A Study to Evaluate Safety, Tolerability, and Efficacy of... | NCT01767311 | Trialant
NCT01767311
Sponsor
Eisai Inc.
Status
Completed
Last Update Posted
Mar 4, 2026Actual
Enrollment
856Actual
Phase
Phase 2
Conditions
Alzheimer's Disease
Interventions
Lecanemab 2.5 mg/kg
Lecanemab 5.0 mg/kg
Lecanemab 10 mg/kg
Lecanemab 5.0 mg/kg
Lecanemab 10 mg/kg
Placebo
Lecanemab 10 mg/kg
Countries
United States
Canada
France
Germany
Italy
Japan
Netherlands
South Korea
Spain
Sweden
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT01767311
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
BAN2401-G000-201
Secondary IDs
ID
Type
Description
Link
2012-002843-11
EudraCT Number
Brief Title
A Study to Evaluate Safety, Tolerability, and Efficacy of Lecanemab in Subjects With Early Alzheimer's Disease
Official Title
A Placebo-Controlled, Double-Blind, Parallel-Group, Bayesian Adaptive Randomization Design and Dose Regimen-finding Study With an Open-Label Extension Phase to Evaluate Safety, Tolerability and Efficacy of BAN2401 in Subjects With Early Alzheimer's Disease
Acronym
Not provided
Organization
Eisai Inc.INDUSTRY
Status Module
Record Verification Date
Jan 2026
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Dec 20, 2012Actual
Primary Completion Date
Dec 10, 2024Actual
Completion Date
Dec 10, 2024Actual
First Submitted Date
Jan 8, 2013
First Submission Date that Met QC Criteria
Jan 10, 2013
First Posted Date
Jan 14, 2013Estimated
Results Waived
Not provided
Results First Submitted Date
Dec 10, 2025
Results First Submitted that Met QC Criteria
Mar 2, 2026
Results First Posted Date
Mar 4, 2026Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Mar 2, 2026
Last Update Posted Date
Mar 4, 2026Actual
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 multinational, multicenter, double-blind, placebo-controlled, parallel-group study using a Bayesian design with response adaptive randomization across placebo or 5 active arms of lecanemab to determine clinical efficacy and to explore the dose response of lecanemab using a composite clinical score (ADCOMS). BAN2401-G000-201 Core study is an 18-month study in which 3 dose levels (2.5, 5, and 10 mg/kg) are given biweekly (once every 2 weeks) to separate groups of participants and 2 dose levels (5 and 10 mg/kg) are given monthly (once every 4 weeks) to separate groups of participants. Participants will be from 2 clinical subgroups: mild cognitive impairment (MCI) due to Alzheimer's disease (AD) or mild Alzheimer's disease dementia. Frequent interim analyses will be conducted to continually update randomization allocation on the basis of the primary clinical endpoint. Any participant who completes the study treatment (Visit 42 [Week 79] of the Core study) or discontinues the Core Study will be eligible to participate in the Extension Phase, provided they meet the Extension Phase inclusion and exclusion criteria. Participants will receive 10 mg/kg biweekly for up to 60 months or until the drug is commercially available in the country, where the subject resides, or until the benefit-to-risk ratio from treatment with lecanemab is no longer considered favorable, whichever comes first. The Follow-up Visit in the Extension Phase will take place 3 months after the last dose of study drug.
Detailed Description
Not provided
Conditions Module
Conditions
Alzheimer's Disease
Keywords
Alzheimer's Disease
BAN2401
Lecanemab
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
856Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Core Study: Lecanemab 2.5 mg/kg biweekly
Experimental
2.5 mg/kg biweekly
Drug: Lecanemab 2.5 mg/kg
Core Study: Lecanemab 5.0 mg/kg biweekly
Experimental
5.0 mg/kg biweekly
Drug: Lecanemab 5.0 mg/kg
Core Study: Lecanemab 10 mg/kg biweekly
Experimental
10 mg/kg biweekly
Drug: Lecanemab 10 mg/kg
Core Study: Lecanemab 5.0 mg/kg monthly
Experimental
5.0 mg/kg monthly
Drug: Lecanemab 5.0 mg/kg
Core Study: Lecanemab 10 mg/kg monthly
Experimental
10 mg/kg monthly
Drug: Lecanemab 10 mg/kg
Core Study: Lecanemab-matched Placebo
Placebo Comparator
Matching placebo biweekly
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Lecanemab 2.5 mg/kg
Drug
2.5 mg/kg biweekly (once every 2 weeks) administered as i.v. infusion
Core Study: Lecanemab 2.5 mg/kg biweekly
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Core Study Phase: Change From Baseline in Alzheimer's Disease Composite Score (ADCOMS) at Month 12
The ADCOMS is a composite score that comprises 4/14 items from the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog), 2 items from the Mini Mental State Examination (MMSE), and all items from the Clinical Dementia Rating (CDR). Composite score is derived from the variables from the 12 items, and ranges from 0 to 1.97, where higher score means greater impairment. Change from baseline was analyzed using Bayesian analysis. Data presented are posterior mean and posterior standard deviation.
Core Study Phase: at Month 12
Core Study Phase: Number of Participants With All Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
A TEAE is defined as an AE that emerged during treatment or within 90 days following the last dose of study drug, having been absent at pretreatment (Baseline) or reemerged during treatment, having been present at pretreatment (Baseline) but stopped before treatment, or worsened in severity during treatment relative to the pretreatment state, when the AE was continuous. 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).
From first dose of the study drug (Week 1) up to 90 days after last dose of study drug (up to 21 months)
OLE Phase: Number of Participants With All TEAEs and SAEs
A TEAE is defined as an AE that emerged during treatment or within 30 days following the last dose of study drug, having been absent at pretreatment (Baseline) or reemerged during treatment, having been present at pretreatment (Baseline) but stopped before treatment, or worsened in severity during treatment relative to the pretreatment state, when the AE was continuous. 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).
Secondary Outcomes
Measure
Description
Time Frame
Core Study Phase: Change From Baseline at Months 12 and 18 in Brain Amyloid Pathophysiology as Measured by Amyloid Positron Emission Tomography (PET)
Amyloid plaque load was identified by PET using 2 tracers (florbetapir and flutemetamol). The imaging uptake was determined via standard uptake value ratio (SUVr) versus a reference region. The SUVr is a quantitative tool and refers to the ratio of the global cortical average as compared to a reference region of choice. Whole cerebellum mask was used as the reference region of choice in this study. PET SUVr values were converted to Centiloid units. Centiloid scale anchor points are 0 and 100, where 0 represents a high-certainty amyloid negative scan and 100 represents the amount of global amyloid deposition.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Key Inclusion Criteria (Core Study) for Mild Cognitive Impairment due to Alzheimer's Disease
- Intermediate likelihood:
Subjects who meet the National Institute of Aging - Alzheimer's Association (NIA-AA) core clinical criteria for mild cognitive impairment due to Alzheimer's disease - intermediate likelihood
Subjects who have a CDR score of 0.5 and a Memory Box score of 0.5 or greater at Screening and Baseline
Subjects who report a history of subjective memory decline with gradual onset and slow progression over the last one year before Screening; MUST be corroborated by an informant
Key Inclusion Criteria (Core Study) for Mild Alzheimer's Disease Dementia:
Subjects who meet the NIA-AA core clinical criteria for probable Alzheimer's disease dementia
Subjects who have a CDR score of 0.5-1.0 and a Memory Box score of 0.5 or greater at Screening and Baseline
Inclusion Criteria (Core Study) that must be met by all subjects:
Subjects with objective impairment in episodic memory as indicated by at least 1 standard deviation below age-adjusted mean in the Wechsler Memory Scale - IV Logical Memory II (WMS-IV LMII):
Less than or equal to 15 for age 50 to 64 years
Less than or equal to 12 for age 65 to 69 years
Less than or equal to 11 for age 70 to 74 years
Less than or equal to 9 for age 75 to 79 years
Less than or equal to 7 for age 80 to 90 years
Positive amyloid load as indicated by PET or CSF assessment
PET assessment of imaging agent uptake into brain
CSF assessment of Aβ(1-42)
Age between 50 and 90 years, inclusive
Mini Mental State Examination (MMSE) score equal to or greater than 22, and equal to or less than 30, at Screening and Baseline
Body Mass Index (BMI) greater than 17 and less than 35 at Screening or Baseline
Females must not be lactating or pregnant at Screening or Baseline (as documented by a negative beta-human chorionic gonadotropin assay [ß-hCG]). A separate baseline assessment is required if a negative screening pregnancy test was obtained more than 72 hours before the first dose of study drug.
Subjects on acetylcholinesterase inhibitor or memantine therapy or both for AD must be on a stable dose for at least 12 weeks prior to Baseline. Treatment naive subjects can be entered into the study. Unless otherwise stated, subjects must have been on stable doses of all other permitted concomitant medications (ie, non-AD related) for at least 4 weeks prior to Baseline.
Subjects must have identified caregivers/informants
Subjects must provide written informed consent
Inclusion Criteria (Extension Phase):
Subjects who have completed Visit 42 (Week 79) of the Core Study or who discontinued study drug during the Core Study due to any of the following reasons:
Alzheimer's Related Imaging Abnormality-Edema (ARIA-E)
Amyloid related imaging abnormality hemorrhage (ARIA-H) (superficial siderosis, macrohemorrhage, or symptomatic microhemorrhage)
Prohibited or restricted medications that were prohibited during Core Study conduct but are no longer prohibited in the Extension Phase
Subjects who were APOE4 positive and receiving treatment with lecanemab 10 mg/kg biweekly
Any reason for discontinuation not related to prohibited medications, including any AE that was considered not related to study drug, and that was not severe or life-threatening
Must continue to have an identified caregiver or informant who is willing and able to provide follow-up information on the subject throughout the course of the Extension Phase
Provide written informed consent. If a subject lacks capacity to consent in the investigator's opinion, the subject's assent should be obtained, if required in accordance with local laws, regulations and customs, plus the written informed consent of a legal representative should be obtained (capacity to consent and definition of legal representative should be determined in accordance with applicable local laws and regulations).
Must be able to physically attend clinic visits and be willing and able to comply with all aspects of the protocol
Key Exclusion Criteria (Core study):
Any neurological condition that may be contributing to cognitive impairment above and beyond that caused by the subject's AD
History of transient ischemic attacks (TIA), stroke, or seizures within 12 months of Screening
Any psychiatric diagnosis or symptoms, (e.g., hallucinations, major depression, or delusions) that could interfere with study procedures in the subject
Geriatric Depression Scale (GDS) score ≥8 at Screening
Contraindications to MRI scanning, including cardiac pacemaker/ defibrillator, ferromagnetic metal implants, e,g., in skull and cardiac devices other than those approved as safe for use in MR scanners
Evidence of other clinically significant lesions that could indicate a dementia diagnosis other than AD on brain MRI at Screening, or other significant pathological findings on brain MRI at Screening
A prolonged QT/QTc interval (QTc greater than 450 ms) as demonstrated by a repeated electrocardiogram (ECG)
Certain other specified medical conditions
Severe visual or hearing impairment that would prevent the subject from performing psychometric tests accurately
Exclusion Criteria (Extension Phase):
Subjects who discontinued from the study drug or from the Core Study for reasons other than the following:
ARIA-E
ARIA-H (superficial siderosis, macrohemorrhage, or symptomatic microhemorrhage)
Prohibited or restricted medications that were prohibited during Core Study conduct but are no longer prohibited in the Extension Phase
Subjects who were APOE4 positive and receiving treatment with lecanemab 10 mg/kg biweekly
AE that was considered not related to study drug, and that was not severe or life-threatening
Females of childbearing potential who do not agree to use a highly effective method of contraception
Severe visual or hearing impairment that would prevent the subject from performing psychometric tests accurately.
Devanarayan V, Ye Y, Zhu L, Tian L, Kramer L, Irizarry M, Dhadda S. Predicted natural progression as an Alzheimer's prognostic covariate improves the precision of lecanemab efficacy assessments and clinical trial efficiency. Alzheimers Dement. 2025 Mar;21(3):e70045. doi: 10.1002/alz.70045.
A total of 3267 participants were screened, of which 2411 participants were screen failures, and 856 participants were randomized. Out of 856, 854 participants were treated in Core Study Phase, and 180 participants were enrolled and treated in OLE Phase.
Recruitment Details
This study has been conducted in two phases: Core Study Phase and an Open-Label Extension (OLE) Phase. Participants took part in the Core study at 149 investigative sites across the North America, Europe and Asia-Pacific. The OLE Phase was conducted at 56 investigative sites across the United States, Europe and Asia-Pacific.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Core Study Phase: Placebo
Participants received lecanemab matching-placebo as 60-minute intravenous (IV) infusions, biweekly or monthly, up to 18 months. Participants were followed up for 3 months after last dose of lecanemab matched placebo in core study phase.
FG001
Core Study Phase: Lecanemab 2.5 mg/kg Biweekly
Periods
Title
Milestones
Reasons Not Completed
Core Study Phase (18 Months)
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Sep 24, 2023
Mar 2, 2026
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
MeSH Terms
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
Drug: Placebo
Extension Phase: Lecanemab 10 mg/kg
Experimental
All participants who fulfill Extension Phase inclusion and exclusion criteria will have the option to participate in the Extension Phase to receive lecanemab 10 mg/kg biweekly for up to 60 months or until the benefit-to-risk ratio from treatment with lecanemab is no longer considered favorable, whichever comes first. Additionally, participants who have received Extension Phase treatment for at least 18 months may opt to enter the dosing regimen substudy during which they will receive either lecanemab 10 mg/kg once every 4 weeks (Q4W) or once every 3 months (Q3M).
Drug: Lecanemab 10 mg/kg
BAN2401
Lecanemab 5.0 mg/kg
Drug
5.0 mg/kg biweekly (once every 2 weeks) administered as i.v. infusion
Core Study: Lecanemab 5.0 mg/kg biweekly
BAN2401
Lecanemab 10 mg/kg
Drug
10 mg/kg biweekly (once every 2 weeks) administered as i.v. infusion.
Core Study: Lecanemab 10 mg/kg biweekly
BAN2401
Lecanemab 5.0 mg/kg
Drug
5.0 mg/kg monthly (once every 4 weeks) administered as i.v. infusion. All participants will receive biweekly infusions, participants will have placebo infusion alternating with BAN2401
Core Study: Lecanemab 5.0 mg/kg monthly
BAN2401
Lecanemab 10 mg/kg
Drug
10 mg/kg monthly (once every 4 weeks) administered as i.v. infusion. All participants will receive biweekly infusions, participants will have placebo infusion alternating with BAN2401
Core Study: Lecanemab 10 mg/kg monthly
BAN2401
Placebo
Drug
biweekly (once every 2 weeks) administered as i.v. infusion
Core Study: Lecanemab-matched Placebo
Lecanemab 10 mg/kg
Drug
10 mg/kg biweekly (once every 2 weeks), once every 4 weeks (Q4W) or once every 3 months (Q3M) i.v. infusion.
Extension Phase: Lecanemab 10 mg/kg
BAN2401
From first dose of the study drug (Week 1) up to 30 days after last dose of study drug (up to 61 months)
Core Study Phase: at Months 12 and 18
Core Study Phase: Change From Baseline in ADCOMS at Month 18
The ADCOMS is a composite score that comprises 4/14 items from the ADAS-cog, 2 items from the MMSE, and all items from the CDR. Composite score is derived from the variables from the 12 items, and ranges from 0 to 1.97, where higher score means greater impairment.
Core Study Phase: at Month 18
Core Study Phase: Change From Baseline in Clinical Dementia Rating- Sum of Boxes (CDR-SB) at Months 12 and 18
The CDR is a clinical scale that describes 5 degrees of impairment in performance on each of 6 categories of function including memory, orientation, judgment and problem solving, community affairs, home and hobbies, and personal care. The ratings of degree of impairment obtained on each of the 6 categories of function are synthesized into 1 global rating of dementia CDR score (ranging from 0 to 3). A sum of boxes score provides an additional measure of change where each category has a maximum possible score of 3 points and the total score is a sum of the category scores giving a total possible score of 0 to 18 with higher scores indicating more impairment.
Core Study Phase: at Months 12 and 18
Core Study Phase: Change From Baseline in Alzheimer Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) at Months 12 and 18
The ADAS-Cog is a cognitive scale which evaluates 14 items- memory (word recall, delayed word recall, and word recognition), reasoning (following commands), language (naming, comprehension), orientation, ideational praxis (placing letter in envelope), constructional praxis (copying geometric designs), spoken language, language comprehension, word finding difficulty, ability to remember test instructions, maze, and number cancellation. The total score ranges from 0 to 90. Higher score indicates greater cognitive impairment.
Core Study Phase: at Months 12 and 18
Core Study Phase: Change From Baseline in Cerebrospinal Fluid (CSF) Biomarker Levels at Months 12 and 18
The measurement of the amyloid proteins- Aβ(1-42) (amyloid beta monomer from amino acid 1 to 42), total (t)-tau, and phospho (p)-tau in CSF have been shown to be important biomarkers for alzheimer's disease.
Core Study Phase: at Months 12 and 18
Core Study Phase: Change From Baseline in Total Hippocampal Volume at Months 6, 12 and 18
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.
Core Study Phase: at Months 6, 12 and 18
Core Study Phase: Change From Baseline in Left and Right Hippocampal Volume at Months 6, 12 and 18
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.
Core Study Phase: at Months 6, 12 and 18
Core Study Phase: Change From Baseline in Whole Brain Volume at Months 6, 12 and 18
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.
Core Study Phase: at Months 6, 12 and 18
Core Study Phase: Change From Baseline in Total Ventricular Volume at Months 6, 12 and 18
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.
Core Study Phase: at Months 6, 12 and 18
OLE Phase: Change From OLE Baseline in Brain Amyloid Levels as Measured by Amyloid PET
Amyloid plaque load was identified by PET using 2 tracers (florbetapir and flutemetamol). The imaging uptake was determined via standard uptake value ratio (SUVr) versus a reference region. The SUVr is a quantitative tool and refers to the ratio of the global cortical average as compared to a reference region of choice. Whole cerebellum mask was used as the reference region of choice in this study. PET SUVr values were converted to Centiloid units. Centiloid scale anchor points are 0 and 100, where 0 represents a high-certainty amyloid negative scan and 100 represents the amount of global amyloid deposition. Change from OLE baseline was analyzed using the Mixed Model for Repeated Measures (MMRM) with Core Study treatment group, visit, Core Study treatment group by visit interaction, APOE4 status as fixed effects, and OLE baseline value and Gap duration as covariates.
OLE Phase: at Months 3, 6, 12, 24, 36 and 48
OLE Phase: Change From End of Core Study at the Baseline of OLE Phase in Brain Amyloid Levels as Measured by Amyloid PET
Amyloid plaque load was identified by PET using 2 tracers (florbetapir and flutemetamol). The imaging uptake was determined via standard uptake value ratio (SUVr) versus a reference region. The SUVr is a quantitative tool and refers to the ratio of the global cortical average as compared to a reference region of choice. Whole cerebellum mask was used as the reference region of choice in this study. PET SUVr values were converted to Centiloid units. Centiloid scale anchor points are 0 and 100, where 0 represents a high-certainty amyloid negative scan and 100 represents the amount of global amyloid deposition. Change from end of core study at the baseline of OLE phase was summarized using change from core study baseline at each visit.
Core Study: Baseline and at Month 18, OLE Phase: Baseline
OLE Phase: Percentage of Amyloid Positive Participants Over Time
Percentage of amyloid positive participants over time was reported. Participants who had Amyloid PET (using Centiloid scales) values greater than or equal to 30.00 were considered as amyloid positive.
OLE Phase: Baseline, at Months 3, 6, 12, 24, 36 and 48
Phoenix
Arizona
85004
United States
Facility #1
Tucson
Arizona
85724
United States
Facility #1
Carson
California
90746
United States
Facility #1
Lomita
California
90717
United States
Facility #1
Long Beach
California
90806
United States
Facility #1
Los Alamitos
California
90720
United States
Facility #1
Los Angeles
California
90024
United States
Facility #2
Los Angeles
California
90024
United States
Facility #3
Los Angeles
California
90024
United States
Facility #1
Orange
California
United States
Facility #1
Oxnard
California
93030
United States
Facility #1
San Diego
California
92123
United States
Facility #1
Denver
Colorado
80239-3133
United States
Facility #1
New Haven
Connecticut
06510
United States
Facility #2
New Haven
Connecticut
06510
United States
Facility #1
Atlantis
Florida
33462
United States
Facility #1
Boca Raton
Florida
33431
United States
Facility #2
Boca Raton
Florida
33486
United States
Facility #1
Bradenton
Florida
34205
United States
Facility #1
Deerfield Beach
Florida
33064
United States
Facility #1
Delray Beach
Florida
33445
United States
Facility #1
Fort Myers
Florida
33912
United States
Facility #1
Hallandale
Florida
33009
United States
Facility #1
Hialeah
Florida
33016
United States
Facility #1
Lake Worth
Florida
33449
United States
Facility #1
Leesburg
Florida
34748
United States
Facility #2
Leesburg
Florida
34749
United States
Facility #1
Miami
Florida
33133
United States
Facility #2
Miami
Florida
33137
United States
Facility #3
Miami
Florida
33145
United States
Facility #1
Miami Springs
Florida
33166
United States
Facility #1
Naples
Florida
34102
United States
Facility #1
Ocala
Florida
34471
United States
Facility #1
Orlando
Florida
32806
United States
Facility #1
Palm Beach Gardens
Florida
33410
United States
Facility #1
St. Petersburg
Florida
33713
United States
Facility #1
Sunrise
Florida
33351
United States
Facility #3
Tampa
Florida
33609
United States
Facility #1
Tampa
Florida
33613
United States
Facility #2
Tampa
Florida
33613
United States
Facility #1
The Villages
Florida
United States
Facility #2
Atlanta
Georgia
30308
United States
Facility #1
Atlanta
Georgia
30329
United States
Facility #1
Columbus
Georgia
31909
United States
Facility #1
Decatur
Georgia
30033
United States
Facility #1
Chicago
Illinois
60640
United States
Facility #1
Elk Grove Village
Illinois
60007
United States
Facility #1
Elkhart
Indiana
46514
United States
Facility #1
Indianapolis
Indiana
46202
United States
Facility #1
Wichita
Kansas
67214
United States
Facility #1
Lexington
Kentucky
40504
United States
Facility #1
Boston
Massachusetts
02115
United States
Facility #2
Boston
Massachusetts
02118
United States
Facility #1
Burlington
Massachusetts
01805
United States
Facility #1
Newton
Massachusetts
02459
United States
Facility #1
Ann Arbor
Michigan
48105-2945
United States
Facility #1
East Lansing
Michigan
United States
Facility #1
Farmington Hills
Michigan
48334
United States
Facility #1
Lansing
Michigan
48824
United States
Facility #1
West Bloomfield
Michigan
48322
United States
Facility #1
St Louis
Missouri
63118
United States
Facility #1
Eatontown
New Jersey
07724
United States
Facility #1
Toms River
New Jersey
08755
United States
Facility #1
Albany
New York
12206
United States
Facility #1
Amherst
New York
14226
United States
Facility #1
Latham
New York
12110
United States
Facility #1
New York
New York
10016
United States
Facility #2
New York
New York
10021
United States
Facility #1
Rochester
New York
14620
United States
Facility #2
Rochester
New York
14623
United States
Facility #1
Charlotte
North Carolina
28211
United States
Facility #1
Centerville
Ohio
45459
United States
Facility #1
Oklahoma City
Oklahoma
73112
United States
Facility #2
Oklahoma City
Oklahoma
73116
United States
Facility #2
Portland
Oregon
97210
United States
Facility #1
Portland
Oregon
97239
United States
Facility #1
Abington
Pennsylvania
19001
United States
Facility #1
Jenkintown
Pennsylvania
19046
United States
Facility #1
East Providence
Rhode Island
02914
United States
Facility #1
Knoxville
Tennessee
37920
United States
Facility #1
Austin
Texas
78757
United States
Facility #1
Dallas
Texas
75214
United States
Facility #2
Dallas
Texas
United States
Facility #1
Houston
Texas
77074
United States
Facility #1
San Antonio
Texas
78229
United States
Facility #2
San Antonio
Texas
78229
United States
Facility #3
San Antonio
Texas
78229
United States
Facility #1
Bennington
Vermont
05201
United States
Facility #1
Richmond
Virginia
23294
United States
Facility #1
Milwaukee
Wisconsin
53226
United States
Facility #1
Kentville
Nova Scotia
Canada
Facility #1
Kingston
Ontario
Canada
Facility #2
London
Ontario
Canada
Facility #1
Ottawa
Ontario
Canada
Facility #1
Peterborough
Ontario
Canada
Facility #1
Toronto
Ontario
Canada
Facility #1
Greenfield Park
Quebec
Canada
Facility #1
Montreal
Quebec
Canada
Facility #1
Verdun
Quebec
Canada
Facility #1
Québec
Canada
Facility #1
Strasbourg
Bas Rhin
France
Facility #1
Toulouse
Haute Garonne
France
Facility #1
Paris
Paris
France
Facility #1
Bron
France
Facility #1
Paris
France
Facility #1
Rennes
France
Facility #1
Villeurbanne
France
Facility #1
Gunzburg
Baden-Wurttemberg
Germany
Facility #1
Karlstadt am Main
Bavaria
Germany
Facility #1
Hanover
Lower Saxony
Germany
Facility #1
Mittweida
Saxony
Germany
Facility #1
Hoppegarten
State of Berlin
Germany
Facility #1
Berlin
Germany
Facility #2
Berlin
Germany
Facility #3
Berlin
Germany
Facility #1
Günzburg
Germany
Facility #1
Hamburg
Germany
Facility #1
Heidelberg
Germany
Facility #1
Leipzig
Germany
Facility #1
Mannheim
Germany
Facility #1
München
Germany
Facility #1
Tübingen
Germany
Facility #1
Brescia
Italy
Facility #1
Genova
Italy
Facility #1
Milan
Italy
Facility #1
Parma
Italy
Facility #1
Perugia
Italy
Facility #1
Pisa
Italy
Facility #1
Roma
Italy
Facility #2
Roma
Italy
Facility #3
Roma
Italy
Eisai Trial Site #1
Otake-shi
Hiroshima
Japan
Eisai Trial Site #1
Himeji-shi
Hyōgo
Japan
Eisai Trial Site #2
Himeji-shi
Hyōgo
Japan
Eisai Trial Site #3
Himeji-shi
Hyōgo
Japan
Eisai Trial Site #1
Kobe
Hyōgo
Japan
Eisai Trial Site #1
Nishinomiya-shi
Hyōgo
Japan
Eisai Trial Site #1
Kyoto
Kyoto
Japan
Eisai Trial Site #1
Kurashiki-shi
Okayama-ken
Japan
Eisai Trial Site #1
Osaka
Osaka
Japan
Eisai Trial Site #1
Saitama-shi
Saitama
Japan
Eisai Trial Site #1
Itabashi-ku
Tokyo-To
Japan
Eisai Trial Site #1
Shinjuku-ku
Tokyo-To
Japan
Eisai Trial Site #2
Shinjuku-ku
Tokyo-To
Japan
Facility #1
Amsterdam
Netherlands
Facility #1
Seongnam-si
Gyeonggi-do
South Korea
Facility #1
Pusan
Gyeongsangnam-do
South Korea
Facility #2
Seoul
South Korea
Facility #3
Seoul
South Korea
Facility #4
Seoul
South Korea
Facility #1
Sant Cugat Del Vallés
Barcelona
Spain
Facility #1
Donostia / San Sebastian
Guipuzcoa
Spain
Facility #1
Barakaldo
Vizcaya
Spain
Facility #1
Alicante
Spain
Facility #1
Barcelona
Spain
Facility #1
Madrid
Spain
Facility #2
Madrid
Spain
Facility #1
Seville
Spain
Facility #1
Malmö
Sweden
Facility #1
Mölndal
Sweden
Facility #1
Stockholm
Sweden
Facility #1
Uppsala
Sweden
Facility #1
London
Greater London
United Kingdom
Facility #1
Isleworth
Middlesex
United Kingdom
Facility #1
Glasgow
Renfrewshire
United Kingdom
Facility #1
Bath
United Kingdom
Facility #2
London
United Kingdom
Facility #1
Swindon
United Kingdom
Devanarayan V, Ye Y, Charil A, Andreozzi E, Sachdev P, Llano DA, Tian L, Zhu L, Hampel H, Kramer L, Dhadda S, Irizarry M; Alzheimer's Disease Neuroimaging Initiative (ADNI). Predicting clinical progression trajectories of early Alzheimer's disease patients. Alzheimers Dement. 2024 Mar;20(3):1725-1738. doi: 10.1002/alz.13565. Epub 2023 Dec 13.
Berry DA, Dhadda S, Kanekiyo M, Li D, Swanson CJ, Irizarry M, Kramer LD, Berry SM. Lecanemab for Patients With Early Alzheimer Disease: Bayesian Analysis of a Phase 2b Dose-Finding Randomized Clinical Trial. JAMA Netw Open. 2023 Apr 3;6(4):e237230. doi: 10.1001/jamanetworkopen.2023.7230.
McDade E, Cummings JL, Dhadda S, Swanson CJ, Reyderman L, Kanekiyo M, Koyama A, Irizarry M, Kramer LD, Bateman RJ. Lecanemab in patients with early Alzheimer's disease: detailed results on biomarker, cognitive, and clinical effects from the randomized and open-label extension of the phase 2 proof-of-concept study. Alzheimers Res Ther. 2022 Dec 21;14(1):191. doi: 10.1186/s13195-022-01124-2.
Dhadda S, Kanekiyo M, Li D, Swanson CJ, Irizarry M, Berry S, Kramer LD, Berry DA. Consistency of efficacy results across various clinical measures and statistical methods in the lecanemab phase 2 trial of early Alzheimer's disease. Alzheimers Res Ther. 2022 Dec 9;14(1):182. doi: 10.1186/s13195-022-01129-x.
Swanson CJ, Zhang Y, Dhadda S, Wang J, Kaplow J, Lai RYK, Lannfelt L, Bradley H, Rabe M, Koyama A, Reyderman L, Berry DA, Berry S, Gordon R, Kramer LD, Cummings JL. A randomized, double-blind, phase 2b proof-of-concept clinical trial in early Alzheimer's disease with lecanemab, an anti-Abeta protofibril antibody. Alzheimers Res Ther. 2021 Apr 17;13(1):80. doi: 10.1186/s13195-021-00813-8.
Participants received lecanemab 2.5 milligrams per kilogram (mg/kg) as 60-minute IV infusions, biweekly, up to 18 months. Participants were followed up for 3 months after last dose of lecanemab in core study phase
FG002
Core Study Phase: Lecanemab 5 mg/kg Monthly
Participants received lecanemab 5 mg/kg as 60-minute IV infusions, monthly, up to 18 months. Participants were followed up for 3 months after last dose of lecanemab in core study phase.
FG003
Core Study Phase: Lecanemab 5 mg/kg Biweekly
Participants received lecanemab 5 mg/kg as 60-minute IV infusions, biweekly, up to 18 months. Participants were followed up for 3 months after last dose of lecanemab in core study phase.
FG004
Core Study Phase: Lecanemab 10 mg/kg Monthly
Participants received lecanemab 10 mg/kg as 60-minute IV infusions, monthly, up to 18 months. Participants were followed up for 3 months after last dose of lecanemab in core study phase.
FG005
Core Study Phase: Lecanemab 10 mg/kg Biweekly
Participants received lecanemab 10 mg/kg as 60-minute IV infusions, biweekly, up to 18 months. Participants were followed up for 3 months after last dose of lecanemab in core study phase.
FG006
Open Label Extension (OLE) Phase: Lecanemab 10 mg/kg Biweekly
Participants received lecanemab 10 mg/kg as 60-minute IV infusions, biweekly, up to 60 months. Participants were followed up for 3 months after last dose of lecanemab in OLE phase.
FG000247 subjects
FG00152 subjects
FG00251 subjects
FG00392 subjects
FG004253 subjects
FG005161 subjects
FG0060 subjects
Treated
FG000245 subjects
FG00152 subjects
FG00251 subjects
FG00392 subjects
FG004253 subjects
FG005161 subjects
FG0060 subjects
Full Analysis Set (FAS)
FG000238 subjects
FG00152 subjects
FG00248 subjects
FG00389 subjects
FG004246 subjects
FG005152 subjects
FG0060 subjects
Safety Analysis Set (SAS)
FG000245 subjects
FG00152 subjects
FG00251 subjects
FG00392 subjects
FG004253 subjects
FG005161 subjects
FG0060 subjects
Not Treated
FG0002 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
PD Analysis Set (Amyloid PET)
FG00099 subjects
FG00128 subjects
FG00228 subjects
FG00327 subjects
FG00489 subjects
FG00544 subjects
FG0060 subjects
COMPLETED
FG000177 subjects
FG00135 subjects
FG00237 subjects
FG00361 subjects
FG004155 subjects
FG00587 subjects
FG0060 subjects
NOT COMPLETED
FG00070 subjects
FG00117 subjects
FG00214 subjects
FG00331 subjects
FG00498 subjects
FG00574 subjects
FG0060 subjects
Type
Comment
Reasons
Subject Choice
FG00015 subjects
FG0015 subjects
FG0022 subjects
FG0037 subjects
FG00414 subjects
FG0058 subjects
FG0060 subjects
Lost to Follow-up
FG0007 subjects
FG0010 subjects
FG0021 subjects
FG0032 subjects
FG004
Adverse Event
FG00010 subjects
FG0014 subjects
FG0022 subjects
FG0035 subjects
FG004
Withdrawal by Subject
FG00023 subjects
FG0011 subjects
FG0025 subjects
FG00313 subjects
FG004
Other
FG00015 subjects
FG0017 subjects
FG0024 subjects
FG0034 subjects
FG004
OLE Phase (60 Months)
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG006180 subjectsParticipants who completed the core study treatment (Visit 42 \[Week 79\] of core study) or discontinued core study and gave consent for OLE phase were enrolled in the OLE phase to receive lecanemab 10 mg/kg, provided they met the inclusion and exclusion criteria of OLE phase.
Treated
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Rolled Over From Core Study Part: Placebo
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
Rolled Over From Core Study Part- 2.5 mg/kg Biweekly, 5 mg/kg Monthly, or 5 mg/kg Biweekly
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
Rolled Over From Core Study Part- 10 mg/kg Monthly
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
Rolled Over From Core Study Part- 10 mg/kg Biweekly
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
Safety Analysis Set
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
PD Analysis Set (Amyloid PET)
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Dosing Regimen Substudy (DRS) - 10 mg/kg Monthly
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
DRS - 10 mg/kg Every 3 Months (Q3M)
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
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 and had at least 1 postdose safety assessment.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Core Study Phase: Placebo
Participants received lecanemab matching-placebo as 60-minute IV infusions, biweekly or monthly, up to 18 months. Participants were followed up for 3 months after last dose of lecanemab matched placebo in core study phase.
BG001
Core Study Phase: Lecanemab 2.5 mg/kg Biweekly
Participants received lecanemab 2.5 mg/kg as 60-minute IV infusions, biweekly, up to 18 months. Participants were followed up for 3 months after last dose of lecanemab in core study phase.
BG002
Core Study Phase: Lecanemab 5 mg/kg Monthly
Participants received lecanemab 5 mg/kg as 60-minute IV infusions, monthly, up to 18 months. Participants were followed up for 3 months after last dose of lecanemab in core study phase.
BG003
Core Study Phase: Lecanemab 5 mg/kg Biweekly
Participants received lecanemab 5 mg/kg as 60-minute IV infusions, biweekly, up to 18 months. Participants were followed up for 3 months after last dose of lecanemab in core study phase.
BG004
Core Study Phase: Lecanemab 10 mg/kg Monthly
Participants received lecanemab 10 mg/kg as 60-minute IV infusions, monthly, up to 18 months. Participants were followed up for 3 months after last dose of lecanemab in core study phase.
BG005
Core Study Phase: Lecanemab 10 mg/kg Biweekly
Participants received lecanemab 10 mg/kg as 60-minute IV infusions, biweekly, up to 18 months. Participants were followed up for 3 months after last dose of lecanemab in core study phase.
BG006
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000245
BG00152
BG00251
BG00392
BG004253
BG005161
BG006854
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Categorical
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
<=18 years
BG0000
BG0010
BG0020
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG000138
BG00126
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG00010
BG0014
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
White
BG000222
BG00148
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 Study Phase: Change From Baseline in Alzheimer's Disease Composite Score (ADCOMS) at Month 12
The ADCOMS is a composite score that comprises 4/14 items from the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog), 2 items from the Mini Mental State Examination (MMSE), and all items from the Clinical Dementia Rating (CDR). Composite score is derived from the variables from the 12 items, and ranges from 0 to 1.97, where higher score means greater impairment. Change from baseline was analyzed using Bayesian analysis. Data presented are posterior mean and posterior standard deviation.
The full analysis set was the group of randomized participants who received at least 1 dose of study drug and had baseline and at least 1 post dose primary efficacy measurement.
Posted
Mean
Standard Deviation
score on a scale
Core Study Phase: at Month 12
ID
Title
Description
OG000
Core Study Phase: Placebo
Participants received lecanemab matching-placebo as 60-minute IV infusions, biweekly or monthly, up to 18 months. Participants were followed up for 3 months after last dose of lecanemab matched placebo in core study phase.
OG001
Core Study Phase: Lecanemab 2.5 mg/kg Biweekly
Participants received lecanemab 2.5 mg/kg as 60-minute IV infusions, biweekly, up to 18 months. Participants were followed up for 3 months after last dose of lecanemab in core study phase.
OG002
Core Study Phase: Lecanemab 5 mg/kg Monthly
Participants received lecanemab 5 mg/kg as 60-minute IV infusions, monthly, up to 18 months. Participants were followed up for 3 months after last dose of lecanemab in core study phase.
OG003
Core Study Phase: Lecanemab 5 mg/kg Biweekly
Participants received lecanemab 5 mg/kg as 60-minute IV infusions, biweekly, up to 18 months. Participants were followed up for 3 months after last dose of lecanemab in core study phase.
OG004
Core Study Phase: Lecanemab 10 mg/kg Monthly
Participants received lecanemab 10 mg/kg as 60-minute IV infusions, monthly, up to 18 months. Participants were followed up for 3 months after last dose of lecanemab in core study phase.
OG005
Core Study Phase: Lecanemab 10 mg/kg Biweekly
Participants received lecanemab 10 mg/kg as 60-minute IV infusions, biweekly, up to 18 months. Participants were followed up for 3 months after last dose of lecanemab in core study phase.
Units
Counts
Participants
OG000238
OG00152
OG00248
OG003
Title
Denominators
Categories
Title
Measurements
OG0000.113± 0.012
OG0010.134± 0.024
OG0020.119± 0.021
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG005
Posterior Probability
63.8
The posterior probability of being better than placebo with 25% less decline.
Other
Primary
Core Study Phase: Number of Participants With All Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
A TEAE is defined as an AE that emerged during treatment or within 90 days following the last dose of study drug, having been absent at pretreatment (Baseline) or reemerged during treatment, having been present at pretreatment (Baseline) but stopped before treatment, or worsened in severity during treatment relative to the pretreatment state, when the AE was continuous. 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 and had at least 1 post dose safety assessment.
Posted
Count of Participants
Participants
From first dose of the study drug (Week 1) up to 90 days after last dose of study drug (up to 21 months)
ID
Title
Description
OG000
Core Study Phase: Placebo
Participants received lecanemab matching-placebo as 60-minute IV infusions, biweekly or monthly, up to 18 months. Participants were followed up for 3 months after last dose of lecanemab matched placebo in core study phase.
Secondary
Core Study Phase: Change From Baseline at Months 12 and 18 in Brain Amyloid Pathophysiology as Measured by Amyloid Positron Emission Tomography (PET)
Amyloid plaque load was identified by PET using 2 tracers (florbetapir and flutemetamol). The imaging uptake was determined via standard uptake value ratio (SUVr) versus a reference region. The SUVr is a quantitative tool and refers to the ratio of the global cortical average as compared to a reference region of choice. Whole cerebellum mask was used as the reference region of choice in this study. PET SUVr values were converted to Centiloid units. Centiloid scale anchor points are 0 and 100, where 0 represents a high-certainty amyloid negative scan and 100 represents the amount of global amyloid deposition.
The pharmacodynamic (PD) analysis set was the group of participants who had sufficient amyloid PET data to derive at least 1 amyloid PET parameter. Here, 'Number Analyzed' refers to number of participants analyzed at given time points.
Posted
Least Squares Mean
Standard Error
centiloids
Core Study Phase: at Months 12 and 18
ID
Title
Description
OG000
Core Study Phase: Placebo
Participants received lecanemab matching-placebo as 60-minute IV infusions, biweekly or monthly, up to 18 months. Participants were followed up for 3 months after last dose of lecanemab matched placebo in core study phase.
OG001
Core Study Phase: Lecanemab 2.5 mg/kg Biweekly
Participants received lecanemab 2.5 mg/kg as 60-minute IV infusions, biweekly, up to 18 months. Participants were followed up for 3 months after last dose of lecanemab in core study phase.
Secondary
Core Study Phase: Change From Baseline in ADCOMS at Month 18
The ADCOMS is a composite score that comprises 4/14 items from the ADAS-cog, 2 items from the MMSE, and all items from the CDR. Composite score is derived from the variables from the 12 items, and ranges from 0 to 1.97, where higher score means greater impairment.
The full analysis set was the group of randomized participants who received at least 1 dose of study drug and had baseline and at least 1 post dose primary efficacy measurement. Here, 'Number of Participants Analyzed' refers to number of participants analyzed at given time point.
Posted
Least Squares Mean
Standard Error
score on a scale
Core Study Phase: at Month 18
ID
Title
Description
OG000
Core Study Phase: Placebo
Participants received lecanemab matching-placebo as 60-minute IV infusions, biweekly or monthly, up to 18 months. Participants were followed up for 3 months after last dose of lecanemab matched placebo in core study phase.
OG001
Core Study Phase: Lecanemab 2.5 mg/kg Biweekly
Participants received lecanemab 2.5 mg/kg as 60-minute IV infusions, biweekly, up to 18 months. Participants were followed up for 3 months after last dose of lecanemab in core study phase.
OG002
Core Study Phase: Lecanemab 5 mg/kg Monthly
Secondary
Core Study Phase: Change From Baseline in Clinical Dementia Rating- Sum of Boxes (CDR-SB) at Months 12 and 18
The CDR is a clinical scale that describes 5 degrees of impairment in performance on each of 6 categories of function including memory, orientation, judgment and problem solving, community affairs, home and hobbies, and personal care. The ratings of degree of impairment obtained on each of the 6 categories of function are synthesized into 1 global rating of dementia CDR score (ranging from 0 to 3). A sum of boxes score provides an additional measure of change where each category has a maximum possible score of 3 points and the total score is a sum of the category scores giving a total possible score of 0 to 18 with higher scores indicating more impairment.
The full analysis set was the group of randomized participants who received at least 1 dose of study drug and had baseline and at least 1 post dose primary efficacy measurement. Here, 'Number Analyzed' refers to number of participants analyzed at given time points.
Posted
Least Squares Mean
Standard Error
score on a scale
Core Study Phase: at Months 12 and 18
ID
Title
Description
OG000
Core Study Phase: Placebo
Participants received lecanemab matching-placebo as 60-minute IV infusions, biweekly or monthly, up to 18 months. Participants were followed up for 3 months after last dose of lecanemab matched placebo in core study phase.
OG001
Core Study Phase: Lecanemab 2.5 mg/kg Biweekly
Secondary
Core Study Phase: Change From Baseline in Alzheimer Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) at Months 12 and 18
The ADAS-Cog is a cognitive scale which evaluates 14 items- memory (word recall, delayed word recall, and word recognition), reasoning (following commands), language (naming, comprehension), orientation, ideational praxis (placing letter in envelope), constructional praxis (copying geometric designs), spoken language, language comprehension, word finding difficulty, ability to remember test instructions, maze, and number cancellation. The total score ranges from 0 to 90. Higher score indicates greater cognitive impairment.
The full analysis set was the group of randomized participants who received at least 1 dose of study drug and had baseline and at least 1 post dose primary efficacy measurement. Here, 'Number Analyzed' refers to number of participants analyzed at given time points.
Posted
Least Squares Mean
Standard Error
score on a scale
Core Study Phase: at Months 12 and 18
ID
Title
Description
OG000
Core Study Phase: Placebo
Participants received lecanemab matching-placebo as 60-minute IV infusions, biweekly or monthly, up to 18 months. Participants were followed up for 3 months after last dose of lecanemab matched placebo in core study phase.
OG001
Core Study Phase: Lecanemab 2.5 mg/kg Biweekly
Participants received lecanemab 2.5 mg/kg as 60-minute IV infusions, biweekly, up to 18 months. Participants were followed up for 3 months after last dose of lecanemab in core study phase.
Secondary
Core Study Phase: Change From Baseline in Cerebrospinal Fluid (CSF) Biomarker Levels at Months 12 and 18
The measurement of the amyloid proteins- Aβ(1-42) (amyloid beta monomer from amino acid 1 to 42), total (t)-tau, and phospho (p)-tau in CSF have been shown to be important biomarkers for alzheimer's disease.
The PD analysis set was the group of participants who had sufficient CSF data to derive at least 1 CSF parameter. Here, 'Number Analyzed' refers to number of participants analyzed at given time points.
Posted
Least Squares Mean
Standard Error
picogram per milliliter (pg/mL)
Core Study Phase: at Months 12 and 18
ID
Title
Description
OG000
Core Study Phase: Placebo
Participants received lecanemab matching-placebo as 60-minute IV infusions, biweekly or monthly, up to 18 months. Participants were followed up for 3 months after last dose of lecanemab matched placebo in core study phase.
OG001
Core Study Phase: Lecanemab 2.5 mg/kg Biweekly
Participants received lecanemab 2.5 mg/kg as 60-minute IV infusions, biweekly, up to 18 months. Participants were followed up for 3 months after last dose of lecanemab in core study phase.
OG002
Core Study Phase: Lecanemab 5 mg/kg Monthly
Secondary
Core Study Phase: Change From Baseline in Total Hippocampal Volume at Months 6, 12 and 18
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 PD analysis set was the group of participants who had sufficient vMRI data to derive at least 1 vMRI parameter. Here, 'Number Analyzed' refers to number of participants analyzed at given time points.
Posted
Least Squares Mean
Standard Error
cubic millimeters
Core Study Phase: at Months 6, 12 and 18
ID
Title
Description
OG000
Core Study Phase: Placebo
Participants received lecanemab matching-placebo as 60-minute IV infusions, biweekly or monthly, up to 18 months. Participants were followed up for 3 months after last dose of lecanemab matched placebo in core study phase.
OG001
Core Study Phase: Lecanemab 2.5 mg/kg Biweekly
Participants received lecanemab 2.5 mg/kg as 60-minute IV infusions, biweekly, up to 18 months. Participants were followed up for 3 months after last dose of lecanemab in core study phase.
OG002
Core Study Phase: Lecanemab 5 mg/kg Monthly
Secondary
Core Study Phase: Change From Baseline in Left and Right Hippocampal Volume at Months 6, 12 and 18
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 PD analysis set was the group of participants who had sufficient vMRI data to derive at least 1 vMRI parameter. Here, 'Number Analyzed' refers to number of participants analyzed at given time points.
Posted
Least Squares Mean
Standard Error
cubic millimeters
Core Study Phase: at Months 6, 12 and 18
ID
Title
Description
OG000
Core Study Phase: Placebo
Participants received lecanemab matching-placebo as 60-minute IV infusions, biweekly or monthly, up to 18 months. Participants were followed up for 3 months after last dose of lecanemab matched placebo in core study phase.
OG001
Core Study Phase: Lecanemab 2.5 mg/kg Biweekly
Participants received lecanemab 2.5 mg/kg as 60-minute IV infusions, biweekly, up to 18 months. Participants were followed up for 3 months after last dose of lecanemab in core study phase.
OG002
Core Study Phase: Lecanemab 5 mg/kg Monthly
Secondary
Core Study Phase: Change From Baseline in Whole Brain Volume at Months 6, 12 and 18
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 PD analysis set was the group of participants who had sufficient vMRI data to derive at least 1 vMRI parameter. Here, 'Number Analyzed' refers to number of participants analyzed at given time points.
Posted
Least Squares Mean
Standard Error
cubic millimeters
Core Study Phase: at Months 6, 12 and 18
ID
Title
Description
OG000
Core Study Phase: Placebo
Participants received lecanemab matching-placebo as 60-minute IV infusions, biweekly or monthly, up to 18 months. Participants were followed up for 3 months after last dose of lecanemab matched placebo in core study phase.
OG001
Core Study Phase: Lecanemab 2.5 mg/kg Biweekly
Participants received lecanemab 2.5 mg/kg as 60-minute IV infusions, biweekly, up to 18 months. Participants were followed up for 3 months after last dose of lecanemab in core study phase.
OG002
Core Study Phase: Lecanemab 5 mg/kg Monthly
Secondary
Core Study Phase: Change From Baseline in Total Ventricular Volume at Months 6, 12 and 18
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 PD analysis set was the group of participants who had sufficient vMRI data to derive at least 1 vMRI parameter. Here, 'Number Analyzed' refers to number of participants analyzed at given time points.
Posted
Least Squares Mean
Standard Error
cubic millimeters
Core Study Phase: at Months 6, 12 and 18
ID
Title
Description
OG000
Core Study Phase: Placebo
Participants received lecanemab matching-placebo as 60-minute IV infusions, biweekly or monthly, up to 18 months. Participants were followed up for 3 months after last dose of lecanemab matched placebo in core study phase.
OG001
Core Study Phase: Lecanemab 2.5 mg/kg Biweekly
Participants received lecanemab 2.5 mg/kg as 60-minute IV infusions, biweekly, up to 18 months. Participants were followed up for 3 months after last dose of lecanemab in core study phase.
OG002
Secondary
OLE Phase: Change From OLE Baseline in Brain Amyloid Levels as Measured by Amyloid PET
Amyloid plaque load was identified by PET using 2 tracers (florbetapir and flutemetamol). The imaging uptake was determined via standard uptake value ratio (SUVr) versus a reference region. The SUVr is a quantitative tool and refers to the ratio of the global cortical average as compared to a reference region of choice. Whole cerebellum mask was used as the reference region of choice in this study. PET SUVr values were converted to Centiloid units. Centiloid scale anchor points are 0 and 100, where 0 represents a high-certainty amyloid negative scan and 100 represents the amount of global amyloid deposition. Change from OLE baseline was analyzed using the Mixed Model for Repeated Measures (MMRM) with Core Study treatment group, visit, Core Study treatment group by visit interaction, APOE4 status as fixed effects, and OLE baseline value and Gap duration as covariates.
OLE PD Analysis Set was the group of participants who had sufficient PD data to derive at least 1 PD parameter during OLE Phase. Here, 'Number Analyzed' refers to number of participants analyzed at given time points.
Posted
Least Squares Mean
Standard Error
centiloids
OLE Phase: at Months 3, 6, 12, 24, 36 and 48
ID
Title
Description
OG000
OLE Phase: Newly Treated Core Placebo
Participants randomized to placebo in the Core Study and newly-treated with lecanemab 10 mg/kg, biweekly, in the OLE phase.
OG001
OLE Phase: Re-treated Core Lower Doses
Secondary
OLE Phase: Change From End of Core Study at the Baseline of OLE Phase in Brain Amyloid Levels as Measured by Amyloid PET
Amyloid plaque load was identified by PET using 2 tracers (florbetapir and flutemetamol). The imaging uptake was determined via standard uptake value ratio (SUVr) versus a reference region. The SUVr is a quantitative tool and refers to the ratio of the global cortical average as compared to a reference region of choice. Whole cerebellum mask was used as the reference region of choice in this study. PET SUVr values were converted to Centiloid units. Centiloid scale anchor points are 0 and 100, where 0 represents a high-certainty amyloid negative scan and 100 represents the amount of global amyloid deposition. Change from end of core study at the baseline of OLE phase was summarized using change from core study baseline at each visit.
The OLE enrolled set was the group of participants who were enrolled in OLE phase. Here, 'Number Analyzed' refers to number of participants analyzed at given time points.
Posted
Mean
Standard Deviation
centiloids
Core Study: Baseline and at Month 18, OLE Phase: Baseline
ID
Title
Description
OG000
OLE Phase: Newly Treated Core Placebo
Participants randomized to placebo in the Core Study and newly-treated with lecanemab 10 mg/kg, biweekly, in the OLE phase.
OG001
OLE Phase: Re-treated Core Lower Doses
Participants randomized to 2.5 mg/kg biweekly, 5 mg/kg monthly, or 5 mg/kg biweekly in the Core Study and re-treated with lecanemab 10 mg/kg, biweekly, in the OLE phase.
Secondary
OLE Phase: Percentage of Amyloid Positive Participants Over Time
Percentage of amyloid positive participants over time was reported. Participants who had Amyloid PET (using Centiloid scales) values greater than or equal to 30.00 were considered as amyloid positive.
The OLE PD analysis set was the group of participants who had sufficient PD data to derive at least 1 PD parameter during the OLE Phase. Here, 'Number Analyzed' refers to number of participants analyzed at given time points.
Posted
Number
percentage of participants
OLE Phase: Baseline, at Months 3, 6, 12, 24, 36 and 48
ID
Title
Description
OG000
OLE Phase: Newly Treated Core Placebo
Participants randomized to placebo in the Core Study and newly-treated with lecanemab 10 mg/kg, biweekly, in the OLE phase.
OG001
OLE Phase: Re-treated Core Lower Doses
Participants randomized to 2.5 mg/kg biweekly, 5 mg/kg monthly, or 5 mg/kg biweekly in the Core Study and re-treated with lecanemab 10 mg/kg, biweekly, in the OLE phase.
OG002
OLE Phase: Re-treated Core 10 mg/kg Monthly
Participants randomized to 10 mg/kg monthly in the Core Study and re-treated with lecanemab 10 mg/kg, biweekly, in the OLE phase.
Primary
OLE Phase: Number of Participants With All TEAEs and SAEs
A TEAE is defined as an AE that emerged during treatment or within 30 days following the last dose of study drug, having been absent at pretreatment (Baseline) or reemerged during treatment, having been present at pretreatment (Baseline) but stopped before treatment, or worsened in severity during treatment relative to the pretreatment state, when the AE was continuous. 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 one active dose of study drug during the OLE Phase.
Posted
Count of Participants
Participants
From first dose of the study drug (Week 1) up to 30 days after last dose of study drug (up to 61 months)
ID
Title
Description
OG000
OLE Phase: Lecanemab 10 mg/kg Biweekly
Participants received lecanemab 10 mg/kg as 60-minute IV infusions, biweekly, up to 60 months. Participants were followed up for 3 months after last dose of lecanemab in OLE phase.
Time Frame
Core Phase: From first dose of the study drug (Week 1) up to 90 days after last dose of study drug (up to 21 months); OLE Phase: From first dose of the study drug (Week 1) up to 30 days after last dose of study drug (up to 61 months)
Description
Adverse events were collected for all the participants who were in the SAS. For core phase, SAS was the group of participants who received at least 1 dose of study drug and had at least 1 post dose safety assessment. For OLE phase, SAS was the group of participants who received at least one active dose of study drug. MedDRA Version 20.1 was used for core phase and Version 25.0 was used for OLE phase as source vocabularies.
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 Study Phase: Placebo
Participants received lecanemab matching-placebo as 60-minute IV infusions, biweekly or monthly, up to 18 months. Participants were followed up for 3 months after last dose of lecanemab matched placebo in core study phase.
2
245
43
245
212
245
EG001
Core Study Phase: Lecanemab 2.5 mg/kg Biweekly
Participants received lecanemab 2.5 mg/kg as 60-minute IV infusions, biweekly, up to 18 months. Participants were followed up for 3 months after last dose of lecanemab in core study phase.
2
52
10
52
46
52
EG002
Core Study Phase: Lecanemab 5 mg/kg Monthly
Participants received lecanemab 5 mg/kg as 60-minute IV infusions, monthly, up to 18 months. Participants were followed up for 3 months after last dose of lecanemab in core study phase.
0
51
4
51
48
51
EG003
Core Study Phase: Lecanemab 5 mg/kg Biweekly
Participants received lecanemab 5 mg/kg as 60-minute IV infusions, biweekly, up to 18 months. Participants were followed up for 3 months after last dose of lecanemab in core study phase.
1
92
16
92
80
92
EG004
Core Study Phase: Lecanemab 10 mg/kg Monthly
Participants received lecanemab 10 mg/kg as 60-minute IV infusions, monthly, up to 18 months. Participants were followed up for 3 months after last dose of lecanemab in core study phase.
2
253
31
253
237
253
EG005
Core Study Phase: Lecanemab 10 mg/kg Biweekly
Participants received lecanemab 10 mg/kg as 60-minute IV infusions, biweekly, up to 18 months. Participants were followed up for 3 months after last dose of lecanemab in core study phase.
0
161
25
161
135
161
EG006
OLE Phase: Lecanemab 10 mg/kg Biweekly
Participants received lecanemab 10 mg/kg as 60-minute IV infusions, biweekly, up to 60 months. Participants were followed up for 3 months after last dose of lecanemab in OLE phase.
5
180
60
180
169
180
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA v20.1; v25.0
Systematic Assessment
EG0000 events0 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG0030 events0 affected92 at risk
EG0040 events0 affected253 at risk
EG0051 events1 affected161 at risk
EG0060 events0 affected180 at risk
Coagulopathy
Blood and lymphatic system disorders
MedDRA v20.1; v25.0
Systematic Assessment
EG0000 events0 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
MedDRA v20.1; v25.0
Systematic Assessment
EG0000 events0 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Angina pectoris
Cardiac disorders
MedDRA v20.1; v25.0
Systematic Assessment
EG0001 events1 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Angina unstable
Cardiac disorders
MedDRA v20.1; v25.0
Systematic Assessment
EG0001 events1 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA v20.1; v25.0
Systematic Assessment
EG0000 events0 affected245 at risk
EG0011 events1 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Atrioventricular block complete
Cardiac disorders
MedDRA v20.1; v25.0
Systematic Assessment
EG0000 events0 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Bradycardia
Cardiac disorders
MedDRA v20.1; v25.0
Systematic Assessment
EG0000 events0 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Cardiac arrest
Cardiac disorders
MedDRA v20.1; v25.0
Systematic Assessment
EG0000 events0 affected245 at risk
EG0011 events1 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Cardiac failure congestive
Cardiac disorders
MedDRA v20.1; v25.0
Systematic Assessment
EG0000 events0 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Coronary artery disease
Cardiac disorders
MedDRA v20.1; v25.0
Systematic Assessment
EG0000 events0 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Coronary artery stenosis
Cardiac disorders
MedDRA v20.1; v25.0
Systematic Assessment
EG0000 events0 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA v20.1; v25.0
Systematic Assessment
EG0000 events0 affected245 at risk
EG0011 events1 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Sinus bradycardia
Cardiac disorders
MedDRA v20.1; v25.0
Systematic Assessment
EG0001 events1 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Sinus node dysfunction
Cardiac disorders
MedDRA v20.1; v25.0
Systematic Assessment
EG0001 events1 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Stress cardiomyopathy
Cardiac disorders
MedDRA v20.1; v25.0
Systematic Assessment
EG0000 events0 affected245 at risk
EG0011 events1 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Ventricular tachycardia
Cardiac disorders
MedDRA v20.1; v25.0
Systematic Assessment
EG0000 events0 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA v20.1; v25.0
Systematic Assessment
EG0001 events1 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Retinal detachment
Eye disorders
MedDRA v20.1; v25.0
Systematic Assessment
EG0000 events0 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA v20.1; v25.0
Systematic Assessment
EG0001 events1 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA v20.1; v25.0
Systematic Assessment
EG0000 events0 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Enterocolitis
Gastrointestinal disorders
MedDRA v20.1; v25.0
Systematic Assessment
EG0000 events0 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA v20.1; v25.0
Systematic Assessment
EG0000 events0 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Inguinal hernia
Gastrointestinal disorders
MedDRA v20.1; v25.0
Systematic Assessment
EG0001 events1 affected245 at risk
EG0011 events1 affected52 at risk
EG0021 events1 affected51 at risk
EG003
Intestinal mass
Gastrointestinal disorders
MedDRA v20.1; v25.0
Systematic Assessment
EG0000 events0 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Intestinal obstruction
Gastrointestinal disorders
MedDRA v20.1; v25.0
Systematic Assessment
EG0000 events0 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Oesophageal food impaction
Gastrointestinal disorders
MedDRA v20.1; v25.0
Systematic Assessment
EG0000 events0 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Upper gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA v20.1; v25.0
Systematic Assessment
EG0000 events0 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA v20.1; v25.0
Systematic Assessment
EG0001 events1 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Chest pain
General disorders
MedDRA v20.1; v25.0
Systematic Assessment
EG0000 events0 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Cyst
General disorders
MedDRA v20.1; v25.0
Systematic Assessment
EG0001 events1 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Fatigue
General disorders
MedDRA v20.1; v25.0
Systematic Assessment
EG0000 events0 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Multiple organ dysfunction syndrome
General disorders
MedDRA v20.1; v25.0
Systematic Assessment
EG0000 events0 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA v20.1; v25.0
Systematic Assessment
EG0000 events0 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Peripheral swelling
General disorders
MedDRA v20.1; v25.0
Systematic Assessment
EG0000 events0 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Pyrexia
General disorders
MedDRA v20.1; v25.0
Systematic Assessment
EG0001 events1 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Ulcer haemorrhage
General disorders
MedDRA v20.1; v25.0
Systematic Assessment
EG0000 events0 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Cholangitis acute
Hepatobiliary disorders
MedDRA v20.1; v25.0
Systematic Assessment
EG0000 events0 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Cholecystitis chronic
Hepatobiliary disorders
MedDRA v20.1; v25.0
Systematic Assessment
EG0000 events0 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Hepatic failure
Hepatobiliary disorders
MedDRA v20.1; v25.0
Systematic Assessment
EG0000 events0 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Hepatitis acute
Hepatobiliary disorders
MedDRA v20.1; v25.0
Systematic Assessment
EG0000 events0 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Appendicitis
Infections and infestations
MedDRA v20.1; v25.0
Systematic Assessment
EG0001 events1 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Bacteraemia
Infections and infestations
MedDRA v20.1; v25.0
Systematic Assessment
EG0000 events0 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Cellulitis
Infections and infestations
MedDRA v20.1; v25.0
Systematic Assessment
EG0000 events0 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Clostridial sepsis
Infections and infestations
MedDRA v20.1; v25.0
Systematic Assessment
EG0001 events1 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Clostridium difficile colitis
Infections and infestations
MedDRA v20.1; v25.0
Systematic Assessment
EG0001 events1 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Clostridium difficile infection
Infections and infestations
MedDRA v20.1; v25.0
Systematic Assessment
EG0000 events0 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Diverticulitis
Infections and infestations
MedDRA v20.1; v25.0
Systematic Assessment
EG0001 events1 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Influenza
Infections and infestations
MedDRA v20.1; v25.0
Systematic Assessment
EG0000 events0 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Pneumonia
Infections and infestations
MedDRA v20.1; v25.0
Systematic Assessment
EG0000 events0 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Sepsis
Infections and infestations
MedDRA v20.1; v25.0
Systematic Assessment
EG0000 events0 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Streptococcal sepsis
Infections and infestations
MedDRA v20.1; v25.0
Systematic Assessment
EG0000 events0 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA v20.1; v25.0
Systematic Assessment
EG0000 events0 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA v20.1; v25.0
Systematic Assessment
EG0001 events1 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Urosepsis
Infections and infestations
MedDRA v20.1; v25.0
Systematic Assessment
EG0001 events1 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Alcohol poisoning
Injury, poisoning and procedural complications
MedDRA v20.1; v25.0
Systematic Assessment
EG0001 events1 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Ankle fracture
Injury, poisoning and procedural complications
MedDRA v20.1; v25.0
Systematic Assessment
EG0000 events0 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Craniocerebral injury
Injury, poisoning and procedural complications
MedDRA v20.1; v25.0
Systematic Assessment
EG0000 events0 affected245 at risk
EG0010 events0 affected52 at risk
EG0021 events1 affected51 at risk
EG003
Facial bones fracture
Injury, poisoning and procedural complications
MedDRA v20.1; v25.0
Systematic Assessment
EG0001 events1 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA v20.1; v25.0
Systematic Assessment
EG0004 events4 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Femoral neck fracture
Injury, poisoning and procedural complications
MedDRA v20.1; v25.0
Systematic Assessment
EG0000 events0 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Femur fracture
Injury, poisoning and procedural complications
MedDRA v20.1; v25.0
Systematic Assessment
EG0001 events1 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Hip fracture
Injury, poisoning and procedural complications
MedDRA v20.1; v25.0
Systematic Assessment
EG0001 events1 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Humerus fracture
Injury, poisoning and procedural complications
MedDRA v20.1; v25.0
Systematic Assessment
EG0001 events1 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA v20.1; v25.0
Systematic Assessment
EG0000 events0 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Jaw fracture
Injury, poisoning and procedural complications
MedDRA v20.1; v25.0
Systematic Assessment
EG0001 events1 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Patella fracture
Injury, poisoning and procedural complications
MedDRA v20.1; v25.0
Systematic Assessment
EG0000 events0 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Pelvic fracture
Injury, poisoning and procedural complications
MedDRA v20.1; v25.0
Systematic Assessment
EG0001 events1 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Post procedural haemorrhage
Injury, poisoning and procedural complications
MedDRA v20.1; v25.0
Systematic Assessment
EG0001 events1 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Rib fracture
Injury, poisoning and procedural complications
MedDRA v20.1; v25.0
Systematic Assessment
EG0001 events1 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Spinal cord injury
Injury, poisoning and procedural complications
MedDRA v20.1; v25.0
Systematic Assessment
EG0000 events0 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Splenic rupture
Injury, poisoning and procedural complications
MedDRA v20.1; v25.0
Systematic Assessment
EG0000 events0 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Sternal fracture
Injury, poisoning and procedural complications
MedDRA v20.1; v25.0
Systematic Assessment
EG0001 events1 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Subdural haematoma
Injury, poisoning and procedural complications
MedDRA v20.1; v25.0
Systematic Assessment
EG0002 events2 affected245 at risk
EG0011 events1 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Subdural haemorrhage
Injury, poisoning and procedural complications
MedDRA v20.1; v25.0
Systematic Assessment
EG0000 events0 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Thoracic vertebral fracture
Injury, poisoning and procedural complications
MedDRA v20.1; v25.0
Systematic Assessment
EG0001 events1 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Upper limb fracture
Injury, poisoning and procedural complications
MedDRA v20.1; v25.0
Systematic Assessment
EG0000 events0 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Wound dehiscence
Injury, poisoning and procedural complications
MedDRA v20.1; v25.0
Systematic Assessment
EG0000 events0 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Blood creatinine abnormal
Investigations
MedDRA v20.1; v25.0
Systematic Assessment
EG0000 events0 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Hypernatraemia
Metabolism and nutrition disorders
MedDRA v20.1; v25.0
Systematic Assessment
EG0000 events0 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA v20.1; v25.0
Systematic Assessment
EG0000 events0 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA v20.1; v25.0
Systematic Assessment
EG0000 events0 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA v20.1; v25.0
Systematic Assessment
EG0000 events0 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA v20.1; v25.0
Systematic Assessment
EG0001 events1 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Intervertebral disc protrusion
Musculoskeletal and connective tissue disorders
MedDRA v20.1; v25.0
Systematic Assessment
EG0000 events0 affected245 at risk
EG0010 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA v20.1; v25.0
Systematic Assessment
EG0004 events4 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Rhabdomyolysis
Musculoskeletal and connective tissue disorders
MedDRA v20.1; v25.0
Systematic Assessment
EG0000 events0 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Adenocarcinoma of colon
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v20.1; v25.0
Systematic Assessment
EG0000 events0 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Brain neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v20.1; v25.0
Systematic Assessment
EG0000 events0 affected245 at risk
EG0011 events1 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Ductal adenocarcinoma of pancreas
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v20.1; v25.0
Systematic Assessment
EG0000 events0 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 affected51 at risk
EG003
Hepatocellular carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v20.1; v25.0
Systematic Assessment
EG0001 events1 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Intraductal proliferative breast lesion
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v20.1; v25.0
Systematic Assessment
EG0001 events1 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Invasive ductal breast carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v20.1; v25.0
Systematic Assessment
EG0001 events1 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Lymphoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v20.1; v25.0
Systematic Assessment
EG0000 events0 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Malignant melanoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v20.1; v25.0
Systematic Assessment
EG0001 events1 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Prostate cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v20.1; v25.0
Systematic Assessment
EG0000 events0 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Sarcoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v20.1; v25.0
Systematic Assessment
EG0001 events1 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Transitional cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v20.1; v25.0
Systematic Assessment
EG0000 events0 affected245 at risk
EG0010 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Altered state of consciousness
Nervous system disorders
MedDRA v20.1; v25.0
Systematic Assessment
EG0000 events0 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Amyloid related imaging abnormalities
Nervous system disorders
MedDRA v20.1; v25.0
Systematic Assessment
EG0000 events0 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Aphasia
Nervous system disorders
MedDRA v20.1; v25.0
Systematic Assessment
EG0000 events0 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Cerebral artery thrombosis
Nervous system disorders
MedDRA v20.1; v25.0
Systematic Assessment
EG0001 events1 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Cerebral microhaemorrhage
Nervous system disorders
MedDRA v20.1; v25.0
Systematic Assessment
EG0000 events0 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA v20.1; v25.0
Systematic Assessment
EG0001 events1 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Cervical radiculopathy
Nervous system disorders
MedDRA v20.1; v25.0
Systematic Assessment
EG0000 events0 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Dizziness
Nervous system disorders
MedDRA v20.1; v25.0
Systematic Assessment
EG0001 events1 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Embolic stroke
Nervous system disorders
MedDRA v20.1; v25.0
Systematic Assessment
EG0001 events1 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Focal dyscognitive seizures
Nervous system disorders
MedDRA v20.1; v25.0
Systematic Assessment
EG0000 events0 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Haemorrhagic transformation stroke
Nervous system disorders
MedDRA v20.1; v25.0
Systematic Assessment
EG0000 events0 affected245 at risk
EG0011 events1 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Headache
Nervous system disorders
MedDRA v20.1; v25.0
Systematic Assessment
EG0001 events1 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Hypoglycaemic seizure
Nervous system disorders
MedDRA v20.1; v25.0
Systematic Assessment
EG0000 events0 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Ischaemic stroke
Nervous system disorders
MedDRA v20.1; v25.0
Systematic Assessment
EG0000 events0 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Metabolic encephalopathy
Nervous system disorders
MedDRA v20.1; v25.0
Systematic Assessment
EG0000 events0 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Normal pressure hydrocephalus
Nervous system disorders
MedDRA v20.1; v25.0
Systematic Assessment
EG0000 events0 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Presyncope
Nervous system disorders
MedDRA v20.1; v25.0
Systematic Assessment
EG0000 events0 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Seizure
Nervous system disorders
MedDRA v20.1; v25.0
Systematic Assessment
EG0000 events0 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Syncope
Nervous system disorders
MedDRA v20.1; v25.0
Systematic Assessment
EG0003 events3 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Transient ischaemic attack
Nervous system disorders
MedDRA v20.1; v25.0
Systematic Assessment
EG0001 events1 affected245 at risk
EG0010 events0 affected52 at risk
EG0022 events2 affected51 at risk
EG003
Device breakage
Product Issues
MedDRA v20.1; v25.0
Systematic Assessment
EG0000 events0 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Aggression
Psychiatric disorders
MedDRA v20.1; v25.0
Systematic Assessment
EG0000 events0 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Agitation
Psychiatric disorders
MedDRA v20.1; v25.0
Systematic Assessment
EG0000 events0 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Delirium
Psychiatric disorders
MedDRA v20.1; v25.0
Systematic Assessment
EG0001 events1 affected24 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Hallucination
Psychiatric disorders
MedDRA v20.1; v25.0
Systematic Assessment
EG0000 events0 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Mental status changes
Psychiatric disorders
MedDRA v20.1; v25.0
Systematic Assessment
EG0000 events0 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Psychotic disorder
Psychiatric disorders
MedDRA v20.1; v25.0
Systematic Assessment
EG0001 events1 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Suicidal ideation
Psychiatric disorders
MedDRA v20.1; v25.0
Systematic Assessment
EG0000 events0 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA v20.1; v25.0
Systematic Assessment
EG0000 events0 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA v20.1; v25.0
Systematic Assessment
EG0001 events1 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Urinary retention
Renal and urinary disorders
MedDRA v20.1; v25.0
Systematic Assessment
EG0000 events0 affected245 at risk
EG0010 events0 affected52 at risk
EG0021 events1 affected51 at risk
EG003
Benign prostatic hyperplasia
Reproductive system and breast disorders
MedDRA v20.1; v25.0
Systematic Assessment
EG0000 events0 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Vaginal prolapse
Reproductive system and breast disorders
MedDRA v20.1; v25.0
Systematic Assessment
EG0001 events1 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Acute respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA v20.1; v25.0
Systematic Assessment
EG0001 events1 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA v20.1; v25.0
Systematic Assessment
EG0000 events0 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA v20.1; v25.0
Systematic Assessment
EG0000 events0 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA v20.1; v25.0
Systematic Assessment
EG0000 events0 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Pulmonary mass
Respiratory, thoracic and mediastinal disorders
MedDRA v20.1; v25.0
Systematic Assessment
EG0000 events0 affected245 at risk
EG0012 events2 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA v20.1; v25.0
Systematic Assessment
EG0000 events0 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Axillary vein thrombosis
Vascular disorders
MedDRA v20.1; v25.0
Systematic Assessment
EG0000 events0 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Internal haemorrhage
Vascular disorders
MedDRA v20.1; v25.0
Systematic Assessment
EG0000 events0 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Blood loss anaemia
Blood and lymphatic system disorders
MedDRA v20.1; v25.0
Systematic Assessment
EG0000 events0 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Pancytopenia
Blood and lymphatic system disorders
MedDRA v20.1; v25.0
Systematic Assessment
EG0000 events0 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Aortic valve stenosis
Cardiac disorders
MedDRA v20.1; v25.0
Systematic Assessment
EG0000 events0 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Arrhythmia
Cardiac disorders
MedDRA v20.1; v25.0
Systematic Assessment
EG0000 events0 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA v20.1; v25.0
Systematic Assessment
EG0000 events0 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA v20.1; v25.0
Systematic Assessment
EG0000 events0 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA v20.1; v25.0
Systematic Assessment
EG0000 events0 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Pancreatitis acute
Gastrointestinal disorders
MedDRA v20.1; v25.0
Systematic Assessment
EG0000 events0 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA v20.1; v25.0
Systematic Assessment
EG0000 events0 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Asthenia
General disorders
MedDRA v20.1; v25.0
Systematic Assessment
EG0000 events0 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Chest discomfort
General disorders
MedDRA v20.1; v25.0
Systematic Assessment
EG0000 events0 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Abdominal infection
Infections and infestations
MedDRA v20.1; v25.0
Systematic Assessment
EG0000 events0 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
COVID-19
Infections and infestations
MedDRA v20.1; v25.0
Systematic Assessment
EG0000 events0 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA v20.1; v25.0
Systematic Assessment
EG0000 events0 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Osteomyelitis
Infections and infestations
MedDRA v20.1; v25.0
Systematic Assessment
EG0000 events0 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Pneumonia aspiration
Infections and infestations
MedDRA v20.1; v25.0
Systematic Assessment
EG0000 events0 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Pyelonephritis
Infections and infestations
MedDRA v20.1; v25.0
Systematic Assessment
EG0000 events0 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Septic shock
Infections and infestations
MedDRA v20.1; v25.0
Systematic Assessment
EG0000 events0 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Cervical vertebral fracture
Injury, poisoning and procedural complications
MedDRA v20.1; v25.0
Systematic Assessment
EG0000 events0 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Craniofacial fracture
Injury, poisoning and procedural complications
MedDRA v20.1; v25.0
Systematic Assessment
EG0000 events0 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Fractured coccyx
Injury, poisoning and procedural complications
MedDRA v20.1; v25.0
Systematic Assessment
EG0000 events0 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Head injury
Injury, poisoning and procedural complications
MedDRA v20.1; v25.0
Systematic Assessment
EG0000 events0 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Joint injury
Injury, poisoning and procedural complications
MedDRA v20.1; v25.0
Systematic Assessment
EG0000 events0 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Post procedural hypotension
Injury, poisoning and procedural complications
MedDRA v20.1; v25.0
Systematic Assessment
EG0000 events0 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Pulmonary contusion
Injury, poisoning and procedural complications
MedDRA v20.1; v25.0
Systematic Assessment
EG0000 events0 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Skin laceration
Injury, poisoning and procedural complications
MedDRA v20.1; v25.0
Systematic Assessment
EG0000 events0 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Traumatic renal injury
Injury, poisoning and procedural complications
MedDRA v20.1; v25.0
Systematic Assessment
EG0000 events0 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA v20.1; v25.0
Systematic Assessment
EG0000 events0 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Rotator cuff syndrome
Musculoskeletal and connective tissue disorders
MedDRA v20.1; v25.0
Systematic Assessment
EG0000 events0 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Spinal stenosis
Musculoskeletal and connective tissue disorders
MedDRA v20.1; v25.0
Systematic Assessment
EG0000 events0 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Breast cancer metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v20.1; v25.0
Systematic Assessment
EG0000 events0 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Lung adenocarcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v20.1; v25.0
Systematic Assessment
EG0000 events0 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Lung adenocarcinoma stage III
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v20.1; v25.0
Systematic Assessment
EG0000 events0 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Malignant neoplasm of unknown primary site
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v20.1; v25.0
Systematic Assessment
EG0000 events0 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Metastases to central nervous system
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v20.1; v25.0
Systematic Assessment
EG0000 events0 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Neuroendocrine carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v20.1; v25.0
Systematic Assessment
EG0000 events0 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Pancreatic carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v20.1; v25.0
Systematic Assessment
EG0000 events0 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Acquired epileptic aphasia
Nervous system disorders
MedDRA v20.1; v25.0
Systematic Assessment
EG0000 events0 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Amyloid related imaging abnormality-oedema/effusion
Nervous system disorders
MedDRA v20.1; v25.0
Systematic Assessment
EG0000 events0 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Cerebral haemorrhage
Nervous system disorders
MedDRA v20.1; v25.0
Systematic Assessment
EG0000 events0 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Cerebral infarction
Nervous system disorders
MedDRA v20.1; v25.0
Systematic Assessment
EG0000 events0 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Generalised tonic-clonic seizure
Nervous system disorders
MedDRA v20.1; v25.0
Systematic Assessment
EG0000 events0 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Subdural hygroma
Nervous system disorders
MedDRA v20.1; v25.0
Systematic Assessment
EG0000 events0 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Superficial siderosis of central nervous system
Nervous system disorders
MedDRA v20.1; v25.0
Systematic Assessment
EG0000 events0 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Thalamic infarction
Nervous system disorders
MedDRA v20.1; v25.0
Systematic Assessment
EG0000 events0 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Toxic encephalopathy
Nervous system disorders
MedDRA v20.1; v25.0
Systematic Assessment
EG0000 events0 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Transient ischaemic attack
Nervous system disorders
MedDRA v20.1; v25.0
Systematic Assessment
EG0000 events0 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Depression
Psychiatric disorders
MedDRA v20.1; v25.0
Systematic Assessment
EG0000 events0 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Calculus urinary
Renal and urinary disorders
MedDRA v20.1; v25.0
Systematic Assessment
EG0000 events0 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Chronic kidney disease
Renal and urinary disorders
MedDRA v20.1; v25.0
Systematic Assessment
EG0000 events0 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA v20.1; v25.0
Systematic Assessment
EG0000 events0 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Aspiration
Respiratory, thoracic and mediastinal disorders
MedDRA v20.1; v25.0
Systematic Assessment
EG0000 events0 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Haemothorax
Respiratory, thoracic and mediastinal disorders
MedDRA v20.1; v25.0
Systematic Assessment
EG0000 events0 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA v20.1; v25.0
Systematic Assessment
EG0000 events0 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
MedDRA v20.1; v25.0
Systematic Assessment
EG0000 events0 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Hypotension
Vascular disorders
MedDRA v20.1; v25.0
Systematic Assessment
EG0000 events0 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA v20.1; v25.0
Systematic Assessment
EG0007 events7 affected245 at risk
EG0012 events2 affected52 at risk
EG0021 events1 affected51 at risk
EG0031 events1 affected92 at risk
EG0046 events5 affected253 at risk
EG0056 events6 affected161 at risk
EG00610 events10 affected180 at risk
Constipation
Gastrointestinal disorders
MedDRA v20.1; v25.0
Systematic Assessment
EG0009 events9 affected245 at risk
EG0012 events2 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA v20.1; v25.0
Systematic Assessment
EG00014 events12 affected245 at risk
EG0016 events5 affected52 at risk
EG0028 events7 affected51 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA v20.1; v25.0
Systematic Assessment
EG00014 events10 affected245 at risk
EG0011 events1 affected52 at risk
EG0026 events4 affected51 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA v20.1; v25.0
Systematic Assessment
EG00014 events8 affected245 at risk
EG0013 events2 affected52 at risk
EG0025 events4 affected51 at risk
EG003
Fatigue
General disorders
MedDRA v20.1; v25.0
Systematic Assessment
EG00039 events15 affected245 at risk
EG0015 events4 affected52 at risk
EG0021 events1 affected51 at risk
EG003
Pyrexia
General disorders
MedDRA v20.1; v25.0
Systematic Assessment
EG0004 events4 affected245 at risk
EG0012 events2 affected52 at risk
EG0023 events2 affected51 at risk
EG003
COVID-19
Infections and infestations
MedDRA v20.1; v25.0
Systematic Assessment
EG0000 events0 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Bronchitis
Infections and infestations
MedDRA v20.1; v25.0
Systematic Assessment
EG00015 events15 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA v20.1; v25.0
Systematic Assessment
EG00033 events28 affected245 at risk
EG0014 events3 affected52 at risk
EG00210 events7 affected51 at risk
EG003
Sinusitis
Infections and infestations
MedDRA v20.1; v25.0
Systematic Assessment
EG0009 events8 affected245 at risk
EG0011 events1 affected52 at risk
EG0028 events5 affected51 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA v20.1; v25.0
Systematic Assessment
EG00052 events41 affected245 at risk
EG0017 events7 affected52 at risk
EG0029 events7 affected51 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA v20.1; v25.0
Systematic Assessment
EG00039 events32 affected245 at risk
EG0016 events5 affected52 at risk
EG0026 events5 affected51 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA v20.1; v25.0
Systematic Assessment
EG0007 events7 affected245 at risk
EG0012 events2 affected52 at risk
EG0026 events5 affected51 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA v20.1; v25.0
Systematic Assessment
EG00040 events28 affected245 at risk
EG0013 events3 affected52 at risk
EG00210 events6 affected51 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA v20.1; v25.0
Systematic Assessment
EG00012 events8 affected245 at risk
EG0013 events3 affected52 at risk
EG0025 events4 affected51 at risk
EG003
Skin abrasion
Injury, poisoning and procedural complications
MedDRA v20.1; v25.0
Systematic Assessment
EG0008 events8 affected245 at risk
EG0010 events0 affected52 at risk
EG0021 events1 affected51 at risk
EG003
Skin laceration
Injury, poisoning and procedural complications
MedDRA v20.1; v25.0
Systematic Assessment
EG0000 events0 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
MedDRA v20.1; v25.0
Systematic Assessment
EG0007 events4 affected245 at risk
EG0013 events3 affected52 at risk
EG0023 events2 affected51 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA v20.1; v25.0
Systematic Assessment
EG00019 events17 affected245 at risk
EG0010 events0 affected52 at risk
EG0024 events4 affected51 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA v20.1; v25.0
Systematic Assessment
EG00026 events24 affected245 at risk
EG0014 events4 affected52 at risk
EG0026 events6 affected51 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA v20.1; v25.0
Systematic Assessment
EG0005 events5 affected245 at risk
EG0012 events1 affected52 at risk
EG0027 events6 affected51 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA v20.1; v25.0
Systematic Assessment
EG00010 events10 affected245 at risk
EG0011 events1 affected52 at risk
EG0022 events2 affected51 at risk
EG003
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v20.1; v25.0
Systematic Assessment
EG00012 events7 affected245 at risk
EG0014 events4 affected52 at risk
EG0022 events2 affected51 at risk
EG003
Squamous cell carcinoma of skin
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v20.1; v25.0
Systematic Assessment
EG0005 events4 affected245 at risk
EG0013 events3 affected52 at risk
EG0023 events1 affected51 at risk
EG003
Amyloid related imaging abnormality-microhaemorrhages and haemosiderin deposits
Nervous system disorders
MedDRA v20.1; v25.0
Systematic Assessment
EG0000 events0 affected245 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Amyloid related imaging abnormality-oedema/effusion
FG0068 subjectsEligible participants were randomized to lecanemab 10 mg/kg monthly (LEC10-M) in the optional DRS. All participants had received lecanemab 10 mg/kg biweekly in OLE phase before participating in the DRS.
0 subjects
FG0050 subjects
FG0069 subjectsEligible participants were randomized to lecanemab 10 mg/kg every 3 months (LEC10-3M) in the optional DRS. All participants had received lecanemab 10 mg/kg biweekly in OLE phase before participating in the DRS.
0 subjects
FG0050 subjects
FG00639 subjects
0 subjects
FG0050 subjects
FG006141 subjects
0 subjects
FG0040 subjects
FG0050 subjects
FG00612 subjects
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0063 subjects
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG00637 subjects
Transition To Commercial LEQEMBI
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG00618 subjects
Treatment Terminated by Sponsor
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG00612 subjects
Subject Choice
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG00637 subjects
Other
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG00622 subjects
0
BG0040
BG0050
BG0060
Between 18 and 65 years
BG00056
BG00111
BG0029
BG00320
BG00446
BG00528
BG006170
>=65 years
BG000189
BG00141
BG00242
BG00372
BG004207
BG005133
BG006684
26
BG00350
BG004112
BG00570
BG006422
Male
BG000107
BG00126
BG00225
BG00342
BG004141
BG00591
BG006432
1
BG0033
BG00410
BG00510
BG00638
Not Hispanic or Latino
BG000235
BG00148
BG00250
BG00389
BG004243
BG005151
BG006816
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
49
BG00376
BG004228
BG005150
BG006773
Black or African American
BG0005
BG0012
BG0021
BG0034
BG0045
BG0054
BG00621
Chinese
BG0001
BG0010
BG0020
BG0030
BG0040
BG0050
BG0061
Japanese
BG00010
BG0011
BG0020
BG0036
BG00412
BG0055
BG00634
Other Asian
BG0006
BG0011
BG0021
BG0033
BG0045
BG0052
BG00618
American Indian or Alaska Native
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
Native Hawaiian or other Pacific Islander
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
Other
BG0001
BG0010
BG0020
BG0033
BG0043
BG0050
BG0067
Missing
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
89
OG004246
OG005152
0.116
± 0.016
OG0040.084± 0.011
OG0050.077± 0.014
OG001
Core Study Phase: Lecanemab 2.5 mg/kg Biweekly
Participants received lecanemab 2.5 mg/kg as 60-minute IV infusions, biweekly, up to 18 months. Participants were followed up for 3 months after last dose of lecanemab in core study phase.
OG002
Core Study Phase: Lecanemab 5 mg/kg Monthly
Participants received lecanemab 5 mg/kg as 60-minute IV infusions, monthly, up to 18 months. Participants were followed up for 3 months after last dose of lecanemab in core study phase.
OG003
Core Study Phase: Lecanemab 5 mg/kg Biweekly
Participants received lecanemab 5 mg/kg as 60-minute IV infusions, biweekly, up to 18 months. Participants were followed up for 3 months after last dose of lecanemab in core study phase.
OG004
Core Study Phase: Lecanemab 10 mg/kg Monthly
Participants received lecanemab 10 mg/kg as 60-minute IV infusions, monthly, up to 18 months. Participants were followed up for 3 months after last dose of lecanemab in core study phase.
OG005
Core Study Phase: Lecanemab 10 mg/kg Biweekly
Participants received lecanemab 10 mg/kg as 60-minute IV infusions, biweekly, up to 18 months. Participants were followed up for 3 months after last dose of lecanemab in core study phase.
Units
Counts
Participants
OG000245
OG00152
OG00251
OG00392
OG004253
OG005161
Title
Denominators
Categories
TEAEs
Title
Measurements
OG000216
OG00146
OG00248
OG00381
OG004238
OG005139
SAEs
Title
Measurements
OG00043
OG00110
OG0024
OG003
OG002
Core Study Phase: Lecanemab 5 mg/kg Monthly
Participants received lecanemab 5 mg/kg as 60-minute IV infusions, monthly, up to 18 months. Participants were followed up for 3 months after last dose of lecanemab in core study phase.
OG003
Core Study Phase: Lecanemab 5 mg/kg Biweekly
Participants received lecanemab 5 mg/kg as 60-minute IV infusions, biweekly, up to 18 months. Participants were followed up for 3 months after last dose of lecanemab in core study phase.
OG004
Core Study Phase: Lecanemab 10 mg/kg Monthly
Participants received lecanemab 10 mg/kg as 60-minute IV infusions, monthly, up to 18 months. Participants were followed up for 3 months after last dose of lecanemab in core study phase.
OG005
Core Phase: Lecanemab 10 mg/kg Biweekly
Participants received lecanemab 10 mg/kg as 60-minute IV infusions, biweekly, up to 18 months. Participants were followed up for 3 months after last dose of lecanemab in core study phase.
Units
Counts
Participants
OG00099
OG00128
OG00228
OG00327
OG00489
OG00544
Title
Denominators
Categories
Change at Month 12
ParticipantsOG00096
ParticipantsOG00127
ParticipantsOG00227
ParticipantsOG00325
ParticipantsOG00488
ParticipantsOG00543
Title
Measurements
OG000-2.154± 2.448
OG001-14.733± 4.345
OG002-16.877± 4.350
OG003
Change at Month 18
ParticipantsOG00088
ParticipantsOG00123
ParticipantsOG00223
ParticipantsOG00324
Participants received lecanemab 5 mg/kg as 60-minute IV infusions, monthly, up to 18 months. Participants were followed up for 3 months after last dose of lecanemab in core study phase.
OG003
Core Study Phase: Lecanemab 5 mg/kg Biweekly
Participants received lecanemab 5 mg/kg as 60-minute IV infusions, biweekly, up to 18 months. Participants were followed up for 3 months after last dose of lecanemab in core study phase.
OG004
Core Study Phase: Lecanemab 10 mg/kg Monthly
Participants received lecanemab 10 mg/kg as 60-minute IV infusions, monthly, up to 18 months. Participants were followed up for 3 months after last dose of lecanemab in core study phase.
OG005
Core Study Phase: Lecanemab 10 mg/kg Biweekly
Participants received lecanemab 10 mg/kg as 60-minute IV infusions, biweekly, up to 18 months. Participants were followed up for 3 months after last dose of lecanemab in core study phase.
Units
Counts
Participants
OG000160
OG00133
OG00235
OG00361
OG004146
OG00579
Title
Denominators
Categories
Title
Measurements
OG0000.193± 0.017
OG0010.173± 0.035
OG0020.192± 0.035
OG0030.199± 0.026
OG0040.166± 0.018
OG0050.136± 0.022
Participants received lecanemab 2.5 mg/kg as 60-minute IV infusions, biweekly, up to 18 months. Participants were followed up for 3 months after last dose of lecanemab in core study phase.
OG002
Core Study Phase: Lecanemab 5 mg/kg Monthly
Participants received lecanemab 5 mg/kg as 60-minute IV infusions, monthly, up to 18 months. Participants were followed up for 3 months after last dose of lecanemab in core study phase.
OG003
Core Study Phase: Lecanemab 5 mg/kg Biweekly
Participants received lecanemab 5 mg/kg as 60-minute IV infusions, biweekly, up to 18 months. Participants were followed up for 3 months after last dose of lecanemab in core study phase.
OG004
Core Study Phase: Lecanemab 10 mg/kg Monthly
Participants received lecanemab 10 mg/kg as 60-minute IV infusions, monthly, up to 18 months. Participants were followed up for 3 months after last dose of lecanemab in core study phase.
OG005
Core Study Phase: Lecanemab 10 mg/kg Biweekly
Participants received lecanemab 10 mg/kg as 60-minute IV infusions, biweekly, up to 18 months. Participants were followed up for 3 months after last dose of lecanemab in core study phase.
Units
Counts
Participants
OG000238
OG00152
OG00248
OG00389
OG004246
OG005152
Title
Denominators
Categories
Change at Month 12
ParticipantsOG000188
ParticipantsOG00138
ParticipantsOG00242
ParticipantsOG00370
ParticipantsOG004166
ParticipantsOG00594
Title
Measurements
OG0000.911± 0.124
OG0011.038± 0.257
OG0021.277± 0.253
OG003
Change at Month 18
ParticipantsOG000161
ParticipantsOG00134
ParticipantsOG00236
ParticipantsOG00367
OG002
Core Study Phase: Lecanemab 5 mg/kg Monthly
Participants received lecanemab 5 mg/kg as 60-minute IV infusions, monthly, up to 18 months. Participants were followed up for 3 months after last dose of lecanemab in core study phase.
OG003
Core Study Phase: Lecanemab 5 mg/kg Biweekly
Participants received lecanemab 5 mg/kg as 60-minute IV infusions, biweekly, up to 18 months. Participants were followed up for 3 months after last dose of lecanemab in core study phase.
OG004
Core Study Phase: Lecanemab 10 mg/kg Monthly
Participants received lecanemab 10 mg/kg as 60-minute IV infusions, monthly, up to 18 months. Participants were followed up for 3 months after last dose of lecanemab in core study phase.
OG005
Core Study Phase: Lecanemab 10 mg/kg Biweekly
Participants received lecanemab 10 mg/kg as 60-minute IV infusions, biweekly, up to 18 months. Participants were followed up for 3 months after last dose of lecanemab in core study phase.
Units
Counts
Participants
OG000238
OG00152
OG00248
OG00389
OG004246
OG005152
Title
Denominators
Categories
Change at Month 12
ParticipantsOG000186
ParticipantsOG00138
ParticipantsOG00241
ParticipantsOG00369
ParticipantsOG004164
ParticipantsOG00594
Title
Measurements
OG0002.842± 0.501
OG0014.251± 1.005
OG0023.426± 1.005
OG003
Change at Month 18
ParticipantsOG000158
ParticipantsOG00133
ParticipantsOG00234
ParticipantsOG00361
Participants received lecanemab 5 mg/kg as 60-minute IV infusions, monthly, up to 18 months. Participants were followed up for 3 months after last dose of lecanemab in core study phase.
OG003
Core Study Phase: Lecanemab 5 mg/kg Biweekly
Participants received lecanemab 5 mg/kg as 60-minute IV infusions, biweekly, up to 18 months. Participants were followed up for 3 months after last dose of lecanemab in core study phase.
OG004
Core Study Phase: Lecanemab 10 mg/kg Monthly
Participants received lecanemab 10 mg/kg as 60-minute IV infusions, monthly, up to 18 months. Participants were followed up for 3 months after last dose of lecanemab in core study phase.
OG005
Core Study Phase: Lecanemab 10 mg/kg Biweekly
Participants received lecanemab 10 mg/kg as 60-minute IV infusions, biweekly, up to 18 months. Participants were followed up for 3 months after last dose of lecanemab in core study phase.
Units
Counts
Participants
OG00024
OG0017
OG00213
OG00320
OG00416
OG00512
Title
Denominators
Categories
Change at Month 12 in CSF Amyloid-beta (1-42)
ParticipantsOG00022
ParticipantsOG0017
ParticipantsOG00213
ParticipantsOG00319
ParticipantsOG00416
ParticipantsOG00510
Title
Measurements
OG000-8.008± 36.952
OG00149.921± 57.175
OG00289.009± 44.816
OG003
Change at Month 18 in CSF Amyloid-beta (1-42)
ParticipantsOG00019
ParticipantsOG0015
ParticipantsOG00210
ParticipantsOG00314
Change at Month 12 in CSF t-tau
ParticipantsOG00017
ParticipantsOG0016
ParticipantsOG0028
ParticipantsOG00314
Change at Month 18 in CSF t-tau
ParticipantsOG00015
ParticipantsOG0014
ParticipantsOG0026
ParticipantsOG00312
Change at Month 12 in CSF p -tau
ParticipantsOG00022
ParticipantsOG0017
ParticipantsOG00213
ParticipantsOG00319
Change at Month 18 in CSF p -tau
ParticipantsOG00019
ParticipantsOG0015
ParticipantsOG00210
ParticipantsOG00314
Participants received lecanemab 5 mg/kg as 60-minute IV infusions, monthly, up to 18 months. Participants were followed up for 3 months after last dose of lecanemab in core study phase.
OG003
Core Study Phase: Lecanemab 5 mg/kg Biweekly
Participants received lecanemab 5 mg/kg as 60-minute IV infusions, biweekly, up to 18 months. Participants were followed up for 3 months after last dose of lecanemab in core study phase.
OG004
Core Study Phase: Lecanemab 10 mg/kg Monthly
Participants received lecanemab 10 mg/kg as 60-minute IV infusions, monthly, up to 18 months. Participants were followed up for 3 months after last dose of lecanemab in core study phase.
OG005
Core Study Phase: Lecanemab 10 mg/kg Biweekly
Participants received lecanemab 10 mg/kg as 60-minute IV infusions, biweekly, up to 18 months. Participants were followed up for 3 months after last dose of lecanemab in core study phase.
Units
Counts
Participants
OG000209
OG00141
OG00246
OG00373
OG004188
OG00599
Title
Denominators
Categories
Change at Month 6
ParticipantsOG000199
ParticipantsOG00139
ParticipantsOG00244
ParticipantsOG00372
ParticipantsOG004185
ParticipantsOG00591
Title
Measurements
OG000-112.881± 9.973
OG001-100.640± 19.511
OG002-127.152± 18.495
OG003
Change at Month 12
ParticipantsOG000178
ParticipantsOG00140
ParticipantsOG00243
ParticipantsOG00366
Change at Month 18
ParticipantsOG000162
ParticipantsOG00134
ParticipantsOG00239
ParticipantsOG00355
Participants received lecanemab 5 mg/kg as 60-minute IV infusions, monthly, up to 18 months. Participants were followed up for 3 months after last dose of lecanemab in core study phase.
OG003
Core Study Phase: Lecanemab 5 mg/kg Biweekly
Participants received lecanemab 5 mg/kg as 60-minute IV infusions, biweekly, up to 18 months. Participants were followed up for 3 months after last dose of lecanemab in core study phase.
OG004
Core Study Phase: Lecanemab 10 mg/kg Monthly
Participants received lecanemab 10 mg/kg as 60-minute IV infusions, monthly, up to 18 months. Participants were followed up for 3 months after last dose of lecanemab in core study phase.
OG005
Core Study Phase: Lecanemab 10 mg/kg Biweekly
Participants received lecanemab 10 mg/kg as 60-minute IV infusions, biweekly, up to 18 months. Participants were followed up for 3 months after last dose of lecanemab in core study phase.
Units
Counts
Participants
OG000209
OG00141
OG00246
OG00373
OG004188
OG00599
Title
Denominators
Categories
Change at Month 6 in Left Hippocampus Volume
ParticipantsOG000199
ParticipantsOG00139
ParticipantsOG00244
ParticipantsOG00372
ParticipantsOG004185
ParticipantsOG00591
Title
Measurements
OG000-54.087± 5.457
OG001-50.434± 10.664
OG002-61.886± 10.120
OG003
Change at Month 12 in Left Hippocampus Volume
ParticipantsOG000178
ParticipantsOG00140
ParticipantsOG00243
ParticipantsOG00366
Change at Month 18 in Left Hippocampus Volume
ParticipantsOG000162
ParticipantsOG00134
ParticipantsOG00239
ParticipantsOG00355
Change at Month 6 in Right Hippocampus Volume
ParticipantsOG000199
ParticipantsOG00139
ParticipantsOG00244
ParticipantsOG00372
Change at Month 12 in Right Hippocampus Volume
ParticipantsOG000178
ParticipantsOG00140
ParticipantsOG00243
ParticipantsOG003
Change at Month 18 in Right Hippocampus Volume
ParticipantsOG000162
ParticipantsOG00134
ParticipantsOG00239
ParticipantsOG003
Participants received lecanemab 5 mg/kg as 60-minute IV infusions, monthly, up to 18 months. Participants were followed up for 3 months after last dose of lecanemab in core study phase.
OG003
Core Study Phase: Lecanemab 5 mg/kg Biweekly
Participants received lecanemab 5 mg/kg as 60-minute IV infusions, biweekly, up to 18 months. Participants were followed up for 3 months after last dose of lecanemab in core study phase.
OG004
Core Study Phase: Lecanemab 10 mg/kg Monthly
Participants received lecanemab 10 mg/kg as 60-minute IV infusions, monthly, up to 18 months. Participants were followed up for 3 months after last dose of lecanemab in core study phase.
OG005
Core Study Phase: Lecanemab 10 mg/kg Biweekly
Participants received lecanemab 10 mg/kg as 60-minute IV infusions, biweekly, up to 18 months. Participants were followed up for 3 months after last dose of lecanemab in core study phase.
Units
Counts
Participants
OG000209
OG00141
OG00246
OG00373
OG004188
OG00599
Title
Denominators
Categories
Change at Month 6
ParticipantsOG000198
ParticipantsOG00138
ParticipantsOG00243
ParticipantsOG00372
ParticipantsOG004183
ParticipantsOG00591
Title
Measurements
OG000-8874.418± 885.172
OG001-10020.371± 1732.015
OG002-13726.830± 1656.368
OG003
Change at Month 12
ParticipantsOG000177
ParticipantsOG00138
ParticipantsOG00242
ParticipantsOG00366
Change at Month 18
ParticipantsOG000162
ParticipantsOG00132
ParticipantsOG00238
ParticipantsOG00355
Core Study Phase: Lecanemab 5 mg/kg Monthly
Participants received lecanemab 5 mg/kg as 60-minute IV infusions, monthly, up to 18 months. Participants were followed up for 3 months after last dose of lecanemab in core study phase.
OG003
Core Study Phase: Lecanemab 5 mg/kg Biweekly
Participants received lecanemab 5 mg/kg as 60-minute IV infusions, biweekly, up to 18 months. Participants were followed up for 3 months after last dose of lecanemab in core study phase.
OG004
Core Study Phase: Lecanemab 10 mg/kg Monthly
Participants received lecanemab 10 mg/kg as 60-minute IV infusions, monthly, up to 18 months. Participants were followed up for 3 months after last dose of lecanemab in core study phase.
OG005
Core Study Phase: Lecanemab 10 mg/kg Biweekly
Participants received lecanemab 10 mg/kg as 60-minute IV infusions, biweekly, up to 18 months. Participants were followed up for 3 months after last dose of lecanemab in core study phase.
Units
Counts
Participants
OG000209
OG00141
OG00246
OG00373
OG004188
OG00599
Title
Denominators
Categories
Change at Month 6
ParticipantsOG000199
ParticipantsOG00139
ParticipantsOG00244
ParticipantsOG00372
ParticipantsOG004185
ParticipantsOG00592
Title
Measurements
OG0001903.815± 233.516
OG0012052.336± 454.966
OG0022528.554± 432.705
OG003
Change at Month 12
ParticipantsOG000178
ParticipantsOG00140
ParticipantsOG00243
ParticipantsOG00366
Change at Month 18
ParticipantsOG000161
ParticipantsOG00134
ParticipantsOG00239
ParticipantsOG00355
Participants randomized to 2.5 mg/kg biweekly, 5 mg/kg monthly, or 5 mg/kg biweekly in the Core Study and re-treated with lecanemab 10 mg/kg, biweekly, in the OLE phase.
OG002
OLE Phase: Re-treated Core 10 mg/kg Monthly
Participants randomized to 10 mg/kg monthly in the Core Study and re-treated with lecanemab 10 mg/kg, biweekly, in the OLE phase.
OG003
OLE Phase: Re-treated Core 10 mg/kg Biweekly
Participants randomized to 10 mg/kg biweekly in the Core Study and re-treated with lecanemab 10 mg/kg, biweekly, in the OLE phase.
Units
Counts
Participants
OG00027
OG00120
OG00236
OG00322
Title
Denominators
Categories
Change at Month 3
ParticipantsOG0009
ParticipantsOG0019
ParticipantsOG00218
ParticipantsOG00310
Title
Measurements
OG000-18.260± 5.481
OG001-9.562± 5.555
OG002-10.136± 8.045
OG003
Change at Month 6
ParticipantsOG00011
ParticipantsOG0017
ParticipantsOG00211
ParticipantsOG00310
Change at Month 12
ParticipantsOG00019
ParticipantsOG00113
ParticipantsOG00225
ParticipantsOG00318
Change at Month 24
ParticipantsOG00017
ParticipantsOG00114
ParticipantsOG00226
ParticipantsOG00313
Change at Month 36
ParticipantsOG00013
ParticipantsOG00110
ParticipantsOG00217
ParticipantsOG0039
Change at Month 48
ParticipantsOG0009
ParticipantsOG0017
ParticipantsOG00212
ParticipantsOG0038
OG002
OLE Phase: Re-treated Core 10 mg/kg Monthly
Participants randomized to 10 mg/kg monthly in the Core Study and re-treated with lecanemab 10 mg/kg, biweekly, in the OLE phase.
OG003
OLE Phase: Re-treated Core 10 mg/kg Biweekly
Participants randomized to 10 mg/kg biweekly in the Core Study and re-treated with lecanemab 10 mg/kg, biweekly, in the OLE phase.
Units
Counts
Participants
OG00018
OG00111
OG00229
OG00317
Title
Denominators
Categories
Change from Core Baseline at the end of Core Study - at Month 18
ParticipantsOG00013
ParticipantsOG0016
ParticipantsOG00224
ParticipantsOG00313
Title
Measurements
OG00012.077± 27.7765
OG001-50.610± 20.3136
OG002-54.491± 33.4376
OG003
Change from Core Baseline at OLE Baseline
ParticipantsOG00016
ParticipantsOG0019
ParticipantsOG00226
ParticipantsOG00315
OG003
OLE Phase: Re-treated Core 10 mg/kg Biweekly
Participants randomized to 10 mg/kg biweekly in the Core Study and re-treated with lecanemab 10 mg/kg, biweekly, in the OLE phase.