Multiple IV Dose Study Of PF-04360365 In Patients With Mi... | NCT00722046 | Trialant
NCT00722046
Sponsor
Pfizer
Status
Completed
Last Update Posted
Nov 7, 2022Actual
Enrollment
198Actual
Phase
Phase 2
Conditions
Alzheimer's Disease
Interventions
PF-04360365 0.1 mg/kg
PF-04360365 0.5 mg/kg
PF-04360365 1 mg/kg
Placebo
PF-04360365 3 mg/kg
PF-04360365 8.5 mg/kg
Countries
United States
Australia
Belgium
Canada
South Korea
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT00722046
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
A9951002
Secondary IDs
ID
Type
Description
Link
2008-000986-42
EudraCT Number
MD IN AD PATIENT
Other Identifier
Alias Study Number
Brief Title
Multiple IV Dose Study Of PF-04360365 In Patients With Mild To Moderate Alzheimer's Disease
Official Title
A PHASE 2 MULTICENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED STUDY OF THE SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF MULTIPLE DOSES OF PF 04360365 IN PATIENTS WITH MILD TO MODERATE ALZHEIMER'S DISEASE.
Acronym
Not provided
Organization
PfizerINDUSTRY
Status Module
Record Verification Date
Oct 2022
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Dec 5, 2008Actual
Primary Completion Date
Aug 16, 2011Actual
Completion Date
Aug 16, 2011Actual
First Submitted Date
Jul 23, 2008
First Submission Date that Met QC Criteria
Jul 24, 2008
First Posted Date
Jul 25, 2008Estimated
Results Waived
Not provided
Results First Submitted Date
Oct 11, 2022
Results First Submitted that Met QC Criteria
Oct 11, 2022
Results First Posted Date
Nov 7, 2022Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Oct 8, 2012
Certification/Extension First Submitted that Passed QC Review
Oct 8, 2012
Certification/Extension First Posted Date
Oct 11, 2012Estimated
Last Update Submitted Date
Oct 11, 2022
Last Update Posted Date
Nov 7, 2022Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
PfizerINDUSTRY
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
Purpose of the study is to determine whether multiple dose administration of PF-04360365 is safe and well tolerated in patient with mild to moderate Alzheimer's disease.
Detailed Description
Not provided
Conditions Module
Conditions
Alzheimer's Disease
Keywords
Alzheimer's disease
antibody
amyloid
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
198Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
PF-04360365 0.1 mg/kg
Experimental
Biological: PF-04360365 0.1 mg/kg
PF-04360365 0.5 mg/kg
Experimental
Biological: PF-04360365 0.5 mg/kg
PF-04360365 1 mg/kg
Experimental
Biological: PF-04360365 1 mg/kg
Placebo
Placebo Comparator
Drug: Placebo
PF-04360365 3 mg/kg
Experimental
Biological: PF-04360365 3 mg/kg
PF-04360365 8.5 mg/kg
Experimental
Biological: PF-04360365 8.5 mg/kg
Interventions
Name
Type
Description
Arm Group Labels
Other Names
PF-04360365 0.1 mg/kg
Biological
0.1 mg/kg every 60 days (10 doses total)
PF-04360365 0.1 mg/kg
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence in a participant who received study medication without regard to possibility of causal relationship. SAE: an AE resulting in any of following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs are events between first dose of study medication and up to 6 months after last dose that were absent before treatment or worsened relative to pre-treatment state.
Day 1 up to 6 months after last dose of study medication, assessed up to Month 24
Number of Participants With Change From Baseline in Brain Magnetic Resonance Imaging (MRI) Abnormalities
Number of participants with new clinical findings not evident on the baseline scans, such as brain edema, hemorrhage, encephalitis and other pathology (cerebral/meningeal enhancement, parenchymal hematoma, subarachnoid hemorrhage, subdural hematoma, cortical infarcts, subcortical grey matter infarcts, white matter infarcts and white matter hyperintensities) were assessed from structural MRI. Participants with brain abnormality other than those listed above, assessed using MRI scan, were reported under other abnormality. Baseline was defined as the last assessment prior to the first study drug infusion.
Baseline up to Month 24
Number of Participants With Gadolinium Use in Brain Magnetic Resonance Imaging (MRI)
Brain MRI included gadolinium contrast if investigator determined this was necessary for participant care either based on clinical signs or the non-contrast MRI. This decision was made by the investigator on the basis of change in the clinical examination or in response to a possible abnormality seen on the non-contrast brain MRI. Baseline was defined as the last assessment prior to the first study drug infusion.
Baseline up to Month 24
Mean Cerebrospinal Fluid (CSF) Concentration of PF-04360365 at 0 Hour on Day 0
Secondary Outcomes
Measure
Description
Time Frame
Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog) Score at Baseline
ADAS-cog is a structured scale assessing the severity of cognitive impairment in Alzheimer's Disease. It comprised of following 11 items (range): word recall (0-10), naming objects and fingers (0-5), following commands (0-5), constructional praxis (0-5), ideational praxis (0-5), orientation (0-8), word recognition (0-12), recall of test instructions (0-5), spoken language ability (0-5), word-finding difficulty (0-5), comprehension of spoken language (0-5). ADAS-cog total score was calculated as the sum of scores for the 11 items and ranged from 0 to 70. Higher total and individual item scores indicate greater cognitive impairment. Baseline was defined as the last assessment prior to the first study drug infusion.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Males or females of non childbearing potential, age > or = 50
Diagnosis of probable Alzheimer's disease, consistent with criterial from both:
National Institute of Neurological and Communicable Disease and Stroke and Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA)
Diagnostic and Statistical Manual of Mental Disorders (DSM IV)
Mini-mental status exam score of 16-26 inclusive
Rosen-Modified Hachinski Ischemia Score of < or = 4
Exclusion Criteria:
Diagnosis or history of other demential or neurodegenerative disorders
Diagnosis or history of clinically significant cerebrovascular disease
Specific findings on magnetic resonance imaging (MRI); cortical infarct, micro hemorrhage, multiple white matter lacunes, extensive white matter abnormalities
History of autoimmune disorders
History of allergic or anaphylactic reactions
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
50 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Pfizer CT.gov Call Center
Pfizer
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Pivotal Research Center
Peoria
Arizona
85381
United States
Sun Radiology- for MRI
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
Plan to Share IPD
Yes
Description
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
PF-04360365 0.1 milligram per kilogram (mg/kg) intravenous infusion over 2 hours every 60 days up to 18 months in Part A of the study.
FG001
PF-04360365 0.5 mg/kg (Part A)
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
0
More Info Module
Limitations and Caveats
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Triple
Masking Description
Not provided
Who Masked
ParticipantCare ProviderInvestigator
PF-04360365 0.5 mg/kg
Biological
0.5 mg/kg every 60 days (10 doses total)
PF-04360365 0.5 mg/kg
PF-04360365 1 mg/kg
Biological
1 mg/kg every 60 days (10 doses total)
PF-04360365 1 mg/kg
Placebo
Drug
Placebo every 60 days (10 doses total)
Placebo
PF-04360365 3 mg/kg
Biological
3 mg/kg every 60 days (10 doses total)
PF-04360365 3 mg/kg
PF-04360365 8.5 mg/kg
Biological
8.5 mg/kg every 60 days (10 doses total)
PF-04360365 8.5 mg/kg
Only participants received PF-04360365 were analyzed for this outcome measure.
0 Hour on Day 0
Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 1
Only participants received PF-04360365 were analyzed for this outcome measure.
0 Hour (pre-dose) on Day 1
Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 1
Only participants received PF-04360365 were analyzed for this outcome measure.
2 Hours on Day 1
Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 60
Only participants received PF-04360365 were analyzed for this outcome measure.
0 Hour (pre-dose) on Day 60
Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 60
Only participants received PF-04360365 were analyzed for this outcome measure.
2 Hours on Day 60
Mean Plasma and Cerebrospinal Fluid (CSF) Concentration of PF-04360365 on Day 90
Only participants received PF-04360365 were analyzed for this outcome measure.
Day 90
Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 120
Only participants received PF-04360365 were analyzed for this outcome measure.
0 Hour (pre-dose) on Day 120
Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 120
Only participants received PF-04360365 were analyzed for this outcome measure.
2 Hours on Day 120
Mean Plasma Concentration of PF-04360365 on Day 150
Only participants received PF-04360365 were analyzed for this outcome measure.
Day 150
Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 180
Only participants received PF-04360365 were analyzed for this outcome measure.
0 Hour (pre-dose) on Day 180
Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 180
Only participants received PF-04360365 were analyzed for this outcome measure.
2 Hours on Day 180
Mean Plasma Concentration of PF-04360365 on Day 210
Only participants received PF-04360365 were analyzed for this outcome measure.
Day 210
Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 240
Only participants received PF-04360365 were analyzed for this outcome measure.
0 Hour (pre-dose) on Day 240
Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 240
Only participants received PF-04360365 were analyzed for this outcome measure.
2 Hours on Day 240
Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 300
Only participants received PF-04360365 were analyzed for this outcome measure.
0 Hour (pre-dose) on Day 300
Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 300
Only participants received PF-04360365 were analyzed for this outcome measure.
2 Hours on Day 300
Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 360
Only participants received PF-04360365 were analyzed for this outcome measure.
0 Hour (pre-dose) on Day 360
Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 360
Only participants received PF-04360365 were analyzed for this outcome measure.
2 Hours on Day 360
Mean Plasma Concentration of PF-04360365 on Day 390
Only participants received PF-04360365 were analyzed for this outcome measure.
Day 390
Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 420
Only participants received PF-04360365 were analyzed for this outcome measure.
0 Hour (pre-dose) on Day 420
Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 420
Only participants received PF-04360365 were analyzed for this outcome measure.
2 Hours on Day 420
Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 480
Only participants received PF-04360365 were analyzed for this outcome measure.
0 Hour (pre-dose) on Day 480
Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 480
Only participants received PF-04360365 were analyzed for this outcome measure.
2 Hours on Day 480
Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 540
Only participants received PF-04360365 were analyzed for this outcome measure.
0 Hour (pre-dose) on Day 540
Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 540
Only participants received PF-04360365 were analyzed for this outcome measure.
2 Hours on Day 540
Mean Plasma and Cerebrospinal Fluid (CSF) Concentration of PF-04360365 on Day 570
Only participants received PF-04360365 were analyzed for this outcome measure.
Day 570
Mean Plasma Concentration of PF-04360365 on Day 660
Only participants received PF-04360365 were analyzed for this outcome measure.
Day 660
Mean Plasma Concentration of PF-04360365 on Day 720
Only participants received PF-04360365 were analyzed for this outcome measure.
Day 720
Baseline
Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog) Score at Month 19
ADAS-cog is a structured scale assessing the severity of cognitive impairment in Alzheimer's Disease. It comprised of following 11 items (range): word recall (0-10), naming objects and fingers (0-5), following commands (0-5), constructional praxis (0-5), ideational praxis (0-5), orientation (0-8), word recognition (0-12), recall of test instructions (0-5), spoken language ability (0-5), word-finding difficulty (0-5), comprehension of spoken language (0-5). ADAS-cog total score was calculated as the sum of scores for the 11 items and ranged from 0 to 70. Higher total and individual item scores indicate greater cognitive impairment. Baseline was defined as the last assessment prior to the first study drug infusion.
Baseline and Month 19
Disability Assessment for Dementia (DAD) Score at Baseline
DAD is a functional assessment based on interview with the caregiver. It consisted of 40 items, 17 related to self-care and 23 items involving instrumental activities of daily living. Each item was scored as yes = 1, no = 0 and not applicable= N/A. A total score was obtained by adding the rating for each question and converting this to a total score out of 100. The items rated N/A were not considered for the total score. DAD total score ranged from 0 to 100, with higher scores indicating better functioning. Baseline was defined as the last assessment prior to the first study drug infusion.
Baseline
Change From Baseline in Disability Assessment for Dementia (DAD) Score at Month 19
DAD is a functional assessment based on interview with the caregiver. It consisted of 40 items, 17 related to self-care and 23 items involving instrumental activities of daily living. Each item was scored as yes = 1, no = 0 and not applicable= N/A. A total score was obtained by adding the rating for each question and converting this to a total score out of 100. The items rated N/A were not considered for the total score. DAD total score ranged from 0 to 100, with higher scores indicating better functioning. Baseline was defined as the last assessment prior to the first study drug infusion.
Baseline and Month 19
Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x)
0 Hour (pre-dose) and 2 hours on Day 1, 60, 120, 180, 240, 300, 360, 420, 480, 540; Day 90, 150, 210, 390, 570, 660, 720
Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40)
0 Hour (pre-dose) and 2 hours on Day 1, 60, 120, 180, 240, 300, 360, 420, 480, 540; Day 90, 150, 210, 390, 570, 660, 720
Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42)
Results are not reported for PF-04360365 0.1, 0.5, 1.0 mg/kg, Placebo (Part A and B) arms because plasma Aβ1-42 concentrations were sporadic and below the lower limit of quantification (20 pg/mL).
0 Hour (pre-dose) and 2 hours on Day 1, 60, 120, 180, 240, 300, 360, 420, 480, 540; Day 90, 150, 210, 390, 570, 660, 720
Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (Aβ1-x)
Day 0 (Hour 0), 90, 570
Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-40 (Aβ1-40)
Day 0 (Hour 0), 90, 570
Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-42 (Aβ1-42)
Day 0 (Hour 0), 90, 570
Mean Cerebrospinal Fluid (CSF) Concentration of Total Tau and Phospho-tau (P-tau)
Day 0 (Hour 0), 90, 570
Number of Participants With Abnormal Cerebrospinal Fluid (CSF) Protein, Red Blood Cells (RBCs), White Blood Cells (WBCs), and Glucose Concentration
Abnormality was defined as concentration either less than lower limit of normal (LLN) or more than upper limit of normal (ULN). Baseline was defined as the last assessment prior to the first study drug infusion
Baseline up to Month 24
Number of Participants With Serum Anti-Drug Anti Body (ADA)
Serum samples were analyzed for the presence or absence of anti-PF-04360365 antibodies using validated semi-quantitative enzyme linked immunosorbent assay (ELISA). Only participants receiving PF-04360365 were analyzed for this outcome measure.
Day 1 up to Month 24
Peoria
Arizona
85381
United States
Dedicated Phase 1
Phoenix
Arizona
85013
United States
Neuroscience Consultants, LLC
Miami
Florida
33176
United States
Miami Research Associates
South Miami
Florida
33143
United States
MRA Clinical Research
South Miami
Florida
33143
United States
Sleep Florida, LLC
South Miami
Florida
33143
United States
Alexian Brothers Medical Center
Elk Grove Village
Illinois
60007
United States
Alexian Brothers Neurosciences Institute
Elk Grove Village
Illinois
60007
United States
Stark Pharmacy
Overland Park
Kansas
66209
United States
Vince and Associates Clinical Research
Overland Park
Kansas
66211
United States
Vince and Associates Clinical Research
Overland Park
Kansas
66212
United States
Memory Enhancement Center of America, Inc
Eatontown
New Jersey
07724
United States
Central Jersey Radiology
Oakhurst
New Jersey
07755
United States
Butler Hospital
Providence
Rhode Island
02906
United States
Royal Adelaide Hospital
Adelaide
South Australia
5000
Australia
The Queen Elizabeth Hospital and Health Service
Woodville South
South Australia
5011
Australia
Heidelberg Repatriation Hospital, Austin Health
Heidelberg West
Victoria
3084
Australia
The McCusker Foundation for Alzheimer's Disease Research
Nedlands
Western Australia
6009
Australia
ZNA Middelheim / Neurology
Antwerp
2020
Belgium
UZ Antwerpen, Department of Neurology
Edegem
2650
Belgium
UZ Brussel / Geriatrie
Jette
1090
Belgium
U.Z. Gasthuisberg / Neurologie
Leuven
3000
Belgium
University of British Columbia Hospital, Division of Neurology
Vancouver
British Columbia
V6T 2B5
Canada
Parkwood Hospital, Geriatric Medicine
London
Ontario
N6C 5J1
Canada
Kawartha Regional Memory Clinic
Peterborough
Ontario
K9H 2P4
Canada
Toronto Memory Program
Toronto
Ontario
M3B 2S7
Canada
Sunnybrook Health Sciences Centre
Toronto
Ontario
M4N 3M5
Canada
Recherche Clinique de Neurologie
Montreal
Quebec
H1T 2M4
Canada
Diex Recherche Inc.
Sherbrooke
Quebec
J1H 1Z1
Canada
Seoul National University Bundang Hospital
Seongnam-si
Gyeonggi-do
463-707
South Korea
Hanyang University Hospital
Seoul
133-792
South Korea
Samsung Medical Center
Seoul
135-710
South Korea
Korea University Anam Hospital
Seoul
136-705
South Korea
Asan Medical Center
Seoul
138-736
South Korea
Konkuk University Medical Center
Seoul
143-914
South Korea
The Pharmacy Department
Cheadle
Chesire
SK8 2PX
United Kingdom
The Shalbourne Suite
Swindon
Wiltshire
SN3 6BB
United Kingdom
Kingshill Research Centre
Swindon
Wiltshire
SN3 6BW
United Kingdom
MAC UK Neuroscience Ltd
Manchester
M50 2GY
United Kingdom
Wellcome Trust Clinical Research Facility
Southampton
SO16 6YD
United Kingdom
Memory Assessment and Research Centre
Southampton
SO30 3JB
United Kingdom
PF-04360365 0.5 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part A of the study.
FG002
PF-04360365 1.0 mg/kg (Part A)
PF-04360365 1.0 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part A of the study.
FG003
Placebo (Part A)
Placebo intravenous infusion over 2 hours every 60 days up to 18 months in Part A of the study.
FG004
PF-04360365 3.0 mg/kg (Part B)
PF-04360365 3.0 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part B of the study.
FG005
PF-04360365 8.5 mg/kg (Part B)
PF-04360365 8.5 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part B of the study.
FG006
Placebo (Part B)
Placebo intravenous infusion over 2 hours every 60 days up to 18 months in Part B of the study.
FG00026 subjects
FG00126 subjects
FG00225 subjects
FG00326 subjects
FG00432 subjects
FG00531 subjects
FG00632 subjects
Treated
FG00025 subjects
FG00125 subjects
FG00225 subjects
FG00324 subjects
FG00432 subjects
FG00531 subjects
FG00632 subjects
COMPLETED
FG00021 subjects
FG00120 subjects
FG00218 subjects
FG00318 subjects
FG00423 subjects
FG00520 subjects
FG00626 subjects
NOT COMPLETED
FG0005 subjects
FG0016 subjects
FG0027 subjects
FG0038 subjects
FG0049 subjects
FG00511 subjects
FG0066 subjects
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0011 subjects
FG0022 subjects
FG0031 subjects
FG0042 subjects
FG0051 subjects
FG0060 subjects
Death
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Protocol Violation
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0003 subjects
FG0013 subjects
FG0024 subjects
FG0034 subjects
FG004
Randomized, but not treated
FG0001 subjects
FG0011 subjects
FG0020 subjects
FG0032 subjects
FG004
Other
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0031 subjects
FG004
Safety analysis set included all participants who received an infusion of study medication (including partial infusions).
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
PF-04360365 0.1 mg/kg (Part A)
PF-04360365 0.1 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part A of the study.
BG001
PF-04360365 0.5 mg/kg (Part A)
PF-04360365 0.5 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part A of the study.
BG002
PF-04360365 1.0 mg/kg (Part A)
PF-04360365 1.0 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part A of the study.
BG003
Placebo (Part A)
Placebo intravenous infusion over 2 hours every 60 days up to 18 months in Part A of the study.
BG004
PF-04360365 3.0 mg/kg (Part B)
PF-04360365 3.0 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part B of the study.
BG005
PF-04360365 8.5 mg/kg (Part B)
PF-04360365 8.5 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part B of the study.
BG006
Placebo (Part B)
Placebo intravenous infusion over 2 hours every 60 days up to 18 months in Part B of the study.
BG007
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00025
BG00125
BG00225
BG00324
BG00432
BG00531
BG00632
BG007194
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± 8.2
BG00171.9± 9.4
BG00272.2± 8.4
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00012
BG00115
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
Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence in a participant who received study medication without regard to possibility of causal relationship. SAE: an AE resulting in any of following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs are events between first dose of study medication and up to 6 months after last dose that were absent before treatment or worsened relative to pre-treatment state.
Safety analysis set included all participants who received an infusion of study medication (including partial infusions).
Posted
Count of Participants
Participants
Day 1 up to 6 months after last dose of study medication, assessed up to Month 24
ID
Title
Description
OG000
PF-04360365 0.1 mg/kg (Part A)
PF-04360365 0.1 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part A of the study.
OG001
PF-04360365 0.5 mg/kg (Part A)
PF-04360365 0.5 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part A of the study.
OG002
PF-04360365 1.0 mg/kg (Part A)
PF-04360365 1.0 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part A of the study.
OG003
Placebo (Part A)
Placebo intravenous infusion over 2 hours every 60 days up to 18 months in Part A of the study.
OG004
PF-04360365 3.0 mg/kg (Part B)
PF-04360365 3.0 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part B of the study.
OG005
PF-04360365 8.5 mg/kg (Part B)
PF-04360365 8.5 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part B of the study.
OG006
Placebo (Part B)
Placebo intravenous infusion over 2 hours every 60 days up to 18 months in Part B of the study.
Units
Counts
Participants
OG00025
OG00125
OG00225
OG003
Title
Denominators
Categories
AEs
Title
Measurements
OG00024
OG00124
OG00224
OG003
Primary
Number of Participants With Change From Baseline in Brain Magnetic Resonance Imaging (MRI) Abnormalities
Number of participants with new clinical findings not evident on the baseline scans, such as brain edema, hemorrhage, encephalitis and other pathology (cerebral/meningeal enhancement, parenchymal hematoma, subarachnoid hemorrhage, subdural hematoma, cortical infarcts, subcortical grey matter infarcts, white matter infarcts and white matter hyperintensities) were assessed from structural MRI. Participants with brain abnormality other than those listed above, assessed using MRI scan, were reported under other abnormality. Baseline was defined as the last assessment prior to the first study drug infusion.
Safety analysis set included all participants who received an infusion of study medication (including partial infusions). Here "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Posted
Count of Participants
Participants
Baseline up to Month 24
ID
Title
Description
OG000
PF-04360365 0.1 mg/kg (Part A)
PF-04360365 0.1 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part A of the study.
OG001
PF-04360365 0.5 mg/kg (Part A)
PF-04360365 0.5 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part A of the study.
OG002
Primary
Number of Participants With Gadolinium Use in Brain Magnetic Resonance Imaging (MRI)
Brain MRI included gadolinium contrast if investigator determined this was necessary for participant care either based on clinical signs or the non-contrast MRI. This decision was made by the investigator on the basis of change in the clinical examination or in response to a possible abnormality seen on the non-contrast brain MRI. Baseline was defined as the last assessment prior to the first study drug infusion.
Safety analysis set included all participants who received an infusion of study medication (including partial infusions). Here "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Posted
Count of Participants
Participants
Baseline up to Month 24
ID
Title
Description
OG000
PF-04360365 0.1 mg/kg (Part A)
PF-04360365 0.1 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part A of the study.
OG001
PF-04360365 0.5 mg/kg (Part A)
PF-04360365 0.5 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part A of the study.
OG002
PF-04360365 1.0 mg/kg (Part A)
PF-04360365 1.0 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part A of the study.
Primary
Mean Cerebrospinal Fluid (CSF) Concentration of PF-04360365 at 0 Hour on Day 0
Only participants received PF-04360365 were analyzed for this outcome measure.
Pharmacokinetic (PK) analysis set included all participants who received at least 1 infusion of study medication. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Posted
Mean
Standard Deviation
Nanogram per milliliter
0 Hour on Day 0
ID
Title
Description
OG000
PF-04360365 0.1 mg/kg (Part A)
PF-04360365 0.1 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part A of the study.
OG001
PF-04360365 0.5 mg/kg (Part A)
PF-04360365 0.5 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part A of the study.
OG002
PF-04360365 1.0 mg/kg (Part A)
PF-04360365 1.0 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part A of the study.
OG003
PF-04360365 3.0 mg/kg (Part B)
Primary
Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 1
Only participants received PF-04360365 were analyzed for this outcome measure.
PK analysis set included all participants who received at least 1 infusion of study medication. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Posted
Mean
Standard Deviation
Nanogram per milliliter
0 Hour (pre-dose) on Day 1
ID
Title
Description
OG000
PF-04360365 0.1 mg/kg (Part A)
PF-04360365 0.1 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part A of the study.
OG001
PF-04360365 0.5 mg/kg (Part A)
PF-04360365 0.5 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part A of the study.
OG002
PF-04360365 1.0 mg/kg (Part A)
PF-04360365 1.0 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part A of the study.
OG003
PF-04360365 3.0 mg/kg (Part B)
PF-04360365 3.0 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part B of the study.
Primary
Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 1
Only participants received PF-04360365 were analyzed for this outcome measure.
PK analysis set included all participants who received at least 1 infusion of study medication. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Posted
Mean
Standard Deviation
Nanogram per milliliter
2 Hours on Day 1
ID
Title
Description
OG000
PF-04360365 0.1 mg/kg (Part A)
PF-04360365 0.1 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part A of the study.
OG001
PF-04360365 0.5 mg/kg (Part A)
PF-04360365 0.5 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part A of the study.
OG002
PF-04360365 1.0 mg/kg (Part A)
PF-04360365 1.0 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part A of the study.
OG003
PF-04360365 3.0 mg/kg (Part B)
PF-04360365 3.0 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part B of the study.
Primary
Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 60
Only participants received PF-04360365 were analyzed for this outcome measure.
PK analysis set included all participants who received at least 1 infusion of study medication. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Posted
Mean
Standard Deviation
Nanogram per milliliter
0 Hour (pre-dose) on Day 60
ID
Title
Description
OG000
PF-04360365 0.1 mg/kg (Part A)
PF-04360365 0.1 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part A of the study.
OG001
PF-04360365 0.5 mg/kg (Part A)
PF-04360365 0.5 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part A of the study.
OG002
PF-04360365 1.0 mg/kg (Part A)
PF-04360365 1.0 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part A of the study.
OG003
PF-04360365 3.0 mg/kg (Part B)
PF-04360365 3.0 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part B of the study.
Primary
Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 60
Only participants received PF-04360365 were analyzed for this outcome measure.
PK analysis set included all participants who received at least 1 infusion of study medication. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Posted
Mean
Standard Deviation
Nanogram per milliliter
2 Hours on Day 60
ID
Title
Description
OG000
PF-04360365 0.1 mg/kg (Part A)
PF-04360365 0.1 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part A of the study.
OG001
PF-04360365 0.5 mg/kg (Part A)
PF-04360365 0.5 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part A of the study.
OG002
PF-04360365 1.0 mg/kg (Part A)
PF-04360365 1.0 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part A of the study.
OG003
PF-04360365 3.0 mg/kg (Part B)
PF-04360365 3.0 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part B of the study.
Primary
Mean Plasma and Cerebrospinal Fluid (CSF) Concentration of PF-04360365 on Day 90
Only participants received PF-04360365 were analyzed for this outcome measure.
PK analysis set included all participants who received at least 1 infusion of study medication. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and 'Number Analyzed' signifies participants evaluable for specified rows.
Posted
Mean
Standard Deviation
Nanogram per milliliter
Day 90
ID
Title
Description
OG000
PF-04360365 0.1 mg/kg (Part A)
PF-04360365 0.1 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part A of the study.
OG001
PF-04360365 0.5 mg/kg (Part A)
PF-04360365 0.5 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part A of the study.
OG002
PF-04360365 1.0 mg/kg (Part A)
PF-04360365 1.0 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part A of the study.
OG003
PF-04360365 3.0 mg/kg (Part B)
Primary
Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 120
Only participants received PF-04360365 were analyzed for this outcome measure.
PK analysis set included all participants who received at least 1 infusion of study medication. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Posted
Mean
Standard Deviation
Nanogram per milliliter
0 Hour (pre-dose) on Day 120
ID
Title
Description
OG000
PF-04360365 0.1 mg/kg (Part A)
PF-04360365 0.1 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part A of the study.
OG001
PF-04360365 0.5 mg/kg (Part A)
PF-04360365 0.5 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part A of the study.
OG002
PF-04360365 1.0 mg/kg (Part A)
PF-04360365 1.0 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part A of the study.
OG003
PF-04360365 3.0 mg/kg (Part B)
PF-04360365 3.0 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part B of the study.
Primary
Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 120
Only participants received PF-04360365 were analyzed for this outcome measure.
PK analysis set included all participants who received at least 1 infusion of study medication. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Posted
Mean
Standard Deviation
Nanogram per milliliter
2 Hours on Day 120
ID
Title
Description
OG000
PF-04360365 0.1 mg/kg (Part A)
PF-04360365 0.1 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part A of the study.
OG001
PF-04360365 0.5 mg/kg (Part A)
PF-04360365 0.5 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part A of the study.
OG002
PF-04360365 1.0 mg/kg (Part A)
PF-04360365 1.0 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part A of the study.
OG003
PF-04360365 3.0 mg/kg (Part B)
PF-04360365 3.0 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part B of the study.
Primary
Mean Plasma Concentration of PF-04360365 on Day 150
Only participants received PF-04360365 were analyzed for this outcome measure.
PK analysis set included all participants who received at least 1 infusion of study medication. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Posted
Mean
Standard Deviation
Nanogram per milliliter
Day 150
ID
Title
Description
OG000
PF-04360365 0.1 mg/kg (Part A)
PF-04360365 0.1 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part A of the study.
OG001
PF-04360365 0.5 mg/kg (Part A)
PF-04360365 0.5 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part A of the study.
OG002
PF-04360365 1.0 mg/kg (Part A)
PF-04360365 1.0 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part A of the study.
OG003
PF-04360365 3.0 mg/kg (Part B)
PF-04360365 3.0 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part B of the study.
Primary
Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 180
Only participants received PF-04360365 were analyzed for this outcome measure.
PK analysis set included all participants who received at least 1 infusion of study medication. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Posted
Mean
Standard Deviation
Nanogram per milliliter
0 Hour (pre-dose) on Day 180
ID
Title
Description
OG000
PF-04360365 0.1 mg/kg (Part A)
PF-04360365 0.1 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part A of the study.
OG001
PF-04360365 0.5 mg/kg (Part A)
PF-04360365 0.5 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part A of the study.
OG002
PF-04360365 1.0 mg/kg (Part A)
PF-04360365 1.0 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part A of the study.
OG003
PF-04360365 3.0 mg/kg (Part B)
PF-04360365 3.0 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part B of the study.
Primary
Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 180
Only participants received PF-04360365 were analyzed for this outcome measure.
PK analysis set included all participants who received at least 1 infusion of study medication. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Posted
Mean
Standard Deviation
Nanogram per milliliter
2 Hours on Day 180
ID
Title
Description
OG000
PF-04360365 0.1 mg/kg (Part A)
PF-04360365 0.1 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part A of the study.
OG001
PF-04360365 0.5 mg/kg (Part A)
PF-04360365 0.5 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part A of the study.
OG002
PF-04360365 1.0 mg/kg (Part A)
PF-04360365 1.0 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part A of the study.
OG003
PF-04360365 3.0 mg/kg (Part B)
PF-04360365 3.0 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part B of the study.
Primary
Mean Plasma Concentration of PF-04360365 on Day 210
Only participants received PF-04360365 were analyzed for this outcome measure.
PK analysis set included all participants who received at least 1 infusion of study medication. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Posted
Mean
Standard Deviation
Nanogram per milliliter
Day 210
ID
Title
Description
OG000
PF-04360365 0.1 mg/kg (Part A)
PF-04360365 0.1 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part A of the study.
OG001
PF-04360365 0.5 mg/kg (Part A)
PF-04360365 0.5 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part A of the study.
OG002
PF-04360365 1.0 mg/kg (Part A)
PF-04360365 1.0 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part A of the study.
OG003
PF-04360365 3.0 mg/kg (Part B)
PF-04360365 3.0 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part B of the study.
Primary
Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 240
Only participants received PF-04360365 were analyzed for this outcome measure.
PK analysis set included all participants who received at least 1 infusion of study medication. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Posted
Mean
Standard Deviation
Nanogram per milliliter
0 Hour (pre-dose) on Day 240
ID
Title
Description
OG000
PF-04360365 0.1 mg/kg (Part A)
PF-04360365 0.1 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part A of the study.
OG001
PF-04360365 0.5 mg/kg (Part A)
PF-04360365 0.5 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part A of the study.
OG002
PF-04360365 1.0 mg/kg (Part A)
PF-04360365 1.0 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part A of the study.
OG003
PF-04360365 3.0 mg/kg (Part B)
PF-04360365 3.0 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part B of the study.
Primary
Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 240
Only participants received PF-04360365 were analyzed for this outcome measure.
PK analysis set included all participants who received at least 1 infusion of study medication. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Posted
Mean
Standard Deviation
Nanogram per milliliter
2 Hours on Day 240
ID
Title
Description
OG000
PF-04360365 0.1 mg/kg (Part A)
PF-04360365 0.1 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part A of the study.
OG001
PF-04360365 0.5 mg/kg (Part A)
PF-04360365 0.5 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part A of the study.
OG002
PF-04360365 1.0 mg/kg (Part A)
PF-04360365 1.0 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part A of the study.
OG003
PF-04360365 3.0 mg/kg (Part B)
PF-04360365 3.0 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part B of the study.
Primary
Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 300
Only participants received PF-04360365 were analyzed for this outcome measure.
PK analysis set included all participants who received at least 1 infusion of study medication. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Posted
Mean
Standard Deviation
Nanogram per milliliter
0 Hour (pre-dose) on Day 300
ID
Title
Description
OG000
PF-04360365 0.1 mg/kg (Part A)
PF-04360365 0.1 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part A of the study.
OG001
PF-04360365 0.5 mg/kg (Part A)
PF-04360365 0.5 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part A of the study.
OG002
PF-04360365 1.0 mg/kg (Part A)
PF-04360365 1.0 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part A of the study.
OG003
PF-04360365 3.0 mg/kg (Part B)
PF-04360365 3.0 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part B of the study.
Primary
Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 300
Only participants received PF-04360365 were analyzed for this outcome measure.
PK analysis set included all participants who received at least 1 infusion of study medication. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Posted
Mean
Standard Deviation
Nanogram per milliliter
2 Hours on Day 300
ID
Title
Description
OG000
PF-04360365 0.1 mg/kg (Part A)
PF-04360365 0.1 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part A of the study.
OG001
PF-04360365 0.5 mg/kg (Part A)
PF-04360365 0.5 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part A of the study.
OG002
PF-04360365 1.0 mg/kg (Part A)
PF-04360365 1.0 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part A of the study.
OG003
PF-04360365 3.0 mg/kg (Part B)
PF-04360365 3.0 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part B of the study.
Primary
Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 360
Only participants received PF-04360365 were analyzed for this outcome measure.
PK analysis set included all participants who received at least 1 infusion of study medication. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Posted
Mean
Standard Deviation
Nanogram per milliliter
0 Hour (pre-dose) on Day 360
ID
Title
Description
OG000
PF-04360365 0.1 mg/kg (Part A)
PF-04360365 0.1 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part A of the study.
OG001
PF-04360365 0.5 mg/kg (Part A)
PF-04360365 0.5 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part A of the study.
OG002
PF-04360365 1.0 mg/kg (Part A)
PF-04360365 1.0 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part A of the study.
OG003
PF-04360365 3.0 mg/kg (Part B)
PF-04360365 3.0 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part B of the study.
Primary
Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 360
Only participants received PF-04360365 were analyzed for this outcome measure.
PK analysis set included all participants who received at least 1 infusion of study medication. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Posted
Mean
Standard Deviation
Nanogram per milliliter
2 Hours on Day 360
ID
Title
Description
OG000
PF-04360365 0.1 mg/kg (Part A)
PF-04360365 0.1 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part A of the study.
OG001
PF-04360365 0.5 mg/kg (Part A)
PF-04360365 0.5 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part A of the study.
OG002
PF-04360365 1.0 mg/kg (Part A)
PF-04360365 1.0 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part A of the study.
OG003
PF-04360365 3.0 mg/kg (Part B)
PF-04360365 3.0 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part B of the study.
Primary
Mean Plasma Concentration of PF-04360365 on Day 390
Only participants received PF-04360365 were analyzed for this outcome measure.
PK analysis set included all participants who received at least 1 infusion of study medication. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Posted
Mean
Standard Deviation
Nanogram per milliliter
Day 390
ID
Title
Description
OG000
PF-04360365 0.1 mg/kg (Part A)
PF-04360365 0.1 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part A of the study.
OG001
PF-04360365 0.5 mg/kg (Part A)
PF-04360365 0.5 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part A of the study.
OG002
PF-04360365 1.0 mg/kg (Part A)
PF-04360365 1.0 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part A of the study.
OG003
PF-04360365 3.0 mg/kg (Part B)
PF-04360365 3.0 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part B of the study.
Primary
Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 420
Only participants received PF-04360365 were analyzed for this outcome measure.
PK analysis set included all participants who received at least 1 infusion of study medication. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Posted
Mean
Standard Deviation
Nanogram per milliliter
0 Hour (pre-dose) on Day 420
ID
Title
Description
OG000
PF-04360365 0.1 mg/kg (Part A)
PF-04360365 0.1 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part A of the study.
OG001
PF-04360365 0.5 mg/kg (Part A)
PF-04360365 0.5 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part A of the study.
OG002
PF-04360365 1.0 mg/kg (Part A)
PF-04360365 1.0 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part A of the study.
OG003
PF-04360365 3.0 mg/kg (Part B)
PF-04360365 3.0 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part B of the study.
Primary
Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 420
Only participants received PF-04360365 were analyzed for this outcome measure.
PK analysis set included all participants who received at least 1 infusion of study medication. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Posted
Mean
Standard Deviation
Nanogram per milliliter
2 Hours on Day 420
ID
Title
Description
OG000
PF-04360365 0.1 mg/kg (Part A)
PF-04360365 0.1 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part A of the study.
OG001
PF-04360365 0.5 mg/kg (Part A)
PF-04360365 0.5 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part A of the study.
OG002
PF-04360365 1.0 mg/kg (Part A)
PF-04360365 1.0 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part A of the study.
OG003
PF-04360365 3.0 mg/kg (Part B)
PF-04360365 3.0 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part B of the study.
Primary
Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 480
Only participants received PF-04360365 were analyzed for this outcome measure.
PK analysis set included all participants who received at least 1 infusion of study medication. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Posted
Mean
Standard Deviation
Nanogram per milliliter
0 Hour (pre-dose) on Day 480
ID
Title
Description
OG000
PF-04360365 0.1 mg/kg (Part A)
PF-04360365 0.1 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part A of the study.
OG001
PF-04360365 0.5 mg/kg (Part A)
PF-04360365 0.5 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part A of the study.
OG002
PF-04360365 1.0 mg/kg (Part A)
PF-04360365 1.0 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part A of the study.
OG003
PF-04360365 3.0 mg/kg (Part B)
PF-04360365 3.0 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part B of the study.
Primary
Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 480
Only participants received PF-04360365 were analyzed for this outcome measure.
PK analysis set included all participants who received at least 1 infusion of study medication. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Posted
Mean
Standard Deviation
Nanogram per milliliter
2 Hours on Day 480
ID
Title
Description
OG000
PF-04360365 0.1 mg/kg (Part A)
PF-04360365 0.1 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part A of the study.
OG001
PF-04360365 0.5 mg/kg (Part A)
PF-04360365 0.5 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part A of the study.
OG002
PF-04360365 1.0 mg/kg (Part A)
PF-04360365 1.0 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part A of the study.
OG003
PF-04360365 3.0 mg/kg (Part B)
PF-04360365 3.0 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part B of the study.
Primary
Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 540
Only participants received PF-04360365 were analyzed for this outcome measure.
PK analysis set included all participants who received at least 1 infusion of study medication. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Posted
Mean
Standard Deviation
Nanogram per milliliter
0 Hour (pre-dose) on Day 540
ID
Title
Description
OG000
PF-04360365 0.1 mg/kg (Part A)
PF-04360365 0.1 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part A of the study.
OG001
PF-04360365 0.5 mg/kg (Part A)
PF-04360365 0.5 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part A of the study.
OG002
PF-04360365 1.0 mg/kg (Part A)
PF-04360365 1.0 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part A of the study.
OG003
PF-04360365 3.0 mg/kg (Part B)
PF-04360365 3.0 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part B of the study.
Primary
Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 540
Only participants received PF-04360365 were analyzed for this outcome measure.
PK analysis set included all participants who received at least 1 infusion of study medication. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Posted
Mean
Standard Deviation
Nanogram per milliliter
2 Hours on Day 540
ID
Title
Description
OG000
PF-04360365 0.1 mg/kg (Part A)
PF-04360365 0.1 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part A of the study.
OG001
PF-04360365 0.5 mg/kg (Part A)
PF-04360365 0.5 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part A of the study.
OG002
PF-04360365 1.0 mg/kg (Part A)
PF-04360365 1.0 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part A of the study.
OG003
PF-04360365 3.0 mg/kg (Part B)
PF-04360365 3.0 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part B of the study.
Primary
Mean Plasma and Cerebrospinal Fluid (CSF) Concentration of PF-04360365 on Day 570
Only participants received PF-04360365 were analyzed for this outcome measure.
PK analysis set included all participants who received at least 1 infusion of study medication. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and 'Number Analyzed' signifies participants evaluable for specified category for rows.
Posted
Mean
Standard Deviation
Nanogram per milliliter
Day 570
ID
Title
Description
OG000
PF-04360365 0.1 mg/kg (Part A)
PF-04360365 0.1 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part A of the study.
OG001
PF-04360365 0.5 mg/kg (Part A)
PF-04360365 0.5 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part A of the study.
OG002
PF-04360365 1.0 mg/kg (Part A)
PF-04360365 1.0 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part A of the study.
OG003
PF-04360365 3.0 mg/kg (Part B)
Primary
Mean Plasma Concentration of PF-04360365 on Day 660
Only participants received PF-04360365 were analyzed for this outcome measure.
PK analysis set included all participants who received at least 1 infusion of study medication. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Posted
Mean
Standard Deviation
Nanogram per milliliter
Day 660
ID
Title
Description
OG000
PF-04360365 0.1 mg/kg (Part A)
PF-04360365 0.1 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part A of the study.
OG001
PF-04360365 0.5 mg/kg (Part A)
PF-04360365 0.5 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part A of the study.
OG002
PF-04360365 1.0 mg/kg (Part A)
PF-04360365 1.0 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part A of the study.
OG003
PF-04360365 3.0 mg/kg (Part B)
PF-04360365 3.0 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part B of the study.
Primary
Mean Plasma Concentration of PF-04360365 on Day 720
Only participants received PF-04360365 were analyzed for this outcome measure.
PK analysis set included all participants who received at least 1 infusion of study medication. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Posted
Mean
Standard Deviation
Nanogram per milliliter
Day 720
ID
Title
Description
OG000
PF-04360365 0.1 mg/kg (Part A)
PF-04360365 0.1 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part A of the study.
OG001
PF-04360365 0.5 mg/kg (Part A)
PF-04360365 0.5 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part A of the study.
OG002
PF-04360365 1.0 mg/kg (Part A)
PF-04360365 1.0 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part A of the study.
OG003
PF-04360365 3.0 mg/kg (Part B)
PF-04360365 3.0 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part B of the study.
Secondary
Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog) Score at Baseline
ADAS-cog is a structured scale assessing the severity of cognitive impairment in Alzheimer's Disease. It comprised of following 11 items (range): word recall (0-10), naming objects and fingers (0-5), following commands (0-5), constructional praxis (0-5), ideational praxis (0-5), orientation (0-8), word recognition (0-12), recall of test instructions (0-5), spoken language ability (0-5), word-finding difficulty (0-5), comprehension of spoken language (0-5). ADAS-cog total score was calculated as the sum of scores for the 11 items and ranged from 0 to 70. Higher total and individual item scores indicate greater cognitive impairment. Baseline was defined as the last assessment prior to the first study drug infusion.
Full analysis set (FAS) included all randomized participants who had received at least 1 infusion of study medication. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Posted
Mean
Standard Deviation
Units on a scale
Baseline
ID
Title
Description
OG000
PF-04360365 0.1 mg/kg (Part A)
PF-04360365 0.1 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part A of the study.
OG001
PF-04360365 0.5 mg/kg (Part A)
PF-04360365 0.5 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part A of the study.
Secondary
Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog) Score at Month 19
ADAS-cog is a structured scale assessing the severity of cognitive impairment in Alzheimer's Disease. It comprised of following 11 items (range): word recall (0-10), naming objects and fingers (0-5), following commands (0-5), constructional praxis (0-5), ideational praxis (0-5), orientation (0-8), word recognition (0-12), recall of test instructions (0-5), spoken language ability (0-5), word-finding difficulty (0-5), comprehension of spoken language (0-5). ADAS-cog total score was calculated as the sum of scores for the 11 items and ranged from 0 to 70. Higher total and individual item scores indicate greater cognitive impairment. Baseline was defined as the last assessment prior to the first study drug infusion.
FAS included all randomized participants who had received at least 1 infusion of study medication. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Posted
Least Squares Mean
Standard Error
Units on a scale
Baseline and Month 19
ID
Title
Description
OG000
PF-04360365 0.1 mg/kg (Part A)
PF-04360365 0.1 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part A of the study.
OG001
PF-04360365 0.5 mg/kg (Part A)
PF-04360365 0.5 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part A of the study.
Secondary
Disability Assessment for Dementia (DAD) Score at Baseline
DAD is a functional assessment based on interview with the caregiver. It consisted of 40 items, 17 related to self-care and 23 items involving instrumental activities of daily living. Each item was scored as yes = 1, no = 0 and not applicable= N/A. A total score was obtained by adding the rating for each question and converting this to a total score out of 100. The items rated N/A were not considered for the total score. DAD total score ranged from 0 to 100, with higher scores indicating better functioning. Baseline was defined as the last assessment prior to the first study drug infusion.
FAS included all randomized participants who had received at least 1 infusion of study medication.
Posted
Mean
Standard Deviation
Units on a scale
Baseline
ID
Title
Description
OG000
PF-04360365 0.1 mg/kg (Part A)
PF-04360365 0.1 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part A of the study.
OG001
PF-04360365 0.5 mg/kg (Part A)
PF-04360365 0.5 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part A of the study.
OG002
PF-04360365 1.0 mg/kg (Part A)
PF-04360365 1.0 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part A of the study.
Secondary
Change From Baseline in Disability Assessment for Dementia (DAD) Score at Month 19
DAD is a functional assessment based on interview with the caregiver. It consisted of 40 items, 17 related to self-care and 23 items involving instrumental activities of daily living. Each item was scored as yes = 1, no = 0 and not applicable= N/A. A total score was obtained by adding the rating for each question and converting this to a total score out of 100. The items rated N/A were not considered for the total score. DAD total score ranged from 0 to 100, with higher scores indicating better functioning. Baseline was defined as the last assessment prior to the first study drug infusion.
FAS included all randomized participants who had received at least 1 infusion of study medication. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Posted
Least Squares Mean
Standard Error
Units on a scale
Baseline and Month 19
ID
Title
Description
OG000
PF-04360365 0.1 mg/kg (Part A)
PF-04360365 0.1 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part A of the study.
OG001
PF-04360365 0.5 mg/kg (Part A)
PF-04360365 0.5 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part A of the study.
OG002
PF-04360365 1.0 mg/kg (Part A)
Secondary
Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x)
FAS included all randomized participants who had received at least 1 infusion of study medication. Here 'Number Analyzed' signifies participants evaluable at the specified time point.
Posted
Mean
Standard Deviation
Picogram per milliliter
0 Hour (pre-dose) and 2 hours on Day 1, 60, 120, 180, 240, 300, 360, 420, 480, 540; Day 90, 150, 210, 390, 570, 660, 720
ID
Title
Description
OG000
PF-04360365 0.1 mg/kg (Part A)
PF-04360365 0.1 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part A of the study.
OG001
PF-04360365 0.5 mg/kg (Part A)
PF-04360365 0.5 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part A of the study.
OG002
PF-04360365 1.0 mg/kg (Part A)
PF-04360365 1.0 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part A of the study.
OG003
Placebo (Part A)
Placebo intravenous infusion over 2 hours every 60 days up to 18 months in Part A of the study.
Secondary
Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40)
FAS included all randomized participants who had received at least 1 infusion of study medication. Here 'Number Analyzed' signifies participants evaluable at the specified time point.
Posted
Mean
Standard Deviation
Picogram per milliliter
0 Hour (pre-dose) and 2 hours on Day 1, 60, 120, 180, 240, 300, 360, 420, 480, 540; Day 90, 150, 210, 390, 570, 660, 720
ID
Title
Description
OG000
PF-04360365 0.1 mg/kg (Part A)
PF-04360365 0.1 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part A of the study.
OG001
PF-04360365 0.5 mg/kg (Part A)
PF-04360365 0.5 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part A of the study.
OG002
PF-04360365 1.0 mg/kg (Part A)
PF-04360365 1.0 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part A of the study.
OG003
Placebo (Part A)
Placebo intravenous infusion over 2 hours every 60 days up to 18 months in Part A of the study.
Secondary
Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42)
Results are not reported for PF-04360365 0.1, 0.5, 1.0 mg/kg, Placebo (Part A and B) arms because plasma Aβ1-42 concentrations were sporadic and below the lower limit of quantification (20 pg/mL).
FAS included all randomized participants who had received at least 1 infusion of study medication. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and 'Number Analyzed' signifies participants evaluable at the specified time point.
Posted
Mean
Standard Deviation
Picogram per milliliter
0 Hour (pre-dose) and 2 hours on Day 1, 60, 120, 180, 240, 300, 360, 420, 480, 540; Day 90, 150, 210, 390, 570, 660, 720
ID
Title
Description
OG000
PF-04360365 0.1 mg/kg (Part A)
PF-04360365 0.1 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part A of the study.
OG001
PF-04360365 0.5 mg/kg (Part A)
PF-04360365 0.5 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part A of the study.
OG002
PF-04360365 1.0 mg/kg (Part A)
PF-04360365 1.0 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part A of the study.
Secondary
Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (Aβ1-x)
FAS included all randomized participants who had received at least 1 infusion of study medication. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and 'Number Analyzed' signifies participants evaluable at the specified time point.
Posted
Mean
Standard Deviation
Picogram per milliliter
Day 0 (Hour 0), 90, 570
ID
Title
Description
OG000
PF-04360365 0.1 mg/kg (Part A)
PF-04360365 0.1 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part A of the study.
OG001
PF-04360365 0.5 mg/kg (Part A)
PF-04360365 0.5 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part A of the study.
OG002
PF-04360365 1.0 mg/kg (Part A)
PF-04360365 1.0 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part A of the study.
OG003
Placebo (Part A)
Placebo intravenous infusion over 2 hours every 60 days up to 18 months in Part A of the study.
Secondary
Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-40 (Aβ1-40)
FAS included all randomized participants who had received at least 1 infusion of study medication. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and 'Number Analyzed' signifies participants evaluable at the specified time point.
Posted
Mean
Standard Deviation
Picogram per milliliter
Day 0 (Hour 0), 90, 570
ID
Title
Description
OG000
PF-04360365 0.1 mg/kg (Part A)
PF-04360365 0.1 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part A of the study.
OG001
PF-04360365 0.5 mg/kg (Part A)
PF-04360365 0.5 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part A of the study.
OG002
PF-04360365 1.0 mg/kg (Part A)
PF-04360365 1.0 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part A of the study.
OG003
Placebo (Part A)
Placebo intravenous infusion over 2 hours every 60 days up to 18 months in Part A of the study.
Secondary
Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-42 (Aβ1-42)
FAS included all randomized participants who had received at least 1 infusion of study medication. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and 'Number Analyzed' signifies participants evaluable at the specified time point.
Posted
Mean
Standard Deviation
Picogram per milliliter
Day 0 (Hour 0), 90, 570
ID
Title
Description
OG000
PF-04360365 0.1 mg/kg (Part A)
PF-04360365 0.1 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part A of the study.
OG001
PF-04360365 0.5 mg/kg (Part A)
PF-04360365 0.5 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part A of the study.
OG002
PF-04360365 1.0 mg/kg (Part A)
PF-04360365 1.0 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part A of the study.
OG003
Placebo (Part A)
Placebo intravenous infusion over 2 hours every 60 days up to 18 months in Part A of the study.
Secondary
Mean Cerebrospinal Fluid (CSF) Concentration of Total Tau and Phospho-tau (P-tau)
FAS included all randomized participants who had received at least 1 infusion of study medication. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and 'Number Analyzed' signifies participants evaluable at the specified time point.
Posted
Mean
Standard Deviation
Picogram per milliliter
Day 0 (Hour 0), 90, 570
ID
Title
Description
OG000
PF-04360365 0.1 mg/kg (Part A)
PF-04360365 0.1 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part A of the study.
OG001
PF-04360365 0.5 mg/kg (Part A)
PF-04360365 0.5 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part A of the study.
OG002
PF-04360365 1.0 mg/kg (Part A)
PF-04360365 1.0 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part A of the study.
OG003
Placebo (Part A)
Placebo intravenous infusion over 2 hours every 60 days up to 18 months in Part A of the study.
Secondary
Number of Participants With Abnormal Cerebrospinal Fluid (CSF) Protein, Red Blood Cells (RBCs), White Blood Cells (WBCs), and Glucose Concentration
Abnormality was defined as concentration either less than lower limit of normal (LLN) or more than upper limit of normal (ULN). Baseline was defined as the last assessment prior to the first study drug infusion
Safety analysis set included all participants who received an infusion of study medication (including partial infusions). Here "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and 'Number Analyzed' signifies participants evaluable for specified row.
Posted
Count of Participants
Participants
Baseline up to Month 24
ID
Title
Description
OG000
PF-04360365 0.1 mg/kg (Part A)
PF-04360365 0.1 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part A of the study.
OG001
PF-04360365 0.5 mg/kg (Part A)
PF-04360365 0.5 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part A of the study.
OG002
PF-04360365 1.0 mg/kg (Part A)
PF-04360365 1.0 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part A of the study.
Secondary
Number of Participants With Serum Anti-Drug Anti Body (ADA)
Serum samples were analyzed for the presence or absence of anti-PF-04360365 antibodies using validated semi-quantitative enzyme linked immunosorbent assay (ELISA). Only participants receiving PF-04360365 were analyzed for this outcome measure.
Safety analysis set included all participants who received an infusion of study medication (including partial infusions).
Posted
Count of Participants
Participants
Day 1 up to Month 24
ID
Title
Description
OG000
PF-04360365 0.1 mg/kg (Part A)
PF-04360365 0.1 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part A of the study.
OG001
PF-04360365 0.5 mg/kg (Part A)
PF-04360365 0.5 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part A of the study.
OG002
PF-04360365 1.0 mg/kg (Part A)
PF-04360365 1.0 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part A of the study.
OG003
PF-04360365 3.0 mg/kg (Part B)
Time Frame
Not provided
Description
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
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
PF-04360365 0.1 mg/kg (Part A)
PF-04360365 0.1 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part A of the study.
7
25
24
25
EG001
PF-04360365 0.5 mg/kg (Part A)
PF-04360365 0.5 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part A of the study.
8
25
24
25
EG002
PF-04360365 1.0 mg/kg (Part A)
PF-04360365 1.0 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part A of the study.
7
25
23
25
EG003
Placebo (Part A)
Placebo intravenous infusion over 2 hours every 60 days up to 18 months in Part A of the study.
3
24
24
24
EG004
PF-04360365 3.0 mg/kg (Part B)
PF-04360365 3.0 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part B of the study.
7
32
26
32
EG005
PF-04360365 8.5 mg/kg (Part B)
PF-04360365 8.5 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part B of the study.
10
31
28
31
EG006
Placebo (Part B)
Placebo intravenous infusion over 2 hours every 60 days up to 18 months in Part B of the study.
3
32
32
32
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0021 affected25 at risk
EG0030 affected24 at risk
EG0040 affected32 at risk
EG0050 affected31 at risk
EG0060 affected32 at risk
Acute coronary syndrome
Cardiac disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Acute myocardial infarction
Cardiac disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Angina pectoris
Cardiac disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0021 affected25 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 14.0
Non-systematic Assessment
EG0001 affected25 at risk
EG0011 affected25 at risk
EG0020 affected25 at risk
EG003
Bradycardia
Cardiac disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0011 affected25 at risk
EG0020 affected25 at risk
EG003
Cardiogenic shock
Cardiac disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Coronary artery stenosis
Cardiac disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Myocardial ischaemia
Cardiac disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Sick sinus syndrome
Cardiac disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Vertigo positional
Ear and labyrinth disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Colonic polyp
Gastrointestinal disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0021 affected25 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Periodontitis
Gastrointestinal disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Rectal haemorrhage
Gastrointestinal disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Chest discomfort
General disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0011 affected25 at risk
EG0020 affected25 at risk
EG003
Pyrexia
General disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Cholecystitis acute
Hepatobiliary disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0011 affected25 at risk
EG0020 affected25 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 14.0
Non-systematic Assessment
EG0001 affected25 at risk
EG0010 affected25 at risk
EG0021 affected25 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0011 affected25 at risk
EG0020 affected25 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0021 affected25 at risk
EG003
Hip fracture
Injury, poisoning and procedural complications
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0021 affected25 at risk
EG003
Humerus fracture
Injury, poisoning and procedural complications
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0021 affected25 at risk
EG003
Incisional hernia
Injury, poisoning and procedural complications
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Joint dislocation
Injury, poisoning and procedural complications
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0021 affected25 at risk
EG003
Medication error
Injury, poisoning and procedural complications
MedDRA 14.0
Non-systematic Assessment
EG0001 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Muscle rupture
Injury, poisoning and procedural complications
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Rib fracture
Injury, poisoning and procedural complications
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0011 affected25 at risk
EG0020 affected25 at risk
EG003
Road traffic accident
Injury, poisoning and procedural complications
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0011 affected25 at risk
EG0020 affected25 at risk
EG003
Skull fracture
Injury, poisoning and procedural complications
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0011 affected25 at risk
EG0020 affected25 at risk
EG003
Spinal compression fracture
Injury, poisoning and procedural complications
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Subdural haematoma
Injury, poisoning and procedural complications
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0011 affected25 at risk
EG0020 affected25 at risk
EG003
Wrong drug administered
Injury, poisoning and procedural complications
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Haemosiderosis
Metabolism and nutrition disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0011 affected25 at risk
EG0020 affected25 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA 14.0
Non-systematic Assessment
EG0001 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Bursitis
Musculoskeletal and connective tissue disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Periarthritis
Musculoskeletal and connective tissue disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Rotator cuff syndrome
Musculoskeletal and connective tissue disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Breast cancer in situ
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Colon adenoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Ovarian neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0011 affected25 at risk
EG0020 affected25 at risk
EG003
Prostate cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Squamous cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 14.0
Non-systematic Assessment
EG0001 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Altered state of consciousness
Nervous system disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Cerebral haemorrhage
Nervous system disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0011 affected25 at risk
EG0020 affected25 at risk
EG003
Cerebral ischaemia
Nervous system disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Convulsion
Nervous system disorders
MedDRA 14.0
Non-systematic Assessment
EG0001 affected25 at risk
EG0011 affected25 at risk
EG0020 affected25 at risk
EG003
Dementia Alzheimer's type
Nervous system disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Guillain-Barre syndrome
Nervous system disorders
MedDRA 14.0
Non-systematic Assessment
EG0001 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Haemorrhage intracranial
Nervous system disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Meningeal disorder
Nervous system disorders
MedDRA 14.0
Non-systematic Assessment
EG0001 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Presyncope
Nervous system disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0021 affected25 at risk
EG003
Subdural hygroma
Nervous system disorders
MedDRA 14.0
Non-systematic Assessment
EG0001 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Syncope
Nervous system disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0011 affected25 at risk
EG0020 affected25 at risk
EG003
Transient ischaemic attack
Nervous system disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Vasogenic cerebral oedema
Nervous system disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0011 affected25 at risk
EG0020 affected25 at risk
EG003
Aggression
Psychiatric disorders
MedDRA 14.0
Non-systematic Assessment
EG0001 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Agitation
Psychiatric disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0021 affected25 at risk
EG003
Delirium
Psychiatric disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0011 affected25 at risk
EG0022 affected25 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0011 affected25 at risk
EG0020 affected25 at risk
EG003
Benign prostatic hyperplasia
Reproductive system and breast disorders
MedDRA 14.0
Non-systematic Assessment
EG0001 affected25 at risk
EG0011 affected25 at risk
EG0020 affected25 at risk
EG003
Fibrocystic breast disease
Reproductive system and breast disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Acute pulmonary oedema
Respiratory, thoracic and mediastinal disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Haemothorax
Respiratory, thoracic and mediastinal disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0011 affected25 at risk
EG0020 affected25 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 14.0
Non-systematic Assessment
EG0001 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 14.0
Non-systematic Assessment
EG0001 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 14.0
Non-systematic Assessment
EG0002 affected25 at risk
EG0013 affected25 at risk
EG0020 affected25 at risk
EG0030 affected24 at risk
EG0040 affected32 at risk
EG0051 affected31 at risk
EG0064 affected32 at risk
Iron deficiency anaemia
Blood and lymphatic system disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Leukocytosis
Blood and lymphatic system disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0011 affected25 at risk
EG0020 affected25 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0021 affected25 at risk
EG003
Angina pectoris
Cardiac disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Arrhythmia
Cardiac disorders
MedDRA 14.0
Non-systematic Assessment
EG0001 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 14.0
Non-systematic Assessment
EG0002 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Atrial flutter
Cardiac disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0021 affected25 at risk
EG003
Atrial tachycardia
Cardiac disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Atrioventricular block second degree
Cardiac disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Bradycardia
Cardiac disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0011 affected25 at risk
EG0020 affected25 at risk
EG003
Coronary artery disease
Cardiac disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Extrasystoles
Cardiac disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0011 affected25 at risk
EG0020 affected25 at risk
EG003
Palpitations
Cardiac disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Sinus bradycardia
Cardiac disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0022 affected25 at risk
EG003
Supraventricular tachycardia
Cardiac disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0021 affected25 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA 14.0
Non-systematic Assessment
EG0001 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Ventricular extrasystoles
Cardiac disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0012 affected25 at risk
EG0020 affected25 at risk
EG003
Phimosis
Congenital, familial and genetic disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Deafness bilateral
Ear and labyrinth disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0021 affected25 at risk
EG003
Deafness unilateral
Ear and labyrinth disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Ear discomfort
Ear and labyrinth disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0011 affected25 at risk
EG0020 affected25 at risk
EG003
Ear disorder
Ear and labyrinth disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Hearing impaired
Ear and labyrinth disorders
MedDRA 14.0
Non-systematic Assessment
EG0001 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Hyperacusis
Ear and labyrinth disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Tinnitus
Ear and labyrinth disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0021 affected25 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0021 affected25 at risk
EG003
Age-related macular degeneration
Eye disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Blepharitis
Eye disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Cataract
Eye disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0011 affected25 at risk
EG0020 affected25 at risk
EG003
Conjunctival haemorrhage
Eye disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Conjunctivitis
Eye disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0021 affected25 at risk
EG003
Conjunctivitis allergic
Eye disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0011 affected25 at risk
EG0020 affected25 at risk
EG003
Erythema of eyelid
Eye disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Eye disorder
Eye disorders
MedDRA 14.0
Non-systematic Assessment
EG0001 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Eye irritation
Eye disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0021 affected25 at risk
EG003
Eyelid retraction
Eye disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0021 affected25 at risk
EG003
Keratitis
Eye disorders
MedDRA 14.0
Non-systematic Assessment
EG0001 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Ocular hyperaemia
Eye disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Photopsia
Eye disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Pupils unequal
Eye disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0021 affected25 at risk
EG003
Retinal haemorrhage
Eye disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0011 affected25 at risk
EG0020 affected25 at risk
EG003
Visual acuity reduced
Eye disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0021 affected25 at risk
EG003
Visual impairment
Eye disorders
MedDRA 14.0
Non-systematic Assessment
EG0001 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Vitreous floaters
Eye disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Xerophthalmia
Eye disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0011 affected25 at risk
EG0020 affected25 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0012 affected25 at risk
EG0022 affected25 at risk
EG003
Abdominal pain lower
Gastrointestinal disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0021 affected25 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0021 affected25 at risk
EG003
Anorectal discomfort
Gastrointestinal disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0011 affected25 at risk
EG0020 affected25 at risk
EG003
Colonic polyp
Gastrointestinal disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 14.0
Non-systematic Assessment
EG0003 affected25 at risk
EG0012 affected25 at risk
EG0022 affected25 at risk
EG003
Dental caries
Gastrointestinal disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0011 affected25 at risk
EG0020 affected25 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 14.0
Non-systematic Assessment
EG0003 affected25 at risk
EG0013 affected25 at risk
EG0025 affected25 at risk
EG003
Diverticulum
Gastrointestinal disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0011 affected25 at risk
EG0020 affected25 at risk
EG003
Diverticulum intestinal
Gastrointestinal disorders
MedDRA 14.0
Non-systematic Assessment
EG0001 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Duodenitis
Gastrointestinal disorders
MedDRA 14.0
Non-systematic Assessment
EG0001 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Faecal incontinence
Gastrointestinal disorders
MedDRA 14.0
Non-systematic Assessment
EG0002 affected25 at risk
EG0012 affected25 at risk
EG0020 affected25 at risk
EG003
Faeces discoloured
Gastrointestinal disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Frequent bowel movements
Gastrointestinal disorders
MedDRA 14.0
Non-systematic Assessment
EG0001 affected25 at risk
EG0010 affected25 at risk
EG0021 affected25 at risk
EG003
Gastric ulcer
Gastrointestinal disorders
MedDRA 14.0
Non-systematic Assessment
EG0001 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Gastritis atrophic
Gastrointestinal disorders
MedDRA 14.0
Non-systematic Assessment
EG0001 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Haematochezia
Gastrointestinal disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0011 affected25 at risk
EG0020 affected25 at risk
EG003
Haemorrhoidal haemorrhage
Gastrointestinal disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Hiatus hernia
Gastrointestinal disorders
MedDRA 14.0
Non-systematic Assessment
EG0001 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Lip swelling
Gastrointestinal disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 14.0
Non-systematic Assessment
EG0003 affected25 at risk
EG0014 affected25 at risk
EG0021 affected25 at risk
EG003
Palatal disorder
Gastrointestinal disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0011 affected25 at risk
EG0020 affected25 at risk
EG003
Pancreatic cyst
Gastrointestinal disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Periodontitis
Gastrointestinal disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0011 affected25 at risk
EG0020 affected25 at risk
EG003
Rectal haemorrhage
Gastrointestinal disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Salivary hypersecretion
Gastrointestinal disorders
MedDRA 14.0
Non-systematic Assessment
EG0001 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0021 affected25 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 14.0
Non-systematic Assessment
EG0003 affected25 at risk
EG0014 affected25 at risk
EG0021 affected25 at risk
EG003
Asthenia
General disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0012 affected25 at risk
EG0022 affected25 at risk
EG003
Chest discomfort
General disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0012 affected25 at risk
EG0021 affected25 at risk
EG003
Chest pain
General disorders
MedDRA 14.0
Non-systematic Assessment
EG0001 affected25 at risk
EG0010 affected25 at risk
EG0021 affected25 at risk
EG003
Fatigue
General disorders
MedDRA 14.0
Non-systematic Assessment
EG0004 affected25 at risk
EG0013 affected25 at risk
EG0025 affected25 at risk
EG003
Gait disturbance
General disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0021 affected25 at risk
EG003
Inflammation
General disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Influenza like illness
General disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Infusion site extravasation
General disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Injection site erythema
General disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0021 affected25 at risk
EG003
Injection site oedema
General disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0011 affected25 at risk
EG0021 affected25 at risk
EG003
Injection site rash
General disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0021 affected25 at risk
EG003
Irritability
General disorders
MedDRA 14.0
Non-systematic Assessment
EG0001 affected25 at risk
EG0012 affected25 at risk
EG0020 affected25 at risk
EG003
Malaise
General disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Oedema peripheral
General disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0011 affected25 at risk
EG0021 affected25 at risk
EG003
Pain
General disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Sensation of foreign body
General disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0011 affected25 at risk
EG0020 affected25 at risk
EG003
Hepatotoxicity
Hepatobiliary disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Drug hypersensitivity
Immune system disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Hypersensitivity
Immune system disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Abscess
Infections and infestations
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0011 affected25 at risk
EG0020 affected25 at risk
EG003
Bacteriuria
Infections and infestations
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0011 affected25 at risk
EG0022 affected25 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0011 affected25 at risk
EG0020 affected25 at risk
EG003
Cystitis
Infections and infestations
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0022 affected25 at risk
EG003
Dermatitis infected
Infections and infestations
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Fungal infection
Infections and infestations
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Furuncle
Infections and infestations
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0021 affected25 at risk
EG003
Helicobacter gastritis
Infections and infestations
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Herpes simplex
Infections and infestations
MedDRA 14.0
Non-systematic Assessment
EG0001 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0012 affected25 at risk
EG0021 affected25 at risk
EG003
Infection
Infections and infestations
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Influenza
Infections and infestations
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0022 affected25 at risk
EG003
Labyrinthitis
Infections and infestations
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Laryngitis
Infections and infestations
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0021 affected25 at risk
EG003
Lobar pneumonia
Infections and infestations
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Localised infection
Infections and infestations
MedDRA 14.0
Non-systematic Assessment
EG0001 affected25 at risk
EG0011 affected25 at risk
EG0020 affected25 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MedDRA 14.0
Non-systematic Assessment
EG0001 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 14.0
Non-systematic Assessment
EG0004 affected25 at risk
EG0010 affected25 at risk
EG0022 affected25 at risk
EG003
Onychomycosis
Infections and infestations
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0012 affected25 at risk
EG0020 affected25 at risk
EG003
Oral herpes
Infections and infestations
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0021 affected25 at risk
EG003
Otitis externa
Infections and infestations
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0011 affected25 at risk
EG0020 affected25 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0023 affected25 at risk
EG003
Pulmonary tuberculosis
Infections and infestations
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Rash pustular
Infections and infestations
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Rhinitis
Infections and infestations
MedDRA 14.0
Non-systematic Assessment
EG0001 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0011 affected25 at risk
EG0021 affected25 at risk
EG003
Tinea pedis
Infections and infestations
MedDRA 14.0
Non-systematic Assessment
EG0001 affected25 at risk
EG0010 affected25 at risk
EG0021 affected25 at risk
EG003
Tooth abscess
Infections and infestations
MedDRA 14.0
Non-systematic Assessment
EG0001 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 14.0
Non-systematic Assessment
EG0005 affected25 at risk
EG0014 affected25 at risk
EG0025 affected25 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 14.0
Non-systematic Assessment
EG0004 affected25 at risk
EG0013 affected25 at risk
EG0022 affected25 at risk
EG003
Arthropod bite
Injury, poisoning and procedural complications
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0011 affected25 at risk
EG0020 affected25 at risk
EG003
Arthropod sting
Injury, poisoning and procedural complications
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Bladder injury
Injury, poisoning and procedural complications
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Concussion
Injury, poisoning and procedural complications
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 14.0
Non-systematic Assessment
EG0001 affected25 at risk
EG0014 affected25 at risk
EG0021 affected25 at risk
EG003
Ear abrasion
Injury, poisoning and procedural complications
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0021 affected25 at risk
EG003
Excoriation
Injury, poisoning and procedural complications
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0021 affected25 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 14.0
Non-systematic Assessment
EG0002 affected25 at risk
EG0013 affected25 at risk
EG0023 affected25 at risk
EG003
Foreign body
Injury, poisoning and procedural complications
MedDRA 14.0
Non-systematic Assessment
EG0001 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Gas poisoning
Injury, poisoning and procedural complications
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Gingival injury
Injury, poisoning and procedural complications
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Head injury
Injury, poisoning and procedural complications
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Joint sprain
Injury, poisoning and procedural complications
MedDRA 14.0
Non-systematic Assessment
EG0001 affected25 at risk
EG0011 affected25 at risk
EG0020 affected25 at risk
EG003
Laceration
Injury, poisoning and procedural complications
MedDRA 14.0
Non-systematic Assessment
EG0001 affected25 at risk
EG0011 affected25 at risk
EG0021 affected25 at risk
EG003
Limb injury
Injury, poisoning and procedural complications
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Lip injury
Injury, poisoning and procedural complications
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Muscle injury
Injury, poisoning and procedural complications
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Muscle strain
Injury, poisoning and procedural complications
MedDRA 14.0
Non-systematic Assessment
EG0001 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Nail injury
Injury, poisoning and procedural complications
MedDRA 14.0
Non-systematic Assessment
EG0001 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Periorbital haematoma
Injury, poisoning and procedural complications
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0011 affected25 at risk
EG0021 affected25 at risk
EG003
Post lumbar puncture syndrome
Injury, poisoning and procedural complications
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Postoperative respiratory distress
Injury, poisoning and procedural complications
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0011 affected25 at risk
EG0020 affected25 at risk
EG003
Pubis fracture
Injury, poisoning and procedural complications
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0011 affected25 at risk
EG0020 affected25 at risk
EG003
Radius fracture
Injury, poisoning and procedural complications
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Rib fracture
Injury, poisoning and procedural complications
MedDRA 14.0
Non-systematic Assessment
EG0001 affected25 at risk
EG0011 affected25 at risk
EG0020 affected25 at risk
EG003
Scratch
Injury, poisoning and procedural complications
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Skeletal injury
Injury, poisoning and procedural complications
MedDRA 14.0
Non-systematic Assessment
EG0001 affected25 at risk
EG0010 affected25 at risk
EG0021 affected25 at risk
EG003
Soft tissue injury
Injury, poisoning and procedural complications
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0011 affected25 at risk
EG0020 affected25 at risk
EG003
Spinal compression fracture
Injury, poisoning and procedural complications
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0011 affected25 at risk
EG0020 affected25 at risk
EG003
Subcutaneous haematoma
Injury, poisoning and procedural complications
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Subdural haematoma
Injury, poisoning and procedural complications
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Traumatic haematoma
Injury, poisoning and procedural complications
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Bacterial test positive
Investigations
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0011 affected25 at risk
EG0020 affected25 at risk
EG003
Bleeding time prolonged
Investigations
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0021 affected25 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0011 affected25 at risk
EG0020 affected25 at risk
EG003
Blood cholesterol increased
Investigations
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 14.0
Non-systematic Assessment
EG0001 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Blood glucose fluctuation
Investigations
MedDRA 14.0
Non-systematic Assessment
EG0001 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Blood glucose increased
Investigations
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Blood potassium decreased
Investigations
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Blood pressure decreased
Investigations
MedDRA 14.0
Non-systematic Assessment
EG0001 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Blood pressure increased
Investigations
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Blood pressure systolic increased
Investigations
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Blood sodium increased
Investigations
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Body temperature increased
Investigations
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Cardiac murmur
Investigations
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Carotid bruit
Investigations
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0011 affected25 at risk
EG0020 affected25 at risk
EG003
Creatinine renal clearance decreased
Investigations
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Electrocardiogram ST segment depression
Investigations
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0011 affected25 at risk
EG0020 affected25 at risk
EG003
Electrocardiogram T wave inversion
Investigations
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0012 affected25 at risk
EG0020 affected25 at risk
EG003
Electrocardiogram abnormal
Investigations
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0021 affected25 at risk
EG003
Haemoglobin decreased
Investigations
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0021 affected25 at risk
EG003
Heart rate decreased
Investigations
MedDRA 14.0
Non-systematic Assessment
EG0001 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Hepatic enzyme increased
Investigations
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Liver function test abnormal
Investigations
MedDRA 14.0
Non-systematic Assessment
EG0001 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA 14.0
Non-systematic Assessment
EG0001 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Platelet count decreased
Investigations
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0021 affected25 at risk
EG003
Prostatic specific antigen abnormal
Investigations
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Prostatic specific antigen increased
Investigations
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Vitamin B12 increased
Investigations
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Weight decreased
Investigations
MedDRA 14.0
Non-systematic Assessment
EG0002 affected25 at risk
EG0013 affected25 at risk
EG0024 affected25 at risk
EG003
Weight increased
Investigations
MedDRA 14.0
Non-systematic Assessment
EG0004 affected25 at risk
EG0012 affected25 at risk
EG0021 affected25 at risk
EG003
White blood cell count increased
Investigations
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
White blood cells urine positive
Investigations
MedDRA 14.0
Non-systematic Assessment
EG0001 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0011 affected25 at risk
EG0022 affected25 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0011 affected25 at risk
EG0020 affected25 at risk
EG003
Diabetes mellitus
Metabolism and nutrition disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Glucose tolerance impaired
Metabolism and nutrition disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Gout
Metabolism and nutrition disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0011 affected25 at risk
EG0020 affected25 at risk
EG003
Haemosiderosis
Metabolism and nutrition disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Hypercholesterolaemia
Metabolism and nutrition disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Hyperlipidaemia
Metabolism and nutrition disorders
MedDRA 14.0
Non-systematic Assessment
EG0001 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Hypertriglyceridaemia
Metabolism and nutrition disorders
MedDRA 14.0
Non-systematic Assessment
EG0001 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 14.0
Non-systematic Assessment
EG0001 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Increased appetite
Metabolism and nutrition disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0011 affected25 at risk
EG0020 affected25 at risk
EG003
Vitamin D deficiency
Metabolism and nutrition disorders
MedDRA 14.0
Non-systematic Assessment
EG0001 affected25 at risk
EG0011 affected25 at risk
EG0020 affected25 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0012 affected25 at risk
EG0022 affected25 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA 14.0
Non-systematic Assessment
EG0001 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 14.0
Non-systematic Assessment
EG0002 affected25 at risk
EG0012 affected25 at risk
EG0024 affected25 at risk
EG003
Bone lesion
Musculoskeletal and connective tissue disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0011 affected25 at risk
EG0020 affected25 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Intervertebral disc degeneration
Musculoskeletal and connective tissue disorders
MedDRA 14.0
Non-systematic Assessment
EG0001 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Intervertebral disc protrusion
Musculoskeletal and connective tissue disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Joint stiffness
Musculoskeletal and connective tissue disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0011 affected25 at risk
EG0020 affected25 at risk
EG003
Joint swelling
Musculoskeletal and connective tissue disorders
MedDRA 14.0
Non-systematic Assessment
EG0001 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 14.0
Non-systematic Assessment
EG0002 affected25 at risk
EG0010 affected25 at risk
EG0021 affected25 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0021 affected25 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0021 affected25 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 14.0
Non-systematic Assessment
EG0002 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Musculoskeletal stiffness
Musculoskeletal and connective tissue disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0011 affected25 at risk
EG0020 affected25 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 14.0
Non-systematic Assessment
EG0001 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0011 affected25 at risk
EG0022 affected25 at risk
EG003
Nodal osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0011 affected25 at risk
EG0020 affected25 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0011 affected25 at risk
EG0020 affected25 at risk
EG003
Osteopenia
Musculoskeletal and connective tissue disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0011 affected25 at risk
EG0020 affected25 at risk
EG003
Osteoporosis
Musculoskeletal and connective tissue disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0011 affected25 at risk
EG0020 affected25 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 14.0
Non-systematic Assessment
EG0002 affected25 at risk
EG0011 affected25 at risk
EG0022 affected25 at risk
EG003
Periarthritis
Musculoskeletal and connective tissue disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Posture abnormal
Musculoskeletal and connective tissue disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Rotator cuff syndrome
Musculoskeletal and connective tissue disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Scoliosis
Musculoskeletal and connective tissue disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0021 affected25 at risk
EG003
Tendonitis
Musculoskeletal and connective tissue disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Fibrous histiocytoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Gastric neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Lipoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Lung neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0021 affected25 at risk
EG003
Metastases to liver
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0011 affected25 at risk
EG0020 affected25 at risk
EG003
Neoplasm skin
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Prostate cancer metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0021 affected25 at risk
EG003
Skin cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Skin papilloma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Squamous cell carcinoma of skin
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Uterine leiomyoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Akathisia
Nervous system disorders
MedDRA 14.0
Non-systematic Assessment
EG0001 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Altered state of consciousness
Nervous system disorders
MedDRA 14.0
Non-systematic Assessment
EG0001 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Aphasia
Nervous system disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0011 affected25 at risk
EG0020 affected25 at risk
EG003
Apraxia
Nervous system disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0021 affected25 at risk
EG003
Balance disorder
Nervous system disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Bradykinesia
Nervous system disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Brain stem microhaemorrhage
Nervous system disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Cerebellar microhaemorrhage
Nervous system disorders
MedDRA 14.0
Non-systematic Assessment
EG0001 affected25 at risk
EG0010 affected25 at risk
EG0021 affected25 at risk
EG003
Cerebral atrophy
Nervous system disorders
MedDRA 14.0
Non-systematic Assessment
EG0001 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Cerebral infarction
Nervous system disorders
MedDRA 14.0
Non-systematic Assessment
EG0001 affected25 at risk
EG0010 affected25 at risk
EG0021 affected25 at risk
EG003
Cerebral ischaemia
Nervous system disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Cerebral microhaemorrhage
Nervous system disorders
MedDRA 14.0
Non-systematic Assessment
EG0004 affected25 at risk
EG0016 affected25 at risk
EG0021 affected25 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Chorea
Nervous system disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0021 affected25 at risk
EG003
Cognitive disorder
Nervous system disorders
MedDRA 14.0
Non-systematic Assessment
EG0001 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Cogwheel rigidity
Nervous system disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Convulsion
Nervous system disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0011 affected25 at risk
EG0020 affected25 at risk
EG003
Dementia Alzheimer's type
Nervous system disorders
MedDRA 14.0
Non-systematic Assessment
EG0001 affected25 at risk
EG0011 affected25 at risk
EG0020 affected25 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 14.0
Non-systematic Assessment
EG0002 affected25 at risk
EG0012 affected25 at risk
EG0021 affected25 at risk
EG003
Dizziness postural
Nervous system disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0022 affected25 at risk
EG003
Dyskinesia
Nervous system disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Dyspraxia
Nervous system disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Essential tremor
Nervous system disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Extrapyramidal disorder
Nervous system disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0021 affected25 at risk
EG003
Gait apraxia
Nervous system disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0011 affected25 at risk
EG0020 affected25 at risk
EG003
Haemorrhagic cerebral infarction
Nervous system disorders
MedDRA 14.0
Non-systematic Assessment
EG0001 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Headache
Nervous system disorders
MedDRA 14.0
Non-systematic Assessment
EG0004 affected25 at risk
EG0013 affected25 at risk
EG0021 affected25 at risk
EG003
Hemiplegia
Nervous system disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Hyperaesthesia
Nervous system disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Hyperreflexia
Nervous system disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Hypertonia
Nervous system disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Intention tremor
Nervous system disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0011 affected25 at risk
EG0021 affected25 at risk
EG003
Lethargy
Nervous system disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Migraine
Nervous system disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0011 affected25 at risk
EG0020 affected25 at risk
EG003
Muscle contractions involuntary
Nervous system disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Myoclonus
Nervous system disorders
MedDRA 14.0
Non-systematic Assessment
EG0001 affected25 at risk
EG0010 affected25 at risk
EG0021 affected25 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Parkinson's disease
Nervous system disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0011 affected25 at risk
EG0020 affected25 at risk
EG003
Parkinsonism
Nervous system disorders
MedDRA 14.0
Non-systematic Assessment
EG0002 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Pleurothotonus
Nervous system disorders
MedDRA 14.0
Non-systematic Assessment
EG0001 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Presyncope
Nervous system disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Somnolence
Nervous system disorders
MedDRA 14.0
Non-systematic Assessment
EG0001 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Subdural hygroma
Nervous system disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Superficial siderosis of central nervous system
Nervous system disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Syncope
Nervous system disorders
MedDRA 14.0
Non-systematic Assessment
EG0001 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Thalamic infarction
Nervous system disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Transient ischaemic attack
Nervous system disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Tremor
Nervous system disorders
MedDRA 14.0
Non-systematic Assessment
EG0002 affected25 at risk
EG0011 affected25 at risk
EG0020 affected25 at risk
EG003
Upper motor neurone lesion
Nervous system disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0021 affected25 at risk
EG003
VIIth nerve paralysis
Nervous system disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0021 affected25 at risk
EG003
Visual field defect
Nervous system disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Abnormal dreams
Psychiatric disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Affect lability
Psychiatric disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Aggression
Psychiatric disorders
MedDRA 14.0
Non-systematic Assessment
EG0002 affected25 at risk
EG0012 affected25 at risk
EG0021 affected25 at risk
EG003
Agitation
Psychiatric disorders
MedDRA 14.0
Non-systematic Assessment
EG0001 affected25 at risk
EG0014 affected25 at risk
EG0023 affected25 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 14.0
Non-systematic Assessment
EG0003 affected25 at risk
EG0015 affected25 at risk
EG0021 affected25 at risk
EG003
Apathy
Psychiatric disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0011 affected25 at risk
EG0020 affected25 at risk
EG003
Behavioural and psychiatric symptoms of dementia
Psychiatric disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0022 affected25 at risk
EG003
Delirium
Psychiatric disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0022 affected25 at risk
EG003
Delusion
Psychiatric disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0011 affected25 at risk
EG0022 affected25 at risk
EG003
Depressed mood
Psychiatric disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0022 affected25 at risk
EG003
Depression
Psychiatric disorders
MedDRA 14.0
Non-systematic Assessment
EG0002 affected25 at risk
EG0010 affected25 at risk
EG0024 affected25 at risk
EG003
Depressive symptom
Psychiatric disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Disinhibition
Psychiatric disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0021 affected25 at risk
EG003
Disorientation
Psychiatric disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0021 affected25 at risk
EG003
Emotional disorder
Psychiatric disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Generalised anxiety disorder
Psychiatric disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Hallucination
Psychiatric disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Hallucination, auditory
Psychiatric disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0011 affected25 at risk
EG0020 affected25 at risk
EG003
Hallucination, visual
Psychiatric disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0021 affected25 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0011 affected25 at risk
EG0021 affected25 at risk
EG003
Jealous delusion
Psychiatric disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Libido decreased
Psychiatric disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Mental status changes
Psychiatric disorders
MedDRA 14.0
Non-systematic Assessment
EG0001 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Nightmare
Psychiatric disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0011 affected25 at risk
EG0020 affected25 at risk
EG003
Panic attack
Psychiatric disorders
MedDRA 14.0
Non-systematic Assessment
EG0001 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Paranoia
Psychiatric disorders
MedDRA 14.0
Non-systematic Assessment
EG0002 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Psychotic disorder
Psychiatric disorders
MedDRA 14.0
Non-systematic Assessment
EG0001 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Sleep disorder
Psychiatric disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0011 affected25 at risk
EG0020 affected25 at risk
EG003
Sleep talking
Psychiatric disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Stereotypy
Psychiatric disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0021 affected25 at risk
EG003
Suicidal ideation
Psychiatric disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Atonic urinary bladder
Renal and urinary disorders
MedDRA 14.0
Non-systematic Assessment
EG0001 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Bladder disorder
Renal and urinary disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Calculus bladder
Renal and urinary disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0021 affected25 at risk
EG003
Enuresis
Renal and urinary disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA 14.0
Non-systematic Assessment
EG0002 affected25 at risk
EG0010 affected25 at risk
EG0022 affected25 at risk
EG003
Hypertonic bladder
Renal and urinary disorders
MedDRA 14.0
Non-systematic Assessment
EG0001 affected25 at risk
EG0010 affected25 at risk
EG0021 affected25 at risk
EG003
Incontinence
Renal and urinary disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0021 affected25 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Pollakiuria
Renal and urinary disorders
MedDRA 14.0
Non-systematic Assessment
EG0002 affected25 at risk
EG0010 affected25 at risk
EG0021 affected25 at risk
EG003
Renal cyst
Renal and urinary disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Renal failure
Renal and urinary disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0011 affected25 at risk
EG0020 affected25 at risk
EG003
Renal impairment
Renal and urinary disorders
MedDRA 14.0
Non-systematic Assessment
EG0001 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Urethral stenosis
Renal and urinary disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0021 affected25 at risk
EG003
Urinary incontinence
Renal and urinary disorders
MedDRA 14.0
Non-systematic Assessment
EG0002 affected25 at risk
EG0012 affected25 at risk
EG0021 affected25 at risk
EG003
Urinary retention
Renal and urinary disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0022 affected25 at risk
EG003
Urinary tract obstruction
Renal and urinary disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0011 affected25 at risk
EG0020 affected25 at risk
EG003
Balanoposthitis
Reproductive system and breast disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Benign prostatic hyperplasia
Reproductive system and breast disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0012 affected25 at risk
EG0024 affected25 at risk
EG003
Breast mass
Reproductive system and breast disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Endometrial hyperplasia
Reproductive system and breast disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Erectile dysfunction
Reproductive system and breast disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Prostatism
Reproductive system and breast disorders
MedDRA 14.0
Non-systematic Assessment
EG0001 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Prostatomegaly
Reproductive system and breast disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Uterine prolapse
Reproductive system and breast disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Vaginal haemorrhage
Reproductive system and breast disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0021 affected25 at risk
EG003
Acute pulmonary oedema
Respiratory, thoracic and mediastinal disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Bronchitis chronic
Respiratory, thoracic and mediastinal disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0011 affected25 at risk
EG0020 affected25 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 14.0
Non-systematic Assessment
EG0002 affected25 at risk
EG0012 affected25 at risk
EG0028 affected25 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0021 affected25 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA 14.0
Non-systematic Assessment
EG0002 affected25 at risk
EG0011 affected25 at risk
EG0020 affected25 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0011 affected25 at risk
EG0020 affected25 at risk
EG003
Hyperventilation
Respiratory, thoracic and mediastinal disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0011 affected25 at risk
EG0020 affected25 at risk
EG003
Nasal discomfort
Respiratory, thoracic and mediastinal disorders
MedDRA 14.0
Non-systematic Assessment
EG0001 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Nasal dryness
Respiratory, thoracic and mediastinal disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0021 affected25 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Paranasal cyst
Respiratory, thoracic and mediastinal disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0011 affected25 at risk
EG0020 affected25 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 14.0
Non-systematic Assessment
EG0001 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Pulmonary granuloma
Respiratory, thoracic and mediastinal disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0011 affected25 at risk
EG0020 affected25 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA 14.0
Non-systematic Assessment
EG0002 affected25 at risk
EG0010 affected25 at risk
EG0021 affected25 at risk
EG003
Wheezing
Respiratory, thoracic and mediastinal disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0021 affected25 at risk
EG003
Acne
Skin and subcutaneous tissue disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0011 affected25 at risk
EG0020 affected25 at risk
EG003
Actinic keratosis
Skin and subcutaneous tissue disorders
MedDRA 14.0
Non-systematic Assessment
EG0001 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Alopecia areata
Skin and subcutaneous tissue disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0021 affected25 at risk
EG003
Dermal cyst
Skin and subcutaneous tissue disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0021 affected25 at risk
EG003
Dermatitis
Skin and subcutaneous tissue disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Dermatitis contact
Skin and subcutaneous tissue disorders
MedDRA 14.0
Non-systematic Assessment
EG0001 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Drug eruption
Skin and subcutaneous tissue disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA 14.0
Non-systematic Assessment
EG0001 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Ecchymosis
Skin and subcutaneous tissue disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0021 affected25 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA 14.0
Non-systematic Assessment
EG0001 affected25 at risk
EG0010 affected25 at risk
EG0021 affected25 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Hyperkeratosis
Skin and subcutaneous tissue disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0021 affected25 at risk
EG003
Ingrowing nail
Skin and subcutaneous tissue disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0011 affected25 at risk
EG0020 affected25 at risk
EG003
Nail disorder
Skin and subcutaneous tissue disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Neurodermatitis
Skin and subcutaneous tissue disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0021 affected25 at risk
EG003
Night sweats
Skin and subcutaneous tissue disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Pain of skin
Skin and subcutaneous tissue disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Petechiae
Skin and subcutaneous tissue disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0011 affected25 at risk
EG0020 affected25 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 14.0
Non-systematic Assessment
EG0002 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Pruritus generalised
Skin and subcutaneous tissue disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 14.0
Non-systematic Assessment
EG0004 affected25 at risk
EG0010 affected25 at risk
EG0021 affected25 at risk
EG003
Rash erythematous
Skin and subcutaneous tissue disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Rash macular
Skin and subcutaneous tissue disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA 14.0
Non-systematic Assessment
EG0001 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Rash papular
Skin and subcutaneous tissue disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0021 affected25 at risk
EG003
Rash vesicular
Skin and subcutaneous tissue disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Skin irritation
Skin and subcutaneous tissue disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0011 affected25 at risk
EG0021 affected25 at risk
EG003
Skin lesion
Skin and subcutaneous tissue disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0011 affected25 at risk
EG0022 affected25 at risk
EG003
Skin plaque
Skin and subcutaneous tissue disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0021 affected25 at risk
EG003
Skin ulcer
Skin and subcutaneous tissue disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Subcutaneous nodule
Skin and subcutaneous tissue disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Telangiectasia
Skin and subcutaneous tissue disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Menopause
Social circumstances
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0021 affected25 at risk
EG003
Verbal abuse
Social circumstances
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0011 affected25 at risk
EG0020 affected25 at risk
EG003
Haemorrhoid operation
Surgical and medical procedures
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Aortic disorder
Vascular disorders
MedDRA 14.0
Non-systematic Assessment
EG0001 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Aortic stenosis
Vascular disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Flushing
Vascular disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Haematoma
Vascular disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0011 affected25 at risk
EG0021 affected25 at risk
EG003
Haemorrhage
Vascular disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Hot flush
Vascular disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0011 affected25 at risk
EG0020 affected25 at risk
EG003
Hypertension
Vascular disorders
MedDRA 14.0
Non-systematic Assessment
EG0004 affected25 at risk
EG0013 affected25 at risk
EG0020 affected25 at risk
EG003
Hypotension
Vascular disorders
MedDRA 14.0
Non-systematic Assessment
EG0001 affected25 at risk
EG0011 affected25 at risk
EG0021 affected25 at risk
EG003
Infarction
Vascular disorders
MedDRA 14.0
Non-systematic Assessment
EG0001 affected25 at risk
EG0010 affected25 at risk
EG0020 affected25 at risk
EG003
Varicose vein
Vascular disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0011 affected25 at risk
EG0020 affected25 at risk
EG003
Data for CSF protein, RBCs, WBCs, and glucose was recorded as number of participants with laboratory test abnormalities and not as change from baseline values as planned.
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Point of Contact
Title
Organization
Phone
Extension
Email
Pfizer ClinicalTrials.gov Call Center
Pfizer Inc.
1-800-718-1021
ClinicalTrials.gov_Inquiries@pfizer.com
ID
Term
D000544
Alzheimer Disease
Ancestor Terms
ID
Term
D003704
Dementia
D001927
Brain Diseases
D002493
Central Nervous System Diseases
D009422
Nervous System Diseases
D024801
Tauopathies
D019636
Neurodegenerative Diseases
D019965
Neurocognitive Disorders
D001523
Mental Disorders
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C572721
ponezumab
Ancestor Terms
Not provided
Browse Leaves
Not provided
Browse Branches
Not provided
0 subjects
FG0050 subjects
FG0062 subjects
0 subjects
FG0051 subjects
FG0060 subjects
4 subjects
FG0057 subjects
FG0063 subjects
0 subjects
FG0050 subjects
FG0060 subjects
3 subjects
FG0052 subjects
FG0061 subjects
70.0
± 7.8
BG00470.5± 8.9
BG00571.8± 7.3
BG00670.4± 10.3
BG00771.1± 8.6
11
BG00313
BG00420
BG00517
BG00617
BG007105
Male
BG00013
BG00110
BG00214
BG00311
BG00412
BG00514
BG00615
BG00789
24
OG00432
OG00531
OG00632
24
OG00427
OG00528
OG00632
SAEs
Title
Measurements
OG0007
OG0018
OG0027
OG0033
OG0047
OG00510
OG0063
PF-04360365 1.0 mg/kg (Part A)
PF-04360365 1.0 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part A of the study.
OG003
Placebo (Part A)
Placebo intravenous infusion over 2 hours every 60 days up to 18 months in Part A of the study.
OG004
PF-04360365 3.0 mg/kg (Part B)
PF-04360365 3.0 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part B of the study.
OG005
PF-04360365 8.5 mg/kg (Part B)
PF-04360365 8.5 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part B of the study.
OG006
Placebo (Part B)
Placebo intravenous infusion over 2 hours every 60 days up to 18 months in Part B of the study.
Units
Counts
Participants
OG00025
OG00125
OG00225
OG00324
OG00431
OG00528
OG00632
Title
Denominators
Categories
Cerebral Edema
Title
Measurements
OG0000
OG0011
OG0020
OG0030
OG0040
OG0050
OG0060
Cerebral/Meningeal Enhancement
Title
Measurements
OG0000
OG0011
OG0020
OG003
Micro Hemorrhage
Title
Measurements
OG0004
OG0017
OG0022
OG003
Subdural Hematoma
Title
Measurements
OG0000
OG0011
OG0020
OG003
Cortical Infarcts
Title
Measurements
OG0001
OG0010
OG0022
OG003
Subcortical Grey Matter Infarcts
Title
Measurements
OG0000
OG0010
OG0020
OG003
White Matter Infarcts
Title
Measurements
OG0000
OG0011
OG0020
OG003
White Matter Hyper Intensities
Title
Measurements
OG0000
OG0013
OG0022
OG003
Other Abnormality
Title
Measurements
OG00012
OG0019
OG0028
OG003
OG003
Placebo (Part A)
Placebo intravenous infusion over 2 hours every 60 days up to 18 months in Part A of the study.
OG004
PF-04360365 3.0 mg/kg (Part B)
PF-04360365 3.0 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part B of the study.
OG005
PF-04360365 8.5 mg/kg (Part B)
PF-04360365 8.5 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part B of the study.
OG006
Placebo (Part B)
Placebo intravenous infusion over 2 hours every 60 days up to 18 months in Part B of the study.
Units
Counts
Participants
OG00025
OG00125
OG00225
OG00324
OG00431
OG00528
OG00632
Title
Denominators
Categories
Title
Measurements
OG0003
OG0011
OG0022
OG0031
OG0041
OG0052
OG0063
PF-04360365 3.0 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part B of the study.
OG004
PF-04360365 8.5 mg/kg (Part B)
PF-04360365 8.5 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part B of the study.
Units
Counts
Participants
OG0003
OG0018
OG0024
OG00313
OG00411
Title
Denominators
Categories
Title
Measurements
OG0000.00± 0.00
OG0010.00± 0.00
OG0020.00± 0.00
OG0030.00± 0.00
OG0040.00± 0.00
OG004
PF-04360365 8.5 mg/kg (Part B)
PF-04360365 8.5 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part B of the study.
Units
Counts
Participants
OG00025
OG00125
OG00224
OG00330
OG00430
Title
Denominators
Categories
Title
Measurements
OG0000.00± 0.00
OG0010.00± 0.00
OG00214.25± 69.81
OG0030.00± 0.00
OG00438.10± 208.68
OG004
PF-04360365 8.5 mg/kg (Part B)
PF-04360365 8.5 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part B of the study.
Units
Counts
Participants
OG00022
OG00120
OG00223
OG00328
OG00427
Title
Denominators
Categories
Title
Measurements
OG0001731.36± 605.07
OG00110051.85± 1857.36
OG00221972.09± 6582.50
OG00365832.36± 23334.31
OG004187953.19± 36763.80
OG004
PF-04360365 8.5 mg/kg (Part B)
PF-04360365 8.5 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part B of the study.
Units
Counts
Participants
OG00025
OG00125
OG00225
OG00329
OG00429
Title
Denominators
Categories
Title
Measurements
OG00033.96± 82.22
OG001792.80± 217.31
OG0021747.04± 311.05
OG0036715.34± 3797.08
OG00430517.76± 34018.99
OG004
PF-04360365 8.5 mg/kg (Part B)
PF-04360365 8.5 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part B of the study.
Units
Counts
Participants
OG00023
OG00124
OG00224
OG00329
OG00423
Title
Denominators
Categories
Title
Measurements
OG0002018.13± 402.12
OG00111372.46± 2730.02
OG00223100.33± 5598.52
OG00381464.62± 25466.75
OG004209962.13± 64637.17
PF-04360365 3.0 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part B of the study.
OG004
PF-04360365 8.5 mg/kg (Part B)
PF-04360365 8.5 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part B of the study.
Units
Counts
Participants
OG00025
OG00125
OG00225
OG00330
OG00428
Title
Denominators
Categories
CSF
ParticipantsOG0004
ParticipantsOG0016
ParticipantsOG0025
ParticipantsOG00311
ParticipantsOG00410
Title
Measurements
OG0000.00± 0.00
OG0010.00± 0.00
OG0026.36± 14.22
OG003
Plasma
ParticipantsOG00025
ParticipantsOG00125
ParticipantsOG00225
ParticipantsOG00330
OG004
PF-04360365 8.5 mg/kg (Part B)
PF-04360365 8.5 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part B of the study.
Units
Counts
Participants
OG00025
OG00125
OG00225
OG00330
OG00427
Title
Denominators
Categories
Title
Measurements
OG000106.08± 116.00
OG0011259.68± 360.11
OG0022573.64± 622.86
OG0038781.20± 3267.52
OG00431916.04± 24631.87
OG004
PF-04360365 8.5 mg/kg (Part B)
PF-04360365 8.5 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part B of the study.
Units
Counts
Participants
OG00022
OG00125
OG00223
OG00327
OG00424
Title
Denominators
Categories
Title
Measurements
OG0002083.14± 549.16
OG00112229.60± 2813.13
OG00225263.43± 6395.62
OG00369437.52± 19262.08
OG004191019.54± 65338.19
OG004
PF-04360365 8.5 mg/kg (Part B)
PF-04360365 8.5 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part B of the study.
Units
Counts
Participants
OG00024
OG00125
OG00225
OG00330
OG00427
Title
Denominators
Categories
Title
Measurements
OG000344.17± 157.08
OG0012512.36± 804.43
OG0024673.32± 932.48
OG00317636.10± 6440.44
OG00453918.22± 15265.59
OG004
PF-04360365 8.5 mg/kg (Part B)
PF-04360365 8.5 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part B of the study.
Units
Counts
Participants
OG00024
OG00125
OG00225
OG00328
OG00426
Title
Denominators
Categories
Title
Measurements
OG000114.71± 137.86
OG0011344.00± 556.59
OG0022819.68± 819.68
OG0039885.71± 3673.92
OG00430306.81± 11823.33
OG004
PF-04360365 8.5 mg/kg (Part B)
PF-04360365 8.5 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part B of the study.
Units
Counts
Participants
OG00021
OG00123
OG00223
OG00326
OG00423
Title
Denominators
Categories
Title
Measurements
OG0001959.05± 650.77
OG00112096.22± 3346.68
OG00224574.57± 5989.22
OG00372597.58± 13930.48
OG004194768.61± 42953.08
OG004
PF-04360365 8.5 mg/kg (Part B)
PF-04360365 8.5 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part B of the study.
Units
Counts
Participants
OG00024
OG00124
OG00225
OG00328
OG00427
Title
Denominators
Categories
Title
Measurements
OG000245.33± 233.16
OG0012419.25± 1034.32
OG0024935.00± 1349.38
OG00317973.43± 6279.98
OG00455881.07± 17445.49
OG004
PF-04360365 8.5 mg/kg (Part B)
PF-04360365 8.5 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part B of the study.
Units
Counts
Participants
OG00025
OG00124
OG00224
OG00327
OG00426
Title
Denominators
Categories
Title
Measurements
OG000170.64± 389.00
OG0011423.83± 582.13
OG0022782.17± 1147.38
OG00311221.22± 4030.07
OG00431093.81± 11083.26
OG004
PF-04360365 8.5 mg/kg (Part B)
PF-04360365 8.5 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part B of the study.
Units
Counts
Participants
OG00021
OG00122
OG00224
OG00325
OG00423
Title
Denominators
Categories
Title
Measurements
OG0001660.76± 511.32
OG00110501.00± 2550.48
OG00222340.46± 5364.94
OG00380142.40± 15093.45
OG004216585.87± 32947.73
OG004
PF-04360365 8.5 mg/kg (Part B)
PF-04360365 8.5 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part B of the study.
Units
Counts
Participants
OG00024
OG00122
OG00224
OG00326
OG00427
Title
Denominators
Categories
Title
Measurements
OG000176.25± 140.95
OG0011690.41± 1585.87
OG0022958.13± 1150.02
OG00311935.88± 3779.50
OG00431766.30± 12335.11
OG004
PF-04360365 8.5 mg/kg (Part B)
PF-04360365 8.5 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part B of the study.
Units
Counts
Participants
OG00024
OG00120
OG00223
OG00324
OG00421
Title
Denominators
Categories
Title
Measurements
OG0001919.42± 446.62
OG00110774.35± 1736.85
OG00222273.26± 6285.72
OG00376511.29± 13832.35
OG004207292.95± 50582.35
OG004
PF-04360365 8.5 mg/kg (Part B)
PF-04360365 8.5 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part B of the study.
Units
Counts
Participants
OG00023
OG00121
OG00223
OG00326
OG00423
Title
Denominators
Categories
Title
Measurements
OG000247.52± 102.75
OG0011377.95± 476.42
OG0023161.00± 972.99
OG00310643.58± 3986.99
OG00431485.52± 12609.26
OG004
PF-04360365 8.5 mg/kg (Part B)
PF-04360365 8.5 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part B of the study.
Units
Counts
Participants
OG00022
OG00119
OG00221
OG00324
OG00419
Title
Denominators
Categories
Title
Measurements
OG0002019.23± 396.63
OG00111047.68± 2232.06
OG00222833.43± 4544.54
OG00371309.58± 12691.07
OG004203124.84± 35756.46
OG004
PF-04360365 8.5 mg/kg (Part B)
PF-04360365 8.5 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part B of the study.
Units
Counts
Participants
OG00022
OG00121
OG00222
OG00326
OG00423
Title
Denominators
Categories
Title
Measurements
OG000411.00± 195.94
OG0012344.76± 780.92
OG0024902.36± 1373.05
OG00318721.04± 6458.67
OG00454956.65± 20091.21
OG004
PF-04360365 8.5 mg/kg (Part B)
PF-04360365 8.5 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part B of the study.
Units
Counts
Participants
OG00021
OG00121
OG00221
OG00324
OG00421
Title
Denominators
Categories
Title
Measurements
OG000204.62± 123.72
OG0011433.52± 550.12
OG0023102.24± 1146.00
OG0039711.42± 3012.62
OG00430782.57± 11295.55
OG004
PF-04360365 8.5 mg/kg (Part B)
PF-04360365 8.5 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part B of the study.
Units
Counts
Participants
OG00018
OG00119
OG00218
OG00321
OG00416
Title
Denominators
Categories
Title
Measurements
OG0001919.50± 600.41
OG00111513.89± 1589.13
OG00223519.67± 4499.54
OG00369975.00± 16885.06
OG004196647.81± 29248.03
OG004
PF-04360365 8.5 mg/kg (Part B)
PF-04360365 8.5 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part B of the study.
Units
Counts
Participants
OG00023
OG00121
OG00220
OG00324
OG00422
Title
Denominators
Categories
Title
Measurements
OG000162.52± 161.33
OG0011480.95± 557.75
OG0023125.25± 1074.07
OG00310585.67± 3272.66
OG00426612.45± 12061.46
OG004
PF-04360365 8.5 mg/kg (Part B)
PF-04360365 8.5 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part B of the study.
Units
Counts
Participants
OG00021
OG00119
OG00219
OG00321
OG00418
Title
Denominators
Categories
Title
Measurements
OG0001936.67± 484.01
OG00111293.26± 2237.99
OG00222930.21± 4146.48
OG00367981.00± 10368.30
OG004169955.72± 35843.29
OG004
PF-04360365 8.5 mg/kg (Part B)
PF-04360365 8.5 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part B of the study.
Units
Counts
Participants
OG00023
OG00119
OG00216
OG00323
OG00423
Title
Denominators
Categories
Title
Measurements
OG000177.30± 163.34
OG0011297.26± 578.84
OG0022718.38± 949.54
OG00310372.65± 4310.28
OG00432303.09± 35225.88
OG004
PF-04360365 8.5 mg/kg (Part B)
PF-04360365 8.5 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part B of the study.
Units
Counts
Participants
OG00020
OG00115
OG00215
OG00322
OG00418
Title
Denominators
Categories
Title
Measurements
OG0001981.20± 591.23
OG00111291.40± 2033.92
OG00220793.73± 4168.51
OG00370660.14± 16140.32
OG004178273.50± 40289.00
PF-04360365 3.0 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part B of the study.
OG004
PF-04360365 8.5 mg/kg (Part B)
PF-04360365 8.5 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part B of the study.
Units
Counts
Participants
OG00022
OG00121
OG00218
OG00322
OG00422
Title
Denominators
Categories
CSF
ParticipantsOG0002
ParticipantsOG0014
ParticipantsOG0023
ParticipantsOG00310
ParticipantsOG0047
Title
Measurements
OG0000.00± 0.00
OG0010.00± 0.00
OG0026.30± 10.91
OG003
Plasma
ParticipantsOG00022
ParticipantsOG00121
ParticipantsOG00218
ParticipantsOG00322
OG004
PF-04360365 8.5 mg/kg (Part B)
PF-04360365 8.5 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part B of the study.
Units
Counts
Participants
OG00021
OG00118
OG00218
OG00322
OG00421
Title
Denominators
Categories
Title
Measurements
OG00010.33± 47.35
OG001480.78± 303.49
OG0021212.22± 596.19
OG0034196.50± 2342.84
OG0047576.29± 5013.34
OG004
PF-04360365 8.5 mg/kg (Part B)
PF-04360365 8.5 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part B of the study.
Units
Counts
Participants
OG00021
OG00120
OG00218
OG00323
OG00420
Title
Denominators
Categories
Title
Measurements
OG0000.00± 0.00
OG001198.70± 206.30
OG002590.56± 380.08
OG0031583.22± 1163.66
OG0042795.30± 1606.90
OG002
PF-04360365 1.0 mg/kg (Part A)
PF-04360365 1.0 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part A of the study.
OG003
Placebo (Part A)
Placebo intravenous infusion over 2 hours every 60 days up to 18 months in Part A of the study.
OG004
PF-04360365 3.0 mg/kg (Part B)
PF-04360365 3.0 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part B of the study.
OG005
PF-04360365 8.5 mg/kg (Part B)
PF-04360365 8.5 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part B of the study.
OG006
Placebo (Part B)
Placebo intravenous infusion over 2 hours every 60 days up to 18 months in Part B of the study.
Units
Counts
Participants
OG00025
OG00124
OG00225
OG00324
OG00431
OG00531
OG00632
Title
Denominators
Categories
Title
Measurements
OG00020.0± 7.87
OG00120.4± 8.19
OG00220.8± 6.08
OG00320.0± 6.98
OG00419.4± 6.96
OG00524.5± 10.15
OG00618.4± 7.45
OG002
PF-04360365 1.0 mg/kg (Part A)
PF-04360365 1.0 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part A of the study.
OG003
Placebo (Part A)
Placebo intravenous infusion over 2 hours every 60 days up to 18 months in Part A of the study.
OG004
PF-04360365 3.0 mg/kg (Part B)
PF-04360365 3.0 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part B of the study.
OG005
PF-04360365 8.5 mg/kg (Part B)
PF-04360365 8.5 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part B of the study.
OG006
Placebo (Part B)
Placebo intravenous infusion over 2 hours every 60 days up to 18 months in Part B of the study.
Units
Counts
Participants
OG00022
OG00118
OG00216
OG00318
OG00421
OG00521
OG00627
Title
Denominators
Categories
Title
Measurements
OG0008.36± 2.07
OG0019.00± 2.20
OG0029.25± 2.20
OG0036.98± 2.22
OG0049.58± 1.95
OG0058.71± 1.99
OG0067.85± 1.81
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
OG003
Mixed model repeated measures used terms for treatment, visit, baseline value, country, and treatment-by-visit interaction, with unstructured covariance matrix.
Mixed Models Analysis
0.6504
Least Squares (LS) Mean Difference
1.38
Standard Error of the Mean
3.04
2-Sided
90
-3.68
6.45
Superiority
OG001
OG003
Mixed model repeated measures used terms for treatment, visit, baseline value, country, and treatment-by-visit interaction, with unstructured covariance matrix.
Mixed Models Analysis
0.5213
LS Mean Difference
2.02
Standard Error of the Mean
3.13
2-Sided
90
-3.20
7.23
Superiority
OG002
OG003
Mixed model repeated measures used terms for treatment, visit, baseline value, country, and treatment-by-visit interaction, with unstructured covariance matrix.
Mixed Models Analysis
0.4698
LS Mean Difference
2.27
Standard Error of the Mean
3.13
2-Sided
90
-2.94
7.48
Superiority
OG004
OG006
Mixed model repeated measures used terms for treatment, visit, baseline value, country, and treatment-by-visit interaction, with unstructured covariance matrix.
Mixed Models Analysis
0.5183
LS Mean Difference
1.73
Standard Error of the Mean
2.66
2-Sided
90
-2.71
6.17
Superiority
OG005
OG006
Mixed model repeated measures used terms for treatment, visit, baseline value, country, and treatment-by-visit interaction, with unstructured covariance matrix.
Mixed Models Analysis
0.7529
LS Mean Difference
0.85
Standard Error of the Mean
2.70
2-Sided
90
-3.65
5.35
Superiority
OG003
Placebo (Part A)
Placebo intravenous infusion over 2 hours every 60 days up to 18 months in Part A of the study.
OG004
PF-04360365 3.0 mg/kg (Part B)
PF-04360365 3.0 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part B of the study.
OG005
PF-04360365 8.5 mg/kg (Part B)
PF-04360365 8.5 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part B of the study.
OG006
Placebo (Part B)
Placebo intravenous infusion over 2 hours every 60 days up to 18 months in Part B of the study.
Units
Counts
Participants
OG00025
OG00125
OG00225
OG00324
OG00432
OG00531
OG00632
Title
Denominators
Categories
Title
Measurements
OG00079.6± 13.73
OG00183.4± 12.83
OG00278.1± 20.55
OG00378.0± 16.40
OG00483.5± 13.16
OG00577.1± 20.16
OG00680.7± 15.60
PF-04360365 1.0 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part A of the study.
OG003
Placebo (Part A)
Placebo intravenous infusion over 2 hours every 60 days up to 18 months in Part A of the study.
OG004
PF-04360365 3.0 mg/kg (Part B)
PF-04360365 3.0 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part B of the study.
OG005
PF-04360365 8.5 mg/kg (Part B)
PF-04360365 8.5 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part B of the study.
OG006
Placebo (Part B)
Placebo intravenous infusion over 2 hours every 60 days up to 18 months in Part B of the study.
Units
Counts
Participants
OG00021
OG00121
OG00218
OG00318
OG00424
OG00522
OG00627
Title
Denominators
Categories
Title
Measurements
OG000-20.09± 3.80
OG001-16.20± 3.90
OG002-15.18± 3.91
OG003-16.02± 4.07
OG004-22.53± 4.17
OG005-18.12± 4.30
OG006-18.44± 4.00
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
OG003
Mixed model repeated measures used terms for treatment, visit, baseline value, country, and treatment-by-visit interaction, with unstructured covariance matrix.
Mixed Models Analysis
0.4688
LS Mean Difference
-4.07
Standard Error of the Mean
5.59
2-Sided
90
-13.38
5.24
Superiority
OG001
OG003
Mixed model repeated measures used terms for treatment, visit, baseline value, country, and treatment-by-visit interaction, with unstructured covariance matrix.
Mixed Models Analysis
0.9743
LS Mean Difference
-0.18
Standard Error of the Mean
5.64
2-Sided
90
-9.59
9.22
Superiority
OG002
OG003
Mixed model repeated measures used terms for treatment, visit, baseline value, country, and treatment-by-visit interaction, with unstructured covariance matrix.
Mixed Models Analysis
0.8824
LS Mean Difference
0.84
Standard Error of the Mean
5.65
2-Sided
90
-8.57
10.25
Superiority
OG004
OG006
Mixed model repeated measures used terms for treatment, visit, baseline value, country, and treatment-by-visit interaction, with unstructured covariance matrix.
Mixed Models Analysis
0.4831
LS Mean Difference
-4.09
Standard Error of the Mean
5.81
2-Sided
90
-13.77
5.58
Superiority
OG005
OG006
Mixed model repeated measures used terms for treatment, visit, baseline value, country, and treatment-by-visit interaction, with unstructured covariance matrix.
Mixed Models Analysis
0.9562
LS Mean Difference
0.32
Standard Error of the Mean
5.88
2-Sided
90
-9.48
10.13
Superiority
OG004
PF-04360365 3.0 mg/kg (Part B)
PF-04360365 3.0 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part B of the study.
OG005
PF-04360365 8.5 mg/kg (Part B)
PF-04360365 8.5 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part B of the study.
OG006
Placebo (Part B)
Placebo intravenous infusion over 2 hours every 60 days up to 18 months in Part B of the study.
Units
Counts
Participants
OG00025
OG00125
OG00225
OG00324
OG00432
OG00531
OG00632
Title
Denominators
Categories
0 Hour Day 1
ParticipantsOG00025
ParticipantsOG00125
ParticipantsOG00225
ParticipantsOG00324
ParticipantsOG00432
ParticipantsOG00531
ParticipantsOG00631
Title
Measurements
OG000294.12± 95.78
OG001229.68± 112.23
OG002355.80± 514.90
OG003
2 Hours Day 1
ParticipantsOG00022
ParticipantsOG00120
ParticipantsOG00223
ParticipantsOG00322
0 Hour Day 60
ParticipantsOG00024
ParticipantsOG00125
ParticipantsOG00225
ParticipantsOG00324
2 Hours Day 60
ParticipantsOG00023
ParticipantsOG00123
ParticipantsOG00224
ParticipantsOG00321
Day 90
ParticipantsOG00025
ParticipantsOG00125
ParticipantsOG00225
ParticipantsOG00324
0 Hour Day 120
ParticipantsOG00025
ParticipantsOG00124
ParticipantsOG00225
ParticipantsOG00323
2 Hours Day 120
ParticipantsOG00022
ParticipantsOG00125
ParticipantsOG00223
ParticipantsOG00320
Day 150
ParticipantsOG00024
ParticipantsOG00125
ParticipantsOG00225
ParticipantsOG00323
0 Hour Day 180
ParticipantsOG00024
ParticipantsOG00125
ParticipantsOG00225
ParticipantsOG00322
2 Hours Day 180
ParticipantsOG00021
ParticipantsOG00123
ParticipantsOG00222
ParticipantsOG00318
Day 210
ParticipantsOG00024
ParticipantsOG00124
ParticipantsOG00225
ParticipantsOG00322
0 Hour Day 240
ParticipantsOG00025
ParticipantsOG00124
ParticipantsOG00224
ParticipantsOG00321
2 Hours Day 240
ParticipantsOG00021
ParticipantsOG00122
ParticipantsOG00224
ParticipantsOG00321
0 Hour Day 300
ParticipantsOG00025
ParticipantsOG00122
ParticipantsOG00224
ParticipantsOG00321
2 Hours Day 300
ParticipantsOG00024
ParticipantsOG00120
ParticipantsOG00223
ParticipantsOG00320
0 Hour Day 360
ParticipantsOG00023
ParticipantsOG00121
ParticipantsOG00223
ParticipantsOG00321
2 Hours Day 360
ParticipantsOG00022
ParticipantsOG00119
ParticipantsOG00221
ParticipantsOG00318
Day 390
ParticipantsOG00022
ParticipantsOG00121
ParticipantsOG00222
ParticipantsOG00321
0 Hour Day 420
ParticipantsOG00021
ParticipantsOG00121
ParticipantsOG00221
ParticipantsOG00320
2 Hours Day 420
ParticipantsOG00018
ParticipantsOG00119
ParticipantsOG00218
ParticipantsOG00316
0 Hour Day 480
ParticipantsOG00023
ParticipantsOG00121
ParticipantsOG00220
ParticipantsOG00319
2 Hours Day 480
ParticipantsOG00021
ParticipantsOG00119
ParticipantsOG00219
ParticipantsOG00316
0 Hour Day 540
ParticipantsOG00023
ParticipantsOG00119
ParticipantsOG00216
ParticipantsOG00318
2 Hours Day 540
ParticipantsOG00020
ParticipantsOG00115
ParticipantsOG00215
ParticipantsOG00317
Day 570
ParticipantsOG00022
ParticipantsOG00121
ParticipantsOG00217
ParticipantsOG00317
Day 660
ParticipantsOG00021
ParticipantsOG00118
ParticipantsOG00218
ParticipantsOG00317
Day 720
ParticipantsOG00021
ParticipantsOG00120
ParticipantsOG00218
ParticipantsOG00318
OG004
PF-04360365 3.0 mg/kg (Part B)
PF-04360365 3.0 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part B of the study.
OG005
PF-04360365 8.5 mg/kg (Part B)
PF-04360365 8.5 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part B of the study.
OG006
Placebo (Part B)
Placebo intravenous infusion over 2 hours every 60 days up to 18 months in Part B of the study.
Units
Counts
Participants
OG00025
OG00125
OG00225
OG00324
OG00432
OG00531
OG00632
Title
Denominators
Categories
0 Hour Day 1
ParticipantsOG00025
ParticipantsOG00125
ParticipantsOG00225
ParticipantsOG00324
ParticipantsOG00432
ParticipantsOG00531
ParticipantsOG00631
Title
Measurements
OG000185.52± 109.70
OG001145.92± 104.50
OG002162.04± 125.00
OG003
2 Hours Day 1
ParticipantsOG00022
ParticipantsOG00120
ParticipantsOG00223
ParticipantsOG00322
0 Hour Day 60
ParticipantsOG00024
ParticipantsOG00125
ParticipantsOG00225
ParticipantsOG00324
2 Hours Day 60
ParticipantsOG00023
ParticipantsOG00123
ParticipantsOG00224
ParticipantsOG00321
Day 90
ParticipantsOG00025
ParticipantsOG00125
ParticipantsOG00225
ParticipantsOG00324
0 Hour Day 120
ParticipantsOG00025
ParticipantsOG00124
ParticipantsOG00225
ParticipantsOG00323
2 Hours Day 120
ParticipantsOG00022
ParticipantsOG00125
ParticipantsOG00223
ParticipantsOG00320
Day 150
ParticipantsOG00024
ParticipantsOG00125
ParticipantsOG00225
ParticipantsOG00323
0 Hour Day 180
ParticipantsOG00024
ParticipantsOG00125
ParticipantsOG00225
ParticipantsOG00322
2 Hours Day 180
ParticipantsOG00021
ParticipantsOG00123
ParticipantsOG00222
ParticipantsOG00318
Day 210
ParticipantsOG00024
ParticipantsOG00124
ParticipantsOG00225
ParticipantsOG00322
0 Hour Day 240
ParticipantsOG00025
ParticipantsOG00124
ParticipantsOG00224
ParticipantsOG00321
2 Hours Day 240
ParticipantsOG00021
ParticipantsOG00122
ParticipantsOG00224
ParticipantsOG00321
0 Hour Day 300
ParticipantsOG00025
ParticipantsOG00122
ParticipantsOG00224
ParticipantsOG00321
2 Hours Day 300
ParticipantsOG00024
ParticipantsOG00120
ParticipantsOG00223
ParticipantsOG00320
0 Hour Day 360
ParticipantsOG00023
ParticipantsOG00121
ParticipantsOG00223
ParticipantsOG00321
2 Hours Day 360
ParticipantsOG00022
ParticipantsOG00119
ParticipantsOG00221
ParticipantsOG00318
Day 390
ParticipantsOG00022
ParticipantsOG00121
ParticipantsOG00222
ParticipantsOG00321
0 Hour Day 420
ParticipantsOG00021
ParticipantsOG00121
ParticipantsOG00221
ParticipantsOG00320
2 Hours Day 420
ParticipantsOG00018
ParticipantsOG00119
ParticipantsOG00218
ParticipantsOG00316
0 Hour Day 480
ParticipantsOG00023
ParticipantsOG00121
ParticipantsOG00220
ParticipantsOG00318
2 Hours Day 480
ParticipantsOG00021
ParticipantsOG00119
ParticipantsOG00219
ParticipantsOG00315
0 Hour Day 540
ParticipantsOG00023
ParticipantsOG00119
ParticipantsOG00216
ParticipantsOG00318
2 Hours Day 540
ParticipantsOG00020
ParticipantsOG00115
ParticipantsOG00215
ParticipantsOG00316
Day 570
ParticipantsOG00022
ParticipantsOG00121
ParticipantsOG00217
ParticipantsOG00317
Day 660
ParticipantsOG00021
ParticipantsOG00117
ParticipantsOG00218
ParticipantsOG00316
Day 720
ParticipantsOG00021
ParticipantsOG00120
ParticipantsOG00217
ParticipantsOG00318
OG003
Placebo (Part A)
Placebo intravenous infusion over 2 hours every 60 days up to 18 months in Part A of the study.
OG004
PF-04360365 3.0 mg/kg (Part B)
PF-04360365 3.0 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part B of the study.
OG005
PF-04360365 8.5 mg/kg (Part B)
PF-04360365 8.5 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part B of the study.
OG006
Placebo (Part B)
Placebo intravenous infusion over 2 hours every 60 days up to 18 months in Part B of the study.
Units
Counts
Participants
OG00025
OG00125
OG00225
OG00324
OG00430
OG00531
OG00632
Title
Denominators
Categories
0 Hour Day 1
ParticipantsOG00025
ParticipantsOG00125
ParticipantsOG00225
ParticipantsOG00324
ParticipantsOG00430
ParticipantsOG00531
ParticipantsOG00632
Title
Measurements
OG000NA± NAResults are not reported because plasma Aβ1-42 concentrations were sporadic and below the lower limit of quantification (20 picogram per milliliter \[pg/mL\]).
OG001NA± NAResults are not reported because plasma Aβ1-42 concentrations were sporadic and below the lower limit of quantification (20 pg/mL).
OG002NA± NAResults are not reported because plasma Aβ1-42 concentrations were sporadic and below the lower limit of quantification (20 pg/mL).
OG003
2 Hours Day 1
ParticipantsOG00025
ParticipantsOG00125
ParticipantsOG00225
ParticipantsOG00324
0 Hour Day 60
ParticipantsOG00025
ParticipantsOG00125
ParticipantsOG00225
ParticipantsOG00324
2 Hours Day 60
ParticipantsOG00025
ParticipantsOG00125
ParticipantsOG00225
ParticipantsOG00324
Day 90
ParticipantsOG00025
ParticipantsOG00125
ParticipantsOG00225
ParticipantsOG00324
0 Hour Day 120
ParticipantsOG00025
ParticipantsOG00125
ParticipantsOG00225
ParticipantsOG00324
2 Hours Day 120
ParticipantsOG00025
ParticipantsOG00125
ParticipantsOG00225
ParticipantsOG00324
Day 150
ParticipantsOG00025
ParticipantsOG00125
ParticipantsOG00225
ParticipantsOG00324
0 Hour Day 180
ParticipantsOG00025
ParticipantsOG00125
ParticipantsOG00225
ParticipantsOG00324
2 Hours Day 180
ParticipantsOG00025
ParticipantsOG00125
ParticipantsOG00225
ParticipantsOG00324
Day 210
ParticipantsOG00025
ParticipantsOG00125
ParticipantsOG00225
ParticipantsOG00324
0 Hour Day 240
ParticipantsOG00025
ParticipantsOG00125
ParticipantsOG00225
ParticipantsOG00324
2 Hours Day 240
ParticipantsOG00025
ParticipantsOG00125
ParticipantsOG00225
ParticipantsOG00324
0 Hour Day 300
ParticipantsOG00025
ParticipantsOG00125
ParticipantsOG00225
ParticipantsOG00324
2 Hours Day 300
ParticipantsOG00025
ParticipantsOG00125
ParticipantsOG00225
ParticipantsOG00324
0 Hour Day 360
ParticipantsOG00025
ParticipantsOG00125
ParticipantsOG00225
ParticipantsOG00324
2 Hours Day 360
ParticipantsOG00025
ParticipantsOG00125
ParticipantsOG00225
ParticipantsOG00324
Day 390
ParticipantsOG00025
ParticipantsOG00125
ParticipantsOG00225
ParticipantsOG00324
0 Hour Day 420
ParticipantsOG00025
ParticipantsOG00125
ParticipantsOG00225
ParticipantsOG00324
2 Hours Day 420
ParticipantsOG00025
ParticipantsOG00125
ParticipantsOG00225
ParticipantsOG00324
0 Hour Day 480
ParticipantsOG00025
ParticipantsOG00125
ParticipantsOG00225
ParticipantsOG00324
2 Hours Day 480
ParticipantsOG00025
ParticipantsOG00125
ParticipantsOG00225
ParticipantsOG00324
0 Hour Day 540
ParticipantsOG00025
ParticipantsOG00125
ParticipantsOG00225
ParticipantsOG00324
2 Hours Day 540
ParticipantsOG00025
ParticipantsOG00125
ParticipantsOG00225
ParticipantsOG00324
Day 570
ParticipantsOG00025
ParticipantsOG00125
ParticipantsOG00225
ParticipantsOG00324
Day 660
ParticipantsOG00025
ParticipantsOG00125
ParticipantsOG00225
ParticipantsOG00324
Day 720
ParticipantsOG00025
ParticipantsOG00125
ParticipantsOG00225
ParticipantsOG00324
OG004
PF-04360365 3.0 mg/kg (Part B)
PF-04360365 3.0 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part B of the study.
OG005
PF-04360365 8.5 mg/kg (Part B)
PF-04360365 8.5 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part B of the study.
OG006
Placebo (Part B)
Placebo intravenous infusion over 2 hours every 60 days up to 18 months in Part B of the study.
Units
Counts
Participants
OG0003
OG0018
OG0024
OG0034
OG00413
OG00511
OG00617
Title
Denominators
Categories
Day 0
ParticipantsOG0003
ParticipantsOG0018
ParticipantsOG0024
ParticipantsOG0034
ParticipantsOG00413
ParticipantsOG00511
ParticipantsOG00617
Title
Measurements
OG00027400.00± 8361.22
OG00130187.50± 10584.28
OG00232150.00± 10033.44
OG003
Day 90
ParticipantsOG0003
ParticipantsOG0016
ParticipantsOG0024
ParticipantsOG0034
Day 570
ParticipantsOG0001
ParticipantsOG0013
ParticipantsOG0022
ParticipantsOG0032
OG004
PF-04360365 3.0 mg/kg (Part B)
PF-04360365 3.0 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part B of the study.
OG005
PF-04360365 8.5 mg/kg (Part B)
PF-04360365 8.5 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part B of the study.
OG006
Placebo (Part B)
Placebo intravenous infusion over 2 hours every 60 days up to 18 months in Part B of the study.
Units
Counts
Participants
OG0003
OG0018
OG0024
OG0034
OG00413
OG00511
OG00617
Title
Denominators
Categories
Day 0
ParticipantsOG0003
ParticipantsOG0018
ParticipantsOG0024
ParticipantsOG0034
ParticipantsOG00413
ParticipantsOG00511
ParticipantsOG00617
Title
Measurements
OG00018100.00± 4513.31
OG00111907.50± 3569.78
OG00211700.00± 1525.34
OG003
Day 90
ParticipantsOG0003
ParticipantsOG0016
ParticipantsOG0024
ParticipantsOG0034
Day 570
ParticipantsOG0001
ParticipantsOG0014
ParticipantsOG0022
ParticipantsOG0032
OG004
PF-04360365 3.0 mg/kg (Part B)
PF-04360365 3.0 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part B of the study.
OG005
PF-04360365 8.5 mg/kg (Part B)
PF-04360365 8.5 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part B of the study.
OG006
Placebo (Part B)
Placebo intravenous infusion over 2 hours every 60 days up to 18 months in Part B of the study.
Units
Counts
Participants
OG0003
OG0018
OG0024
OG0034
OG00413
OG00511
OG00617
Title
Denominators
Categories
Day 0
ParticipantsOG0003
ParticipantsOG0018
ParticipantsOG0024
ParticipantsOG0034
ParticipantsOG00413
ParticipantsOG00511
ParticipantsOG00617
Title
Measurements
OG000983.00± 370.31
OG001800.13± 267.63
OG002851.75± 17.75
OG003
Day 90
ParticipantsOG0003
ParticipantsOG0016
ParticipantsOG0024
ParticipantsOG0034
Day 570
ParticipantsOG0001
ParticipantsOG0013
ParticipantsOG0021
ParticipantsOG0032
OG004
PF-04360365 3.0 mg/kg (Part B)
PF-04360365 3.0 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part B of the study.
OG005
PF-04360365 8.5 mg/kg (Part B)
PF-04360365 8.5 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part B of the study.
OG006
Placebo (Part B)
Placebo intravenous infusion over 2 hours every 60 days up to 18 months in Part B of the study.
Units
Counts
Participants
OG0003
OG0018
OG0024
OG0034
OG00413
OG00511
OG00617
Title
Denominators
Categories
Day 0: tau
ParticipantsOG0003
ParticipantsOG0018
ParticipantsOG0024
ParticipantsOG0034
ParticipantsOG00413
ParticipantsOG00511
ParticipantsOG00617
Title
Measurements
OG000188.90± 118.60
OG001223.79± 99.03
OG002190.43± 102.86
OG003
Day 90: tau
ParticipantsOG0003
ParticipantsOG0016
ParticipantsOG0024
ParticipantsOG0034
Day 570: tau
ParticipantsOG0001
ParticipantsOG0014
ParticipantsOG0022
ParticipantsOG0032
Day 0: p-tau
ParticipantsOG0003
ParticipantsOG0018
ParticipantsOG0024
ParticipantsOG0034
Day 90: p-tau
ParticipantsOG0003
ParticipantsOG0016
ParticipantsOG0024
ParticipantsOG0033
Day 570: p-tau
ParticipantsOG0001
ParticipantsOG0014
ParticipantsOG0022
ParticipantsOG0032
OG003
Placebo (Part A)
Placebo intravenous infusion over 2 hours every 60 days up to 18 months in Part A of the study.
OG004
PF-04360365 3.0 mg/kg (Part B)
PF-04360365 3.0 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part B of the study.
OG005
PF-04360365 8.5 mg/kg (Part B)
PF-04360365 8.5 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part B of the study.
OG006
Placebo (Part B)
Placebo intravenous infusion over 2 hours every 60 days up to 18 months in Part B of the study.
Units
Counts
Participants
OG0004
OG0016
OG0025
OG0035
OG00411
OG00510
OG00614
Title
Denominators
Categories
CSF Protein (>ULN)
ParticipantsOG0004
ParticipantsOG0016
ParticipantsOG0025
ParticipantsOG0035
ParticipantsOG00411
ParticipantsOG00510
ParticipantsOG00614
Title
Measurements
OG0001
OG0013
OG0021
OG003
CSF RBCs (>ULN)
ParticipantsOG0004
ParticipantsOG0016
ParticipantsOG0025
ParticipantsOG0035
CSF WBCs (>ULN)
ParticipantsOG0004
ParticipantsOG0016
ParticipantsOG0025
ParticipantsOG0035
CSF Glucose (>ULN)
ParticipantsOG0004
ParticipantsOG0016
ParticipantsOG0025
ParticipantsOG0035
PF-04360365 3.0 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part B of the study.
OG004
PF-04360365 8.5 mg/kg (Part B)
PF-04360365 8.5 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part B of the study.
Units
Counts
Participants
OG00025
OG00125
OG00225
OG00332
OG00431
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
0 affected
24 at risk
EG0040 affected32 at risk
EG0050 affected31 at risk
EG0061 affected32 at risk
0 affected
24 at risk
EG0040 affected32 at risk
EG0050 affected31 at risk
EG0061 affected32 at risk
0 affected
24 at risk
EG0040 affected32 at risk
EG0050 affected31 at risk
EG0060 affected32 at risk
0 affected
24 at risk
EG0040 affected32 at risk
EG0050 affected31 at risk
EG0060 affected32 at risk
0 affected
24 at risk
EG0040 affected32 at risk
EG0050 affected31 at risk
EG0060 affected32 at risk
0 affected
24 at risk
EG0041 affected32 at risk
EG0050 affected31 at risk
EG0060 affected32 at risk
0 affected
24 at risk
EG0041 affected32 at risk
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EG0062 affected32 at risk
0 affected
24 at risk
EG0041 affected32 at risk
EG0050 affected31 at risk
EG0060 affected32 at risk
0 affected
24 at risk
EG0040 affected32 at risk
EG0050 affected31 at risk
EG0060 affected32 at risk
0 affected
24 at risk
EG0040 affected32 at risk
EG0050 affected31 at risk
EG0060 affected32 at risk
0
OG0040
OG0050
OG0060
6
OG0043
OG0056
OG0066
0
OG0040
OG0050
OG0060
0
OG0040
OG0051
OG0060
0
OG0041
OG0051
OG0060
0
OG0040
OG0050
OG0062
2
OG0044
OG0050
OG0062
10
OG0048
OG00512
OG00610
43.44
± 17.76
OG004157.40± 85.17
Participants
OG004
28
Title
Measurements
OG000286.20± 133.25
OG0012074.48± 558.85
OG0024277.88± 1073.25
OG00316733.03± 5624.57
OG00449141.68± 11941.83
56.77
± 23.14
OG004115.36± 79.21
Participants
OG004
22
Title
Measurements
OG000360.05± 165.65
OG0012023.95± 911.00
OG0024374.00± 1465.99
OG00319638.68± 8134.26
OG00444945.95± 25370.94
273.21
± 96.00
OG004607.50± 765.24
OG005337.87± 112.84
OG006382.10± 158.90
ParticipantsOG00428
ParticipantsOG00528
ParticipantsOG00627
Title
Measurements
OG0002128.73± 537.63
OG0012106.50± 480.76
OG0022199.87± 621.29
OG003282.86± 75.09
OG0042446.64± 1055.11
OG0052648.93± 695.78
OG006380.07± 101.11
ParticipantsOG00429
ParticipantsOG00529
ParticipantsOG00632
Title
Measurements
OG0001828.13± 976.47
OG0018122.40± 2209.66
OG00215558.40± 4994.54
OG003332.46± 94.47
OG00448603.45± 20147.32
OG00591475.86± 22246.33
OG006405.44± 245.46
ParticipantsOG00429
ParticipantsOG00522
ParticipantsOG00629
Title
Measurements
OG0003892.17± 1013.64
OG0019645.22± 1953.32
OG00216952.50± 4358.13
OG003291.62± 108.42
OG00441772.41± 11979.65
OG00583050.00± 28159.10
OG006380.90± 119.24
Participants
OG004
30
ParticipantsOG00528
ParticipantsOG00632
Title
Measurements
OG0003997.20± 1322.48
OG00120476.00± 5034.49
OG00236904.00± 12258.21
OG003341.33± 80.25
OG00489856.67± 20377.45
OG005127132.14± 25567.72
OG006386.50± 167.65
ParticipantsOG00430
ParticipantsOG00527
ParticipantsOG00632
Title
Measurements
OG0002440.00± 1054.77
OG00111435.00± 3379.92
OG00222416.00± 6636.56
OG003340.87± 96.43
OG00461270.00± 22462.23
OG005110074.07± 23932.00
OG006375.22± 118.27
ParticipantsOG00427
ParticipantsOG00523
ParticipantsOG00629
Title
Measurements
OG0004425.05± 1427.10
OG00112988.80± 4021.06
OG00222260.87± 6276.85
OG003361.80± 53.92
OG00449233.33± 18308.66
OG00591508.70± 20558.34
OG006396.10± 117.46
Participants
OG004
30
ParticipantsOG00527
ParticipantsOG00632
Title
Measurements
OG0004531.25± 1597.31
OG00123600.00± 6871.74
OG00243872.00± 10714.22
OG003360.30± 74.99
OG00485203.33± 21436.55
OG005135288.89± 29714.08
OG006363.38± 126.56
ParticipantsOG00428
ParticipantsOG00525
ParticipantsOG00631
Title
Measurements
OG0003017.50± 1296.78
OG00114386.00± 5203.12
OG00226036.00± 7745.58
OG003367.55± 63.64
OG00455125.00± 15273.79
OG00593180.00± 28531.81
OG006297.87± 122.91
ParticipantsOG00425
ParticipantsOG00523
ParticipantsOG00629
Title
Measurements
OG0005544.76± 2044.34
OG00116894.78± 5283.81
OG00227118.18± 7787.09
OG003363.61± 72.24
OG00447316.00± 15189.79
OG00581960.87± 26561.69
OG006289.24± 139.31
Participants
OG004
28
ParticipantsOG00526
ParticipantsOG00631
Title
Measurements
OG0004673.33± 1524.00
OG00125108.33± 8120.77
OG00249676.00± 12637.16
OG003385.27± 71.98
OG00484810.71± 20382.91
OG005116703.85± 37969.45
OG006301.84± 110.90
ParticipantsOG00427
ParticipantsOG00526
ParticipantsOG00630
Title
Measurements
OG0003085.20± 1190.23
OG00115445.83± 5718.03
OG00228520.83± 8766.83
OG003327.29± 67.08
OG00448344.44± 14065.65
OG00583653.85± 28195.07
OG006318.37± 116.19
ParticipantsOG00425
ParticipantsOG00524
ParticipantsOG00629
Title
Measurements
OG0005269.05± 1614.58
OG00115930.91± 6681.72
OG00225532.50± 7102.35
OG003336.24± 47.77
OG00447100.00± 15547.48
OG00578354.17± 28042.48
OG006350.28± 130.39
ParticipantsOG00426
ParticipantsOG00527
ParticipantsOG00630
Title
Measurements
OG0002963.6± 1047.13
OG00114710.45± 6472.62
OG00228366.67± 14592.96
OG003311.43± 63.44
OG00462607.69± 21254.16
OG00596537.04± 44313.44
OG006327.83± 112.77
ParticipantsOG00424
ParticipantsOG00521
ParticipantsOG00629
Title
Measurements
OG0004984.58± 1496.74
OG00115878.00± 7211.88
OG00228647.83± 14306.10
OG003297.20± 97.78
OG00453808.33± 18101.79
OG00579900.00± 26477.07
OG006353.24± 129.21
ParticipantsOG00426
ParticipantsOG00523
ParticipantsOG00628
Title
Measurements
OG0003053.04± 972.76
OG00114313.81± 6254.35
OG00227999.13± 13280.23
OG003287.90± 103.73
OG00458157.69± 15871.24
OG005100691.30± 37696.25
OG006353.86± 108.68
ParticipantsOG00424
ParticipantsOG00519
ParticipantsOG00626
Title
Measurements
OG0005253.18± 1802.73
OG00114153.16± 6473.23
OG00223664.29± 11040.37
OG003277.72± 94.14
OG00450820.83± 16118.20
OG00584168.42± 34779.51
OG006351.31± 105.35
Participants
OG004
26
ParticipantsOG00523
ParticipantsOG00628
Title
Measurements
OG0004300.82± 1647.44
OG00119984.76± 7108.94
OG00240330.45± 13327.52
OG003303.76± 125.67
OG00475133.85± 23426.25
OG005114104.35± 31087.60
OG006338.79± 92.17
ParticipantsOG00423
ParticipantsOG00521
ParticipantsOG00626
Title
Measurements
OG0003123.19± 1245.10
OG00114675.24± 6367.51
OG00226109.52± 13214.13
OG003318.45± 76.39
OG00455273.91± 22852.20
OG00589038.10± 31754.61
OG006376.08± 172.83
ParticipantsOG00421
ParticipantsOG00515
ParticipantsOG00625
Title
Measurements
OG0005090.56± 1713.37
OG00114711.58± 5023.57
OG00223987.78± 9082.14
OG003318.88± 61.86
OG00454461.90± 22287.94
OG00589080.00± 25517.79
OG006394.04± 229.59
ParticipantsOG00424
ParticipantsOG00523
ParticipantsOG00627
Title
Measurements
OG0002899.17± 1058.84
OG00113864.29± 6772.94
OG00229448.00± 11647.42
OG003339.16± 86.94
OG00475033.33± 29410.21
OG00597239.57± 40197.50
OG006356.11± 197.30
ParticipantsOG00421
ParticipantsOG00517
ParticipantsOG00625
Title
Measurements
OG0005196.19± 1676.54
OG00116105.79± 7332.47
OG00228064.21± 11182.90
OG003396.44± 98.10
OG00477633.33± 35071.25
OG005100941.18± 36351.53
OG006402.72± 195.38
ParticipantsOG00422
ParticipantsOG00520
ParticipantsOG00624
Title
Measurements
OG0003163.48± 1389.06
OG00114449.47± 6474.26
OG00232468.13± 14928.53
OG003359.06± 91.66
OG00453154.55± 18919.37
OG00577400.00± 37951.50
OG006493.71± 251.99
ParticipantsOG00420
ParticipantsOG00514
ParticipantsOG00624
Title
Measurements
OG0005755.50± 3402.11
OG00115516.00± 6002.06
OG00230778.67± 16628.98
OG003387.65± 119.66
OG00454190.00± 20426.89
OG00594271.43± 36384.07
OG006455.04± 201.94
Participants
OG004
21
ParticipantsOG00521
ParticipantsOG00624
Title
Measurements
OG0004568.64± 2097.91
OG00122257.14± 10734.97
OG00249461.76± 22369.81
OG003356.71± 151.05
OG00469914.29± 19836.82
OG00590576.19± 60817.37
OG006400.58± 175.08
Participants
OG004
22
ParticipantsOG00521
ParticipantsOG00626
Title
Measurements
OG0002422.29± 1956.43
OG0018181.11± 7497.62
OG00220496.11± 20540.31
OG003421.71± 140.09
OG00428198.18± 10933.08
OG00549011.19± 35384.55
OG006475.46± 386.01
Participants
OG004
23
ParticipantsOG00520
ParticipantsOG00625
Title
Measurements
OG0001383.76± 449.57
OG0013773.5± 2447.14
OG0027876.67± 5846.23
OG003419.11± 143.12
OG00414912.65± 8037.28
OG00522663.00± 14507.34
OG006421.44± 170.96
180.54
± 108.32
OG004318.09± 495.37
OG005192.03± 199.53
OG006184.19± 124.59
ParticipantsOG00428
ParticipantsOG00528
ParticipantsOG00627
Title
Measurements
OG0001239.41± 388.07
OG0011580.70± 500.06
OG0021665.57± 953.50
OG003187.95± 55.99
OG0041924.50± 773.00
OG0051764.64± 546.77
OG006180.22± 117.09
ParticipantsOG00429
ParticipantsOG00529
ParticipantsOG00632
Title
Measurements
OG0001073.50± 409.71
OG0015860.00± 1923.23
OG00211643.20± 4588.36
OG003209.46± 71.27
OG00433203.45± 13116.74
OG00566972.41± 19944.83
OG006158.16± 121.12
ParticipantsOG00429
ParticipantsOG00522
ParticipantsOG00629
Title
Measurements
OG0002502.39± 920.12
OG0018676.09± 2600.95
OG00214517.08± 6129.96
OG003227.57± 60.84
OG00432306.90± 11373.09
OG00569627.27± 21824.67
OG006195.83± 110.94
Participants
OG004
30
ParticipantsOG00528
ParticipantsOG00632
Title
Measurements
OG0002096.40± 896.20
OG00113888.80± 5357.63
OG00225008.00± 8167.92
OG003204.25± 71.71
OG00457333.33± 15829.03
OG00595967.86± 27202.68
OG006157.31± 107.72
ParticipantsOG00430
ParticipantsOG00527
ParticipantsOG00632
Title
Measurements
OG0001345.72± 525.64
OG0017823.75± 3119.88
OG00216724.00± 7330.78
OG003192.91± 110.77
OG00436926.67± 15677.13
OG00575514.81± 22013.70
OG006168.41± 81.95
ParticipantsOG00427
ParticipantsOG00523
ParticipantsOG00629
Title
Measurements
OG0003000.00± 1145.59
OG00111108.00± 3594.09
OG00220834.78± 8115.40
OG003191.95± 76.36
OG00438466.67± 12659.44
OG00576860.87± 22351.34
OG006177.55± 94.50
Participants
OG004
30
ParticipantsOG00527
ParticipantsOG00632
Title
Measurements
OG0002564.21± 1566.85
OG00116254.80± 5774.43
OG00227640.00± 11619.21
OG003195.96± 78.74
OG00452753.33± 19076.48
OG00575033.33± 19112.32
OG006148.47± 106.04
ParticipantsOG00428
ParticipantsOG00526
ParticipantsOG00631
Title
Measurements
OG0001632.54± 931.22
OG0018604.40± 3269.47
OG00217727.60± 7878.69
OG003182.41± 86.46
OG00435539.29± 12873.73
OG00567450.00± 21320.30
OG006161.48± 166.60
ParticipantsOG00425
ParticipantsOG00523
ParticipantsOG00629
Title
Measurements
OG0002973.05± 1614.36
OG00111533.48± 3718.57
OG00223146.36± 9074.15
OG003225.17± 94.23
OG00438644.00± 13630.61
OG00561634.78± 21758.96
OG006150.79± 99.12
Participants
OG004
28
ParticipantsOG00527
ParticipantsOG00631
Title
Measurements
OG0002274.58± 878.71
OG00114409.58± 5966.02
OG00228548.00± 11006.03
OG003191.82± 92.92
OG00451135.71± 14603.53
OG00571200.00± 17902.92
OG006189.13± 78.73
ParticipantsOG00427
ParticipantsOG00526
ParticipantsOG00630
Title
Measurements
OG0001471.84± 549.70
OG0018583.75± 4003.84
OG00216937.08± 7343.63
OG003164.29± 46.78
OG00436451.85± 10133.13
OG00558873.08± 21088.17
OG006141.40± 106.52
ParticipantsOG00425
ParticipantsOG00524
ParticipantsOG00629
Title
Measurements
OG0002868.10± 778.74
OG00111830.45± 5542.51
OG00220021.25± 7600.16
OG003182.71± 60.37
OG00435996.00± 9149.79
OG00558225.00± 20401.28
OG006171.66± 98.41
ParticipantsOG00426
ParticipantsOG00527
ParticipantsOG00630
Title
Measurements
OG0001630.16± 662.16
OG0018989.55± 4776.13
OG00217817.08± 13181.85
OG003190.38± 80.76
OG00437692.31± 15132.16
OG00555488.89± 17874.01
OG006149.20± 122.88
ParticipantsOG00424
ParticipantsOG00521
ParticipantsOG00629
Title
Measurements
OG0002756.25± 1012.41
OG00110428.50± 2989.20
OG00217809.57± 6105.73
OG003208.85± 108.79
OG00442245.83± 12637.11
OG00554838.10± 14484.59
OG006245.31± 239.90
ParticipantsOG00426
ParticipantsOG00523
ParticipantsOG00628
Title
Measurements
OG0001694.26± 566.45
OG0018194.76± 3665.29
OG00215651.74± 5075.04
OG003236.71± 190.38
OG00430459.62± 13619.52
OG00548904.35± 18386.82
OG00687.18± 96.11
ParticipantsOG00424
ParticipantsOG00519
ParticipantsOG00625
Title
Measurements
OG0003277.27± 983.77
OG00111555.79± 3710.85
OG00216970.95± 6137.24
OG003211.33± 101.44
OG00431191.67± 10742.40
OG00564868.42± 30014.29
OG006156.68± 148.86
Participants
OG004
25
ParticipantsOG00523
ParticipantsOG00628
Title
Measurements
OG0002543.50± 1446.05
OG00110594.76± 3948.17
OG00221660.45± 7216.95
OG003150.81± 85.06
OG00454165.20± 20804.90
OG00577274.78± 33435.47
OG006131.07± 102.02
ParticipantsOG00424
ParticipantsOG00521
ParticipantsOG00626
Title
Measurements
OG0001451.33± 602.01
OG0017863.81± 3449.31
OG00214975.24± 7980.85
OG003157.80± 91.81
OG00447820.83± 23683.71
OG00565819.05± 42467.11
OG006201.31± 165.16
ParticipantsOG00421
ParticipantsOG00515
ParticipantsOG00624
Title
Measurements
OG0002647.78± 826.97
OG00110538.42± 4177.09
OG00216612.22± 5658.05
OG003151.13± 86.07
OG00444047.62± 21069.28
OG00570846.67± 41555.50
OG006181.83± 123.40
ParticipantsOG00423
ParticipantsOG00522
ParticipantsOG00625
Title
Measurements
OG0001931.78± 1339.28
OG00110108.10± 5878.70
OG00216535.00± 9242.28
OG003139.61± 106.88
OG00474334.78± 21163.94
OG00577302.27± 44463.25
OG006252.00± 135.67
ParticipantsOG00421
ParticipantsOG00518
ParticipantsOG00623
Title
Measurements
OG0003336.29± 1529.23
OG00112793.68± 5639.73
OG00216610.00± 6540.14
OG003133.53± 91.30
OG00466049.05± 37625.89
OG005102094.44± 43738.40
OG006310.39± 302.75
ParticipantsOG00422
ParticipantsOG00521
ParticipantsOG00623
Title
Measurements
OG0002437.70± 1483.48
OG00110103.16± 6545.00
OG00227048.75± 23150.54
OG003190.94± 127.00
OG00452720.91± 26005.06
OG00577010.48± 50743.64
OG006198.00± 114.84
ParticipantsOG00420
ParticipantsOG00516
ParticipantsOG00623
Title
Measurements
OG0004149.30± 1711.36
OG00112428.67± 6799.53
OG00231972.67± 24882.62
OG003186.69± 95.55
OG00452960.00± 25018.95
OG00584750.00± 42228.62
OG006230.30± 71.67
Participants
OG004
21
ParticipantsOG00521
ParticipantsOG00624
Title
Measurements
OG0003147.27± 1910.78
OG00116370.00± 10166.72
OG00232728.24± 20157.92
OG003237.12± 176.71
OG00458548.10± 25034.67
OG00577292.38± 46608.10
OG006192.13± 104.14
Participants
OG004
22
ParticipantsOG00521
ParticipantsOG00616
Title
Measurements
OG0001318.67± 927.31
OG0014411.24± 3426.58
OG0028720.00± 4958.03
OG003290.63± 244.94
OG00427949.09± 14956.33
OG00542087.62± 26245.07
OG006321.46± 140.99
Participants
OG004
23
ParticipantsOG00520
ParticipantsOG00625
Title
Measurements
OG000913.57± 273.04
OG0013631.50± 2062.26
OG0026642.94± 5669.98
OG003330.11± 112.78
OG00413954.48± 9828.94
OG00522094.00± 13058.87
OG006358.04± 148.65
NA
± NA
Results are not reported because plasma Aβ1-42 concentrations were sporadic and below the lower limit of quantification (20 pg/mL).
OG00413.43± 25.72
OG00519.14± 46.75
OG006NA± NAResults are not reported because plasma Aβ1-42 concentrations were sporadic and below the lower limit of quantification (20 pg/mL).
ParticipantsOG00425
ParticipantsOG00528
ParticipantsOG00632
Title
Measurements
OG000NA± NAResults are not reported because plasma Aβ1-42 concentrations were sporadic and below the lower limit of quantification (20 pg/mL).
OG001NA± NAResults are not reported because plasma Aβ1-42 concentrations were sporadic and below the lower limit of quantification (20 pg/mL).
OG002NA± NAResults are not reported because plasma Aβ1-42 concentrations were sporadic and below the lower limit of quantification (20 pg/mL).
OG003NA± NAResults are not reported because plasma Aβ1-42 concentrations were sporadic and below the lower limit of quantification (20 pg/mL).
OG00411.13± 24.15
OG00522.23± 56.62
OG006NA± NAResults are not reported because plasma Aβ1-42 concentrations were sporadic and below the lower limit of quantification (20 pg/mL).
ParticipantsOG00428
ParticipantsOG00529
ParticipantsOG00632
Title
Measurements
OG000NA± NAResults are not reported because plasma Aβ1-42 concentrations were sporadic and below the lower limit of quantification (20 pg/mL).
OG001NA± NAResults are not reported because plasma Aβ1-42 concentrations were sporadic and below the lower limit of quantification (20 pg/mL).
OG002NA± NAResults are not reported because plasma Aβ1-42 concentrations were sporadic and below the lower limit of quantification (20 pg/mL).
OG003NA± NAResults are not reported because plasma Aβ1-42 concentrations were sporadic and below the lower limit of quantification (20 pg/mL).
OG00424.82± 50.09
OG00533.21± 51.41
OG006NA± NAResults are not reported because plasma Aβ1-42 concentrations were sporadic and below the lower limit of quantification (20 pg/mL).
ParticipantsOG00429
ParticipantsOG00522
ParticipantsOG00632
Title
Measurements
OG000NA± NAResults are not reported because plasma Aβ1-42 concentrations were sporadic and below the lower limit of quantification (20 pg/mL).
OG001NA± NAResults are not reported because plasma Aβ1-42 concentrations were sporadic and below the lower limit of quantification (20 pg/mL).
OG002NA± NAResults are not reported because plasma Aβ1-42 concentrations were sporadic and below the lower limit of quantification (20 pg/mL).
OG003NA± NAResults are not reported because plasma Aβ1-42 concentrations were sporadic and below the lower limit of quantification (20 pg/mL).
OG00415.27± 38.72
OG00560.77± 210.62
OG006NA± NAResults are not reported because plasma Aβ1-42 concentrations were sporadic and below the lower limit of quantification (20 pg/mL).
Participants
OG004
27
ParticipantsOG00528
ParticipantsOG00632
Title
Measurements
OG000NA± NAResults are not reported because plasma Aβ1-42 concentrations were sporadic and below the lower limit of quantification (20 pg/mL).
OG001NA± NAResults are not reported because plasma Aβ1-42 concentrations were sporadic and below the lower limit of quantification (20 pg/mL).
OG002NA± NAResults are not reported because plasma Aβ1-42 concentrations were sporadic and below the lower limit of quantification (20 pg/mL).
OG003NA± NAResults are not reported because plasma Aβ1-42 concentrations were sporadic and below the lower limit of quantification (20 pg/mL).
OG00415.34± 37.22
OG00541.53± 89.72
OG006NA± NAResults are not reported because plasma Aβ1-42 concentrations were sporadic and below the lower limit of quantification (20 pg/mL).
ParticipantsOG00430
ParticipantsOG00527
ParticipantsOG00632
Title
Measurements
OG000NA± NAResults are not reported because plasma Aβ1-42 concentrations were sporadic and below the lower limit of quantification (20 pg/mL).
OG001NA± NAResults are not reported because plasma Aβ1-42 concentrations were sporadic and below the lower limit of quantification (20 pg/mL).
OG002NA± NAResults are not reported because plasma Aβ1-42 concentrations were sporadic and below the lower limit of quantification (20 pg/mL).
OG003NA± NAResults are not reported because plasma Aβ1-42 concentrations were sporadic and below the lower limit of quantification (20 pg/mL).
OG00413.62± 31.54
OG00532.26± 56.72
OG006NA± NAResults are not reported because plasma Aβ1-42 concentrations were sporadic and below the lower limit of quantification (20 pg/mL).
ParticipantsOG00427
ParticipantsOG00523
ParticipantsOG00632
Title
Measurements
OG000NA± NAResults are not reported because plasma Aβ1-42 concentrations were sporadic and below the lower limit of quantification (20 pg/mL).
OG001NA± NAResults are not reported because plasma Aβ1-42 concentrations were sporadic and below the lower limit of quantification (20 pg/mL).
OG002NA± NAResults are not reported because plasma Aβ1-42 concentrations were sporadic and below the lower limit of quantification (20 pg/mL).
OG003NA± NAResults are not reported because plasma Aβ1-42 concentrations were sporadic and below the lower limit of quantification (20 pg/mL).
OG00411.35± 27.02
OG00514.86± 37.79
OG006NA± NAResults are not reported because plasma Aβ1-42 concentrations were sporadic and below the lower limit of quantification (20 pg/mL).
Participants
OG004
30
ParticipantsOG00527
ParticipantsOG00632
Title
Measurements
OG000NA± NAResults are not reported because plasma Aβ1-42 concentrations were sporadic and below the lower limit of quantification (20 pg/mL).
OG001NA± NAResults are not reported because plasma Aβ1-42 concentrations were sporadic and below the lower limit of quantification (20 pg/mL).
OG002NA± NAResults are not reported because plasma Aβ1-42 concentrations were sporadic and below the lower limit of quantification (20 pg/mL).
OG003NA± NAResults are not reported because plasma Aβ1-42 concentrations were sporadic and below the lower limit of quantification (20 pg/mL).
OG00412.01± 32.98
OG00543.57± 125.33
OG006NA± NAResults are not reported because plasma Aβ1-42 concentrations were sporadic and below the lower limit of quantification (20 pg/mL).
ParticipantsOG00427
ParticipantsOG00526
ParticipantsOG00632
Title
Measurements
OG000NA± NAResults are not reported because plasma Aβ1-42 concentrations were sporadic and below the lower limit of quantification (20 pg/mL).
OG001NA± NAResults are not reported because plasma Aβ1-42 concentrations were sporadic and below the lower limit of quantification (20 pg/mL).
OG002NA± NAResults are not reported because plasma Aβ1-42 concentrations were sporadic and below the lower limit of quantification (20 pg/mL).
OG003NA± NAResults are not reported because plasma Aβ1-42 concentrations were sporadic and below the lower limit of quantification (20 pg/mL).
OG00413.11± 30.57
OG00541.39± 77.77
OG006NA± NAResults are not reported because plasma Aβ1-42 concentrations were sporadic and below the lower limit of quantification (20 pg/mL).
ParticipantsOG00425
ParticipantsOG00523
ParticipantsOG00632
Title
Measurements
OG000NA± NAResults are not reported because plasma Aβ1-42 concentrations were sporadic and below the lower limit of quantification (20 pg/mL).
OG001NA± NAResults are not reported because plasma Aβ1-42 concentrations were sporadic and below the lower limit of quantification (20 pg/mL).
OG002NA± NAResults are not reported because plasma Aβ1-42 concentrations were sporadic and below the lower limit of quantification (20 pg/mL).
OG003NA± NAResults are not reported because plasma Aβ1-42 concentrations were sporadic and below the lower limit of quantification (20 pg/mL).
OG00412.66± 27.27
OG00521.64± 43.59
OG006NA± NAResults are not reported because plasma Aβ1-42 concentrations were sporadic and below the lower limit of quantification (20 pg/mL).
Participants
OG004
27
ParticipantsOG00527
ParticipantsOG00632
Title
Measurements
OG000NA± NAResults are not reported because plasma Aβ1-42 concentrations were sporadic and below the lower limit of quantification (20 pg/mL).
OG001NA± NAResults are not reported because plasma Aβ1-42 concentrations were sporadic and below the lower limit of quantification (20 pg/mL).
OG002NA± NAResults are not reported because plasma Aβ1-42 concentrations were sporadic and below the lower limit of quantification (20 pg/mL).
OG003NA± NAResults are not reported because plasma Aβ1-42 concentrations were sporadic and below the lower limit of quantification (20 pg/mL).
OG00410.08± 32.66
OG00524.06± 57.43
OG006NA± NAResults are not reported because plasma Aβ1-42 concentrations were sporadic and below the lower limit of quantification (20 pg/mL).
ParticipantsOG00427
ParticipantsOG00526
ParticipantsOG00632
Title
Measurements
OG000NA± NAResults are not reported because plasma Aβ1-42 concentrations were sporadic and below the lower limit of quantification (20 pg/mL).
OG001NA± NAResults are not reported because plasma Aβ1-42 concentrations were sporadic and below the lower limit of quantification (20 pg/mL).
OG002NA± NAResults are not reported because plasma Aβ1-42 concentrations were sporadic and below the lower limit of quantification (20 pg/mL).
OG003NA± NAResults are not reported because plasma Aβ1-42 concentrations were sporadic and below the lower limit of quantification (20 pg/mL).
OG00413.19± 26.27
OG00535.47± 83.01
OG006NA± NAResults are not reported because plasma Aβ1-42 concentrations were sporadic and below the lower limit of quantification (20 pg/mL).
ParticipantsOG00425
ParticipantsOG00524
ParticipantsOG00632
Title
Measurements
OG000NA± NAResults are not reported because plasma Aβ1-42 concentrations were sporadic and below the lower limit of quantification (20 pg/mL).
OG001NA± NAResults are not reported because plasma Aβ1-42 concentrations were sporadic and below the lower limit of quantification (20 pg/mL).
OG002NA± NAResults are not reported because plasma Aβ1-42 concentrations were sporadic and below the lower limit of quantification (20 pg/mL).
OG003NA± NAResults are not reported because plasma Aβ1-42 concentrations were sporadic and below the lower limit of quantification (20 pg/mL).
OG0048.83± 20.44
OG00528.11± 66.93
OG006NA± NAResults are not reported because plasma Aβ1-42 concentrations were sporadic and below the lower limit of quantification (20 pg/mL).
ParticipantsOG00426
ParticipantsOG00527
ParticipantsOG00632
Title
Measurements
OG000NA± NAResults are not reported because plasma Aβ1-42 concentrations were sporadic and below the lower limit of quantification (20 pg/mL).
OG001NA± NAResults are not reported because plasma Aβ1-42 concentrations were sporadic and below the lower limit of quantification (20 pg/mL).
OG002NA± NAResults are not reported because plasma Aβ1-42 concentrations were sporadic and below the lower limit of quantification (20 pg/mL).
OG003NA± NAResults are not reported because plasma Aβ1-42 concentrations were sporadic and below the lower limit of quantification (20 pg/mL).
OG00412.68± 25.00
OG00555.96± 142.05
OG006NA± NAResults are not reported because plasma Aβ1-42 concentrations were sporadic and below the lower limit of quantification (20 pg/mL).
ParticipantsOG00424
ParticipantsOG00521
ParticipantsOG00632
Title
Measurements
OG000NA± NAResults are not reported because plasma Aβ1-42 concentrations were sporadic and below the lower limit of quantification (20 pg/mL).
OG001NA± NAResults are not reported because plasma Aβ1-42 concentrations were sporadic and below the lower limit of quantification (20 pg/mL).
OG002NA± NAResults are not reported because plasma Aβ1-42 concentrations were sporadic and below the lower limit of quantification (20 pg/mL).
OG003NA± NAResults are not reported because plasma Aβ1-42 concentrations were sporadic and below the lower limit of quantification (20 pg/mL).
OG00412.21± 22.64
OG00557.44± 156.63
OG006NA± NAResults are not reported because plasma Aβ1-42 concentrations were sporadic and below the lower limit of quantification (20 pg/mL).
ParticipantsOG00426
ParticipantsOG00523
ParticipantsOG00632
Title
Measurements
OG000NA± NAResults are not reported because plasma Aβ1-42 concentrations were sporadic and below the lower limit of quantification (20 pg/mL).
OG001NA± NAResults are not reported because plasma Aβ1-42 concentrations were sporadic and below the lower limit of quantification (20 pg/mL).
OG002NA± NAResults are not reported because plasma Aβ1-42 concentrations were sporadic and below the lower limit of quantification (20 pg/mL).
OG003NA± NAResults are not reported because plasma Aβ1-42 concentrations were sporadic and below the lower limit of quantification (20 pg/mL).
OG00412.08± 30.02
OG00566.16± 194.92
OG006NA± NAResults are not reported because plasma Aβ1-42 concentrations were sporadic and below the lower limit of quantification (20 pg/mL).
ParticipantsOG00424
ParticipantsOG00519
ParticipantsOG00632
Title
Measurements
OG000NA± NAResults are not reported because plasma Aβ1-42 concentrations were sporadic and below the lower limit of quantification (20 pg/mL).
OG001NA± NAResults are not reported because plasma Aβ1-42 concentrations were sporadic and below the lower limit of quantification (20 pg/mL).
OG002NA± NAResults are not reported because plasma Aβ1-42 concentrations were sporadic and below the lower limit of quantification (20 pg/mL).
OG003NA± NAResults are not reported because plasma Aβ1-42 concentrations were sporadic and below the lower limit of quantification (20 pg/mL).
OG00411.93± 22.97
OG00562.57± 164.16
OG006NA± NAResults are not reported because plasma Aβ1-42 concentrations were sporadic and below the lower limit of quantification (20 pg/mL).
Participants
OG004
26
ParticipantsOG00523
ParticipantsOG00632
Title
Measurements
OG000NA± NAResults are not reported because plasma Aβ1-42 concentrations were sporadic and below the lower limit of quantification (20 pg/mL).
OG001NA± NAResults are not reported because plasma Aβ1-42 concentrations were sporadic and below the lower limit of quantification (20 pg/mL).
OG002NA± NAResults are not reported because plasma Aβ1-42 concentrations were sporadic and below the lower limit of quantification (20 pg/mL).
OG003NA± NAResults are not reported because plasma Aβ1-42 concentrations were sporadic and below the lower limit of quantification (20 pg/mL).
OG00412.57± 30.68
OG00572.92± 220.09
OG006NA± NAResults are not reported because plasma Aβ1-42 concentrations were sporadic and below the lower limit of quantification (20 pg/mL).
ParticipantsOG00424
ParticipantsOG00521
ParticipantsOG00632
Title
Measurements
OG000NA± NAResults are not reported because plasma Aβ1-42 concentrations were sporadic and below the lower limit of quantification (20 pg/mL).
OG001NA± NAResults are not reported because plasma Aβ1-42 concentrations were sporadic and below the lower limit of quantification (20 pg/mL).
OG002NA± NAResults are not reported because plasma Aβ1-42 concentrations were sporadic and below the lower limit of quantification (20 pg/mL).
OG003NA± NAResults are not reported because plasma Aβ1-42 concentrations were sporadic and below the lower limit of quantification (20 pg/mL).
OG0049.89± 28.01
OG00554.91± 131.76
OG006NA± NAResults are not reported because plasma Aβ1-42 concentrations were sporadic and below the lower limit of quantification (20 pg/mL).
ParticipantsOG00421
ParticipantsOG00515
ParticipantsOG00632
Title
Measurements
OG000NA± NAResults are not reported because plasma Aβ1-42 concentrations were sporadic and below the lower limit of quantification (20 pg/mL).
OG001NA± NAResults are not reported because plasma Aβ1-42 concentrations were sporadic and below the lower limit of quantification (20 pg/mL).
OG002NA± NAResults are not reported because plasma Aβ1-42 concentrations were sporadic and below the lower limit of quantification (20 pg/mL).
OG003NA± NAResults are not reported because plasma Aβ1-42 concentrations were sporadic and below the lower limit of quantification (20 pg/mL).
OG0046.09± 22.85
OG00564.51± 162.91
OG006NA± NAResults are not reported because plasma Aβ1-42 concentrations were sporadic and below the lower limit of quantification (20 pg/mL).
ParticipantsOG00424
ParticipantsOG00523
ParticipantsOG00632
Title
Measurements
OG000NA± NAResults are not reported because plasma Aβ1-42 concentrations were sporadic and below the lower limit of quantification (20 pg/mL).
OG001NA± NAResults are not reported because plasma Aβ1-42 concentrations were sporadic and below the lower limit of quantification (20 pg/mL).
OG002NA± NAResults are not reported because plasma Aβ1-42 concentrations were sporadic and below the lower limit of quantification (20 pg/mL).
OG003NA± NAResults are not reported because plasma Aβ1-42 concentrations were sporadic and below the lower limit of quantification (20 pg/mL).
OG0046.94± 16.00
OG00530.32± 91.79
OG006NA± NAResults are not reported because plasma Aβ1-42 concentrations were sporadic and below the lower limit of quantification (20 pg/mL).
ParticipantsOG00421
ParticipantsOG00518
ParticipantsOG00632
Title
Measurements
OG000NA± NAResults are not reported because plasma Aβ1-42 concentrations were sporadic and below the lower limit of quantification (20 pg/mL).
OG001NA± NAResults are not reported because plasma Aβ1-42 concentrations were sporadic and below the lower limit of quantification (20 pg/mL).
OG002NA± NAResults are not reported because plasma Aβ1-42 concentrations were sporadic and below the lower limit of quantification (20 pg/mL).
OG003NA± NAResults are not reported because plasma Aβ1-42 concentrations were sporadic and below the lower limit of quantification (20 pg/mL).
OG0047.50± 14.00
OG00537.13± 98.93
OG006NA± NAResults are not reported because plasma Aβ1-42 concentrations were sporadic and below the lower limit of quantification (20 pg/mL).
ParticipantsOG00422
ParticipantsOG00521
ParticipantsOG00632
Title
Measurements
OG000NA± NAResults are not reported because plasma Aβ1-42 concentrations were sporadic and below the lower limit of quantification (20 pg/mL).
OG001NA± NAResults are not reported because plasma Aβ1-42 concentrations were sporadic and below the lower limit of quantification (20 pg/mL).
OG002NA± NAResults are not reported because plasma Aβ1-42 concentrations were sporadic and below the lower limit of quantification (20 pg/mL).
OG003NA± NAResults are not reported because plasma Aβ1-42 concentrations were sporadic and below the lower limit of quantification (20 pg/mL).
OG0045.05± 14.19
OG00536.62± 87.98
OG006NA± NAResults are not reported because plasma Aβ1-42 concentrations were sporadic and below the lower limit of quantification (20 pg/mL).
ParticipantsOG00420
ParticipantsOG00516
ParticipantsOG00632
Title
Measurements
OG000NA± NAResults are not reported because plasma Aβ1-42 concentrations were sporadic and below the lower limit of quantification (20 pg/mL).
OG001NA± NAResults are not reported because plasma Aβ1-42 concentrations were sporadic and below the lower limit of quantification (20 pg/mL).
OG002NA± NAResults are not reported because plasma Aβ1-42 concentrations were sporadic and below the lower limit of quantification (20 pg/mL).
OG003NA± NAResults are not reported because plasma Aβ1-42 concentrations were sporadic and below the lower limit of quantification (20 pg/mL).
OG0044.36± 11.09
OG00526.73± 70.63
OG006NA± NAResults are not reported because plasma Aβ1-42 concentrations were sporadic and below the lower limit of quantification (20 pg/mL).
Participants
OG004
21
ParticipantsOG00521
ParticipantsOG00632
Title
Measurements
OG000NA± NAResults are not reported because plasma Aβ1-42 concentrations were sporadic and below the lower limit of quantification (20 pg/mL).
OG001NA± NAResults are not reported because plasma Aβ1-42 concentrations were sporadic and below the lower limit of quantification (20 pg/mL).
OG002NA± NAResults are not reported because plasma Aβ1-42 concentrations were sporadic and below the lower limit of quantification (20 pg/mL).
OG003NA± NAResults are not reported because plasma Aβ1-42 concentrations were sporadic and below the lower limit of quantification (20 pg/mL).
OG0044.53± 15.68
OG00543.1± 114.46
OG006NA± NAResults are not reported because plasma Aβ1-42 concentrations were sporadic and below the lower limit of quantification (20 pg/mL).
Participants
OG004
22
ParticipantsOG00521
ParticipantsOG00632
Title
Measurements
OG000NA± NAResults are not reported because plasma Aβ1-42 concentrations were sporadic and below the lower limit of quantification (20 pg/mL).
OG001NA± NAResults are not reported because plasma Aβ1-42 concentrations were sporadic and below the lower limit of quantification (20 pg/mL).
OG002NA± NAResults are not reported because plasma Aβ1-42 concentrations were sporadic and below the lower limit of quantification (20 pg/mL).
OG003NA± NAResults are not reported because plasma Aβ1-42 concentrations were sporadic and below the lower limit of quantification (20 pg/mL).
OG0047.09± 33.26
OG00526.21± 106.89
OG006NA± NAResults are not reported because plasma Aβ1-42 concentrations were sporadic and below the lower limit of quantification (20 pg/mL).
Participants
OG004
22
ParticipantsOG00519
ParticipantsOG00632
Title
Measurements
OG000NA± NAResults are not reported because plasma Aβ1-42 concentrations were sporadic and below the lower limit of quantification (20 pg/mL).
OG001NA± NAResults are not reported because plasma Aβ1-42 concentrations were sporadic and below the lower limit of quantification (20 pg/mL).
OG002NA± NAResults are not reported because plasma Aβ1-42 concentrations were sporadic and below the lower limit of quantification (20 pg/mL).
OG003NA± NAResults are not reported because plasma Aβ1-42 concentrations were sporadic and below the lower limit of quantification (20 pg/mL).
OG0047.70± 29.70
OG00533.11± 144.30
OG006NA± NAResults are not reported because plasma Aβ1-42 concentrations were sporadic and below the lower limit of quantification (20 pg/mL).
18425.00
± 5034.13
OG00431553.85± 10242.12
OG00525536.36± 9602.63
OG00625923.53± 8724.93
Participants
OG004
11
ParticipantsOG00510
ParticipantsOG00614
Title
Measurements
OG00031766.67± 6906.04
OG00131050.00± 9056.88
OG00222775.00± 3856.06
OG00316025.00± 3279.61
OG00427850.00± 11601.40
OG00531580.00± 16461.79
OG00622888.57± 9294.70
Participants
OG004
8
ParticipantsOG0057
ParticipantsOG0068
Title
Measurements
OG00012200.00± NAStandard deviation was not estimable since only 1 participant was evaluable.
OG00132466.67± 7305.02
OG00215250.00± 7424.62
OG00311650.00± 1626.35
OG00413378.75± 3643.53
OG00510688.57± 2937.67
OG00610467.50± 2876.30
7947.50
± 2501.00
OG00414672.31± 6776.14
OG00512301.82± 4272.94
OG00612713.53± 5960.78
Participants
OG004
11
ParticipantsOG00510
ParticipantsOG00614
Title
Measurements
OG00016833.33± 4244.21
OG00114733.33± 4341.27
OG00212350.00± 2537.06
OG0037977.50± 1542.95
OG00414106.36± 5225.42
OG00513733.00± 4712.08
OG00611745.71± 3627.05
Participants
OG004
9
ParticipantsOG0056
ParticipantsOG0068
Title
Measurements
OG0004930.00± NAStandard deviation was not estimable since only 1 participant was evaluable.
OG00110775.00± 5811.55
OG0028445.00± 2128.39
OG0035235.00± 572.76
OG0047108.89± 1712.55
OG0059315.00± 3779.86
OG0064730.00± 1235.86
694.00
± 217.22
OG004959.54± 281.30
OG005817.36± 323.31
OG006803.41± 232.38
Participants
OG004
11
ParticipantsOG00510
ParticipantsOG00614
Title
Measurements
OG0001009.00± 298.29
OG001821.33± 235.97
OG002866.00± 176.40
OG003557.50± 159.32
OG004949.36± 223.50
OG005895.80± 273.28
OG006778.29± 221.01
Participants
OG004
9
ParticipantsOG0056
ParticipantsOG0068
Title
Measurements
OG000802.00± NAStandard deviation was not estimable since only 1 participant was evaluable.
OG001803.00± 7.55
OG002958.00± NAStandard deviation was not estimable since only 1 participant was evaluable.
OG003421.50± 142.13
OG004487.11± 483.28
OG005582.33± 489.19
OG006665.25± 358.57
96.13
± 34.73
OG004219.09± 192.54
OG005167.40± 101.42
OG006196.31± 147.04
Participants
OG004
10
ParticipantsOG00510
ParticipantsOG00613
Title
Measurements
OG000202.33± 112.51
OG001210.33± 98.42
OG002167.78± 83.20
OG003117.38± 22.52
OG004217.64± 149.25
OG005169.76± 121.25
OG006158.00± 62.91
Participants
OG004
8
ParticipantsOG0057
ParticipantsOG0068
Title
Measurements
OG00078.00± NAStandard deviation was not estimable since only 1 participant was evaluable.
OG001158.98± 93.46
OG00290.80± 28.57
OG00349.20± 5.37
OG004166.18± 115.72
OG005139.94± 83.16
OG006124.24± 51.28
Participants
OG004
13
ParticipantsOG00511
ParticipantsOG00617
Title
Measurements
OG00072.53± 10.46
OG00165.89± 28.22
OG00249.13± 13.83
OG00334.98± 11.40
OG00456.72± 30.64
OG00549.45± 23.76
OG00659.17± 28.41
Participants
OG004
10
ParticipantsOG00510
ParticipantsOG00613
Title
Measurements
OG00073.27± 7.28
OG00170.15± 31.21
OG00264.50± 30.38
OG00347.13± 19.96
OG00460.26± 36.98
OG00557.77± 31.63
OG00647.98± 16.91
Participants
OG004
8
ParticipantsOG0057
ParticipantsOG0068
Title
Measurements
OG00070.70± NAStandard deviation was not estimable since only 1 participant was evaluable.