221AD301 Phase 3 Study of Aducanumab (BIIB037) in Early A... | NCT02477800 | Trialant
NCT02477800
Sponsor
Biogen
Status
Terminated
Last Update Posted
Sep 2, 2021Actual
Enrollment
1,653Actual
Phase
Phase 3
Conditions
Alzheimer's Disease
Interventions
Aducanumab (BIIB037)
Aducanumab (BIIB037)
Placebo
Countries
United States
Australia
Austria
Canada
Denmark
France
Germany
Italy
Japan
Portugal
South Korea
Spain
Taiwan
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT02477800
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
221AD301
Secondary IDs
ID
Type
Description
Link
2015-000966-72
EudraCT Number
Brief Title
221AD301 Phase 3 Study of Aducanumab (BIIB037) in Early Alzheimer's Disease
Official Title
A Phase 3 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Aducanumab (BIIB037) in Subjects With Early Alzheimer's Disease
Acronym
ENGAGE
Organization
BiogenINDUSTRY
Status Module
Record Verification Date
Aug 2021
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Study was discontinued based on futility analysis done and not based on safety concerns. Follow-up visits and closing out study activities are completed
Expanded Access Info
No
Start Date
Aug 13, 2015Actual
Primary Completion Date
Aug 8, 2019Actual
Completion Date
Aug 8, 2019Actual
First Submitted Date
Jun 18, 2015
First Submission Date that Met QC Criteria
Jun 18, 2015
First Posted Date
Jun 23, 2015Estimated
Results Waived
Not provided
Results First Submitted Date
Jul 1, 2021
Results First Submitted that Met QC Criteria
Aug 9, 2021
Results First Posted Date
Sep 2, 2021Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Aug 7, 2020
Certification/Extension First Submitted that Passed QC Review
Aug 7, 2020
Certification/Extension First Posted Date
Aug 14, 2020Actual
Last Update Submitted Date
Aug 9, 2021
Last Update Posted Date
Sep 2, 2021Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
BiogenINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
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
The primary objective of the study is to evaluate the efficacy of monthly doses of aducanumab in slowing cognitive and functional impairment as measured by changes in the Clinical Dementia Rating-Sum of Boxes (CDR-SB) score as compared with placebo in participants with early AD. Secondary objectives are to assess the effect of monthly doses of aducanumab as compared with placebo on clinical progression as measured by Mini-Mental State Examination (MMSE), AD Assessment Scale-Cognitive Subscale (13 items) [ADAS-Cog 13], and AD Cooperative Study-Activities of Daily Living Inventory (Mild Cognitive Impairment version) [ADCS-ADL-MCI].
Detailed Description
Not provided
Conditions Module
Conditions
Alzheimer's Disease
Keywords
BIIB037
Aducanumab
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
1,653Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Low Dose
Experimental
Monthly intravenous (IV) infusion
Drug: Aducanumab (BIIB037)
Drug: Placebo
High Dose
Experimental
Monthly intravenous (IV) infusion
Drug: Aducanumab (BIIB037)
Drug: Placebo
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Aducanumab (BIIB037)
Drug
Low dose
Low Dose
Aducanumab (BIIB037)
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Change From Baseline in Clinical Dementia Rating Sum of Boxes (CDR-SB) Score at Week 78
CDR-SB integrates assessments from 3 domains of cognition (memory, orientation, judgment/problem-solving) and 3 domains of function (community affairs, home/hobbies, personal care). Following caregiver interview and systematic patient examination, the rater assigns a score describing the participant's current performance level in each of these domains of life functioning. Prespecified severity anchors range from none = 0, questionable = 0.5, mild = 1, moderate = 2 to severe = 3 (the personal care domain omits the 0.5 score). "Sum of boxes" scoring methodology sums the score for each of the 6 domains and provides a value ranging from 0 to 18 that can change in increments of 0.5 or greater. Higher scores indicate greater disease severity. Mixed model for repeated measures (MMRM) analysis was used to analyze change from baseline in CDR-SB. A positive change from baseline indicates clinical decline.
Baseline, Week 78
Secondary Outcomes
Measure
Description
Time Frame
Change From Baseline in Mini-Mental State Examination (MMSE) Score at Week 78
The MMSE is a widely used performance-based test of global cognitive status. It consists of 11 tasks that assess orientation, word recall, attention and calculation, language abilities, and visuospatial functions. The scores from the 11 tests are combined to obtain the total score, which ranges from 0 to 30, with lower scores over time indicating increasing cognitive impairment. MMRM analysis was used to analyze change from baseline in MMSE. A negative change from baseline indicates clinical decline.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Key Inclusion Criteria:
Must meet all of the following clinical criteria for MCI due to AD or mild AD and must have:
A Clinical Dementia Rating (CDR)-Global Score of 0.5.
Objective evidence of cognitive impairment at screening
An MMSE score between 24 and 30 (inclusive)
Must have a positive amyloid Positron Emission Tomography (PET) scan
Must consent to apolipoprotein E (ApoE) genotyping
If using drugs to treat symptoms related to AD, doses must be stable for at least 8 weeks prior to screening visit 1
Must have a reliable informant or caregiver
Key Exclusion Criteria:
Any medical or neurological condition (other than Alzheimer's Disease) that might be a contributing cause of the subject's cognitive impairment
Have had a stroke or Transient Ischemic Attack (TIA) or unexplained loss of consciousness in the past 1 year
Clinically significant unstable psychiatric illness in past 6 months
History of unstable angina, myocardial infarction, advanced chronic heart failure, or clinically significant conduction abnormalities within 1 year prior to Screening
Indication of impaired renal or liver function
Have human immunodeficiency virus (HIV) infection
Have a significant systematic illness or infection in past 30 days
Relevant brain hemorrhage, bleeding disorder and cerebrovascular abnormalities
Any contraindications to brain magnetic resonance imaging (MRI) or PET scans
Alcohol or substance abuse in past 1 year
Taking blood thinners (except for aspirin at a prophylactic dose or less)
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
A total of 1653 participants with Alzheimer's disease were enrolled and randomized in the study. Of these, 1647 participants received the study drug in placebo-controlled (PC) period. After completing PC period, 852 participants entered and dosed in long-term extension (LTE) period and no participants completed the study due to early termination of the study.
Recruitment Details
Participants were enrolled at 169 investigational sites in Australia, Austria, Canada, Denmark, France, Germany, Italy, Japan, Portugal, Republic of Korea, Spain, Taiwan, the United Kingdom (UK) and the United States (US) from 13 August, 2015 to 04 July, 2018.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Placebo (PC Period)
Participants received a maximum of 20 infusions of BIIB037-matching placebo intravenously (IV) in PC period, administered approximately once every 4 weeks for up to approximately 1.5 years.
Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (13 Items) (ADAS-Cog 13) Score at Week 78
ADAS-Cog13 comprises both cognitive tasks and clinical ratings of cognitive performance. The scale items capture word recall, ability to follow commands, the ability to correctly copy or draw an image, naming, the ability to interact with everyday objects, orientation, word recognition, memory, comprehension of spoken language, word-finding, and language ability, with a measure for delayed word recall and concentration/distractibility. The total score ranges from 0 to 85. An increase in score over time indicates increasing cognitive impairment. MMRM analysis was used to analyze change from baseline in ADAS-Cog 13. A positive change from baseline indicates clinical decline.
Baseline, Week 78
Change From Baseline in Alzheimer's Disease Cooperative Study-Activities of Daily Living Inventory (Mild Cognitive Impairment Version) (ADCS-ADL-MCI) Score at Week 78
The ADCS-ADL-MCI consists of 17 instrumental items (e.g., shopping, preparing meals, using household appliances) and 1 basic item (getting dressed). Ratings reflect caregiver observations about the patient's actual functioning over the previous month and provide an assessment of change in the functional state of the participant over time. The total score ranges from 0 to 53, with lower values over time reflecting functional deterioration. MMRM analysis was used to analyze change from baseline in ADAS-ADL-MCI. A negative change from baseline indicates clinical decline.
Baseline, Week 78
Tucson
Arizona
85718
United States
Neurology Center of North Orange County
Fullerton
California
92835
United States
Senior Clinical Trials, Inc.
Laguna Hills
California
92653
United States
Torrance Clinical Research Institute, Inc.
Lomita
California
90717
United States
University of California - Los Angeles
Los Angeles
California
90095
United States
UCSF - Memory and Aging Center
San Francisco
California
94158
United States
California Neuroscience Research Medical Group Inc.
Sherman Oaks
California
91403
United States
Southern California Research LLC
Simi Valley
California
93065
United States
Institute for Neurodegenerative Disorders
New Haven
Connecticut
06510
United States
Georgetown University Hospital
Washington D.C.
District of Columbia
20057
United States
Brain Matters Research, Inc.
Delray Beach
Florida
33445
United States
Neuropsychiatric Research Center of Southwest Florida
Fort Myers
Florida
33912
United States
Jacksonville Center for Clinical Research
Jacksonville
Florida
32216
United States
University of Miami
Miami
Florida
33136
United States
Miami Jewish Health Systems
Miami
Florida
33137
United States
Compass Research Main
Orlando
Florida
32806
United States
Palm Beach Neurological Center
Palm Beach Gardens
Florida
33410
United States
Stedman Clinical Trials, LLC
Tampa
Florida
33613
United States
USF Health Byrd Institute
Tampa
Florida
33616
United States
Meridien Research
Tampa
Florida
33634
United States
Compass Research Main
The Villages
Florida
32162
United States
Premiere Research Institute
West Palm Beach
Florida
33407
United States
Cleveland Clinic Florida - Weston
Weston
Florida
33331
United States
Alexian Brothers Neurosciences Institute
Elk Grove Village
Illinois
60007
United States
Advocate Lutheran General Hospital
Park Ridge
Illinois
60068
United States
Fort Wayne Neurological Center
Fort Wayne
Indiana
46804
United States
Indiana University School of Medicine
Indianapolis
Indiana
46202
United States
University of Kansas Medical Center Research Institute, Inc.
Kansas City
Kansas
66160
United States
Via Christi Research, a division of Via Christi Hospitals Wichita, Inc.
Wichita
Kansas
67214
United States
Baptist Health Lexington
Lexington
Kentucky
40503
United States
Brigham & Women's Hosp End/Dbt
Boston
Massachusetts
02115
United States
Beth Israel Deaconess Medical Center
Boston
Massachusetts
02215
United States
ActivMed Practices & Research
Methuen
Massachusetts
01844
United States
Donald S. Marks, M.D., P.C.
Plymouth
Massachusetts
02360
United States
Mayo Clinic
Rochester
Minnesota
55905
United States
Washington University
St Louis
Missouri
63131
United States
Las Vegas Medical research
Las Vegas
Nevada
89113
United States
Advanced Memory Research Institute of NJ, PC
Toms River
New Jersey
08755
United States
Albany Medical College
Albany
New York
12208
United States
New York University Medical Center PRIME
New York
New York
10016
United States
University of Rochester
Rochester
New York
14620
United States
ANI Neurology, PLLC d/b/a Alzheimer's Memory Center
Charlotte
North Carolina
28270
United States
Raleigh Neurology Associates, P.A.
Raleigh
North Carolina
27607-6010
United States
Cleveland Clinic
Cleveland
Ohio
44195
United States
Lynn Health Science Institute
Oklahoma City
Oklahoma
73112
United States
The Clinical Trial Center, LLC
Jenkintown
Pennsylvania
19046
United States
University of Pittsburgh
Pittsburgh
Pennsylvania
15213
United States
Northeastern Pennsylvania Memory and Alzheimer's Center
Azienda Ospedaliera Universitaria OO. RR. S. Giovanni di Dio e Ruggi D'Aragona
Salerno
84131
Italy
A.O.U. Senese Policlinico Santa Maria alle Scotte
Siena
53100
Italy
Research Site
Chiba
Chiba
263-0043
Japan
Research Site
Inzai-shi
Chiba
Japan
Research Site
Kurume-shi
Fukuoka
830-0011
Japan
Research Site
Aizuwakamatsu-shi
Fukushima
965-8585
Japan
Research Site
Asahikawa-shi
Hokkaido
070-8644
Japan
Research Site
Sapporo
Hokkaido
006-8555
Japan
Research Site
Sapporo
Hokkaido
064-8570
Japan
Research Site
Atsugi-shi
Kanagawa
243-8551
Japan
Research Site
Kamakura-shi
Kanagawa
247-8533
Japan
Research Site
Kawasaki-Shi
Kanagawa
211-8533
Japan
Yokohama
Kanagawa
223-0059
Japan
Research Site
Yokohama
Kanagawa
225-0013
Japan
Research Site
Yokohama
Kanagawa
225-0025
Japan
Research Site
Kyoto
Kyoto
616-8255
Japan
Research Site
Nagaoka-shi
Niigata
940-2081
Japan
Research Site
Iruma-gun
Saitama
350-0495
Japan
Research Site
Kasukabe-shi
Saitama
344-0036
Japan
Research Site
Ōta-ku
Tokyo
143-8541
Japan
Research Site
Bunkyō City
Tokyo-To
113-0034
Japan
Research Site
Shinjuku-ku (I)
Tokyo-To
162-8655
Japan
Research Site
Shinjuku-ku
Tokyo-To
162-8655
Japan
Research Site
Yamagata
Yamagata
990-0834
Japan
Research Site
Itabashi-ku
173-0015
Japan
Research Site
Itabashi-ku
173-8610
Japan
Research Site
Kiyose-shi
Japan
Research Site
Kodaira-shi
187-8551
Japan
Hospital Professor Doutor Fernando Fonseca, E.P.E.
Amadora
2720-276
Portugal
Hospital de Braga
Braga
4710-243
Portugal
Centro Hospitalar e Universitário de Coimbra E.P.E
Coimbra
3040-278
Portugal
CUF Alvalade
Lisbon
1600-618
Portugal
Hospital Beatriz Ângelo
Loures
2674-514
Portugal
Campus Neurologico Senior
Torres Vedras
2560-280
Portugal
Inha University Hospital
Incheon
Gyeonggi-do
22332
South Korea
Seoul National University Bundang Hospital
Seongnam-si
Gyeonggi-do
13620
South Korea
Gachon University Gil Medical Center
Incheon
21565
South Korea
Asan Medical Center
Seoul
05505
South Korea
Samsung Medical Center
Seoul
06351
South Korea
Konkuk University Medical Center
Seoul
143-729
South Korea
Policlinica Guipuzcoa
Donostia / San Sebastian
Guipuzcoa
20014
Spain
Hospital de Cruces
Barakaldo
Vizcaya
48903
Spain
Fundacio ACE
Barcelona
08028
Spain
Hospital Clinic i Provincial de Barcelona
Barcelona
08036
Spain
Hospital de la Santa Creu i Sant Pau
Barcelona
08041
Spain
Clinica Ruber
Madrid
28006
Spain
Hospital Universitario Dr. Peset
Valencia
46017
Spain
Hospital Universitari i Politecnic La Fe
Valencia
46026
Spain
Changhua Christian Hospital
Changhua
500
Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City
807
Taiwan
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City
83301
Taiwan
National Cheng Kung University Hospital
Tainan
704
Taiwan
National Taiwan University Hospital
Taipei
100
Taiwan
Chang Gung Memorial Hospital, Linkou
Taoyuan County
333
Taiwan
Southmead Hospital
Bristol
Avon
BS16 1LE
United Kingdom
Re:Cognition Health Ltd
London
Greater London
W1G 9JF
United Kingdom
Charing Cross Hospital
London
Greater London
W6 8RF
United Kingdom
The National Hospital for Neurology and Neurosurgery Centre
London
Greater London
WC1N 3BG
United Kingdom
Salford Royal
Salford
Greater Manchester
M6 8HD
United Kingdom
The University of Edinburgh
Edinburgh
Lothian Region
EH8 9YL
United Kingdom
Manchester Royal Infirmary
Blackburn
Merseyside
BB3 2HH
United Kingdom
The RICE Centre
Bath
Somerset
BA1 3NG
United Kingdom
Glasgow Memory Clinic Ltd
Glasgow
Strathclyde
G20 0XA
United Kingdom
Stobhill ACH Hospital
Glasgow
Strathclyde
G21 3UW
United Kingdom
Ninewells Hospital
Dundee
Tayside Region
DD2 1GZ
United Kingdom
Newcastle University
Newcastle upon Tyne
Tyne & Wear
NE4 5PL
United Kingdom
Kingshill Research Centre
Chippenham
Wiltshire
SN15 1GG
United Kingdom
Muralidharan KK, Kowalski KG, Tong X, Haeberlein SB, Rajagovindan R, Nestorov I. Characterization of exposure-Clinical Dementia Rating-Sum of Boxes relationship in subjects with early Alzheimer's disease from the aducanumab Phase 3 trials. J Pharmacokinet Pharmacodyn. 2023 Feb;50(1):45-62. doi: 10.1007/s10928-022-09839-3. Epub 2023 Jan 4.
Salloway S, Chalkias S, Barkhof F, Burkett P, Barakos J, Purcell D, Suhy J, Forrestal F, Tian Y, Umans K, Wang G, Singhal P, Budd Haeberlein S, Smirnakis K. Amyloid-Related Imaging Abnormalities in 2 Phase 3 Studies Evaluating Aducanumab in Patients With Early Alzheimer Disease. JAMA Neurol. 2022 Jan 1;79(1):13-21. doi: 10.1001/jamaneurol.2021.4161.
Participants received a maximum of 20 infusions of BIIB037 low dose IV in PC period, administered approximately once every 4 weeks for up to approximately 1.5 years.
FG002
BIIB037 High Dose (PC Period)
Participants received a maximum of 20 infusions of BIIB037 high dose IV in PC period, administered approximately once every 4 weeks for up to approximately 1.5 years.
FG003
BIIB037 Late Start: Low Dose (LTE Period)
Following PC period, participants randomized to placebo received BIIB037 low dose, IV infusion, approximately every 4 weeks for up to 2 years in LTE period.
FG004
BIIB037 Late Start: High Dose (LTE Period)
Following PC period, participants randomized to placebo received BIIB037 high dose, IV infusion, approximately every 4 weeks for up to 2 years in LTE period.
FG005
BIIB037 Early Start: Low Dose (LTE Period)
Following PC period, participants randomized to low dose BIIB037 continued to receive the same dose, IV infusion, approximately every 4 weeks for up to 2 years in LTE period.
FG006
BIIB037 Early Start: High Dose (LTE Period)
Following PC period, participants randomized to high dose BIIB037 continued to receive the same dose, IV infusion, approximately every 4 weeks for up to 2 years in LTE period.
FG000545 subjects
FG001547 subjects
FG002555 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
COMPLETED
FG000325 subjects
FG001325 subjects
FG002288 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
NOT COMPLETED
FG000220 subjects
FG001222 subjects
FG002267 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
Type
Comment
Reasons
Adverse Event
FG00016 subjects
FG00125 subjects
FG00228 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
Change of Treatment
FG0001 subjects
FG0012 subjects
FG0021 subjects
FG0030 subjects
FG004
Consent Withdrawn
FG00026 subjects
FG00116 subjects
FG00227 subjects
FG0030 subjects
FG004
Death
FG0000 subjects
FG0013 subjects
FG0022 subjects
FG0030 subjects
FG004
Disease Progression
FG0001 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Investigator Decision
FG0003 subjects
FG0012 subjects
FG0021 subjects
FG0030 subjects
FG004
Lost to Follow-up
FG0001 subjects
FG0013 subjects
FG0023 subjects
FG0030 subjects
FG004
Relocation
FG0002 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Site Terminated by Investigator
FG0001 subjects
FG0011 subjects
FG0021 subjects
FG0030 subjects
FG004
Site Terminated by Sponsor
FG0002 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Study Visit Burden
FG0005 subjects
FG0013 subjects
FG00211 subjects
FG0030 subjects
FG004
Withdrawal by Parent/Guardian
FG0001 subjects
FG0015 subjects
FG0023 subjects
FG0030 subjects
FG004
Reason not Specified
FG000161 subjects
FG001161 subjects
FG002189 subjects
FG0030 subjects
FG004
Long Term Extension Period
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003150 subjects12 PC completers did not enter LTE.
FG004152 subjects11 PC completers did not enter LTE.
FG005299 subjects26 PC completers did not enter LTE.
FG006251 subjects37 PC completers did not enter LTE.
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003150 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
The Intent to Treat (ITT) population was defined as all randomized participants who received at least 1 dose of study treatment.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Placebo (PC Period)
Participants received a maximum of 20 infusions of BIIB037-matching placebo intravenously (IV) in PC period, administered approximately once every 4 weeks for up to approximately 1.5 years.
BG001
BIIB037 Low Dose (PC Period)
Participants received a maximum of 20 infusions of BIIB037 low dose IV in PC period, administered approximately once every 4 weeks for up to approximately 1.5 years.
BG002
BIIB037 High Dose (PC Period)
Participants received a maximum of 20 infusions of BIIB037 high dose IV in PC period, administered approximately once every 4 weeks for up to approximately 1.5 years.
BG003
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000545
BG001547
BG002555
BG0031647
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00069.8± 7.72
BG00170.4± 6.96
BG00270.0± 7.65
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG000287
BG001284
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Asian
BG00055
BG00155
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG00013
BG00111
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Change From Baseline in Clinical Dementia Rating Sum of Boxes (CDR-SB) Score at Week 78
CDR-SB integrates assessments from 3 domains of cognition (memory, orientation, judgment/problem-solving) and 3 domains of function (community affairs, home/hobbies, personal care). Following caregiver interview and systematic patient examination, the rater assigns a score describing the participant's current performance level in each of these domains of life functioning. Prespecified severity anchors range from none = 0, questionable = 0.5, mild = 1, moderate = 2 to severe = 3 (the personal care domain omits the 0.5 score). "Sum of boxes" scoring methodology sums the score for each of the 6 domains and provides a value ranging from 0 to 18 that can change in increments of 0.5 or greater. Higher scores indicate greater disease severity. Mixed model for repeated measures (MMRM) analysis was used to analyze change from baseline in CDR-SB. A positive change from baseline indicates clinical decline.
ITT was defined as all randomized participants who had received at least one dose of study treatment (Aducanumab or Placebo). 'Number of Participants Analyzed' signifies number of participants analyzed in this outcome measure.
Posted
Mean
Standard Error
score on a scale
Baseline, Week 78
ID
Title
Description
OG000
Placebo (PC Period)
Participants received a maximum of 20 infusions of BIIB037-matching placebo intravenously (IV) in PC period, administered approximately once every 4 weeks for up to approximately 1.5 years.
OG001
BIIB037 Low Dose (PC Period)
Participants received a maximum of 20 infusions of BIIB037 low dose IV in PC period, administered approximately once every 4 weeks for up to approximately 1.5 years.
OG002
BIIB037 High Dose (PC Period)
Participants received a maximum of 20 infusions of BIIB037 high dose IV in PC period, administered approximately once every 4 weeks for up to approximately 1.5 years.
Units
Counts
Participants
OG000333
OG001331
OG002295
Title
Denominators
Categories
Title
Measurements
OG0001.56± 0.108
OG0011.38± 0.108
OG0021.59± 0.111
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
Adjusted mean for each treatment group (Placebo, BIIB037 Low Dose, BIIB037 High Dose), difference with Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in CDR-SB as dependent variable and with fixed effects of treatment group, categorical visit, treatment-by-visit interaction, baseline CDR-SB, baseline CDR-SB by visit interaction, baseline MMSE, AD symptomatic medication use at baseline, region, and laboratory ApoE status.
MMRM Model
0.2250
Difference from Placebo
0.110
2-Sided
95
-0.469
0.403
Superiority
Secondary
Change From Baseline in Mini-Mental State Examination (MMSE) Score at Week 78
The MMSE is a widely used performance-based test of global cognitive status. It consists of 11 tasks that assess orientation, word recall, attention and calculation, language abilities, and visuospatial functions. The scores from the 11 tests are combined to obtain the total score, which ranges from 0 to 30, with lower scores over time indicating increasing cognitive impairment. MMRM analysis was used to analyze change from baseline in MMSE. A negative change from baseline indicates clinical decline.
ITT was defined as all randomized participants who had received at least one dose of study treatment (Aducanumab or Placebo). 'Number of Participants Analyzed' signifies number of participants analyzed in this outcome measure.
Posted
Mean
Standard Error
score on a scale
Baseline, Week 78
ID
Title
Description
OG000
Placebo (PC Period)
Participants received a maximum of 20 infusions of BIIB037-matching placebo intravenously (IV) in PC period, administered approximately once every 4 weeks for up to approximately 1.5 years.
OG001
BIIB037 Low Dose (PC Period)
Participants received a maximum of 20 infusions of BIIB037 low dose IV in PC period, administered approximately once every 4 weeks for up to approximately 1.5 years.
OG002
Secondary
Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (13 Items) (ADAS-Cog 13) Score at Week 78
ADAS-Cog13 comprises both cognitive tasks and clinical ratings of cognitive performance. The scale items capture word recall, ability to follow commands, the ability to correctly copy or draw an image, naming, the ability to interact with everyday objects, orientation, word recognition, memory, comprehension of spoken language, word-finding, and language ability, with a measure for delayed word recall and concentration/distractibility. The total score ranges from 0 to 85. An increase in score over time indicates increasing cognitive impairment. MMRM analysis was used to analyze change from baseline in ADAS-Cog 13. A positive change from baseline indicates clinical decline.
ITT was defined as all randomized participants who had received at least one dose of study treatment (Aducanumab or Placebo). 'Number of Participants Analyzed' signifies number of participants analyzed in this outcome measure.
Posted
Mean
Standard Error
score on a scale
Baseline, Week 78
ID
Title
Description
OG000
Placebo (PC Period)
Participants received a maximum of 20 infusions of BIIB037-matching placebo intravenously (IV) in PC period, administered approximately once every 4 weeks for up to approximately 1.5 years.
OG001
BIIB037 Low Dose (PC Period)
Participants received a maximum of 20 infusions of BIIB037 low dose IV in PC period, administered approximately once every 4 weeks for up to approximately 1.5 years.
Secondary
Change From Baseline in Alzheimer's Disease Cooperative Study-Activities of Daily Living Inventory (Mild Cognitive Impairment Version) (ADCS-ADL-MCI) Score at Week 78
The ADCS-ADL-MCI consists of 17 instrumental items (e.g., shopping, preparing meals, using household appliances) and 1 basic item (getting dressed). Ratings reflect caregiver observations about the patient's actual functioning over the previous month and provide an assessment of change in the functional state of the participant over time. The total score ranges from 0 to 53, with lower values over time reflecting functional deterioration. MMRM analysis was used to analyze change from baseline in ADAS-ADL-MCI. A negative change from baseline indicates clinical decline.
ITT was defined as all randomized participants who had received at least one dose of study treatment (Aducanumab or Placebo). 'Number of Participants Analyzed' signifies number of participants analyzed in this outcome measure.
Posted
Mean
Standard Error
score on a scale
Baseline, Week 78
ID
Title
Description
OG000
Placebo (PC Period)
Participants received a maximum of 20 infusions of BIIB037-matching placebo intravenously (IV) in PC period, administered approximately once every 4 weeks for up to approximately 1.5 years.
OG001
BIIB037 Low Dose (PC Period)
Participants received a maximum of 20 infusions of BIIB037 low dose IV in PC period, administered approximately once every 4 weeks for up to approximately 1.5 years.
Time Frame
From First Dose to End of Study (up to 4 years)
Description
Safety population was all randomized participants who received at least one dose of study treatment. In PC period, 5 participants randomized to placebo, inadvertently received 1 or more doses of active treatment during the PC period. For participants affected, a participant was counted only once within each system organ class/preferred term/study period.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Placebo (PC Period)
Participants received a maximum of 20 infusions of BIIB037-matching placebo intravenously (IV) in PC period, administered approximately once every 4 weeks for up to approximately 1.5 years.
0
540
70
540
327
540
EG001
BIIB037 Low Dose (PC Period)
Participants received a maximum of 20 infusions of BIIB037 low dose IV in PC period, administered approximately once every 4 weeks for up to approximately 1.5 years.
3
549
76
549
396
549
EG002
BIIB037 High Dose (PC Period)
Participants received a maximum of 20 infusions of BIIB037 high dose IV in PC period, administered approximately once every 4 weeks for up to approximately 1.5 years.
2
558
79
558
410
558
EG003
BIIB037 Late Start: Low Dose (LTE Period)
Following PC period, participants randomized to placebo received BIIB037 low dose, IV infusion, approximately every 4 weeks for up to 2 years in LTE period.
1
150
19
150
89
150
EG004
BIIB037 Late Start: High Dose (LTE Period)
Following PC period, participants randomized to placebo received BIIB037 high dose, IV infusion, approximately every 4 weeks for up to 2 years in LTE period.
1
152
14
152
90
152
EG005
BIIB037 Early Start: Low Dose (LTE Period)
Following PC period, participants randomized to low dose BIIB037 continued to receive the same dose, IV infusion, approximately every 4 weeks for up to 2 years in LTE period.
1
299
35
299
130
299
EG006
BIIB037 Early Start: High Dose (LTE Period)
Following PC period, participants randomized to high dose BIIB037 continued to receive the same dose, IV infusion, approximately every 4 weeks for up to 2 years in LTE period.
2
251
25
251
121
251
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Blood loss anaemia
Blood and lymphatic system disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0010 affected549 at risk
EG0020 affected558 at risk
EG0030 affected150 at risk
EG0040 affected152 at risk
EG0051 affected299 at risk
EG0060 affected251 at risk
Leukocytosis
Blood and lymphatic system disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected540 at risk
EG0010 affected549 at risk
EG0020 affected558 at risk
EG003
Acute myocardial infarction
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected540 at risk
EG0010 affected549 at risk
EG0021 affected558 at risk
EG003
Angina pectoris
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0010 affected549 at risk
EG0021 affected558 at risk
EG003
Arrhythmia
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0010 affected549 at risk
EG0020 affected558 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0006 affected540 at risk
EG0014 affected549 at risk
EG0023 affected558 at risk
EG003
Atrial flutter
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0010 affected549 at risk
EG0020 affected558 at risk
EG003
Atrioventricular block
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0011 affected549 at risk
EG0021 affected558 at risk
EG003
Atrioventricular block complete
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected540 at risk
EG0010 affected549 at risk
EG0020 affected558 at risk
EG003
Bradycardia
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected540 at risk
EG0011 affected549 at risk
EG0021 affected558 at risk
EG003
Bundle branch block right
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0010 affected549 at risk
EG0021 affected558 at risk
EG003
Cardiac arrest
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0011 affected549 at risk
EG0022 affected558 at risk
EG003
Cardiac failure
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0010 affected549 at risk
EG0021 affected558 at risk
EG003
Cardiac failure congestive
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected540 at risk
EG0010 affected549 at risk
EG0021 affected558 at risk
EG003
Coronary artery disease
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected540 at risk
EG0010 affected549 at risk
EG0021 affected558 at risk
EG003
Coronary artery occlusion
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0010 affected549 at risk
EG0020 affected558 at risk
EG003
Coronary artery stenosis
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected540 at risk
EG0010 affected549 at risk
EG0020 affected558 at risk
EG003
Mitral valve incompetence
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0010 affected549 at risk
EG0021 affected558 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0010 affected549 at risk
EG0021 affected558 at risk
EG003
Myocardial ischaemia
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0011 affected549 at risk
EG0020 affected558 at risk
EG003
Sinus bradycardia
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected540 at risk
EG0010 affected549 at risk
EG0020 affected558 at risk
EG003
Sinus node dysfunction
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected540 at risk
EG0010 affected549 at risk
EG0020 affected558 at risk
EG003
Supraventricular tachycardia
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0011 affected549 at risk
EG0020 affected558 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0010 affected549 at risk
EG0020 affected558 at risk
EG003
Encephalocele
Congenital, familial and genetic disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0010 affected549 at risk
EG0021 affected558 at risk
EG003
Hypertrophic cardiomyopathy
Congenital, familial and genetic disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected540 at risk
EG0010 affected549 at risk
EG0020 affected558 at risk
EG003
Labyrinthine fistula
Ear and labyrinth disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0010 affected549 at risk
EG0021 affected558 at risk
EG003
Cataract
Eye disorders
MedDRA 22.0
Systematic Assessment
EG0002 affected540 at risk
EG0010 affected549 at risk
EG0021 affected558 at risk
EG003
Diplopia
Eye disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0010 affected549 at risk
EG0020 affected558 at risk
EG003
Retinal artery occlusion
Eye disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0010 affected549 at risk
EG0021 affected558 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0010 affected549 at risk
EG0020 affected558 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0010 affected549 at risk
EG0020 affected558 at risk
EG003
Abdominal pain lower
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0011 affected549 at risk
EG0020 affected558 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0011 affected549 at risk
EG0021 affected558 at risk
EG003
Diverticulum intestinal
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0010 affected549 at risk
EG0021 affected558 at risk
EG003
Duodenal ulcer
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected540 at risk
EG0011 affected549 at risk
EG0021 affected558 at risk
EG003
Enteritis
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0011 affected549 at risk
EG0020 affected558 at risk
EG003
Gastric ulcer haemorrhage
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0011 affected549 at risk
EG0020 affected558 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0010 affected549 at risk
EG0020 affected558 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected540 at risk
EG0010 affected549 at risk
EG0021 affected558 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0010 affected549 at risk
EG0021 affected558 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected540 at risk
EG0010 affected549 at risk
EG0020 affected558 at risk
EG003
Hiatus hernia
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0011 affected549 at risk
EG0020 affected558 at risk
EG003
Ileus
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0010 affected549 at risk
EG0020 affected558 at risk
EG003
Inguinal hernia
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0010 affected549 at risk
EG0021 affected558 at risk
EG003
Intestinal obstruction
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0011 affected549 at risk
EG0020 affected558 at risk
EG003
Intestinal perforation
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected540 at risk
EG0010 affected549 at risk
EG0021 affected558 at risk
EG003
Large intestinal ulcer
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0010 affected549 at risk
EG0021 affected558 at risk
EG003
Large intestine perforation
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0010 affected549 at risk
EG0021 affected558 at risk
EG003
Large intestine polyp
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0010 affected549 at risk
EG0021 affected558 at risk
EG003
Mallory-weiss syndrome
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0010 affected549 at risk
EG0021 affected558 at risk
EG003
Melaena
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0010 affected549 at risk
EG0021 affected558 at risk
EG003
Obstructive pancreatitis
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0012 affected549 at risk
EG0020 affected558 at risk
EG003
Oesophageal ulcer
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0010 affected549 at risk
EG0020 affected558 at risk
EG003
Pancreatic disorder
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0010 affected549 at risk
EG0020 affected558 at risk
EG003
Pancreatitis acute
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0010 affected549 at risk
EG0020 affected558 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0010 affected549 at risk
EG0020 affected558 at risk
EG003
Upper gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0011 affected549 at risk
EG0020 affected558 at risk
EG003
Asthenia
General disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected540 at risk
EG0010 affected549 at risk
EG0021 affected558 at risk
EG003
Chest pain
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0010 affected549 at risk
EG0021 affected558 at risk
EG003
Fatigue
General disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected540 at risk
EG0010 affected549 at risk
EG0020 affected558 at risk
EG003
Gait disturbance
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0012 affected549 at risk
EG0020 affected558 at risk
EG003
General physical health deterioration
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0010 affected549 at risk
EG0020 affected558 at risk
EG003
Incarcerated hernia
General disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected540 at risk
EG0010 affected549 at risk
EG0020 affected558 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 22.0
Systematic Assessment
EG0003 affected540 at risk
EG0011 affected549 at risk
EG0022 affected558 at risk
EG003
Bile duct stone
Hepatobiliary disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected540 at risk
EG0010 affected549 at risk
EG0020 affected558 at risk
EG003
Cholangitis acute
Hepatobiliary disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0011 affected549 at risk
EG0020 affected558 at risk
EG003
Cholecystitis
Hepatobiliary disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0010 affected549 at risk
EG0021 affected558 at risk
EG003
Cholecystitis acute
Hepatobiliary disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected540 at risk
EG0010 affected549 at risk
EG0021 affected558 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected540 at risk
EG0010 affected549 at risk
EG0021 affected558 at risk
EG003
Appendicitis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0001 affected540 at risk
EG0011 affected549 at risk
EG0021 affected558 at risk
EG003
Appendicitis perforated
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0010 affected549 at risk
EG0021 affected558 at risk
EG003
Arthritis bacterial
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0011 affected549 at risk
EG0020 affected558 at risk
EG003
Arthritis infective
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0010 affected549 at risk
EG0020 affected558 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0010 affected549 at risk
EG0021 affected558 at risk
EG003
Candida infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0011 affected549 at risk
EG0020 affected558 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0002 affected540 at risk
EG0010 affected549 at risk
EG0020 affected558 at risk
EG003
Cholecystitis infective
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0010 affected549 at risk
EG0020 affected558 at risk
EG003
Diverticulitis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0010 affected549 at risk
EG0022 affected558 at risk
EG003
Escherichia urinary tract infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0001 affected540 at risk
EG0010 affected549 at risk
EG0020 affected558 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0010 affected549 at risk
EG0022 affected558 at risk
EG003
Infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0010 affected549 at risk
EG0021 affected558 at risk
EG003
Influenza
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0002 affected540 at risk
EG0011 affected549 at risk
EG0020 affected558 at risk
EG003
Paronychia
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0001 affected540 at risk
EG0011 affected549 at risk
EG0020 affected558 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0002 affected540 at risk
EG0011 affected549 at risk
EG0024 affected558 at risk
EG003
Pneumonia pneumococcal
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0010 affected549 at risk
EG0020 affected558 at risk
EG003
Post procedural infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0010 affected549 at risk
EG0020 affected558 at risk
EG003
Post procedural sepsis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0001 affected540 at risk
EG0010 affected549 at risk
EG0020 affected558 at risk
EG003
Postoperative wound infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0010 affected549 at risk
EG0020 affected558 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0010 affected549 at risk
EG0020 affected558 at risk
EG003
Sepsis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0010 affected549 at risk
EG0021 affected558 at risk
EG003
Serratia infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0011 affected549 at risk
EG0020 affected558 at risk
EG003
Staphylococcal infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0011 affected549 at risk
EG0020 affected558 at risk
EG003
Subcutaneous abscess
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0010 affected549 at risk
EG0020 affected558 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0001 affected540 at risk
EG0010 affected549 at risk
EG0020 affected558 at risk
EG003
Urosepsis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0001 affected540 at risk
EG0010 affected549 at risk
EG0020 affected558 at risk
EG003
Wound infection staphylococcal
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0011 affected549 at risk
EG0020 affected558 at risk
EG003
Cervical vertebral fracture
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0002 affected540 at risk
EG0010 affected549 at risk
EG0020 affected558 at risk
EG003
Compression fracture
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0011 affected549 at risk
EG0020 affected558 at risk
EG003
Concussion
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0010 affected549 at risk
EG0020 affected558 at risk
EG003
Craniocerebral injury
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0010 affected549 at risk
EG0021 affected558 at risk
EG003
Exposure to toxic agent
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0010 affected549 at risk
EG0020 affected558 at risk
EG003
Extradural haematoma
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0010 affected549 at risk
EG0020 affected558 at risk
EG003
Facial bones fracture
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0010 affected549 at risk
EG0020 affected558 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0006 affected540 at risk
EG00112 affected549 at risk
EG0024 affected558 at risk
EG003
Femoral neck fracture
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0002 affected540 at risk
EG0011 affected549 at risk
EG0021 affected558 at risk
EG003
Femur fracture
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0001 affected540 at risk
EG0012 affected549 at risk
EG0020 affected558 at risk
EG003
Fibula fracture
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0011 affected549 at risk
EG0021 affected558 at risk
EG003
Foot fracture
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0001 affected540 at risk
EG0010 affected549 at risk
EG0020 affected558 at risk
EG003
Forearm fracture
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0011 affected549 at risk
EG0020 affected558 at risk
EG003
Hand fracture
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0002 affected540 at risk
EG0010 affected549 at risk
EG0020 affected558 at risk
EG003
Heat illness
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0010 affected549 at risk
EG0020 affected558 at risk
EG003
Humerus fracture
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0011 affected549 at risk
EG0021 affected558 at risk
EG003
Jaw fracture
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0011 affected549 at risk
EG0020 affected558 at risk
EG003
Joint dislocation
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0012 affected549 at risk
EG0020 affected558 at risk
EG003
Ligament injury
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0010 affected549 at risk
EG0021 affected558 at risk
EG003
Limb crushing injury
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0001 affected540 at risk
EG0010 affected549 at risk
EG0020 affected558 at risk
EG003
Lower limb fracture
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0010 affected549 at risk
EG0020 affected558 at risk
EG003
Lumbar vertebral fracture
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0001 affected540 at risk
EG0010 affected549 at risk
EG0020 affected558 at risk
EG003
Meniscus injury
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0011 affected549 at risk
EG0020 affected558 at risk
EG003
Overdose
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0011 affected549 at risk
EG0020 affected558 at risk
EG003
Post procedural complication
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0001 affected540 at risk
EG0010 affected549 at risk
EG0020 affected558 at risk
EG003
Postoperative respiratory failure
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0010 affected549 at risk
EG0020 affected558 at risk
EG003
Radius fracture
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0012 affected549 at risk
EG0021 affected558 at risk
EG003
Rib fracture
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0011 affected549 at risk
EG0021 affected558 at risk
EG003
Road traffic accident
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0002 affected540 at risk
EG0011 affected549 at risk
EG0021 affected558 at risk
EG003
Scapula fracture
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0010 affected549 at risk
EG0021 affected558 at risk
EG003
Skull fracture
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0001 affected540 at risk
EG0010 affected549 at risk
EG0020 affected558 at risk
EG003
Spinal compression fracture
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0011 affected549 at risk
EG0020 affected558 at risk
EG003
Spinal fracture
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0001 affected540 at risk
EG0010 affected549 at risk
EG0020 affected558 at risk
EG003
Subdural haematoma
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0001 affected540 at risk
EG0010 affected549 at risk
EG0021 affected558 at risk
EG003
Subdural haemorrhage
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0001 affected540 at risk
EG0010 affected549 at risk
EG0020 affected558 at risk
EG003
Thermal burn
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0001 affected540 at risk
EG0010 affected549 at risk
EG0020 affected558 at risk
EG003
Tibia fracture
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0010 affected549 at risk
EG0020 affected558 at risk
EG003
Tooth fracture
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0010 affected549 at risk
EG0021 affected558 at risk
EG003
Ulna fracture
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0010 affected549 at risk
EG0021 affected558 at risk
EG003
Upper limb fracture
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0001 affected540 at risk
EG0010 affected549 at risk
EG0020 affected558 at risk
EG003
Wrist fracture
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0011 affected549 at risk
EG0020 affected558 at risk
EG003
Blood ketone body increased
Investigations
MedDRA 22.0
Systematic Assessment
EG0001 affected540 at risk
EG0010 affected549 at risk
EG0020 affected558 at risk
EG003
Blood pressure increased
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0010 affected549 at risk
EG0021 affected558 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0011 affected549 at risk
EG0020 affected558 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0002 affected540 at risk
EG0010 affected549 at risk
EG0020 affected558 at risk
EG003
Gout
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected540 at risk
EG0010 affected549 at risk
EG0020 affected558 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected540 at risk
EG0010 affected549 at risk
EG0020 affected558 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0011 affected549 at risk
EG0020 affected558 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0010 affected549 at risk
EG0020 affected558 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected540 at risk
EG0010 affected549 at risk
EG0020 affected558 at risk
EG003
Intervertebral disc compression
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0010 affected549 at risk
EG0020 affected558 at risk
EG003
Intervertebral disc protrusion
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0011 affected549 at risk
EG0021 affected558 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0010 affected549 at risk
EG0020 affected558 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0012 affected549 at risk
EG0022 affected558 at risk
EG003
Osteonecrosis
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0011 affected549 at risk
EG0020 affected558 at risk
EG003
Rotator cuff syndrome
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0010 affected549 at risk
EG0020 affected558 at risk
EG003
Spondylolisthesis
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected540 at risk
EG0010 affected549 at risk
EG0020 affected558 at risk
EG003
Vertebral foraminal stenosis
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected540 at risk
EG0010 affected549 at risk
EG0020 affected558 at risk
EG003
Vertebral osteophyte
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0010 affected549 at risk
EG0020 affected558 at risk
EG003
Acute myeloid leukaemia
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0001 affected540 at risk
EG0010 affected549 at risk
EG0020 affected558 at risk
EG003
Adenocarcinoma of colon
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0011 affected549 at risk
EG0020 affected558 at risk
EG003
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0010 affected549 at risk
EG0021 affected558 at risk
EG003
Breast cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0001 affected540 at risk
EG0010 affected549 at risk
EG0021 affected558 at risk
EG003
Breast cancer stage i
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0011 affected549 at risk
EG0020 affected558 at risk
EG003
Colon cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0001 affected540 at risk
EG0011 affected549 at risk
EG0020 affected558 at risk
EG003
Gastric cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0010 affected549 at risk
EG0020 affected558 at risk
EG003
Invasive papillary breast carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0011 affected549 at risk
EG0020 affected558 at risk
EG003
Lung adenocarcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0010 affected549 at risk
EG0020 affected558 at risk
EG003
Lung neoplasm malignant
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0010 affected549 at risk
EG0021 affected558 at risk
EG003
Lymphoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0001 affected540 at risk
EG0010 affected549 at risk
EG0020 affected558 at risk
EG003
Malignant melanoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0002 affected540 at risk
EG0011 affected549 at risk
EG0020 affected558 at risk
EG003
Mesothelioma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0001 affected540 at risk
EG0010 affected549 at risk
EG0020 affected558 at risk
EG003
Metastases to liver
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0011 affected549 at risk
EG0020 affected558 at risk
EG003
Metastases to peritoneum
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0010 affected549 at risk
EG0021 affected558 at risk
EG003
Myeloproliferative neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0010 affected549 at risk
EG0020 affected558 at risk
EG003
Neurofibrosarcoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0011 affected549 at risk
EG0020 affected558 at risk
EG003
Non-small cell lung cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0010 affected549 at risk
EG0020 affected558 at risk
EG003
Oesophageal adenocarcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0011 affected549 at risk
EG0020 affected558 at risk
EG003
Ovarian cancer stage iii
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0001 affected540 at risk
EG0010 affected549 at risk
EG0020 affected558 at risk
EG003
Pancreatic carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0010 affected549 at risk
EG0020 affected558 at risk
EG003
Pancreatic carcinoma metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0011 affected549 at risk
EG0020 affected558 at risk
EG003
Polycythaemia vera
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0011 affected549 at risk
EG0020 affected558 at risk
EG003
Prostate cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0001 affected540 at risk
EG0010 affected549 at risk
EG0020 affected558 at risk
EG003
Prostate cancer stage 0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0010 affected549 at risk
EG0021 affected558 at risk
EG003
Transitional cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0001 affected540 at risk
EG0010 affected549 at risk
EG0020 affected558 at risk
EG003
Tubular breast carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0011 affected549 at risk
EG0020 affected558 at risk
EG003
Amyloid related imaging abnormality-microhaemorrhages and haemosiderin deposits
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0010 affected549 at risk
EG0022 affected558 at risk
EG003
Amyloid related imaging abnormality-oedema/effusion
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0012 affected549 at risk
EG0027 affected558 at risk
EG003
Balance disorder
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0011 affected549 at risk
EG0020 affected558 at risk
EG003
Carotid artery stenosis
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected540 at risk
EG0010 affected549 at risk
EG0020 affected558 at risk
EG003
Cerebral haematoma
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0010 affected549 at risk
EG0021 affected558 at risk
EG003
Cerebral haemorrhage
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected540 at risk
EG0010 affected549 at risk
EG0020 affected558 at risk
EG003
Cerebral infarction
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0010 affected549 at risk
EG0021 affected558 at risk
EG003
Cerebral ischaemia
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected540 at risk
EG0010 affected549 at risk
EG0020 affected558 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0012 affected549 at risk
EG0020 affected558 at risk
EG003
Dementia
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0011 affected549 at risk
EG0020 affected558 at risk
EG003
Dementia alzheimer's type
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0010 affected549 at risk
EG0020 affected558 at risk
EG003
Dementia with lewy bodies
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0011 affected549 at risk
EG0020 affected558 at risk
EG003
Dysarthria
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0010 affected549 at risk
EG0020 affected558 at risk
EG003
Dystonia
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0011 affected549 at risk
EG0020 affected558 at risk
EG003
Focal dyscognitive seizures
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0010 affected549 at risk
EG0021 affected558 at risk
EG003
Generalised tonic-clonic seizure
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0010 affected549 at risk
EG0021 affected558 at risk
EG003
Haemorrhage intracranial
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected540 at risk
EG0010 affected549 at risk
EG0020 affected558 at risk
EG003
Head discomfort
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0010 affected549 at risk
EG0021 affected558 at risk
EG003
Headache
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected540 at risk
EG0011 affected549 at risk
EG0020 affected558 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0010 affected549 at risk
EG0021 affected558 at risk
EG003
Ischaemic stroke
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected540 at risk
EG0010 affected549 at risk
EG0020 affected558 at risk
EG003
Lacunar infarction
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected540 at risk
EG0010 affected549 at risk
EG0020 affected558 at risk
EG003
Lacunar stroke
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0010 affected549 at risk
EG0021 affected558 at risk
EG003
Loss of consciousness
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0011 affected549 at risk
EG0020 affected558 at risk
EG003
Migraine
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0010 affected549 at risk
EG0021 affected558 at risk
EG003
Myasthenia gravis
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0010 affected549 at risk
EG0021 affected558 at risk
EG003
Myelitis transverse
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected540 at risk
EG0010 affected549 at risk
EG0020 affected558 at risk
EG003
Myoclonus
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0010 affected549 at risk
EG0020 affected558 at risk
EG003
Nervous system disorder
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected540 at risk
EG0010 affected549 at risk
EG0020 affected558 at risk
EG003
Orthostatic intolerance
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0010 affected549 at risk
EG0020 affected558 at risk
EG003
Parkinson's disease
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0010 affected549 at risk
EG0020 affected558 at risk
EG003
Partial seizures
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected540 at risk
EG0010 affected549 at risk
EG0020 affected558 at risk
EG003
Peroneal nerve palsy
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected540 at risk
EG0010 affected549 at risk
EG0020 affected558 at risk
EG003
Presyncope
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0011 affected549 at risk
EG0021 affected558 at risk
EG003
Seizure
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0012 affected549 at risk
EG0020 affected558 at risk
EG003
Subarachnoid haemorrhage
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0002 affected540 at risk
EG0010 affected549 at risk
EG0020 affected558 at risk
EG003
Superficial siderosis of central nervous system
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0010 affected549 at risk
EG0022 affected558 at risk
EG003
Syncope
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0002 affected540 at risk
EG0014 affected549 at risk
EG0025 affected558 at risk
EG003
Transient ischaemic attack
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected540 at risk
EG0012 affected549 at risk
EG0021 affected558 at risk
EG003
Vertebral artery dissection
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected540 at risk
EG0010 affected549 at risk
EG0020 affected558 at risk
EG003
Agitation
Psychiatric disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected540 at risk
EG0011 affected549 at risk
EG0020 affected558 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected540 at risk
EG0010 affected549 at risk
EG0020 affected558 at risk
EG003
Completed suicide
Psychiatric disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0010 affected549 at risk
EG0021 affected558 at risk
EG003
Delirium
Psychiatric disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0011 affected549 at risk
EG0020 affected558 at risk
EG003
Depression
Psychiatric disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0010 affected549 at risk
EG0020 affected558 at risk
EG003
Generalised anxiety disorder
Psychiatric disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0010 affected549 at risk
EG0021 affected558 at risk
EG003
Mental status changes
Psychiatric disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0010 affected549 at risk
EG0021 affected558 at risk
EG003
Persistent depressive disorder
Psychiatric disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected540 at risk
EG0010 affected549 at risk
EG0020 affected558 at risk
EG003
Psychogenic tremor
Psychiatric disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0010 affected549 at risk
EG0020 affected558 at risk
EG003
Psychotic disorder
Psychiatric disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0010 affected549 at risk
EG0020 affected558 at risk
EG003
Suicide attempt
Psychiatric disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0012 affected549 at risk
EG0020 affected558 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected540 at risk
EG0010 affected549 at risk
EG0020 affected558 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected540 at risk
EG0010 affected549 at risk
EG0020 affected558 at risk
EG003
Renal colic
Renal and urinary disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0010 affected549 at risk
EG0020 affected558 at risk
EG003
Ureterolithiasis
Renal and urinary disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0010 affected549 at risk
EG0020 affected558 at risk
EG003
Urinary retention
Renal and urinary disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0010 affected549 at risk
EG0020 affected558 at risk
EG003
Benign prostatic hyperplasia
Reproductive system and breast disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0010 affected549 at risk
EG0020 affected558 at risk
EG003
Prostatic dysplasia
Reproductive system and breast disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0011 affected549 at risk
EG0020 affected558 at risk
EG003
Acute respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0010 affected549 at risk
EG0021 affected558 at risk
EG003
Asthmatic crisis
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0010 affected549 at risk
EG0021 affected558 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0010 affected549 at risk
EG0020 affected558 at risk
EG003
Nasal obstruction
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected540 at risk
EG0010 affected549 at risk
EG0020 affected558 at risk
EG003
Organising pneumonia
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0011 affected549 at risk
EG0020 affected558 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected540 at risk
EG0010 affected549 at risk
EG0020 affected558 at risk
EG003
Pneumonia aspiration
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0010 affected549 at risk
EG0020 affected558 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0011 affected549 at risk
EG0020 affected558 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0002 affected540 at risk
EG0011 affected549 at risk
EG0023 affected558 at risk
EG003
Pulmonary infarction
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected540 at risk
EG0010 affected549 at risk
EG0020 affected558 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0011 affected549 at risk
EG0020 affected558 at risk
EG003
Angioedema
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0011 affected549 at risk
EG0020 affected558 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0011 affected549 at risk
EG0020 affected558 at risk
EG003
Aortic aneurysm
Vascular disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected540 at risk
EG0010 affected549 at risk
EG0020 affected558 at risk
EG003
Aortic dissection
Vascular disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0011 affected549 at risk
EG0020 affected558 at risk
EG003
Aortic stenosis
Vascular disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected540 at risk
EG0010 affected549 at risk
EG0020 affected558 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected540 at risk
EG0011 affected549 at risk
EG0024 affected558 at risk
EG003
Hypertension
Vascular disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected540 at risk
EG0011 affected549 at risk
EG0020 affected558 at risk
EG003
Hypertensive emergency
Vascular disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0010 affected549 at risk
EG0020 affected558 at risk
EG003
Hypotension
Vascular disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0011 affected549 at risk
EG0020 affected558 at risk
EG003
Orthostatic hypotension
Vascular disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0010 affected549 at risk
EG0020 affected558 at risk
EG003
Peripheral arterial occlusive disease
Vascular disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0010 affected549 at risk
EG0021 affected558 at risk
EG003
Peripheral artery stenosis
Vascular disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0010 affected549 at risk
EG0021 affected558 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Diarrhoea
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG00044 affected540 at risk
EG00149 affected549 at risk
EG00252 affected558 at risk
EG0036 affected150 at risk
EG0048 affected152 at risk
EG00516 affected299 at risk
EG0069 affected251 at risk
Nausea
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG00042 affected540 at risk
EG00130 affected549 at risk
EG00240 affected558 at risk
EG003
Fatigue
General disorders
MedDRA 22.0
Systematic Assessment
EG00038 affected540 at risk
EG00130 affected549 at risk
EG00234 affected558 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG00064 affected540 at risk
EG00165 affected549 at risk
EG00268 affected558 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG00049 affected540 at risk
EG00147 affected549 at risk
EG00251 affected558 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG00037 affected540 at risk
EG00130 affected549 at risk
EG00234 affected558 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG00023 affected540 at risk
EG00133 affected549 at risk
EG00236 affected558 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG00054 affected540 at risk
EG00170 affected549 at risk
EG00283 affected558 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG00028 affected540 at risk
EG00127 affected549 at risk
EG00235 affected558 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG00042 affected540 at risk
EG00126 affected549 at risk
EG00244 affected558 at risk
EG003
Amyloid related imaging abnormality-microhaemorrhages and haemosiderin deposits
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG00034 affected540 at risk
EG00189 affected549 at risk
EG002102 affected558 at risk
EG003
Amyloid related imaging abnormality-oedema/effusion
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG00016 affected540 at risk
EG001140 affected549 at risk
EG002195 affected558 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG00054 affected540 at risk
EG00149 affected549 at risk
EG00254 affected558 at risk
EG003
Headache
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG00081 affected540 at risk
EG00198 affected549 at risk
EG002115 affected558 at risk
EG003
Superficial siderosis of central nervous system
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG00010 affected540 at risk
EG00151 affected549 at risk
EG00288 affected558 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 22.0
Systematic Assessment
EG00028 affected540 at risk
EG00132 affected549 at risk
EG00228 affected558 at risk
EG003
Depression
Psychiatric disorders
MedDRA 22.0
Systematic Assessment
EG00034 affected540 at risk
EG00140 affected549 at risk
EG00234 affected558 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG00033 affected540 at risk
EG00129 affected549 at risk
EG00219 affected558 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected540 at risk
EG0010 affected549 at risk
EG0020 affected558 at risk
EG003
The study was halted prematurely based on a prespecified futility analysis and not based on safety concerns. Participants discontinued due to study termination are included in "Reason not Specified" category in participant flow tables above.
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Our agreement is subject to confidentiality but generally the PI can publish, for noncommercial purposes only, results and methods of the trial, but no other Sponsor Confidential Information. PI must give Sponsor no less than 60 days to review any manuscript for a proposed publication and must delay publication for up to an additional 90 days thereafter if Sponsor needs to file any patent application to protect any of Sponsor's intellectual property contained in the proposed publication.
Adjusted mean for each treatment group (Placebo, BIIB037 Low Dose, BIIB037 High Dose), difference with Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in CDR-SB as dependent variable and with fixed effects of treatment group, categorical visit, treatment-by-visit interaction, baseline CDR-SB, baseline CDR-SB by visit interaction, baseline MMSE, AD symptomatic medication use at baseline, region, and laboratory ApoE status.
MMRM Model
0.8330
Difference from late start group
0.03
2-Sided
95
-0.262
0.326
Superiority
BIIB037 High Dose (PC Period)
Participants received a maximum of 20 infusions of BIIB037 high dose IV in PC period, administered approximately once every 4 weeks for up to approximately 1.5 years.
Units
Counts
Participants
OG000332
OG001334
OG002297
Title
Denominators
Categories
Title
Measurements
OG000-3.5± 0.21
OG001-3.3± 0.21
OG002-3.6± 0.21
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
Adjusted mean for each treatment group (Placebo, BIIB037 Low Dose, BIIB037 High Dose), difference from Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in MMSE as dependent variable and with fixed effects of treatment group, categorical visit, treatment-by-visit interaction, baseline MMSE, baseline MMSE by visit interaction, AD symptomatic medication use at baseline, region, and laboratory ApoE status.
MMRM Model
0.4795
Difference from Placebo
0.2
2-Sided
95
-0.35
0.74
Superiority
OG000
OG002
Adjusted mean for each treatment group (Placebo, BIIB037 Low Dose, BIIB037 High Dose), difference from Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in MMSE as dependent variable and with fixed effects of treatment group, categorical visit, treatment-by-visit interaction, baseline MMSE, baseline MMSE by visit interaction, AD symptomatic medication use at baseline, region, and laboratory ApoE status.
MMRM Model
0.8106
Difference from Placebo
-0.1
2-Sided
95
-0.62
0.49
Superiority
OG002
BIIB037 High Dose (PC Period)
Participants received a maximum of 20 infusions of BIIB037 high dose IV in PC period, administered approximately once every 4 weeks for up to approximately 1.5 years.
Units
Counts
Participants
OG000331
OG001332
OG002294
Title
Denominators
Categories
Title
Measurements
OG0005.140± 0.3783
OG0014.558± 0.3780
OG0024.552± 0.3872
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
Adjusted mean for each treatment group (Placebo,BIIB037 Low Dose,BIIB037 High Dose),difference with Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in ADAS-Cog 13 as dependent variable and with fixed effects of treatment group,categorical visit,treatment-by-visit interaction,baseline ADAS-Cog 13,baseline ADAS-Cog 13 by visit interaction,baseline MMSE,AD symptomatic medication use at baseline,region,and laboratory ApoE status.
MMRM Model
0.2536
Difference from Placebo
-0.583
2-Sided
95
-1.5835
0.4181
Superiority
OG000
OG002
Adjusted mean for each treatment group (Placebo,BIIB037 Low Dose,BIIB037 High Dose),difference with Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in ADAS-Cog 13 as dependent variable and with fixed effects of treatment group,categorical visit,treatment-by-visit interaction,baseline ADAS-Cog 13,baseline ADAS-Cog 13 by visit interaction,baseline MMSE,AD symptomatic medication use at baseline,region,and laboratory ApoE status.
MMRM Model
0.2578
Difference from Placebo
-0.588
2-Sided
95
-1.6067
0.4309
Superiority
OG002
BIIB037 High Dose (PC Period)
Participants received a maximum of 20 infusions of BIIB037 high dose IV in PC period, administered approximately once every 4 weeks for up to approximately 1.5 years.
Units
Counts
Participants
OG000331
OG001330
OG002298
Title
Denominators
Categories
Title
Measurements
OG000-3.8± 0.35
OG001-3.1± 0.35
OG002-3.1± 0.35
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
Adjusted mean for each group (Placebo, BIIB037 Low Dose, BIIB037 High Dose), difference with Placebo,95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in ADCS-ADL-MCI as dependent variable and with fixed effects of treatment group,categorical visit,treatment-by-visit interaction, baseline ADCS-ADL-MCI, baseline ADCS-ADL-MCI by visit interaction, baseline MMSE AD symptomatic medication use at baseline,region, and laboratory ApoE status.
MMRM Model
0.1225
Difference from Placebo
0.7
2-Sided
95
-0.19
1.64
Superiority
OG000
OG002
Adjusted mean for each group (Placebo, BIIB037 Low Dose, BIIB037 High Dose), difference with Placebo,95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in ADCS-ADL-MCI as dependent variable and with fixed effects of treatment group,categorical visit,treatment-by-visit interaction, baseline ADCS-ADL-MCI, baseline ADCS-ADL-MCI by visit interaction, baseline MMSE AD symptomatic medication use at baseline,region, and laboratory ApoE status.