Efficacy and Safety Study of Gantenerumab in Participants... | NCT03444870 | Trialant
NCT03444870
Sponsor
Hoffmann-La Roche
Status
Terminated
Last Update Posted
Jan 30, 2024Actual
Enrollment
1,053Actual
Phase
Phase 3
Conditions
Alzheimer Disease
Interventions
Gantenerumab
Placebo
Countries
United States
Australia
Brazil
Canada
China
France
Germany
Hungary
Italy
Japan
Lithuania
Peru
Russia
Spain
Taiwan
Protocol Section
Identification Module
NCT ID
NCT03444870
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
WN29922
Secondary IDs
ID
Type
Description
Link
2017-001364-38
EudraCT Number
Brief Title
Efficacy and Safety Study of Gantenerumab in Participants With Early Alzheimer's Disease (AD)
Official Title
A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Efficacy, and Safety Study of Gantenerumab in Patients With Early (Prodromal to Mild) Alzheimer's Disease
Acronym
Not provided
Organization
Hoffmann-La RocheINDUSTRY
Status Module
Record Verification Date
Jan 2024
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Decision to terminate development of Gantenerumab for treatment of prodromal/mild/early-stage Alzheimer's disease following results of a pre-planned analysis of the safety and efficacy of Gant in Graduate I&II (WN29922/WN39658).
Expanded Access Info
Not provided
Start Date
Jun 6, 2018Actual
Primary Completion Date
Dec 28, 2022Actual
Completion Date
Feb 17, 2023Actual
First Submitted Date
Feb 19, 2018
First Submission Date that Met QC Criteria
Feb 19, 2018
First Posted Date
Feb 23, 2018Actual
Results Waived
Not provided
Results First Submitted Date
Dec 22, 2023
Results First Submitted that Met QC Criteria
Jan 25, 2024
Results First Posted Date
Jan 30, 2024Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Jan 25, 2024
Last Update Posted Date
Jan 30, 2024Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Hoffmann-La RocheINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This randomized, double-blind, placebo-controlled, parallel-group study will evaluate the efficacy and safety of gantenerumab versus placebo in participants with early (prodromal to mild) AD. All participants must show evidence of beta-amyloid pathology. Eligible participants will be randomized 1:1 to receive either subcutaneous (SC) injection of gantenerumab or placebo. The primary efficacy assessment will be performed at the end of the double blind period at week 116. Participants will then be offered to enter into an open-label extension (OLE). Participants not willing to go to the OLE will participate in a long term follow-up period for up to 50 weeks after the last gantenerumab dose.
Detailed Description
Not provided
Conditions Module
Conditions
Alzheimer Disease
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
1,053Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Gantenerumab
Experimental
Gantenerumab will be administered as SC injections with gradual uptitration.
Drug: Gantenerumab
Placebo
Placebo Comparator
Placebo will be administered as SC injections with gradual uptitration.
Drug: Placebo
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Gantenerumab
Drug
Gantenerumab will be administered as per the schedule specified in the respective arm.
Gantenerumab
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
DBT Period: Change From Baseline to Week 116 in Global Outcome, as Measured by CDR-SB
CDR was derived through semi-structured interview with the participant and an appropriate informant, and it rated impairment across six domains: memory, orientation, judgment, and problem solving, community affairs, home and hobbies, and personal care on a 5-point scale for which 0=no impairment, 0.5=questionable impairment, and 1, 2, and 3=mild, moderate, and severe impairment, respectively. The CDR-SB is based on summing each of the domain box scores with total score ranging from 0-18 with higher scores reflecting greater cognitive and functional impairment. A negative change from baseline indicates improvement.
Baseline, Week 116
China Extension: DBT Period: Change From Baseline to Week 116 in Global Outcome, as Measured by CDR-SB
CDR was derived through semi-structured interview with the participant and an appropriate informant, and it rated impairment across six domains: memory, orientation, judgment, and problem solving, community affairs, home and hobbies, and personal care on a 5-point scale for which 0=no impairment, 0.5=questionable impairment, and 1, 2, and 3=mild, moderate, and severe impairment, respectively. The CDR-SB is based on summing each of the domain box scores with total score ranging from 0-18 with higher scores reflecting greater cognitive and functional impairment. A negative change from baseline indicates improvement.
Baseline, Week 116
Secondary Outcomes
Measure
Description
Time Frame
DBT Period: Change From Baseline to Week 116 in Alzheimer Disease Assessment Scale-Cognition Subscale 13 (ADAS-Cog13) Score
The ADAS-Cog13 total score includes all of the items in the ADAS-Cog11 in addition to delayed word recall and the number cancellation. For the ADAS-cog 13 the range is 0-85 (score range for Delayed Word Recall [DWR] score is 0-10 and for Number Cancellation [NC] is 0-5, thus the score is ADAS-cog 11[0-70] plus the scores for DWR and NC). A higher score indicates worse performance. A negative change from baseline indicates improvement in cognitive function.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Key Inclusion criteria:
Meets National Institute on Aging/Alzheimer's Association (NIAAA) core clinical criteria for probable AD dementia or prodromal AD (consistent with the NIAAA diagnostic criteria and guidelines for mild cognitive impairment)
Evidence of the AD pathological process, as confirmed by CSF tau/A-beta42or amyloid PET scan
Demonstrated abnormal memory function
MMSE score greater than or equal to 22 (≥ 22)
Clinical dementia rating-global score (CDR-GS) of 0.5 or 1.0
Availability of a reliable study partner who accepts to participate in study procedures throughout the 2 years duration of study
If receiving symptomatic AD medications, the dosing regimen must have been stable for 3 months prior to screening and until randomization
For enrollment in the China extension, patients must have residence in mainland China, Hong Kong, or Taiwan and be of Chinese ancestry
For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods
Key Exclusion criteria:
Any evidence of a condition other than AD that may affect cognition
History of schizophrenia, schizoaffective disorder, major depression, or bipolar disorder
History or presence of clinically evident systemic vascular disease that in the opinion of the investigator has the potential to affect cognitive function
History or presence of clinically evident cerebrovascular disease
History or presence of posterior reversible encephalopathy syndrome
History or presence of any stroke with clinical symptoms within the past 12 months, or documented history within the last 6 months of an acute event that is consistent with a transient ischemic attack
History of severe, clinically significant CNS trauma
History or presence of intracranial mass (e.g., glioma, meningioma) that could potentially impair cognition
Presence of infections that affect brain function or history of infections that resulted in neurologic sequelae
History or presence of systemic autoimmune disorders that potentially cause progressive neurologic disease with associated cognitive deficits
At risk for suicide in the opinion of the investigator
Alcohol and/or substance abuse or dependants in past 2 years
Relevant brain hemorrhage, bleeding disorder and cerebrovascular abnormalities
Any contraindications to brain MRI
Unstable or clinically significant cardiovascular, kidney or liver disease
Uncontrolled hypertension
Unstable or clinically significant cardiovascular disease
Abnormal thyroid function
Patients with evidence of folic acid deficiency
Exclusion for Open-Label Extension (OLE):
Discontinued from study treatment during the double-blind treatment period
Received any other investigational medication during the double-blind treatment period or after the end of double-blind treatment
Participation in the OLE deemed inappropriate by the investigator
Presence of ARIA-E findings at the Week 116 MRI scan
Chandler JM, Lansdall CJ, Ye W, McDougall F, Belger M, Toth B, Mi X, Sink KM, Atkins AS. The Alzheimer's Disease Cooperative Study - Activities of Daily Living dependence score: revision and validation of an algorithm evaluating patient dependence across the spectrum of AD severity. J Prev Alzheimers Dis. 2025 Sep;12(8):100261. doi: 10.1016/j.tjpad.2025.100261. Epub 2025 Jul 1.
A total of 985 participants with early (prodromal to mild) Alzheimer's Disease (AD) were randomized to either the gantenerumab (n=499) or placebo arm (n=486) to enter the double-blind treatment (DBT) period of the global phase. A total of 68 early (prodromal to mild) AD participants were randomized to the gantenerumab (n=35) or placebo arm (n=33) to enter the DBT period of the China extension phase.
Recruitment Details
Participants were enrolled in this study at 137 sites across 15 countries (Australia, Brazil, Canada, China, France, Germany, Hungary, Italy, Japan, Lithuania, Peru, Russia, Taiwan, Spain, and the United States) during the global phase. Participants were enrolled at 21 sites in China during the China extension phase of the study.
The open-label period in China was not started as the study was terminated early by the Sponsor.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Global - DBT Period: Placebo
Participants received gantenerumab matching placebo, SC injection, every four weeks (Q4W) up to Week 36 and then every two weeks (Q2W) up to approximately 114 weeks of the DBT period.
FG001
Global - DBT Period: Gantenerumab
Periods
Title
Milestones
Reasons Not Completed
Double-Blind Treatment (DBT) Period
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
Aug 2, 2021
Dec 22, 2023
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Colombia
Submission Tracking
Estimated Results First Submitted Date
Not provided
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Double
Masking Description
Not provided
Who Masked
ParticipantInvestigator
RO4909832
Placebo
Drug
Placebo will be administered as per the schedule specified in the respective arm.
Placebo
Baseline, Week 116
DBT Period: Change From Baseline to Week 116 in Alzheimer's Disease Cooperative Study- Activities of Daily Living (ADCS-ADL) Total Score
ADCS-ADL is a 23-item rater-administered, observer-reported outcome (ObsRO) that captures a participant's ability to perform basic activities of daily living (e.g., eating and toileting) and more complex ADL or instrumental activities of daily living (iADL, e.g., using the telephone, managing finances, preparing a meal). Total score ranges from 0-78, with higher scores reflecting better functioning. A positive change from baseline indicates improvement.
Baseline, Week 116
DBT Period: Change From Baseline to Week 116 in Functional Activities Questionnaire (FAQ) Score
FAQ is a rater-administered ObsRO (informant-based measure) that measures a participant's functional ability to perform complex higher-order activities. The observer provides performance ratings of the target person on ten complex higher-order activities. Total score that ranges from 0-30, with higher scores reflecting greater functional impairment. A negative change from baseline indicates improvement.
Baseline, Week 116
DBT Period: Change From Baseline to Week 116 in Mini-Mental State Examination (MMSE) Total Score
MMSE is a rater-administered performance-based outcome (PerfO) that includes a set of standardized questions used to evaluate possible cognitive impairment and help stage the severity level of this impairment. The questions target six areas: orientation, registration, attention, short-term recall, language, and constructional praxis/visuospatial abilities. Total score ranges from 0-30, with lower scores indicating greater impairment. A positive change from baseline indicates improvement.
Baseline, Week 116
DBT Period: Change From Baseline to Week 116 in Alzheimer Disease Assessment Scale-Cognition Subscale 11 (ADAS-Cog11) Score
The ADAS-Cog11 was designed to measure cognitive symptom change in participants with Alzheimer's Disease (AD) and consisted of 11 tasks. The standard 11 items (and corresponding score range) were: word recall (0-10), commands (0-5), constructional praxis (0-5), naming objects and fingers (0-5), ideational praxis (0-5), orientation (0-8), word recognition (0-12), spoken language ability (0-5), comprehension of spoken language (0-5), word-finding difficulty (0-5), and remembering test instructions (0-5). The test included 7 performance items and 4 clinician-rated items. The ADAS-Cog11 total score was the sum of all 11 individual items, with a total score ranging from 0 (no impairment) to 70 (severe impairment). Higher scores indicated more severe cognitive impairment. A negative change from baseline indicates improvement.
Baseline, Week 116
DBT Period: Change From Baseline to Week 116 in Verbal Fluency Task (VFT) Score
VFT is a rater administered PerfO that measures speed and flexibility of verbal thought with a total score that ranges from 0-99 (lower scores indicating lower performance). A positive change from baseline indicates improvement.
Baseline, Week 116
DBT Period: Change From Baseline to Week 116 in the Coding (Digit Symbol Substitution Test [DSST]) Subtest
Coding, also called DSST is a rater administered PerfO that measures speed of processing and associative memory with a total score that ranges from 0-135 (lower scores indicating lower performance). The DSST was adapted from the Wechsler Adult Intelligence Scale. The 120-second version of the test was used in this study. Positive change from baseline indicates improvement.
Baseline, Week 116
DBT Period: Change From Baseline to Week 116 in Alzheimer's Disease Cooperative Study-Instrumental Activities of Daily Living (ADCS-iADL) Instrumental Score
The ADCS-iADL measures activities such as using the telephone, shopping and preparing a meal. The ADCS-iADL consists of 16 questions with a score range of 0 to 56 where a higher score represents better function. Positive change from baseline indicates improvement.
Baseline, Week 116
DBT Period: Number of Participants With at Least One Adverse Event (AE)
An AE is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution.
From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 131 weeks)
DBT Period: Number of Participants With Post-baseline Suicidal Ideation or Suicidal Behavior as Measured Using Columbia-Suicide Severity Rating Scale (C-SSRS)
C-SSRS=assessment tool used to assess lifetime suicidality of a participant (at baseline) as well as any new instances of suicidality (C-SSRS since last visit). Structured interview prompts recollection of suicidal ideation, including intensity of ideation, behavior, & attempts with actual/potential lethality. Categories have binary responses (yes/no) & include Wish to be Dead; Non-specific Active Suicidal Thoughts; Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act; Active Suicidal Ideation with Some Intent to Act, without Specific Plan; Active Suicidal Ideation with Specific Plan and Intent, Preparatory Acts and Behavior; Aborted Attempt; Interrupted Attempt; Actual Attempt (non-fatal); Completed Suicide. Suicidal ideation/behavior is indicated by a "yes" answer to any of the listed categories. Score of 0 is assigned if no suicide risk is present. Score of 1 or higher= suicidal ideation or behavior. Categories with non-zero values are only reported here.
From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 131 weeks)
DBT Period: Number of Participants With at Least One Amyloid-Related Imaging Abnormalities-Edema (ARIA-E) Magnetic Resonance Imaging (MRI) Finding
ARIA are an identified risk with anti-amyloid antibodies, including gantenerumab. These changes can be identified on brain MRI. In ARIA-E, (E for oedema or effusion), oedema can be seen in different areas of the brain on MRI, representing fluid leakage into the brain parenchyma or sulcal spaces.
From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 131 weeks)
DBT Period: Number of Participants With at Least One Amyloid-Related Imaging Abnormalities-Haemosiderin Deposition (ARIA-H) MRI Finding
ARIA are an identified risk with anti-amyloid antibodies, including gantenerumab. These changes can be identified on brain MRI. ARIA-H (H for hemosiderosis) are small foci of signal loss observed on MRI sequences sensitive for paramagnetic tissue properties and comprise cerebral microbleeds (small foci of bleeding in the brain parenchyma) and leptomeningeal hemosiderosis (small foci of bleeding on the surface of the brain). These changes also occur sporadically in AD.
From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 131 weeks)
DBT Period: Number of Participants With Injection-Site Reactions
An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational product or other protocol-imposed intervention, regardless of attribution. Local injection reactions (or injection site reactions) are defined as AEs related to the injection site that occur during or within 24 hours after study drug administration that are judged to be related to the study drug injection.
From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 131 weeks)
DBT Period: Number of Participants With Anti-Drug Antibodies (ADA) to Gantenerumab
The number of participants with positive results for ADA against gantenerumab at any of the post-baseline assessment time-points were reported. Participant with an ADA assay result from at least one post-baseline sample was defined as a post-baseline evaluable participant. Treatment Emergent ADA = A participant with a negative or missing baseline ADA result(s) and at least one positive post-baseline ADA result.
From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 131 weeks)
DBT Period: Change From Baseline to Week 116 in Brain Amyloid Load as Measured by Amyloid Positron Emission Tomography (PET) Scan in a Subset of Participants
Brain amyloid load over time was assessed using [18F] florbetaben or [18F] flutemetamol tracers. These are PET radioligand selective to amyloid. Amyloid PET burden was measured in a composite region of interest (ROI) by using standardized uptake value ratio (SUVR) mapped to the centiloid scale. The weighted composite target region are composed of (both left and right side): frontal lobe, parietal lobe, temporal lobe lateral, cingulum posterior and anterior cingulate gyrus. The reference region used to normalize the composite region was the whole cerebellum. The 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 found in a typical AD scan.
Baseline, Week 116
DBT Period: Change From Baseline to Week 116 in Brain Tau Load, as Measured by Tau PET Scan in a Subset of Participants
Change in tau load= how much neurofibrillary tau pathology is present in brain assessed by PET Scan. [18F] GTP1 was the tau PET radioligand. Tau load was measured using SUVR in 4 composite target ROIs: Temporal composite target region (left & right)=anterior & posterior superior temporal gyrus, posterior temporal lobe, fusiform gyrus, & middle & inferior temporal gyrus; Medial temporal composite region excluding hippocampus (left & right): amygdala, parahippocampus & anterior medial & lateral temporal lobe; Frontal lobe (left & right) & Parietal lobe (left & right). Inferior cerebellar grey matter=reference region for calculating SUVRs for all 4 regions. Tau-PET-mITT analysis set=all participants in ITT analysis set who participated in Tau PET sub-study & who had at least one Tau PET scan with a valid quantitative measurement & who did not withdraw from Tau PET substudy before randomization. Overall number analyzed=number of participants with data available for analysis.
Baseline, Week 116
DBT Period: Percent Change From Baseline to Week 116 in Cerebrospinal Fluid (CSF) Marker of Disease in a Subset of Participants - Total Tau (tTau)
CSF biomarker tTau has been considered as a general marker of neurodegeneration. An elevation in levels of tau, as well as specific pTau species, is thought to be a marker for progressive cellular degeneration in AD.
Baseline, Week 116
DBT Period: Percent Change From Baseline to Week 116 in CSF Marker of Disease in a Subset of Participants - Phosphorylated Tau (pTau-181)
CSF phospho-tau is an indicator of neuronal injury and neurodegeneration. CSF biomarker tTau has been considered as a general marker of neurodegeneration. An elevation in levels of pTau species, is thought to be a marker for progressive cellular degeneration in AD.
Baseline, Week 116
DBT Period: Percent Change From Baseline to Week 116 in CSF Marker of Disease in a Subset of Participants - Neurofilament Light Chain (NFL)
NFL is a neuronal cytoplasmic protein highly expressed in large, myelinated axons. Its levels increase in CSF and blood proportionally to the degree of axonal damage in a variety of neurological disorders, including AD.
Baseline, Week 116
DBT Period: Percent Change From Baseline to Week 116 in CSF Marker of Disease in a Subset of Participants - Neurogranin
Baseline, Week 116
China - DBT Period: Change From Baseline to Week 116 in ADAS-Cog13 Score
The ADAS-Cog13 total score includes all of the items in the ADAS-Cog11 in addition to delayed word recall and the number cancellation. For the ADAS-cog 13 the range is 0-85 (score range for Delayed Word Recall [DWR] score is 0-10 and for Number Cancellation [NC] is 0-5, thus the score is ADAS-cog 11[0-70] plus the scores for DWR and NC). A higher score indicates worse performance. A negative change from baseline indicates improvement in cognitive function.
Baseline, Week 116
China - DBT Period: Change From Baseline to Week 116 in ADCS-ADL Total Score
ADCS-ADL is a 23-item rater-administered, ObsRO that captures a participant's ability to perform basic activities of daily living (e.g., eating and toileting) and more complex ADL or instrumental activities of daily living (iADL, e.g., using the telephone, managing finances, preparing a meal). Total score ranges from 0-78, with higher scores reflecting better functioning. A positive change from baseline indicates improvement.
Baseline, Week 116
China - DBT Period: Change From Baseline to Week 116 in FAQ Score
FAQ is a rater-administered ObsRO (informant-based measure) that measures a participant's functional ability to perform complex higher-order activities. The observer provides performance ratings of the target person on ten complex higher-order activities. Total score that ranges from 0-30, with higher scores reflecting greater functional impairment. A negative change from baseline indicates improvement.
Baseline, Week 116
China - DBT Period: DBT Period: Change From Baseline to Week 116 in MMSE Total Score
MMSE is a rater-administered PerfO that includes a set of standardized questions used to evaluate possible cognitive impairment and help stage the severity level of this impairment. The questions target six areas: orientation, registration, attention, short-term recall, language, and constructional praxis/visuospatial abilities. Total score ranges from 0-30, with lower scores indicating greater impairment. A positive change from baseline indicates improvement.
Baseline, Week 116
China - DBT Period: Change From Baseline to Week 116 in ADAS-Cog11 Score
The ADAS-Cog11 was designed to measure cognitive symptom change in participants with AD and consisted of 11 tasks. The standard 11 items (and corresponding score range) were: word recall (0-10), commands (0-5), constructional praxis (0-5), naming objects and fingers (0-5), ideational praxis (0-5), orientation (0-8), word recognition (0-12), spoken language ability (0-5), comprehension of spoken language (0-5), word-finding difficulty (0-5), and remembering test instructions (0-5). The test included 7 performance items and 4 clinician-rated items. The ADAS-Cog11 total score was the sum of all 11 individual items, with a total score ranging from 0 (no impairment) to 70 (severe impairment). Higher scores indicated more severe cognitive impairment. A negative change from baseline indicates improvement.
Baseline, Week 116
China - DBT Period: Change From Baseline to Week 116 in VFT Score
VFT is a rater administered PerfO that measures speed and flexibility of verbal thought with a total score that ranges from 0-99 (lower scores indicating lower performance). A positive change from baseline indicates improvement.
Baseline, Week 116
China - DBT Period: Change From Baseline to Week 116 in the Coding (DSST) Subtest
Coding, also called DSST is a rater administered PerfO that measures speed of processing and associative memory with a total score that ranges from 0-135 (lower scores indicating lower performance). The DSST was adapted from the Wechsler Adult Intelligence Scale. The 120-second version of the test was used in this study. Positive change from baseline indicates improvement.
Baseline, Week 116
China - DBT Period: Number of Participants With at Least One AE
An AE is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. Total number of participants with at least one event (AEs) have been reported here.
From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 124 weeks)
China - DBT Period: Number of Participants With Post-baseline Suicidal Ideation or Suicidal Behavior as Measured Using C-SSRS
C-SSRS=assessment tool used to assess lifetime suicidality of a participant (at baseline) as well as any new instances of suicidality (C-SSRS since last visit). Structured interview prompts recollection of suicidal ideation, including intensity of ideation, behavior, & attempts with actual/potential lethality. Categories have binary responses (yes/no) & include Wish to be Dead; Non-specific Active Suicidal Thoughts; Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act; Active Suicidal Ideation with Some Intent to Act, without Specific Plan; Active Suicidal Ideation with Specific Plan and Intent, Preparatory Acts and Behavior; Aborted Attempt; Interrupted Attempt; Actual Attempt (non-fatal); Completed Suicide. Suicidal ideation/behavior is indicated by a "yes" answer to any of the listed categories. Score of 0 is assigned if no suicide risk is present. Score of 1 or higher= suicidal ideation or behavior. Categories with non-zero values are only reported here.
From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 124 weeks)
China - DBT Period: Number of Participants With at Least One ARIA-E MRI Finding
ARIA are an identified risk with anti-amyloid antibodies, including gantenerumab. These changes can be identified on brain MRI. In ARIA-E, (E for oedema or effusion), oedema can be seen in different areas of the brain on MRI, representing fluid leakage into the brain parenchyma or sulcal spaces.
From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 124 weeks)
China - DBT Period: Number of Participants With at Least One ARIA-H MRI Finding
ARIA are an identified risk with anti-amyloid antibodies, including gantenerumab. These changes can be identified on brain MRI. ARIA-H (H for hemosiderosis) are small foci of signal loss observed on MRI sequences sensitive for paramagnetic tissue properties and comprise cerebral microbleeds (small foci of bleeding in the brain parenchyma) and leptomeningeal hemosiderosis (small foci of bleeding on the surface of the brain). These changes also occur sporadically in AD.
From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 124 weeks)
China - DBT Period: Number of Participants With Injection-Site Reactions
An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational product or other protocol-imposed intervention, regardless of attribution. Local injection reactions (or injection site reactions) are defined as AEs related to the injection site that occur during or within 24 hours after study drug administration that are judged to be related to the study drug injection.
From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 124 weeks)
OLE Period: Number of Participants With at Least One AEs
An AE is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution.
From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 68 weeks)
OLE Period: Number of Participants With Post-baseline Suicidal Ideation or Suicidal Behavior as Measured Using C-SSRS
C-SSRS=assessment tool used to assess lifetime suicidality of a participant (at baseline) as well as any new instances of suicidality (C-SSRS since last visit). Structured interview prompts recollection of suicidal ideation, including intensity of ideation, behavior, & attempts with actual/potential lethality. Categories have binary responses (yes/no) & include Wish to be Dead; Non-specific Active Suicidal Thoughts; Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act; Active Suicidal Ideation with Some Intent to Act, without Specific Plan; Active Suicidal Ideation with Specific Plan and Intent, Preparatory Acts and Behavior; Aborted Attempt; Interrupted Attempt; Actual Attempt (non-fatal); Completed Suicide. Suicidal ideation/behavior is indicated by a "yes" answer to any of the listed categories. Score of 0 is assigned if no suicide risk is present. Score of 1 or higher= suicidal ideation or behavior. Categories with non-zero values are only reported here.
From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 68 weeks)
OLE Period: Number of Participants With at Least One ARIA-H MRI Finding
ARIA are an identified risk with anti-amyloid antibodies, including gantenerumab. These changes can be identified on brain MRI. ARIA-H (H for hemosiderosis) are small foci of signal loss observed on MRI sequences sensitive for paramagnetic tissue properties and comprise cerebral microbleeds (small foci of bleeding in the brain parenchyma) and leptomeningeal hemosiderosis (small foci of bleeding on the surface of the brain). These changes also occur sporadically in AD.
From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 68 weeks)
OLE Period: Number of Participants With at Least One ARIA-E MRI Finding
ARIA are an identified risk with anti-amyloid antibodies, including gantenerumab. These changes can be identified on brain MRI. In ARIA-E, (E for oedema or effusion), oedema can be seen in different areas of the brain on MRI, representing fluid leakage into the brain parenchyma or sulcal spaces.
From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 68 weeks)
Irvine
California
92614
United States
Sutter Medical Group, Neurology
Sacramento
California
95816
United States
Syrentis Clinical Research
Santa Ana
California
92705
United States
California Neuroscience Research Medical Group, Inc
Sherman Oaks
California
91403
United States
Research Center for Clinical Studies, Inc.
Norwalk
Connecticut
06851
United States
JEM Research LLC
Atlantis
Florida
33462
United States
Bradenton Research Center
Bradenton
Florida
34205
United States
Brain Matters Research, Inc.
Delray Beach
Florida
33445
United States
Alzheimer?s Research and Treatment Center
Wellington
Florida
33414
United States
Columbus Memory Center
Columbus
Georgia
31909
United States
Center for Advanced Research & Education
Gainesville
Georgia
30501
United States
Southern Illinois University, School of Medicine
Springfield
Illinois
62702
United States
Fort Wayne Neurological Center
Fort Wayne
Indiana
46805
United States
Via Christi Research
Wichita
Kansas
67214
United States
Precise Research Centers
Flowood
Mississippi
39232
United States
University of Mississippi Medical Center
Jackson
Mississippi
39216
United States
Advanced Memory Research Institute of NJ
Toms River
New Jersey
08755
United States
Neurological Associates of Long Island, PC
Lake Success
New York
11042
United States
Columbia University Medical Center
New York
New York
10032
United States
Ohio State University; College of Medicine
Columbus
Ohio
43210
United States
Abington Neurological Associates
Abington
Pennsylvania
19001
United States
The Clinical Trial Center, LLC
Jenkintown
Pennsylvania
19046
United States
Drexel University; College of Medicine
Philadelphia
Pennsylvania
19102
United States
Coastal Neurology
Port Royal
South Carolina
29935
United States
Senior Adults Specialty Research
Austin
Texas
78757
United States
Neurology Consultants of Dallas; Research Department
Dallas
Texas
75243
United States
Wasatch Clinical Research, LLC
Salt Lake City
Utah
84107
United States
University of Virginia
Charlottesville
Virginia
22906
United States
Sentara Neurology Specialists
Norfolk
Virginia
23507
United States
Neurological Associates, Inc.
Richmond
Virginia
23229
United States
National Clinical Research Inc.-Richmond
Richmond
Virginia
23294
United States
UW Wisconsin-Madison
Madison
Wisconsin
53705
United States
St Vincent's Hospital Sydney; Neurology
Darlinghurst
New South Wales
2010
Australia
Central Coast Neurosciences Research
Erina
New South Wales
2250
Australia
Southern Neurology
Kogarah
New South Wales
2217
Australia
The Queen Elizabeth Hospital; Neurology
Woodville
South Australia
5011
Australia
Heidelberg Repatriation Hospital; Medical and Cognitive Research Centre
Heidelberg West
Victoria
3081
Australia
Neuro Trials Victoria
Noble Park
Victoria
3174
Australia
Australian Alzheimer's Research Foundation
Nedlands
Western Australia
6009
Australia
Hospital Nossa Senhora das Graças; Setor de Pesquisa em Neurologia
Curitiba
Paraná
80810-040
Brazil
Instituto de Neurologia de Curitiba
Curitiba
Paraná
81210-310
Brazil
Clinica Clinilive ltda
Maringá
Paraná
87013-250
Brazil
Hospital das Clinicas - UFRGS
Porto Alegre
Rio Grande do Sul
90035-903
Brazil
ClÃnica Dr. Norton Sayeg LTDA - EPP
São Paulo
São Paulo
04534-011
Brazil
Hospital das Clinicas - FMUSP_X; Neurologia
São Paulo
São Paulo
05403-000
Brazil
Medical Arts Health Research Group
Penticton
British Columbia
V1Y 1Z9
Canada
The Medical Arts Health Research Group - West Vancouver
Vancouver
British Columbia
V7T 2Z3
Canada
Parkwood Hospital; Geriatric Medicine
London
Ontario
N6C 5J1
Canada
Centre for Memory and Aging
Toronto
Ontario
M4G 3E8
Canada
Sunnybrook Health Sciences Centre
Toronto
Ontario
M4N 3M5
Canada
St. Michael'S Hospital
Toronto
Ontario
M5B 1W8
Canada
Baycrest Health Sciences
Toronto
Ontario
M6A 2E1
Canada
Devonshire Clinical Research
Woodstock
Ontario
N4S 5P5
Canada
Center for Diagnosis and Research on Alzheimer's disease
Universitätsklinikum Köln; Klinik und Poliklinik für Psychiatrie und Psychotherapie
Cologne
50937
Germany
PANAKEIA - Arzneimittelforschung Leipzig GmbH
Leipzig
04275
Germany
Universitätsmedizin derJohannes Gutenberg-Universität Mainz;Klinik für Psychiatrie und Psychotherapi
Mainz
55131
Germany
Klinikum rechts der Isar der TU München; Klinik für Psychiatrie und Psychotherapie
München
81675
Germany
Universitätsklinikum Münster; Klinik und Poliklinik für Neurologie
Münster
48149
Germany
Universitätsklinikum Rostock Zentrum für Nervenheilkunde
Rostock
18147
Germany
Universitätsklinikum Ulm; Klinik für Neurologie
Ulm
89081
Germany
Studienzentrum Nordwest Dr med Joachim Springub Herr Wolfgang Schwarz
Westerstede
26655
Germany
Forschungszentrum Ruhr
Witten
58455
Germany
Semmelweis University; Department of Neurology
Budapest
1083
Hungary
Nuovo Ospedale Civile S. Agostino-Estense; Clinica Neurologica ? Dipartimento di Neuroscienze
Modena
Emilia-Romagna
41126
Italy
Fondazione Santa Lucia IRCCS; Neurologia e Riabilitazione Neurologica
Rome
Lazio
00179
Italy
Umberto I Policlinico di Roma-Università di Roma La Sapienza
Rome
Lazio
00185
Italy
Ospedale San Giovanni Calibita Fatebenefratell;Neurologia
Rome
Lazio
00186
Italy
IRCCS ?Centro S. Giovanni di Dio? Fatebenefratelli -UO Alzheimer
Brescia
Lombardy
25125
Italy
IRCCS Ospedale San Raffaele; Centro Disturbi della Memoria
Milan
Lombardy
20132
Italy
ASST DI MONZA; Neurologia
Monza
Lombardy
20900
Italy
IRCCS Neuromed; Neurologia I-Centro studio e cura delle demenze e UVA
Pozzilli
Molise
86077
Italy
AO Città della Salute e della Scienza Osp.S.Giov.Battista Molinette; SC Geriatria
Turin
Piedmont
10126
Italy
Dipartimento delle Patologie Emergenti; Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
Palermo
Sicily
90127
Italy
Medical Corporation Hakuyokai Kashiwado Hospital
Chiba
260-8656
Japan
Inage Neurology and Memory Clinic
Chiba
263-0043
Japan
Juntendo University Urayasu Hospital
Chiba
279-0021
Japan
Southern Tohoku Medical Clinic
Fukushima
963-8052
Japan
Yuai Clinic
Kanagawa
223-0059
Japan
Shonan Kamakura General Hospital
Kanagawa
247-8533
Japan
Mishima Hospital
Niigata
940-2302
Japan
NHO Shizuoka Institute of Epilepsy and Neurological Disorders
Shizuoka
420-8688
Japan
Shizuoka City Shimizu Hospital
Shizuoka
424-0911
Japan
Jichiidai Station Brain Clinic
Tochigi
329-0403
Japan
Yotsuya Medical Cube
Tokyo
102-0084
Japan
Tokyo Medical and Dental University Hospital
Tokyo
113-8519
Japan
Tokyo Medical University Hospital
Tokyo
160-0023
Japan
Tokyo Metropolitan Geriatric Hospital
Tokyo
173-0015
Japan
Nozomi Memory Clinic
Tokyo
181-0013
Japan
National Center of Neurology and Psychiatry
Tokyo
187-8551
Japan
P-One Clinic
Tokyo
192-0071
Japan
Yamagata Tokusyukai Hospital
Yamagata
990-0834
Japan
Vilnius University Hospital Santariskiu Clinics; Neurology
Vilnius
08661
Lithuania
Hospital IV Alberto Sabogal Sologuren; Unidad de Investigacion
Bellavista
Callao 2
Peru
Clinica Internacional; Unidad De Investigacion
Lima
15001
Peru
Hospital Nacional Dos de Mayo; Unidad de Investigacion de Neurologia
Lima
15003
Peru
Hospital Nacional Cayetano Heredia; Servicio de Neurologia
San MartÃn de Porres
15102
Peru
FSBHI Siberian Clinical Center of the Federal Medical and Biological Agency
Krasnoyarsk
Krasnoyarsk Krai
660037
Russia
University ?linic of headaches
Moscow
Moscow Oblast
121467
Russia
City Clin Hosp n.a. S.P.Botkin
Moscow
Moscow Oblast
125101
Russia
Central Clinical Hospital #2 N.A. Semashko OAO RJHD
Moskva
Moscow Oblast
107150
Russia
Russian Medical Military Academy n.a. S.M.Kirov; Neurology Department
Saint Petersburg
Sankt-Peterburg
194044
Russia
Vertebronevrologiya LLC
Kazan'
Tatarstan Republic
420047
Russia
State autonomous institution of healthcare Inter-regional clinical and diagnostic center
Kazan'
Tatarstan Republic
420101
Russia
City Clinical Hospital # 2 n.a. V.I. Razumovsky
Saratov
410028
Russia
Nebbiolo Center for Clinical Trials
Tomsk
634009
Russia
Hospital Universitari de Bellvitge; Servicio de Neurologia
L'Hospitalet de Llobregat
Barcelona
08907
Spain
Hospital General De Catalunya; Servicio de Neurologia
Sant Cugat del Vallès
Barcelona
8195
Spain
Hospital Universitario Marques de Valdecilla; Servicio de NeurologÃa
Santander
Cantabria
39011
Spain
Hospital San Pedro; Servicio de NeurologÃa
Logroño
La Rioja
26006
Spain
HM Universitario Puerta del Sur CINAC (C.Integ.Neuroc);; Servicio de PsiquiatrÃa
Móstoles
Madrid
28938
Spain
Hospital General Universitario de Albacete; Servicio de NeurologÃa
Albacete
Spain
Hospital Vall d'Hebron; Servicio de NeurologÃa
Barcelona
08035
Spain
Hospital Clinic i Provincial; Servicio de Neurologia
Barcelona
08036
Spain
Hospital de la Santa Creu i Sant Pau; Servicio de Neurologia
Barcelona
08041
Spain
Hospital Universitario Reina Sofia; Servicio de Neurologia
Córdoba
14004
Spain
Hospital Ramon y Cajal; Servicio de Neurologia
Madrid
28034
Spain
Hospital Ruber Internacional; Servicio de NeurologÃa
Madrid
28034
Spain
Hospital Universitario 12 de Octubre; Servicio de Neurologia
Madrid
28041
Spain
Complejo Asistencial Universitario de Salamanca; Servicio de PsiquiatrÃa
Salamanca
37005
Spain
Hospital Virgen del RocÃo; Servicio de NeurologÃa
Seville
41013
Spain
Hospital Universitario Dr. Peset; Servicio de Neurologia
Valencia
46017
Spain
Servicio de NeurologÃa Hospital Viamed Montecanal.
Zaragoza
50012
Spain
Changhua Christian Hospital; Neurology
Changhua County
500
Taiwan
Kaohsiung Medical University Hospital; Neurology
Kaohsiung City
807
Taiwan
Chang Gung Memorial Foundation - Kaohsiung - Neurology
Niaosong Dist.
83301
Taiwan
China Medical University Hospital; Neurology
North Dist.
40447
Taiwan
National Taiwan University Hospital; Neurology
Taipei
100
Taiwan
Chang Gung Memorial Foundation - Linkou - Neurology
Taoyuan
333
Taiwan
Derived
Asada T, Thanasopoulou A, Delmar P, Wojtowicz J, Smith J, Yoshiyama Y, Yokoi K, Watanabe C, Isozaki M, Ozaki R, Ishida T, Tatsuda H, Tamaoka A. Japanese participant data from three gantenerumab trials in early Alzheimer's disease. Alzheimers Dement. 2025 Apr;21(4):e70192. doi: 10.1002/alz.70192.
Bittner T, Tonietto M, Klein G, Belusov A, Illiano V, Voyle N, Delmar P, Scelsi MA, Gobbi S, Silvestri E, Barakovic M, Napolitano A, Galli C, Abaei M, Blennow K, Barkhof F. Biomarker treatment effects in two phase 3 trials of gantenerumab. Alzheimers Dement. 2025 Feb;21(2):e14414. doi: 10.1002/alz.14414. Epub 2025 Jan 30.
Salloway S, Wojtowicz J, Voyle N, Lane CA, Klein G, Lyons M, Rossomanno S, Mazzo F, Bullain S, Barkhof F, Bittner T, Schneider A, Grundman M, Aldea R, Boada M, Smith J, Doody R. Amyloid-Related Imaging Abnormalities (ARIA) in Clinical Trials of Gantenerumab in Early Alzheimer Disease. JAMA Neurol. 2025 Jan 1;82(1):19-29. doi: 10.1001/jamaneurol.2024.3937.
Bateman RJ, Smith J, Donohue MC, Delmar P, Abbas R, Salloway S, Wojtowicz J, Blennow K, Bittner T, Black SE, Klein G, Boada M, Grimmer T, Tamaoka A, Perry RJ, Turner RS, Watson D, Woodward M, Thanasopoulou A, Lane C, Baudler M, Fox NC, Cummings JL, Fontoura P, Doody RS; GRADUATE I and II Investigators and the Gantenerumab Study Group. Two Phase 3 Trials of Gantenerumab in Early Alzheimer's Disease. N Engl J Med. 2023 Nov 16;389(20):1862-1876. doi: 10.1056/NEJMoa2304430.
Participants received gantenerumab, SC injection with gradual up-titration starting at a dose of 120 milligrams (mg), Q4W for 3 doses, followed by 255 mg, Q4W for 3 doses, and 510 mg, Q4W for 3 doses, and 510 mg, Q4W for 3 doses. Following this, from Week 36 onwards, participants received gantenerumab, SC injection at a dose of 510 mg, Q2W up to Week 114 of the DBT period.
FG002
China Extension - DBT Period: Placebo
Participants received gantenerumab matching placebo, SC injection, Q4W up to Week 36 and then Q2W up to approximately 110 weeks of the DBT period.
FG003
China Extension - DBT Period: Gantenerumab
Participants received gantenerumab, SC injection with gradual up-titration starting at a dose of 120 mg, Q4W for 3 doses, followed by 255 mg, Q4W for 3 doses, and 510 mg, Q4W for 3 doses. Following this, from Week 36 onwards, participants received gantenerumab, SC injection at a dose of 510 mg, Q2W up to approximately 110 weeks of the DBT period.
FG004
Global - OLE Period: Placebo (DBT) to Gantenerumab
Participants who received gantenerumab matching placebo in the DBT period received gantenerumab SC injections with gradual up titration starting at a dose of 120 mg, Q4W for 3 doses, followed by 255 mg, Q4W for 3 doses, and then at a dose of 510 mg, Q4W up to Week 34 of the OLE period. To maintain the blind to previous treatment assignment, participants received Q2W, SC injections, with alternate doses containing gantenerumab matching placebo.
FG005
Global - OLE Period: Gantenerumab (DBT) to Gantenerumab
Participants who received gantenerumab in the DBT period continued receiving gantenerumab, SC injections, 510 mg, Q2W up to Week 34 of the OLE period.
FG000486 subjects
FG001499 subjects
FG00233 subjects
FG00335 subjects
FG0040 subjects
FG0050 subjects
Intent-to-treat (ITT) Analysis Set
ITT analysis set included all participants randomized during the global phase, who received at least one dose of study drug.
FG000485 subjects
FG001499 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
Safety-evaluable (SE) Analysis Set
SE analysis set included all participants randomized during the global phase who received at least one dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period.
FG000481 subjects
FG001503 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
ITT Analysis Set (China)
ITT analysis set (China) included all participants enrolled in China in the China extension phase who received at least one dose of study drug.
FG0000 subjects
FG0010 subjects
FG00233 subjects
FG00335 subjects
FG0040 subjects
FG0050 subjects
SE Analysis Set (China)
SE analysis set (China) included all participants enrolled in China in the China extension phase who received at least one dose of study drug.
FG0000 subjects
FG0010 subjects
FG00233 subjects
FG00335 subjects
FG0040 subjects
FG0050 subjects
Safety Magnetic Resonance Imaging (MRI)-Evaluable (SEMRI) Analysis Set
SEMRI analysis set included all participants in the SE analysis set who had at least one post-baseline safety MRI scan.
FG000476 subjects
FG001497 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
COMPLETED
FG000387 subjects
FG001375 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
NOT COMPLETED
FG00099 subjects
FG001124 subjects
FG00233 subjects
FG00335 subjects
FG0040 subjects
FG0050 subjects
Type
Comment
Reasons
Study Terminated By Sponsor
FG0000 subjects
FG0010 subjects
FG00230 subjects
FG00335 subjects
FG0040 subjects
FG0050 subjects
Reason not Specified
FG00017 subjects
FG00116 subjects
FG0021 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG00056 subjects
FG00163 subjects
FG0022 subjects
FG0030 subjects
FG004
Protocol Deviation
FG0004 subjects
FG0013 subjects
FG0020 subjects
FG0030 subjects
FG004
Physician Decision
FG0003 subjects
FG00111 subjects
FG0020 subjects
FG0030 subjects
FG004
Lost to Follow-up
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Death
FG00010 subjects
FG0012 subjects
FG0020 subjects
FG0030 subjects
FG004
Adverse Event
FG0007 subjects
FG00129 subjects
FG0020 subjects
FG0030 subjects
FG004
Randomized, but not Treated
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Open-Label Extension (OLE) Period
Type
Comment
Milestone Data
STARTED
FG0000 subjectsParticipants who completed the DBT Period were given the option to enroll in the OLE Period to receive gantenerumab.
FG0010 subjectsParticipants who completed the DBT Period were given the option to enroll in the OLE Period to receive gantenerumab.
FG0020 subjectsParticipants who completed the China Extension -DBT Period were given the option to enroll in the OLE Period to receive gantenerumab.
FG0030 subjectsParticipants who completed the China Extension -DBT Period were given the option to enroll in the OLE Period to receive gantenerumab.
FG00410 subjects10 participants who completed the DBT Period enrolled into the OLE Period.
FG00519 subjects19 Participants who completed the DBT Period enrolled into the OLE Period.
SE Analysis Set
SE analysis set included all participants randomized during the global phase who received at least one dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period.
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
ITT analysis set included all participants randomized during the global phase, who received at least one dose of study drug. ITT analysis set (China) included all participants enrolled in China in the China extension phase who received at least one dose of study drug.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Global - DBT Period: Placebo
Participants received gantenerumab matching placebo, SC injection, Q4W up to Week 36 and then Q2W up to approximately 114 weeks of the DBT period.
BG001
Global - DBT Period: Gantenerumab
Participants received gantenerumab, SC injection with gradual up-titration starting at a dose of 120 mg, Q4W for 3 doses, followed by 255 mg, Q4W for 3 doses, and 510 mg, Q4W for 3 doses, and 510 mg, Q4W for 3 doses. Following this, from Week 36 onwards, participants received gantenerumab, SC injection at a dose of 510 mg, Q2W up to Week 114 of the DBT period.
BG002
China Extension - DBT Period: Placebo
Participants received gantenerumab matching placebo, SC injection, Q4W up to Week 36 and then Q2W up to approximately 110 weeks of the DBT period.
BG003
China Extension - DBT Period: Gantenerumab
Participants received gantenerumab, SC injection with gradual up-titration starting at a dose of 120 mg, Q4W for 3 doses, followed by 255 mg, Q4W for 3 doses, and 510 mg, Q4W for 3 doses. Following this, from Week 36 onwards, participants received gantenerumab, SC injection at a dose of 510 mg, Q2W up to approximately 110 weeks of the DBT period.
BG004
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000485
BG001499
BG00233
BG00335
BG0041052
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
ParticipantsBG000485
ParticipantsBG001499
ParticipantsBG00233
ParticipantsBG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG000485
ParticipantsBG001499
ParticipantsBG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG000485
ParticipantsBG001499
ParticipantsBG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG000485
ParticipantsBG001499
ParticipantsBG002
China Extension: Clinical Dementia Rating-Sum of Boxes (CDR-SB)
CDR was derived through semi-structured interview with participant and appropriate informant. It rated impairment across 6 domains: memory,orientation,judgment,and problem solving,community affairs,home and hobbies, and personal care on a 5-point scale for which 0=no impairment, 0.5=questionable impairment, and 1, 2, and 3=mild, moderate, severe impairment respectively. The CDR-SB is based on summing each of the domain box scores with total score ranging from 0-18 with higher scores reflecting greater cognitive and functional impairment.
ITT analysis set (China) included all participants enrolled in China in the China extension phase who received at least one dose of study drug.
Mean
Standard Deviation
score on a scale
Title
Denominators
Categories
ParticipantsBG0000
ParticipantsBG001
DBT Period: CDR-SB
CDR was derived through semi-structured interview with participant and appropriate informant. It rated impairment across 6 domains: memory,orientation,judgment,and problem solving,community affairs,home and hobbies, and personal care on a 5-point scale for which 0=no impairment, 0.5=questionable impairment, and 1, 2, and 3=mild, moderate, severe impairment respectively. The CDR-SB is based on summing each of the domain box scores with total score ranging from 0-18 with higher scores reflecting greater cognitive and functional impairment.
ITT analysis set included all participants randomized during the global phase, who received at least one dose of study drug.
Mean
Standard Deviation
score on a scale
Title
Denominators
Categories
ParticipantsBG000485
ParticipantsBG001
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
DBT Period: Change From Baseline to Week 116 in Global Outcome, as Measured by CDR-SB
CDR was derived through semi-structured interview with the participant and an appropriate informant, and it rated impairment across six domains: memory, orientation, judgment, and problem solving, community affairs, home and hobbies, and personal care on a 5-point scale for which 0=no impairment, 0.5=questionable impairment, and 1, 2, and 3=mild, moderate, and severe impairment, respectively. The CDR-SB is based on summing each of the domain box scores with total score ranging from 0-18 with higher scores reflecting greater cognitive and functional impairment. A negative change from baseline indicates improvement.
ITT analysis set included all participants randomized during the global phase, who received at least one dose of study drug.
Posted
Mean
Standard Error
score on a scale
Baseline, Week 116
ID
Title
Description
OG000
Global - DBT Period: Placebo
Participants received gantenerumab matching placebo, SC injection, Q4W up to Week 36 and then Q2W up to approximately 114 weeks of the DBT period.
OG001
Global - DBT Period: Gantenerumab
Participants received gantenerumab, SC injection with gradual up-titration starting at a dose of 120 mg, Q4W for 3 doses, followed by 255 mg, Q4W for 3 doses, and 510 mg, Q4W for 3 doses, and 510 mg, Q4W for 3 doses. Following this, from Week 36 onwards, participants received gantenerumab, SC injection at a dose of 510 mg, Q2W up to Week 114 of the DBT period.
Units
Counts
Participants
OG000485
OG001499
Title
Denominators
Categories
Title
Measurements
OG0003.65± 0.16
OG0013.35± 0.14
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Change from Baseline was calculated based on ANCOVA analysis model which included the following covariates and stratification factors =Treatment + Baseline (BL) + Geographic Region + Disease Stage + AD Medication at BL + Apolipoprotein E, Allele e4 (APOE e4) + Baseline Alzheimer Disease Assessment Scale-Cognition Subscale 13 (ADAS-Cog13) Score + Baseline Alzheimer Disease Cooperative Study Group-Activities of Daily Living (ADCS-ADL).
ANCOVA
0.0954
Difference in adjusted mean
-0.31
Standard Error of the Mean
0.18
2-Sided
95
-0.66
0.05
Superiority
Primary
China Extension: DBT Period: Change From Baseline to Week 116 in Global Outcome, as Measured by CDR-SB
CDR was derived through semi-structured interview with the participant and an appropriate informant, and it rated impairment across six domains: memory, orientation, judgment, and problem solving, community affairs, home and hobbies, and personal care on a 5-point scale for which 0=no impairment, 0.5=questionable impairment, and 1, 2, and 3=mild, moderate, and severe impairment, respectively. The CDR-SB is based on summing each of the domain box scores with total score ranging from 0-18 with higher scores reflecting greater cognitive and functional impairment. A negative change from baseline indicates improvement.
The study was terminated early by the sponsor before any participant had reached Week 116 visit in the China extension phase.
Posted
Baseline, Week 116
ID
Title
Description
OG000
China Extension - DBT Period: Placebo
Participants received gantenerumab matching placebo, SC injection, Q4W up to Week 36 and then Q2W up to approximately 110 weeks of the DBT period.
OG001
China Extension - DBT Period: Gantenerumab
Participants received gantenerumab, SC injection with gradual up-titration starting at a dose of 120 mg, Q4W for 3 doses, followed by 255 mg, Q4W for 3 doses, and 510 mg, Q4W for 3 doses. Following this, from Week 36 onwards, participants received gantenerumab, SC injection at a dose of 510 mg, Q2W up to approximately 110 weeks of the DBT period.
Secondary
DBT Period: Change From Baseline to Week 116 in Alzheimer Disease Assessment Scale-Cognition Subscale 13 (ADAS-Cog13) Score
The ADAS-Cog13 total score includes all of the items in the ADAS-Cog11 in addition to delayed word recall and the number cancellation. For the ADAS-cog 13 the range is 0-85 (score range for Delayed Word Recall [DWR] score is 0-10 and for Number Cancellation [NC] is 0-5, thus the score is ADAS-cog 11[0-70] plus the scores for DWR and NC). A higher score indicates worse performance. A negative change from baseline indicates improvement in cognitive function.
ITT analysis set included all participants randomized during the global phase, who received at least one dose of study drug. Overall number analyzed is the number of participants with data available for analysis.
Posted
Mean
Standard Error
score on a scale
Baseline, Week 116
ID
Title
Description
OG000
Global - DBT Period: Placebo
Participants received gantenerumab matching placebo, SC injection, Q4W up to Week 36 and then Q2W up to approximately 114 weeks of the DBT period.
OG001
Global - DBT Period: Gantenerumab
Participants received gantenerumab, SC injection with gradual up-titration starting at a dose of 120 mg, Q4W for 3 doses, followed by 255 mg, Q4W for 3 doses, and 510 mg, Q4W for 3 doses, and 510 mg, Q4W for 3 doses. Following this, from Week 36 onwards, participants received gantenerumab, SC injection at a dose of 510 mg, Q2W up to Week 114 of the DBT period.
Secondary
DBT Period: Change From Baseline to Week 116 in Alzheimer's Disease Cooperative Study- Activities of Daily Living (ADCS-ADL) Total Score
ADCS-ADL is a 23-item rater-administered, observer-reported outcome (ObsRO) that captures a participant's ability to perform basic activities of daily living (e.g., eating and toileting) and more complex ADL or instrumental activities of daily living (iADL, e.g., using the telephone, managing finances, preparing a meal). Total score ranges from 0-78, with higher scores reflecting better functioning. A positive change from baseline indicates improvement.
ITT analysis set included all participants randomized during the global phase, who received at least one dose of study drug. Overall number analyzed is the number of participants with data available for analysis.
Posted
Mean
Standard Error
score on a scale
Baseline, Week 116
ID
Title
Description
OG000
Global - DBT Period: Placebo
Participants received gantenerumab matching placebo, SC injection, Q4W up to Week 36 and then Q2W up to approximately 114 weeks of the DBT period.
OG001
Global - DBT Period: Gantenerumab
Participants received gantenerumab, SC injection with gradual up-titration starting at a dose of 120 mg, Q4W for 3 doses, followed by 255 mg, Q4W for 3 doses, and 510 mg, Q4W for 3 doses, and 510 mg, Q4W for 3 doses. Following this, from Week 36 onwards, participants received gantenerumab, SC injection at a dose of 510 mg, Q2W up to Week 114 of the DBT period.
Secondary
DBT Period: Change From Baseline to Week 116 in Functional Activities Questionnaire (FAQ) Score
FAQ is a rater-administered ObsRO (informant-based measure) that measures a participant's functional ability to perform complex higher-order activities. The observer provides performance ratings of the target person on ten complex higher-order activities. Total score that ranges from 0-30, with higher scores reflecting greater functional impairment. A negative change from baseline indicates improvement.
ITT analysis set included all participants randomized during the global phase, who received at least one dose of study drug. Overall number analyzed is the number of participants with data available for analysis.
Posted
Mean
Standard Error
score on a scale
Baseline, Week 116
ID
Title
Description
OG000
Global - DBT Period: Placebo
Participants received gantenerumab matching placebo, SC injection, Q4W up to Week 36 and then Q2W up to approximately 114 weeks of the DBT period.
OG001
Global - DBT Period: Gantenerumab
Participants received gantenerumab, SC injection with gradual up-titration starting at a dose of 120 mg, Q4W for 3 doses, followed by 255 mg, Q4W for 3 doses, and 510 mg, Q4W for 3 doses, and 510 mg, Q4W for 3 doses. Following this, from Week 36 onwards, participants received gantenerumab, SC injection at a dose of 510 mg, Q2W up to Week 114 of the DBT period.
Secondary
DBT Period: Change From Baseline to Week 116 in Mini-Mental State Examination (MMSE) Total Score
MMSE is a rater-administered performance-based outcome (PerfO) that includes a set of standardized questions used to evaluate possible cognitive impairment and help stage the severity level of this impairment. The questions target six areas: orientation, registration, attention, short-term recall, language, and constructional praxis/visuospatial abilities. Total score ranges from 0-30, with lower scores indicating greater impairment. A positive change from baseline indicates improvement.
ITT analysis set included all participants randomized during the global phase, who received at least one dose of study drug.
Posted
Mean
Standard Error
score on a scale
Baseline, Week 116
ID
Title
Description
OG000
Global - DBT Period: Placebo
Participants received gantenerumab matching placebo, SC injection, Q4W up to Week 36 and then Q2W up to approximately 114 weeks of the DBT period.
OG001
Global - DBT Period: Gantenerumab
Participants received gantenerumab, SC injection with gradual up-titration starting at a dose of 120 mg, Q4W for 3 doses, followed by 255 mg, Q4W for 3 doses, and 510 mg, Q4W for 3 doses, and 510 mg, Q4W for 3 doses. Following this, from Week 36 onwards, participants received gantenerumab, SC injection at a dose of 510 mg, Q2W up to Week 114 of the DBT period.
Secondary
DBT Period: Change From Baseline to Week 116 in Alzheimer Disease Assessment Scale-Cognition Subscale 11 (ADAS-Cog11) Score
The ADAS-Cog11 was designed to measure cognitive symptom change in participants with Alzheimer's Disease (AD) and consisted of 11 tasks. The standard 11 items (and corresponding score range) were: word recall (0-10), commands (0-5), constructional praxis (0-5), naming objects and fingers (0-5), ideational praxis (0-5), orientation (0-8), word recognition (0-12), spoken language ability (0-5), comprehension of spoken language (0-5), word-finding difficulty (0-5), and remembering test instructions (0-5). The test included 7 performance items and 4 clinician-rated items. The ADAS-Cog11 total score was the sum of all 11 individual items, with a total score ranging from 0 (no impairment) to 70 (severe impairment). Higher scores indicated more severe cognitive impairment. A negative change from baseline indicates improvement.
ITT analysis set included all participants randomized during the global phase, who received at least one dose of study drug. Overall number analyzed is the number of participants with data available for analysis.
Posted
Mean
Standard Error
score on a scale
Baseline, Week 116
ID
Title
Description
OG000
Global - DBT Period: Placebo
Participants received gantenerumab matching placebo, SC injection, Q4W up to Week 36 and then Q2W up to approximately 114 weeks of the DBT period.
OG001
Global - DBT Period: Gantenerumab
Secondary
DBT Period: Change From Baseline to Week 116 in Verbal Fluency Task (VFT) Score
VFT is a rater administered PerfO that measures speed and flexibility of verbal thought with a total score that ranges from 0-99 (lower scores indicating lower performance). A positive change from baseline indicates improvement.
ITT analysis set included all participants randomized during the global phase, who received at least one dose of study drug. Overall number analyzed is the number of participants with data available for analysis.
Posted
Mean
Standard Error
score on a scale
Baseline, Week 116
ID
Title
Description
OG000
Global - DBT Period: Placebo
Participants received gantenerumab matching placebo, SC injection, Q4W up to Week 36 and then Q2W up to approximately 114 weeks of the DBT period.
OG001
Global - DBT Period: Gantenerumab
Participants received gantenerumab, SC injection with gradual up-titration starting at a dose of 120 mg, Q4W for 3 doses, followed by 255 mg, Q4W for 3 doses, and 510 mg, Q4W for 3 doses, and 510 mg, Q4W for 3 doses. Following this, from Week 36 onwards, participants received gantenerumab, SC injection at a dose of 510 mg, Q2W up to Week 114 of the DBT period.
Units
Secondary
DBT Period: Change From Baseline to Week 116 in the Coding (Digit Symbol Substitution Test [DSST]) Subtest
Coding, also called DSST is a rater administered PerfO that measures speed of processing and associative memory with a total score that ranges from 0-135 (lower scores indicating lower performance). The DSST was adapted from the Wechsler Adult Intelligence Scale. The 120-second version of the test was used in this study. Positive change from baseline indicates improvement.
ITT analysis set included all participants randomized during the global phase, who received at least one dose of study drug. Overall number analyzed is the number of participants with data available for analysis.
Posted
Mean
Standard Error
score on a scale
Baseline, Week 116
ID
Title
Description
OG000
Global - DBT Period: Placebo
Participants received gantenerumab matching placebo, SC injection, Q4W up to Week 36 and then Q2W up to approximately 114 weeks of the DBT period.
OG001
Global - DBT Period: Gantenerumab
Participants received gantenerumab, SC injection with gradual up-titration starting at a dose of 120 mg, Q4W for 3 doses, followed by 255 mg, Q4W for 3 doses, and 510 mg, Q4W for 3 doses, and 510 mg, Q4W for 3 doses. Following this, from Week 36 onwards, participants received gantenerumab, SC injection at a dose of 510 mg, Q2W up to Week 114 of the DBT period.
Secondary
DBT Period: Change From Baseline to Week 116 in Alzheimer's Disease Cooperative Study-Instrumental Activities of Daily Living (ADCS-iADL) Instrumental Score
The ADCS-iADL measures activities such as using the telephone, shopping and preparing a meal. The ADCS-iADL consists of 16 questions with a score range of 0 to 56 where a higher score represents better function. Positive change from baseline indicates improvement.
ITT analysis set included all participants randomized during the global phase, who received at least one dose of study drug. Overall number analyzed is the number of participants with data available for analysis.
Posted
Mean
Standard Error
score on a scale
Baseline, Week 116
ID
Title
Description
OG000
Global - DBT Period: Placebo
Participants received gantenerumab matching placebo, SC injection, Q4W up to Week 36 and then Q2W up to approximately 114 weeks of the DBT period.
OG001
Global - DBT Period: Gantenerumab
Participants received gantenerumab, SC injection with gradual up-titration starting at a dose of 120 mg, Q4W for 3 doses, followed by 255 mg, Q4W for 3 doses, and 510 mg, Q4W for 3 doses, and 510 mg, Q4W for 3 doses. Following this, from Week 36 onwards, participants received gantenerumab, SC injection at a dose of 510 mg, Q2W up to Week 114 of the DBT period.
Secondary
DBT Period: Number of Participants With at Least One Adverse Event (AE)
An AE is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution.
SE analysis set included all participants randomized during the global phase who received at least one dose of study drug. In the DBT period, four participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety analysis set.
Posted
Count of Participants
Participants
From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 131 weeks)
ID
Title
Description
OG000
Global - DBT Period: Placebo
Participants received gantenerumab matching placebo, SC injection, Q4W up to Week 36 and then Q2W up to approximately 114 weeks of the DBT period.
OG001
Global - DBT Period: Gantenerumab
Participants received gantenerumab, SC injection with gradual up-titration starting at a dose of 120 mg, Q4W for 3 doses, followed by 255 mg, Q4W for 3 doses, and 510 mg, Q4W for 3 doses, and 510 mg, Q4W for 3 doses. Following this, from Week 36 onwards, participants received gantenerumab, SC injection at a dose of 510 mg, Q2W up to Week 114 of the DBT period.
Secondary
DBT Period: Number of Participants With Post-baseline Suicidal Ideation or Suicidal Behavior as Measured Using Columbia-Suicide Severity Rating Scale (C-SSRS)
C-SSRS=assessment tool used to assess lifetime suicidality of a participant (at baseline) as well as any new instances of suicidality (C-SSRS since last visit). Structured interview prompts recollection of suicidal ideation, including intensity of ideation, behavior, & attempts with actual/potential lethality. Categories have binary responses (yes/no) & include Wish to be Dead; Non-specific Active Suicidal Thoughts; Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act; Active Suicidal Ideation with Some Intent to Act, without Specific Plan; Active Suicidal Ideation with Specific Plan and Intent, Preparatory Acts and Behavior; Aborted Attempt; Interrupted Attempt; Actual Attempt (non-fatal); Completed Suicide. Suicidal ideation/behavior is indicated by a "yes" answer to any of the listed categories. Score of 0 is assigned if no suicide risk is present. Score of 1 or higher= suicidal ideation or behavior. Categories with non-zero values are only reported here.
SE analysis set included all participants randomized during the global phase who received at least one dose of study drug. In the DBT period, four participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety analysis set. Overall number analyzed is the number of participants with data available for analysis.
Posted
Count of Participants
Participants
From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 131 weeks)
ID
Title
Description
OG000
Global - DBT Period: Placebo
Secondary
DBT Period: Number of Participants With at Least One Amyloid-Related Imaging Abnormalities-Edema (ARIA-E) Magnetic Resonance Imaging (MRI) Finding
ARIA are an identified risk with anti-amyloid antibodies, including gantenerumab. These changes can be identified on brain MRI. In ARIA-E, (E for oedema or effusion), oedema can be seen in different areas of the brain on MRI, representing fluid leakage into the brain parenchyma or sulcal spaces.
SEMRI analysis set included all participants in the SE analysis set who had at least one post-baseline safety MRI scan.
Posted
Count of Participants
Participants
From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 131 weeks)
ID
Title
Description
OG000
Global - DBT Period: Placebo
Participants received gantenerumab matching placebo, SC injection, Q4W up to Week 36 and then Q2W up to approximately 114 weeks of the DBT period.
OG001
Global - DBT Period: Gantenerumab
Participants received gantenerumab, SC injection with gradual up-titration starting at a dose of 120 mg, Q4W for 3 doses, followed by 255 mg, Q4W for 3 doses, and 510 mg, Q4W for 3 doses, and 510 mg, Q4W for 3 doses. Following this, from Week 36 onwards, participants received gantenerumab, SC injection at a dose of 510 mg, Q2W up to Week 114 of the DBT period.
Secondary
DBT Period: Number of Participants With at Least One Amyloid-Related Imaging Abnormalities-Haemosiderin Deposition (ARIA-H) MRI Finding
ARIA are an identified risk with anti-amyloid antibodies, including gantenerumab. These changes can be identified on brain MRI. ARIA-H (H for hemosiderosis) are small foci of signal loss observed on MRI sequences sensitive for paramagnetic tissue properties and comprise cerebral microbleeds (small foci of bleeding in the brain parenchyma) and leptomeningeal hemosiderosis (small foci of bleeding on the surface of the brain). These changes also occur sporadically in AD.
SEMRI analysis set included all participants in the SE analysis set who had at least one post-baseline safety MRI scan.
Posted
Count of Participants
Participants
From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 131 weeks)
ID
Title
Description
OG000
Global - DBT Period: Placebo
Participants received gantenerumab matching placebo, SC injection, Q4W up to Week 36 and then Q2W up to approximately 114 weeks of the DBT period.
OG001
Global - DBT Period: Gantenerumab
Participants received gantenerumab, SC injection with gradual up-titration starting at a dose of 120 mg, Q4W for 3 doses, followed by 255 mg, Q4W for 3 doses, and 510 mg, Q4W for 3 doses, and 510 mg, Q4W for 3 doses. Following this, from Week 36 onwards, participants received gantenerumab, SC injection at a dose of 510 mg, Q2W up to Week 114 of the DBT period.
Secondary
DBT Period: Number of Participants With Injection-Site Reactions
An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational product or other protocol-imposed intervention, regardless of attribution. Local injection reactions (or injection site reactions) are defined as AEs related to the injection site that occur during or within 24 hours after study drug administration that are judged to be related to the study drug injection.
SE analysis set included all participants randomized during the global phase who received at least one dose of study drug. In the DBT period, four participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety analysis set.
Posted
Count of Participants
Participants
From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 131 weeks)
ID
Title
Description
OG000
Global - DBT Period: Placebo
Participants received gantenerumab matching placebo, SC injection, Q4W up to Week 36 and then Q2W up to approximately 114 weeks of the DBT period.
OG001
Global - DBT Period: Gantenerumab
Participants received gantenerumab, SC injection with gradual up-titration starting at a dose of 120 mg, Q4W for 3 doses, followed by 255 mg, Q4W for 3 doses, and 510 mg, Q4W for 3 doses, and 510 mg, Q4W for 3 doses. Following this, from Week 36 onwards, participants received gantenerumab, SC injection at a dose of 510 mg, Q2W up to Week 114 of the DBT period.
Secondary
DBT Period: Number of Participants With Anti-Drug Antibodies (ADA) to Gantenerumab
The number of participants with positive results for ADA against gantenerumab at any of the post-baseline assessment time-points were reported. Participant with an ADA assay result from at least one post-baseline sample was defined as a post-baseline evaluable participant. Treatment Emergent ADA = A participant with a negative or missing baseline ADA result(s) and at least one positive post-baseline ADA result.
SE analysis set included all participants randomized during the global phase who received at least one dose of study drug. In the DBT period, four participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety analysis set. Overall number analyzed is the number of participants with data available for analysis.
Posted
Count of Participants
Participants
From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 131 weeks)
ID
Title
Description
OG000
Global - DBT Period: Gantenerumab
Participants received gantenerumab, SC injection with gradual up-titration starting at a dose of 120 mg, Q4W for 3 doses, followed by 255 mg, Q4W for 3 doses, and 510 mg, Q4W for 3 doses, and 510 mg, Q4W for 3 doses. Following this, from Week 36 onwards, participants received gantenerumab, SC injection at a dose of 510 mg, Q2W up to Week 114 of the DBT period.
Units
Secondary
DBT Period: Change From Baseline to Week 116 in Brain Amyloid Load as Measured by Amyloid Positron Emission Tomography (PET) Scan in a Subset of Participants
Brain amyloid load over time was assessed using [18F] florbetaben or [18F] flutemetamol tracers. These are PET radioligand selective to amyloid. Amyloid PET burden was measured in a composite region of interest (ROI) by using standardized uptake value ratio (SUVR) mapped to the centiloid scale. The weighted composite target region are composed of (both left and right side): frontal lobe, parietal lobe, temporal lobe lateral, cingulum posterior and anterior cingulate gyrus. The reference region used to normalize the composite region was the whole cerebellum. The 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 found in a typical AD scan.
Amyloid-PET modified ITT (mITT) analysis set included all participants in the ITT analysis set who participated in the Amyloid-PET substudy and who had at least one Amyloid-PET scan with a valid quantitative measurement performed with either florbetaben or flutemetamol and who did not withdraw from the Amyloid-PET substudy before randomization. Overall number analyzed is the number of participants with data available for analysis.
Posted
Mean
Standard Error
score on a scale
Baseline, Week 116
ID
Title
Description
OG000
Global - DBT Period: Placebo
Participants received gantenerumab matching placebo, SC injection, Q4W up to Week 36 and then Q2W up to approximately 114 weeks of the DBT period.
Secondary
DBT Period: Change From Baseline to Week 116 in Brain Tau Load, as Measured by Tau PET Scan in a Subset of Participants
Change in tau load= how much neurofibrillary tau pathology is present in brain assessed by PET Scan. [18F] GTP1 was the tau PET radioligand. Tau load was measured using SUVR in 4 composite target ROIs: Temporal composite target region (left & right)=anterior & posterior superior temporal gyrus, posterior temporal lobe, fusiform gyrus, & middle & inferior temporal gyrus; Medial temporal composite region excluding hippocampus (left & right): amygdala, parahippocampus & anterior medial & lateral temporal lobe; Frontal lobe (left & right) & Parietal lobe (left & right). Inferior cerebellar grey matter=reference region for calculating SUVRs for all 4 regions. Tau-PET-mITT analysis set=all participants in ITT analysis set who participated in Tau PET sub-study & who had at least one Tau PET scan with a valid quantitative measurement & who did not withdraw from Tau PET substudy before randomization. Overall number analyzed=number of participants with data available for analysis.
As pre-specified in protocol/SAP, single tau PET substudy analyzed participants from 2 studies i.e. WN29922 (NCT03444870) & WN39658 (NCT03443973), hence data for Tau PET was analyzed at pooled level of WN29922 &WN39658. These studies had identical study design & enrolled an Early AD population. Tau PET analysis was planned in a subset of participants, to get an optimum sample size for analysis, it was pre-planned to conduct 1 tau PET substudy for participants willing to consent to the procedure.
Posted
Mean
Standard Error
SUVR
Baseline, Week 116
ID
Title
Description
OG000
Global - DBT Period: Placebo
Secondary
DBT Period: Percent Change From Baseline to Week 116 in Cerebrospinal Fluid (CSF) Marker of Disease in a Subset of Participants - Total Tau (tTau)
CSF biomarker tTau has been considered as a general marker of neurodegeneration. An elevation in levels of tau, as well as specific pTau species, is thought to be a marker for progressive cellular degeneration in AD.
CSF mITT Analysis Set included all participants in the ITT analysis set who had at least one valid quantitative CSF measurement. Overall number analyzed is the number of participants with data available for analysis.
Posted
Geometric Mean
95% Confidence Interval
percent change in tTau
Baseline, Week 116
ID
Title
Description
OG000
Global - DBT Period: Placebo
Participants received gantenerumab matching placebo, SC injection, Q4W up to Week 36 and then Q2W up to approximately 114 weeks of the DBT period.
OG001
Global - DBT Period: Gantenerumab
Participants received gantenerumab, SC injection with gradual up-titration starting at a dose of 120 mg, Q4W for 3 doses, followed by 255 mg, Q4W for 3 doses, and 510 mg, Q4W for 3 doses, and 510 mg, Q4W for 3 doses. Following this, from Week 36 onwards, participants received gantenerumab, SC injection at a dose of 510 mg, Q2W up to Week 114 of the DBT period.
Secondary
DBT Period: Percent Change From Baseline to Week 116 in CSF Marker of Disease in a Subset of Participants - Phosphorylated Tau (pTau-181)
CSF phospho-tau is an indicator of neuronal injury and neurodegeneration. CSF biomarker tTau has been considered as a general marker of neurodegeneration. An elevation in levels of pTau species, is thought to be a marker for progressive cellular degeneration in AD.
CSF modified ITT analysis set included all participants in the ITT analysis set who had at least one valid quantitative CSF measurement. Overall number analyzed is the number of participants with data available for analysis.
Posted
Geometric Mean
95% Confidence Interval
percent change in pTau-181
Baseline, Week 116
ID
Title
Description
OG000
Global - DBT Period: Placebo
Participants received gantenerumab matching placebo, SC injection, Q4W up to Week 36 and then Q2W up to approximately 114 weeks of the DBT period.
OG001
Global - DBT Period: Gantenerumab
Participants received gantenerumab, SC injection with gradual up-titration starting at a dose of 120 mg, Q4W for 3 doses, followed by 255 mg, Q4W for 3 doses, and 510 mg, Q4W for 3 doses, and 510 mg, Q4W for 3 doses. Following this, from Week 36 onwards, participants received gantenerumab, SC injection at a dose of 510 mg, Q2W up to Week 114 of the DBT period.
Secondary
DBT Period: Percent Change From Baseline to Week 116 in CSF Marker of Disease in a Subset of Participants - Neurofilament Light Chain (NFL)
NFL is a neuronal cytoplasmic protein highly expressed in large, myelinated axons. Its levels increase in CSF and blood proportionally to the degree of axonal damage in a variety of neurological disorders, including AD.
CSF mITT Analysis Set included all participants in the ITT analysis set who had at least one valid quantitative CSF measurement. Overall number analyzed is the number of participants with data available for analysis.
Posted
Geometric Mean
95% Confidence Interval
percent change in NFL
Baseline, Week 116
ID
Title
Description
OG000
Global - DBT Period: Placebo
Participants received gantenerumab matching placebo, SC injection, Q4W up to Week 36 and then Q2W up to approximately 114 weeks of the DBT period.
OG001
Global - DBT Period: Gantenerumab
Participants received gantenerumab, SC injection with gradual up-titration starting at a dose of 120 mg, Q4W for 3 doses, followed by 255 mg, Q4W for 3 doses, and 510 mg, Q4W for 3 doses, and 510 mg, Q4W for 3 doses. Following this, from Week 36 onwards, participants received gantenerumab, SC injection at a dose of 510 mg, Q2W up to Week 114 of the DBT period.
Secondary
DBT Period: Percent Change From Baseline to Week 116 in CSF Marker of Disease in a Subset of Participants - Neurogranin
CSF mITT Analysis Set included all participants in the ITT analysis set who had at least one valid quantitative CSF measurement. Overall number analyzed is the number of participants with data available for analysis.
Posted
Geometric Mean
95% Confidence Interval
percent change in neurogranin
Baseline, Week 116
ID
Title
Description
OG000
Global - DBT Period: Placebo
Participants received gantenerumab matching placebo, SC injection, Q4W up to Week 36 and then Q2W up to approximately 114 weeks of the DBT period.
OG001
Global - DBT Period: Gantenerumab
Participants received gantenerumab, SC injection with gradual up-titration starting at a dose of 120 mg, Q4W for 3 doses, followed by 255 mg, Q4W for 3 doses, and 510 mg, Q4W for 3 doses, and 510 mg, Q4W for 3 doses. Following this, from Week 36 onwards, participants received gantenerumab, SC injection at a dose of 510 mg, Q2W up to Week 114 of the DBT period.
Units
Counts
Participants
Secondary
China - DBT Period: Change From Baseline to Week 116 in ADAS-Cog13 Score
The ADAS-Cog13 total score includes all of the items in the ADAS-Cog11 in addition to delayed word recall and the number cancellation. For the ADAS-cog 13 the range is 0-85 (score range for Delayed Word Recall [DWR] score is 0-10 and for Number Cancellation [NC] is 0-5, thus the score is ADAS-cog 11[0-70] plus the scores for DWR and NC). A higher score indicates worse performance. A negative change from baseline indicates improvement in cognitive function.
The study was terminated early by the sponsor before any participant had reached Week 116 visit in the China extension phase.
Posted
Baseline, Week 116
ID
Title
Description
OG000
China Extension - DBT Period: Placebo
Participants received gantenerumab matching placebo, SC injection, Q4W up to Week 36 and then Q2W up to approximately 110 weeks of the DBT period
OG001
China Extension - DBT Period: Gantenerumab
Participants received gantenerumab, SC injection with gradual up-titration starting at a dose of 120 mg, Q4W for 3 doses, followed by 255 mg, Q4W for 3 doses, and 510 mg, Q4W for 3 doses. Following this, from Week 36 onwards, participants received gantenerumab, SC injection at a dose of 510 mg, Q2W up to approximately 110 weeks of the DBT period.
Secondary
China - DBT Period: Change From Baseline to Week 116 in ADCS-ADL Total Score
ADCS-ADL is a 23-item rater-administered, ObsRO that captures a participant's ability to perform basic activities of daily living (e.g., eating and toileting) and more complex ADL or instrumental activities of daily living (iADL, e.g., using the telephone, managing finances, preparing a meal). Total score ranges from 0-78, with higher scores reflecting better functioning. A positive change from baseline indicates improvement.
The study was terminated early by the sponsor before any participant had reached Week 116 visit in the China extension phase.
Posted
Baseline, Week 116
ID
Title
Description
OG000
China Extension - DBT Period: Placebo
Participants received gantenerumab matching placebo, SC injection, Q4W up to Week 36 and then Q2W up to approximately 110 weeks of the DBT period.
OG001
China Extension - DBT Period: Gantenerumab
Participants received gantenerumab, SC injection with gradual up-titration starting at a dose of 120 mg, Q4W for 3 doses, followed by 255 mg, Q4W for 3 doses, and 510 mg, Q4W for 3 doses. Following this, from Week 36 onwards, participants received gantenerumab, SC injection at a dose of 510 mg, Q2W up to approximately 110 weeks of the DBT period.
Secondary
China - DBT Period: Change From Baseline to Week 116 in FAQ Score
FAQ is a rater-administered ObsRO (informant-based measure) that measures a participant's functional ability to perform complex higher-order activities. The observer provides performance ratings of the target person on ten complex higher-order activities. Total score that ranges from 0-30, with higher scores reflecting greater functional impairment. A negative change from baseline indicates improvement.
The study was terminated early by the sponsor before any participant had reached Week 116 visit in the China extension phase.
Posted
Baseline, Week 116
ID
Title
Description
OG000
China Extension - DBT Period: Placebo
Participants received gantenerumab matching placebo, SC injection, Q4W up to Week 36 and then Q2W up to approximately 110 weeks of the DBT period.
OG001
China Extension - DBT Period: Gantenerumab
Participants received gantenerumab, SC injection with gradual up-titration starting at a dose of 120 mg, Q4W for 3 doses, followed by 255 mg, Q4W for 3 doses, and 510 mg, Q4W for 3 doses. Following this, from Week 36 onwards, participants received gantenerumab, SC injection at a dose of 510 mg, Q2W up to approximately 110 weeks of the DBT period.
Secondary
China - DBT Period: DBT Period: Change From Baseline to Week 116 in MMSE Total Score
MMSE is a rater-administered PerfO that includes a set of standardized questions used to evaluate possible cognitive impairment and help stage the severity level of this impairment. The questions target six areas: orientation, registration, attention, short-term recall, language, and constructional praxis/visuospatial abilities. Total score ranges from 0-30, with lower scores indicating greater impairment. A positive change from baseline indicates improvement.
The study was terminated early by the sponsor before any participant had reached Week 116 visit in the China extension phase.
Posted
Baseline, Week 116
ID
Title
Description
OG000
China Extension - DBT Period: Placebo
Participants received gantenerumab matching placebo, SC injection, Q4W up to Week 36 and then Q2W up to approximately 110 weeks of the DBT period.
OG001
China Extension - DBT Period: Gantenerumab
Participants received gantenerumab, SC injection with gradual up-titration starting at a dose of 120 mg, Q4W for 3 doses, followed by 255 mg, Q4W for 3 doses, and 510 mg, Q4W for 3 doses. Following this, from Week 36 onwards, participants received gantenerumab, SC injection at a dose of 510 mg, Q2W up to approximately 110 weeks of the DBT period.
Secondary
China - DBT Period: Change From Baseline to Week 116 in ADAS-Cog11 Score
The ADAS-Cog11 was designed to measure cognitive symptom change in participants with AD and consisted of 11 tasks. The standard 11 items (and corresponding score range) were: word recall (0-10), commands (0-5), constructional praxis (0-5), naming objects and fingers (0-5), ideational praxis (0-5), orientation (0-8), word recognition (0-12), spoken language ability (0-5), comprehension of spoken language (0-5), word-finding difficulty (0-5), and remembering test instructions (0-5). The test included 7 performance items and 4 clinician-rated items. The ADAS-Cog11 total score was the sum of all 11 individual items, with a total score ranging from 0 (no impairment) to 70 (severe impairment). Higher scores indicated more severe cognitive impairment. A negative change from baseline indicates improvement.
The study was terminated early by the sponsor before any participant had reached Week 116 visit in the China extension phase.
Posted
Baseline, Week 116
ID
Title
Description
OG000
China Extension - DBT Period: Placebo
Participants received gantenerumab matching placebo, SC injection, Q4W up to Week 36 and then Q2W up to approximately 110 weeks of the DBT period.
OG001
China Extension - DBT Period: Gantenerumab
Participants received gantenerumab, SC injection with gradual up-titration starting at a dose of 120 mg, Q4W for 3 doses, followed by 255 mg, Q4W for 3 doses, and 510 mg, Q4W for 3 doses. Following this, from Week 36 onwards, participants received gantenerumab, SC injection at a dose of 510 mg, Q2W up to approximately 110 weeks of the DBT period.
Secondary
China - DBT Period: Change From Baseline to Week 116 in VFT Score
VFT is a rater administered PerfO that measures speed and flexibility of verbal thought with a total score that ranges from 0-99 (lower scores indicating lower performance). A positive change from baseline indicates improvement.
The study was terminated early by the sponsor before any participant had reached Week 116 visit in the China extension phase.
Posted
Baseline, Week 116
ID
Title
Description
OG000
China Extension - DBT Period: Placebo
Participants received gantenerumab matching placebo, SC injection, Q4W up to Week 36 and then Q2W up to approximately 110 weeks of the DBT period.
OG001
China Extension - DBT Period: Gantenerumab
Participants received gantenerumab, SC injection with gradual up-titration starting at a dose of 120 mg, Q4W for 3 doses, followed by 255 mg, Q4W for 3 doses, and 510 mg, Q4W for 3 doses. Following this, from Week 36 onwards, participants received gantenerumab, SC injection at a dose of 510 mg, Q2W up to approximately 110 weeks of the DBT period.
Units
Counts
Participants
Secondary
China - DBT Period: Change From Baseline to Week 116 in the Coding (DSST) Subtest
Coding, also called DSST is a rater administered PerfO that measures speed of processing and associative memory with a total score that ranges from 0-135 (lower scores indicating lower performance). The DSST was adapted from the Wechsler Adult Intelligence Scale. The 120-second version of the test was used in this study. Positive change from baseline indicates improvement.
The study was terminated early by the sponsor before any participant had reached Week 116 visit in the China extension phase.
Posted
Baseline, Week 116
ID
Title
Description
OG000
China Extension - DBT Period: Placebo
Participants received gantenerumab matching placebo, SC injection, Q4W up to Week 36 and then Q2W up to approximately 110 weeks of the DBT period.
OG001
China Extension - DBT Period: Gantenerumab
Participants received gantenerumab, SC injection with gradual up-titration starting at a dose of 120 mg, Q4W for 3 doses, followed by 255 mg, Q4W for 3 doses, and 510 mg, Q4W for 3 doses. Following this, from Week 36 onwards, participants received gantenerumab, SC injection at a dose of 510 mg, Q2W up to approximately 110 weeks of the DBT period.
Secondary
China - DBT Period: Number of Participants With at Least One AE
An AE is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. Total number of participants with at least one event (AEs) have been reported here.
SE analysis set (China) included all participants enrolled in China in the China extension phase who received at least one dose of study drug.
Posted
Count of Participants
Participants
From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 124 weeks)
ID
Title
Description
OG000
China Extension - DBT Period: Placebo
Participants received gantenerumab matching placebo, SC injection, Q4W up to Week 36 and then Q2W up to approximately 110 weeks of the DBT period.
OG001
China Extension - DBT Period: Gantenerumab
Participants received gantenerumab, SC injection with gradual up-titration starting at a dose of 120 mg, Q4W for 3 doses, followed by 255 mg, Q4W for 3 doses, and 510 mg, Q4W for 3 doses. Following this, from Week 36 onwards, participants received gantenerumab, SC injection at a dose of 510 mg, Q2W up to approximately 110 weeks of the DBT period.
Units
Secondary
China - DBT Period: Number of Participants With Post-baseline Suicidal Ideation or Suicidal Behavior as Measured Using C-SSRS
C-SSRS=assessment tool used to assess lifetime suicidality of a participant (at baseline) as well as any new instances of suicidality (C-SSRS since last visit). Structured interview prompts recollection of suicidal ideation, including intensity of ideation, behavior, & attempts with actual/potential lethality. Categories have binary responses (yes/no) & include Wish to be Dead; Non-specific Active Suicidal Thoughts; Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act; Active Suicidal Ideation with Some Intent to Act, without Specific Plan; Active Suicidal Ideation with Specific Plan and Intent, Preparatory Acts and Behavior; Aborted Attempt; Interrupted Attempt; Actual Attempt (non-fatal); Completed Suicide. Suicidal ideation/behavior is indicated by a "yes" answer to any of the listed categories. Score of 0 is assigned if no suicide risk is present. Score of 1 or higher= suicidal ideation or behavior. Categories with non-zero values are only reported here.
SE analysis set (China) included all participants enrolled in China in the China extension phase who received at least one dose of study drug. Overall number analyzed is the number of participants with data available for analysis.
Posted
Count of Participants
Participants
From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 124 weeks)
ID
Title
Description
OG000
China Extension - DBT Period: Placebo
Participants received gantenerumab matching placebo, SC injection, Q4W up to Week 36 and then Q2W up to approximately 110 weeks of the DBT period.
Secondary
China - DBT Period: Number of Participants With at Least One ARIA-E MRI Finding
ARIA are an identified risk with anti-amyloid antibodies, including gantenerumab. These changes can be identified on brain MRI. In ARIA-E, (E for oedema or effusion), oedema can be seen in different areas of the brain on MRI, representing fluid leakage into the brain parenchyma or sulcal spaces.
SE analysis set (China) included all participants enrolled in China in the China extension phase who received at least one dose of study drug.
Posted
Count of Participants
Participants
From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 124 weeks)
ID
Title
Description
OG000
China Extension - DBT Period: Placebo
Participants received gantenerumab matching placebo, SC injection, Q4W up to Week 36 and then Q2W up to approximately 110 weeks of the DBT period.
OG001
China Extension - DBT Period: Gantenerumab
Participants received gantenerumab, SC injection with gradual up-titration starting at a dose of 120 mg, Q4W for 3 doses, followed by 255 mg, Q4W for 3 doses, and 510 mg, Q4W for 3 doses. Following this, from Week 36 onwards, participants received gantenerumab, SC injection at a dose of 510 mg, Q2W up to approximately 110 weeks of the DBT period.
Secondary
China - DBT Period: Number of Participants With at Least One ARIA-H MRI Finding
ARIA are an identified risk with anti-amyloid antibodies, including gantenerumab. These changes can be identified on brain MRI. ARIA-H (H for hemosiderosis) are small foci of signal loss observed on MRI sequences sensitive for paramagnetic tissue properties and comprise cerebral microbleeds (small foci of bleeding in the brain parenchyma) and leptomeningeal hemosiderosis (small foci of bleeding on the surface of the brain). These changes also occur sporadically in AD.
SE analysis set (China) included all participants enrolled in China in the China extension phase who received at least one dose of study drug.
Posted
Count of Participants
Participants
From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 124 weeks)
ID
Title
Description
OG000
China Extension - DBT Period: Placebo
Participants received gantenerumab matching placebo, SC injection, Q4W up to Week 36 and then Q2W up to approximately 110 weeks of the DBT period.
OG001
China Extension - DBT Period: Gantenerumab
Participants received gantenerumab, SC injection with gradual up-titration starting at a dose of 120 mg, Q4W for 3 doses, followed by 255 mg, Q4W for 3 doses, and 510 mg, Q4W for 3 doses. Following this, from Week 36 onwards, participants received gantenerumab, SC injection at a dose of 510 mg, Q2W up to approximately 110 weeks of the DBT period.
Secondary
China - DBT Period: Number of Participants With Injection-Site Reactions
An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational product or other protocol-imposed intervention, regardless of attribution. Local injection reactions (or injection site reactions) are defined as AEs related to the injection site that occur during or within 24 hours after study drug administration that are judged to be related to the study drug injection.
SE analysis set (China) included all participants enrolled in China in the China extension phase who received at least one dose of study drug.
Posted
Count of Participants
Participants
From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 124 weeks)
ID
Title
Description
OG000
China Extension - DBT Period: Placebo
Participants received gantenerumab matching placebo, SC injection, Q4W up to Week 36 and then Q2W up to approximately 110 weeks of the DBT period.
OG001
China Extension - DBT Period: Gantenerumab
Participants received gantenerumab, SC injection with gradual up-titration starting at a dose of 120 mg, Q4W for 3 doses, followed by 255 mg, Q4W for 3 doses, and 510 mg, Q4W for 3 doses. Following this, from Week 36 onwards, participants received gantenerumab, SC injection at a dose of 510 mg, Q2W up to approximately 110 weeks of the DBT period.
Secondary
OLE Period: Number of Participants With at Least One AEs
An AE is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution.
SE analysis set included all participants randomized during the global phase who received at least one dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety analysis set, of which one participant entered OLE period.
Posted
Count of Participants
Participants
From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 68 weeks)
ID
Title
Description
OG000
Global - OLE Period: Placebo (DBT) to Gantenerumab
Participants who received gantenerumab matching placebo in the DBT period received gantenerumab SC injections with gradual up titration starting at a dose of 120 mg, Q4W for 3 doses, followed by 255 mg, Q4W for 3 doses, and then at a dose of 510 mg, Q4W up to Week 34 of the OLE period. To maintain the blind to previous treatment assignment, participants received Q2W, SC injections, with alternate doses containing gantenerumab matching placebo.
OG001
Global - OLE Period: Gantenerumab (DBT) to Gantenerumab
Participants who received gantenerumab in the DBT period continued receiving gantenerumab, SC injections, 510 mg, Q2W up to Week 34 of the OLE period.
Secondary
OLE Period: Number of Participants With Post-baseline Suicidal Ideation or Suicidal Behavior as Measured Using C-SSRS
C-SSRS=assessment tool used to assess lifetime suicidality of a participant (at baseline) as well as any new instances of suicidality (C-SSRS since last visit). Structured interview prompts recollection of suicidal ideation, including intensity of ideation, behavior, & attempts with actual/potential lethality. Categories have binary responses (yes/no) & include Wish to be Dead; Non-specific Active Suicidal Thoughts; Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act; Active Suicidal Ideation with Some Intent to Act, without Specific Plan; Active Suicidal Ideation with Specific Plan and Intent, Preparatory Acts and Behavior; Aborted Attempt; Interrupted Attempt; Actual Attempt (non-fatal); Completed Suicide. Suicidal ideation/behavior is indicated by a "yes" answer to any of the listed categories. Score of 0 is assigned if no suicide risk is present. Score of 1 or higher= suicidal ideation or behavior. Categories with non-zero values are only reported here.
SE analysis set included all participants randomized during the global phase who received at least one dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety analysis set, of which one participant entered OLE period. Overall number analyzed is the number of participants with data available for analysis.
Posted
Count of Participants
Participants
From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 68 weeks)
ID
Title
Description
OG000
Global - OLE Period: Placebo (DBT) to Gantenerumab
Secondary
OLE Period: Number of Participants With at Least One ARIA-H MRI Finding
ARIA are an identified risk with anti-amyloid antibodies, including gantenerumab. These changes can be identified on brain MRI. ARIA-H (H for hemosiderosis) are small foci of signal loss observed on MRI sequences sensitive for paramagnetic tissue properties and comprise cerebral microbleeds (small foci of bleeding in the brain parenchyma) and leptomeningeal hemosiderosis (small foci of bleeding on the surface of the brain). These changes also occur sporadically in AD.
SEMRI analysis set included all participants in SE analysis set who had at least one post-baseline safety MRI scan. In DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in gantenerumab arm for SE analysis set, of which 1 participant entered OLE period.
Posted
Count of Participants
Participants
From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 68 weeks)
ID
Title
Description
OG000
Global - OLE Period: Placebo (DBT) to Gantenerumab
Participants who received gantenerumab matching placebo in the DBT period received gantenerumab SC injections with gradual up titration starting at a dose of 120 mg, Q4W for 3 doses, followed by 255 mg, Q4W for 3 doses, and then at a dose of 510 mg, Q4W up to Week 34 of the OLE period. To maintain the blind to previous treatment assignment, participants received Q2W, SC injections, with alternate doses containing gantenerumab matching placebo.
OG001
Global - OLE Period: Gantenerumab (DBT) to Gantenerumab
Secondary
OLE Period: Number of Participants With at Least One ARIA-E MRI Finding
ARIA are an identified risk with anti-amyloid antibodies, including gantenerumab. These changes can be identified on brain MRI. In ARIA-E, (E for oedema or effusion), oedema can be seen in different areas of the brain on MRI, representing fluid leakage into the brain parenchyma or sulcal spaces.
SEMRI analysis set included all participants in SE analysis set who had at least one post-baseline safety MRI scan. In DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in gantenerumab arm for SE analysis set, of which 1 participant entered OLE period. Overall number analyzed is the number of participants with data available for analysis. Overall number analyzed is the number of participants with data available for analysis.
Posted
Count of Participants
Participants
From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 68 weeks)
ID
Title
Description
OG000
Global - OLE Period: Placebo (DBT) to Gantenerumab
Participants who received gantenerumab matching placebo in the DBT period received gantenerumab SC injections with gradual up titration starting at a dose of 120 mg, Q4W for 3 doses, followed by 255 mg, Q4W for 3 doses, and then at a dose of 510 mg, Q4W up to Week 34 of the OLE period. To maintain the blind to previous treatment assignment, participants received Q2W, SC injections, with alternate doses containing gantenerumab matching placebo.
OG001
Global - OLE Period: Gantenerumab (DBT) to Gantenerumab
Time Frame
Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
Description
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase & received at least 1 dose of study drug.
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
Global - DBT Period: Placebo
Participants received gantenerumab matching placebo, SC injection, Q4W up to Week 36 and then Q2W up to approximately 114 weeks of the DBT period.
11
481
95
481
329
481
EG001
Global - DBT Period: Gantenerumab
Participants received gantenerumab, SC injection with gradual up-titration starting at a dose of 120 mg, Q4W for 3 doses, followed by 255 mg, Q4W for 3 doses, and 510 mg, Q4W for 3 doses, and 510 mg, Q4W for 3 doses. Following this, from Week 36 onwards, participants received gantenerumab, SC injection at a dose of 510 mg, Q2W up to Week 114 of the DBT period.
3
503
76
503
366
503
EG002
China Extension - DBT Period: Placebo
Participants received gantenerumab matching placebo, SC injection, Q4W up to Week 36 and then Q2W up to approximately 110 weeks of the DBT period.
0
33
0
33
11
33
EG003
China Extension - DBT Period: Gantenerumab
Participants received gantenerumab, SC injection with gradual up-titration starting at a dose of 120 mg, Q4W for 3 doses, followed by 255 mg, Q4W for 3 doses, and 510 mg, Q4W for 3 doses. Following this, from Week 36 onwards, participants received gantenerumab, SC injection at a dose of 510 mg, Q2W up to approximately 110 weeks of the DBT period.
0
35
2
35
20
35
EG004
Global - OLE Period: Placebo (DBT) to Gantenerumab
Participants who received gantenerumab matching placebo in the DBT period received gantenerumab SC injections with gradual up titration starting at a dose of 120 mg, Q4W for 3 doses, followed by 255 mg, Q4W for 3 doses, and then at a dose of 510 mg, Q4W up to Week 34 of the OLE period. To maintain the blind to previous treatment assignment, participants received Q2W, SC injections, with alternate doses containing gantenerumab matching placebo.
1
9
2
9
8
9
EG005
Global - OLE Period: Gantenerumab (DBT) to Gantenerumab
Participants who received gantenerumab in the DBT period continued receiving gantenerumab, SC injections, 510 mg, Q2W up to Week 34 of the OLE period.
0
20
2
20
16
20
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Iron deficiency anaemia
Blood and lymphatic system disorders
MedDRA version: 25.0
Systematic Assessment
EG0000 events0 affected481 at risk
EG0011 events1 affected503 at risk
EG0020 events0 affected33 at risk
EG0030 events0 affected35 at risk
EG004
Lymphadenopathy
Blood and lymphatic system disorders
MedDRA version: 25.0
Systematic Assessment
EG0001 events1 affected481 at risk
EG0010 events0 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Arrhythmia
Cardiac disorders
MedDRA version: 25.0
Systematic Assessment
EG0001 events1 affected481 at risk
EG0010 events0 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Arrhythmia supraventricular
Cardiac disorders
MedDRA version: 25.0
Systematic Assessment
EG0001 events1 affected481 at risk
EG0010 events0 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA version: 25.0
Systematic Assessment
EG0001 events1 affected481 at risk
EG0012 events2 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Atrial flutter
Cardiac disorders
MedDRA version: 25.0
Systematic Assessment
EG0001 events1 affected481 at risk
EG0010 events0 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Bradycardia
Cardiac disorders
MedDRA version: 25.0
Systematic Assessment
EG0001 events1 affected481 at risk
EG0010 events0 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Cardiac arrest
Cardiac disorders
MedDRA version: 25.0
Systematic Assessment
EG0001 events1 affected481 at risk
EG0010 events0 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Cardiac failure congestive
Cardiac disorders
MedDRA version: 25.0
Systematic Assessment
EG0001 events1 affected481 at risk
EG0010 events0 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Coronary artery disease
Cardiac disorders
MedDRA version: 25.0
Systematic Assessment
EG0001 events1 affected481 at risk
EG0010 events0 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA version: 25.0
Systematic Assessment
EG0001 events1 affected481 at risk
EG0010 events0 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Paroxysmal atrioventricular block
Cardiac disorders
MedDRA version: 25.0
Systematic Assessment
EG0001 events1 affected481 at risk
EG0010 events0 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Sinus node dysfunction
Cardiac disorders
MedDRA version: 25.0
Systematic Assessment
EG0000 events0 affected481 at risk
EG0011 events1 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Acute vestibular syndrome
Ear and labyrinth disorders
MedDRA version: 25.0
Systematic Assessment
EG0001 events1 affected481 at risk
EG0010 events0 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Deafness unilateral
Ear and labyrinth disorders
MedDRA version: 25.0
Systematic Assessment
EG0000 events0 affected481 at risk
EG0011 events1 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA version: 25.0
Systematic Assessment
EG0001 events1 affected481 at risk
EG0010 events0 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA version: 25.0
Systematic Assessment
EG0000 events0 affected481 at risk
EG0011 events1 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Cataract
Eye disorders
MedDRA version: 25.0
Systematic Assessment
EG0001 events1 affected481 at risk
EG0010 events0 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Glaucoma
Eye disorders
MedDRA version: 25.0
Systematic Assessment
EG0001 events1 affected481 at risk
EG0010 events0 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA version: 25.0
Systematic Assessment
EG0000 events0 affected481 at risk
EG0011 events1 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Diverticulum intestinal haemorrhagic
Gastrointestinal disorders
MedDRA version: 25.0
Systematic Assessment
EG0001 events1 affected481 at risk
EG0011 events1 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Duodenal ulcer
Gastrointestinal disorders
MedDRA version: 25.0
Systematic Assessment
EG0001 events1 affected481 at risk
EG0010 events0 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Femoral hernia strangulated
Gastrointestinal disorders
MedDRA version: 25.0
Systematic Assessment
EG0001 events1 affected481 at risk
EG0010 events0 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Inguinal hernia
Gastrointestinal disorders
MedDRA version: 25.0
Systematic Assessment
EG0002 events2 affected481 at risk
EG0010 events0 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Inguinal hernia strangulated
Gastrointestinal disorders
MedDRA version: 25.0
Systematic Assessment
EG0000 events0 affected481 at risk
EG0011 events1 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Intestinal ischaemia
Gastrointestinal disorders
MedDRA version: 25.0
Systematic Assessment
EG0001 events1 affected481 at risk
EG0010 events0 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Intestinal obstruction
Gastrointestinal disorders
MedDRA version: 25.0
Systematic Assessment
EG0002 events2 affected481 at risk
EG0010 events0 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Large intestine perforation
Gastrointestinal disorders
MedDRA version: 25.0
Systematic Assessment
EG0000 events0 affected481 at risk
EG0011 events1 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Large intestine polyp
Gastrointestinal disorders
MedDRA version: 25.0
Systematic Assessment
EG0000 events0 affected481 at risk
EG0011 events1 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA version: 25.0
Systematic Assessment
EG0000 events0 affected481 at risk
EG0011 events1 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA version: 25.0
Systematic Assessment
EG0001 events1 affected481 at risk
EG0010 events0 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Chest pain
General disorders
MedDRA version: 25.0
Systematic Assessment
EG0000 events0 affected481 at risk
EG0012 events2 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Sudden cardiac death
General disorders
MedDRA version: 25.0
Systematic Assessment
EG0000 events0 affected481 at risk
EG0011 events1 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Cholecystitis acute
Hepatobiliary disorders
MedDRA version: 25.0
Systematic Assessment
EG0001 events1 affected481 at risk
EG0011 events1 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA version: 25.0
Systematic Assessment
EG0001 events1 affected481 at risk
EG0010 events0 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Hepatic cirrhosis
Hepatobiliary disorders
MedDRA version: 25.0
Systematic Assessment
EG0001 events1 affected481 at risk
EG0010 events0 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Appendicitis
Infections and infestations
MedDRA version: 25.0
Systematic Assessment
EG0001 events1 affected481 at risk
EG0010 events0 affected503 at risk
EG0020 events0 affected33 at risk
EG003
COVID-19
Infections and infestations
MedDRA version: 25.0
Systematic Assessment
EG0009 events9 affected481 at risk
EG0013 events3 affected503 at risk
EG0020 events0 affected33 at risk
EG003
COVID-19 pneumonia
Infections and infestations
MedDRA version: 25.0
Systematic Assessment
EG0003 events3 affected481 at risk
EG0012 events2 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Cellulitis
Infections and infestations
MedDRA version: 25.0
Systematic Assessment
EG0001 events1 affected481 at risk
EG0010 events0 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Clostridium difficile colitis
Infections and infestations
MedDRA version: 25.0
Systematic Assessment
EG0001 events1 affected481 at risk
EG0010 events0 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Cystitis
Infections and infestations
MedDRA version: 25.0
Systematic Assessment
EG0001 events1 affected481 at risk
EG0010 events0 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Diverticulitis
Infections and infestations
MedDRA version: 25.0
Systematic Assessment
EG0002 events2 affected481 at risk
EG0010 events0 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Diverticulitis intestinal perforated
Infections and infestations
MedDRA version: 25.0
Systematic Assessment
EG0001 events1 affected481 at risk
EG0010 events0 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Ear infection
Infections and infestations
MedDRA version: 25.0
Systematic Assessment
EG0000 events0 affected481 at risk
EG0011 events1 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA version: 25.0
Systematic Assessment
EG0001 events1 affected481 at risk
EG0010 events0 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Medical device site abscess
Infections and infestations
MedDRA version: 25.0
Systematic Assessment
EG0001 events1 affected481 at risk
EG0010 events0 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Peritonitis
Infections and infestations
MedDRA version: 25.0
Systematic Assessment
EG0002 events2 affected481 at risk
EG0010 events0 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Pneumonia
Infections and infestations
MedDRA version: 25.0
Systematic Assessment
EG0005 events5 affected481 at risk
EG0010 events0 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Pneumonia aspiration
Infections and infestations
MedDRA version: 25.0
Systematic Assessment
EG0001 events1 affected481 at risk
EG0010 events0 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Pneumonia bacterial
Infections and infestations
MedDRA version: 25.0
Systematic Assessment
EG0001 events1 affected481 at risk
EG0010 events0 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Pyelonephritis acute
Infections and infestations
MedDRA version: 25.0
Systematic Assessment
EG0001 events1 affected481 at risk
EG0010 events0 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Sepsis
Infections and infestations
MedDRA version: 25.0
Systematic Assessment
EG0001 events1 affected481 at risk
EG0011 events1 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Septic shock
Infections and infestations
MedDRA version: 25.0
Systematic Assessment
EG0001 events1 affected481 at risk
EG0010 events0 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Suspected COVID-19
Infections and infestations
MedDRA version: 25.0
Systematic Assessment
EG0001 events1 affected481 at risk
EG0011 events1 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA version: 25.0
Systematic Assessment
EG0003 events3 affected481 at risk
EG0011 events1 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Urosepsis
Infections and infestations
MedDRA version: 25.0
Systematic Assessment
EG0001 events1 affected481 at risk
EG0010 events0 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Concussion
Injury, poisoning and procedural complications
MedDRA version: 25.0
Systematic Assessment
EG0001 events1 affected481 at risk
EG0010 events0 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Facial bones fracture
Injury, poisoning and procedural complications
MedDRA version: 25.0
Systematic Assessment
EG0002 events2 affected481 at risk
EG0010 events0 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA version: 25.0
Systematic Assessment
EG0002 events2 affected481 at risk
EG0016 events6 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Femoral neck fracture
Injury, poisoning and procedural complications
MedDRA version: 25.0
Systematic Assessment
EG0001 events1 affected481 at risk
EG0010 events0 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Femur fracture
Injury, poisoning and procedural complications
MedDRA version: 25.0
Systematic Assessment
EG0000 events0 affected481 at risk
EG0011 events1 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Hip fracture
Injury, poisoning and procedural complications
MedDRA version: 25.0
Systematic Assessment
EG0001 events1 affected481 at risk
EG0010 events0 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Humerus fracture
Injury, poisoning and procedural complications
MedDRA version: 25.0
Systematic Assessment
EG0000 events0 affected481 at risk
EG0012 events2 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Ilium fracture
Injury, poisoning and procedural complications
MedDRA version: 25.0
Systematic Assessment
EG0000 events0 affected481 at risk
EG0011 events1 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Lower limb fracture
Injury, poisoning and procedural complications
MedDRA version: 25.0
Systematic Assessment
EG0001 events1 affected481 at risk
EG0011 events1 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Pelvic fracture
Injury, poisoning and procedural complications
MedDRA version: 25.0
Systematic Assessment
EG0001 events1 affected481 at risk
EG0012 events2 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Post procedural haemorrhage
Injury, poisoning and procedural complications
MedDRA version: 25.0
Systematic Assessment
EG0002 events1 affected481 at risk
EG0010 events0 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Radius fracture
Injury, poisoning and procedural complications
MedDRA version: 25.0
Systematic Assessment
EG0001 events1 affected481 at risk
EG0010 events0 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Rib fracture
Injury, poisoning and procedural complications
MedDRA version: 25.0
Systematic Assessment
EG0001 events1 affected481 at risk
EG0011 events1 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Subdural haematoma
Injury, poisoning and procedural complications
MedDRA version: 25.0
Systematic Assessment
EG0003 events3 affected481 at risk
EG0010 events0 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Subdural haemorrhage
Injury, poisoning and procedural complications
MedDRA version: 25.0
Systematic Assessment
EG0001 events1 affected481 at risk
EG0010 events0 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Traumatic intracranial haemorrhage
Injury, poisoning and procedural complications
MedDRA version: 25.0
Systematic Assessment
EG0000 events0 affected481 at risk
EG0010 events0 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Upper limb fracture
Injury, poisoning and procedural complications
MedDRA version: 25.0
Systematic Assessment
EG0000 events0 affected481 at risk
EG0011 events1 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Wound dehiscence
Injury, poisoning and procedural complications
MedDRA version: 25.0
Systematic Assessment
EG0000 events0 affected481 at risk
EG0011 events1 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Wrist fracture
Injury, poisoning and procedural complications
MedDRA version: 25.0
Systematic Assessment
EG0000 events0 affected481 at risk
EG0011 events1 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA version: 25.0
Systematic Assessment
EG0002 events2 affected481 at risk
EG0010 events0 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA version: 25.0
Systematic Assessment
EG0001 events1 affected481 at risk
EG0010 events0 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA version: 25.0
Systematic Assessment
EG0001 events1 affected481 at risk
EG0010 events0 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA version: 25.0
Systematic Assessment
EG0002 events2 affected481 at risk
EG0010 events0 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Malnutrition
Metabolism and nutrition disorders
MedDRA version: 25.0
Systematic Assessment
EG0000 events0 affected481 at risk
EG0011 events1 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA version: 25.0
Systematic Assessment
EG0001 events1 affected481 at risk
EG0010 events0 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Greater trochanteric pain syndrome
Musculoskeletal and connective tissue disorders
MedDRA version: 25.0
Systematic Assessment
EG0000 events0 affected481 at risk
EG0011 events1 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Intervertebral disc protrusion
Musculoskeletal and connective tissue disorders
MedDRA version: 25.0
Systematic Assessment
EG0001 events1 affected481 at risk
EG0010 events0 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA version: 25.0
Systematic Assessment
EG0003 events3 affected481 at risk
EG0012 events2 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Rhabdomyolysis
Musculoskeletal and connective tissue disorders
MedDRA version: 25.0
Systematic Assessment
EG0000 events0 affected481 at risk
EG0011 events1 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Rotator cuff syndrome
Musculoskeletal and connective tissue disorders
MedDRA version: 25.0
Systematic Assessment
EG0000 events0 affected481 at risk
EG0011 events1 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Adenocarcinoma metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 25.0
Systematic Assessment
EG0000 events0 affected481 at risk
EG0011 events1 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Adenocarcinoma of the cervix
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 25.0
Systematic Assessment
EG0001 events1 affected481 at risk
EG0010 events0 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Anal squamous cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 25.0
Systematic Assessment
EG0001 events1 affected481 at risk
EG0010 events0 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Bladder neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 25.0
Systematic Assessment
EG0001 events1 affected481 at risk
EG0010 events0 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Bladder transitional cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 25.0
Systematic Assessment
EG0001 events1 affected481 at risk
EG0011 events1 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Breast cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 25.0
Systematic Assessment
EG0001 events1 affected481 at risk
EG0010 events0 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Colon cancer stage I
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 25.0
Systematic Assessment
EG0001 events1 affected481 at risk
EG0010 events0 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Colorectal adenocarcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 25.0
Systematic Assessment
EG0000 events0 affected481 at risk
EG0011 events1 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Gastric cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 25.0
Systematic Assessment
EG0000 events0 affected481 at risk
EG0011 events1 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Gastric leiomyoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 25.0
Systematic Assessment
EG0000 events0 affected481 at risk
EG0011 events1 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Gingival cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 25.0
Systematic Assessment
EG0001 events1 affected481 at risk
EG0010 events0 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Lung neoplasm malignant
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 25.0
Systematic Assessment
EG0001 events1 affected481 at risk
EG0010 events0 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Myelodysplastic syndrome
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 25.0
Systematic Assessment
EG0000 events0 affected481 at risk
EG0011 events1 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Prostate cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 25.0
Systematic Assessment
EG0002 events2 affected481 at risk
EG0010 events0 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Prostate cancer recurrent
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 25.0
Systematic Assessment
EG0000 events0 affected481 at risk
EG0011 events1 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Prostatic adenoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 25.0
Systematic Assessment
EG0001 events1 affected481 at risk
EG0011 events1 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Squamous cell carcinoma of the vulva
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 25.0
Systematic Assessment
EG0000 events0 affected481 at risk
EG0011 events1 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Amyloid related imaging abnormality-microhaemorrhages and haemosiderin deposits
Nervous system disorders
MedDRA version: 25.0
Systematic Assessment
EG0000 events0 affected481 at risk
EG0012 events2 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Amyloid related imaging abnormality-oedema/effusion
Nervous system disorders
MedDRA version: 25.0
Systematic Assessment
EG0000 events0 affected481 at risk
EG0018 events7 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Aphasia
Nervous system disorders
MedDRA version: 25.0
Systematic Assessment
EG0000 events0 affected481 at risk
EG0011 events1 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Cerebral haemorrhage
Nervous system disorders
MedDRA version: 25.0
Systematic Assessment
EG0002 events2 affected481 at risk
EG0010 events0 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Cerebral infarction
Nervous system disorders
MedDRA version: 25.0
Systematic Assessment
EG0001 events1 affected481 at risk
EG0010 events0 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Cerebral ischaemia
Nervous system disorders
MedDRA version: 25.0
Systematic Assessment
EG0001 events1 affected481 at risk
EG0010 events0 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Clonic convulsion
Nervous system disorders
MedDRA version: 25.0
Systematic Assessment
EG0000 events0 affected481 at risk
EG0011 events1 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Encephalopathy
Nervous system disorders
MedDRA version: 25.0
Systematic Assessment
EG0000 events0 affected481 at risk
EG0011 events1 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Generalised tonic-clonic seizure
Nervous system disorders
MedDRA version: 25.0
Systematic Assessment
EG0000 events0 affected481 at risk
EG0011 events1 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Haemorrhagic stroke
Nervous system disorders
MedDRA version: 25.0
Systematic Assessment
EG0001 events1 affected481 at risk
EG0010 events0 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Headache
Nervous system disorders
MedDRA version: 25.0
Systematic Assessment
EG0001 events1 affected481 at risk
EG0010 events0 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Hemianopia
Nervous system disorders
MedDRA version: 25.0
Systematic Assessment
EG0000 events0 affected481 at risk
EG0011 events1 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Hypoxic-ischaemic encephalopathy
Nervous system disorders
MedDRA version: 25.0
Systematic Assessment
EG0001 events1 affected481 at risk
EG0010 events0 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Ischaemic stroke
Nervous system disorders
MedDRA version: 25.0
Systematic Assessment
EG0002 events2 affected481 at risk
EG0012 events2 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Loss of consciousness
Nervous system disorders
MedDRA version: 25.0
Systematic Assessment
EG0001 events1 affected481 at risk
EG0010 events0 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Metabolic encephalopathy
Nervous system disorders
MedDRA version: 25.0
Systematic Assessment
EG0001 events1 affected481 at risk
EG0010 events0 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Myoclonus
Nervous system disorders
MedDRA version: 25.0
Systematic Assessment
EG0000 events0 affected481 at risk
EG0011 events1 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Sciatica
Nervous system disorders
MedDRA version: 25.0
Systematic Assessment
EG0000 events0 affected481 at risk
EG0011 events1 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Seizure
Nervous system disorders
MedDRA version: 25.0
Systematic Assessment
EG0000 events0 affected481 at risk
EG0010 events0 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Subarachnoid haemorrhage
Nervous system disorders
MedDRA version: 25.0
Systematic Assessment
EG0001 events1 affected481 at risk
EG0010 events0 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Subdural hygroma
Nervous system disorders
MedDRA version: 25.0
Systematic Assessment
EG0001 events1 affected481 at risk
EG0010 events0 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Syncope
Nervous system disorders
MedDRA version: 25.0
Systematic Assessment
EG0002 events2 affected481 at risk
EG0011 events1 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Thalamic infarction
Nervous system disorders
MedDRA version: 25.0
Systematic Assessment
EG0000 events0 affected481 at risk
EG0011 events1 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Toxic encephalopathy
Nervous system disorders
MedDRA version: 25.0
Systematic Assessment
EG0000 events0 affected481 at risk
EG0010 events0 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Transient global amnesia
Nervous system disorders
MedDRA version: 25.0
Systematic Assessment
EG0000 events0 affected481 at risk
EG0011 events1 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Transient ischaemic attack
Nervous system disorders
MedDRA version: 25.0
Systematic Assessment
EG0000 events0 affected481 at risk
EG0011 events1 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Tremor
Nervous system disorders
MedDRA version: 25.0
Systematic Assessment
EG0001 events1 affected481 at risk
EG0010 events0 affected503 at risk
EG0020 events0 affected33 at risk
EG003
VIth nerve paresis
Nervous system disorders
MedDRA version: 25.0
Systematic Assessment
EG0000 events0 affected481 at risk
EG0011 events1 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Vertebrobasilar artery dissection
Nervous system disorders
MedDRA version: 25.0
Systematic Assessment
EG0001 events1 affected481 at risk
EG0010 events0 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Aggression
Psychiatric disorders
MedDRA version: 25.0
Systematic Assessment
EG0000 events0 affected481 at risk
EG0013 events2 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA version: 25.0
Systematic Assessment
EG0002 events2 affected481 at risk
EG0010 events0 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA version: 25.0
Systematic Assessment
EG0000 events0 affected481 at risk
EG0012 events2 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Delirium
Psychiatric disorders
MedDRA version: 25.0
Systematic Assessment
EG0002 events2 affected481 at risk
EG0011 events1 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Hallucination
Psychiatric disorders
MedDRA version: 25.0
Systematic Assessment
EG0000 events0 affected481 at risk
EG0011 events1 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Mental status changes
Psychiatric disorders
MedDRA version: 25.0
Systematic Assessment
EG0001 events1 affected481 at risk
EG0010 events0 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Paranoia
Psychiatric disorders
MedDRA version: 25.0
Systematic Assessment
EG0000 events0 affected481 at risk
EG0011 events1 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Psychomotor retardation
Psychiatric disorders
MedDRA version: 25.0
Systematic Assessment
EG0000 events0 affected481 at risk
EG0011 events1 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Psychotic disorder
Psychiatric disorders
MedDRA version: 25.0
Systematic Assessment
EG0000 events0 affected481 at risk
EG0011 events1 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Suicide attempt
Psychiatric disorders
MedDRA version: 25.0
Systematic Assessment
EG0001 events1 affected481 at risk
EG0010 events0 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Bladder diverticulum
Renal and urinary disorders
MedDRA version: 25.0
Systematic Assessment
EG0001 events1 affected481 at risk
EG0010 events0 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA version: 25.0
Systematic Assessment
EG0000 events0 affected481 at risk
EG0011 events1 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Ureterolithiasis
Renal and urinary disorders
MedDRA version: 25.0
Systematic Assessment
EG0001 events1 affected481 at risk
EG0010 events0 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Urinary retention
Renal and urinary disorders
MedDRA version: 25.0
Systematic Assessment
EG0002 events2 affected481 at risk
EG0010 events0 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Benign prostatic hyperplasia
Reproductive system and breast disorders
MedDRA version: 25.0
Systematic Assessment
EG0001 events1 affected481 at risk
EG0010 events0 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Uterine cyst
Reproductive system and breast disorders
MedDRA version: 25.0
Systematic Assessment
EG0000 events0 affected481 at risk
EG0011 events1 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Uterine prolapse
Reproductive system and breast disorders
MedDRA version: 25.0
Systematic Assessment
EG0000 events0 affected481 at risk
EG0011 events1 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Acute pulmonary oedema
Respiratory, thoracic and mediastinal disorders
MedDRA version: 25.0
Systematic Assessment
EG0001 events1 affected481 at risk
EG0010 events0 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Acute respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA version: 25.0
Systematic Assessment
EG0001 events1 affected481 at risk
EG0010 events0 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA version: 25.0
Systematic Assessment
EG0001 events1 affected481 at risk
EG0010 events0 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Emphysema
Respiratory, thoracic and mediastinal disorders
MedDRA version: 25.0
Systematic Assessment
EG0001 events1 affected481 at risk
EG0010 events0 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Lung infiltration
Respiratory, thoracic and mediastinal disorders
MedDRA version: 25.0
Systematic Assessment
EG0001 events1 affected481 at risk
EG0010 events0 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Obstructive airways disorder
Respiratory, thoracic and mediastinal disorders
MedDRA version: 25.0
Systematic Assessment
EG0001 events1 affected481 at risk
EG0010 events0 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA version: 25.0
Systematic Assessment
EG0002 events2 affected481 at risk
EG0015 events5 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA version: 25.0
Systematic Assessment
EG0001 events1 affected481 at risk
EG0010 events0 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Aortic aneurysm
Vascular disorders
MedDRA version: 25.0
Systematic Assessment
EG0001 events1 affected481 at risk
EG0010 events0 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Arterial occlusive disease
Vascular disorders
MedDRA version: 25.0
Systematic Assessment
EG0001 events1 affected481 at risk
EG0010 events0 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA version: 25.0
Systematic Assessment
EG0001 events1 affected481 at risk
EG0010 events0 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Hypertension
Vascular disorders
MedDRA version: 25.0
Systematic Assessment
EG0000 events0 affected481 at risk
EG0012 events2 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Hypertensive crisis
Vascular disorders
MedDRA version: 25.0
Systematic Assessment
EG0000 events0 affected481 at risk
EG0011 events1 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Hypotension
Vascular disorders
MedDRA version: 25.0
Systematic Assessment
EG0002 events2 affected481 at risk
EG0010 events0 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Orthostatic hypotension
Vascular disorders
MedDRA version: 25.0
Systematic Assessment
EG0001 events1 affected481 at risk
EG0010 events0 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Peripheral artery thrombosis
Vascular disorders
MedDRA version: 25.0
Systematic Assessment
EG0001 events1 affected481 at risk
EG0010 events0 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Superficial vein thrombosis
Vascular disorders
MedDRA version: 25.0
Systematic Assessment
EG0001 events1 affected481 at risk
EG0010 events0 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Arrhythmia
Cardiac disorders
MedDRA version: 25.0
Systematic Assessment
EG0001 events1 affected481 at risk
EG0010 events0 affected503 at risk
EG0020 events0 affected33 at risk
EG0030 events0 affected35 at risk
EG0040 events0 affected9 at risk
EG0053 events2 affected20 at risk
Cardiac failure chronic
Cardiac disorders
MedDRA version: 25.0
Systematic Assessment
EG0001 events1 affected481 at risk
EG0010 events0 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Myocardial ischaemia
Cardiac disorders
MedDRA version: 25.0
Systematic Assessment
EG0001 events1 affected481 at risk
EG0010 events0 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA version: 25.0
Systematic Assessment
EG00029 events26 affected481 at risk
EG00148 events33 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA version: 25.0
Systematic Assessment
EG0003 events3 affected481 at risk
EG0012 events1 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA version: 25.0
Systematic Assessment
EG00020 events17 affected481 at risk
EG00143 events26 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Injection site reaction
General disorders
MedDRA version: 25.0
Systematic Assessment
EG00095 events43 affected481 at risk
EG001392 events94 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Pyrexia
General disorders
MedDRA version: 25.0
Systematic Assessment
EG00014 events12 affected481 at risk
EG0016 events6 affected503 at risk
EG0021 events1 affected33 at risk
EG003
Vaccination site pain
General disorders
MedDRA version: 25.0
Systematic Assessment
EG0003 events3 affected481 at risk
EG0011 events1 affected503 at risk
EG0020 events0 affected33 at risk
EG003
COVID-19
Infections and infestations
MedDRA version: 25.0
Systematic Assessment
EG00035 events35 affected481 at risk
EG00126 events26 affected503 at risk
EG0023 events3 affected33 at risk
EG003
Gingivitis
Infections and infestations
MedDRA version: 25.0
Systematic Assessment
EG0001 events1 affected481 at risk
EG0011 events1 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Influenza
Infections and infestations
MedDRA version: 25.0
Systematic Assessment
EG0005 events5 affected481 at risk
EG0012 events1 affected503 at risk
EG0021 events1 affected33 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA version: 25.0
Systematic Assessment
EG00037 events33 affected481 at risk
EG00160 events46 affected503 at risk
EG0021 events1 affected33 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA version: 25.0
Systematic Assessment
EG0006 events3 affected481 at risk
EG0014 events4 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Rhinitis
Infections and infestations
MedDRA version: 25.0
Systematic Assessment
EG0006 events6 affected481 at risk
EG00110 events9 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA version: 25.0
Systematic Assessment
EG00039 events28 affected481 at risk
EG00137 events30 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA version: 25.0
Systematic Assessment
EG00018 events13 affected481 at risk
EG00123 events21 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA version: 25.0
Systematic Assessment
EG00082 events62 affected481 at risk
EG00194 events60 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Hip fracture
Injury, poisoning and procedural complications
MedDRA version: 25.0
Systematic Assessment
EG0000 events0 affected481 at risk
EG0010 events0 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Joint dislocation
Injury, poisoning and procedural complications
MedDRA version: 25.0
Systematic Assessment
EG0002 events2 affected481 at risk
EG0011 events1 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Ligament sprain
Injury, poisoning and procedural complications
MedDRA version: 25.0
Systematic Assessment
EG0008 events8 affected481 at risk
EG0018 events8 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Rib fracture
Injury, poisoning and procedural complications
MedDRA version: 25.0
Systematic Assessment
EG0003 events3 affected481 at risk
EG0012 events2 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Spinal compression fracture
Injury, poisoning and procedural complications
MedDRA version: 25.0
Systematic Assessment
EG0002 events2 affected481 at risk
EG0014 events4 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Blood glucose increased
Investigations
MedDRA version: 25.0
Systematic Assessment
EG0000 events0 affected481 at risk
EG0014 events4 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Blood pressure increased
Investigations
MedDRA version: 25.0
Systematic Assessment
EG0002 events2 affected481 at risk
EG0014 events3 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA version: 25.0
Systematic Assessment
EG0001 events1 affected481 at risk
EG0014 events3 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA version: 25.0
Systematic Assessment
EG00036 events29 affected481 at risk
EG00151 events37 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA version: 25.0
Systematic Assessment
EG00051 events40 affected481 at risk
EG00149 events43 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA version: 25.0
Systematic Assessment
EG0004 events3 affected481 at risk
EG00115 events13 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Amyloid related imaging abnormality-microhaemorrhages and haemosiderin deposits
Nervous system disorders
MedDRA version: 25.0
Systematic Assessment
EG0005 events4 affected481 at risk
EG00135 events33 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Amyloid related imaging abnormality-oedema/effusion
Nervous system disorders
MedDRA version: 25.0
Systematic Assessment
EG0005 events5 affected481 at risk
EG001161 events102 affected503 at risk
EG0021 events1 affected33 at risk
EG003
Dizziness
Nervous system disorders
MedDRA version: 25.0
Systematic Assessment
EG00049 events41 affected481 at risk
EG00164 events45 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Dysarthria
Nervous system disorders
MedDRA version: 25.0
Systematic Assessment
EG0000 events0 affected481 at risk
EG0013 events3 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Focal dyscognitive seizures
Nervous system disorders
MedDRA version: 25.0
Systematic Assessment
EG0001 events1 affected481 at risk
EG0010 events0 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Headache
Nervous system disorders
MedDRA version: 25.0
Systematic Assessment
EG00085 events42 affected481 at risk
EG00199 events60 affected503 at risk
EG0021 events1 affected33 at risk
EG003
Ischaemic stroke
Nervous system disorders
MedDRA version: 25.0
Systematic Assessment
EG0000 events0 affected481 at risk
EG0010 events0 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Somnolence
Nervous system disorders
MedDRA version: 25.0
Systematic Assessment
EG0007 events6 affected481 at risk
EG0012 events2 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Agitation
Psychiatric disorders
MedDRA version: 25.0
Systematic Assessment
EG00018 events15 affected481 at risk
EG00110 events10 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA version: 25.0
Systematic Assessment
EG00021 events19 affected481 at risk
EG00121 events19 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Depressed mood
Psychiatric disorders
MedDRA version: 25.0
Systematic Assessment
EG0004 events4 affected481 at risk
EG0015 events5 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Depression
Psychiatric disorders
MedDRA version: 25.0
Systematic Assessment
EG00022 events22 affected481 at risk
EG00128 events28 affected503 at risk
EG0021 events1 affected33 at risk
EG003
Disorientation
Psychiatric disorders
MedDRA version: 25.0
Systematic Assessment
EG0003 events3 affected481 at risk
EG0012 events2 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA version: 25.0
Systematic Assessment
EG00023 events21 affected481 at risk
EG00126 events25 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Bladder irritation
Renal and urinary disorders
MedDRA version: 25.0
Systematic Assessment
EG0000 events0 affected481 at risk
EG0010 events0 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA version: 25.0
Systematic Assessment
EG0004 events4 affected481 at risk
EG0011 events1 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA version: 25.0
Systematic Assessment
EG00013 events11 affected481 at risk
EG00119 events19 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA version: 25.0
Systematic Assessment
EG0007 events7 affected481 at risk
EG0017 events5 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA version: 25.0
Systematic Assessment
EG0003 events3 affected481 at risk
EG0012 events2 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA version: 25.0
Systematic Assessment
EG0008 events7 affected481 at risk
EG0018 events8 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA version: 25.0
Systematic Assessment
EG00013 events13 affected481 at risk
EG00115 events12 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Arteriosclerosis
Vascular disorders
MedDRA version: 25.0
Systematic Assessment
EG0001 events1 affected481 at risk
EG0010 events0 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Hypertension
Vascular disorders
MedDRA version: 25.0
Systematic Assessment
EG00038 events35 affected481 at risk
EG00154 events41 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Hypotension
Vascular disorders
MedDRA version: 25.0
Systematic Assessment
EG0008 events7 affected481 at risk
EG00113 events12 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Peripheral ischaemia
Vascular disorders
MedDRA version: 25.0
Systematic Assessment
EG0000 events0 affected481 at risk
EG0010 events0 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Sinus bradycardia
Cardiac disorders
MedDRA version: 25.0
Systematic Assessment
EG0002 events2 affected481 at risk
EG0015 events5 affected503 at risk
EG0024 events3 affected33 at risk
EG003
Large intestine polyp
Gastrointestinal disorders
MedDRA version: 25.0
Systematic Assessment
EG0005 events5 affected481 at risk
EG0013 events3 affected503 at risk
EG0022 events2 affected33 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA version: 25.0
Systematic Assessment
EG00010 events9 affected481 at risk
EG00113 events13 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Coronavirus infection
Infections and infestations
MedDRA version: 25.0
Systematic Assessment
EG0000 events0 affected481 at risk
EG0010 events0 affected503 at risk
EG0021 events1 affected33 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA version: 25.0
Systematic Assessment
EG00023 events19 affected481 at risk
EG00124 events19 affected503 at risk
EG0022 events2 affected33 at risk
EG003
Ankle fracture
Injury, poisoning and procedural complications
MedDRA version: 25.0
Systematic Assessment
EG0000 events0 affected481 at risk
EG0010 events0 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Dermatitis
Skin and subcutaneous tissue disorders
MedDRA version: 25.0
Systematic Assessment
EG0001 events1 affected481 at risk
EG0012 events2 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA version: 25.0
Systematic Assessment
EG0006 events6 affected481 at risk
EG0019 events9 affected503 at risk
EG0020 events0 affected33 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Change from BL was calculated based on ANCOVA analysis model which included the following covariates and stratification factors = Treatment + Baseline + Geographical Region + Disease Stage + AD Medication at BL + APOE e4.
ANCOVA
0.0544
Difference in adjusted mean
-1.25
Standard Error of the Mean
0.65
2-Sided
95
-2.52
0.02
Superiority
Units
Counts
Participants
OG000479
OG001497
Title
Denominators
Categories
Title
Measurements
OG000-12.32± 0.68
OG001-11.21± 0.60
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Change from BL was calculated based on ANCOVA analysis model which included the following covariates and stratification factors = Treatment + Baseline + Region + Disease Stage + AD Medication at BL + APOE e4.
ANCOVA
0.1729
Difference in adjusted mean
1.11
Standard Error of the Mean
0.81
2-Sided
95
-0.48
2.70
Superiority
Units
Counts
Participants
OG000479
OG001498
Title
Denominators
Categories
Title
Measurements
OG0008.13± 0.33
OG0017.28± 0.30
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Change from BL was calculated based on ANCOVA analysis model which included the following covariates and stratification factors = Treatment + Baseline + Geographical Region + Disease Stage + AD Medication at BL + APOE e4.
ANCOVA
0.0425
Difference in adjusted mean
-0.86
Standard Error of the Mean
0.42
2-Sided
95
-1.68
-0.03
Superiority
Units
Counts
Participants
OG000485
OG001499
Title
Denominators
Categories
Title
Measurements
OG000-5.18± 0.25
OG001-4.86± 0.23
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Change from Baseline was calculated based on ANCOVA analysis model which included the following covariates and stratification factors =Treatment + Baseline + Geographic Region + Disease Stage + AD Medication at BL + APOE e4.
ANCOVA
0.2904
Difference in adjusted mean
0.32
Standard Error of the Mean
0.31
2-Sided
95
-0.28
0.93
Superiority
Participants received gantenerumab, SC injection with gradual up-titration starting at a dose of 120 mg, Q4W for 3 doses, followed by 255 mg, Q4W for 3 doses, and 510 mg, Q4W for 3 doses, and 510 mg, Q4W for 3 doses. Following this, from Week 36 onwards, participants received gantenerumab, SC injection at a dose of 510 mg, Q2W up to Week 114 of the DBT period.
Units
Counts
Participants
OG000481
OG001498
Title
Denominators
Categories
Title
Measurements
OG0008.42± 0.52
OG0017.44± 0.43
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Change from BL was calculated based on ANCOVA analysis model which included the following covariates and stratification factors = Treatment + Baseline + Geographical Region + Disease Stage + AD Medication at BL + APOE e4.
ANCOVA
0.1036
Difference in adjusted mean
-0.97
Standard Error of the Mean
0.60
2-Sided
95
-2.14
0.20
Superiority
Counts
Participants
OG000481
OG001499
Title
Denominators
Categories
Title
Measurements
OG000-3.46± 0.31
OG001-3.53± 0.30
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Change from BL was calculated based on ANCOVA analysis model which included the following covariates and stratification factors = Treatment + Baseline + Geographical Region + Disease Stage + AD Medication at BL + APOE e4.
ANCOVA
0.8468
Difference in adjusted mean
-0.07
Standard Error of the Mean
0.37
2-Sided
95
-0.79
0.65
Superiority
Units
Counts
Participants
OG000480
OG001498
Title
Denominators
Categories
Title
Measurements
OG000-6.47± 0.64
OG001-6.27± 0.54
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Change from BL was calculated based on ANCOVA analysis model which included the following covariates and stratification factors = Treatment + Baseline + Geographical Region + Disease Stage + AD Medication at BL + APOE e4.
ANCOVA
0.8030
Difference in adjusted mean
0.20
Standard Error of the Mean
0.79
2-Sided
95
-1.35
1.74
Superiority
Units
Counts
Participants
OG000479
OG001497
Title
Denominators
Categories
Title
Measurements
OG000-10.80± 0.56
OG001-9.80± 0.51
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Change from BL was calculated based on ANCOVA analysis model which included the following covariates and stratification factors = Treatment + Baseline + Geographical Region + Disease Stage + AD Medication at BL + APOE e4.
ANCOVA
0.1439
Difference in adjusted mean
1.00
Standard Error of the Mean
0.68
2-Sided
95
-0.34
2.34
Superiority
Units
Counts
Participants
OG000481
OG001503
Title
Denominators
Categories
Title
Measurements
OG000423
OG001454
Participants received gantenerumab matching placebo, SC injection, Q4W up to Week 36 and then Q2W up to approximately 114 weeks of the DBT period.
OG001
Global - DBT Period: Gantenerumab
Participants received gantenerumab, SC injection with gradual up-titration starting at a dose of 120 mg, Q4W for 3 doses, followed by 255 mg, Q4W for 3 doses, and 510 mg, Q4W for 3 doses, and 510 mg, Q4W for 3 doses. Following this, from Week 36 onwards, participants received gantenerumab, SC injection at a dose of 510 mg, Q2W up to Week 114 of the DBT period.
Units
Counts
Participants
OG000467
OG001489
Title
Denominators
Categories
Suicidal Ideation: Passive
Title
Measurements
OG00013
OG00117
Suicidal Ideation: Active-Nonspecific
Title
Measurements
OG0001
OG0013
Suicidal Ideation: Active-Method, But No Intent or Plan
Title
Measurements
OG0006
OG0013
Suicidal Ideation: Active-Method and Intent, But No Plan
Title
Measurements
OG0002
OG0010
Suicidal Ideation: Active-Method, Intent, and Plan
Title
Measurements
OG0002
OG0010
Suicidal Ideation: No Event
Title
Measurements
OG000443
OG001466
Suicidal Behavior: Interrupted Attempt
Title
Measurements
OG0000
OG0011
Suicidal Behavior: No Event
Title
Measurements
OG000467
OG001488
Self-injurious Behavior Without Suicidal Intent: No Event
Title
Measurements
OG000467
OG001489
Units
Counts
Participants
OG000476
OG001497
Title
Denominators
Categories
Title
Measurements
OG0005
OG001105
Units
Counts
Participants
OG000476
OG001497
Title
Denominators
Categories
Title
Measurements
OG0006
OG00140
Units
Counts
Participants
OG000481
OG001503
Title
Denominators
Categories
Title
Measurements
OG00043
OG00194
Counts
Participants
OG000489
Title
Denominators
Categories
Title
Measurements
OG00010
OG001
Global - DBT Period: Gantenerumab
Participants received gantenerumab, SC injection with gradual up-titration starting at a dose of 120 mg, Q4W for 3 doses, followed by 255 mg, Q4W for 3 doses, and 510 mg, Q4W for 3 doses, and 510 mg, Q4W for 3 doses. Following this, from Week 36 onwards, participants received gantenerumab, SC injection at a dose of 510 mg, Q2W up to Week 114 of the DBT period.
Units
Counts
Participants
OG00041
OG00149
Title
Denominators
Categories
Title
Measurements
OG0009.06± 3.046
OG001-57.38± 2.841
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Change from BL was calculated based on mixed-effect model of repeated measure which included the following covariates and stratification factors = Baseline + APOE e4 status + Type of Tracer + Analysis Visit + Treatment + Treatment*Analysis Visit + Analysis Visit*Baseline.
Mixed Model for Repeated Measures
<.0001
Difference in adjusted means
-66.44
Standard Error of the Mean
4.171
2-Sided
95
-74.71
-58.16
Superiority
Participants received gantenerumab matching placebo, SC injection, Q4W up to Week 36 and then Q2W up to approximately 114 weeks of the DBT period.
OG001
Global - DBT Period: Gantenerumab
Participants received gantenerumab, SC injection with gradual up-titration starting at a dose of 120 mg, Q4W for 3 doses, followed by 255 mg, Q4W for 3 doses, and 510 mg, Q4W for 3 doses, and 510 mg, Q4W for 3 doses. Following this, from Week 36 onwards, participants received gantenerumab, SC injection at a dose of 510 mg, Q2W up to Week 114 of the DBT period.
Units
Counts
Participants
OG00029
OG00148
Title
Denominators
Categories
ROI: Temporal Composite Region
Title
Measurements
OG0000.12± 0.018
OG0010.13± 0.014
ROI: Medial Temporal Composite Region [not including the Hippocampus]
Title
Measurements
OG0000.08± 0.014
OG0010.09± 0.011
ROI: Frontal Lobe
Title
Measurements
OG0000.08± 0.012
OG0010.08± 0.009
ROI: Parietal Lobe
Title
Measurements
OG0000.09± 0.020
OG0010.09± 0.016
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Temporal Composite Region: Change from BL was calculated based on mixed-effect model of repeated measure which included the following covariates and stratification factors = Baseline + APOE e4 status + Study + Analysis Visit + Treatment + Treatment*Analysis Visit + Analysis Visit*Baseline.
Mixed Model for Repeated Measures
0.7816
Difference in adjusted mean
0.01
Standard Error of the Mean
0.023
2-Sided
95
-0.04
0.05
Superiority
OG000
OG001
Medial Temporal Composite Region: Change from BL was calculated based on mixed-effect model of repeated measure which included the following covariates and stratification factors = Baseline + APOE e4 status + Study + Analysis Visit + Treatment + Treatment*Analysis Visit + Analysis Visit*Baseline.
Mixed Model for Repeated Measures
0.6203
Difference in adjusted means
0.01
Standard Error of the Mean
0.018
2-Sided
95
-0.03
0.05
Superiority
OG000
OG001
Frontal Lobe: Change from BL was calculated based on mixed-effect model of repeated measure which included the following covariates and stratification factors = Baseline + APOE e4 status + Study + Analysis Visit + Treatment + Treatment*Analysis Visit + Analysis Visit*Baseline.
Mixed Model for Repeated Measures
0.7754
Difference in adjusted means
0.00
Standard Error of the Mean
0.015
2-Sided
95
-0.03
0.03
Superiority
OG000
OG001
Parietal Lobe: Change from BL was calculated based on mixed-effect model of repeated measure which included the following covariates and stratification factors = Baseline + APOE e4 status + Study + Analysis Visit + Treatment + Treatment*Analysis Visit + Analysis Visit*Baseline.
Mixed Model for Repeated Measures
0.9022
Difference in adjusted means
0.00
Standard Error of the Mean
0.026
2-Sided
95
-0.05
0.05
Superiority
Units
Counts
Participants
OG00084
OG00191
Title
Denominators
Categories
Title
Measurements
OG0003.2(-1.74 to 8.37)
OG001-16.6(-20.40 to -12.54)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Parietal Lobe: Change from BL was calculated based on mixed-effect model of repeated measure which included the following covariates and stratification factors = Baseline + APOE e4 status + Study + Analysis Visit + Treatment + Treatment*Analysis Visit + Analysis Visit*Baseline.
ANCOVA
<.001
Superiority
Units
Counts
Participants
OG00084
OG00189
Title
Denominators
Categories
Title
Measurements
OG0001.1(-3.76 to 6.20)
OG001-25.2(-28.65 to -21.49)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
ANCOVA
<.001
Superiority
Units
Counts
Participants
OG00085
OG00193
Title
Denominators
Categories
Title
Measurements
OG00015.8(9.67 to 22.32)
OG00112.1(6.41 to 18.11)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
ANCOVA
0.396
Superiority
OG00084
OG00193
Title
Denominators
Categories
Title
Measurements
OG000-0.6(-5.93 to 5.05)
OG001-22.3(-26.28 to -18.13)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
ANCOVA
<.001
Superiority
Units
Counts
Participants
OG0000
OG0010
Units
Counts
Participants
OG0000
OG0010
Units
Counts
Participants
OG0000
OG0010
Units
Counts
Participants
OG0000
OG0010
Units
Counts
Participants
OG0000
OG0010
OG0000
OG0010
Units
Counts
Participants
OG0000
OG0010
Counts
Participants
OG00033
OG00135
Title
Denominators
Categories
Title
Measurements
OG00017
OG00124
OG001
China Extension - DBT Period: Gantenerumab
Participants received gantenerumab, SC injection with gradual up-titration starting at a dose of 120 mg, Q4W for 3 doses, followed by 255 mg, Q4W for 3 doses, and 510 mg, Q4W for 3 doses. Following this, from Week 36 onwards, participants received gantenerumab, SC injection at a dose of 510 mg, Q2W up to approximately 110 weeks of the DBT period.
Units
Counts
Participants
OG00025
OG00130
Title
Denominators
Categories
Suicidal Ideation: Passive
Title
Measurements
OG0001
OG0011
Suicidal Ideation: Active-Nonspecific (no method, intent, or plan)
Title
Measurements
OG0000
OG0011
Suicidal Ideation: Active-Method and intent, but no plan
Title
Measurements
OG0001
OG0010
Suicidal Ideation: No Event
Title
Measurements
OG00023
OG00128
Suicidal Behavior: No Event
Title
Measurements
OG00025
OG00130
Self-injurious Behavior Without Suicidal Intent: No event
Title
Measurements
OG00025
OG00130
Units
Counts
Participants
OG00033
OG00135
Title
Denominators
Categories
Title
Measurements
OG0001
OG0014
Units
Counts
Participants
OG00033
OG00135
Title
Denominators
Categories
Title
Measurements
OG0000
OG0011
Units
Counts
Participants
OG00033
OG00135
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
Units
Counts
Participants
OG0009
OG00120
Title
Denominators
Categories
Title
Measurements
OG0008
OG00116
Participants who received gantenerumab matching placebo in the DBT period received gantenerumab SC injections with gradual up titration starting at a dose of 120 mg, Q4W for 3 doses, followed by 255 mg, Q4W for 3 doses, and then at a dose of 510 mg, Q4W up to Week 34 of the OLE period. To maintain the blind to previous treatment assignment, participants received Q2W, SC injections, with alternate doses containing gantenerumab matching placebo.
OG001
Global - OLE Period: Gantenerumab (DBT) to Gantenerumab
Participants who received gantenerumab in the DBT period continued receiving gantenerumab, SC injections, 510 mg, Q2W up to Week 34 of the OLE period.
Units
Counts
Participants
OG0006
OG00119
Title
Denominators
Categories
Suicidal Ideation: Active-Method, but no intent or plan
Title
Measurements
OG0000
OG0011
Suicidal Ideation: No Event
Title
Measurements
OG0006
OG00118
Suicidal Behavior: No Event
Title
Measurements
OG0006
OG00119
Self-injurious Behavior Without Suicidal Intent: No event
Title
Measurements
OG0006
OG00119
Participants who received gantenerumab in the DBT period continued receiving gantenerumab, SC injections, 510 mg, Q2W up to Week 34 of the OLE period.
Units
Counts
Participants
OG0009
OG00120
Title
Denominators
Categories
Title
Measurements
OG0001
OG0011
Participants who received gantenerumab in the DBT period continued receiving gantenerumab, SC injections, 510 mg, Q2W up to Week 34 of the OLE period.