
General disorders
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected10 at risk
EG003
Temperature intolerance
General disorders
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected10 at risk
EG003
Blood pressure increased
Investigations
Systematic Assessment
EG0000 affected73 at risk
EG0011 affected73 at risk
EG0020 affected10 at risk
EG003
Alanine aminotranferase increased
Investigations
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected10 at risk
EG003
Blood potassium increased
Investigations
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected10 at risk
EG003
Cardiac murmur
Investigations
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected10 at risk
EG003
Prostatic specific antigen increased
Investigations
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected10 at risk
EG003
Weight decreased
Investigations
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected10 at risk
EG003
Weight increased
Investigations
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected10 at risk
EG003
Contusion
Injury, poisoning and procedural complications
Systematic Assessment
EG0000 affected73 at risk
EG0011 affected73 at risk
EG0020 affected10 at risk
EG003
Fall
Injury, poisoning and procedural complications
Systematic Assessment
EG0000 affected73 at risk
EG0011 affected73 at risk
EG0021 affected10 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
Systematic Assessment
EG0001 affected73 at risk
EG0011 affected73 at risk
EG0020 affected10 at risk
EG003
Acetabulum fracture
Injury, poisoning and procedural complications
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected10 at risk
EG003
Chest injury
Injury, poisoning and procedural complications
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected10 at risk
EG003
Epicondylitis
Injury, poisoning and procedural complications
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected10 at risk
EG003
Hand fracture
Injury, poisoning and procedural complications
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected10 at risk
EG003
Ligament sprain
Injury, poisoning and procedural complications
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected10 at risk
EG003
Limb injury
Injury, poisoning and procedural complications
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected10 at risk
EG003
Pelvic fracture
Injury, poisoning and procedural complications
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected10 at risk
EG003
Skull fracture
Injury, poisoning and procedural complications
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected10 at risk
EG003
Toxicity to various agents
Injury, poisoning and procedural complications
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected10 at risk
EG003
Ulnar nerve injury
Injury, poisoning and procedural complications
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected10 at risk
EG003
Wound
Injury, poisoning and procedural complications
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected10 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected10 at risk
EG003
The study was early terminated and development of brazikumab stopped. Following cessation of development all study related dosing was immediately stopped. Site data cleaning engagement proved challenging. A patient centric approach was taken to focus data cleaning on key safety variables (adverse events). However, the database was locked with unclean data for the outcome measures. Please be aware that the data submitted needs to be considered with the data quality in mind.