Dose-Finding Study To Evaluate Safety, Tolerability, and... | NCT02322021 | Trialant
NCT02322021
Sponsor
Eisai Inc.
Status
Terminated
Last Update Posted
Mar 5, 2021Actual
Enrollment
70Actual
Phase
Phase 2
Conditions
Alzheimer Disease
Dementia, Alzheimer Type
Interventions
E2609
Placebo
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT02322021
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
E2609-G000-202
Secondary IDs
ID
Type
Description
Link
2014-002723-94
EudraCT Number
Brief Title
Dose-Finding Study To Evaluate Safety, Tolerability, and Efficacy of E2609 in Participants With Mild Cognitive Impairment Due to Alzheimer's Disease (Prodromal Alzheimer's Disease) and Mild to Moderate Dementia Due to Alzheimer's Disease
Official Title
A Placebo-Controlled, Double-Blind, Parallel-Group, Randomized, Proof-of-Concept, Dose-Finding Study To Evaluate Safety, Tolerability, and Efficacy of E2609 in Subjects With Mild Cognitive Impairment Due to Alzheimer's Disease (Prodromal Alzheimer's Disease) and Mild to Moderate Dementia Due to Alzheimer's Disease
Acronym
Not provided
Organization
Eisai Inc.INDUSTRY
Status Module
Record Verification Date
Mar 2021
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
This study was terminated early by the sponsor on the recommendation of an independent data safety monitoring board following review of unblinded data from the Phase 3 studies E2609-G000-301 (NCT02956486) and E2609-G000-302 (NCT03036280).
Expanded Access Info
No
Start Date
Nov 26, 2014Actual
Primary Completion Date
Dec 20, 2019Actual
Completion Date
Dec 20, 2019Actual
First Submitted Date
Dec 17, 2014
First Submission Date that Met QC Criteria
Dec 19, 2014
First Posted Date
Dec 22, 2014Estimated
Results Waived
Not provided
Results First Submitted Date
Jan 21, 2021
Results First Submitted that Met QC Criteria
Mar 4, 2021
Results First Posted Date
Mar 5, 2021Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Jun 7, 2019
Certification/Extension First Submitted that Passed QC Review
Jun 7, 2019
Certification/Extension First Posted Date
Jun 10, 2019Actual
Last Update Submitted Date
Mar 4, 2021
Last Update Posted Date
Mar 5, 2021Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Eisai Inc.INDUSTRY
Collaborators
Name
Class
Biogen
INDUSTRY
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
This is a Phase 2 study to evaluate safety and efficacy in participants with Mild Cognitive Impairment due to Alzheimer's Disease/Prodromal Alzheimer's Disease (referred to as MCI/Prodromal) and mild to moderate dementia due to Alzheimer's Disease (referred to as mild to moderate AD). This study will have a Core Phase and an Extension Phase.
Detailed Description
Not provided
Conditions Module
Conditions
Alzheimer Disease
Dementia, Alzheimer Type
Keywords
E2609
Mild Cognitive Impairment
Mild to Moderate Dementia
Alzheimer's Disease
Prodromal Alzheimer's Disease
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
70Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
MCI/Prodromal Cohort: Low Dose
Experimental
A low dose of E2609 will be assessed.
Drug: E2609
MCI/Prodromal Cohort: Middle Dose
Experimental
A middle dose of E2609 will be assessed.
Drug: E2609
MCI/Prodromal Cohort: High Dose
Experimental
A high dose of E2609 will be assessed.
Drug: E2609
MCI/Prodromal Cohort: Placebo
Placebo Comparator
Drug: Placebo
Mild to Moderate AD Cohort: Low Dose
Experimental
A low dose of E2609 will be assessed.
Drug: E2609
Mild to Moderate AD Cohort: High Dose
Experimental
A high dose of E2609 will be assessed.
Drug: E2609
Interventions
Name
Type
Description
Arm Group Labels
Other Names
E2609
Drug
Each participant will receive 2 tablets, which when combined will make up the required doses of E2609 or placebo, to be administered orally once per day (QD) with food.
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Core Phase: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
A TEAE is defined as an adverse event that emerges during treatment, having been absent at pre-treatment (Baseline) or re-emerges during treatment, having been present at pre-treatment (Baseline) but stopped before treatment, or worsens in severity during treatment relative to the pre-treatment state, when the adverse event is continuous.
Up to 21 months
Core Phase: Number of Participants With Serious Adverse Events (SAEs)
A SAE is any untoward medical occurrence that at any dose: results in death; is life-threatening (that is, the participant is at immediate risk of death from the adverse event as it occurs, this does not include an event that, has it occurred in a more severe form or is allowed to continue, might have cause death); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability or incapacity; is a congenital anomaly or birth defect (in the child of a participant who is exposed to the study drug).
Up to 21 months
Core Phase: Number of Participants With Treatment Emergent Markedly Abnormal Laboratory Safety Test Values
Up to 21 months
Core Phase: Number of Participants With Markedly Abnormal Vital Sign Values
Participants having no markedly abnormal vital sign values (no markedly abnormal high or no markedly abnormal low) in all core phase arms were not included in the data reported.
Core Phase: Number of Participants With Markedly Abnormal Electrocardiogram (ECG) Findings
Secondary Outcomes
Measure
Description
Time Frame
Core Phase: Percent Change From Baseline in Cerebrospinal Fluid (CSF) Amyloid (A) Beta(1-x) and Abeta(1-42) After 1 Month and 18 Months of Treatment
The measurement of the amyloid proteins Abeta(1-x) and Abeta(1-42), in CSF have been shown to be important biomarkers for alzheimer's disease.
Month 1 (Week 5) and Month 18 (Week 79)
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion criteria:
Participants must meet all of the following criteria to be included in this study:
Meets the core clinical research criteria of the National Institute on Aging-Alzheimer's Association (NIA-AA) for MCI due to AD (which is consistent with Prodromal AD) or AD dementia and is 'staged' or classified as either MCI or mild to moderate dementia.
Amyloid positive Positron Emission Tomography (PET) image based on centralized PET scan reading.
Male or female, age 50 to 85 years, inclusive at time of consent.
Must have an identified caregiver or informant who is willing and able to provide follow-up information on the participant throughout the course of the study.
If receiving an Acetylcholinesterase Inhibitor (AChEI) or memantine, must have been on a stable dose for at least 12 weeks before the Baseline cognitive assessments, with no plans for dose adjustment in the foreseeable future. Treatment-naive participants can be entered into the study but there should be no plans to initiate treatment with AChEIs or memantine at the time of entry into the study.
Must have been on stable doses of all other permitted chronically used concomitant medications (that is, not related to their cognitive decline) for at least 4 weeks before randomization.
Exclusion criteria:
Participants who meet any of the following criteria will be excluded from this study:
Any neurological condition that may be contributing to cognitive impairment above and beyond that caused by the participant's AD pathology, including any co-morbidities such as cerebrovascular disease, detected by medical history, neurological examination, or magnetic resonance imaging (MRI).
History of transient ischemic attacks or stroke within 12 months of Screening.
History of epilepsy.
Evidence of depression on a rating scale at Screening or any psychiatric diagnosis or symptoms, (example, hallucinations, major depression, etc.) that could confound the diagnosis or could interfere with study assessments or procedures. This includes suicidal ideation or suicidal behavior within 6 months prior to Screening, or hospitalization or treatment for suicidal behavior in the past 5 years.
Abnormally low serum vitamin B12.
Thyroid stimulating hormone above the normal range. This applies to all participants regardless of whether or not they are taking thyroid supplements.
Participants with liver disease (hepatic impairment), at Screening or Baseline. Participant with Gilbert's syndrome need not be excluded.
Not able to have a MRI, PET scanning, or cerebrospinal fluid (CSF) collection by Lumbar Puncture (LP).
Severe visual or hearing impairment that would prevent the participant from performing psychometric tests accurately.
History of immunodeficiency disorders.
Participants with chronic viral hepatitis.
History of Tuberculosis (TB). Participants with no history of TB will be tested for previous TB exposure and a positive test will be exclusionary.
History of ophthalmic shingles or ocular Herpes Simplex Virus (HSV) infection.
Any live vaccine in the 3 months or any active infection within the last 4 weeks before study drug administration (that is, randomization).
Any chronic inflammatory disease that is not adequately controlled or requires immunosuppressive or immunomodulatory therapy.
T helper cell, cytotoxic T cell, or B cell absolute counts below normal.
Immunoglobulin (Ig) IgG, IgA, or IgM levels below normal at Screening or Baseline, unless both the Investigator and the Medical Monitor agree that the finding is not clinically significant.
Clinically significant deviation from normal in physical examination, vital signs, or clinical laboratory tests at Screening or Baseline.
Exclusionary cardiac factors include: prolonged QT interval greater than 450 millisecond from Electrocardiograms (ECGs); history of risk factors for torsade de pointes or the use of concomitant medications that prolong the QT/corrected QT interval (QTc); left bundle branch block; persistent low or high heart rate; persistent low or high blood pressure; history of cardiac arrhythmias; other clinically significant ECG abnormalities.
Type 1 or Type 2 diabetes mellitus that is not well controlled.
Malignant neoplasms within 5 years before Screening (except for basal or squamous cell carcinoma in situ of the skin, or localized prostate cancer that did not require systemic therapy; these do not exclude the participant).
Medical conditions (example, cardiac, respiratory, gastrointestinal, renal disease) that are not stably controlled, or which, in the opinion of the investigator(s), could affect the participant's safety or interfere with the study assessments.
Hypopigmentation conditions (example, albinism and vitiligo).
Known or suspected history of drug or alcohol dependency or abuse within 2 years, current use of recreational drugs or a positive urine drug test.
Planned surgery that requires general, spinal, or epidural anesthesia that would take place during the study.
Participation in any other interventional clinical study related to cognitive impairment within 6 months before Screening unless it can be documented that the participant was in a placebo treatment arm.
Currently enrolled in another clinical study or used any investigational drug or device within 60 days or 5 half-lives of the investigational medication (whichever is longer) proceeding informed consent.
Hypersensitivity to the study drug or any of the excipients or to other Beta Secretase Cleaving Enzyme (BACE) inhibitors, or to the PET tracer, or components of its formulation.
Females who are lactating or pregnant. Females of childbearing potential who do not agree to adhere to the protocol specified methods for avoiding pregnancy.
Males who do not meet the protocol requirements for avoiding their partners becoming pregnant. Sperm donation is not permitted.
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
50 Years
Maximum Age
85 Years
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Not provided
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Bellflower
California
United States
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
A total of 444 participants were screened, of which 374 participants were screen failures and 70 participants were randomized and treated, out of which 43 participants completed the core phase and 41 participants entered the extension phase. No participant completed the extension phase. This study has Core Phase and an Extension Phase.
Recruitment Details
Participants took part in the study at 30 investigative sites in the United States from 26 November 2014 to 20 December 2019.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Core Phase: Placebo
Participants with mild cognitive impairment due to alzheimer's disease (AD)/prodromal AD and mild to moderate AD received two elenbecestat matched-placebo tablets, orally, once daily with food up to 18 months. Participants who completed 18 months treatment or who discontinued taking study drug prematurely were followed up to 3 months (12 weeks) after last dose of elenbecestat matched-placebo in core phase.
Periods
Title
Milestones
Reasons Not Completed
Core Phase
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
0
More Info Module
Limitations and Caveats
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
Dec 10, 2018
Jan 14, 2021
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
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
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Triple
Masking Description
Not provided
Who Masked
ParticipantCare ProviderInvestigator
Mild to Moderate AD Cohort: Placebo
Placebo Comparator
Drug: Placebo
Mild to Moderate AD cohort: Middle Dose
Experimental
A middle dose of E2609 will be assessed.
Drug: E2609
MCI/Prodromal Cohort: High Dose
MCI/Prodromal Cohort: Low Dose
MCI/Prodromal Cohort: Middle Dose
Mild to Moderate AD Cohort: High Dose
Mild to Moderate AD Cohort: Low Dose
Mild to Moderate AD cohort: Middle Dose
Placebo
Drug
Each participant will receive 2 tablets, which when combined will make up the required doses of E2609 or placebo, to be administered orally once per day (QD) with food.
MCI/Prodromal Cohort: Placebo
Mild to Moderate AD Cohort: Placebo
QTcF interval means corrected QT interval (QTc) calculated using Fridericia's formula.
Up to 21 months
Extension Phase: Number of Participants With TEAEs and SAEs
TEAE: adverse event that emerges during treatment, having been absent at pre-treatment or reemerges during treatment, having been present at pre-treatment but stopped before treatment, or worsens in severity during treatment relative to pre-treatment state. Number of participants with TEAEs were reported based on safety assessments of laboratory tests, physical examination, regular measurement of vital signs, magnetic resonance imaging and electrocardiogram parameter values. SAE: any untoward medical occurrence that at any dose: results in death; is life-threatening (immediate risk of death from adverse event, this does not include event that, had it occurred in more severe form or is allowed to continue, might have caused death); requires inpatient or prolongation of existing hospitalization; results in persistent/significant disability/incapacity; is congenital anomaly/birth defect (in child of participant exposed to drug). Number of participants with TEAEs and SAEs were reported.
Up to 34 months
Extension Phase: Number of Participants With Markedly Abnormal Vital Sign Values
Up to 34 months
Extension Phase: Number of Participants With Markedly Abnormal ECG Findings
QTcF interval means QTc interval calculated using Fridericia's formula.
Up to 34 months
Extension Phase: Number of Participants With Treatment Emergent Markedly Abnormal Laboratory Safety Test Values
Up to 34 months
Extension Phase: Number of Participants With Abnormal Magnetic Resonance Imaging (MRI) Findings
Brain MRIs are collected to assess for potential drug-related changes that might have constituted a safety concern. Safety brain MRI is assessed using a standardized procedure that included fluid-attenuated inversion recovery (FLAIR), gradient-echo, T1, and diffusion-weighted sequences to determine the presence of focal lesions including, but not limited to, evidence for ischemic and hemorrhagic stroke, subdural hematoma, neoplasm, arteriovenous malformation, micro and macrohemorrhages, superficial siderosis, lacunar infarcts, white matter abnormalities, and vasogenic edema. Participants with abnormal values related to safety brain MRI were reported.
Up to 34 months
Core Phase: Mean Concentration of Elenbecestat in CSF
Month 1 (Week 5) and Month 18 (Week 79)
Core Phase: Mean Concentration of Elenbecestat in Plasma
Extension Phase: Change From Extension Phase Baseline in the Mini-Mental State Examination (MMSE) Scores
MMSE is a 30-point scale that measures orientation to time and place, registration, immediate and delayed recall, attention, language, and drawing. Scores ranges from 0 (most impaired) to 30 (no impairment). Lower score indicates more impairment.
Baseline, at Month 3, at Month 6, at Month 9, at Month 12, at Month 15, at Month 18, at Month 21, at Month 24, at Month 28 and at Month 32
Extension Phase: Change From Extension Phase Baseline in the Functional Assessment Questionnaire (FAQ) Score
The FAQ has 10 items concerned with performing daily tasks necessary for independent living. The caregiver or informant provides performance ratings on 10 complex activities of daily living performed within the preceding 4 weeks. Score ranges from 0 (independent) to 30 (dependent). Lower score indicates that participant can live independently. Higher score indicates that participant cannot live independently.
Baseline, at Month 3, at Month 6, at Month 9, at Month 12, at Month 15, at Month 18, at Month 21, at Month 24, at Month 28 and at Month 32
Extension Phase: Percent Change From Extension Phase Baseline in Plasma Amyloid (A) Beta(1-x) Measurements at Months 12 and 24
The measurement of the amyloid protein Abeta(1-x), in plasma has been shown to be an important biomarker for alzheimer's disease.
Month 12 and Month 24
Extension Phase: Percent Change From Extension Phase Baseline in Total Hippocampal Volume at Month 24
Total hippocampal volume is measured by volumetric magnetic resonance imaging (vMRI). Volumetric imaging is a 3D technique where all the MRI signals are collected from the entire tissue sample and imaged as a whole entity, therefore providing a high signal to noise ratio. Total hippocampal volume is calculated by summing up right and left hippocampal volumes.
Month 24
Extension Phase: Percent Change From Extension Phase Baseline in Left and Right Hippocampal Volume at Month 24
Left and right hippocampal volume is measured by vMRI. Volumetric imaging is a 3D technique where all the MRI signals are collected from the entire tissue sample and imaged as a whole entity, therefore providing a high signal to noise ratio. Left and right hippocampal volumes represent a summary measure in the left and right hippocampal regions.
Month 24
Extension Phase: Percent Change From Extension Phase Baseline in Whole Brain Volume at Month 24
Whole brain volume is measured by vMRI. Volumetric imaging is a 3D technique where all the MRI signals are collected from the entire tissue sample and imaged as a whole entity, therefore providing a high signal to noise ratio. Whole brain volume represents a summary measure of total brain parenchyma which includes the cerebrum, basal ganglia, diencephalon, and cerebellum.
Month 24
Extension Phase: Percent Change From Extension Phase Baseline in Total Ventricular Volume at Month 24
Total Ventricular Volume is measured by vMRI. Volumetric imaging is a 3D technique where all the MRI signals are collected from the entire tissue sample and imaged as a whole entity, therefore providing a high signal to noise ratio. Total ventricular volume represents a summary measure of total including right and left lateral ventricles, third ventricle and fourth ventricle of brain.
Month 24
Costa Mesa
California
United States
Glendale
California
United States
Irvine
California
United States
Aventura
Florida
United States
Boca Raton
Florida
United States
Brooksville
Florida
United States
Lake Worth
Florida
United States
Orlando
Florida
United States
Port Charlotte
Florida
United States
Atlanta
Georgia
United States
Savannah
Georgia
United States
Wichita
Kansas
United States
Kalamazoo
Michigan
United States
Mount Arlington
New Jersey
United States
Scotch Plains
New Jersey
United States
Charlotte
North Carolina
United States
Dayton
Ohio
United States
Port Royal
South Carolina
United States
Dallas
Texas
United States
San Antonio
Texas
United States
FG001
Core Phase: Elenbecestat 5 mg Then 50 mg
Participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD received one elenbecestat 5 milligram (mg) tablet and one elenbecestat-matched placebo tablet (to maintain blinding), orally, once daily with food up to 18 months. Participants who remained on treatment were reassigned to elenbecestat 50 mg (two 25 mg tablets) if they had at least 3 months (12 weeks) of treatment remaining in the randomization phase (treatment and follow-up), orally, once daily with food up to 18 months. Participants who completed 18 months treatment or who discontinued taking study drug prematurely were followed up to 3 months (12 weeks) after last dose of elenbecestat in core phase.
FG002
Core Phase: Elenbecestat 15 mg Then 50 mg
Participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD received elenbecestat 15 mg (one 10 mg and one 5 mg tablets), orally, once daily with food up to 18 months. Participants who remained on treatment were reassigned to elenbecestat 50 mg (two 25 mg tablets) if they had at least 3 months (12 weeks) of treatment remaining in the randomization phase (treatment and follow-up), orally, once daily with food up to 18 months. Participants who completed 18 months treatment or who discontinued taking study drug prematurely were followed up to 3 months (12 weeks) after last dose of elenbecestat in core phase.
FG003
Core Phase: Elenbecestat 50 mg
Participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD received elenbecestat 50 mg (two 25 mg tablets), orally, once daily with food up to 18 months. Participants who completed 18 months treatment or who discontinued taking study drug prematurely were followed up to 3 months (12 weeks) after last dose of elenbecestat in core phase.
FG004
Extension Phase: Elenbecestat 50 mg
Eligible participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD who completed the core phase entered the extension phase and received one elenbecestat 50 mg tablet, orally, once daily with or without food until early discontinuation of study drug or early termination of the study, whichever occurred first. Participants were followed up to 3 months (12 weeks) after last dose of elenbecestat in extension phase.
FG00017 subjects
FG00117 subjects
FG00219 subjects
FG00317 subjects
FG0040 subjects
COMPLETED
FG00012 subjects
FG0019 subjects
FG00210 subjects
FG00312 subjects
FG0040 subjects
NOT COMPLETED
FG0005 subjects
FG0018 subjects
FG0029 subjects
FG0035 subjects
FG0040 subjects
Type
Comment
Reasons
Adverse Event
FG0001 subjects
FG0013 subjects
FG0024 subjects
FG0032 subjects
FG0040 subjects
Participant Choice
FG0004 subjects
FG0015 subjects
FG0024 subjects
FG0032 subjects
FG004
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Other
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Extension Phase
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG00441 subjectsParticipants who completed Core Phase, were eligible and gave consent, entered Extension Phase.
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
The safety analysis set was the group of participants who received at least 1 dose of study drug in the core phase and had at least 1 post-dose safety assessment.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Core Phase: Placebo
Participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD received two elenbecestat matched-placebo tablets, orally, once daily with food up to 18 months. Participants who completed 18 months treatment or who discontinued taking study drug prematurely were followed up to 3 months (12 weeks) after last dose of elenbecestat matched-placebo in core phase.
BG001
Core Phase: Elenbecestat 5 mg Then 50 mg
Participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD received one elenbecestat 5 mg tablet and one elenbecestat-matched placebo tablet (to maintain blinding), orally, once daily with food up to 18 months. Participants who remained on treatment were reassigned to elenbecestat 50 mg (two 25 mg tablets) if they had at least 3 months (12 weeks) of treatment remaining in the randomization phase (treatment and follow-up), orally, once daily with food up to 18 months. Participants who completed 18 months treatment or who discontinued taking study drug prematurely were followed up to 3 months (12 weeks) after last dose of elenbecestat in core phase.
BG002
Core Phase: Elenbecestat 15 mg Then 50 mg
Participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD received elenbecestat 15 mg (one 10 mg and one 5 mg tablets), orally, once daily with food up to 18 months. Participants who remained on treatment were reassigned to elenbecestat 50 mg (two 25 mg tablets) if they had at least 3 months (12 weeks) of treatment remaining in the randomization phase (treatment and follow-up), orally, once daily with food up to 18 months. Participants who completed 18 months treatment or who discontinued taking study drug prematurely were followed up to 3 months (12 weeks) after last dose of elenbecestat in core phase.
BG003
Core Phase: Elenbecestat 50 mg
Participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD received elenbecestat 50 mg (two 25 mg tablets), orally, once daily with food up to 18 months. Participants who completed 18 months treatment or who discontinued taking study drug prematurely were followed up to 3 months (12 weeks) after last dose of elenbecestat in core phase.
BG004
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00017
BG00117
BG00219
BG00317
BG00470
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Customized
Count of Participants
Participants
Title
Denominators
Categories
Less than or equal to (<=) 65 years
Title
Measurements
BG0004
BG0013
BG0022
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00011
BG0019
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0001
BG0010
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
Core Phase: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
A TEAE is defined as an adverse event that emerges during treatment, having been absent at pre-treatment (Baseline) or re-emerges during treatment, having been present at pre-treatment (Baseline) but stopped before treatment, or worsens in severity during treatment relative to the pre-treatment state, when the adverse event is continuous.
The safety analysis set was the group of participants who received at least 1 dose of study drug in the core phase and had at least 1 post-dose safety assessment.
Posted
Count of Participants
Participants
Up to 21 months
ID
Title
Description
OG000
Core Phase: Placebo
Participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD received two elenbecestat matched-placebo tablets, orally, once daily with food up to 18 months. Participants who completed 18 months treatment or who discontinued taking study drug prematurely were followed up to 3 months (12 weeks) after last dose of elenbecestat matched-placebo in core phase.
OG001
Core Phase: Elenbecestat 5 mg Then 50 mg
Participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD received one elenbecestat 5 mg tablet and one elenbecestat-matched placebo tablet (to maintain blinding), orally, once daily with food up to 18 months. Participants who remained on treatment were reassigned to elenbecestat 50 mg (two 25 mg tablets) if they had at least 3 months (12 weeks) of treatment remaining in the randomization phase (treatment and follow-up), orally, once daily with food up to 18 months. Participants who completed 18 months treatment or who discontinued taking study drug prematurely were followed up to 3 months (12 weeks) after last dose of elenbecestat in core phase.
OG002
Core Phase: Elenbecestat 15 mg Then 50 mg
Participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD received elenbecestat 15 mg (one 10 mg and one 5 mg tablets), orally, once daily with food up to 18 months. Participants who remained on treatment were reassigned to elenbecestat 50 mg (two 25 mg tablets) if they had at least 3 months (12 weeks) of treatment remaining in the randomization phase (treatment and follow-up), orally, once daily with food up to 18 months. Participants who completed 18 months treatment or who discontinued taking study drug prematurely were followed up to 3 months (12 weeks) after last dose of elenbecestat in core phase.
OG003
Core Phase: Elenbecestat 50 mg
Participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD received elenbecestat 50 mg (two 25 mg tablets), orally, once daily with food up to 18 months. Participants who completed 18 months treatment or who discontinued taking study drug prematurely were followed up to 3 months (12 weeks) after last dose of elenbecestat in core phase.
Units
Counts
Participants
OG00017
OG00117
OG00219
OG003
Title
Denominators
Categories
Title
Measurements
OG00015
OG00115
OG00218
OG003
Primary
Core Phase: Number of Participants With Serious Adverse Events (SAEs)
A SAE is any untoward medical occurrence that at any dose: results in death; is life-threatening (that is, the participant is at immediate risk of death from the adverse event as it occurs, this does not include an event that, has it occurred in a more severe form or is allowed to continue, might have cause death); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability or incapacity; is a congenital anomaly or birth defect (in the child of a participant who is exposed to the study drug).
The safety analysis set was the group of participants who received at least 1 dose of study drug in the core phase and had at least 1 post-dose safety assessment.
Posted
Count of Participants
Participants
Up to 21 months
ID
Title
Description
OG000
Core Phase: Placebo
Participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD received two elenbecestat matched-placebo tablets, orally, once daily with food up to 18 months. Participants who completed 18 months treatment or who discontinued taking study drug prematurely were followed up to 3 months (12 weeks) after last dose of elenbecestat matched-placebo in core phase.
OG001
Core Phase: Elenbecestat 5 mg Then 50 mg
Participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD received one elenbecestat 5 mg tablet and one elenbecestat-matched placebo tablet (to maintain blinding), orally, once daily with food up to 18 months. Participants who remained on treatment were reassigned to elenbecestat 50 mg (two 25 mg tablets) if they had at least 3 months (12 weeks) of treatment remaining in the randomization phase (treatment and follow-up), orally, once daily with food up to 18 months. Participants who completed 18 months treatment or who discontinued taking study drug prematurely were followed up to 3 months (12 weeks) after last dose of elenbecestat in core phase.
Primary
Core Phase: Number of Participants With Treatment Emergent Markedly Abnormal Laboratory Safety Test Values
The safety analysis set was the group of participants who received at least 1 dose of study drug in the core phase and had at least 1 post-dose safety assessment.
Posted
Count of Participants
Participants
Up to 21 months
ID
Title
Description
OG000
Core Phase: Placebo
Participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD received two elenbecestat matched-placebo tablets, orally, once daily with food up to 18 months. Participants who completed 18 months treatment or who discontinued taking study drug prematurely were followed up to 3 months (12 weeks) after last dose of elenbecestat matched-placebo in core phase.
OG001
Core Phase: Elenbecestat 5 mg Then 50 mg
Participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD received one elenbecestat 5 mg tablet and one elenbecestat-matched placebo tablet (to maintain blinding), orally, once daily with food up to 18 months. Participants who remained on treatment were reassigned to elenbecestat 50 mg (two 25 mg tablets) if they had at least 3 months (12 weeks) of treatment remaining in the randomization phase (treatment and follow-up), orally, once daily with food up to 18 months. Participants who completed 18 months treatment or who discontinued taking study drug prematurely were followed up to 3 months (12 weeks) after last dose of elenbecestat in core phase.
Primary
Core Phase: Number of Participants With Markedly Abnormal Vital Sign Values
Participants having no markedly abnormal vital sign values (no markedly abnormal high or no markedly abnormal low) in all core phase arms were not included in the data reported.
The safety analysis set was the group of participants who received at least 1 dose of study drug in the core phase and had at least 1 post-dose safety assessment. Here "number analyzed" signifies participants who were evaluable for this outcome measure for specific categories at given time points.
Participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD received two elenbecestat matched-placebo tablets, orally, once daily with food up to 18 months. Participants who completed 18 months treatment or who discontinued taking study drug prematurely were followed up to 3 months (12 weeks) after last dose of elenbecestat matched-placebo in core phase.
OG001
Core Phase: Elenbecestat 5 mg Then 50 mg
Participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD received one elenbecestat 5 mg tablet and one elenbecestat-matched placebo tablet (to maintain blinding), orally, once daily with food up to 18 months. Participants who remained on treatment were reassigned to elenbecestat 50 mg (two 25 mg tablets) if they had at least 3 months (12 weeks) of treatment remaining in the randomization phase (treatment and follow-up), orally, once daily with food up to 18 months. Participants who completed 18 months treatment or who discontinued taking study drug prematurely were followed up to 3 months (12 weeks) after last dose of elenbecestat in core phase.
Primary
Core Phase: Number of Participants With Markedly Abnormal Electrocardiogram (ECG) Findings
QTcF interval means corrected QT interval (QTc) calculated using Fridericia's formula.
The safety analysis set was the group of participants who received at least 1 dose of study drug in the core phase and had at least 1 post-dose safety assessment.
Posted
Count of Participants
Participants
Up to 21 months
ID
Title
Description
OG000
Core Phase: Placebo
Participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD received two elenbecestat matched-placebo tablets, orally, once daily with food up to 18 months. Participants who completed 18 months treatment or who discontinued taking study drug prematurely were followed up to 3 months (12 weeks) after last dose of elenbecestat matched-placebo in core phase.
OG001
Core Phase: Elenbecestat 5 mg Then 50 mg
Participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD received one elenbecestat 5 mg tablet and one elenbecestat-matched placebo tablet (to maintain blinding), orally, once daily with food up to 18 months. Participants who remained on treatment were reassigned to elenbecestat 50 mg (two 25 mg tablets) if they had at least 3 months (12 weeks) of treatment remaining in the randomization phase (treatment and follow-up), orally, once daily with food up to 18 months. Participants who completed 18 months treatment or who discontinued taking study drug prematurely were followed up to 3 months (12 weeks) after last dose of elenbecestat in core phase.
Primary
Extension Phase: Number of Participants With TEAEs and SAEs
TEAE: adverse event that emerges during treatment, having been absent at pre-treatment or reemerges during treatment, having been present at pre-treatment but stopped before treatment, or worsens in severity during treatment relative to pre-treatment state. Number of participants with TEAEs were reported based on safety assessments of laboratory tests, physical examination, regular measurement of vital signs, magnetic resonance imaging and electrocardiogram parameter values. SAE: any untoward medical occurrence that at any dose: results in death; is life-threatening (immediate risk of death from adverse event, this does not include event that, had it occurred in more severe form or is allowed to continue, might have caused death); requires inpatient or prolongation of existing hospitalization; results in persistent/significant disability/incapacity; is congenital anomaly/birth defect (in child of participant exposed to drug). Number of participants with TEAEs and SAEs were reported.
The safety analysis set was the group of participants who received at least 1 dose of study drug in the extension phase.
Posted
Count of Participants
Participants
Up to 34 months
ID
Title
Description
OG000
Extension Phase: Elenbecestat 50 mg
Eligible participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD who completed the core phase entered the extension phase and received one elenbecestat 50 mg tablet, orally, once daily with or without food until early discontinuation of study drug or early termination of the study, whichever occurred first. Participants were followed up to 3 months (12 weeks) after last dose of elenbecestat in extension phase.
Primary
Extension Phase: Number of Participants With Markedly Abnormal Vital Sign Values
The safety analysis set was the group of participants who received at least 1 dose of study drug in the extension phase.
Posted
Count of Participants
Participants
Up to 34 months
ID
Title
Description
OG000
Extension Phase: Elenbecestat 50 mg
Eligible participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD who completed the core phase entered the extension phase and received one elenbecestat 50 mg tablet, orally, once daily with or without food until early discontinuation of study drug or early termination of the study, whichever occurred first. Participants were followed up to 3 months (12 weeks) after last dose of elenbecestat in extension phase.
Units
Counts
Participants
OG000
Primary
Extension Phase: Number of Participants With Markedly Abnormal ECG Findings
QTcF interval means QTc interval calculated using Fridericia's formula.
The safety analysis set was the group of participants who received at least 1 dose of study drug in the extension phase.
Posted
Count of Participants
Participants
Up to 34 months
ID
Title
Description
OG000
Extension Phase: Elenbecestat 50 mg
Eligible participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD who completed the core phase entered the extension phase and received one elenbecestat 50 mg tablet, orally, once daily with or without food until early discontinuation of study drug or early termination of the study, whichever occurred first. Participants were followed up to 3 months (12 weeks) after last dose of elenbecestat in extension phase.
Units
Counts
Participants
OG000
Primary
Extension Phase: Number of Participants With Treatment Emergent Markedly Abnormal Laboratory Safety Test Values
The safety analysis set was the group of participants who received at least 1 dose of study drug in the extension phase.
Posted
Count of Participants
Participants
Up to 34 months
ID
Title
Description
OG000
Extension Phase: Elenbecestat 50 mg
Eligible participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD who completed the core phase entered the extension phase and received one elenbecestat 50 mg tablet, orally, once daily with or without food until early discontinuation of study drug or early termination of the study, whichever occurred first. Participants were followed up to 3 months (12 weeks) after last dose of elenbecestat in extension phase.
Units
Counts
Participants
OG000
Primary
Extension Phase: Number of Participants With Abnormal Magnetic Resonance Imaging (MRI) Findings
Brain MRIs are collected to assess for potential drug-related changes that might have constituted a safety concern. Safety brain MRI is assessed using a standardized procedure that included fluid-attenuated inversion recovery (FLAIR), gradient-echo, T1, and diffusion-weighted sequences to determine the presence of focal lesions including, but not limited to, evidence for ischemic and hemorrhagic stroke, subdural hematoma, neoplasm, arteriovenous malformation, micro and macrohemorrhages, superficial siderosis, lacunar infarcts, white matter abnormalities, and vasogenic edema. Participants with abnormal values related to safety brain MRI were reported.
The safety analysis set was the group of participants who received at least 1 dose of study drug in the extension phase. Here "number analyzed" signifies participants who were evaluable for this outcome measure for specific categories.
Posted
Count of Participants
Participants
Up to 34 months
ID
Title
Description
OG000
Extension Phase: Elenbecestat 50 mg
Eligible participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD who completed the core phase entered the extension phase and received one elenbecestat 50 mg tablet, orally, once daily with or without food until early discontinuation of study drug or early termination of the study, whichever occurred first. Participants were followed up to 3 months (12 weeks) after last dose of elenbecestat in extension phase.
Secondary
Core Phase: Percent Change From Baseline in Cerebrospinal Fluid (CSF) Amyloid (A) Beta(1-x) and Abeta(1-42) After 1 Month and 18 Months of Treatment
The measurement of the amyloid proteins Abeta(1-x) and Abeta(1-42), in CSF have been shown to be important biomarkers for alzheimer's disease.
The pharmacodynamic (PD) analysis set was the group of participants who had a baseline PD measurement and at least 1 post-dose PD measurement in the core phase. Here "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure. Here "number analyzed" signifies participants who were evaluable for this outcome measure for specific categories and timepoints.
Posted
Mean
Standard Deviation
percent change
Month 1 (Week 5) and Month 18 (Week 79)
ID
Title
Description
OG000
Core Phase: Placebo
Participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD received two elenbecestat matched-placebo tablets, orally, once daily with food up to 18 months. Participants who completed 18 months treatment or who discontinued taking study drug prematurely were followed up to 3 months (12 weeks) after last dose of elenbecestat matched-placebo in core phase.
OG001
Core Phase: Elenbecestat 5 mg Then 50 mg
Participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD received one elenbecestat 5 mg tablet and one elenbecestat-matched placebo tablet (to maintain blinding), orally, once daily with food up to 18 months. Participants who remained on treatment were reassigned to elenbecestat 50 mg (two 25 mg tablets) if they had at least 3 months (12 weeks) of treatment remaining in the randomization phase (treatment and follow-up), orally, once daily with food up to 18 months. Participants who completed 18 months treatment or who discontinued taking study drug prematurely were followed up to 3 months (12 weeks) after last dose of elenbecestat in core phase.
Secondary
Core Phase: Mean Concentration of Elenbecestat in CSF
The pharmacokinetic (PK) analysis set was the group of participants with at least 1 quantifiable elenbecestat plasma concentration accompanied by a documented dosing history in the core phase. Here "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure. Here "number analyzed" signifies participants who were evaluable for this outcome measure at given time points.
Posted
Mean
Standard Deviation
nanogram per milliliter (ng/mL)
Month 1 (Week 5) and Month 18 (Week 79)
ID
Title
Description
OG000
Core Phase: Elenbecestat 5 mg Then 50 mg
Participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD received one elenbecestat 5 mg tablet and one elenbecestat-matched placebo tablet (to maintain blinding), orally, once daily with food up to 18 months. Participants who remained on treatment were reassigned to elenbecestat 50 mg (two 25 mg tablets) if they had at least 3 months (12 weeks) of treatment remaining in the randomization phase (treatment and follow-up), orally, once daily with food up to 18 months. Participants who completed 18 months treatment or who discontinued taking study drug prematurely were followed up to 3 months (12 weeks) after last dose of elenbecestat in core phase.
OG001
Core Phase: Elenbecestat 15 mg Then 50 mg
Participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD received elenbecestat 15 mg (one 10 mg and one 5 mg tablets), orally, once daily with food up to 18 months. Participants who remained on treatment were reassigned to elenbecestat 50 mg (two 25 mg tablets) if they had at least 3 months (12 weeks) of treatment remaining in the randomization phase (treatment and follow-up), orally, once daily with food up to 18 months. Participants who completed 18 months treatment or who discontinued taking study drug prematurely were followed up to 3 months (12 weeks) after last dose of elenbecestat in core phase.
Secondary
Core Phase: Mean Concentration of Elenbecestat in Plasma
The PK analysis set was the group of participants with at least 1 quantifiable elenbecestat plasma concentration accompanied by a documented dosing history in the core phase. Here "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure. Here "number analyzed" signifies participants who were evaluable for this outcome measure at given time points.
Participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD received one elenbecestat 5 mg tablet and one elenbecestat-matched placebo tablet (to maintain blinding), orally, once daily with food up to 18 months. Participants who remained on treatment were reassigned to elenbecestat 50 mg (two 25 mg tablets) if they had at least 3 months (12 weeks) of treatment remaining in the randomization phase (treatment and follow-up), orally, once daily with food up to 18 months. Participants who completed 18 months treatment or who discontinued taking study drug prematurely were followed up to 3 months (12 weeks) after last dose of elenbecestat in core phase.
OG001
Core Phase: Elenbecestat 15 mg Then 50 mg
Participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD received elenbecestat 15 mg (one 10 mg and one 5 mg tablets), orally, once daily with food up to 18 months. Participants who remained on treatment were reassigned to elenbecestat 50 mg (two 25 mg tablets) if they had at least 3 months (12 weeks) of treatment remaining in the randomization phase (treatment and follow-up), orally, once daily with food up to 18 months. Participants who completed 18 months treatment or who discontinued taking study drug prematurely were followed up to 3 months (12 weeks) after last dose of elenbecestat in core phase.
Secondary
Extension Phase: Change From Extension Phase Baseline in the Mini-Mental State Examination (MMSE) Scores
MMSE is a 30-point scale that measures orientation to time and place, registration, immediate and delayed recall, attention, language, and drawing. Scores ranges from 0 (most impaired) to 30 (no impairment). Lower score indicates more impairment.
The full analysis set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose efficacy assessment in the extension phase. Here "number analyzed" signifies participants who were evaluable for this outcome measure at given time points.
Posted
Mean
Standard Deviation
score on a scale
Baseline, at Month 3, at Month 6, at Month 9, at Month 12, at Month 15, at Month 18, at Month 21, at Month 24, at Month 28 and at Month 32
ID
Title
Description
OG000
Extension Phase: Elenbecestat 50 mg
Eligible participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD who completed the core phase entered the extension phase and received one elenbecestat 50 mg tablet, orally, once daily with or without food until early discontinuation of study drug or early termination of the study, whichever occurred first. Participants were followed up to 3 months (12 weeks) after last dose of elenbecestat in extension phase.
Units
Counts
Participants
Secondary
Extension Phase: Change From Extension Phase Baseline in the Functional Assessment Questionnaire (FAQ) Score
The FAQ has 10 items concerned with performing daily tasks necessary for independent living. The caregiver or informant provides performance ratings on 10 complex activities of daily living performed within the preceding 4 weeks. Score ranges from 0 (independent) to 30 (dependent). Lower score indicates that participant can live independently. Higher score indicates that participant cannot live independently.
The full analysis set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose efficacy assessment in the extension phase. Here "number analyzed" signifies participants who were evaluable for this outcome measure at given time points.
Posted
Mean
Standard Deviation
score on a scale
Baseline, at Month 3, at Month 6, at Month 9, at Month 12, at Month 15, at Month 18, at Month 21, at Month 24, at Month 28 and at Month 32
ID
Title
Description
OG000
Extension Phase: Elenbecestat 50 mg
Eligible participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD who completed the core phase entered the extension phase and received one elenbecestat 50 mg tablet, orally, once daily with or without food until early discontinuation of study drug or early termination of the study, whichever occurred first. Participants were followed up to 3 months (12 weeks) after last dose of elenbecestat in extension phase.
Secondary
Extension Phase: Percent Change From Extension Phase Baseline in Plasma Amyloid (A) Beta(1-x) Measurements at Months 12 and 24
The measurement of the amyloid protein Abeta(1-x), in plasma has been shown to be an important biomarker for alzheimer's disease.
The PD analysis set was the group of participants who had at least 1 post-treatment PD measurement in the extension phase. Here "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure. Here "number analyzed" signifies participants who were evaluable for this outcome measure at given time points.
Posted
Mean
Standard Deviation
percent change
Month 12 and Month 24
ID
Title
Description
OG000
Extension Phase: Elenbecestat 50 mg
Eligible participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD who completed the core phase entered the extension phase and received one elenbecestat 50 mg tablet, orally, once daily with or without food until early discontinuation of study drug or early termination of the study, whichever occurred first. Participants were followed up to 3 months (12 weeks) after last dose of elenbecestat in extension phase.
Units
Counts
Participants
Secondary
Extension Phase: Percent Change From Extension Phase Baseline in Total Hippocampal Volume at Month 24
Total hippocampal volume is measured by volumetric magnetic resonance imaging (vMRI). Volumetric imaging is a 3D technique where all the MRI signals are collected from the entire tissue sample and imaged as a whole entity, therefore providing a high signal to noise ratio. Total hippocampal volume is calculated by summing up right and left hippocampal volumes.
The full analysis set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose efficacy assessment in the extension phase. Here "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure.
Posted
Mean
Standard Deviation
percent change
Month 24
ID
Title
Description
OG000
Extension Phase: Elenbecestat 50 mg
Eligible participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD who completed the core phase entered the extension phase and received one elenbecestat 50 mg tablet, orally, once daily with or without food until early discontinuation of study drug or early termination of the study, whichever occurred first. Participants were followed up to 3 months (12 weeks) after last dose of elenbecestat in extension phase.
Units
Counts
Participants
Secondary
Extension Phase: Percent Change From Extension Phase Baseline in Left and Right Hippocampal Volume at Month 24
Left and right hippocampal volume is measured by vMRI. Volumetric imaging is a 3D technique where all the MRI signals are collected from the entire tissue sample and imaged as a whole entity, therefore providing a high signal to noise ratio. Left and right hippocampal volumes represent a summary measure in the left and right hippocampal regions.
The full analysis set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose efficacy assessment in the extension phase. Here "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure.
Posted
Mean
Standard Deviation
percent change
Month 24
ID
Title
Description
OG000
Extension Phase: Elenbecestat 50 mg
Eligible participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD who completed the core phase entered the extension phase and received one elenbecestat 50 mg tablet, orally, once daily with or without food until early discontinuation of study drug or early termination of the study, whichever occurred first. Participants were followed up to 3 months (12 weeks) after last dose of elenbecestat in extension phase.
Units
Counts
Participants
Secondary
Extension Phase: Percent Change From Extension Phase Baseline in Whole Brain Volume at Month 24
Whole brain volume is measured by vMRI. Volumetric imaging is a 3D technique where all the MRI signals are collected from the entire tissue sample and imaged as a whole entity, therefore providing a high signal to noise ratio. Whole brain volume represents a summary measure of total brain parenchyma which includes the cerebrum, basal ganglia, diencephalon, and cerebellum.
The full analysis set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose efficacy assessment in the extension phase. Here "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure.
Posted
Mean
Standard Deviation
percent change
Month 24
ID
Title
Description
OG000
Extension Phase: Elenbecestat 50 mg
Eligible participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD who completed the core phase entered the extension phase and received one elenbecestat 50 mg tablet, orally, once daily with or without food until early discontinuation of study drug or early termination of the study, whichever occurred first. Participants were followed up to 3 months (12 weeks) after last dose of elenbecestat in extension phase.
Units
Counts
Participants
Secondary
Extension Phase: Percent Change From Extension Phase Baseline in Total Ventricular Volume at Month 24
Total Ventricular Volume is measured by vMRI. Volumetric imaging is a 3D technique where all the MRI signals are collected from the entire tissue sample and imaged as a whole entity, therefore providing a high signal to noise ratio. Total ventricular volume represents a summary measure of total including right and left lateral ventricles, third ventricle and fourth ventricle of brain.
The full analysis set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose efficacy assessment in the extension phase. Here "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure.
Posted
Mean
Standard Deviation
percent change
Month 24
ID
Title
Description
OG000
Extension Phase: Elenbecestat 50 mg
Eligible participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD who completed the core phase entered the extension phase and received one elenbecestat 50 mg tablet, orally, once daily with or without food until early discontinuation of study drug or early termination of the study, whichever occurred first. Participants were followed up to 3 months (12 weeks) after last dose of elenbecestat in extension phase.
Units
Counts
Participants
Time Frame
Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Description
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
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
Core Phase: Placebo
Participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD received two elenbecestat matched-placebo tablets, orally, once daily with food up to 18 months. Participants who completed 18 months treatment or who discontinued taking study drug prematurely were followed up to 3 months (12 weeks) after last dose of elenbecestat matched-placebo in core phase.
0
17
2
17
15
17
EG001
Core Phase: Elenbecestat 5 mg Then 50 mg
Participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD received one elenbecestat 5 mg tablet and one elenbecestat-matched placebo tablet (to maintain blinding), orally, once daily with food up to 18 months. Participants who remained on treatment were reassigned to elenbecestat 50 mg (two 25 mg tablets) if they had at least 3 months (12 weeks) of treatment remaining in the randomization phase (treatment and follow-up), orally, once daily with food up to 18 months. Participants who completed 18 months treatment or who discontinued taking study drug prematurely were followed up to 3 months (12 weeks) after last dose of elenbecestat in core phase.
0
17
2
17
15
17
EG002
Core Phase: Elenbecestat 15 mg Then 50 mg
Participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD received elenbecestat 15 mg (one 10 mg and one 5 mg tablets), orally, once daily with food up to 18 months. Participants who remained on treatment were reassigned to elenbecestat 50 mg (two 25 mg tablets) if they had at least 3 months (12 weeks) of treatment remaining in the randomization phase (treatment and follow-up), orally, once daily with food up to 18 months. Participants who completed 18 months treatment or who discontinued taking study drug prematurely were followed up to 3 months (12 weeks) after last dose of elenbecestat in core phase.
0
19
5
19
18
19
EG003
Core Phase: Elenbecestat 50 mg
Participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD received elenbecestat 50 mg (two 25 mg tablets), orally, once daily with food up to 18 months. Participants who completed 18 months treatment or who discontinued taking study drug prematurely were followed up to 3 months (12 weeks) after last dose of elenbecestat in core phase.
0
17
1
17
15
17
EG004
Extension Phase: Elenbecestat 50 mg
Eligible participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD who completed the core phase entered the extension phase and received one elenbecestat 50 mg tablet, orally, once daily with or without food until early discontinuation of study drug or early termination of the study, whichever occurred first. Participants were followed up to 3 months (12 weeks) after last dose of elenbecestat in extension phase.
1
41
6
41
30
41
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Appendicitis
Infections and infestations
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected19 at risk
EG0031 events1 affected17 at risk
EG0040 events0 affected41 at risk
Influenza
Infections and infestations
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected17 at risk
EG0021 events1 affected19 at risk
EG003
Cellulitis
Infections and infestations
MedDRA (22.0)
Systematic Assessment
EG0001 events1 affected17 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Localised infection
Infections and infestations
MedDRA (22.0)
Systematic Assessment
EG0001 events1 affected17 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Syncope
Nervous system disorders
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0012 events1 affected17 at risk
EG0021 events1 affected19 at risk
EG003
Major depression
Psychiatric disorders
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected17 at risk
EG0021 events1 affected19 at risk
EG003
Affective disorder
Infections and infestations
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected17 at risk
EG0021 events1 affected19 at risk
EG003
Agitation
Psychiatric disorders
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected17 at risk
EG0021 events1 affected19 at risk
EG003
Neuropsychiatric symptoms
Psychiatric disorders
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected17 at risk
EG0021 events1 affected19 at risk
EG003
Angina pectoris
Cardiac disorders
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0011 events1 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Chest pain
General disorders
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected17 at risk
EG0021 events1 affected19 at risk
EG003
Rib fracture
Injury, poisoning and procedural complications
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected17 at risk
EG0021 events1 affected19 at risk
EG003
Spinal column stenosis
Musculoskeletal and connective tissue disorders
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected17 at risk
EG0021 events1 affected19 at risk
EG003
Delusion
Psychiatric disorders
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected17 at risk
EG0021 events1 affected19 at risk
EG003
Meningoencephalitis viral
Infections and infestations
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Pneumonia
Infections and infestations
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Pneumonia viral
Infections and infestations
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Dementia Alzheimer's type
Nervous system disorders
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Encephalopathy
Nervous system disorders
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Asthenia
General disorders
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Delirium
Psychiatric disorders
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Diverticulum Intestinal Haemorrhagic
Gastrointestinal disorders
MedDRA (22.0)
Systematic Assessment
EG0001 events1 affected17 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Wound Infection
Infections and infestations
MedDRA (22.0)
Systematic Assessment
EG0001 events1 affected17 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Leukopenia
Blood and lymphatic system disorders
MedDRA (22.0)
Systematic Assessment
EG0002 events1 affected17 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected19 at risk
EG0030 events0 affected17 at risk
EG0040 events0 affected41 at risk
Neutropenia
Blood and lymphatic system disorders
MedDRA (22.0)
Systematic Assessment
EG0002 events1 affected17 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Atrioventricular Block Second Degree
Cardiac disorders
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0012 events1 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Cardiac Failure Congestive
Cardiac disorders
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected17 at risk
EG0021 events1 affected19 at risk
EG003
Cardiomegaly
Cardiac disorders
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected17 at risk
EG0021 events1 affected19 at risk
EG003
Heart Valve Incompetence
Cardiac disorders
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected17 at risk
EG0021 events1 affected19 at risk
EG003
Heart Valve Stenosis
Cardiac disorders
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected17 at risk
EG0021 events1 affected19 at risk
EG003
Right Ventricular Enlargement
Cardiac disorders
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected17 at risk
EG0021 events1 affected19 at risk
EG003
Sinus Bradycardia
Cardiac disorders
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Ventricular Extrasystoles
Cardiac disorders
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected17 at risk
EG0021 events1 affected19 at risk
EG003
Cerumen Impaction
Ear and labyrinth disorders
MedDRA (22.0)
Systematic Assessment
EG0001 events1 affected17 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0011 events1 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Dry Eye
Eye disorders
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0011 events1 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Ocular Rosacea
Eye disorders
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0011 events1 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Vision Blurred
Eye disorders
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected17 at risk
EG0021 events1 affected19 at risk
EG003
Visual Impairment
Eye disorders
MedDRA (22.0)
Systematic Assessment
EG0001 events1 affected17 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Abdominal Pain
Gastrointestinal disorders
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Abdominal Pain Upper
Gastrointestinal disorders
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0011 events1 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Anal Incontinence
Gastrointestinal disorders
MedDRA (22.0)
Systematic Assessment
EG0001 events1 affected17 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Colitis Microscopic
Gastrointestinal disorders
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0011 events1 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA (22.0)
Systematic Assessment
EG0001 events1 affected17 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0012 events2 affected17 at risk
EG0021 events1 affected19 at risk
EG003
Dry Mouth
Gastrointestinal disorders
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Intra-Abdominal Haematoma
Gastrointestinal disorders
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected17 at risk
EG0021 events1 affected19 at risk
EG003
Lip Swelling
Gastrointestinal disorders
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0011 events1 affected17 at risk
EG0021 events1 affected19 at risk
EG003
Peritoneal Disorder
Gastrointestinal disorders
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA (22.0)
Systematic Assessment
EG0001 events1 affected17 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Asthenia
General disorders
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected17 at risk
EG0021 events1 affected19 at risk
EG003
Breast Complication Associated With Device
General disorders
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Fatigue
General disorders
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected17 at risk
EG0023 events3 affected19 at risk
EG003
Gait Disturbance
General disorders
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Oedema Peripheral
General disorders
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected17 at risk
EG0022 events2 affected19 at risk
EG003
Peripheral Swelling
General disorders
MedDRA (22.0)
Systematic Assessment
EG0001 events1 affected17 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA (22.0)
Systematic Assessment
EG0001 events1 affected17 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Hepatic Steatosis
Hepatobiliary disorders
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Seasonal Allergy
Immune system disorders
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected17 at risk
EG0021 events1 affected19 at risk
EG003
Bronchitis
Infections and infestations
MedDRA (22.0)
Systematic Assessment
EG0001 events1 affected17 at risk
EG0011 events1 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Diverticulitis
Infections and infestations
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Fungal Skin Infection
Infections and infestations
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0011 events1 affected17 at risk
EG0021 events1 affected19 at risk
EG003
Furuncle
Infections and infestations
MedDRA (22.0)
Systematic Assessment
EG0001 events1 affected17 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Gastroenteritis Viral
Infections and infestations
MedDRA (22.0)
Systematic Assessment
EG0001 events1 affected17 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Gastrointestinal Viral Infection
Infections and infestations
MedDRA (22.0)
Systematic Assessment
EG0001 events1 affected17 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Influenza
Infections and infestations
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected17 at risk
EG0021 events1 affected19 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA (22.0)
Systematic Assessment
EG0001 events1 affected17 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Oral Herpes
Infections and infestations
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0011 events1 affected17 at risk
EG0021 events1 affected19 at risk
EG003
Rhinitis
Infections and infestations
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Scrotal Infection
Infections and infestations
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0011 events1 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Sinusitis
Infections and infestations
MedDRA (22.0)
Systematic Assessment
EG0001 events1 affected17 at risk
EG0012 events2 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Tooth Abscess
Infections and infestations
MedDRA (22.0)
Systematic Assessment
EG0001 events1 affected17 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Upper Respiratory Tract Infection
Infections and infestations
MedDRA (22.0)
Systematic Assessment
EG0006 events4 affected17 at risk
EG0014 events4 affected17 at risk
EG0021 events1 affected19 at risk
EG003
Urinary Tract Infection
Infections and infestations
MedDRA (22.0)
Systematic Assessment
EG0002 events2 affected17 at risk
EG0014 events2 affected17 at risk
EG0023 events1 affected19 at risk
EG003
Viral Upper Respiratory Tract Infection
Infections and infestations
MedDRA (22.0)
Systematic Assessment
EG0002 events1 affected17 at risk
EG0010 events0 affected17 at risk
EG0021 events1 affected19 at risk
EG003
Vulvovaginal Candidiasis
Infections and infestations
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0011 events1 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Vulvovaginal Mycotic Infection
Infections and infestations
MedDRA (22.0)
Systematic Assessment
EG0001 events1 affected17 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Wound Infection
Infections and infestations
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected17 at risk
EG0021 events1 affected19 at risk
EG003
Accidental Overdose
Injury, poisoning and procedural complications
MedDRA (22.0)
Systematic Assessment
EG0002 events1 affected17 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Arthropod Bite
Injury, poisoning and procedural complications
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0011 events1 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Arthropod Sting
Injury, poisoning and procedural complications
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0011 events1 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0011 events1 affected17 at risk
EG0021 events1 affected19 at risk
EG003
Facial Bones Fracture
Injury, poisoning and procedural complications
MedDRA (22.0)
Systematic Assessment
EG0001 events1 affected17 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA (22.0)
Systematic Assessment
EG0002 events1 affected17 at risk
EG0011 events1 affected17 at risk
EG0022 events2 affected19 at risk
EG003
Foot Fracture
Injury, poisoning and procedural complications
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected17 at risk
EG0021 events1 affected19 at risk
EG003
Head Injury
Injury, poisoning and procedural complications
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Laceration
Injury, poisoning and procedural complications
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0011 events1 affected17 at risk
EG0022 events2 affected19 at risk
EG003
Ligament Sprain
Injury, poisoning and procedural complications
MedDRA (22.0)
Systematic Assessment
EG0001 events1 affected17 at risk
EG0011 events1 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Muscle Strain
Injury, poisoning and procedural complications
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Skin Abrasion
Injury, poisoning and procedural complications
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0011 events1 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Wrist Fracture
Injury, poisoning and procedural complications
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected17 at risk
EG0021 events1 affected19 at risk
EG003
B-Lymphocyte Count Decreased
Investigations
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected17 at risk
EG0021 events1 affected19 at risk
EG003
Bacterial Test Positive
Investigations
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Blood Calcium Decreased
Investigations
MedDRA (22.0)
Systematic Assessment
EG0001 events1 affected17 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Blood Cholesterol Increased
Investigations
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Blood Creatinine Increased
Investigations
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0011 events1 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Blood Glucose Increased
Investigations
MedDRA (22.0)
Systematic Assessment
EG0001 events1 affected17 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Blood Immunoglobulin G Increased
Investigations
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Blood Potassium Decreased
Investigations
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected17 at risk
EG0021 events1 affected19 at risk
EG003
Blood Potassium Increased
Investigations
MedDRA (22.0)
Systematic Assessment
EG0001 events1 affected17 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Blood Pressure Decreased
Investigations
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Blood Pressure Increased
Investigations
MedDRA (22.0)
Systematic Assessment
EG0001 events1 affected17 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Blood Sodium Increased
Investigations
MedDRA (22.0)
Systematic Assessment
EG0001 events1 affected17 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Cd4 Lymphocytes Decreased
Investigations
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Cd8 Lymphocytes Decreased
Investigations
MedDRA (22.0)
Systematic Assessment
EG0004 events2 affected17 at risk
EG0010 events0 affected17 at risk
EG0021 events1 affected19 at risk
EG003
Glomerular Filtration Rate Decreased
Investigations
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0011 events1 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Lymphocyte Count Decreased
Investigations
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0011 events1 affected17 at risk
EG0021 events1 affected19 at risk
EG003
Monocyte Count Increased
Investigations
MedDRA (22.0)
Systematic Assessment
EG0001 events1 affected17 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Neurological Examination Abnormal
Investigations
MedDRA (22.0)
Systematic Assessment
EG0001 events1 affected17 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Neutrophil Count Increased
Investigations
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected17 at risk
EG0021 events1 affected19 at risk
EG003
Olfactory Test Abnormal
Investigations
MedDRA (22.0)
Systematic Assessment
EG0002 events2 affected17 at risk
EG0011 events1 affected17 at risk
EG0021 events1 affected19 at risk
EG003
Platelet Count Decreased
Investigations
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0011 events1 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Primitive Reflex Test Positive
Investigations
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Respiratory Rate Increased
Investigations
MedDRA (22.0)
Systematic Assessment
EG0001 events1 affected17 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Romberg Test Positive
Investigations
MedDRA (22.0)
Systematic Assessment
EG0001 events1 affected17 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Temperature Perception Test Decreased
Investigations
MedDRA (22.0)
Systematic Assessment
EG0001 events1 affected17 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Transaminases Increased
Investigations
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected17 at risk
EG0021 events1 affected19 at risk
EG003
Urinary Casts
Investigations
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Weight Decreased
Investigations
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected17 at risk
EG0021 events1 affected19 at risk
EG003
Weight Increased
Investigations
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected19 at risk
EG003
White Blood Cells Urine Positive
Investigations
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Decreased Appetite
Metabolism and nutrition disorders
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected17 at risk
EG0021 events1 affected19 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected17 at risk
EG0022 events2 affected19 at risk
EG003
Gout
Metabolism and nutrition disorders
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Hypercholesterolaemia
Metabolism and nutrition disorders
MedDRA (22.0)
Systematic Assessment
EG0001 events1 affected17 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected17 at risk
EG0021 events1 affected19 at risk
EG003
Vitamin D Deficiency
Metabolism and nutrition disorders
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0011 events1 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA (22.0)
Systematic Assessment
EG0002 events1 affected17 at risk
EG0012 events2 affected17 at risk
EG0021 events1 affected19 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA (22.0)
Systematic Assessment
EG0001 events1 affected17 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Back Pain
Musculoskeletal and connective tissue disorders
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected17 at risk
EG0021 events1 affected19 at risk
EG003
Coccydynia
Musculoskeletal and connective tissue disorders
MedDRA (22.0)
Systematic Assessment
EG0001 events1 affected17 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Muscle Spasms
Musculoskeletal and connective tissue disorders
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected17 at risk
EG0021 events1 affected19 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0011 events1 affected17 at risk
EG0021 events1 affected19 at risk
EG003
Osteopenia
Musculoskeletal and connective tissue disorders
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0011 events1 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Pain In Extremity
Musculoskeletal and connective tissue disorders
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected17 at risk
EG0022 events2 affected19 at risk
EG003
Spinal Column Stenosis
Musculoskeletal and connective tissue disorders
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected17 at risk
EG0021 events1 affected19 at risk
EG003
Tendonitis
Musculoskeletal and connective tissue disorders
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Basal Cell Carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Skin Papilloma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0011 events1 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Squamous Cell Carcinoma Of Skin
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0011 events1 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Cerebellar Microhaemorrhage
Nervous system disorders
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected17 at risk
EG0021 events1 affected19 at risk
EG003
Cerebral Microhaemorrhage
Nervous system disorders
MedDRA (22.0)
Systematic Assessment
EG0001 events1 affected17 at risk
EG0010 events0 affected17 at risk
EG0021 events1 affected19 at risk
EG003
Decreased Vibratory Sense
Nervous system disorders
MedDRA (22.0)
Systematic Assessment
EG0001 events1 affected17 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Dementia
Nervous system disorders
MedDRA (22.0)
Systematic Assessment
EG0001 events1 affected17 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Disturbance In Attention
Nervous system disorders
MedDRA (22.0)
Systematic Assessment
EG0002 events1 affected17 at risk
EG0011 events1 affected17 at risk
EG0021 events1 affected19 at risk
EG003
Dizziness
Nervous system disorders
MedDRA (22.0)
Systematic Assessment
EG0001 events1 affected17 at risk
EG0011 events1 affected17 at risk
EG0023 events3 affected19 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA (22.0)
Systematic Assessment
EG0001 events1 affected17 at risk
EG0010 events0 affected17 at risk
EG0021 events1 affected19 at risk
EG003
Dysmetria
Nervous system disorders
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected17 at risk
EG0021 events1 affected19 at risk
EG003
Headache
Nervous system disorders
MedDRA (22.0)
Systematic Assessment
EG0001 events1 affected17 at risk
EG0011 events1 affected17 at risk
EG0023 events3 affected19 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA (22.0)
Systematic Assessment
EG0001 events1 affected17 at risk
EG0010 events0 affected17 at risk
EG0021 events1 affected19 at risk
EG003
Hypokinesia
Nervous system disorders
MedDRA (22.0)
Systematic Assessment
EG0001 events1 affected17 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Hyposmia
Nervous system disorders
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected17 at risk
EG0021 events1 affected19 at risk
EG003
Memory Impairment
Nervous system disorders
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0011 events1 affected17 at risk
EG0021 events1 affected19 at risk
EG003
Neuropathy Peripheral
Nervous system disorders
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected17 at risk
EG0021 events1 affected19 at risk
EG003
Nystagmus
Nervous system disorders
MedDRA (22.0)
Systematic Assessment
EG0001 events1 affected17 at risk
EG0011 events1 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Presyncope
Nervous system disorders
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0011 events1 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Superficial Siderosis Of Central Nervous System
Nervous system disorders
MedDRA (22.0)
Systematic Assessment
EG0001 events1 affected17 at risk
EG0011 events1 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Syncope
Nervous system disorders
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected17 at risk
EG0021 events1 affected19 at risk
EG003
Transient Ischaemic Attack
Nervous system disorders
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Tremor
Nervous system disorders
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected17 at risk
EG0021 events1 affected19 at risk
EG003
Vasogenic Cerebral Oedema
Nervous system disorders
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0011 events1 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Abnormal Dreams
Psychiatric disorders
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0012 events2 affected17 at risk
EG0021 events1 affected19 at risk
EG003
Agitation
Psychiatric disorders
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0011 events1 affected17 at risk
EG0021 events1 affected19 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Confusional State
Psychiatric disorders
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0011 events1 affected17 at risk
EG0021 events1 affected19 at risk
EG003
Depressed Mood
Psychiatric disorders
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected17 at risk
EG0022 events2 affected19 at risk
EG003
Depression
Psychiatric disorders
MedDRA (22.0)
Systematic Assessment
EG0001 events1 affected17 at risk
EG0010 events0 affected17 at risk
EG0022 events2 affected19 at risk
EG003
Hallucination, Visual
Psychiatric disorders
MedDRA (22.0)
Systematic Assessment
EG0002 events1 affected17 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Hypersexuality
Psychiatric disorders
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected17 at risk
EG0021 events1 affected19 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected17 at risk
EG0021 events1 affected19 at risk
EG003
Nightmare
Psychiatric disorders
MedDRA (22.0)
Systematic Assessment
EG0001 events1 affected17 at risk
EG0012 events2 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Psychotic Disorder
Psychiatric disorders
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0011 events1 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Rapid Eye Movement Sleep Behaviour Disorder
Psychiatric disorders
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected17 at risk
EG0021 events1 affected19 at risk
EG003
Restlessness
Psychiatric disorders
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Suicidal Ideation
Psychiatric disorders
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0011 events1 affected17 at risk
EG0021 events1 affected19 at risk
EG003
Thinking Abnormal
Psychiatric disorders
MedDRA (22.0)
Systematic Assessment
EG0001 events1 affected17 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA (22.0)
Systematic Assessment
EG0001 events1 affected17 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Pollakiuria
Renal and urinary disorders
MedDRA (22.0)
Systematic Assessment
EG0001 events1 affected17 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Polyuria
Renal and urinary disorders
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected17 at risk
EG0021 events1 affected19 at risk
EG003
Renal Artery Stenosis
Renal and urinary disorders
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected17 at risk
EG0021 events1 affected19 at risk
EG003
Renal Impairment
Renal and urinary disorders
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Urinary Incontinence
Renal and urinary disorders
MedDRA (22.0)
Systematic Assessment
EG0001 events1 affected17 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Breast Cyst
Reproductive system and breast disorders
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0011 events1 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Erectile Dysfunction
Reproductive system and breast disorders
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0011 events1 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA (22.0)
Systematic Assessment
EG0001 events1 affected17 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Atelectasis
Respiratory, thoracic and mediastinal disorders
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected17 at risk
EG0021 events1 affected19 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0012 events2 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0012 events1 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Lower Respiratory Tract Congestion
Respiratory, thoracic and mediastinal disorders
MedDRA (22.0)
Systematic Assessment
EG0001 events1 affected17 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Nasal Congestion
Respiratory, thoracic and mediastinal disorders
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Nasal Turbinate Hypertrophy
Respiratory, thoracic and mediastinal disorders
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Oropharyngeal Pain
Respiratory, thoracic and mediastinal disorders
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0011 events1 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Pleural Thickening
Respiratory, thoracic and mediastinal disorders
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected17 at risk
EG0021 events1 affected19 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Rhonchi
Respiratory, thoracic and mediastinal disorders
MedDRA (22.0)
Systematic Assessment
EG0001 events1 affected17 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Upper Respiratory Tract Congestion
Respiratory, thoracic and mediastinal disorders
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0011 events1 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Acne
Skin and subcutaneous tissue disorders
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected17 at risk
EG0022 events1 affected19 at risk
EG003
Actinic Keratosis
Skin and subcutaneous tissue disorders
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected17 at risk
EG0021 events1 affected19 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Dermatitis
Skin and subcutaneous tissue disorders
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0011 events1 affected17 at risk
EG0021 events1 affected19 at risk
EG003
Dermatitis Contact
Skin and subcutaneous tissue disorders
MedDRA (22.0)
Systematic Assessment
EG0001 events1 affected17 at risk
EG0013 events3 affected17 at risk
EG0023 events2 affected19 at risk
EG003
Erythematotelangiectatic Rosacea
Skin and subcutaneous tissue disorders
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected17 at risk
EG0021 events1 affected19 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Ingrowing Nail
Skin and subcutaneous tissue disorders
MedDRA (22.0)
Systematic Assessment
EG0001 events1 affected17 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Night Sweats
Skin and subcutaneous tissue disorders
MedDRA (22.0)
Systematic Assessment
EG0001 events1 affected17 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected17 at risk
EG0021 events1 affected19 at risk
EG003
Skin Lesion
Skin and subcutaneous tissue disorders
MedDRA (22.0)
Systematic Assessment
EG0001 events1 affected17 at risk
EG0010 events0 affected17 at risk
EG0021 events1 affected19 at risk
EG003
Skin Ulcer
Skin and subcutaneous tissue disorders
MedDRA (22.0)
Systematic Assessment
EG0001 events1 affected17 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Rhinoplasty
Surgical and medical procedures
MedDRA (22.0)
Systematic Assessment
EG0001 events1 affected17 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Tooth Extraction
Surgical and medical procedures
MedDRA (22.0)
Systematic Assessment
EG0001 events1 affected17 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Aortic Arteriosclerosis
Vascular disorders
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected17 at risk
EG0021 events1 affected19 at risk
EG003
Hypertension
Vascular disorders
MedDRA (22.0)
Systematic Assessment
EG0002 events2 affected17 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Orthostatic Hypotension
Vascular disorders
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected17 at risk
EG0021 events1 affected19 at risk
EG003
Tinnitus
Ear and labyrinth disorders
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Thyroid Cyst
Endocrine disorders
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Cataract
Eye disorders
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Gastrooesophageal Reflux Disease
Gastrointestinal disorders
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Large Intestine Polyp
Gastrointestinal disorders
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Ulcerative Gastritis
Gastrointestinal disorders
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Propulsive Gait
General disorders
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Cellulitis
Infections and infestations
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Gastritis Bacterial
Infections and infestations
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Onychomycosis
Infections and infestations
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Osteomyelitis
Infections and infestations
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Otitis Media
Infections and infestations
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Respiratory Syncytial Virus Infection
Infections and infestations
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Tooth Infection
Infections and infestations
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Hand Fracture
Injury, poisoning and procedural complications
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Meniscus Injury
Injury, poisoning and procedural complications
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Product Administration Error
Injury, poisoning and procedural complications
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Skin Laceration
Injury, poisoning and procedural complications
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Spinal Compression Fracture
Injury, poisoning and procedural complications
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Wound
Injury, poisoning and procedural complications
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Activated Partial Thromboplastin Time Prolonged
Investigations
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Liver Function Test Increased
Investigations
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Occult Blood Positive
Investigations
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Prostatic Specific Antigen Increased
Investigations
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Hyperlipidaemia
Metabolism and nutrition disorders
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Flank Pain
Musculoskeletal and connective tissue disorders
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Intervertebral Disc Protrusion
Musculoskeletal and connective tissue disorders
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Pain In Jaw
Musculoskeletal and connective tissue disorders
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Adrenal Adenoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Aphasia
Nervous system disorders
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Balance Disorder
Nervous system disorders
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Cervical Radiculopathy
Nervous system disorders
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Coordination Abnormal
Nervous system disorders
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Lethargy
Nervous system disorders
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Postural Tremor
Nervous system disorders
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Sciatica
Nervous system disorders
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Delusion
Psychiatric disorders
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Major Depression
Psychiatric disorders
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Uterine Prolapse
Reproductive system and breast disorders
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Lung Cyst
Respiratory, thoracic and mediastinal disorders
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Sleep Apnoea Syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Throat Irritation
Respiratory, thoracic and mediastinal disorders
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Dermatitis Atopic
Skin and subcutaneous tissue disorders
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Cataract Operation
Surgical and medical procedures
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Hip Arthroplasty
Surgical and medical procedures
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Thrombosis
Vascular disorders
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Dementia Alzheimer's Type
Nervous system disorders
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected17 at risk
EG0020 events0 affected19 at risk
EG003
This study was terminated early by the sponsor on the recommendation of an independent data safety monitoring board following review of unblinded data from the Phase 3 studies E2609-G000-301 (NCT02956486) and E2609-G000-302 (NCT03036280).
Participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD received elenbecestat 15 mg (one 10 mg and one 5 mg tablets), orally, once daily with food up to 18 months. Participants who remained on treatment were reassigned to elenbecestat 50 mg (two 25 mg tablets) if they had at least 3 months (12 weeks) of treatment remaining in the randomization phase (treatment and follow-up), orally, once daily with food up to 18 months. Participants who completed 18 months treatment or who discontinued taking study drug prematurely were followed up to 3 months (12 weeks) after last dose of elenbecestat in core phase.
OG003
Core Phase: Elenbecestat 50 mg
Participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD received elenbecestat 50 mg (two 25 mg tablets), orally, once daily with food up to 18 months. Participants who completed 18 months treatment or who discontinued taking study drug prematurely were followed up to 3 months (12 weeks) after last dose of elenbecestat in core phase.
Units
Counts
Participants
OG00017
OG00117
OG00219
OG00317
Title
Denominators
Categories
Title
Measurements
OG0002
OG0012
OG0025
OG0031
OG002
Core Phase: Elenbecestat 15 mg Then 50 mg
Participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD received elenbecestat 15 mg (one 10 mg and one 5 mg tablets), orally, once daily with food up to 18 months. Participants who remained on treatment were reassigned to elenbecestat 50 mg (two 25 mg tablets) if they had at least 3 months (12 weeks) of treatment remaining in the randomization phase (treatment and follow-up), orally, once daily with food up to 18 months. Participants who completed 18 months treatment or who discontinued taking study drug prematurely were followed up to 3 months (12 weeks) after last dose of elenbecestat in core phase.
OG003
Core Phase: Elenbecestat 50 mg
Participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD received elenbecestat 50 mg (two 25 mg tablets), orally, once daily with food up to 18 months. Participants who completed 18 months treatment or who discontinued taking study drug prematurely were followed up to 3 months (12 weeks) after last dose of elenbecestat in core phase.
Participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD received elenbecestat 15 mg (one 10 mg and one 5 mg tablets), orally, once daily with food up to 18 months. Participants who remained on treatment were reassigned to elenbecestat 50 mg (two 25 mg tablets) if they had at least 3 months (12 weeks) of treatment remaining in the randomization phase (treatment and follow-up), orally, once daily with food up to 18 months. Participants who completed 18 months treatment or who discontinued taking study drug prematurely were followed up to 3 months (12 weeks) after last dose of elenbecestat in core phase.
OG003
Core Phase: Elenbecestat 50 mg
Participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD received elenbecestat 50 mg (two 25 mg tablets), orally, once daily with food up to 18 months. Participants who completed 18 months treatment or who discontinued taking study drug prematurely were followed up to 3 months (12 weeks) after last dose of elenbecestat in core phase.
Units
Counts
Participants
OG00017
OG00117
OG00219
OG00317
Title
Denominators
Categories
Markedly Abnormal Low: Temperature (Month 0: Baseline)
ParticipantsOG00017
ParticipantsOG00117
ParticipantsOG00219
ParticipantsOG00317
Title
Measurements
OG0000
OG0012
OG0020
OG003
Markedly Abnormal Low: Temperature (Month 0: Week 2)
ParticipantsOG00016
ParticipantsOG00117
ParticipantsOG00219
ParticipantsOG003
Markedly Abnormal Low: Temperature (Month 0: Week 3)
ParticipantsOG00017
ParticipantsOG00117
ParticipantsOG00219
ParticipantsOG003
Markedly Abnormal Low: Temperature (Month 0: Week 4)
ParticipantsOG00017
ParticipantsOG00117
ParticipantsOG00219
ParticipantsOG003
Markedly Abnormal High: Temperature (Month 0: Week 4)
ParticipantsOG00017
ParticipantsOG00117
ParticipantsOG00219
ParticipantsOG003
Markedly Abnormal Low: Temperature (Month 1: Week 5)
ParticipantsOG00017
ParticipantsOG00117
ParticipantsOG00219
ParticipantsOG003
Markedly Abnormal Low: Temperature (Month 1: Week 7)
ParticipantsOG00017
ParticipantsOG00117
ParticipantsOG00218
ParticipantsOG003
Markedly Abnormal Low: Temperature (Month 2: Week 9)
ParticipantsOG00017
ParticipantsOG00117
ParticipantsOG00215
ParticipantsOG003
Markedly Abnormal Low: Temperature (Month 2: Week 11)
ParticipantsOG00016
ParticipantsOG00116
ParticipantsOG00215
ParticipantsOG003
Markedly Abnormal Low: Temperature (Month 3: Week 13)
ParticipantsOG00016
ParticipantsOG00116
ParticipantsOG00215
ParticipantsOG003
Markedly Abnormal Low: Temperature (Month 4: Week 17)
ParticipantsOG00015
ParticipantsOG00116
ParticipantsOG00213
ParticipantsOG003
Markedly Abnormal Low: Temperature (Month 5: Week 21)
ParticipantsOG00015
ParticipantsOG00116
ParticipantsOG00213
ParticipantsOG003
Markedly Abnormal Low: Temperature (Month 6: Week 27)
ParticipantsOG00015
ParticipantsOG00115
ParticipantsOG00212
ParticipantsOG003
Markedly Abnormal Low: Temperature (Month 9: Week 40)
ParticipantsOG00014
ParticipantsOG00113
ParticipantsOG00211
ParticipantsOG003
Markedly Abnormal Low: Temperature (Month 12: Week 53)
ParticipantsOG00013
ParticipantsOG00112
ParticipantsOG00211
ParticipantsOG003
Markedly Abnormal Low: Temperature (Month 15: Week 66)
ParticipantsOG00013
ParticipantsOG00111
ParticipantsOG00210
ParticipantsOG003
Markedly Abnormal Low: Temperature (Month 18: Week 79)
ParticipantsOG00012
ParticipantsOG00111
ParticipantsOG00210
ParticipantsOG003
Markedly Abnormal Low: Temperature (Follow-up: Month 1)
ParticipantsOG00013
ParticipantsOG00112
ParticipantsOG00215
ParticipantsOG003
Markedly Abnormal Low: Temperature (Follow-up: Month 3)
Participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD received elenbecestat 15 mg (one 10 mg and one 5 mg tablets), orally, once daily with food up to 18 months. Participants who remained on treatment were reassigned to elenbecestat 50 mg (two 25 mg tablets) if they had at least 3 months (12 weeks) of treatment remaining in the randomization phase (treatment and follow-up), orally, once daily with food up to 18 months. Participants who completed 18 months treatment or who discontinued taking study drug prematurely were followed up to 3 months (12 weeks) after last dose of elenbecestat in core phase.
OG003
Core Phase: Elenbecestat 50 mg
Participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD received elenbecestat 50 mg (two 25 mg tablets), orally, once daily with food up to 18 months. Participants who completed 18 months treatment or who discontinued taking study drug prematurely were followed up to 3 months (12 weeks) after last dose of elenbecestat in core phase.
Units
Counts
Participants
OG00017
OG00117
OG00219
OG00317
Title
Denominators
Categories
At least one post-baseline increase of >30 millisecond (msec) in QTcF interval
Title
Measurements
OG0002
OG0014
OG0024
OG0032
At least one post-baseline value of >450 msec in QTcF interval
Title
Measurements
OG0001
OG0016
OG0024
OG003
At least one post-baseline value of >480 msec in QTcF interval
Title
Measurements
OG0000
OG0010
OG0021
OG003
Units
Counts
Participants
OG00041
Title
Denominators
Categories
TEAEs
Title
Measurements
OG00030
SAEs
Title
Measurements
OG0006
41
Title
Denominators
Categories
Markedly Abnormal High: Diastolic Blood Pressure
Title
Measurements
OG0001
Markedly Abnormal Low: Diastolic Blood Pressure
Title
Measurements
OG0001
Markedly Abnormal High: Systolic Blood Pressure
Title
Measurements
OG0005
Markedly Abnormal High: Temperature
Title
Measurements
OG0001
Markedly Abnormal Low: Temperature
Title
Measurements
OG00010
Markedly Abnormal High: Weight
Title
Measurements
OG0001
41
Title
Denominators
Categories
At least one post-baseline increase of >30 msec in QTcF interval
Title
Measurements
OG0002
At least one post-baseline value of >450 msec in QTcF interval
Participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD received elenbecestat 15 mg (one 10 mg and one 5 mg tablets), orally, once daily with food up to 18 months. Participants who remained on treatment were reassigned to elenbecestat 50 mg (two 25 mg tablets) if they had at least 3 months (12 weeks) of treatment remaining in the randomization phase (treatment and follow-up), orally, once daily with food up to 18 months. Participants who completed 18 months treatment or who discontinued taking study drug prematurely were followed up to 3 months (12 weeks) after last dose of elenbecestat in core phase.
OG003
Core Phase: Elenbecestat 50 mg
Participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD received elenbecestat 50 mg (two 25 mg tablets), orally, once daily with food up to 18 months. Participants who completed 18 months treatment or who discontinued taking study drug prematurely were followed up to 3 months (12 weeks) after last dose of elenbecestat in core phase.
Units
Counts
Participants
OG0004
OG0017
OG0026
OG0036
Title
Denominators
Categories
Percent Change from Baseline in CSF Abeta(1-x) at Month 1 (Week 5)
ParticipantsOG0004
ParticipantsOG0017
ParticipantsOG0026
ParticipantsOG0036
Title
Measurements
OG0006.63± 12.545
OG001-18.16± 17.873
OG002-36.43± 16.026
OG003
Percent Change from Baseline in CSF Abeta(1-x) at Month 18 (Week 79)
ParticipantsOG0001
ParticipantsOG0012
ParticipantsOG0021
ParticipantsOG003
Percent Change from Baseline in CSF Abeta(1-42) at Month 1 (Week 5)
ParticipantsOG0004
ParticipantsOG0017
ParticipantsOG0026
ParticipantsOG003
Percent Change from Baseline in CSF Abeta(1-42) at Month 18 (Week 79)
ParticipantsOG0002
ParticipantsOG0012
ParticipantsOG0023
ParticipantsOG003
OG002
Core Phase: Elenbecestat 50 mg
Participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD received elenbecestat 50 mg (two 25 mg tablets), orally, once daily with food up to 18 months. Participants who completed 18 months treatment or who discontinued taking study drug prematurely were followed up to 3 months (12 weeks) after last dose of elenbecestat in core phase.
Units
Counts
Participants
OG0007
OG0016
OG0026
Title
Denominators
Categories
Month 1 (Week 5)
ParticipantsOG0007
ParticipantsOG0016
ParticipantsOG0026
Title
Measurements
OG0001.10± 0.438
OG0013.71± 1.360
OG0029.93± 3.568
Month 18 (Week 79)
ParticipantsOG0002
ParticipantsOG0012
ParticipantsOG0024
Title
Measurements
OG000
OG002
Core Phase: Elenbecestat 50 mg
Participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD received elenbecestat 50 mg (two 25 mg tablets), orally, once daily with food up to 18 months. Participants who completed 18 months treatment or who discontinued taking study drug prematurely were followed up to 3 months (12 weeks) after last dose of elenbecestat in core phase.
Units
Counts
Participants
OG00017
OG00119
OG00216
Title
Denominators
Categories
Month 0 (Week 3): Pre-dose
ParticipantsOG00017
ParticipantsOG00118
ParticipantsOG00213
Title
Measurements
OG0001.43± 1.105
OG0015.81± 3.785
OG00215.77± 11.281
Month 0 (Week 3): 1 to 6 hours Post-dose
ParticipantsOG00017
ParticipantsOG00118
ParticipantsOG00213
Title
Measurements
OG000
Month 1 (Week 5): Pre-dose
ParticipantsOG00015
ParticipantsOG00119
ParticipantsOG00215
Title
Measurements
OG000
Month 1 (Week 5): 4 to 8 hours Post-dose
ParticipantsOG00016
ParticipantsOG00119
ParticipantsOG00216
Title
Measurements
OG000
Month 3 (Week 13): Pre-dose
ParticipantsOG00016
ParticipantsOG00115
ParticipantsOG00216
Title
Measurements
OG000
Month 3 (Week 13): 1 to 6 hours Post-dose
ParticipantsOG00016
ParticipantsOG00114
ParticipantsOG00216
Title
Measurements
OG000
Month 6 (Week 27): Pre-dose
ParticipantsOG00015
ParticipantsOG00111
ParticipantsOG00215
Title
Measurements
OG000
Month 6 (Week 27): 1 to 6 hours Post-dose
ParticipantsOG00015
ParticipantsOG00112
ParticipantsOG00215
Title
Measurements
OG000
Month 12 (Week 53): Pre-dose
ParticipantsOG00011
ParticipantsOG00110
ParticipantsOG00211
Title
Measurements
OG000
Month 12 (Week 53): 1 to 6 hours Post-dose
ParticipantsOG00012
ParticipantsOG00110
ParticipantsOG00211
Title
Measurements
OG000
Month 18 (Week 79): Pre-dose
ParticipantsOG00010
ParticipantsOG0018
ParticipantsOG00212
Title
Measurements
OG000
Month 18 (Week 79): 4 to 8 hours Post-dose
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG00211
Title
Measurements
OG000
OG00041
Title
Denominators
Categories
Baseline
ParticipantsOG00041
Title
Measurements
OG00021.5± 5.67
Change at Month 3
ParticipantsOG00041
Title
Measurements
OG000-0.6± 2.32
Change at Month 6
ParticipantsOG00039
Title
Measurements
OG000-0.6± 2.39
Change at Month 9
ParticipantsOG00036
Title
Measurements
OG000-0.9± 2.89
Change at Month 12
ParticipantsOG00036
Title
Measurements
OG000-1.4± 2.43
Change at Month 15
ParticipantsOG00033
Title
Measurements
OG000-1.8± 2.78
Change at Month 18
ParticipantsOG00032
Title
Measurements
OG000-1.7± 3.01
Change at Month 21
ParticipantsOG00021
Title
Measurements
OG000-2.5± 3.27
Change at Month 24
ParticipantsOG00010
Title
Measurements
OG000-3.9± 4.46
Change at Month 28
ParticipantsOG0005
Title
Measurements
OG000-6.4± 4.28
Change at Month 32
ParticipantsOG0001
Title
Measurements
OG000-2.0± NAStandard deviation could not be calculated due to only one participant was analyzed.
Units
Counts
Participants
OG00041
Title
Denominators
Categories
Baseline
ParticipantsOG00041
Title
Measurements
OG00014.4± 7.31
Change at Month 3
ParticipantsOG00041
Title
Measurements
OG0001.3± 5.51
Change at Month 6
ParticipantsOG00039
Title
Measurements
OG0001.4± 3.74
Change at Month 9
ParticipantsOG00035
Title
Measurements
OG0002.2± 4.33
Change at Month 12
ParticipantsOG00036
Title
Measurements
OG0002.6± 4.86
Change at Month 15
ParticipantsOG00034
Title
Measurements
OG0003.0± 5.17
Change at Month 18
ParticipantsOG00032
Title
Measurements
OG0003.4± 4.83
Change at Month 21
ParticipantsOG00022
Title
Measurements
OG0003.0± 3.88
Change at Month 24
ParticipantsOG00010
Title
Measurements
OG0006.8± 5.92
Change at Month 28
ParticipantsOG0006
Title
Measurements
OG0009.2± 4.67
Change at Month 32
ParticipantsOG0001
Title
Measurements
OG00015.0± NAStandard deviation could not be calculated due to only one participant was analyzed.
OG00027
Title
Denominators
Categories
Percent Change from Extension Phase Baseline in plasma Abeta(1-x) at Month 12
ParticipantsOG00027
Title
Measurements
OG000-71.8± 23.30
Percent Change from Extension Phase Baseline in plasma Abeta(1-x) at Month 24
ParticipantsOG0005
Title
Measurements
OG000-71.1± 31.20
OG00012
Title
Denominators
Categories
Title
Measurements
OG000-4.33± 2.080
OG00012
Title
Denominators
Categories
Percent Change at Month 24 (Left Hippocampal Volume)
Title
Measurements
OG000-4.31± 2.065
Percent Change at Month 24 (Right Hippocampal Volume)
Title
Measurements
OG000-4.37± 2.667
OG00012
Title
Denominators
Categories
Title
Measurements
OG000-3.26± 1.555
OG00012
Title
Denominators
Categories
Title
Measurements
OG00015.18± 8.544
0 events
0 affected
17 at risk
EG0040 events0 affected41 at risk
0 events
0 affected
17 at risk
EG0040 events0 affected41 at risk
0 events
0 affected
17 at risk
EG0040 events0 affected41 at risk
0 events
0 affected
17 at risk
EG0041 events1 affected41 at risk
1 events
1 affected
17 at risk
EG0040 events0 affected41 at risk
0 events
0 affected
17 at risk
EG0040 events0 affected41 at risk
0 events
0 affected
17 at risk
EG0040 events0 affected41 at risk
0 events
0 affected
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EG0040 events0 affected41 at risk
0 events
0 affected
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EG0041 events1 affected41 at risk
0 events
0 affected
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EG0040 events0 affected41 at risk
0 events
0 affected
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EG0040 events0 affected41 at risk
0 events
0 affected
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EG0040 events0 affected41 at risk
0 events
0 affected
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EG0040 events0 affected41 at risk
0 events
0 affected
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EG0041 events1 affected41 at risk
0 events
0 affected
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EG0041 events1 affected41 at risk
0 events
0 affected
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EG0041 events1 affected41 at risk
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0 affected
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EG0041 events1 affected41 at risk
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EG0041 events1 affected41 at risk
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EG0041 events1 affected41 at risk
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EG0041 events1 affected41 at risk
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EG0041 events1 affected41 at risk
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EG0040 events0 affected41 at risk
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EG0040 events0 affected41 at risk
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EG0040 events0 affected41 at risk
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EG0040 events0 affected41 at risk
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EG0040 events0 affected41 at risk
1 events
1 affected
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EG0040 events0 affected41 at risk
0 events
0 affected
17 at risk
EG0040 events0 affected41 at risk
0 events
0 affected
17 at risk
EG0040 events0 affected41 at risk
1 events
1 affected
17 at risk
EG0041 events1 affected41 at risk
0 events
0 affected
17 at risk
EG0040 events0 affected41 at risk
0 events
0 affected
17 at risk
EG0040 events0 affected41 at risk
0 events
0 affected
17 at risk
EG0040 events0 affected41 at risk
0 events
0 affected
17 at risk
EG0041 events1 affected41 at risk
1 events
1 affected
17 at risk
EG0040 events0 affected41 at risk
0 events
0 affected
17 at risk
EG0040 events0 affected41 at risk
0 events
0 affected
17 at risk
EG0041 events1 affected41 at risk
0 events
0 affected
17 at risk
EG0040 events0 affected41 at risk
0 events
0 affected
17 at risk
EG0040 events0 affected41 at risk
3 events
3 affected
17 at risk
EG0040 events0 affected41 at risk
1 events
1 affected
17 at risk
EG0040 events0 affected41 at risk
1 events
1 affected
17 at risk
EG0041 events1 affected41 at risk
0 events
0 affected
17 at risk
EG0040 events0 affected41 at risk
1 events
1 affected
17 at risk
EG0040 events0 affected41 at risk
3 events
2 affected
17 at risk
EG0041 events1 affected41 at risk
1 events
1 affected
17 at risk
EG0040 events0 affected41 at risk
0 events
0 affected
17 at risk
EG0040 events0 affected41 at risk
1 events
1 affected
17 at risk
EG0041 events1 affected41 at risk
1 events
1 affected
17 at risk
EG0040 events0 affected41 at risk
1 events
1 affected
17 at risk
EG0040 events0 affected41 at risk
0 events
0 affected
17 at risk
EG0040 events0 affected41 at risk
1 events
1 affected
17 at risk
EG0040 events0 affected41 at risk
0 events
0 affected
17 at risk
EG0042 events2 affected41 at risk
0 events
0 affected
17 at risk
EG0040 events0 affected41 at risk
0 events
0 affected
17 at risk
EG0040 events0 affected41 at risk
1 events
1 affected
17 at risk
EG0040 events0 affected41 at risk
0 events
0 affected
17 at risk
EG0040 events0 affected41 at risk
1 events
1 affected
17 at risk
EG0042 events2 affected41 at risk
1 events
1 affected
17 at risk
EG0040 events0 affected41 at risk
0 events
0 affected
17 at risk
EG0040 events0 affected41 at risk
0 events
0 affected
17 at risk
EG0040 events0 affected41 at risk
0 events
0 affected
17 at risk
EG0040 events0 affected41 at risk
0 events
0 affected
17 at risk
EG0040 events0 affected41 at risk
0 events
0 affected
17 at risk
EG0040 events0 affected41 at risk
1 events
1 affected
17 at risk
EG0040 events0 affected41 at risk
0 events
0 affected
17 at risk
EG0040 events0 affected41 at risk
1 events
1 affected
17 at risk
EG0040 events0 affected41 at risk
0 events
0 affected
17 at risk
EG0040 events0 affected41 at risk
0 events
0 affected
17 at risk
EG0042 events2 affected41 at risk
0 events
0 affected
17 at risk
EG0040 events0 affected41 at risk
6 events
4 affected
17 at risk
EG0042 events2 affected41 at risk
1 events
1 affected
17 at risk
EG0045 events3 affected41 at risk
0 events
0 affected
17 at risk
EG0040 events0 affected41 at risk
0 events
0 affected
17 at risk
EG0040 events0 affected41 at risk
0 events
0 affected
17 at risk
EG0040 events0 affected41 at risk
0 events
0 affected
17 at risk
EG0040 events0 affected41 at risk
0 events
0 affected
17 at risk
EG0040 events0 affected41 at risk
1 events
1 affected
17 at risk
EG0042 events2 affected41 at risk
0 events
0 affected
17 at risk
EG0040 events0 affected41 at risk
0 events
0 affected
17 at risk
EG0042 events2 affected41 at risk
0 events
0 affected
17 at risk
EG0040 events0 affected41 at risk
3 events
3 affected
17 at risk
EG0045 events4 affected41 at risk
0 events
0 affected
17 at risk
EG0040 events0 affected41 at risk
1 events
1 affected
17 at risk
EG0040 events0 affected41 at risk
0 events
0 affected
17 at risk
EG0040 events0 affected41 at risk
0 events
0 affected
17 at risk
EG0042 events2 affected41 at risk
1 events
1 affected
17 at risk
EG0040 events0 affected41 at risk
0 events
0 affected
17 at risk
EG0041 events1 affected41 at risk
0 events
0 affected
17 at risk
EG0040 events0 affected41 at risk
2 events
2 affected
17 at risk
EG0040 events0 affected41 at risk
1 events
1 affected
17 at risk
EG0040 events0 affected41 at risk
0 events
0 affected
17 at risk
EG0040 events0 affected41 at risk
1 events
1 affected
17 at risk
EG0040 events0 affected41 at risk
0 events
0 affected
17 at risk
EG0040 events0 affected41 at risk
0 events
0 affected
17 at risk
EG0040 events0 affected41 at risk
1 events
1 affected
17 at risk
EG0040 events0 affected41 at risk
0 events
0 affected
17 at risk
EG0040 events0 affected41 at risk
0 events
0 affected
17 at risk
EG0040 events0 affected41 at risk
1 events
1 affected
17 at risk
EG0040 events0 affected41 at risk
0 events
0 affected
17 at risk
EG0040 events0 affected41 at risk
0 events
0 affected
17 at risk
EG0040 events0 affected41 at risk
1 events
1 affected
17 at risk
EG0040 events0 affected41 at risk
2 events
2 affected
17 at risk
EG0040 events0 affected41 at risk
0 events
0 affected
17 at risk
EG0041 events1 affected41 at risk
0 events
0 affected
17 at risk
EG0040 events0 affected41 at risk
0 events
0 affected
17 at risk
EG0040 events0 affected41 at risk
1 events
1 affected
17 at risk
EG0040 events0 affected41 at risk
0 events
0 affected
17 at risk
EG0040 events0 affected41 at risk
0 events
0 affected
17 at risk
EG0040 events0 affected41 at risk
0 events
0 affected
17 at risk
EG0040 events0 affected41 at risk
1 events
1 affected
17 at risk
EG0040 events0 affected41 at risk
0 events
0 affected
17 at risk
EG0040 events0 affected41 at risk
0 events
0 affected
17 at risk
EG0040 events0 affected41 at risk
0 events
0 affected
17 at risk
EG0040 events0 affected41 at risk
0 events
0 affected
17 at risk
EG0040 events0 affected41 at risk
1 events
1 affected
17 at risk
EG0040 events0 affected41 at risk
1 events
1 affected
17 at risk
EG0040 events0 affected41 at risk
1 events
1 affected
17 at risk
EG0040 events0 affected41 at risk
1 events
1 affected
17 at risk
EG0040 events0 affected41 at risk
1 events
1 affected
17 at risk
EG0040 events0 affected41 at risk
0 events
0 affected
17 at risk
EG0040 events0 affected41 at risk
1 events
1 affected
17 at risk
EG0040 events0 affected41 at risk
0 events
0 affected
17 at risk
EG0040 events0 affected41 at risk
0 events
0 affected
17 at risk
EG0040 events0 affected41 at risk
0 events
0 affected
17 at risk
EG0041 events1 affected41 at risk
0 events
0 affected
17 at risk
EG0041 events1 affected41 at risk
0 events
0 affected
17 at risk
EG0041 events1 affected41 at risk
0 events
0 affected
17 at risk
EG0041 events1 affected41 at risk
0 events
0 affected
17 at risk
EG0040 events0 affected41 at risk
0 events
0 affected
17 at risk
EG0040 events0 affected41 at risk
0 events
0 affected
17 at risk
EG0040 events0 affected41 at risk
0 events
0 affected
17 at risk
EG0040 events0 affected41 at risk
0 events
0 affected
17 at risk
EG0041 events1 affected41 at risk
0 events
0 affected
17 at risk
EG0040 events0 affected41 at risk
1 events
1 affected
17 at risk
EG0040 events0 affected41 at risk
1 events
1 affected
17 at risk
EG0042 events2 affected41 at risk
0 events
0 affected
17 at risk
EG0040 events0 affected41 at risk
1 events
1 affected
17 at risk
EG0040 events0 affected41 at risk
0 events
0 affected
17 at risk
EG0040 events0 affected41 at risk
4 events
1 affected
17 at risk
EG0040 events0 affected41 at risk
2 events
2 affected
17 at risk
EG0040 events0 affected41 at risk
0 events
0 affected
17 at risk
EG0040 events0 affected41 at risk
0 events
0 affected
17 at risk
EG0040 events0 affected41 at risk
0 events
0 affected
17 at risk
EG0042 events2 affected41 at risk
0 events
0 affected
17 at risk
EG0040 events0 affected41 at risk
0 events
0 affected
17 at risk
EG0040 events0 affected41 at risk
3 events
3 affected
17 at risk
EG0040 events0 affected41 at risk
0 events
0 affected
17 at risk
EG0040 events0 affected41 at risk
0 events
0 affected
17 at risk
EG0040 events0 affected41 at risk
1 events
1 affected
17 at risk
EG0040 events0 affected41 at risk
0 events
0 affected
17 at risk
EG0040 events0 affected41 at risk
0 events
0 affected
17 at risk
EG0040 events0 affected41 at risk
0 events
0 affected
17 at risk
EG0040 events0 affected41 at risk
0 events
0 affected
17 at risk
EG0041 events1 affected41 at risk
0 events
0 affected
17 at risk
EG0040 events0 affected41 at risk
0 events
0 affected
17 at risk
EG0040 events0 affected41 at risk
1 events
1 affected
17 at risk
EG0040 events0 affected41 at risk
2 events
1 affected
17 at risk
EG0041 events1 affected41 at risk
0 events
0 affected
17 at risk
EG0040 events0 affected41 at risk
3 events
3 affected
17 at risk
EG0040 events0 affected41 at risk
4 events
3 affected
17 at risk
EG0046 events5 affected41 at risk
1 events
1 affected
17 at risk
EG0040 events0 affected41 at risk
1 events
1 affected
17 at risk
EG0041 events1 affected41 at risk
0 events
0 affected
17 at risk
EG0041 events1 affected41 at risk
0 events
0 affected
17 at risk
EG0043 events3 affected41 at risk
0 events
0 affected
17 at risk
EG0040 events0 affected41 at risk
0 events
0 affected
17 at risk
EG0040 events0 affected41 at risk
1 events
1 affected
17 at risk
EG0045 events4 affected41 at risk
0 events
0 affected
17 at risk
EG0040 events0 affected41 at risk
0 events
0 affected
17 at risk
EG0040 events0 affected41 at risk
0 events
0 affected
17 at risk
EG0040 events0 affected41 at risk
1 events
1 affected
17 at risk
EG0040 events0 affected41 at risk
1 events
1 affected
17 at risk
EG0040 events0 affected41 at risk
0 events
0 affected
17 at risk
EG0040 events0 affected41 at risk
0 events
0 affected
17 at risk
EG0040 events0 affected41 at risk
0 events
0 affected
17 at risk
EG0040 events0 affected41 at risk
0 events
0 affected
17 at risk
EG0040 events0 affected41 at risk
0 events
0 affected
17 at risk
EG0040 events0 affected41 at risk
1 events
1 affected
17 at risk
EG0040 events0 affected41 at risk
0 events
0 affected
17 at risk
EG0040 events0 affected41 at risk
0 events
0 affected
17 at risk
EG0040 events0 affected41 at risk
0 events
0 affected
17 at risk
EG0040 events0 affected41 at risk
0 events
0 affected
17 at risk
EG0040 events0 affected41 at risk
0 events
0 affected
17 at risk
EG0040 events0 affected41 at risk
0 events
0 affected
17 at risk
EG0043 events3 affected41 at risk
0 events
0 affected
17 at risk
EG0040 events0 affected41 at risk
0 events
0 affected
17 at risk
EG0040 events0 affected41 at risk
1 events
1 affected
17 at risk
EG0040 events0 affected41 at risk
1 events
1 affected
17 at risk
EG0040 events0 affected41 at risk
0 events
0 affected
17 at risk
EG0040 events0 affected41 at risk
0 events
0 affected
17 at risk
EG0040 events0 affected41 at risk
1 events
1 affected
17 at risk
EG0040 events0 affected41 at risk
0 events
0 affected
17 at risk
EG0040 events0 affected41 at risk
0 events
0 affected
17 at risk
EG0040 events0 affected41 at risk
0 events
0 affected
17 at risk
EG0040 events0 affected41 at risk
0 events
0 affected
17 at risk
EG0040 events0 affected41 at risk
1 events
1 affected
17 at risk
EG0040 events0 affected41 at risk
2 events
2 affected
17 at risk
EG0040 events0 affected41 at risk
3 events
3 affected
17 at risk
EG0043 events3 affected41 at risk
0 events
0 affected
17 at risk
EG0040 events0 affected41 at risk
1 events
1 affected
17 at risk
EG0040 events0 affected41 at risk
0 events
0 affected
17 at risk
EG0040 events0 affected41 at risk
0 events
0 affected
17 at risk
EG0040 events0 affected41 at risk
0 events
0 affected
17 at risk
EG0040 events0 affected41 at risk
0 events
0 affected
17 at risk
EG0040 events0 affected41 at risk
0 events
0 affected
17 at risk
EG0040 events0 affected41 at risk
0 events
0 affected
17 at risk
EG0040 events0 affected41 at risk
0 events
0 affected
17 at risk
EG0040 events0 affected41 at risk
0 events
0 affected
17 at risk
EG0040 events0 affected41 at risk
1 events
1 affected
17 at risk
EG0040 events0 affected41 at risk
1 events
1 affected
17 at risk
EG0040 events0 affected41 at risk
0 events
0 affected
17 at risk
EG0041 events1 affected41 at risk
0 events
0 affected
17 at risk
EG0041 events1 affected41 at risk
0 events
0 affected
17 at risk
EG0041 events1 affected41 at risk
0 events
0 affected
17 at risk
EG0041 events1 affected41 at risk
0 events
0 affected
17 at risk
EG0041 events1 affected41 at risk
0 events
0 affected
17 at risk
EG0041 events1 affected41 at risk
0 events
0 affected
17 at risk
EG0041 events1 affected41 at risk
0 events
0 affected
17 at risk
EG0041 events1 affected41 at risk
0 events
0 affected
17 at risk
EG0041 events1 affected41 at risk
0 events
0 affected
17 at risk
EG0041 events1 affected41 at risk
0 events
0 affected
17 at risk
EG0041 events1 affected41 at risk
0 events
0 affected
17 at risk
EG0041 events1 affected41 at risk
0 events
0 affected
17 at risk
EG0041 events1 affected41 at risk
0 events
0 affected
17 at risk
EG0041 events1 affected41 at risk
0 events
0 affected
17 at risk
EG0041 events1 affected41 at risk
0 events
0 affected
17 at risk
EG0041 events1 affected41 at risk
0 events
0 affected
17 at risk
EG0042 events2 affected41 at risk
0 events
0 affected
17 at risk
EG0042 events2 affected41 at risk
0 events
0 affected
17 at risk
EG0041 events1 affected41 at risk
0 events
0 affected
17 at risk
EG0041 events1 affected41 at risk
0 events
0 affected
17 at risk
EG0041 events1 affected41 at risk
0 events
0 affected
17 at risk
EG0041 events1 affected41 at risk
0 events
0 affected
17 at risk
EG0041 events1 affected41 at risk
0 events
0 affected
17 at risk
EG0041 events1 affected41 at risk
0 events
0 affected
17 at risk
EG0041 events1 affected41 at risk
0 events
0 affected
17 at risk
EG0041 events1 affected41 at risk
0 events
0 affected
17 at risk
EG0041 events1 affected41 at risk
0 events
0 affected
17 at risk
EG0041 events1 affected41 at risk
0 events
0 affected
17 at risk
EG0041 events1 affected41 at risk
0 events
0 affected
17 at risk
EG0041 events1 affected41 at risk
0 events
0 affected
17 at risk
EG0041 events1 affected41 at risk
0 events
0 affected
17 at risk
EG0041 events1 affected41 at risk
0 events
0 affected
17 at risk
EG0042 events2 affected41 at risk
0 events
0 affected
17 at risk
EG0041 events1 affected41 at risk
0 events
0 affected
17 at risk
EG0041 events1 affected41 at risk
0 events
0 affected
17 at risk
EG0041 events1 affected41 at risk
0 events
0 affected
17 at risk
EG0041 events1 affected41 at risk
0 events
0 affected
17 at risk
EG0041 events1 affected41 at risk
0 events
0 affected
17 at risk
EG0041 events1 affected41 at risk
0 events
0 affected
17 at risk
EG0041 events1 affected41 at risk
0 events
0 affected
17 at risk
EG0041 events1 affected41 at risk
0 events
0 affected
17 at risk
EG0041 events1 affected41 at risk
0 events
0 affected
17 at risk
EG0041 events1 affected41 at risk
0 events
0 affected
17 at risk
EG0042 events2 affected41 at risk
0 events
0 affected
17 at risk
EG0041 events1 affected41 at risk
0 events
0 affected
17 at risk
EG0041 events1 affected41 at risk
0 events
0 affected
17 at risk
EG0041 events1 affected41 at risk
0 events
0 affected
17 at risk
EG0041 events1 affected41 at risk
0 events
0 affected
17 at risk
EG0041 events1 affected41 at risk
0 events
0 affected
17 at risk
EG0041 events1 affected41 at risk
0 events
0 affected
17 at risk
EG0041 events1 affected41 at risk
0
1
0
0
0
0
1
1
1
1
0
1
0
2
0
2
17
Title
Measurements
OG0000
OG0010
OG0022
OG0032
16
Title
Measurements
OG0002
OG0011
OG0024
OG0030
17
Title
Measurements
OG0001
OG0013
OG0021
OG0031
17
Title
Measurements
OG0000
OG0010
OG0021
OG0030
17
Title
Measurements
OG0001
OG0010
OG0022
OG0030
16
Title
Measurements
OG0000
OG0011
OG0023
OG0030
16
Title
Measurements
OG0000
OG0011
OG0021
OG0032
16
Title
Measurements
OG0001
OG0011
OG0021
OG0032
16
Title
Measurements
OG0001
OG0012
OG0023
OG0031
16
Title
Measurements
OG0001
OG0013
OG0021
OG0031
16
Title
Measurements
OG0001
OG0013
OG0020
OG0030
16
Title
Measurements
OG0000
OG0011
OG0020
OG0031
15
Title
Measurements
OG0001
OG0012
OG0020
OG0031
12
Title
Measurements
OG0000
OG0011
OG0021
OG0030
12
Title
Measurements
OG0000
OG0013
OG0022
OG0032
12
Title
Measurements
OG0000
OG0011
OG0020
OG0031
14
Title
Measurements
OG0000
OG0010
OG0022
OG0030
14
Title
Measurements
OG0000
OG0012
OG0024
OG0030
17
Title
Measurements
OG0000
OG0010
OG0021
OG0030
17
Title
Measurements
OG0001
OG0013
OG0022
OG0031
16
Title
Measurements
OG0000
OG0012
OG0022
OG0032
15
Title
Measurements
OG0000
OG0011
OG0021
OG0031
14
Title
Measurements
OG0000
OG0010
OG0020
OG0031
14
Title
Measurements
OG0000
OG0011
OG0021
OG0030
17
Title
Measurements
OG0000
OG0010
OG0020
OG0031
17
Title
Measurements
OG0001
OG0010
OG0020
OG0030
16
Title
Measurements
OG0001
OG0010
OG0020
OG0030
17
Title
Measurements
OG0001
OG0010
OG0020
OG0030
17
Title
Measurements
OG0001
OG0010
OG0020
OG0030
16
Title
Measurements
OG0000
OG0011
OG0020
OG0030
16
Title
Measurements
OG0000
OG0010
OG0020
OG0031
16
Title
Measurements
OG0001
OG0010
OG0020
OG0030
16
Title
Measurements
OG0000
OG0010
OG0021
OG0031
15
Title
Measurements
OG0000
OG0010
OG0021
OG0031
12
Title
Measurements
OG0000
OG0011
OG0021
OG0031
12
Title
Measurements
OG0001
OG0011
OG0020
OG0031
12
Title
Measurements
OG0000
OG0011
OG0021
OG0031
14
Title
Measurements
OG0001
OG0010
OG0021
OG0031
14
Title
Measurements
OG0000
OG0010
OG0020
OG0031
16
Title
Measurements
OG0001
OG0010
OG0020
OG0030
17
Title
Measurements
OG0001
OG0011
OG0020
OG0030
17
Title
Measurements
OG0000
OG0010
OG0020
OG0031
15
Title
Measurements
OG0000
OG0011
OG0020
OG0030
15
Title
Measurements
OG0001
OG0010
OG0020
OG0030
14
Title
Measurements
OG0001
OG0010
OG0020
OG0030
14
Title
Measurements
OG0000
OG0010
OG0020
OG0031
3
0
-56.66
± 14.431
2
Title
Measurements
OG000-1.81± NAStandard deviation could not be calculated due to only one participant was analyzed.
OG001-33.86± 11.039
OG002-0.71± NAStandard deviation could not be calculated due to only one participant was analyzed.