Long Term Extension Study Evaluating Safety, Tolerability... | NCT01238991 | Trialant
NCT01238991
Sponsor
Pfizer
Status
Terminated
Last Update Posted
Dec 22, 2014Estimated
Enrollment
53Actual
Phase
Phase 2
Conditions
Alzheimer's Disease
Interventions
ACC-001
ACC-001
ACC-001
Countries
Japan
Protocol Section
Identification Module
NCT ID
NCT01238991
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
B2571001
Secondary IDs
ID
Type
Description
Link
3134K1-2207
Other Identifier
Alias Study Number
Brief Title
Long Term Extension Study Evaluating Safety, Tolerability And Immunogenicity Of ACC-001 In Japanese Subjects With Mild To Moderate Alzheimer's Disease
Official Title
A Phase Iia, Multicenter, Treatment Assigned, Open-label, Long-term Extension Study To Determine Safety, Tolerability, And Immunogenicity Of Acc-001 With Qs-21 Adjuvant In Japanese Subjects With Mild To Moderate Alzheimer's Disease
Acronym
Not provided
Organization
PfizerINDUSTRY
Status Module
Record Verification Date
Dec 2014
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Dec 2010
Primary Completion Date
Dec 2013Actual
Completion Date
Dec 2013Actual
First Submitted Date
Oct 21, 2010
First Submission Date that Met QC Criteria
Nov 9, 2010
First Posted Date
Nov 11, 2010Estimated
Results Waived
Not provided
Results First Submitted Date
Dec 12, 2014
Results First Submitted that Met QC Criteria
Dec 12, 2014
Results First Posted Date
Dec 22, 2014Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Dec 12, 2014
Last Update Posted Date
Dec 22, 2014Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
PfizerINDUSTRY
Collaborators
Name
Class
JANSSEN Alzheimer Immunotherapy Research & Development, LLC
INDUSTRY
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of this long term extension study is to assess safety, tolerability and immunogenicity of ACC-001 with QS-21 adjuvant in Japanese subjects with mild to moderate AD who were randomized in the preceding P2 double blind studies.
Detailed Description
Not provided
Conditions Module
Conditions
Alzheimer's Disease
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
53Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
ACC-001 (3 micrograms) + QS-21
Experimental
Active vaccine dose of 3 micrograms +adjuvant, IM injection, at Day 1, month 6, 12 and 18
Biological: ACC-001
ACC-001 (10 micrograms) + QS-21
Experimental
Active vaccine dose of 10 micrograms +adjuvant, IM injection, at Day 1, month 6, 12 and 18
Biological: ACC-001
ACC-001 (30 micrograms) + QS-21
Experimental
Active vaccine dose of 30 micrograms +adjuvant, IM injection, at Day 1, month 6, 12 and 18
Biological: ACC-001
Interventions
Name
Type
Description
Arm Group Labels
Other Names
ACC-001
Biological
IM injection, dose of 3 micrograms, at Day 1, month 6, 12 and 18
ACC-001 (3 micrograms) + QS-21
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Treatment Emergent Adverse Events (AEs) by Severity
Number of mild, moderate, and severe AEs (mild = does not interfere with subject's usual function; moderate = interferes to some extent with subject's usual function; severe = interferes significantly with subject's usual function)
Baseline up to 24 months
Number of Participants With Brain Abnormalities in Magnetic Resonance Imaging (MRI) Data
Number of participants with brain abnormalities in MRI data that are either consistent or not consistent with AD, as determined by radiologists.
Baseline up to 24 months
Number of Participants With Abnormalities in Neurological Examination
Number of participants with abnormalities in neurological examinations as determined by the investigators. Neurological examinations included Mental Status, Speech, Cranial Nerve Function, Cranial Nerve II, Sensory Function, Motor Function, Coordination, Gait and Station, Reflexes and Deep Tendon Reflexes.
Baseline of the preceding studies through 24 months of this study
Secondary Outcomes
Not provided
Other Outcomes
Measure
Description
Time Frame
Anti-A-beta IgG (Immunoglobulin G) Titer at Specified Visits
Geometric mean of anti-a-beta IgG titer from baseline of the preceding studies through the end of this study
Baseline of preceding studies to month 24 of this study (Week 210)
Anti-A-beta IgM (Immunoglobulin M) Titer at Specified Visits
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Subjects randomized under previous 3134K1-2202-JA (NCT00752232) and 3134K1-2206-JA (NCT00959192) and met all inclusion criteria and non of the exclusion criteria.
Screening brain MRI scan is consistent with the diagnosis of AD.
MMSE score 10 and above.
Exclusion Criteria:
Significant neurological diseases other than AD.
Brain MRI evidence of vasogenic edema during the preceding studies.
Clinically significant illness.
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
52 Years
Maximum Age
87 Years
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
Meitetsu Hospital
Nagoya
Aichi-ken
451-8511
Japan
Ibaraki Prefectural Central Hospital
References Module
Citations
Not provided
See Also Links
Label
URL
To obtain contact information for a study center near you, click here.
The study enrolled those who completed the preceding studies (NCT00752232 and NCT00959192), where active vaccine ACC-001 (3, 10 or 30 μg) + adjuvant QS-21 (50 μg), as well as ACC-001, QS-21 and phosphate buffered saline (PBS) alone, were administered at Day 1, month 3, 6, 9 and 12 and at Day 1, month 1, 3, 6 and 12, respectively.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
3 μg ACC-001+QS-21
A group of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
FG001
QS-21+(3 μg ACC-001+QS-21)
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
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
Non-Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
ACC-001
Biological
IM injection, dose of 10 micrograms, at Day 1, month 6, 12 and 18
ACC-001 (10 micrograms) + QS-21
ACC-001
Biological
IM injection, dose of 30 micrograms, at Day 1, month 6, 12 and 18
ACC-001 (30 micrograms) + QS-21
Geotmetric mean of anti-a-beta IgM titer from baseline of the preceding studies through the end of this study
Baseline of preceding studies to month 24 of this study (Week 210)
The Mean Changes in Alzheimer's Disease Assessment Scale-Cognitive Behavior (ADAS-Cog) Score From Baseline at Week 26, 52, 78 and 104.
The ADAS-Cog is a 12-item,objective measure of cognitive function, consisting of 1) Word Recall, 2) Naming Objects and Fingers, 3) Following Commands, 4) Constructional Praxis, 5) Ideational Praxis, 6) Orientation, 7) Word Recognition, 8) Recall of Test Instructions, 9) Spoken Language Ability, 10) Word-Finding Difficulty, 11) Comprehension of Spoken Language and 12) Concentration/Distractibility. For this study, the ADAS-Cog total score is derived by summing the individual scores from items 1 to 11, with higher scores indicating a greater degree of impairment. The total score ranges from 0 (no impairment) to 70 (worst impairment).
Baseline up to 24 Months
The Mean Changes in Disability Assessment for Dementia (DAD) Score From Baseline at Week 26, 52,78 and 104.
The DAD is administered through an interview with the caregiver and measures instrumental and basic activities of daily living. A total score is obtained by adding the rating for each question and converting this total score out of 100. Higher scores represent less disability in ADL while lower scores indicate more dysfunction.
Baseline up to 24 Months
The Mean Changes in Neuropsychological Test Battery (NTB) Score From Baseline at Week 26, 52, 78 and 104.
The NTB is a composite of nine widely used neuropsychological tests that assess immediate and delayed recall of verbal and visual information, attention, verbal fluency and executive function. The cognitive tests included in the NTB are the Wechsler Memory Scale (WMS) Visual-Paired Associates (immediate and delayed), WMS-Verbal Paired Associates (immediate and delayed), Rey Auditory Verbal Learning Test (immediate and delayed), WMS-Digit Span, Controlled Word Association Test, and Category Fluency Test. The NTB z-score is used for analysis. The z-score for each component is calculated through the following formula: z = (y_visit - y_base)/SD_base, where y_visit is a value at a particular time point and y_base is the average test score, and SD_base is the SD based on all participants' observed baseline scores in the study.
Baseline up to 24 Months
The Mean Changes in Mini-Mental State Examination (MMSE) Score From Baseline at Week 12, 26, 36, 52, 66, 78, 91 and 104.
The MMSE is a brief, structured examination of cognitive function. It has a total score of 30 points, and any score equal to or lower than 26 points indicates cognitive impairment.
Baseline up to 24 Months
Kasama
Ibaraki
309-1793
Japan
Shonan Atsugi Hospital
Atsugi
Kanagawa
243-8551
Japan
Kitasato University East Hospital
Sagamihara-shi
Kanagawa
252-0380
Japan
Suwa Red Cross Hospital
Suwa
Nagano
392-8510
Japan
Tazuke Kofukai Medical Research Institute Kitano Hospital
Osaka
Osaka
530-8480
Japan
Osaka Medical College Hospital
Takatsuki
Osaka
569-8686
Japan
Juntendo University Hospital
Bunkyo-ku
Tokyo
113-8431
Japan
Juntendo Tokyo Koto Geriatric Medical Center
Koto-ku
Tokyo
136-0075
Japan
The Tokyo Jikei University School of Medicine
Minato-ku
Tokyo
105-8471
Japan
Kanto Central Hospital of the Mutual Aid Association of Public School Teachers
Setagaya-ku
Tokyo
158-8531
Japan
A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001 (3 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
FG002
10 μg ACC-001+QS-21
A group of participants who received IM injection of active vaccine ACC-001(10 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
FG003
10 μg ACC-001+ (10 μg ACC-001+QS-21)
A group of participants who received IM injection of active vaccine ACC-001(10 μg) in the preceding studies and ACC-001 (10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
FG004
QS-21+(10 μg ACC-001+QS-21)
A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001(10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
FG005
PBS+(10 μg ACC-001+QS-21)
A group of participants who received IM injection of PBS in the preceding studies and active vaccine ACC-001 (10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
FG006
30 μg ACC-001+QS-21
A group of participants who received IM injection of active vaccine ACC-001 (30 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
FG007
30 μg ACC-001+(30 μg ACC-001+QS-21)
A group of participants who received IM injection of active vaccine ACC-001(30 μg) in the preceding studies and ACC-001(30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
FG008
QS-21+(30 μg ACC-001+QS-21)
A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001(30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
FG009
PBS+(30 μg ACC-001+QS-21)
A group of participants who received IM injection of PBS in the preceding studies and active vaccine ACC-001(30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
FG0007 subjects
FG0013 subjects
FG00211 subjects
FG0036 subjects
FG0045 subjects
FG0052 subjects
FG0068 subjects
FG0075 subjects
FG0084 subjects
FG0092 subjects
Received Treatment
FG0007 subjects
FG0013 subjects
FG00211 subjects
FG0036 subjects
FG0045 subjects
FG0052 subjects
FG0068 subjects
FG0075 subjects
FG0084 subjects
FG0092 subjects
COMPLETED
FG0005 subjects
FG0013 subjects
FG0025 subjects
FG0034 subjects
FG0043 subjects
FG0052 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
NOT COMPLETED
FG0002 subjects
FG0010 subjects
FG0026 subjects
FG0032 subjects
FG0042 subjects
FG0050 subjects
FG0068 subjects
FG0075 subjects
FG0084 subjects
FG0092 subjects
Type
Comment
Reasons
Adverse Event
FG0001 subjects
FG0010 subjects
FG0023 subjects
FG0031 subjects
FG0041 subjects
FG0050 subjects
FG0061 subjects
FG0071 subjects
FG0080 subjects
FG0090 subjects
Death
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Lack of Efficacy
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Study Terminated by Sponsor
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Caregiver's request
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Admission to a nursing home
FG0001 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
3 μg ACC-001+QS-21
A group of participants who received IM injection of active vaccine ACC-001 (3 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
BG001
QS-21+(3 μg ACC-001+QS-21)
A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001 (3 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
BG002
10 μg ACC-001+QS-21
A group of participants who received IM injection of active vaccine ACC-001(10 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
BG003
10 μg ACC-001+ (10 μg ACC-001+QS-21)
A group of participants who received IM injection of active vaccine ACC-001(10 μg) in the preceding studies and ACC-001 (10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
BG004
QS-21+(10 μg ACC-001+QS-21)
A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001(10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
BG005
PBS+(10 μg ACC-001+QS-21)
A group of participants who received IM injection of PBS in the preceding studies and active vaccine ACC-001 (10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
BG006
30 μg ACC-001+QS-21
A group of participants who received IM injection of active vaccine ACC-001 (30 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
BG007
30 μg ACC-001+(30 μg ACC-001+QS-21)
A group of participants who received IM injection of active vaccine ACC-001(30 μg) in the preceding studies and ACC-001(30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
BG008
QS-21+(30 μg ACC-001+QS-21)
A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001(30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
BG009
PBS+(30 μg ACC-001+QS-21)
A group of participants who received IM injection of PBS in the preceding studies and active vaccine ACC-001(30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
BG010
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0007
BG0013
BG00211
BG0036
BG0045
BG0052
BG0068
BG0075
BG0084
BG0092
BG01053
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00069± 9.8
BG00173.3± 9.2
BG00267.5± 9.8
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0004
BG0013
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 Treatment Emergent Adverse Events (AEs) by Severity
Number of mild, moderate, and severe AEs (mild = does not interfere with subject's usual function; moderate = interferes to some extent with subject's usual function; severe = interferes significantly with subject's usual function)
The population for safety analysis consisted of all enrolled participants who received at least one injection of study medication in this study.
Posted
Number
Events
Baseline up to 24 months
ID
Title
Description
OG000
3 μg ACC-001 Treat
A group of participants who received IM injection of active vaccine ACC-001 (3 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
OG001
3 μg Control
A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001 (3 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
OG002
10 μg ACC-001 Treat
A group of participants who received IM injection of active vaccine ACC-001(10 μg) with or without adjuvant QS-21 (50 μg) in the preceding studies and ACC-001 (10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
OG003
10 μg Control
A group of participants who received IM injection of adjuvant QS-21 (50 μg) or PBS in the preceding studies and active vaccine ACC-001(10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
OG004
30 μg ACC-001 Treat
A group of participants who received IM injection of active vaccine ACC-001 (30 μg) with or without adjuvant QS-21 (50 μg) in the preceding studies and ACC-001 (30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
OG005
30 μg Control
A group of participants who received IM injection of adjuvant QS-21 (50 μg) or PBS in the preceding studies and active vaccine ACC-001 (30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
Units
Counts
Participants
OG0007
OG0013
OG00217
OG003
Title
Denominators
Categories
Mild
Title
Measurements
OG00014
OG0017
OG00297
OG003
Primary
Number of Participants With Brain Abnormalities in Magnetic Resonance Imaging (MRI) Data
Number of participants with brain abnormalities in MRI data that are either consistent or not consistent with AD, as determined by radiologists.
The population for safety analysis consisted of all enrolled participants who received at least one injection of study medication in this study. Since the study was early terminated and the data could not be obtained as planned, the MRI data were not summarized.
Posted
Baseline up to 24 months
ID
Title
Description
OG000
3 μg ACC-001 Treat
A group of participants who received IM injection of active vaccine ACC-001 (3 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
OG001
3 μg Control
A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001 (3 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
OG002
10 μg ACC-001 Treat
A group of participants who received IM injection of active vaccine ACC-001(10 μg) with or without adjuvant QS-21 (50 μg) in the preceding studies and ACC-001 (10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
Primary
Number of Participants With Abnormalities in Neurological Examination
Number of participants with abnormalities in neurological examinations as determined by the investigators. Neurological examinations included Mental Status, Speech, Cranial Nerve Function, Cranial Nerve II, Sensory Function, Motor Function, Coordination, Gait and Station, Reflexes and Deep Tendon Reflexes.
The population for safety analysis consisted of all enrolled participants who received at least one injection of study medication in this study.
Posted
Number
Participants
Baseline of the preceding studies through 24 months of this study
ID
Title
Description
OG000
3 μg ACC-001 Treat
A group of participants who received IM injection of active vaccine ACC-001 (3 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
OG001
3 μg Control
A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001 (3 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
OG002
10 μg ACC-001 Treat
A group of participants who received IM injection of active vaccine ACC-001(10 μg) with or without adjuvant QS-21 (50 μg) in the preceding studies and ACC-001 (10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
Other Pre-specified
Anti-A-beta IgG (Immunoglobulin G) Titer at Specified Visits
Geometric mean of anti-a-beta IgG titer from baseline of the preceding studies through the end of this study
The immunogenicity analysis population consisted of those in the safety analysis population who had baseline immunogenicity evaluation in the preceding study and at least one immunogenicity evaluation post injection.
Posted
Geometric Mean
95% Confidence Interval
Units/mL
Baseline of preceding studies to month 24 of this study (Week 210)
ID
Title
Description
OG000
3 μg ACC-001+QS-21
A group of participants who received IM injection of active vaccine ACC-001 (3 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
OG001
QS-21+(3 μg ACC-001+QS-21)
A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001 (3 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
OG002
10 μg ACC-001+QS-21
A group of participants who received IM injection of active vaccine ACC-001(10 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
Other Pre-specified
Anti-A-beta IgM (Immunoglobulin M) Titer at Specified Visits
Geotmetric mean of anti-a-beta IgM titer from baseline of the preceding studies through the end of this study
The immunogenicity analysis population consisted of those in the safety analysis population who had baseline immunogenicity evaluation in the preceding study and at least one immunogenicity evaluation post injection. Since the study was early terminated and the data could not be obtained as planned, the IgM data were not summarized.
Posted
Baseline of preceding studies to month 24 of this study (Week 210)
ID
Title
Description
OG000
3 μg ACC-001+QS-21
A group of participants who received IM injection of active vaccine ACC-001 (3 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
OG001
QS-21+(3 μg ACC-001+QS-21)
A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001 (3 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
OG002
10 μg ACC-001+QS-21
A group of participants who received IM injection of active vaccine ACC-001(10 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
Other Pre-specified
The Mean Changes in Alzheimer's Disease Assessment Scale-Cognitive Behavior (ADAS-Cog) Score From Baseline at Week 26, 52, 78 and 104.
The ADAS-Cog is a 12-item,objective measure of cognitive function, consisting of 1) Word Recall, 2) Naming Objects and Fingers, 3) Following Commands, 4) Constructional Praxis, 5) Ideational Praxis, 6) Orientation, 7) Word Recognition, 8) Recall of Test Instructions, 9) Spoken Language Ability, 10) Word-Finding Difficulty, 11) Comprehension of Spoken Language and 12) Concentration/Distractibility. For this study, the ADAS-Cog total score is derived by summing the individual scores from items 1 to 11, with higher scores indicating a greater degree of impairment. The total score ranges from 0 (no impairment) to 70 (worst impairment).
The efficacy analysis population was all of the participants who received at least one injection in this study and had baseline efficacy evaluation in the preceding study and at least one efficacy evaluation post injection. Since the study was early terminated and the data could not be obtained as planned, the ADAS-Cog scores were not summarized.
Posted
Baseline up to 24 Months
ID
Title
Description
OG000
3 μg ACC-001+QS-21
A group of participants who received IM injection of active vaccine ACC-001 (3 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
OG001
QS-21+(3 μg ACC-001+QS-21)
A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001 (3 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
Other Pre-specified
The Mean Changes in Disability Assessment for Dementia (DAD) Score From Baseline at Week 26, 52,78 and 104.
The DAD is administered through an interview with the caregiver and measures instrumental and basic activities of daily living. A total score is obtained by adding the rating for each question and converting this total score out of 100. Higher scores represent less disability in ADL while lower scores indicate more dysfunction.
The efficacy analysis population was all of the participants who received at least one injection in this study and had baseline efficacy evaluation in the preceding study and at least one efficacy evaluation post injection. Since the study was early terminated and the data could not be obtained as planned, the DAD scores were not summarized.
Posted
Baseline up to 24 Months
ID
Title
Description
OG000
3 μg ACC-001+QS-21
A group of participants who received IM injection of active vaccine ACC-001 (3 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
OG001
QS-21+(3 μg ACC-001+QS-21)
A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001 (3 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
OG002
10 μg ACC-001+QS-21
Other Pre-specified
The Mean Changes in Neuropsychological Test Battery (NTB) Score From Baseline at Week 26, 52, 78 and 104.
The NTB is a composite of nine widely used neuropsychological tests that assess immediate and delayed recall of verbal and visual information, attention, verbal fluency and executive function. The cognitive tests included in the NTB are the Wechsler Memory Scale (WMS) Visual-Paired Associates (immediate and delayed), WMS-Verbal Paired Associates (immediate and delayed), Rey Auditory Verbal Learning Test (immediate and delayed), WMS-Digit Span, Controlled Word Association Test, and Category Fluency Test. The NTB z-score is used for analysis. The z-score for each component is calculated through the following formula: z = (y_visit - y_base)/SD_base, where y_visit is a value at a particular time point and y_base is the average test score, and SD_base is the SD based on all participants' observed baseline scores in the study.
The efficacy analysis population was all of the participants who received at least one injection in this study and had baseline efficacy evaluation in the preceding study and at least one efficacy evaluation post injection. Since the study was early terminated and the data could not be obtained as planned, the NTB scores were not summarized.
Posted
Baseline up to 24 Months
ID
Title
Description
OG000
3 μg ACC-001+QS-21
A group of participants who received IM injection of active vaccine ACC-001 (3 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
OG001
QS-21+(3 μg ACC-001+QS-21)
Other Pre-specified
The Mean Changes in Mini-Mental State Examination (MMSE) Score From Baseline at Week 12, 26, 36, 52, 66, 78, 91 and 104.
The MMSE is a brief, structured examination of cognitive function. It has a total score of 30 points, and any score equal to or lower than 26 points indicates cognitive impairment.
The efficacy analysis population was all of the participants who received at least one injection in this study and had baseline efficacy evaluation in the preceding study and at least one efficacy evaluation post injection. Since the study was early terminated and the data could not be obtained as planned, the MMSE scores were not summarized.
Posted
Baseline up to 24 Months
ID
Title
Description
OG000
3 μg ACC-001+QS-21
A group of participants who received IM injection of active vaccine ACC-001 (3 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
OG001
QS-21+(3 μg ACC-001+QS-21)
A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001 (3 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
OG002
10 μg ACC-001+QS-21
A group of participants who received IM injection of active vaccine ACC-001(10 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious 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
3μg ACC-001 Treat
A group of participants who received IM injection of active vaccine ACC-001 (3 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
0
7
7
7
EG001
3μg Control
A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and acctive vaccine ACC-001 (3 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
0
3
3
3
EG002
10ug ACC-001 Treat
A group of participants who received IM injection of active vaccine ACC-001 (10 μg) with or without adjuvant QS-21 (50 μg) in the preceding studies and ACC-001 (10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
7
17
15
17
EG003
10μg Control
A group of participants who received IM injection of adjuvant QS-21 (50 μg) or PBS in the preceding studies and active vaccine ACC-001(10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
1
7
5
7
EG004
30μg ACC-001 Treat
A group of participants who received IM injection of active vaccine ACC-001 (30 μg) with or without adjuvant QS-21 (50 μg) in the preceding studies and ACC-001 (30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
2
13
10
13
EG005
30μg Control
A group of participants who received IM injection of adjuvant QS-21(50 μg) or PBS in the preceding studies and active vaccine ACC-001 (30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
0
6
6
6
EG006
Total
All participants
10
53
46
53
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Cardiac failure
Cardiac disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected3 at risk
EG0021 affected17 at risk
EG0030 affected7 at risk
EG0040 affected13 at risk
EG0050 affected6 at risk
EG0061 affected53 at risk
Myocardial infarction
Cardiac disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected3 at risk
EG0021 affected17 at risk
EG003
Inguinal hernia
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected3 at risk
EG0021 affected17 at risk
EG003
Pyelonephritis
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected3 at risk
EG0021 affected17 at risk
EG003
Subdural haematoma
Injury, poisoning and procedural complications
MedDRA 16.1
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected3 at risk
EG0021 affected17 at risk
EG003
Polychondritis
Musculoskeletal and connective tissue disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected3 at risk
EG0021 affected17 at risk
EG003
Colon cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 16.1
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected3 at risk
EG0021 affected17 at risk
EG003
Gastric cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 16.1
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected3 at risk
EG0020 affected17 at risk
EG003
Metastases to spine
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 16.1
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected3 at risk
EG0020 affected17 at risk
EG003
Prostate cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 16.1
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected3 at risk
EG0020 affected17 at risk
EG003
Altered state of consciousness
Nervous system disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected3 at risk
EG0021 affected17 at risk
EG003
Brain oedema
Nervous system disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected3 at risk
EG0021 affected17 at risk
EG003
Cerebral atrophy
Nervous system disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected3 at risk
EG0021 affected17 at risk
EG003
Normal pressure hydrocephalus
Nervous system disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected3 at risk
EG0021 affected17 at risk
EG003
Impulsive behaviour
Psychiatric disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected3 at risk
EG0020 affected17 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Iron deficiency anaemia
Blood and lymphatic system disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected3 at risk
EG0020 affected17 at risk
EG0030 affected7 at risk
EG0041 affected13 at risk
EG0050 affected6 at risk
EG0061 affected53 at risk
Hypertrophic cardiomyopathy
Congenital, familial and genetic disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected3 at risk
EG0021 affected17 at risk
EG003
Tinnitus
Ear and labyrinth disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected3 at risk
EG0020 affected17 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected3 at risk
EG0021 affected17 at risk
EG003
Cataract
Eye disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected3 at risk
EG0022 affected17 at risk
EG003
Conjunctival haemorrhage
Eye disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected3 at risk
EG0020 affected17 at risk
EG003
Glaucoma
Eye disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected3 at risk
EG0021 affected17 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected3 at risk
EG0022 affected17 at risk
EG003
Dental caries
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected3 at risk
EG0022 affected17 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected3 at risk
EG0021 affected17 at risk
EG003
Enterocolitis
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected3 at risk
EG0021 affected17 at risk
EG003
Epigastric discomfort
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected3 at risk
EG0020 affected17 at risk
EG003
Eructation
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0001 affected7 at risk
EG0010 affected3 at risk
EG0020 affected17 at risk
EG003
Gastric ulcer
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected3 at risk
EG0020 affected17 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected3 at risk
EG0020 affected17 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected3 at risk
EG0021 affected17 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected3 at risk
EG0020 affected17 at risk
EG003
Large intestine polyp
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected3 at risk
EG0020 affected17 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected3 at risk
EG0022 affected17 at risk
EG003
Rectal prolapse
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected3 at risk
EG0021 affected17 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected3 at risk
EG0020 affected17 at risk
EG003
Gait disturbance
General disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected3 at risk
EG0021 affected17 at risk
EG003
Injection site erythema
General disorders
MedDRA 16.1
Systematic Assessment
EG0002 affected7 at risk
EG0011 affected3 at risk
EG0022 affected17 at risk
EG003
Injection site haemorrhage
General disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected3 at risk
EG0021 affected17 at risk
EG003
Injection site nodule
General disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected3 at risk
EG0021 affected17 at risk
EG003
Injection site pain
General disorders
MedDRA 16.1
Systematic Assessment
EG0001 affected7 at risk
EG0012 affected3 at risk
EG0021 affected17 at risk
EG003
Injection site pruritus
General disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected3 at risk
EG0020 affected17 at risk
EG003
Injection site swelling
General disorders
MedDRA 16.1
Systematic Assessment
EG0001 affected7 at risk
EG0010 affected3 at risk
EG0021 affected17 at risk
EG003
Irritability
General disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected3 at risk
EG0021 affected17 at risk
EG003
Malaise
General disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected3 at risk
EG0020 affected17 at risk
EG003
Puncture site pain
General disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected3 at risk
EG0021 affected17 at risk
EG003
Pyrexia
General disorders
MedDRA 16.1
Systematic Assessment
EG0001 affected7 at risk
EG0010 affected3 at risk
EG0022 affected17 at risk
EG003
Biliary cirrhosis primary
Hepatobiliary disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected3 at risk
EG0020 affected17 at risk
EG003
Balanitis candida
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected3 at risk
EG0021 affected17 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected3 at risk
EG0021 affected17 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected3 at risk
EG0021 affected17 at risk
EG003
Cystitis
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0000 affected7 at risk
EG0011 affected3 at risk
EG0020 affected17 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected3 at risk
EG0021 affected17 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected3 at risk
EG0021 affected17 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0001 affected7 at risk
EG0011 affected3 at risk
EG0024 affected17 at risk
EG003
Periodontitis
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected3 at risk
EG0021 affected17 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0000 affected7 at risk
EG0011 affected3 at risk
EG0020 affected17 at risk
EG003
Tinea pedis
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected3 at risk
EG0023 affected17 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected3 at risk
EG0021 affected17 at risk
EG003
Animal bite
Injury, poisoning and procedural complications
MedDRA 16.1
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected3 at risk
EG0021 affected17 at risk
EG003
Arthropod bite
Injury, poisoning and procedural complications
MedDRA 16.1
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected3 at risk
EG0020 affected17 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 16.1
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected3 at risk
EG0021 affected17 at risk
EG003
Excoriation
Injury, poisoning and procedural complications
MedDRA 16.1
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected3 at risk
EG0021 affected17 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 16.1
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected3 at risk
EG0024 affected17 at risk
EG003
Laceration
Injury, poisoning and procedural complications
MedDRA 16.1
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected3 at risk
EG0021 affected17 at risk
EG003
Ligament sprain
Injury, poisoning and procedural complications
MedDRA 16.1
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected3 at risk
EG0021 affected17 at risk
EG003
Radius fracture
Injury, poisoning and procedural complications
MedDRA 16.1
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected3 at risk
EG0020 affected17 at risk
EG003
Rib fracture
Injury, poisoning and procedural complications
MedDRA 16.1
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected3 at risk
EG0021 affected17 at risk
EG003
Spinal compression fracture
Injury, poisoning and procedural complications
MedDRA 16.1
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected3 at risk
EG0021 affected17 at risk
EG003
Subdural haematoma
Injury, poisoning and procedural complications
MedDRA 16.1
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected3 at risk
EG0021 affected17 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 16.1
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected3 at risk
EG0021 affected17 at risk
EG003
Blood pressure increased
Investigations
MedDRA 16.1
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected3 at risk
EG0022 affected17 at risk
EG003
Blood triglycerides increased
Investigations
MedDRA 16.1
Systematic Assessment
EG0001 affected7 at risk
EG0010 affected3 at risk
EG0020 affected17 at risk
EG003
C-reactive protein increased
Investigations
MedDRA 16.1
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected3 at risk
EG0021 affected17 at risk
EG003
Liver function test abnormal
Investigations
MedDRA 16.1
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected3 at risk
EG0020 affected17 at risk
EG003
Lymphocyte morphology abnormal
Investigations
MedDRA 16.1
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected3 at risk
EG0021 affected17 at risk
EG003
Metamyelocyte percentage increased
Investigations
MedDRA 16.1
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected3 at risk
EG0020 affected17 at risk
EG003
Platelet count decreased
Investigations
MedDRA 16.1
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected3 at risk
EG0020 affected17 at risk
EG003
Protein urine present
Investigations
MedDRA 16.1
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected3 at risk
EG0021 affected17 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected3 at risk
EG0020 affected17 at risk
EG003
Diabetes mellitus
Metabolism and nutrition disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected3 at risk
EG0020 affected17 at risk
EG003
Diabetes mellitus inadequate control
Metabolism and nutrition disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected3 at risk
EG0021 affected17 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected3 at risk
EG0020 affected17 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected3 at risk
EG0022 affected17 at risk
EG003
Bone cyst
Musculoskeletal and connective tissue disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected3 at risk
EG0021 affected17 at risk
EG003
Joint swelling
Musculoskeletal and connective tissue disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected3 at risk
EG0021 affected17 at risk
EG003
Limb discomfort
Musculoskeletal and connective tissue disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected3 at risk
EG0020 affected17 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected3 at risk
EG0020 affected17 at risk
EG003
Osteoporosis
Musculoskeletal and connective tissue disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected3 at risk
EG0020 affected17 at risk
EG003
Spinal osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected3 at risk
EG0020 affected17 at risk
EG003
Colon adenoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 16.1
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected3 at risk
EG0020 affected17 at risk
EG003
Uterine leiomyoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 16.1
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected3 at risk
EG0021 affected17 at risk
EG003
Apraxia
Nervous system disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected3 at risk
EG0021 affected17 at risk
EG003
Cerebral microhaemorrhage
Nervous system disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected3 at risk
EG0020 affected17 at risk
EG003
Cerebral ventricle dilatation
Nervous system disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected3 at risk
EG0021 affected17 at risk
EG003
Cognitive disorder
Nervous system disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected3 at risk
EG0021 affected17 at risk
EG003
Haemorrhagic cerebral infarction
Nervous system disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected3 at risk
EG0021 affected17 at risk
EG003
Headache
Nervous system disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected3 at risk
EG0020 affected17 at risk
EG003
Intercostal neuralgia
Nervous system disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected3 at risk
EG0020 affected17 at risk
EG003
Lacunar infarction
Nervous system disorders
MedDRA 16.1
Systematic Assessment
EG0001 affected7 at risk
EG0010 affected3 at risk
EG0020 affected17 at risk
EG003
Occipital neuralgia
Nervous system disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected3 at risk
EG0020 affected17 at risk
EG003
Sciatica
Nervous system disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected3 at risk
EG0020 affected17 at risk
EG003
Speech disorder
Nervous system disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected3 at risk
EG0021 affected17 at risk
EG003
Visual field defect
Nervous system disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected3 at risk
EG0021 affected17 at risk
EG003
Abnormal behaviour
Psychiatric disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected3 at risk
EG0021 affected17 at risk
EG003
Aggression
Psychiatric disorders
MedDRA 16.1
Systematic Assessment
EG0001 affected7 at risk
EG0010 affected3 at risk
EG0020 affected17 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected3 at risk
EG0022 affected17 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected3 at risk
EG0021 affected17 at risk
EG003
Delirium
Psychiatric disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected3 at risk
EG0021 affected17 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected3 at risk
EG0020 affected17 at risk
EG003
Intentional self-injury
Psychiatric disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected3 at risk
EG0021 affected17 at risk
EG003
Logorrhoea
Psychiatric disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected3 at risk
EG0021 affected17 at risk
EG003
Restlessness
Psychiatric disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected3 at risk
EG0022 affected17 at risk
EG003
Suicidal ideation
Psychiatric disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected3 at risk
EG0021 affected17 at risk
EG003
Calculus ureteric
Renal and urinary disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected3 at risk
EG0021 affected17 at risk
EG003
Cystitis noninfective
Renal and urinary disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected3 at risk
EG0021 affected17 at risk
EG003
Enuresis
Renal and urinary disorders
MedDRA 16.1
Systematic Assessment
EG0001 affected7 at risk
EG0010 affected3 at risk
EG0020 affected17 at risk
EG003
Hydronephrosis
Renal and urinary disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected3 at risk
EG0021 affected17 at risk
EG003
Urinary incontinence
Renal and urinary disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected3 at risk
EG0022 affected17 at risk
EG003
Benign prostatic hyperplasia
Reproductive system and breast disorders
MedDRA 16.1
Systematic Assessment
EG0001 affected7 at risk
EG0010 affected3 at risk
EG0020 affected17 at risk
EG003
Uterine prolapse
Reproductive system and breast disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected3 at risk
EG0021 affected17 at risk
EG003
Bronchitis chronic
Respiratory, thoracic and mediastinal disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected3 at risk
EG0020 affected17 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected3 at risk
EG0020 affected17 at risk
EG003
Dermatitis contact
Skin and subcutaneous tissue disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected3 at risk
EG0021 affected17 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected3 at risk
EG0021 affected17 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected3 at risk
EG0021 affected17 at risk
EG003
Swelling face
Skin and subcutaneous tissue disorders
MedDRA 16.1
Systematic Assessment
EG0001 affected7 at risk
EG0010 affected3 at risk
EG0020 affected17 at risk
EG003
Hypertension
Vascular disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected7 at risk
EG0010 affected3 at risk
EG0021 affected17 at risk
EG003
Since the study was early terminated and the data could not be obtained as planned, only part of the immunogenicity and safety results were summarized.
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
C000603458
vanutide cridificar
Ancestor Terms
Not provided
Browse Leaves
Not provided
Browse Branches
Not provided
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0081 subjects
FG0090 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
1 subjects
FG0050 subjects
FG0067 subjects
FG0074 subjects
FG0082 subjects
FG0092 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0081 subjects
FG0090 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
69.5
± 6.9
BG00465.2± 6.7
BG00570.5± 7.8
BG00673.9± 5.4
BG00771.2± 2
BG00864± 7.1
BG00968.5± 2.1
BG01069.2± 7.6
8
BG0034
BG0043
BG0052
BG0064
BG0073
BG0084
BG0091
BG01036
Male
BG0003
BG0010
BG0023
BG0032
BG0042
BG0050
BG0064
BG0072
BG0080
BG0091
BG01017
7
OG00413
OG0056
38
OG00428
OG00517
Moderate
Title
Measurements
OG0002
OG0010
OG00214
OG0032
OG0043
OG0054
Severe
Title
Measurements
OG0000
OG0010
OG0026
OG0030
OG0042
OG0050
OG003
10 μg Control
A group of participants who received IM injection of adjuvant QS-21 (50 μg) or PBS in the preceding studies and active vaccine ACC-001(10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
OG004
30 μg ACC-001 Treat
A group of participants who received IM injection of active vaccine ACC-001 (30 μg) with or without adjuvant QS-21 (50 μg) in the preceding studies and ACC-001 (30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
OG005
30 μg Control
A group of participants who received IM injection of adjuvant QS-21 (50 μg) or PBS in the preceding studies and active vaccine ACC-001 (30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG003
10 μg Control
A group of participants who received IM injection of adjuvant QS-21 (50 μg) or PBS in the preceding studies and active vaccine ACC-001(10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
OG004
30 μg ACC-001 Treat
A group of participants who received IM injection of active vaccine ACC-001 (30 μg) with or without adjuvant QS-21 (50 μg) in the preceding studies and ACC-001 (30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
OG005
30 μg Control
A group of participants who received IM injection of adjuvant QS-21 (50 μg) or PBS in the preceding studies and active vaccine ACC-001 (30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
Units
Counts
Participants
OG0007
OG0013
OG00217
OG0037
OG00413
OG0056
Title
Denominators
Categories
Mental Status
Title
Measurements
OG0000
OG0010
OG0022
OG0030
OG0040
OG0051
Speech
Title
Measurements
OG0000
OG0010
OG0021
OG003
Cranial Nerve Function
Title
Measurements
OG0000
OG0010
OG0020
OG003
Cranial Nerve II
Title
Measurements
OG0000
OG0010
OG0021
OG003
Sensory Function
Title
Measurements
OG0000
OG0010
OG0020
OG003
Motor Function
Title
Measurements
OG0000
OG0010
OG0020
OG003
Coordination
Title
Measurements
OG0000
OG0010
OG0020
OG003
Gait and Station
Title
Measurements
OG0000
OG0010
OG0022
OG003
Reflexes
Title
Measurements
OG0000
OG0010
OG0020
OG003
Deep Tendon Reflexes
Title
Measurements
OG0000
OG0010
OG0020
OG003
OG003
10 μg ACC-001+(10 μg ACC-001+QS-21)
A group of participants who received IM injection of active vaccine ACC-001 (10 μg) in the preceding studies and ACC-001 (10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
OG004
QS-21+(10 μg ACC-001+QS-21)
A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001(10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
OG005
PBS+(10 μg ACC-001+QS-21)
A group of participants who received IM injection of PBS in the preceding studies and active vaccine ACC-001 (10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
OG006
30 μg ACC-001+QS-21
A group of participants who received IM injection of active vaccine ACC-001 (30 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
OG007
30 μg ACC-001+(30 μg ACC-001+QS-21)
A group of participants who received IM injection of active vaccine ACC-001(30 μg) in the preceding studies and ACC-001(30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
OG008
QS-21+(30 μg ACC-001+QS-21)
A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001(30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
OG009
PBS+(30 μg ACC-001+QS-21)
A group of participants who received IM injection of PBS in the preceding studies and active vaccine ACC-001(30 μg) + adjuvant QS-21(50 μg) in this study (Day 1, month 6, 12, and 18)
Units
Counts
Participants
OG0007
OG0013
OG00211
OG0036
OG0045
OG0052
OG0068
OG0075
OG0084
OG0092
Title
Denominators
Categories
Pre-study (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)
Title
Measurements
OG00050.0(50.0 to 50.0)
OG00150.0(50.0 to 50.0)
OG00250.0(50.0 to 50.0)
OG00350.0(50.0 to 50.0)
OG00450.0(50.0 to 50.0)
OG00550.0(50.0 to 50.0)
OG00650.0(50.0 to 50.0)
OG00750.0(50.0 to 50.0)
OG00850.0(50.0 to 50.0)
OG00950.0(50.0 to 50.0)
Week 2 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)
Title
Measurements
OG00060.3(38.1 to 95.5)
OG00150.0(50.0 to 50.0)
OG00267.2(34.7 to 130.1)
OG003
Week 4 (n=4, 2, 7, 0, 3, 0, 5, 0, 2, 0)
Title
Measurements
OG000158.5(18.2 to 1381.1)
OG00150.0(50.0 to 50.0)
OG00273.5(36.6 to 147.2)
OG003
Week 6 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)
Title
Measurements
OG000797.2(49.7 to 12776.7)
OG00150.0(50.0 to 50.0)
OG0021346.8(289.6 to 6264.0)
OG003
Week 8 (n=4, 2, 7, 0, 3, 0, 5, 0, 2, 0)
Title
Measurements
OG0003202.0(168.8 to 60744.5)
OG00150.0(50.0 to 50.0)
OG0022950.3(837.0 to 10399.3)
OG003
Week 10 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)
Title
Measurements
OG000494.2(49.1 to 4970.9)
OG00150.0(50.0 to 50.0)
OG002638.8(160.2 to 2547.6)
OG003
Week 14 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)
Title
Measurements
OG0006174.8(1628.1 to 23419.5)
OG00150.0(50.0 to 50.0)
OG0025696.9(2541.3 to 12771.2)
OG003
Week 16 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)
Title
Measurements
OG0004239.5(895.3 to 20075.3)
OG00150.0(50.0 to 50.0)
OG0023471.2(1569.0 to 7680.0)
OG003
Week 24 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)
Title
Measurements
OG0001292.4(263.8 to 6331.1)
OG00150.0(50.0 to 50.0)
OG0021122.5(502.5 to 2507.3)
OG003
Week 28 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)
Title
Measurements
OG0006460.4(1521.1 to 27438.5)
OG00150.0(50.0 to 50.0)
OG0026712.0(1862.9 to 24183.8)
OG003
Week 30 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)
Title
Measurements
OG0004928.0(1015.9 to 23904.5)
OG00150.0(50.0 to 50.0)
OG0025417.0(1626.4 to 18042.7)
OG003
Week 34 (n=3, 1, 4, 6, 2, 2, 3, 5, 2, 2)
Title
Measurements
OG000992.7(9.5 to 103353.0)
OG00150.0(NA to NA)95% confidence interval was not estimable since only one participant was evaluable.
OG0024480.4(34.4 to 583150.4)
OG003
Week 38 (n=3, 1, 4, 6, 2, 2, 3, 5, 2, 2)
Title
Measurements
OG0005444.2(634.1 to 46744.1)
OG00150.0(NA to NA)95% confidence interval was not estimable since only one participant was evaluable.
OG0024923.0(65.7 to 368774.1)
OG003
Week 40 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)
Title
Measurements
OG0004584.4(2315.0 to 9078.7)
OG00150.0(50.0 to 50.0)
OG0022639.5(839.1 to 8302.7)
OG003
Week 50 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)
Title
Measurements
OG0002153.0(1108.4 to 4182.2)
OG00150.0(50.0 to 50.0)
OG0021603.8(528.8 to 4864.7)
OG003
Week 54 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)
Title
Measurements
OG0005374.9(2019.8 to 14303.3)
OG00150.0(50.0 to 50.0)
OG0027559.6(2614.6 to 21857.4)
OG003
Week 56 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)
Title
Measurements
OG0007811.2(2656.5 to 22968.2)
OG00150.0(50.0 to 50.0)
OG0026204.2(1855.1 to 20749.6)
OG003
Week 66 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)
Title
Measurements
OG0004668.7(1533.4 to 14214.4)
OG00150.0(50.0 to 50.0)
OG0023877.2(1217.4 to 12347.8)
OG003
Week 78 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)
Title
Measurements
OG0002983.3(954.1 to 9328.0)
OG00150.0(50.0 to 50.0)
OG0022488.3(836.1 to 7405.1)
OG003
Week 82 (n=4, 2, 11, 6, 5, 2, 8, 5, 4, 2)
Title
Measurements
OG00016812.5(2685.3 to 105259.9)
OG00150.0(50.0 to 50.0)
OG0029783.0(3283.5 to 29148.1)
OG003
Week 84 (n=4, 2, 11, 6, 5, 2, 8, 5, 4, 2)
Title
Measurements
OG00014763.7(3422.9 to 63679.1)
OG001188.0(188.0 to 188.0)
OG0027058.6(2484.5 to 20054.3)
OG003
Week 91 (n=3, 1, 0, 0, 0, 0, 0, 0, 0, 0)
Title
Measurements
OG0001030.3(51.7 to 20540.2)
OG00150.0(NA to NA)95% confidence interval was not estimable since only one participant was evaluable.
OG002NA(NA to NA)Data were not analyzed as no participants were evaluable for the particular week.
OG003
Week 92 (n=4, 2, 11, 6, 5, 2, 8, 5, 4, 2)
Title
Measurements
OG0006100.2(1730.5 to 21504.2)
OG001277.1(1.1 to 71502.3)
OG0024142.3(1719.9 to 9976.6)
OG003
Week 104 (n=7, 3, 11, 6, 5, 2, 7, 4, 3, 2)
Title
Measurements
OG0002173.6(652.1 to 7244.7)
OG00183.4(9.2 to 753.5)
OG0022224.8(934.8 to 5295.0)
OG003
Week 108 (n=7, 3, 11, 6, 5, 2, 7, 4, 4, 2)
Title
Measurements
OG00014800.8(4544.9 to 48199.8)
OG001872.2(1.7 to 459286.2)
OG0028306.6(4126.8 to 16719.9)
OG003
Week 110 (n=7, 3, 10, 6, 5, 2, 7, 4, 2, 2)
Title
Measurements
OG0009185.4(3237.8 to 26058.4)
OG0011257.0(15.9 to 99324.4)
OG0028081.4(4125.7 to 15829.8)
OG003
Week 116 (n=4, 2, 10, 4, 5, 2, 7, 4, 2, 2)
Title
Measurements
OG0001682.2(38.5 to 73591.4)
OG0011548.4(1.3 to 1837780.1)
OG0025926.3(2682.3 to 13093.5)
OG003
Week 118 (n=3, 1, 0, 0, 0, 0, 0, 0, 0, 0)
Title
Measurements
OG0004506.7(59.6 to 340984.3)
OG00150.0(NA to NA)95% confidence interval was not estimable since only one participant was evaluable.
OG002NA(NA to NA)Data were not analyzed as no participants were evaluable for the particular week.
OG003
Week 130 (n=6, 3, 10, 5, 5, 2, 7, 4, 2, 2)
Title
Measurements
OG0003312.9(918.1 to 11954.2)
OG001323.7(4.0 to 25932.8)
OG0022251.0(704.2 to 7195.9)
OG003
Week 134 (n=5, 3, 8, 4, 5, 2, 6, 4, 1, 2)
Title
Measurements
OG0005904.2(2760.4 to 12628.6)
OG0014418.8(32.8 to 595262.2)
OG00211064.6(3340.9 to 36644.9)
OG003
Week 136 (n=6, 3, 8, 4, 5, 2, 2, 4, 0, 2)
Title
Measurements
OG0007816.8(2323.1 to 26302.4)
OG0013706.5(28.6 to 480359.1)
OG00210195.4(3243.3 to 32049.6)
OG003
Week 142 (n=3, 1, 0, 0, 0, 0, 0, 0, 0, 0)
Title
Measurements
OG0002353.6(164.1 to 33761.9)
OG00112571.0(NA to NA)95% confidence interval was not estimable since only one participant was evaluable.
OG002NA(NA to NA)Data were not analyzed as no participants were evaluable for the particular week.
OG003
Week 146 (n=3, 2, 9, 4, 5, 2, 2, 4, 0, 2)
Title
Measurements
OG0006813.3(1976.2 to 23490.5)
OG001979.6(447.2 to 2146.1)
OG0027269.6(2546.0 to 20756.9)
OG003
Week 156 (n=6, 3, 8, 4, 4, 2, 2, 4, 0, 2)
Title
Measurements
OG0002998.5(853.4 to 10536.3)
OG0011410.5(237.4 to 8381.7)
OG0024600.8(1798.3 to 11770.3)
OG003
Week 160 (n=5, 3, 7, 4, 2, 2, 1, 2, 0, 1)
Title
Measurements
OG0006305.4(2243.7 to 17719.5)
OG0011833.3(101.1 to 33260.5)
OG0026945.3(3865.8 to 12477.7)
OG003
Week 162 (n=6, 3, 8, 4, 4, 2, 0, 0, 0, 0)
Title
Measurements
OG0008513.5(2074.4 to 34940.7)
OG0011586.1(125.6 to 20025.2)
OG00210450.4(5734.0 to 19046.0)
OG003
Week 171 (n=3, 2, 7, 4, 4, 2, 0, 0, 0, 0)
Title
Measurements
OG0008602.3(4440.7 to 16664.0)
OG001739.7(32.9 to 16622.6)
OG0027551.2(3117.9 to 18288.2)
OG003
Week 172 (n=2, 1, 0, 0, 0, 0, 0, 0, 0, 0)
Title
Measurements
OG0001074.9(0.1 to 8576667.2)
OG0012981.0(NA to NA)95% confidence interval was not estimable since only one participant was evaluable.
OG002NA(NA to NA)Data were not analyzed as no participants were evaluable for the particular week.
OG003
Week 182 (n=3, 1, 0, 0, 0, 0, 0, 0, 0, 0)
Title
Measurements
OG0001944.9(81.6 to 46329.0)
OG0012555.0(NA to NA)95% confidence interval was not estimable since only one participant was evaluable.
OG002NA(NA to NA)Data were not analyzed as no participants were evaluable for the particular week.
OG003
Week 184 (n=3, 2, 6, 4, 3, 2, 0, 0, 0, 0)
Title
Measurements
OG0007062.8(5311.4 to 9391.7)
OG001636.6(4.1 to 98882.9)
OG0023378.1(1687.3 to 6763.1)
OG003
Week 186 (n=2, 1, 0, 0, 0, 0, 0, 0, 0, 0)
Title
Measurements
OG0003653.9(0.0 to 8947070499.4)
OG00113166.0(NA to NA)95% confidence interval was not estimable since only one participant was evaluable.
OG002NA(NA to NA)Data were not analyzed as no participants were evaluable for the particular week.
OG003
Week 188 (n=2, 1, 0, 0, 0, 0, 0, 0, 0, 0)
Title
Measurements
OG0003033.0(0.0 to 11447766146.8)
OG00114096.0(NA to NA)95% confidence interval was not estimable since only one participant was evaluable.
OG002NA(NA to NA)Data were not analyzed as no participants were evaluable for the particular week.
OG003
Week 197 (n=3 1, 0, 0, 0, 0, 0, 0, 0, 0)
Title
Measurements
OG0002074.7(78.6 to 54786.4)
OG0015502.0(NA to NA)95% confidence interval was not estimable since only one participant was evaluable.
OG002NA(NA to NA)Data were not analyzed as no participants were evaluable for the particular week.
OG003
Week 210 (n=2, 1, 0, 0, 0, 0, 0, 0, 0, 0)
Title
Measurements
OG0001291.4(0.0 to 404404006.6)
OG0011997.0(NA to NA)95% confidence interval was not estimable since only one participant was evaluable.
OG002NA(NA to NA)Data were not analyzed as no participants were evaluable for the particular week.
OG003
OG003
10 μg ACC-001+(10 μg ACC-001+QS-21)
A group of participants who received IM injection of active vaccine ACC-001 (10 μg) in the preceding studies and ACC-001 (10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
OG004
QS-21+(10 μg ACC-001+QS-21)
A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001(10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
OG005
PBS+(10 μg ACC-001+QS-21)
A group of participants who received IM injection of PBS in the preceding studies and active vaccine ACC-001 (10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
OG006
30 μg ACC-001+QS-21
A group of participants who received IM injection of active vaccine ACC-001 (30 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
OG007
30 μg ACC-001+(30 μg ACC-001+QS-21)
A group of participants who received IM injection of active vaccine ACC-001(30 μg) in the preceding studies and ACC-001(30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
OG008
QS-21+(30 μg ACC-001+QS-21)
A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001(30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
OG009
PBS+(30 μg ACC-001+QS-21)
A group of participants who received IM injection of PBS in the preceding studies and active vaccine ACC-001(30 μg) + adjuvant QS-21(50 μg) in this study (Day 1, month 6, 12, and 18)
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG002
10 μg ACC-001+QS-21
A group of participants who received IM injection of active vaccine ACC-001(10 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
OG003
10 μg ACC-001+(10 μg ACC-001+QS-21)
A group of participants who received IM injection of active vaccine ACC-001 (10 μg) in the preceding studies and ACC-001 (10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
OG004
QS-21+(10 μg ACC-001+QS-21)
A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001(10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
OG005
PBS+(10 μg ACC-001+QS-21)
A group of participants who received IM injection of PBS in the preceding studies and active vaccine ACC-001 (10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
OG006
30 μg ACC-001+QS-21
A group of participants who received IM injection of active vaccine ACC-001 (30 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
OG007
30 μg ACC-001+(30 μg ACC-001+QS-21)
A group of participants who received IM injection of active vaccine ACC-001(30 μg) in the preceding studies and ACC-001(30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
OG008
QS-21+(30 μg ACC-001+QS-21)
A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001(30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
OG009
PBS+(30 μg ACC-001+QS-21)
A group of participants who received IM injection of PBS in the preceding studies and active vaccine ACC-001(30 μg) + adjuvant QS-21(50 μg) in this study (Day 1, month 6, 12, and 18)
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
A group of participants who received IM injection of active vaccine ACC-001(10 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
OG003
10 μg ACC-001+(10 μg ACC-001+QS-21)
A group of participants who received IM injection of active vaccine ACC-001 (10 μg) in the preceding studies and ACC-001 (10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
OG004
QS-21+(10 μg ACC-001+QS-21)
A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001(10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
OG005
PBS+(10 μg ACC-001+QS-21)
A group of participants who received IM injection of PBS in the preceding studies and active vaccine ACC-001 (10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
OG006
30 μg ACC-001+QS-21
A group of participants who received IM injection of active vaccine ACC-001 (30 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
OG007
30 μg ACC-001+(30 μg ACC-001+QS-21)
A group of participants who received IM injection of active vaccine ACC-001(30 μg) in the preceding studies and ACC-001(30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
OG008
QS-21+(30 μg ACC-001+QS-21)
A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001(30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
OG009
PBS+(30 μg ACC-001+QS-21)
A group of participants who received IM injection of PBS in the preceding studies and active vaccine ACC-001(30 μg) + adjuvant QS-21(50 μg) in this study (Day 1, month 6, 12, and 18)
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001 (3 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
OG002
10 μg ACC-001+QS-21
A group of participants who received IM injection of active vaccine ACC-001(10 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
OG003
10 μg ACC-001+(10 μg ACC-001+QS-21)
A group of participants who received IM injection of active vaccine ACC-001 (10 μg) in the preceding studies and ACC-001 (10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
OG004
QS-21+(10 μg ACC-001+QS-21)
A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001(10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
OG005
PBS+(10 μg ACC-001+QS-21)
A group of participants who received IM injection of PBS in the preceding studies and active vaccine ACC-001 (10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
OG006
30 μg ACC-001+QS-21
A group of participants who received IM injection of active vaccine ACC-001 (30 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
OG007
30 μg ACC-001+(30 μg ACC-001+QS-21)
A group of participants who received IM injection of active vaccine ACC-001(30 μg) in the preceding studies and ACC-001(30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
OG008
QS-21+(30 μg ACC-001+QS-21)
A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001(30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
OG009
PBS+(30 μg ACC-001+QS-21)
A group of participants who received IM injection of PBS in the preceding studies and active vaccine ACC-001(30 μg) + adjuvant QS-21(50 μg) in this study (Day 1, month 6, 12, and 18)
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG003
10 μg ACC-001+(10 μg ACC-001+QS-21)
A group of participants who received IM injection of active vaccine ACC-001 (10 μg) in the preceding studies and ACC-001 (10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
OG004
QS-21+(10 μg ACC-001+QS-21)
A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001(10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
OG005
PBS+(10 μg ACC-001+QS-21)
A group of participants who received IM injection of PBS in the preceding studies and active vaccine ACC-001 (10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
OG006
30 μg ACC-001+QS-21
A group of participants who received IM injection of active vaccine ACC-001 (30 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
OG007
30 μg ACC-001+(30 μg ACC-001+QS-21)
A group of participants who received IM injection of active vaccine ACC-001(30 μg) in the preceding studies and ACC-001(30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
OG008
QS-21+(30 μg ACC-001+QS-21)
A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001(30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
OG009
PBS+(30 μg ACC-001+QS-21)
A group of participants who received IM injection of PBS in the preceding studies and active vaccine ACC-001(30 μg) + adjuvant QS-21(50 μg) in this study (Day 1, month 6, 12, and 18)
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
0 affected
7 at risk
EG0040 affected13 at risk
EG0050 affected6 at risk
EG0061 affected53 at risk
0 affected
7 at risk
EG0040 affected13 at risk
EG0050 affected6 at risk
EG0061 affected53 at risk
0 affected
7 at risk
EG0040 affected13 at risk
EG0050 affected6 at risk
EG0061 affected53 at risk
0 affected
7 at risk
EG0040 affected13 at risk
EG0050 affected6 at risk
EG0061 affected53 at risk
0 affected
7 at risk
EG0040 affected13 at risk
EG0050 affected6 at risk
EG0061 affected53 at risk
0 affected
7 at risk
EG0040 affected13 at risk
EG0050 affected6 at risk
EG0061 affected53 at risk
0 affected
7 at risk
EG0041 affected13 at risk
EG0050 affected6 at risk
EG0061 affected53 at risk
0 affected
7 at risk
EG0041 affected13 at risk
EG0050 affected6 at risk
EG0061 affected53 at risk
0 affected
7 at risk
EG0041 affected13 at risk
EG0050 affected6 at risk
EG0061 affected53 at risk
0 affected
7 at risk
EG0040 affected13 at risk
EG0050 affected6 at risk
EG0061 affected53 at risk
0 affected
7 at risk
EG0040 affected13 at risk
EG0050 affected6 at risk
EG0061 affected53 at risk
0 affected
7 at risk
EG0040 affected13 at risk
EG0050 affected6 at risk
EG0061 affected53 at risk
0 affected
7 at risk
EG0040 affected13 at risk
EG0050 affected6 at risk
EG0061 affected53 at risk
1 affected
7 at risk
EG0040 affected13 at risk
EG0050 affected6 at risk
EG0061 affected53 at risk
0 affected
7 at risk
EG0040 affected13 at risk
EG0050 affected6 at risk
EG0061 affected53 at risk
1 affected
7 at risk
EG0040 affected13 at risk
EG0050 affected6 at risk
EG0061 affected53 at risk
0 affected
7 at risk
EG0040 affected13 at risk
EG0050 affected6 at risk
EG0061 affected53 at risk
0 affected
7 at risk
EG0040 affected13 at risk
EG0050 affected6 at risk
EG0062 affected53 at risk
0 affected
7 at risk
EG0041 affected13 at risk
EG0051 affected6 at risk
EG0062 affected53 at risk
0 affected
7 at risk
EG0040 affected13 at risk
EG0050 affected6 at risk
EG0061 affected53 at risk
0 affected
7 at risk
EG0040 affected13 at risk
EG0050 affected6 at risk
EG0062 affected53 at risk
0 affected
7 at risk
EG0040 affected13 at risk
EG0050 affected6 at risk
EG0062 affected53 at risk
2 affected
7 at risk
EG0040 affected13 at risk
EG0050 affected6 at risk
EG0063 affected53 at risk
0 affected
7 at risk
EG0040 affected13 at risk
EG0050 affected6 at risk
EG0061 affected53 at risk
1 affected
7 at risk
EG0040 affected13 at risk
EG0050 affected6 at risk
EG0061 affected53 at risk
0 affected
7 at risk
EG0040 affected13 at risk
EG0050 affected6 at risk
EG0061 affected53 at risk
0 affected
7 at risk
EG0041 affected13 at risk
EG0050 affected6 at risk
EG0061 affected53 at risk
1 affected
7 at risk
EG0040 affected13 at risk
EG0050 affected6 at risk
EG0061 affected53 at risk
0 affected
7 at risk
EG0040 affected13 at risk
EG0050 affected6 at risk
EG0061 affected53 at risk
1 affected
7 at risk
EG0040 affected13 at risk
EG0050 affected6 at risk
EG0061 affected53 at risk
1 affected
7 at risk
EG0040 affected13 at risk
EG0050 affected6 at risk
EG0061 affected53 at risk
0 affected
7 at risk
EG0040 affected13 at risk
EG0050 affected6 at risk
EG0062 affected53 at risk
0 affected
7 at risk
EG0040 affected13 at risk
EG0050 affected6 at risk
EG0061 affected53 at risk
0 affected
7 at risk
EG0040 affected13 at risk
EG0051 affected6 at risk
EG0061 affected53 at risk
0 affected
7 at risk
EG0040 affected13 at risk
EG0050 affected6 at risk
EG0061 affected53 at risk
2 affected
7 at risk
EG0042 affected13 at risk
EG0052 affected6 at risk
EG00611 affected53 at risk
0 affected
7 at risk
EG0040 affected13 at risk
EG0050 affected6 at risk
EG0061 affected53 at risk
0 affected
7 at risk
EG0040 affected13 at risk
EG0050 affected6 at risk
EG0061 affected53 at risk
2 affected
7 at risk
EG0042 affected13 at risk
EG0051 affected6 at risk
EG0069 affected53 at risk
1 affected
7 at risk
EG0040 affected13 at risk
EG0050 affected6 at risk
EG0061 affected53 at risk
1 affected
7 at risk
EG0040 affected13 at risk
EG0051 affected6 at risk
EG0064 affected53 at risk
0 affected
7 at risk
EG0040 affected13 at risk
EG0051 affected6 at risk
EG0062 affected53 at risk
1 affected
7 at risk
EG0040 affected13 at risk
EG0050 affected6 at risk
EG0061 affected53 at risk
0 affected
7 at risk
EG0040 affected13 at risk
EG0050 affected6 at risk
EG0061 affected53 at risk
1 affected
7 at risk
EG0040 affected13 at risk
EG0050 affected6 at risk
EG0064 affected53 at risk
1 affected
7 at risk
EG0040 affected13 at risk
EG0050 affected6 at risk
EG0061 affected53 at risk
0 affected
7 at risk
EG0040 affected13 at risk
EG0050 affected6 at risk
EG0061 affected53 at risk
0 affected
7 at risk
EG0040 affected13 at risk
EG0050 affected6 at risk
EG0061 affected53 at risk
0 affected
7 at risk
EG0040 affected13 at risk
EG0050 affected6 at risk
EG0061 affected53 at risk
0 affected
7 at risk
EG0040 affected13 at risk
EG0051 affected6 at risk
EG0062 affected53 at risk
0 affected
7 at risk
EG0040 affected13 at risk
EG0050 affected6 at risk
EG0061 affected53 at risk
0 affected
7 at risk
EG0040 affected13 at risk
EG0051 affected6 at risk
EG0062 affected53 at risk
2 affected
7 at risk
EG0043 affected13 at risk
EG0051 affected6 at risk
EG00612 affected53 at risk
0 affected
7 at risk
EG0040 affected13 at risk
EG0050 affected6 at risk
EG0061 affected53 at risk
0 affected
7 at risk
EG0040 affected13 at risk
EG0050 affected6 at risk
EG0061 affected53 at risk
0 affected
7 at risk
EG0040 affected13 at risk
EG0050 affected6 at risk
EG0063 affected53 at risk
0 affected
7 at risk
EG0040 affected13 at risk
EG0050 affected6 at risk
EG0061 affected53 at risk
0 affected
7 at risk
EG0040 affected13 at risk
EG0050 affected6 at risk
EG0061 affected53 at risk
0 affected
7 at risk
EG0041 affected13 at risk
EG0050 affected6 at risk
EG0061 affected53 at risk
0 affected
7 at risk
EG0040 affected13 at risk
EG0050 affected6 at risk
EG0061 affected53 at risk
0 affected
7 at risk
EG0040 affected13 at risk
EG0050 affected6 at risk
EG0061 affected53 at risk
0 affected
7 at risk
EG0040 affected13 at risk
EG0051 affected6 at risk
EG0065 affected53 at risk
0 affected
7 at risk
EG0040 affected13 at risk
EG0050 affected6 at risk
EG0061 affected53 at risk
0 affected
7 at risk
EG0040 affected13 at risk
EG0050 affected6 at risk
EG0061 affected53 at risk
0 affected
7 at risk
EG0040 affected13 at risk
EG0051 affected6 at risk
EG0061 affected53 at risk
0 affected
7 at risk
EG0040 affected13 at risk
EG0050 affected6 at risk
EG0061 affected53 at risk
0 affected
7 at risk
EG0040 affected13 at risk
EG0050 affected6 at risk
EG0061 affected53 at risk
0 affected
7 at risk
EG0040 affected13 at risk
EG0050 affected6 at risk
EG0061 affected53 at risk
0 affected
7 at risk
EG0040 affected13 at risk
EG0050 affected6 at risk
EG0061 affected53 at risk
0 affected
7 at risk
EG0040 affected13 at risk
EG0050 affected6 at risk
EG0062 affected53 at risk
0 affected
7 at risk
EG0040 affected13 at risk
EG0050 affected6 at risk
EG0061 affected53 at risk
0 affected
7 at risk
EG0040 affected13 at risk
EG0050 affected6 at risk
EG0061 affected53 at risk
0 affected
7 at risk
EG0041 affected13 at risk
EG0050 affected6 at risk
EG0061 affected53 at risk
0 affected
7 at risk
EG0040 affected13 at risk
EG0050 affected6 at risk
EG0061 affected53 at risk
0 affected
7 at risk
EG0041 affected13 at risk
EG0050 affected6 at risk
EG0061 affected53 at risk
1 affected
7 at risk
EG0040 affected13 at risk
EG0050 affected6 at risk
EG0061 affected53 at risk
0 affected
7 at risk
EG0041 affected13 at risk
EG0050 affected6 at risk
EG0062 affected53 at risk
0 affected
7 at risk
EG0041 affected13 at risk
EG0050 affected6 at risk
EG0061 affected53 at risk
1 affected
7 at risk
EG0040 affected13 at risk
EG0050 affected6 at risk
EG0061 affected53 at risk
0 affected
7 at risk
EG0040 affected13 at risk
EG0050 affected6 at risk
EG0061 affected53 at risk
0 affected
7 at risk
EG0040 affected13 at risk
EG0051 affected6 at risk
EG0061 affected53 at risk
1 affected
7 at risk
EG0041 affected13 at risk
EG0051 affected6 at risk
EG0065 affected53 at risk
0 affected
7 at risk
EG0040 affected13 at risk
EG0050 affected6 at risk
EG0061 affected53 at risk
0 affected
7 at risk
EG0040 affected13 at risk
EG0050 affected6 at risk
EG0061 affected53 at risk
0 affected
7 at risk
EG0040 affected13 at risk
EG0051 affected6 at risk
EG0061 affected53 at risk
0 affected
7 at risk
EG0041 affected13 at risk
EG0050 affected6 at risk
EG0061 affected53 at risk
1 affected
7 at risk
EG0040 affected13 at risk
EG0050 affected6 at risk
EG0061 affected53 at risk
0 affected
7 at risk
EG0042 affected13 at risk
EG0050 affected6 at risk
EG0062 affected53 at risk
0 affected
7 at risk
EG0041 affected13 at risk
EG0050 affected6 at risk
EG0061 affected53 at risk
0 affected
7 at risk
EG0040 affected13 at risk
EG0050 affected6 at risk
EG0061 affected53 at risk
0 affected
7 at risk
EG0040 affected13 at risk
EG0050 affected6 at risk
EG0061 affected53 at risk
0 affected
7 at risk
EG0041 affected13 at risk
EG0050 affected6 at risk
EG0061 affected53 at risk
0 affected
7 at risk
EG0040 affected13 at risk
EG0050 affected6 at risk
EG0061 affected53 at risk
1 affected
7 at risk
EG0040 affected13 at risk
EG0051 affected6 at risk
EG0063 affected53 at risk
0 affected
7 at risk
EG0040 affected13 at risk
EG0050 affected6 at risk
EG0061 affected53 at risk
0 affected
7 at risk
EG0041 affected13 at risk
EG0050 affected6 at risk
EG0061 affected53 at risk
0 affected
7 at risk
EG0040 affected13 at risk
EG0051 affected6 at risk
EG0061 affected53 at risk
0 affected
7 at risk
EG0041 affected13 at risk
EG0050 affected6 at risk
EG0062 affected53 at risk
1 affected
7 at risk
EG0040 affected13 at risk
EG0050 affected6 at risk
EG0061 affected53 at risk
1 affected
7 at risk
EG0040 affected13 at risk
EG0050 affected6 at risk
EG0061 affected53 at risk
0 affected
7 at risk
EG0040 affected13 at risk
EG0050 affected6 at risk
EG0061 affected53 at risk
0 affected
7 at risk
EG0040 affected13 at risk
EG0050 affected6 at risk
EG0061 affected53 at risk
0 affected
7 at risk
EG0040 affected13 at risk
EG0050 affected6 at risk
EG0061 affected53 at risk
0 affected
7 at risk
EG0040 affected13 at risk
EG0050 affected6 at risk
EG0061 affected53 at risk
0 affected
7 at risk
EG0040 affected13 at risk
EG0050 affected6 at risk
EG0062 affected53 at risk
0 affected
7 at risk
EG0040 affected13 at risk
EG0050 affected6 at risk
EG0061 affected53 at risk
0 affected
7 at risk
EG0040 affected13 at risk
EG0050 affected6 at risk
EG0061 affected53 at risk
1 affected
7 at risk
EG0040 affected13 at risk
EG0050 affected6 at risk
EG0061 affected53 at risk
0 affected
7 at risk
EG0040 affected13 at risk
EG0050 affected6 at risk
EG0061 affected53 at risk
0 affected
7 at risk
EG0040 affected13 at risk
EG0050 affected6 at risk
EG0061 affected53 at risk
0 affected
7 at risk
EG0040 affected13 at risk
EG0050 affected6 at risk
EG0062 affected53 at risk
0 affected
7 at risk
EG0040 affected13 at risk
EG0050 affected6 at risk
EG0061 affected53 at risk
0 affected
7 at risk
EG0040 affected13 at risk
EG0050 affected6 at risk
EG0061 affected53 at risk
0 affected
7 at risk
EG0040 affected13 at risk
EG0050 affected6 at risk
EG0061 affected53 at risk
0 affected
7 at risk
EG0040 affected13 at risk
EG0050 affected6 at risk
EG0061 affected53 at risk
0 affected
7 at risk
EG0040 affected13 at risk
EG0050 affected6 at risk
EG0061 affected53 at risk
0 affected
7 at risk
EG0040 affected13 at risk
EG0050 affected6 at risk
EG0062 affected53 at risk
0 affected
7 at risk
EG0040 affected13 at risk
EG0050 affected6 at risk
EG0061 affected53 at risk
0 affected
7 at risk
EG0040 affected13 at risk
EG0050 affected6 at risk
EG0061 affected53 at risk
1 affected
7 at risk
EG0040 affected13 at risk
EG0050 affected6 at risk
EG0061 affected53 at risk
0 affected
7 at risk
EG0040 affected13 at risk
EG0051 affected6 at risk
EG0061 affected53 at risk
0 affected
7 at risk
EG0040 affected13 at risk
EG0050 affected6 at risk
EG0061 affected53 at risk
1 affected
7 at risk
EG0040 affected13 at risk
EG0050 affected6 at risk
EG0062 affected53 at risk
0 affected
7 at risk
EG0040 affected13 at risk
EG0050 affected6 at risk
EG0061 affected53 at risk
0 affected
7 at risk
EG0040 affected13 at risk
EG0050 affected6 at risk
EG0061 affected53 at risk
0 affected
7 at risk
EG0042 affected13 at risk
EG0050 affected6 at risk
EG0063 affected53 at risk
0
OG0040
OG0050
0
OG0040
OG0050
0
OG0040
OG0050
0
OG0040
OG0051
0
OG0040
OG0050
0
OG0040
OG0050
0
OG0041
OG0050
0
OG0040
OG0050
0
OG0040
OG0050
50.0
(50.0 to 50.0)
OG00450.0(50.0 to 50.0)
OG00550.0(50.0 to 50.0)
OG00650.0(50.0 to 50.0)
OG00750.0(50.0 to 50.0)
OG00850.0(50.0 to 50.0)
OG00950.0(50.0 to 50.0)
NA
(NA to NA)
Data were not analyzed as no participants were evaluable for the particular week.
OG00450.0(50.0 to 50.0)
OG005NA(NA to NA)Data were not analyzed as no participants were evaluable for the particular week.
OG00650.0(50.0 to 50.0)
OG007NA(NA to NA)Data were not analyzed as no participants were evaluable for the particular week.
OG00850.0(50.0 to 50.0)
OG009NA(NA to NA)Data were not analyzed as no participants were evaluable for the particular week.
50.0
(50.0 to 50.0)
OG00450.0(50.0 to 50.0)
OG00550.0(50.0 to 50.0)
OG006924.1(142.2 to 6003.5)
OG00750.0(50.0 to 50.0)
OG00850.0(50.0 to 50.0)
OG00950.0(50.0 to 50.0)
NA
(NA to NA)
Data were not analyzed as no participants were evaluable for the particular week.
OG00450.0(50.0 to 50.0)
OG005NA(NA to NA)Data were not analyzed as no participants were evaluable for the particular week.
OG0062543.1(969.3 to 6672.1)
OG007NA(NA to NA)Data were not analyzed as no participants were evaluable for the particular week.
OG00850.0(50.0 to 50.0)
OG009NA(NA to NA)Data were not analyzed as no participants were evaluable for the particular week.
50.0
(50.0 to 50.0)
OG00450.0(50.0 to 50.0)
OG00550.0(50.0 to 50.0)
OG006386.9(87.7 to 1707.3)
OG00761.3(34.9 to 107.6)
OG00850.0(50.0 to 50.0)
OG00950.0(50.0 to 50.0)
50.0
(50.0 to 50.0)
OG00450.0(50.0 to 50.0)
OG00550.0(50.0 to 50.0)
OG0065266.4(1852.1 to 14975.0)
OG007207.5(24.9 to 1726.5)
OG00850.0(50.0 to 50.0)
OG00950.0(50.0 to 50.0)
50.0
(50.0 to 50.0)
OG00450.0(50.0 to 50.0)
OG00550.0(50.0 to 50.0)
OG0065014.4(1788.3 to 14060.5)
OG007166.0(20.3 to 1355.0)
OG00850.0(50.0 to 50.0)
OG00950.0(50.0 to 50.0)
50.0
(50.0 to 50.0)
OG00450.0(50.0 to 50.0)
OG00550.0(50.0 to 50.0)
OG0061765.8(638.5 to 4883.6)
OG007133.6(24.5 to 727.2)
OG00850.0(50.0 to 50.0)
OG00950.0(50.0 to 50.0)
50.0
(50.0 to 50.0)
OG00450.0(50.0 to 50.0)
OG00550.0(50.0 to 50.0)
OG0068383.3(4000.7 to 17566.9)
OG007471.9(24.3 to 9181.4)
OG00850.0(50.0 to 50.0)
OG00950.0(50.0 to 50.0)
50.0
(50.0 to 50.0)
OG00450.0(50.0 to 50.0)
OG00550.0(50.0 to 50.0)
OG0067927.9(4408.1 to 14258.0)
OG007408.1(19.8 to 8412.5)
OG00850.0(50.0 to 50.0)
OG00950.0(50.0 to 50.0)
50.0
(50.0 to 50.0)
OG00450.0(50.0 to 50.0)
OG00550.0(50.0 to 50.0)
OG0067851.2(1669.4 to 36923.6)
OG007287.4(21.2 to 3888.4)
OG00850.0(50.0 to 50.0)
OG00950.0(50.0 to 50.0)
50.0
(50.0 to 50.0)
OG00450.0(50.0 to 50.0)
OG00550.0(50.0 to 50.0)
OG00618040.4(1536.5 to 211818.5)
OG007522.7(30.5 to 8951.6)
OG00850.0(50.0 to 50.0)
OG00950.0(50.0 to 50.0)
50.0
(50.0 to 50.0)
OG00450.0(50.0 to 50.0)
OG00550.0(50.0 to 50.0)
OG0064899.8(1919.8 to 12505.5)
OG007408.9(29.2 to 5733.6)
OG00850.0(50.0 to 50.0)
OG00950.0(50.0 to 50.0)
50.0
(50.0 to 50.0)
OG00450.0(50.0 to 50.0)
OG00550.0(50.0 to 50.0)
OG0062587.5(999.3 to 6699.7)
OG007205.0(27.1 to 1549.9)
OG00850.0(50.0 to 50.0)
OG00950.0(50.0 to 50.0)
50.0
(50.0 to 50.0)
OG00450.0(50.0 to 50.0)
OG00550.0(50.0 to 50.0)
OG00610900.6(5915.4 to 20087.3)
OG007611.2(72.8 to 5131.5)
OG00850.0(50.0 to 50.0)
OG00950.0(50.0 to 50.0)
50.0
(50.0 to 50.0)
OG00450.0(50.0 to 50.0)
OG00550.0(50.0 to 50.0)
OG0068052.1(4251.8 to 15249.1)
OG007458.0(65.9 to 3180.4)
OG00850.0(50.0 to 50.0)
OG00950.0(50.0 to 50.0)
50.0
(50.0 to 50.0)
OG00450.0(50.0 to 50.0)
OG00550.0(50.0 to 50.0)
OG0063885.1(1951.3 to 7735.2)
OG007227.2(32.6 to 1582.8)
OG008194.0(2.6 to 14517.7)
OG00950.0(50.0 to 50.0)
50.0
(50.0 to 50.0)
OG00450.0(50.0 to 50.0)
OG00550.0(50.0 to 50.0)
OG0062272.0(1192.1 to 4330.1)
OG007231.0(34.2 to 1559.2)
OG00850.0(50.0 to 50.0)
OG00950.0(50.0 to 50.0)
108.7
(41.8 to 282.7)
OG004110.7(12.2 to 1006.4)
OG00550.0(50.0 to 50.0)
OG00614160.9(8518.5 to 23540.4)
OG007975.6(209.4 to 4546.5)
OG008196.4(30.3 to 1275.0)
OG009385.1(0.0 to 70941268874642)
94.9
(43.4 to 207.3)
OG004136.0(18.7 to 989.2)
OG005109.3(0.0 to 2265473.2)
OG0069998.6(5487.3 to 18218.7)
OG007768.3(126.4 to 4669.5)
OG008383.9(39.8 to 3700.8)
OG009316.9(0.0 to 4897026295844.7)
NA
(NA to NA)
Data were not analyzed as no participants were evaluable for the particular week.
OG004NA(NA to NA)Data were not analyzed as no participants were evaluable for the particular week.
OG005NA(NA to NA)Data were not analyzed as no participants were evaluable for the particular week.
OG006NA(NA to NA)Data were not analyzed as no participants were evaluable for the particular week.
OG007NA(NA to NA)Data were not analyzed as no participants were evaluable for the particular week.
OG008NA(NA to NA)Data were not analyzed as no participants were evaluable for the particular week.
OG009NA(NA to NA)Data were not analyzed as no participants were evaluable for the particular week.
67.6
(41.1 to 111.1)
OG004169.3(50.3 to 569.9)
OG00550.0(50.0 to 50.0)
OG0064291.7(2472.4 to 7449.7)
OG007391.5(56.2 to 2724.4)
OG008299.8(40.3 to 2229.5)
OG009285.8(0.0 to 1192613970596.0)
50.0
(50.0 to 50.0)
OG004105.9(40.1 to 279.5)
OG00550.0(50.0 to 50.0)
OG0063167.0(1460.6 to 6867.2)
OG007464.0(40.3 to 5344.9)
OG008256.1(7.6 to 8678.4)
OG009213.8(0.0 to 22254714647.2)
688.8
(118.8 to 3993.8)
OG0044818.1(1026.0 to 22626.7)
OG0051172.0(0.0 to 54658314329.3)
OG00613370.6(6739.1 to 26527.7)
OG0073596.0(469.5 to 26042.1)
OG008448.0(4.4 to 45743.6)
OG00914665.8(0.0 to 2439205485421.2)
551.4
(81.2 to 3743.4)
OG0043726.2(1084.8 to 12799.5)
OG005497.9(0.0 to 39348525251.6)
OG00612209.4(6421.3 to 23215.2)
OG0072504.2(464.4 to 13505.3)
OG0082670.5(0.0 to 463269086196.1)
OG0099454.1(0.0 to 2972501787380.5)
831.0
(59.8 to 11548.2)
OG0042335.3(715.0 to 7628.0)
OG005258.0(0.0 to 292460133977.7)
OG0068613.4(4540.7 to 16339.2)
OG0071136.1(153.1 to 8429.8)
OG0082929.2(0.0 to 4137410775629.6)
OG0095735.6(0.0 to 50649360975.1)
NA
(NA to NA)
Data were not analyzed as no participants were evaluable for the particular week.
OG004NA(NA to NA)Data were not analyzed as no participants were evaluable for the particular week.
OG005NA(NA to NA)Data were not analyzed as no participants were evaluable for the particular week.
OG006NA(NA to NA)Data were not analyzed as no participants were evaluable for the particular week.
OG007NA(NA to NA)Data were not analyzed as no participants were evaluable for the particular week.
OG008NA(NA to NA)Data were not analyzed as no participants were evaluable for the particular week.
OG009NA(NA to NA)Data were not analyzed as no participants were evaluable for the particular week.
435.9
(45.5 to 4172.4)
OG0041231.0(471.1 to 3216.5)
OG005185.1(0.0 to 3083418082.5)
OG0064197.4(2224.2 to 7921.3)
OG007516.8(42.1 to 6345.2)
OG0081427.2(0.0 to 61098419244.5)
OG0093359.9(0.0 to 416391434.9)
2718.6
(83.6 to 88360.8)
OG0045233.2(2190.3 to 12503.5)
OG0054957.3(0.0 to 89132252682601)
OG0066043.9(1405.3 to 25993.5)
OG0072189.8(39.4 to 121572.0)
OG0084629.0(NA to NA)95% confidence interval was not estimable since only one participant was evaluable.
OG00914525.7(1101.4 to 191573.6)
2572.6
(101.9 to 64964.0)
OG0044614.4(1945.0 to 10947.8)
OG0053490.4(0.0 to 129808983536252)
OG00618653.9(20.0 to 17387177.2)
OG0071799.7(40.1 to 80796.0)
OG008NA(NA to NA)Data were not analyzed as no participants were evaluable for the particular week.
OG0096296.3(3108.1 to 12754.9)
NA
(NA to NA)
Data were not analyzed as no participants were evaluable for the particular week.
OG004NA(NA to NA)Data were not analyzed as no participants were evaluable for the particular week.
OG005NA(NA to NA)Data were not analyzed as no participants were evaluable for the particular week.
OG006NA(NA to NA)Data were not analyzed as no participants were evaluable for the particular week.
OG007NA(NA to NA)Data were not analyzed as no participants were evaluable for the particular week.
OG008NA(NA to NA)Data were not analyzed as no participants were evaluable for the particular week.
OG009NA(NA to NA)Data were not analyzed as no participants were evaluable for the particular week.
3252.9
(156.4 to 67657.2)
OG0043163.7(1153.6 to 8676.4)
OG0051338.7(0.0 to 2432477307830.6)
OG0069664.4(6383.5 to 14631.5)
OG0071022.4(41.4 to 25279.5)
OG008NA(NA to NA)Data were not analyzed as no participants were evaluable for the particular week.
OG0094277.9(538.3 to 33999.7)
2532.8
(97.0 to 66111.6)
OG0042880.8(1242.7 to 6678.3)
OG005737.9(0.0 to 11966762355531)
OG0066706.3(164.9 to 272699.3)
OG007706.6(41.7 to 11981.1)
OG008NA(NA to NA)Data were not analyzed as no participants were evaluable for the particular week.
OG0092643.6(1902.1 to 3674.2)
4810.2
(366.0 to 63211.9)
OG0044080.8(0.0 to 11159747036.1)
OG0053632.1(434.2 to 30382.4)
OG0067731.0(NA to NA)95% confidence interval was not estimable since only one participant was evaluable.
OG0071779.5(362.3 to 8741.0)
OG008NA(NA to NA)Data were not analyzed as no participants were evaluable for the particular week.
OG0092518.0(NA to NA)95% confidence interval was not estimable since only one participant was evaluable.
6398.1
(417.4 to 98070.7)
OG0046453.5(1202.3 to 34641.3)
OG0052362.8(0.4 to 13656178.6)
OG006NA(NA to NA)Data were not analyzed as no participants were evaluable for the particular week.
OG007NA(NA to NA)Data were not analyzed as no participants were evaluable for the particular week.
OG008NA(NA to NA)Data were not analyzed as no participants were evaluable for the particular week.
OG009NA(NA to NA)Data were not analyzed as no participants were evaluable for the particular week.
7027.0
(485.8 to 101644.6)
OG0044351.5(1055.3 to 17944.0)
OG0051404.9(0.0 to 328577560.1)
OG006NA(NA to NA)Data were not analyzed as no participants were evaluable for the particular week.
OG007NA(NA to NA)Data were not analyzed as no participants were evaluable for the particular week.
OG008NA(NA to NA)Data were not analyzed as no participants were evaluable for the particular week.
OG009NA(NA to NA)Data were not analyzed as no participants were evaluable for the particular week.
NA
(NA to NA)
Data were not analyzed as no participants were evaluable for the particular week.
OG004NA(NA to NA)Data were not analyzed as no participants were evaluable for the particular week.
OG005NA(NA to NA)Data were not analyzed as no participants were evaluable for the particular week.
OG006NA(NA to NA)Data were not analyzed as no participants were evaluable for the particular week.
OG007NA(NA to NA)Data were not analyzed as no participants were evaluable for the particular week.
OG008NA(NA to NA)Data were not analyzed as no participants were evaluable for the particular week.
OG009NA(NA to NA)Data were not analyzed as no participants were evaluable for the particular week.
NA
(NA to NA)
Data were not analyzed as no participants were evaluable for the particular week.
OG004NA(NA to NA)Data were not analyzed as no participants were evaluable for the particular week.
OG005NA(NA to NA)Data were not analyzed as no participants were evaluable for the particular week.
OG006NA(NA to NA)Data were not analyzed as no participants were evaluable for the particular week.
OG007NA(NA to NA)Data were not analyzed as no participants were evaluable for the particular week.
OG008NA(NA to NA)Data were not analyzed as no participants were evaluable for the particular week.
OG009NA(NA to NA)Data were not analyzed as no participants were evaluable for the particular week.
5682.1
(345.0 to 93583.6)
OG0045064.1(3850.7 to 6659.9)
OG005824.3(0.0 to 32731187354.9)
OG006NA(NA to NA)Data were not analyzed as no participants were evaluable for the particular week.
OG007NA(NA to NA)Data were not analyzed as no participants were evaluable for the particular week.
OG008NA(NA to NA)Data were not analyzed as no participants were evaluable for the particular week.
OG009NA(NA to NA)Data were not analyzed as no participants were evaluable for the particular week.
NA
(NA to NA)
Data were not analyzed as no participants were evaluable for the particular week.
OG004NA(NA to NA)Data were not analyzed as no participants were evaluable for the particular week.
OG005NA(NA to NA)Data were not analyzed as no participants were evaluable for the particular week.
OG006NA(NA to NA)Data were not analyzed as no participants were evaluable for the particular week.
OG007NA(NA to NA)Data were not analyzed as no participants were evaluable for the particular week.
OG008NA(NA to NA)Data were not analyzed as no participants were evaluable for the particular week.
OG009NA(NA to NA)Data were not analyzed as no participants were evaluable for the particular week.
NA
(NA to NA)
Data were not analyzed as no participants were evaluable for the particular week.
OG004NA(NA to NA)Data were not analyzed as no participants were evaluable for the particular week.
OG005NA(NA to NA)Data were not analyzed as no participants were evaluable for the particular week.
OG006NA(NA to NA)Data were not analyzed as no participants were evaluable for the particular week.
OG007NA(NA to NA)Data were not analyzed as no participants were evaluable for the particular week.
OG008NA(NA to NA)Data were not analyzed as no participants were evaluable for the particular week.
OG009NA(NA to NA)Data were not analyzed as no participants were evaluable for the particular week.
NA
(NA to NA)
Data were not analyzed as no participants were evaluable for the particular week.
OG004NA(NA to NA)Data were not analyzed as no participants were evaluable for the particular week.
OG005NA(NA to NA)Data were not analyzed as no participants were evaluable for the particular week.
OG006NA(NA to NA)Data were not analyzed as no participants were evaluable for the particular week.
OG007NA(NA to NA)Data were not analyzed as no participants were evaluable for the particular week.
OG008NA(NA to NA)Data were not analyzed as no participants were evaluable for the particular week.
OG009NA(NA to NA)Data were not analyzed as no participants were evaluable for the particular week.
NA
(NA to NA)
Data were not analyzed as no participants were evaluable for the particular week.
OG004NA(NA to NA)Data were not analyzed as no participants were evaluable for the particular week.
OG005NA(NA to NA)Data were not analyzed as no participants were evaluable for the particular week.
OG006NA(NA to NA)Data were not analyzed as no participants were evaluable for the particular week.
OG007NA(NA to NA)Data were not analyzed as no participants were evaluable for the particular week.
OG008NA(NA to NA)Data were not analyzed as no participants were evaluable for the particular week.
OG009NA(NA to NA)Data were not analyzed as no participants were evaluable for the particular week.