221AD302 Phase 3 Study of Aducanumab (BIIB037) in Early A... | NCT02484547 | Trialant
NCT02484547
Sponsor
Biogen
Status
Terminated
Last Update Posted
Sep 2, 2021Actual
Enrollment
1,643Actual
Phase
Phase 3
Conditions
Alzheimer's Disease
Interventions
Aducanumab (BIIB037)
Aducanumab (BIIB037)
Placebo
Countries
United States
Belgium
Canada
Finland
France
Germany
Italy
Japan
Netherlands
Poland
Spain
Sweden
Switzerland
Protocol Section
Identification Module
NCT ID
NCT02484547
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
221AD302
Secondary IDs
ID
Type
Description
Link
2015-000967-15
EudraCT Number
Brief Title
221AD302 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
EMERGE
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
Sep 15, 2015Actual
Primary Completion Date
Aug 5, 2019Actual
Completion Date
Aug 5, 2019Actual
First Submitted Date
Jun 18, 2015
First Submission Date that Met QC Criteria
Jun 26, 2015
First Posted Date
Jun 29, 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 4, 2020
Certification/Extension First Submitted that Passed QC Review
Aug 4, 2020
Certification/Extension First Posted Date
Aug 5, 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
Aducanumab
BIIB037
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
1,643Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Low Dose
Experimental
Monthly intravenous (IV) infusions
Drug: Aducanumab (BIIB037)
Drug: Placebo
High Dose
Experimental
Monthly intravenous (IV) infusions
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 Scale - 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
Cummings J, Cohen S, Murphy J, Brothers HM, Nejati M, Forrestal F, de Moor C, O'Gorman J, Harrison J, Jaeger J, Mummery CJ, Porsteinsson AP, Potashman M, Tian Y, Yang L, He P, Haeberlein SB. Evaluation of cognitive, functional, and behavioral effects observed in EMERGE, a phase 3 trial of aducanumab in people with early Alzheimer's disease. Alzheimers Dement. 2025 Jun;21(6):e70224. doi: 10.1002/alz.70224.
A total of 1643 participants with Alzhiemer's disease were enrolled and randomized in the study. Of these, 1638 participants received the study drug in placebo-controlled (PC) period. After completing PC period, 771 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 181 investigative sites in the United States, Belgium, Canada, Finland, France, Germany, Italy, Japan, Netherlands, Poland, Spain, Sweden, and Switzerland from 15 September 2015 to 13 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) 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
Phoenix
Arizona
85006
United States
Xenoscience Inc.
Phoenix
Arizona
85013
United States
Banner Sun Health Research Institute
Sun City
Arizona
85351
United States
Institute for Memory Impairments
Irvine
California
92607
United States
Renewal Behavioral Health
Long Beach
California
85013
United States
USC Keck School of Medicine
Los Angeles
California
90033
United States
Hoag Memorial Hospital Presbyterian
Newport Beach
California
92663
United States
Excell Research, Inc.
Oceanside
California
92056
United States
Pacific Neuroscience Medical Group
Oxnard
California
93030
United States
Anderson Clinical Research
Redlands
California
92354
United States
Pacific Research Network
San Diego
California
92103
United States
University of California San Diego Medical Center
San Diego
California
92103
United States
California Pacific Medical Center
San Francisco
California
94114
United States
Syrentis Clinical Research
Santa Ana
California
92705
United States
St Joseph Heritage Healthcare
Santa Rosa
California
95403
United States
Stanford University Medical Center
Stanford
California
94305
United States
University Of Colorado Denver
Aurora
Colorado
80045
United States
IMMUNOe International Research Centers
Thornton
Colorado
80233
United States
Associated Neurologists of Southern Connecticut, PC
Fairfield
Connecticut
06824
United States
Yale University School Of Medicine
New Haven
Connecticut
06520
United States
Research Center for Clinical Studies, Inc.
Norwalk
Connecticut
06851
United States
JEM Research Institute
Atlantis
Florida
33462
United States
Bradenton Research Center, Inc.
Bradenton
Florida
34205
United States
Meridien Research
Brooksville
Florida
34601
United States
Quantum Laboratories Inc.
Deerfield Beach
Florida
33064
United States
Infinity Clinical Research, LLC
Hollywood
Florida
33021
United States
Mayo Clinic in Florida
Jacksonville
Florida
32224
United States
Renstar Medical Research
Ocala
Florida
34470
United States
Clinical Neuroscience Solutions, Inc.
Orlando
Florida
32801
United States
Axiom Clinical Research of Florida
Tampa
Florida
33609
United States
Emory University Cognitive Neurology Clinic & ADRC
Atlanta
Georgia
30329
United States
Medical Research Health and Education Foundation, Inc
Columbus
Georgia
31909
United States
NeuroStudies.net, LLC
Decatur
Georgia
30033
United States
Josephson, Wallack, Munshower Neurology, PC
Indianapolis
Indiana
46256
United States
McLean Hospital
Belmont
Massachusetts
02478
United States
Boston Center for Memory
Newton
Massachusetts
05201
United States
Hattiesburg Clinic, PA
Hattiesburg
Mississippi
39401
United States
Cleveland Clinic Lou Ruvo Center for Brain Health
Las Vegas
Nevada
89106
United States
ActivMed Practices & Research
Portsmouth
New Hampshire
03801
United States
AdvanceMed Research
Lawrenceville
New Jersey
08648
United States
Empire Neurology, PC
Latham
New York
12110
United States
Weill Cornell Medical College-New York Presbyterian Hospital
New York
New York
10021
United States
Mount Sinai School of Medicine
New York
New York
10029
United States
PMG Research of Winston-Salem, LLC
Winston-Salem
North Carolina
27103
United States
Wake Forest Baptist Health
Winston-Salem
North Carolina
27103
United States
Ohio State University Medical Center
Dublin
Ohio
43017
United States
Lehigh Center for Clinical Research, LLC
Allentown
Pennsylvania
18104
United States
Penn Memory Center
Philadelphia
Pennsylvania
19104
United States
Rhode Island Hospital
Providence
Rhode Island
02903
United States
Roper St. Francis Healthcare
North Charleston
South Carolina
29406-6076
United States
Senior Adult Specialty Research
Austin
Texas
78757
United States
The Methodist Hospital Research Institute
Houston
Texas
77030
United States
Clinical Trial Network
Houston
Texas
77074
United States
University of Utah Health Sciences Center
Salt Lake City
Utah
84132
United States
Clinical Neuroscience Research Association, Inc
Bennington
Vermont
05201
United States
University of Washington Medical Center
Seattle
Washington
98195
United States
Northwest Neurological, PLLC
Spokane
Washington
99202
United States
A.Z. Klina
Brasschaat
Belgium
AZ Sint-Jan Brugge
Bruges
8000
Belgium
Universitair Ziekenhuis Brussel
Brussels
1090
Belgium
Centre Neurologique & de Réadaptation Fonctionnelle
Fraiture
4557
Belgium
Universitair Ziekenhuis Gent
Ghent
9000
Belgium
AZ Groeninge - Campus Kennedylaan
Kortrijk
8500
Belgium
UZ Leuven
Leuven
3000
Belgium
AZ Delta
Roeselare
8800
Belgium
Health Research.
Kamloops
British Columbia
Canada
Health Research
West Vancouver
British Columbia
Canada
True North Clinical Research - Halifax Inc.
Halifax
Nova Scotia
B3S 1M7
Canada
True North Clinical Research Kentville, Inc
Kentville
Nova Scotia
B4N 4K9
Canada
JBN Medical Diagnostic Services Inc.
Burlington
Ontario
L7M 4Y1
Canada
St. Joseph's HC- Parkwood Institute
London
Ontario
N6C 5J1
Canada
Bruyere Continuing Care
Ottawa
Ontario
K1N 5C8
Canada
Kawartha Regional Memory Clinic
Peterborough
Ontario
K9H 2P4
Canada
Toronto Western Hospital
Toronto
Ontario
M5T 2S8
Canada
Recherches Neuro-Hippocampe Inc.
Gatineau
Quebec
J8T 8J1
Canada
Recherche Sepmus, Inc.
Greenfield Park
Quebec
J4V 2J2
Canada
DIEX Recherche Sherbrooke Inc.
Sherbrooke
Quebec
J1H 1Z1
Canada
Douglas Hospital Research Centre
Verdun
Quebec
H4H 1R3
Canada
Terveystalo Kamppi
Helsinki
00100
Finland
Itä-Suomen yliopisto, Aivotutkimusyksikkö
Kuopio
70210
Finland
CRST, Clinical Research Services Turku
Turku
20520
Finland
Hôpital de la Timone
Marseille
Bouches-du-Rhône
13385
France
Centre de Recherche Clinique du Gérontopôle - Cité de la Santé
Toulouse
Haute Garonne
31052
France
CHU de Toulouse - Hôpital Purpan
Toulouse
Haute Garonne
31059
France
Hôpital Gui de Chauliac
Montpellier
Herault
34295
France
CHU Rennes - Hopital Pontchaillou
Rennes
Ille Et Vilaine
35033
France
CHU Nantes - Hopital Nord Laënnec
Nantes
Loire Atlantique
44093
France
Hopital Roger Salengro - CHU Lille
Lille
Nord
59037
France
Hôpital des Charpennes
Villeurbanne
Rhone
69100
France
Hôpital Fernand Widal
Paris
75010
France
Bezirkskrankenhaus Guenzburg
Gunzburg
Baden-Wurttemberg
89312
Germany
ISPG - Institut fuer Studien zur Psychischen Gesundheit
Mannheim
Baden-Wurttemberg
68165
Germany
Nervenfachaerztlichen Gemeinschaftspraxis Ulm
Ulm
Baden-Wurttemberg
89078
Germany
Universitaetsklinikum Ulm
Ulm
Baden-Wurttemberg
89081
Germany
Klinik Hohe Warte Bayreuth
Bayreuth
Bavaria
95445
Germany
Institut fuer Schlaganfall- und Demenzforschung (ISD)
Munich
Bavaria
81377
Germany
Klinikum rechts der Isar der TU Muenchen
Munich
Bavaria
81675
Germany
Neuropraxis Muenchen Sued
Unterhaching
Bavaria
82008
Germany
Neuro Centrum Odenwald
Erbach im Odenwald
Hesse
64711
Germany
Schwerpunktpraxis fuer Neurologie, Psychiatrie und Klinische Studien
Bielefeld
North Rhine-Westphalia
33647
Germany
Universitaetsklinikum Duesseldorf AoeR
Düsseldorf
North Rhine-Westphalia
40629
Germany
Universitaetsklinikum Muenster
Münster
North Rhine-Westphalia
48149
Germany
Zentrum f. Neurologisch- Psychiatrische Studien und Begutachtung
Siegen
North Rhine-Westphalia
57076
Germany
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz
Mainz
Rhineland-Palatinate
55131
Germany
Klinikum Chemnitz gGmbH
Chemnitz
Saxony
09131
Germany
Kopfzentrum Leipzig
Leipzig
Saxony
04275
Germany
Klinikum Altenburger Land GmbH
Altenburg
Thuringia
04600
Germany
emovis GmbH
Berlin
10629
Germany
Neurologie im Tempelhofer Hafen
Berlin
12099
Germany
Ospedale degli Infermi
Ponderano
Biella
13875
Italy
Azienda Ospedaliera Card. G. Panico
Tricase
Lecce
73039
Italy
ASST di Monza
Monza
Milano
20052
Italy
Fondazione IRCCS Istituto Neurologico Carlo Besta
Milan
20133
Italy
Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone
Palermo
90100
Italy
Azienda Ospedaliera di Perugia Ospedale S. Maria della Misericordia
Perugia
06156
Italy
Fondazione Santa Lucia IRCCS
Roma
00179
Italy
Umberto I Pol. di Roma-Università di Roma La Sapienza
Roma
00185
Italy
Research Site
Obu-shi
Aichi-ken
474-8511
Japan
Research Site
Toon-shi
Ehime
791-0295
Japan
Research Site
Fukuoka
Fukuoka
814-0180
Japan
Research Site
Kurume-shi
Fukuoka
830-0011
Japan
Research Site
Otake-shi
Hiroshima
739-0696
Japan
Research Site
Amagasaki-shi
Hyōgo
660-8511
Japan
Research site
Himeji-shi
Hyōgo
670-0981
Japan
Research Site
Himeji-shi
Hyōgo
672-8043
Japan
Research Site
Kobe
Hyōgo
650-0047
Japan
Research Site
Kita-gun
Kagawa-ken
761-0793
Japan
Research Site
Kyoto
Kyoto
607-8113
Japan
Research Site
Kyoto
Kyoto
616-8255
Japan
Research Site
Tsu
Mie-ken
514-8507
Japan
Research Site
Nishisonogi
Nagasaki
851-2103
Japan
Research Site
Yufu-shi
Oita Prefecture
879-5593
Japan
Research Site
Kurashiki-shi
Okayama-ken
710-0813
Japan
Research Site
Okayama
Okayama-ken
703-8265
Japan
Research Site
Tsukuba-gun
Okayama-ken
701-0304
Japan
Research Site
Kishiwada-shi
Osaka
596-8522
Japan
Research Site
Osaka
Osaka
530-0001
Japan
Research Site
Osaka
Osaka
545-8586
Japan
Research Site
Osaka
Osaka
553-0003
Japan
Research Site
Sennan-shi
Osaka
590-0503
Japan
Research Site
Suita-shi
Osaka
565-0871
Japan
Research Site
Iwata-shi
Shizuoka
438-0043
Japan
Research Site
Shizuoka
Shizuoka
420-8688
Japan
Research Site
Shizuoka
Shizuoka
424-8636
Japan
Alzheimer Research Center
Amsterdam
1081 GM
Netherlands
Erasmus Medisch Centrum
Rotterdam
3015 CE
Netherlands
Podlaskie Centrum Psychogeriatrii
Bialystok
15-732
Poland
PALLMED Sp. z o.o.
Bydgoszcz
85-796
Poland
Uniwersyteckie Centrum Kliniczne
Gdansk
Poland
Novo-Med Zielinski i wspolnicy Sp. j.
Katowice
40-650
Poland
SPZOZ Centralny Szpital Kliniczny UM w Lodzi
Lodz
92-216
Poland
Centrum Diagnostyczno - Terapeutyczne "MEDICUS" Sp.z o.o.
Lubin
59-300
Poland
Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie
Lublin
20-950
Poland
Neurologiczny NZOZ Centrum Leczenia SM
Plewiska
62-064
Poland
NZOZ "NEURO-KARD", "Ilkowski i Partnerzy" Sp. Partn. Lek.
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.
FG000548 subjects
FG001543 subjects
FG002547 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
COMPLETED
FG000288 subjects
FG001291 subjects
FG002295 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
NOT COMPLETED
FG000260 subjects
FG001252 subjects
FG002252 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
Type
Comment
Reasons
Adverse Event
FG00010 subjects
FG00113 subjects
FG00220 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
Change of Treatment
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Consent Withdrawn
FG00015 subjects
FG00132 subjects
FG00226 subjects
FG0030 subjects
FG004
Death
FG0005 subjects
FG0010 subjects
FG0026 subjects
FG0030 subjects
FG004
Disease Progression
FG0002 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Investigator Decision
FG0002 subjects
FG0012 subjects
FG0025 subjects
FG0030 subjects
FG004
Lost to Follow-up
FG0003 subjects
FG0011 subjects
FG0023 subjects
FG0030 subjects
FG004
Relocation
FG0001 subjects
FG0011 subjects
FG0021 subjects
FG0030 subjects
FG004
Study Visit Burden
FG0002 subjects
FG0018 subjects
FG0025 subjects
FG0030 subjects
FG004
Withdrawal by Parent/Guardian
FG0004 subjects
FG0011 subjects
FG0021 subjects
FG0030 subjects
FG004
Reason not Specified
FG000216 subjects
FG001194 subjects
FG002183 subjects
FG0030 subjects
FG004
Long-Term Extension Period
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003131 subjects11 PC completers did not enter LTE.
FG004132 subjects14 PC completers did not enter LTE.
FG005251 subjects40 PC completers did not enter LTE.
FG006257 subjects38 PC completers did not enter LTE.
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003131 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Intent-to-Treat (ITT) population was defined as all randomized participants who had received at least one dose of study treatment (Aducanumab or Placebo).
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
BG000548
BG001543
BG002547
BG0031638
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
BG00070.8± 7.40
BG00170.6± 7.45
BG00270.6± 7.47
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG000290
BG001269
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
Race
Title
Measurements
American Indian or Alaska Native
BG0001
BG0010
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
Ethinicity
Title
Measurements
Hispanic or Latino
BG00022
BG00122
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 Scale - 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
OG000288
OG001290
OG002299
Title
Denominators
Categories
Title
Measurements
OG0001.74± 0.115
OG0011.47± 0.116
OG0021.35± 0.115
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
0.0901
Difference
-0.26
2-Sided
95
-0.569
0.041
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) 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
The safety population was defined as all randomised participants who had received at least one dose of study treatment. In PC period, 1 participant randomized to placebo, inadvertently received 1 or more doses of active treatment (Low Dose) 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.
5
547
81
547
353
547
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.
0
544
72
544
385
544
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.
6
547
73
547
428
547
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.
0
131
15
131
55
131
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.
0
132
9
132
56
132
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.
3
251
25
251
87
251
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.
0
257
25
257
107
257
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Iron deficiency anaemia
Blood and lymphatic system disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected547 at risk
EG0010 affected544 at risk
EG0020 affected547 at risk
EG0030 affected131 at risk
EG004
Acute coronary syndrome
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected547 at risk
EG0010 affected544 at risk
EG0020 affected547 at risk
EG003
Acute left ventricular failure
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected547 at risk
EG0010 affected544 at risk
EG0020 affected547 at risk
EG003
Acute myocardial infarction
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected547 at risk
EG0010 affected544 at risk
EG0020 affected547 at risk
EG003
Angina pectoris
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected547 at risk
EG0011 affected544 at risk
EG0020 affected547 at risk
EG003
Angina unstable
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected547 at risk
EG0010 affected544 at risk
EG0020 affected547 at risk
EG003
Aortic valve incompetence
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected547 at risk
EG0011 affected544 at risk
EG0020 affected547 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0002 affected547 at risk
EG0010 affected544 at risk
EG0020 affected547 at risk
EG003
Atrial flutter
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected547 at risk
EG0010 affected544 at risk
EG0020 affected547 at risk
EG003
Atrioventricular block second degree
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected547 at risk
EG0010 affected544 at risk
EG0021 affected547 at risk
EG003
Bradycardia
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected547 at risk
EG0011 affected544 at risk
EG0020 affected547 at risk
EG003
Cardiac arrest
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected547 at risk
EG0010 affected544 at risk
EG0022 affected547 at risk
EG003
Cardiac failure congestive
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0002 affected547 at risk
EG0010 affected544 at risk
EG0020 affected547 at risk
EG003
Coronary artery disease
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected547 at risk
EG0010 affected544 at risk
EG0021 affected547 at risk
EG003
Ischaemic cardiomyopathy
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected547 at risk
EG0010 affected544 at risk
EG0020 affected547 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0002 affected547 at risk
EG0011 affected544 at risk
EG0021 affected547 at risk
EG003
Sinus bradycardia
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected547 at risk
EG0011 affected544 at risk
EG0020 affected547 at risk
EG003
Sinus node dysfunction
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected547 at risk
EG0010 affected544 at risk
EG0020 affected547 at risk
EG003
Sinus tachycardia
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected547 at risk
EG0010 affected544 at risk
EG0020 affected547 at risk
EG003
Stress cardiomyopathy
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected547 at risk
EG0011 affected544 at risk
EG0020 affected547 at risk
EG003
Supraventricular extrasystoles
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected547 at risk
EG0010 affected544 at risk
EG0020 affected547 at risk
EG003
Deafness bilateral
Ear and labyrinth disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected547 at risk
EG0011 affected544 at risk
EG0020 affected547 at risk
EG003
Meniere's disease
Ear and labyrinth disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected547 at risk
EG0010 affected544 at risk
EG0020 affected547 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected547 at risk
EG0010 affected544 at risk
EG0020 affected547 at risk
EG003
Inappropriate antidiuretic hormone secretion
Endocrine disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected547 at risk
EG0011 affected544 at risk
EG0020 affected547 at risk
EG003
Age-related macular degeneration
Eye disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected547 at risk
EG0010 affected544 at risk
EG0020 affected547 at risk
EG003
Cataract nuclear
Eye disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected547 at risk
EG0010 affected544 at risk
EG0021 affected547 at risk
EG003
Retinal detachment
Eye disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected547 at risk
EG0010 affected544 at risk
EG0020 affected547 at risk
EG003
Vitreous floaters
Eye disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected547 at risk
EG0010 affected544 at risk
EG0020 affected547 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected547 at risk
EG0010 affected544 at risk
EG0020 affected547 at risk
EG003
Acquired oesophageal web
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected547 at risk
EG0010 affected544 at risk
EG0020 affected547 at risk
EG003
Barrett's oesophagus
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected547 at risk
EG0011 affected544 at risk
EG0020 affected547 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected547 at risk
EG0011 affected544 at risk
EG0020 affected547 at risk
EG003
Colitis ischaemic
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected547 at risk
EG0010 affected544 at risk
EG0020 affected547 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected547 at risk
EG0010 affected544 at risk
EG0020 affected547 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0002 affected547 at risk
EG0010 affected544 at risk
EG0020 affected547 at risk
EG003
Diverticular perforation
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected547 at risk
EG0010 affected544 at risk
EG0020 affected547 at risk
EG003
Diverticulum intestinal haemorrhagic
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected547 at risk
EG0010 affected544 at risk
EG0020 affected547 at risk
EG003
Duodenal ulcer perforation
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected547 at risk
EG0011 affected544 at risk
EG0021 affected547 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected547 at risk
EG0010 affected544 at risk
EG0020 affected547 at risk
EG003
Femoral hernia strangulated
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected547 at risk
EG0010 affected544 at risk
EG0020 affected547 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected547 at risk
EG0010 affected544 at risk
EG0022 affected547 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected547 at risk
EG0010 affected544 at risk
EG0021 affected547 at risk
EG003
Gastrointestinal necrosis
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected547 at risk
EG0010 affected544 at risk
EG0020 affected547 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected547 at risk
EG0010 affected544 at risk
EG0020 affected547 at risk
EG003
Haemorrhoidal haemorrhage
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected547 at risk
EG0012 affected544 at risk
EG0020 affected547 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected547 at risk
EG0010 affected544 at risk
EG0020 affected547 at risk
EG003
Ileus
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected547 at risk
EG0010 affected544 at risk
EG0020 affected547 at risk
EG003
Inguinal hernia
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected547 at risk
EG0012 affected544 at risk
EG0023 affected547 at risk
EG003
Intestinal obstruction
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected547 at risk
EG0010 affected544 at risk
EG0020 affected547 at risk
EG003
Intestinal perforation
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected547 at risk
EG0010 affected544 at risk
EG0020 affected547 at risk
EG003
Large intestine polyp
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0002 affected547 at risk
EG0010 affected544 at risk
EG0021 affected547 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected547 at risk
EG0010 affected544 at risk
EG0020 affected547 at risk
EG003
Obstructive pancreatitis
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected547 at risk
EG0010 affected544 at risk
EG0021 affected547 at risk
EG003
Pancreatitis
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected547 at risk
EG0011 affected544 at risk
EG0021 affected547 at risk
EG003
Pancreatitis acute
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected547 at risk
EG0010 affected544 at risk
EG0021 affected547 at risk
EG003
Pneumoperitoneum
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected547 at risk
EG0011 affected544 at risk
EG0020 affected547 at risk
EG003
Rectal prolapse
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected547 at risk
EG0011 affected544 at risk
EG0021 affected547 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0002 affected547 at risk
EG0010 affected544 at risk
EG0020 affected547 at risk
EG003
Asthenia
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected547 at risk
EG0010 affected544 at risk
EG0020 affected547 at risk
EG003
Chest pain
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected547 at risk
EG0010 affected544 at risk
EG0020 affected547 at risk
EG003
Death
General disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected547 at risk
EG0010 affected544 at risk
EG0020 affected547 at risk
EG003
Discomfort
General disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected547 at risk
EG0010 affected544 at risk
EG0020 affected547 at risk
EG003
Gait disturbance
General disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected547 at risk
EG0011 affected544 at risk
EG0020 affected547 at risk
EG003
Medical device site joint pain
General disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected547 at risk
EG0010 affected544 at risk
EG0020 affected547 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 22.0
Systematic Assessment
EG0002 affected547 at risk
EG0011 affected544 at risk
EG0022 affected547 at risk
EG003
Pyrexia
General disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected547 at risk
EG0010 affected544 at risk
EG0020 affected547 at risk
EG003
Cholecystitis
Hepatobiliary disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected547 at risk
EG0010 affected544 at risk
EG0020 affected547 at risk
EG003
Cholecystitis acute
Hepatobiliary disorders
MedDRA 22.0
Systematic Assessment
EG0002 affected547 at risk
EG0010 affected544 at risk
EG0020 affected547 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected547 at risk
EG0010 affected544 at risk
EG0021 affected547 at risk
EG003
Hepatitis acute
Hepatobiliary disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected547 at risk
EG0010 affected544 at risk
EG0020 affected547 at risk
EG003
Jaundice
Hepatobiliary disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected547 at risk
EG0010 affected544 at risk
EG0020 affected547 at risk
EG003
Hypersensitivity
Immune system disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected547 at risk
EG0010 affected544 at risk
EG0020 affected547 at risk
EG003
Appendicitis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0001 affected547 at risk
EG0010 affected544 at risk
EG0020 affected547 at risk
EG003
Bacterial infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected547 at risk
EG0011 affected544 at risk
EG0020 affected547 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0001 affected547 at risk
EG0010 affected544 at risk
EG0020 affected547 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected547 at risk
EG0011 affected544 at risk
EG0022 affected547 at risk
EG003
Cystitis klebsiella
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected547 at risk
EG0011 affected544 at risk
EG0020 affected547 at risk
EG003
Erysipelas
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected547 at risk
EG0011 affected544 at risk
EG0020 affected547 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected547 at risk
EG0010 affected544 at risk
EG0020 affected547 at risk
EG003
Gastroenteritis viral
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected547 at risk
EG0010 affected544 at risk
EG0021 affected547 at risk
EG003
Human anaplasmosis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected547 at risk
EG0010 affected544 at risk
EG0021 affected547 at risk
EG003
Lymphangitis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected547 at risk
EG0011 affected544 at risk
EG0020 affected547 at risk
EG003
Otitis media
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected547 at risk
EG0010 affected544 at risk
EG0020 affected547 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0002 affected547 at risk
EG0012 affected544 at risk
EG0021 affected547 at risk
EG003
Pneumonia bacterial
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected547 at risk
EG0010 affected544 at risk
EG0020 affected547 at risk
EG003
Pneumonia influenzal
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected547 at risk
EG0010 affected544 at risk
EG0020 affected547 at risk
EG003
Pneumonia respiratory syncytial viral
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected547 at risk
EG0011 affected544 at risk
EG0020 affected547 at risk
EG003
Pulmonary sepsis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected547 at risk
EG0010 affected544 at risk
EG0021 affected547 at risk
EG003
Sepsis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected547 at risk
EG0010 affected544 at risk
EG0022 affected547 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0001 affected547 at risk
EG0010 affected544 at risk
EG0021 affected547 at risk
EG003
Urosepsis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0001 affected547 at risk
EG0010 affected544 at risk
EG0020 affected547 at risk
EG003
Accident
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0001 affected547 at risk
EG0010 affected544 at risk
EG0020 affected547 at risk
EG003
Accidental overdose
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 affected547 at risk
EG0011 affected544 at risk
EG0021 affected547 at risk
EG003
Alcohol poisoning
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 affected547 at risk
EG0011 affected544 at risk
EG0020 affected547 at risk
EG003
Animal attack
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0001 affected547 at risk
EG0010 affected544 at risk
EG0020 affected547 at risk
EG003
Animal scratch
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 affected547 at risk
EG0011 affected544 at risk
EG0020 affected547 at risk
EG003
Ankle fracture
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0002 affected547 at risk
EG0011 affected544 at risk
EG0020 affected547 at risk
EG003
Bone contusion
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 affected547 at risk
EG0010 affected544 at risk
EG0021 affected547 at risk
EG003
Cardiac contusion
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0001 affected547 at risk
EG0010 affected544 at risk
EG0020 affected547 at risk
EG003
Concussion
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0001 affected547 at risk
EG0010 affected544 at risk
EG0020 affected547 at risk
EG003
Craniocerebral injury
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0001 affected547 at risk
EG0010 affected544 at risk
EG0020 affected547 at risk
EG003
Epiphyseal fracture
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0001 affected547 at risk
EG0010 affected544 at risk
EG0020 affected547 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG00012 affected547 at risk
EG0019 affected544 at risk
EG0024 affected547 at risk
EG003
Femoral neck fracture
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0003 affected547 at risk
EG0012 affected544 at risk
EG0020 affected547 at risk
EG003
Foot fracture
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0001 affected547 at risk
EG0010 affected544 at risk
EG0020 affected547 at risk
EG003
Gastrointestinal procedural complication
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 affected547 at risk
EG0010 affected544 at risk
EG0021 affected547 at risk
EG003
Hand fracture
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0001 affected547 at risk
EG0010 affected544 at risk
EG0020 affected547 at risk
EG003
Head injury
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0001 affected547 at risk
EG0011 affected544 at risk
EG0020 affected547 at risk
EG003
Hip fracture
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 affected547 at risk
EG0010 affected544 at risk
EG0020 affected547 at risk
EG003
Humerus fracture
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 affected547 at risk
EG0011 affected544 at risk
EG0021 affected547 at risk
EG003
Joint dislocation
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 affected547 at risk
EG0010 affected544 at risk
EG0021 affected547 at risk
EG003
Lower limb fracture
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 affected547 at risk
EG0011 affected544 at risk
EG0020 affected547 at risk
EG003
Lumbar vertebral fracture
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0001 affected547 at risk
EG0010 affected544 at risk
EG0020 affected547 at risk
EG003
Pelvic fracture
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 affected547 at risk
EG0011 affected544 at risk
EG0020 affected547 at risk
EG003
Pubis fracture
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 affected547 at risk
EG0010 affected544 at risk
EG0021 affected547 at risk
EG003
Pulmonary contusion
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0001 affected547 at risk
EG0010 affected544 at risk
EG0020 affected547 at risk
EG003
Radius fracture
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 affected547 at risk
EG0011 affected544 at risk
EG0021 affected547 at risk
EG003
Rib fracture
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0005 affected547 at risk
EG0010 affected544 at risk
EG0020 affected547 at risk
EG003
Road traffic accident
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0001 affected547 at risk
EG0012 affected544 at risk
EG0020 affected547 at risk
EG003
Skin laceration
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0001 affected547 at risk
EG0010 affected544 at risk
EG0020 affected547 at risk
EG003
Skull fracture
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 affected547 at risk
EG0010 affected544 at risk
EG0020 affected547 at risk
EG003
Spinal fracture
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0001 affected547 at risk
EG0010 affected544 at risk
EG0020 affected547 at risk
EG003
Subdural haematoma
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 affected547 at risk
EG0013 affected544 at risk
EG0022 affected547 at risk
EG003
Thoracic vertebral fracture
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 affected547 at risk
EG0010 affected544 at risk
EG0021 affected547 at risk
EG003
Upper limb fracture
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 affected547 at risk
EG0011 affected544 at risk
EG0020 affected547 at risk
EG003
Wrist fracture
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0001 affected547 at risk
EG0010 affected544 at risk
EG0020 affected547 at risk
EG003
Weight decreased
Investigations
MedDRA 22.0
Systematic Assessment
EG0001 affected547 at risk
EG0010 affected544 at risk
EG0020 affected547 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected547 at risk
EG0010 affected544 at risk
EG0021 affected547 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected547 at risk
EG0011 affected544 at risk
EG0020 affected547 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected547 at risk
EG0011 affected544 at risk
EG0020 affected547 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected547 at risk
EG0011 affected544 at risk
EG0021 affected547 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected547 at risk
EG0010 affected544 at risk
EG0020 affected547 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected547 at risk
EG0011 affected544 at risk
EG0020 affected547 at risk
EG003
Bursitis
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected547 at risk
EG0011 affected544 at risk
EG0021 affected547 at risk
EG003
Intervertebral disc protrusion
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected547 at risk
EG0010 affected544 at risk
EG0020 affected547 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected547 at risk
EG0010 affected544 at risk
EG0021 affected547 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected547 at risk
EG0010 affected544 at risk
EG0020 affected547 at risk
EG003
Musculoskeletal stiffness
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected547 at risk
EG0010 affected544 at risk
EG0020 affected547 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0002 affected547 at risk
EG0013 affected544 at risk
EG0021 affected547 at risk
EG003
Osteonecrosis
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected547 at risk
EG0011 affected544 at risk
EG0021 affected547 at risk
EG003
Rhabdomyolysis
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected547 at risk
EG0011 affected544 at risk
EG0020 affected547 at risk
EG003
Spinal osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected547 at risk
EG0010 affected544 at risk
EG0020 affected547 at risk
EG003
Vertebral foraminal stenosis
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected547 at risk
EG0010 affected544 at risk
EG0020 affected547 at risk
EG003
Adenocarcinoma of colon
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 affected547 at risk
EG0010 affected544 at risk
EG0021 affected547 at risk
EG003
Adenocarcinoma pancreas
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 affected547 at risk
EG0010 affected544 at risk
EG0020 affected547 at risk
EG003
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 affected547 at risk
EG0012 affected544 at risk
EG0021 affected547 at risk
EG003
Bladder papilloma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 affected547 at risk
EG0011 affected544 at risk
EG0020 affected547 at risk
EG003
Breast cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0001 affected547 at risk
EG0010 affected544 at risk
EG0020 affected547 at risk
EG003
Cholangiocarcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 affected547 at risk
EG0010 affected544 at risk
EG0020 affected547 at risk
EG003
Cholesteatoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 affected547 at risk
EG0011 affected544 at risk
EG0020 affected547 at risk
EG003
Diffuse large b-cell lymphoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 affected547 at risk
EG0011 affected544 at risk
EG0020 affected547 at risk
EG003
Endometrial adenocarcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0001 affected547 at risk
EG0010 affected544 at risk
EG0020 affected547 at risk
EG003
Endometrial cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 affected547 at risk
EG0010 affected544 at risk
EG0021 affected547 at risk
EG003
Gastric cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0001 affected547 at risk
EG0011 affected544 at risk
EG0020 affected547 at risk
EG003
Gastrointestinal neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 affected547 at risk
EG0010 affected544 at risk
EG0021 affected547 at risk
EG003
Invasive ductal breast carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0001 affected547 at risk
EG0010 affected544 at risk
EG0021 affected547 at risk
EG003
Invasive lobular breast carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 affected547 at risk
EG0011 affected544 at risk
EG0020 affected547 at risk
EG003
Lung adenocarcinoma stage iv
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0001 affected547 at risk
EG0010 affected544 at risk
EG0020 affected547 at risk
EG003
Lung neoplasm malignant
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 affected547 at risk
EG0011 affected544 at risk
EG0020 affected547 at risk
EG003
Malignant melanoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 affected547 at risk
EG0010 affected544 at risk
EG0020 affected547 at risk
EG003
Malignant melanoma in situ
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 affected547 at risk
EG0010 affected544 at risk
EG0021 affected547 at risk
EG003
Medullary thyroid cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 affected547 at risk
EG0011 affected544 at risk
EG0020 affected547 at risk
EG003
Metastatic neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 affected547 at risk
EG0011 affected544 at risk
EG0020 affected547 at risk
EG003
Oesophageal carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 affected547 at risk
EG0011 affected544 at risk
EG0020 affected547 at risk
EG003
Ovarian cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 affected547 at risk
EG0010 affected544 at risk
EG0021 affected547 at risk
EG003
Pancreatic carcinoma metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 affected547 at risk
EG0010 affected544 at risk
EG0021 affected547 at risk
EG003
Pleural mesothelioma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 affected547 at risk
EG0010 affected544 at risk
EG0021 affected547 at risk
EG003
Prostate cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0001 affected547 at risk
EG0012 affected544 at risk
EG0021 affected547 at risk
EG003
Prostatic adenoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 affected547 at risk
EG0010 affected544 at risk
EG0020 affected547 at risk
EG003
Salivary gland cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 affected547 at risk
EG0011 affected544 at risk
EG0020 affected547 at risk
EG003
Small cell lung cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 affected547 at risk
EG0011 affected544 at risk
EG0020 affected547 at risk
EG003
Squamous cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0001 affected547 at risk
EG0010 affected544 at risk
EG0020 affected547 at risk
EG003
Squamous cell carcinoma of the oral cavity
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 affected547 at risk
EG0011 affected544 at risk
EG0020 affected547 at risk
EG003
T-cell lymphoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 affected547 at risk
EG0011 affected544 at risk
EG0020 affected547 at risk
EG003
Thymoma malignant
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0001 affected547 at risk
EG0010 affected544 at risk
EG0020 affected547 at risk
EG003
Amyloid related imaging abnormality-microhaemorrhages and haemosiderin deposits
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected547 at risk
EG0014 affected544 at risk
EG0022 affected547 at risk
EG003
Amyloid related imaging abnormality-oedema/effusion
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected547 at risk
EG0015 affected544 at risk
EG0028 affected547 at risk
EG003
Carpal tunnel syndrome
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected547 at risk
EG0010 affected544 at risk
EG0020 affected547 at risk
EG003
Cerebellar infarction
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected547 at risk
EG0010 affected544 at risk
EG0021 affected547 at risk
EG003
Cerebral haematoma
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected547 at risk
EG0010 affected544 at risk
EG0020 affected547 at risk
EG003
Cerebral haemorrhage
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected547 at risk
EG0010 affected544 at risk
EG0021 affected547 at risk
EG003
Cerebral infarction
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0002 affected547 at risk
EG0012 affected544 at risk
EG0020 affected547 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected547 at risk
EG0011 affected544 at risk
EG0020 affected547 at risk
EG003
Dementia alzheimer's type
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0002 affected547 at risk
EG0010 affected544 at risk
EG0021 affected547 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected547 at risk
EG0010 affected544 at risk
EG0020 affected547 at risk
EG003
Embolic cerebral infarction
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected547 at risk
EG0010 affected544 at risk
EG0021 affected547 at risk
EG003
Embolic stroke
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected547 at risk
EG0010 affected544 at risk
EG0020 affected547 at risk
EG003
Encephalopathy
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected547 at risk
EG0010 affected544 at risk
EG0021 affected547 at risk
EG003
Focal dyscognitive seizures
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected547 at risk
EG0010 affected544 at risk
EG0020 affected547 at risk
EG003
Generalised tonic-clonic seizure
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected547 at risk
EG0010 affected544 at risk
EG0021 affected547 at risk
EG003
Guillain-barre syndrome
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected547 at risk
EG0010 affected544 at risk
EG0020 affected547 at risk
EG003
Headache
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected547 at risk
EG0011 affected544 at risk
EG0020 affected547 at risk
EG003
Intracranial venous sinus thrombosis
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected547 at risk
EG0010 affected544 at risk
EG0021 affected547 at risk
EG003
Ischaemic stroke
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected547 at risk
EG0010 affected544 at risk
EG0020 affected547 at risk
EG003
Lacunar infarction
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected547 at risk
EG0011 affected544 at risk
EG0021 affected547 at risk
EG003
Loss of consciousness
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected547 at risk
EG0010 affected544 at risk
EG0020 affected547 at risk
EG003
Memory impairment
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected547 at risk
EG0011 affected544 at risk
EG0020 affected547 at risk
EG003
Metabolic encephalopathy
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected547 at risk
EG0010 affected544 at risk
EG0021 affected547 at risk
EG003
Presyncope
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected547 at risk
EG0011 affected544 at risk
EG0020 affected547 at risk
EG003
Quadriparesis
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected547 at risk
EG0010 affected544 at risk
EG0021 affected547 at risk
EG003
Seizure
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected547 at risk
EG0010 affected544 at risk
EG0021 affected547 at risk
EG003
Sensorimotor disorder
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected547 at risk
EG0010 affected544 at risk
EG0020 affected547 at risk
EG003
Superficial siderosis of central nervous system
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected547 at risk
EG0011 affected544 at risk
EG0023 affected547 at risk
EG003
Syncope
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0003 affected547 at risk
EG0012 affected544 at risk
EG0024 affected547 at risk
EG003
Thrombotic stroke
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected547 at risk
EG0010 affected544 at risk
EG0020 affected547 at risk
EG003
Toxic encephalopathy
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected547 at risk
EG0010 affected544 at risk
EG0020 affected547 at risk
EG003
Transient ischaemic attack
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected547 at risk
EG0010 affected544 at risk
EG0022 affected547 at risk
EG003
Agitation
Psychiatric disorders
MedDRA 22.0
Systematic Assessment
EG0003 affected547 at risk
EG0010 affected544 at risk
EG0020 affected547 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected547 at risk
EG0010 affected544 at risk
EG0020 affected547 at risk
EG003
Behaviour disorder
Psychiatric disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected547 at risk
EG0010 affected544 at risk
EG0020 affected547 at risk
EG003
Bipolar disorder
Psychiatric disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected547 at risk
EG0011 affected544 at risk
EG0020 affected547 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected547 at risk
EG0011 affected544 at risk
EG0021 affected547 at risk
EG003
Delirium
Psychiatric disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected547 at risk
EG0010 affected544 at risk
EG0021 affected547 at risk
EG003
Delusion
Psychiatric disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected547 at risk
EG0010 affected544 at risk
EG0021 affected547 at risk
EG003
Depression
Psychiatric disorders
MedDRA 22.0
Systematic Assessment
EG0002 affected547 at risk
EG0010 affected544 at risk
EG0021 affected547 at risk
EG003
Intentional self-injury
Psychiatric disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected547 at risk
EG0010 affected544 at risk
EG0020 affected547 at risk
EG003
Mania
Psychiatric disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected547 at risk
EG0011 affected544 at risk
EG0020 affected547 at risk
EG003
Mental status changes
Psychiatric disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected547 at risk
EG0011 affected544 at risk
EG0020 affected547 at risk
EG003
Neuropsychiatric symptoms
Psychiatric disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected547 at risk
EG0010 affected544 at risk
EG0020 affected547 at risk
EG003
Psychotic disorder
Psychiatric disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected547 at risk
EG0010 affected544 at risk
EG0020 affected547 at risk
EG003
Somatic symptom disorder
Psychiatric disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected547 at risk
EG0010 affected544 at risk
EG0021 affected547 at risk
EG003
Suicidal ideation
Psychiatric disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected547 at risk
EG0010 affected544 at risk
EG0020 affected547 at risk
EG003
Suicide attempt
Psychiatric disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected547 at risk
EG0010 affected544 at risk
EG0020 affected547 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected547 at risk
EG0010 affected544 at risk
EG0021 affected547 at risk
EG003
Calculus bladder
Renal and urinary disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected547 at risk
EG0011 affected544 at risk
EG0020 affected547 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected547 at risk
EG0011 affected544 at risk
EG0021 affected547 at risk
EG003
Prerenal failure
Renal and urinary disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected547 at risk
EG0010 affected544 at risk
EG0020 affected547 at risk
EG003
Renal failure
Renal and urinary disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected547 at risk
EG0010 affected544 at risk
EG0021 affected547 at risk
EG003
Urethral disorder
Renal and urinary disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected547 at risk
EG0010 affected544 at risk
EG0020 affected547 at risk
EG003
Urethral stenosis
Renal and urinary disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected547 at risk
EG0010 affected544 at risk
EG0021 affected547 at risk
EG003
Urinary retention
Renal and urinary disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected547 at risk
EG0010 affected544 at risk
EG0021 affected547 at risk
EG003
Adnexa uteri cyst
Reproductive system and breast disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected547 at risk
EG0010 affected544 at risk
EG0021 affected547 at risk
EG003
Benign prostatic hyperplasia
Reproductive system and breast disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected547 at risk
EG0011 affected544 at risk
EG0021 affected547 at risk
EG003
Cervical polyp
Reproductive system and breast disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected547 at risk
EG0010 affected544 at risk
EG0021 affected547 at risk
EG003
Gynaecomastia
Reproductive system and breast disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected547 at risk
EG0010 affected544 at risk
EG0020 affected547 at risk
EG003
Ovarian cyst
Reproductive system and breast disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected547 at risk
EG0010 affected544 at risk
EG0021 affected547 at risk
EG003
Spermatic cord cyst
Reproductive system and breast disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected547 at risk
EG0010 affected544 at risk
EG0021 affected547 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected547 at risk
EG0010 affected544 at risk
EG0021 affected547 at risk
EG003
Haemothorax
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected547 at risk
EG0010 affected544 at risk
EG0020 affected547 at risk
EG003
Laryngeal oedema
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected547 at risk
EG0010 affected544 at risk
EG0020 affected547 at risk
EG003
Lung perforation
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected547 at risk
EG0010 affected544 at risk
EG0020 affected547 at risk
EG003
Pneumonia aspiration
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected547 at risk
EG0010 affected544 at risk
EG0020 affected547 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected547 at risk
EG0010 affected544 at risk
EG0020 affected547 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected547 at risk
EG0010 affected544 at risk
EG0022 affected547 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected547 at risk
EG0010 affected544 at risk
EG0021 affected547 at risk
EG003
Aortic aneurysm rupture
Vascular disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected547 at risk
EG0010 affected544 at risk
EG0021 affected547 at risk
EG003
Aortic stenosis
Vascular disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected547 at risk
EG0010 affected544 at risk
EG0021 affected547 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected547 at risk
EG0011 affected544 at risk
EG0020 affected547 at risk
EG003
Hypertension
Vascular disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected547 at risk
EG0010 affected544 at risk
EG0020 affected547 at risk
EG003
Hypertensive crisis
Vascular disorders
MedDRA 22.0
Systematic Assessment
EG0002 affected547 at risk
EG0010 affected544 at risk
EG0020 affected547 at risk
EG003
Hypertensive urgency
Vascular disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected547 at risk
EG0010 affected544 at risk
EG0021 affected547 at risk
EG003
Hypotension
Vascular disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected547 at risk
EG0010 affected544 at risk
EG0020 affected547 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Diarrhoea
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG00029 affected547 at risk
EG00138 affected544 at risk
EG00242 affected547 at risk
EG0033 affected131 at risk
EG0047 affected132 at risk
EG0059 affected251 at risk
EG0066 affected257 at risk
Nausea
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG00027 affected547 at risk
EG00129 affected544 at risk
EG00231 affected547 at risk
EG003
Fatigue
General disorders
MedDRA 22.0
Systematic Assessment
EG00037 affected547 at risk
EG00127 affected544 at risk
EG00234 affected547 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG00091 affected547 at risk
EG00171 affected544 at risk
EG00289 affected547 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG00041 affected547 at risk
EG00142 affected544 at risk
EG00238 affected547 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG00036 affected547 at risk
EG00139 affected544 at risk
EG00229 affected547 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG00062 affected547 at risk
EG00159 affected544 at risk
EG00273 affected547 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG00031 affected547 at risk
EG00117 affected544 at risk
EG00234 affected547 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG00036 affected547 at risk
EG00138 affected544 at risk
EG00242 affected547 at risk
EG003
Amyloid related imaging abnormality-microhaemorrhages and haemosiderin deposits
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG00037 affected547 at risk
EG00186 affected544 at risk
EG002106 affected547 at risk
EG003
Amyloid related imaging abnormality-oedema/effusion
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG00012 affected547 at risk
EG001138 affected544 at risk
EG002183 affected547 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG00043 affected547 at risk
EG00142 affected544 at risk
EG00255 affected547 at risk
EG003
Headache
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG00084 affected547 at risk
EG001109 affected544 at risk
EG002107 affected547 at risk
EG003
Superficial siderosis of central nervous system
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG00014 affected547 at risk
EG00151 affected544 at risk
EG00271 affected547 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 22.0
Systematic Assessment
EG00021 affected547 at risk
EG00130 affected544 at risk
EG00219 affected547 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA 22.0
Systematic Assessment
EG00015 affected547 at risk
EG00116 affected544 at risk
EG00228 affected547 at risk
EG003
Depression
Psychiatric disorders
MedDRA 22.0
Systematic Assessment
EG00028 affected547 at risk
EG00129 affected544 at risk
EG00223 affected547 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG00028 affected547 at risk
EG00124 affected544 at risk
EG00233 affected547 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.
MMRM
0.0120
Difference
-0.39
2-Sided
95
-0.694
-0.086
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
OG000288
OG001293
OG002299
Title
Denominators
Categories
Title
Measurements
OG000-3.3± 0.22
OG001-3.3± 0.22
OG002-2.7± 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
0.7578
Difference
-0.1
2-Sided
95
-0.65
0.48
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
0.0493
Difference
0.6
2-Sided
95
0.00
1.13
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
OG000287
OG001289
OG002293
Title
Denominators
Categories
Title
Measurements
OG0005.162± 0.4049
OG0014.461± 0.4074
OG0023.763± 0.4036
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 ADASCog 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
0.1962
Difference
-0.701
2-Sided
95
-1.7649
0.3627
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 ADASCog 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
0.0097
Difference
-1.400
2-Sided
95
-2.4596
-0.3396
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
OG000283
OG001286
OG002295
Title
Denominators
Categories
Title
Measurements
OG000-4.3± 0.38
OG001-3.5± 0.38
OG002-2.5± 0.38
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 and BIIB037 High Dose), difference from Placebo,95% CI and p-value at each time point were based on an MMRM model, with change from baseline in ADCSADL-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
0.1515
Difference
0.7
2-Sided
95
-0.27
1.73
Superiority
OG000
OG002
Adjusted mean for each treatment group (Placebo, BIIB037 Low dose and BIIB037 High Dose), difference from Placebo,95% CI and p-value at each time point were based on an MMRM model, with change from baseline in ADCSADL-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.