Study Evaluating Safety, Tolerability, And Immunogenicity... | NCT00479557 | Trialant
NCT00479557
Sponsor
Pfizer
Status
Completed
Last Update Posted
Jan 1, 2016Estimated
Enrollment
86Actual
Phase
Phase 2
Conditions
Alzheimer Disease
Interventions
ACC-001 + QS-21
ACC-001
QS-21
Placebo: Phosphate buffered saline
Countries
France
Germany
Spain
Protocol Section
Identification Module
NCT ID
NCT00479557
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
3134K1-200
Secondary IDs
ID
Type
Description
Link
B2571004
Other Identifier
Alias Study Number
2006-002061-39
EudraCT Number
Brief Title
Study Evaluating Safety, Tolerability, And Immunogenicity Of ACC-001 In Subjects With Mild To Moderate Alzheimer's Disease
Official Title
A Phase Iia, Multicenter, Randomized, Third-party Unblinded, Adjuvant And Placebo-controlled, Multiple Ascending Dose, Safety, Tolerability And Immunogenicity Trial Of Acc-001 And Qs-21 Adjuvant In Subjects With Mild To Moderate Alzheimer's Disease
Acronym
Not provided
Organization
PfizerINDUSTRY
Status Module
Record Verification Date
Nov 2015
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
May 2007
Primary Completion Date
Jan 2013Actual
Completion Date
Jan 2013Actual
First Submitted Date
May 24, 2007
First Submission Date that Met QC Criteria
May 24, 2007
First Posted Date
May 28, 2007Estimated
Results Waived
Not provided
Results First Submitted Date
May 6, 2014
Results First Submitted that Met QC Criteria
Nov 30, 2015
Results First Posted Date
Jan 1, 2016Estimated
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
Nov 30, 2015
Last Update Posted Date
Jan 1, 2016Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
PfizerINDUSTRY
Collaborators
Name
Class
Janssen Alzheimer Immunotherapy (JAI) Research and Development, LLC
UNKNOWN
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
To assess the safety, tolerability, and immunogenicity of ACC-001, an investigational active immunization, in patients with mild to moderate Alzheimer's disease.
Detailed Description
Not provided
Conditions Module
Conditions
Alzheimer Disease
Keywords
Alzheimer's Disease
active immunization
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
86Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
1
Active Comparator
arm 1: ACC-001 (Vanutide Cridificar)+ QS-21
Biological: ACC-001 + QS-21
2
Active Comparator
arm 2: ACC-001
Biological: ACC-001
3
Placebo Comparator
arm 3: QS-21
Biological: QS-21
4
Placebo Comparator
Drug: Phosphate Buffered Saline (PBS)
Drug: Placebo: Phosphate buffered saline
Interventions
Name
Type
Description
Arm Group Labels
Other Names
ACC-001 + QS-21
Biological
Vanutide Cridificar (3, 10, 30µg) + QS-21 (50µg), IM on day 1, month 1, month 3, month 6 and month 12
1
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentage of Participants With Treatment-emergent AEs or Serious Adverse Events (SAEs)
An AE was any untoward, undesired, or unplanned clinical event in the form of signs, symptoms, disease, or laboratory or physiologic observations occurring in a person given study drug or in a sponsor's clinical study. The event did not need to be causally related to the study drug or the clinical studies. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
approximately 110 weeks, including a 6-week screening period, 52 weeks of dosing and 54 weeks for follow-up after the last dose.
Secondary Outcomes
Measure
Description
Time Frame
Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104
The lower limit of quantification (LLOQ) was 100 U/mL and when the assay result was below LLOQ (100 U/mL), 50 U/mL was imputed for IgG.
Pasquier F, Sadowsky C, Holstein A, Leterme Gle P, Peng Y, Jackson N, Fox NC, Ketter N, Liu E, Ryan JM; ACC-001 (QS-21) Study Team. Two Phase 2 Multiple Ascending-Dose Studies of Vanutide Cridificar (ACC-001) and QS-21 Adjuvant in Mild-to-Moderate Alzheimer's Disease. J Alzheimers Dis. 2016;51(4):1131-43. doi: 10.3233/JAD-150376.
See Also Links
Label
URL
To obtain contact information for a study center near you, click here.
The Basic Results disclose pooled data from studies NCT00479557 and NCT00498602.
Recruitment Details
Planned duration was approximately 110 weeks (including 6 week screening period, 52 weeks of dosing, and 52 weeks of follow-up). Participants who completed the 3134K1-200-EU (B2571004) study through Week 78 had the option to exit after this time point, for continued treatment and follow-up under extension protocol 3134K1-2203-EU (B2571007).
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
ACC 3 µg+QS-21
Participants received 3 µg of ACC-001 and 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
Change From Baseline GMTs of Anti-A-beta IgG Subtypes Using ELISA at Visits Where an IgG Total Response is Measurable (at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 if Applicable)
Klinik fuer Psychiatrie und Psychotherapie, Charite Universitaetsmedizin Berlin
Berlin
14050
Germany
Zentralinstitut fuer Seelische Gesundheit
Frankenthal
67227
Germany
Klinik fuer Psychiatrie und Psychotherapie
Göttingen
37075
Germany
Zentralinstitut fuer Seelische Gesundheit
Mannheim
68159
Germany
Technische Universitaet Muenchen, Klinikum rechts der Isar
München
81675
Germany
Universitaetsklinikum Muenster
Münster
48149
Germany
Universitaetsklinikum Muenster
Münster
48165
Germany
Hospital del Mar
Barcelona
Barcelona
08003
Spain
Hospital de la Santa Creu i Sant Pau
Barcelona
Barcelona
08025
Spain
Hospital Clinico y Provincial
Barcelona
Barcelona
08036
Spain
Hospital Universitario Clinico San Carlos
Madrid
Madrid
28040
Spain
Participants received 10 µg of ACC-001 and 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
FG002
ACC 30 µg+QS-21
Participants received 30 µg of ACC-001 and 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
FG003
ACC 10 µg
Participants received 10 µg of ACC-001. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
FG004
ACC 30 µg
Participants received 30 µg of ACC-001. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
FG005
QS-21 Alone
Participants received 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
FG006
Phosphate Buffered Saline
Participants received Phosphate buffered Saline (PBS). Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
FG00036 subjects
FG00161 subjects
FG00240 subjects
FG00335 subjects
FG00412 subjects
FG00544 subjects
FG00617 subjects
Treated
FG00036 subjects
FG00160 subjectsOne participant discontinued due to an AE, with an outcome of death.
FG00240 subjects
FG00335 subjects
FG00412 subjects
FG00544 subjects
FG00617 subjects
COMPLETED
FG00026 subjects
FG00151 subjects
FG00232 subjects
FG00330 subjects
FG0048 subjects
FG00531 subjects
FG00615 subjects
NOT COMPLETED
FG00010 subjects
FG00110 subjects
FG0028 subjects
FG0035 subjects
FG0044 subjects
FG00513 subjects
FG0062 subjects
Type
Comment
Reasons
Death
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0051 subjects
FG0060 subjects
Lack of Efficacy
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Lost to Follow-up
FG0000 subjects
FG0012 subjects
FG0020 subjects
FG0032 subjects
FG004
Adverse Event (AE) related to Study Drug
FG0001 subjects
FG0010 subjects
FG0023 subjects
FG0032 subjects
FG004
AE not related to Study Drug
FG0001 subjects
FG0013 subjects
FG0020 subjects
FG0030 subjects
FG004
Caregiver Request
FG0002 subjects
FG0012 subjects
FG0022 subjects
FG0030 subjects
FG004
Investigator Request
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Subject Request
FG0003 subjects
FG0010 subjects
FG0021 subjects
FG0031 subjects
FG004
Other
FG0002 subjects
FG0013 subjects
FG0021 subjects
FG0030 subjects
FG004
245 participants were randomized in both studies (86 participants in 3134K1-200-EU [B2571004] and 159 participants in 3134K1-2201-US [B2571005]) and included in the analysis below. One participant of the randomized participants did not receive treatment.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
ACC 3 µg+QS-21
Participants received 3 µg of ACC-001 and 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
BG001
ACC 10 µg+QS-21
Participants received 10 µg of ACC-001 and 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
BG002
ACC 30 µg+QS-21
Participants received 30 µg of ACC-001 and 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
BG003
ACC 10 µg
Participants received 10 µg of ACC-001. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
BG004
ACC 30 µg
Participants received 30 µg of ACC-001. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
BG005
QS-21 Alone
Participants received 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
BG006
Phosphate Buffered Saline
Participants received Phosphate buffered Saline (PBS). Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
BG007
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00036
BG00161
BG00240
BG00335
BG00412
BG00544
BG00617
BG007245
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
year
Title
Denominators
Categories
Title
Measurements
BG00065.7± 7.75
BG00169.3± 9.57
BG00269.0± 9.27
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00016
BG00129
BG002
Race/Ethnicity, Customized
Number
number of participants
Title
Denominators
Categories
Asian
Title
Measurements
BG0000
BG0010
BG002
Mini-Mental State Examination (MMSE) Score
The MMSE was used to systematically and thoroughly assess mental status of participants. It is an 11-question measure that tests five areas of cognitive function: orientation, registration, attention and calculation, recall, and language. The total score ranges from 0 to 30. A score of 23 or lower is indicative of cognitive impairment.
Mean
Standard Deviation
score
Title
Denominators
Categories
Title
Measurements
BG00021.4± 2.96
BG001
MMSE Stratum
The MMSE was used to systematically and thoroughly assess mental status of participants. It is an 11-question measure that tests five areas of cognitive function: orientation, registration, attention and calculation, recall, and language. The total score ranges from 0 to 30. A score of 23 or lower is indicative of cognitive impairment.
Number
number of participants
Title
Denominators
Categories
High (21 - 26)
Title
Measurements
BG00026
BG001
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
Percentage of Participants With Treatment-emergent AEs or Serious Adverse Events (SAEs)
An AE was any untoward, undesired, or unplanned clinical event in the form of signs, symptoms, disease, or laboratory or physiologic observations occurring in a person given study drug or in a sponsor's clinical study. The event did not need to be causally related to the study drug or the clinical studies. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
The safety population included all randomized participants with documented use of at least one dose of study drug.
Posted
Number
percentage of participants
approximately 110 weeks, including a 6-week screening period, 52 weeks of dosing and 54 weeks for follow-up after the last dose.
ID
Title
Description
OG000
ACC 3 µg+QS-21
Participants received 3 µg of ACC-001 and 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
OG001
ACC 10 µg+QS-21
Participants received 10 µg of ACC-001 and 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
OG002
ACC 30 µg+QS-21
Participants received 30 µg of ACC-001 and 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
OG003
ACC 10 µg
Participants received 10 µg of ACC. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
OG004
ACC 30 µg
Participants received 30 µg of ACC. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
OG005
QS-21 Alone
Participants received 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
OG006
Phosphate Buffered Saline
Participants received Phosphate buffered Saline (PBS). Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
Units
Counts
Participants
OG00036
OG00160
OG00240
OG003
Title
Denominators
Categories
Percentage of participants with AEs
Title
Measurements
OG00097.2
OG00193.3
OG00290.0
OG003
Secondary
Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104
The lower limit of quantification (LLOQ) was 100 U/mL and when the assay result was below LLOQ (100 U/mL), 50 U/mL was imputed for IgG.
The immunogenicity population included all randomized participants with documented injection of at least one dose of study drug and at least one immunogenicity data point collected.
Participants received 3 µg of ACC-001 and 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
OG001
ACC 10 µg+QS-21
Participants received 10 µg of ACC-001 and 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
OG002
ACC 30 µg+QS-21
Participants received 30 µg of ACC-001 and 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
Secondary
GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104
The LLOQ was 50 U/mL and when the assay result was below LLOQ (50 U/mL), 25 U/mL was imputed for IgM.
The immunogenicity population included all randomized participants with documented injection of at least one dose of study drug and at least one immunogenicity data point collected.
Participants received 3 µg of ACC-001 and 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
OG001
ACC 10 µg+QS-21
Participants received 10 µg of ACC-001 and 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
OG002
ACC 30 µg+QS-21
Participants received 30 µg of ACC-001 and 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
Secondary
Change From Baseline GMTs of Anti-A-beta IgG Subtypes Using ELISA at Visits Where an IgG Total Response is Measurable (at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 if Applicable)
Participants received 3 μg of ACC-001 and 50 μg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
OG001
ACC 10 μg+QS-21
Participants received 10 μg of ACC-001 and 50 μg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
OG002
ACC 30 μg+QS-21
Participants received 30 μg of ACC-001 and 50 μg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
OG003
ACC 10 μg
Participants received 10 μg of ACC. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
Time Frame
Approximately 110 weeks, including a 6-week screening period, 52 weeks of dosing and 54 weeks for follow-up after the last dose.
Description
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant 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
ACC 3 µg+QS-21
Participants received 3 µg of ACC-001 and 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
6
36
34
36
EG001
ACC 10 µg+QS-21
Participants received 10 µg of ACC-001 and 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
11
60
48
60
EG002
ACC 30 µg+QS-21
Participants received 30 µg of ACC-001 and 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
7
40
35
40
EG003
ACC 10 µg
Participants received 10 µg of ACC-001. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
5
35
28
35
EG004
ACC 30 µg
Participants received 30 µg of ACC-001. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
5
12
10
12
EG005
QS-21 Alone
Participants received 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
5
44
40
44
EG006
Phosphate Buffered Saline
Participants received Phosphate buffered Saline (PBS). Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
3
17
17
17
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Dizziness
Nervous system disorders
MedDRA 15.1
Non-systematic Assessment
EG0001 affected36 at risk
EG0011 affected60 at risk
EG0020 affected40 at risk
EG0030 affected35 at risk
EG0040 affected12 at risk
EG0050 affected44 at risk
EG0060 affected17 at risk
Syncope
Nervous system disorders
MedDRA 15.1
Non-systematic Assessment
EG0001 affected36 at risk
EG0010 affected60 at risk
EG0021 affected40 at risk
EG003
Vasogenic cerebral oedema
Nervous system disorders
MedDRA 15.1
Non-systematic Assessment
EG0000 affected36 at risk
EG0010 affected60 at risk
EG0021 affected40 at risk
EG003
Ataxia
Nervous system disorders
MedDRA 15.1
Non-systematic Assessment
EG0000 affected36 at risk
EG0010 affected60 at risk
EG0020 affected40 at risk
EG003
Balance disorder
Nervous system disorders
MedDRA 15.1
Non-systematic Assessment
EG0000 affected36 at risk
EG0010 affected60 at risk
EG0020 affected40 at risk
EG003
Bradykinesia
Nervous system disorders
MedDRA 15.1
Non-systematic Assessment
EG0000 affected36 at risk
EG0010 affected60 at risk
EG0020 affected40 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA 15.1
Non-systematic Assessment
EG0000 affected36 at risk
EG0010 affected60 at risk
EG0020 affected40 at risk
EG003
Convulsion
Nervous system disorders
MedDRA 15.1
Non-systematic Assessment
EG0000 affected36 at risk
EG0010 affected60 at risk
EG0021 affected40 at risk
EG003
Dementia Alzheimers type
Nervous system disorders
MedDRA 15.1
Non-systematic Assessment
EG0000 affected36 at risk
EG0010 affected60 at risk
EG0020 affected40 at risk
EG003
Dystonia
Nervous system disorders
MedDRA 15.1
Non-systematic Assessment
EG0000 affected36 at risk
EG0010 affected60 at risk
EG0020 affected40 at risk
EG003
Embolic stroke
Nervous system disorders
MedDRA 15.1
Non-systematic Assessment
EG0000 affected36 at risk
EG0010 affected60 at risk
EG0020 affected40 at risk
EG003
Headache
Nervous system disorders
MedDRA 15.1
Non-systematic Assessment
EG0000 affected36 at risk
EG0010 affected60 at risk
EG0020 affected40 at risk
EG003
Transient ischaemic attack
Nervous system disorders
MedDRA 15.1
Non-systematic Assessment
EG0000 affected36 at risk
EG0011 affected60 at risk
EG0020 affected40 at risk
EG003
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 15.1
Non-systematic Assessment
EG0000 affected36 at risk
EG0011 affected60 at risk
EG0020 affected40 at risk
EG003
Carcinoid tumour pulmonary
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 15.1
Non-systematic Assessment
EG0000 affected36 at risk
EG0010 affected60 at risk
EG0020 affected40 at risk
EG003
Lung cancer metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 15.1
Non-systematic Assessment
EG0000 affected36 at risk
EG0010 affected60 at risk
EG0020 affected40 at risk
EG003
Lung neoplasm malignant
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 15.1
Non-systematic Assessment
EG0000 affected36 at risk
EG0010 affected60 at risk
EG0020 affected40 at risk
EG003
Non-Hodgkins lymphoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 15.1
Non-systematic Assessment
EG0000 affected36 at risk
EG0011 affected60 at risk
EG0020 affected40 at risk
EG003
Prostate cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 15.1
Non-systematic Assessment
EG0000 affected36 at risk
EG0010 affected60 at risk
EG0020 affected40 at risk
EG003
Squamous cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 15.1
Non-systematic Assessment
EG0000 affected36 at risk
EG0011 affected60 at risk
EG0020 affected40 at risk
EG003
Uterine cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 15.1
Non-systematic Assessment
EG0000 affected36 at risk
EG0010 affected60 at risk
EG0021 affected40 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA 15.1
Non-systematic Assessment
EG0001 affected36 at risk
EG0011 affected60 at risk
EG0020 affected40 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 15.1
Non-systematic Assessment
EG0000 affected36 at risk
EG0010 affected60 at risk
EG0020 affected40 at risk
EG003
Cardiac arrest
Cardiac disorders
MedDRA 15.1
Non-systematic Assessment
EG0000 affected36 at risk
EG0011 affected60 at risk
EG0020 affected40 at risk
EG003
Cyanosis
Cardiac disorders
MedDRA 15.1
Non-systematic Assessment
EG0001 affected36 at risk
EG0010 affected60 at risk
EG0020 affected40 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 15.1
Non-systematic Assessment
EG0001 affected36 at risk
EG0010 affected60 at risk
EG0021 affected40 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 15.1
Non-systematic Assessment
EG0000 affected36 at risk
EG0010 affected60 at risk
EG0021 affected40 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA 15.1
Non-systematic Assessment
EG0000 affected36 at risk
EG0010 affected60 at risk
EG0020 affected40 at risk
EG003
Hypotension
Vascular disorders
MedDRA 15.1
Non-systematic Assessment
EG0000 affected36 at risk
EG0010 affected60 at risk
EG0021 affected40 at risk
EG003
Orthostatic hypotension
Vascular disorders
MedDRA 15.1
Non-systematic Assessment
EG0001 affected36 at risk
EG0010 affected60 at risk
EG0020 affected40 at risk
EG003
Vasculitis
Vascular disorders
MedDRA 15.1
Non-systematic Assessment
EG0001 affected36 at risk
EG0010 affected60 at risk
EG0020 affected40 at risk
EG003
Fatigue
General disorders
MedDRA 15.1
Non-systematic Assessment
EG0001 affected36 at risk
EG0010 affected60 at risk
EG0020 affected40 at risk
EG003
Feeling cold
General disorders
MedDRA 15.1
Non-systematic Assessment
EG0001 affected36 at risk
EG0010 affected60 at risk
EG0020 affected40 at risk
EG003
Gait disturbance
General disorders
MedDRA 15.1
Non-systematic Assessment
EG0000 affected36 at risk
EG0010 affected60 at risk
EG0020 affected40 at risk
EG003
Malaise
General disorders
MedDRA 15.1
Non-systematic Assessment
EG0000 affected36 at risk
EG0011 affected60 at risk
EG0020 affected40 at risk
EG003
Oedema peripheral
General disorders
MedDRA 15.1
Non-systematic Assessment
EG0001 affected36 at risk
EG0010 affected60 at risk
EG0020 affected40 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 15.1
Non-systematic Assessment
EG0000 affected36 at risk
EG0010 affected60 at risk
EG0021 affected40 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 15.1
Non-systematic Assessment
EG0000 affected36 at risk
EG0010 affected60 at risk
EG0020 affected40 at risk
EG003
Agitation
Psychiatric disorders
MedDRA 15.1
Non-systematic Assessment
EG0000 affected36 at risk
EG0010 affected60 at risk
EG0020 affected40 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA 15.1
Non-systematic Assessment
EG0000 affected36 at risk
EG0010 affected60 at risk
EG0020 affected40 at risk
EG003
Delusion
Psychiatric disorders
MedDRA 15.1
Non-systematic Assessment
EG0000 affected36 at risk
EG0010 affected60 at risk
EG0020 affected40 at risk
EG003
Hallucination
Psychiatric disorders
MedDRA 15.1
Non-systematic Assessment
EG0000 affected36 at risk
EG0010 affected60 at risk
EG0020 affected40 at risk
EG003
Restlessness
Psychiatric disorders
MedDRA 15.1
Non-systematic Assessment
EG0000 affected36 at risk
EG0010 affected60 at risk
EG0020 affected40 at risk
EG003
Renal failure acute
Renal and urinary disorders
MedDRA 15.1
Non-systematic Assessment
EG0000 affected36 at risk
EG0011 affected60 at risk
EG0020 affected40 at risk
EG003
Stress urinary incontinence
Renal and urinary disorders
MedDRA 15.1
Non-systematic Assessment
EG0001 affected36 at risk
EG0010 affected60 at risk
EG0020 affected40 at risk
EG003
Vertigo positional
Ear and labyrinth disorders
MedDRA 15.1
Non-systematic Assessment
EG0000 affected36 at risk
EG0012 affected60 at risk
EG0020 affected40 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 15.1
Non-systematic Assessment
EG0001 affected36 at risk
EG0010 affected60 at risk
EG0020 affected40 at risk
EG003
Intestinal obstruction
Gastrointestinal disorders
MedDRA 15.1
Non-systematic Assessment
EG0000 affected36 at risk
EG0011 affected60 at risk
EG0020 affected40 at risk
EG003
Bile duct stone
Hepatobiliary disorders
MedDRA 15.1
Non-systematic Assessment
EG0000 affected36 at risk
EG0010 affected60 at risk
EG0020 affected40 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA 15.1
Non-systematic Assessment
EG0000 affected36 at risk
EG0010 affected60 at risk
EG0020 affected40 at risk
EG003
Clavicle fracture
Injury, poisoning and procedural complications
MedDRA 15.1
Non-systematic Assessment
EG0000 affected36 at risk
EG0010 affected60 at risk
EG0020 affected40 at risk
EG003
Humerus fracture
Injury, poisoning and procedural complications
MedDRA 15.1
Non-systematic Assessment
EG0000 affected36 at risk
EG0010 affected60 at risk
EG0020 affected40 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 15.1
Non-systematic Assessment
EG0000 affected36 at risk
EG0010 affected60 at risk
EG0021 affected40 at risk
EG003
Intervertebral disc protrusion
Musculoskeletal and connective tissue disorders
MedDRA 15.1
Non-systematic Assessment
EG0000 affected36 at risk
EG0010 affected60 at risk
EG0021 affected40 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 15.1
Non-systematic Assessment
EG0000 affected36 at risk
EG0010 affected60 at risk
EG0020 affected40 at risk
EG003
Skin erosion
Skin and subcutaneous tissue disorders
MedDRA 15.1
Non-systematic Assessment
EG0001 affected36 at risk
EG0010 affected60 at risk
EG0020 affected40 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Injection site pain
General disorders
MedDRA 15.1
Non-systematic Assessment
EG0007 affected36 at risk
EG00117 affected60 at risk
EG0029 affected40 at risk
EG0034 affected35 at risk
EG0041 affected12 at risk
EG0056 affected44 at risk
EG0060 affected17 at risk
Fatigue
General disorders
MedDRA 15.1
Non-systematic Assessment
EG0005 affected36 at risk
EG0017 affected60 at risk
EG0024 affected40 at risk
EG003
Injection site erythema
General disorders
MedDRA 15.1
Non-systematic Assessment
EG0007 affected36 at risk
EG0019 affected60 at risk
EG0026 affected40 at risk
EG003
Injection site swelling
General disorders
MedDRA 15.1
Non-systematic Assessment
EG0002 affected36 at risk
EG0016 affected60 at risk
EG0027 affected40 at risk
EG003
Asthenia
General disorders
MedDRA 15.1
Non-systematic Assessment
EG0001 affected36 at risk
EG0012 affected60 at risk
EG0021 affected40 at risk
EG003
Oedema peripheral
General disorders
MedDRA 15.1
Non-systematic Assessment
EG0002 affected36 at risk
EG0012 affected60 at risk
EG0022 affected40 at risk
EG003
Injection site pruritus
General disorders
MedDRA 15.1
Non-systematic Assessment
EG0001 affected36 at risk
EG0013 affected60 at risk
EG0023 affected40 at risk
EG003
Gait disturbance
General disorders
MedDRA 15.1
Non-systematic Assessment
EG0001 affected36 at risk
EG0013 affected60 at risk
EG0020 affected40 at risk
EG003
Injection site induration
General disorders
MedDRA 15.1
Non-systematic Assessment
EG0000 affected36 at risk
EG0014 affected60 at risk
EG0021 affected40 at risk
EG003
Malaise
General disorders
MedDRA 15.1
Non-systematic Assessment
EG0002 affected36 at risk
EG0011 affected60 at risk
EG0021 affected40 at risk
EG003
Injection site bruising
General disorders
MedDRA 15.1
Non-systematic Assessment
EG0001 affected36 at risk
EG0010 affected60 at risk
EG0022 affected40 at risk
EG003
Injection site reaction
General disorders
MedDRA 15.1
Non-systematic Assessment
EG0003 affected36 at risk
EG0010 affected60 at risk
EG0020 affected40 at risk
EG003
Injection site warmth
General disorders
MedDRA 15.1
Non-systematic Assessment
EG0001 affected36 at risk
EG0013 affected60 at risk
EG0020 affected40 at risk
EG003
Pyrexia
General disorders
MedDRA 15.1
Non-systematic Assessment
EG0000 affected36 at risk
EG0013 affected60 at risk
EG0020 affected40 at risk
EG003
Injection site inflammation
General disorders
MedDRA 15.1
Non-systematic Assessment
EG0000 affected36 at risk
EG0010 affected60 at risk
EG0022 affected40 at risk
EG003
Irritability
General disorders
MedDRA 15.1
Non-systematic Assessment
EG0002 affected36 at risk
EG0010 affected60 at risk
EG0020 affected40 at risk
EG003
Injection site haemorrhage
General disorders
MedDRA 15.1
Non-systematic Assessment
EG0000 affected36 at risk
EG0010 affected60 at risk
EG0021 affected40 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 15.1
Non-systematic Assessment
EG0003 affected36 at risk
EG0016 affected60 at risk
EG0022 affected40 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 15.1
Non-systematic Assessment
EG0004 affected36 at risk
EG0016 affected60 at risk
EG0021 affected40 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 15.1
Non-systematic Assessment
EG0003 affected36 at risk
EG0013 affected60 at risk
EG0025 affected40 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 15.1
Non-systematic Assessment
EG0000 affected36 at risk
EG0012 affected60 at risk
EG0021 affected40 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 15.1
Non-systematic Assessment
EG0003 affected36 at risk
EG0011 affected60 at risk
EG0020 affected40 at risk
EG003
Viral upper respiratory tract infection
Infections and infestations
MedDRA 15.1
Non-systematic Assessment
EG0001 affected36 at risk
EG0012 affected60 at risk
EG0020 affected40 at risk
EG003
Influenza
Infections and infestations
MedDRA 15.1
Non-systematic Assessment
EG0000 affected36 at risk
EG0010 affected60 at risk
EG0020 affected40 at risk
EG003
Oral herpes
Infections and infestations
MedDRA 15.1
Non-systematic Assessment
EG0000 affected36 at risk
EG0012 affected60 at risk
EG0020 affected40 at risk
EG003
Rhinitis
Infections and infestations
MedDRA 15.1
Non-systematic Assessment
EG0000 affected36 at risk
EG0011 affected60 at risk
EG0020 affected40 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MedDRA 15.1
Non-systematic Assessment
EG0001 affected36 at risk
EG0010 affected60 at risk
EG0020 affected40 at risk
EG003
Tooth infection
Infections and infestations
MedDRA 15.1
Non-systematic Assessment
EG0001 affected36 at risk
EG0010 affected60 at risk
EG0020 affected40 at risk
EG003
Fungal skin infection
Infections and infestations
MedDRA 15.1
Non-systematic Assessment
EG0000 affected36 at risk
EG0010 affected60 at risk
EG0020 affected40 at risk
EG003
Furuncle
Infections and infestations
MedDRA 15.1
Non-systematic Assessment
EG0000 affected36 at risk
EG0011 affected60 at risk
EG0020 affected40 at risk
EG003
Gingivitis
Infections and infestations
MedDRA 15.1
Non-systematic Assessment
EG0000 affected36 at risk
EG0010 affected60 at risk
EG0020 affected40 at risk
EG003
Herpes simplex ophthalmic
Infections and infestations
MedDRA 15.1
Non-systematic Assessment
EG0000 affected36 at risk
EG0010 affected60 at risk
EG0020 affected40 at risk
EG003
Headache
Nervous system disorders
MedDRA 15.1
Non-systematic Assessment
EG0003 affected36 at risk
EG00114 affected60 at risk
EG0024 affected40 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 15.1
Non-systematic Assessment
EG0003 affected36 at risk
EG0017 affected60 at risk
EG0024 affected40 at risk
EG003
Cognitive disorder
Nervous system disorders
MedDRA 15.1
Non-systematic Assessment
EG0001 affected36 at risk
EG0013 affected60 at risk
EG0021 affected40 at risk
EG003
Somnolence
Nervous system disorders
MedDRA 15.1
Non-systematic Assessment
EG0001 affected36 at risk
EG0012 affected60 at risk
EG0020 affected40 at risk
EG003
Syncope
Nervous system disorders
MedDRA 15.1
Non-systematic Assessment
EG0000 affected36 at risk
EG0012 affected60 at risk
EG0023 affected40 at risk
EG003
Aphasia
Nervous system disorders
MedDRA 15.1
Non-systematic Assessment
EG0002 affected36 at risk
EG0010 affected60 at risk
EG0020 affected40 at risk
EG003
Dementia Alzheimers type
Nervous system disorders
MedDRA 15.1
Non-systematic Assessment
EG0001 affected36 at risk
EG0010 affected60 at risk
EG0021 affected40 at risk
EG003
Apraxia
Nervous system disorders
MedDRA 15.1
Non-systematic Assessment
EG0002 affected36 at risk
EG0010 affected60 at risk
EG0020 affected40 at risk
EG003
Cerebral microhaemorrhage
Nervous system disorders
MedDRA 15.1
Non-systematic Assessment
EG0000 affected36 at risk
EG0011 affected60 at risk
EG0020 affected40 at risk
EG003
Lethargy
Nervous system disorders
MedDRA 15.1
Non-systematic Assessment
EG0003 affected36 at risk
EG0010 affected60 at risk
EG0020 affected40 at risk
EG003
Presyncope
Nervous system disorders
MedDRA 15.1
Non-systematic Assessment
EG0001 affected36 at risk
EG0010 affected60 at risk
EG0022 affected40 at risk
EG003
Clonus
Nervous system disorders
MedDRA 15.1
Non-systematic Assessment
EG0001 affected36 at risk
EG0010 affected60 at risk
EG0020 affected40 at risk
EG003
Extrapyramidal disorder
Nervous system disorders
MedDRA 15.1
Non-systematic Assessment
EG0000 affected36 at risk
EG0010 affected60 at risk
EG0020 affected40 at risk
EG003
Sciatica
Nervous system disorders
MedDRA 15.1
Non-systematic Assessment
EG0000 affected36 at risk
EG0010 affected60 at risk
EG0020 affected40 at risk
EG003
Amnesia
Nervous system disorders
MedDRA 15.1
Non-systematic Assessment
EG0000 affected36 at risk
EG0010 affected60 at risk
EG0020 affected40 at risk
EG003
Memory impairment
Nervous system disorders
MedDRA 15.1
Non-systematic Assessment
EG0000 affected36 at risk
EG0010 affected60 at risk
EG0020 affected40 at risk
EG003
Mental impairment
Nervous system disorders
MedDRA 15.1
Non-systematic Assessment
EG0000 affected36 at risk
EG0010 affected60 at risk
EG0020 affected40 at risk
EG003
Migraine
Nervous system disorders
MedDRA 15.1
Non-systematic Assessment
EG0000 affected36 at risk
EG0010 affected60 at risk
EG0020 affected40 at risk
EG003
Speech disorder
Nervous system disorders
MedDRA 15.1
Non-systematic Assessment
EG0000 affected36 at risk
EG0010 affected60 at risk
EG0020 affected40 at risk
EG003
Unresponsive to stimuli
Nervous system disorders
MedDRA 15.1
Non-systematic Assessment
EG0000 affected36 at risk
EG0010 affected60 at risk
EG0020 affected40 at risk
EG003
Depression
Psychiatric disorders
MedDRA 15.1
Non-systematic Assessment
EG0005 affected36 at risk
EG0014 affected60 at risk
EG0024 affected40 at risk
EG003
Agitation
Psychiatric disorders
MedDRA 15.1
Non-systematic Assessment
EG0004 affected36 at risk
EG0014 affected60 at risk
EG0020 affected40 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 15.1
Non-systematic Assessment
EG0003 affected36 at risk
EG0015 affected60 at risk
EG0021 affected40 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA 15.1
Non-systematic Assessment
EG0002 affected36 at risk
EG0011 affected60 at risk
EG0020 affected40 at risk
EG003
Abnormal dreams
Psychiatric disorders
MedDRA 15.1
Non-systematic Assessment
EG0003 affected36 at risk
EG0010 affected60 at risk
EG0021 affected40 at risk
EG003
Aggression
Psychiatric disorders
MedDRA 15.1
Non-systematic Assessment
EG0001 affected36 at risk
EG0011 affected60 at risk
EG0021 affected40 at risk
EG003
Delusion
Psychiatric disorders
MedDRA 15.1
Non-systematic Assessment
EG0001 affected36 at risk
EG0011 affected60 at risk
EG0020 affected40 at risk
EG003
Hallucination
Psychiatric disorders
MedDRA 15.1
Non-systematic Assessment
EG0000 affected36 at risk
EG0011 affected60 at risk
EG0020 affected40 at risk
EG003
Hallucination, visual
Psychiatric disorders
MedDRA 15.1
Non-systematic Assessment
EG0001 affected36 at risk
EG0010 affected60 at risk
EG0020 affected40 at risk
EG003
Paranoia
Psychiatric disorders
MedDRA 15.1
Non-systematic Assessment
EG0002 affected36 at risk
EG0011 affected60 at risk
EG0020 affected40 at risk
EG003
Delirium
Psychiatric disorders
MedDRA 15.1
Non-systematic Assessment
EG0001 affected36 at risk
EG0010 affected60 at risk
EG0021 affected40 at risk
EG003
Depressive symptom
Psychiatric disorders
MedDRA 15.1
Non-systematic Assessment
EG0000 affected36 at risk
EG0010 affected60 at risk
EG0021 affected40 at risk
EG003
Disorientation
Psychiatric disorders
MedDRA 15.1
Non-systematic Assessment
EG0000 affected36 at risk
EG0011 affected60 at risk
EG0020 affected40 at risk
EG003
Hallucination, auditory
Psychiatric disorders
MedDRA 15.1
Non-systematic Assessment
EG0000 affected36 at risk
EG0010 affected60 at risk
EG0020 affected40 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 15.1
Non-systematic Assessment
EG0002 affected36 at risk
EG0015 affected60 at risk
EG0023 affected40 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 15.1
Non-systematic Assessment
EG0002 affected36 at risk
EG0015 affected60 at risk
EG0024 affected40 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 15.1
Non-systematic Assessment
EG0001 affected36 at risk
EG0013 affected60 at risk
EG0022 affected40 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 15.1
Non-systematic Assessment
EG0004 affected36 at risk
EG0013 affected60 at risk
EG0021 affected40 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 15.1
Non-systematic Assessment
EG0001 affected36 at risk
EG0012 affected60 at risk
EG0024 affected40 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 15.1
Non-systematic Assessment
EG0001 affected36 at risk
EG0011 affected60 at risk
EG0021 affected40 at risk
EG003
Osteoporosis
Musculoskeletal and connective tissue disorders
MedDRA 15.1
Non-systematic Assessment
EG0001 affected36 at risk
EG0010 affected60 at risk
EG0021 affected40 at risk
EG003
Bursitis
Musculoskeletal and connective tissue disorders
MedDRA 15.1
Non-systematic Assessment
EG0001 affected36 at risk
EG0010 affected60 at risk
EG0022 affected40 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA 15.1
Non-systematic Assessment
EG0000 affected36 at risk
EG0010 affected60 at risk
EG0022 affected40 at risk
EG003
Torticollis
Musculoskeletal and connective tissue disorders
MedDRA 15.1
Non-systematic Assessment
EG0000 affected36 at risk
EG0010 affected60 at risk
EG0020 affected40 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 15.1
Non-systematic Assessment
EG00010 affected36 at risk
EG0016 affected60 at risk
EG0024 affected40 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 15.1
Non-systematic Assessment
EG0005 affected36 at risk
EG0019 affected60 at risk
EG0021 affected40 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 15.1
Non-systematic Assessment
EG0005 affected36 at risk
EG0014 affected60 at risk
EG0021 affected40 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 15.1
Non-systematic Assessment
EG0000 affected36 at risk
EG0014 affected60 at risk
EG0020 affected40 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 15.1
Non-systematic Assessment
EG0000 affected36 at risk
EG0012 affected60 at risk
EG0021 affected40 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 15.1
Non-systematic Assessment
EG0000 affected36 at risk
EG0011 affected60 at risk
EG0022 affected40 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA 15.1
Non-systematic Assessment
EG0001 affected36 at risk
EG0011 affected60 at risk
EG0021 affected40 at risk
EG003
Functional gastrointestinal disorder
Gastrointestinal disorders
MedDRA 15.1
Non-systematic Assessment
EG0000 affected36 at risk
EG0010 affected60 at risk
EG0020 affected40 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 15.1
Non-systematic Assessment
EG0003 affected36 at risk
EG0013 affected60 at risk
EG0023 affected40 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 15.1
Non-systematic Assessment
EG0001 affected36 at risk
EG0011 affected60 at risk
EG0023 affected40 at risk
EG003
Laceration
Injury, poisoning and procedural complications
MedDRA 15.1
Non-systematic Assessment
EG0001 affected36 at risk
EG0013 affected60 at risk
EG0021 affected40 at risk
EG003
Arthropod bite
Injury, poisoning and procedural complications
MedDRA 15.1
Non-systematic Assessment
EG0002 affected36 at risk
EG0012 affected60 at risk
EG0020 affected40 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
MedDRA 15.1
Non-systematic Assessment
EG0002 affected36 at risk
EG0010 affected60 at risk
EG0022 affected40 at risk
EG003
Excoriation
Injury, poisoning and procedural complications
MedDRA 15.1
Non-systematic Assessment
EG0000 affected36 at risk
EG0013 affected60 at risk
EG0020 affected40 at risk
EG003
Wound
Injury, poisoning and procedural complications
MedDRA 15.1
Non-systematic Assessment
EG0000 affected36 at risk
EG0010 affected60 at risk
EG0021 affected40 at risk
EG003
Thermal burn
Injury, poisoning and procedural complications
MedDRA 15.1
Non-systematic Assessment
EG0001 affected36 at risk
EG0010 affected60 at risk
EG0020 affected40 at risk
EG003
Skin injury
Injury, poisoning and procedural complications
MedDRA 15.1
Non-systematic Assessment
EG0000 affected36 at risk
EG0010 affected60 at risk
EG0020 affected40 at risk
EG003
Spinal compression fracture
Injury, poisoning and procedural complications
MedDRA 15.1
Non-systematic Assessment
EG0000 affected36 at risk
EG0010 affected60 at risk
EG0020 affected40 at risk
EG003
Tooth fracture
Injury, poisoning and procedural complications
MedDRA 15.1
Non-systematic Assessment
EG0000 affected36 at risk
EG0010 affected60 at risk
EG0020 affected40 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 15.1
Non-systematic Assessment
EG0006 affected36 at risk
EG0014 affected60 at risk
EG0022 affected40 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 15.1
Non-systematic Assessment
EG0001 affected36 at risk
EG0013 affected60 at risk
EG0021 affected40 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA 15.1
Non-systematic Assessment
EG0002 affected36 at risk
EG0010 affected60 at risk
EG0020 affected40 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA 15.1
Non-systematic Assessment
EG0000 affected36 at risk
EG0011 affected60 at risk
EG0020 affected40 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 15.1
Non-systematic Assessment
EG0000 affected36 at risk
EG0010 affected60 at risk
EG0020 affected40 at risk
EG003
Hypertension
Vascular disorders
MedDRA 15.1
Non-systematic Assessment
EG0004 affected36 at risk
EG0013 affected60 at risk
EG0021 affected40 at risk
EG003
Haematoma
Vascular disorders
MedDRA 15.1
Non-systematic Assessment
EG0000 affected36 at risk
EG0011 affected60 at risk
EG0021 affected40 at risk
EG003
Orthostatic hypotension
Vascular disorders
MedDRA 15.1
Non-systematic Assessment
EG0000 affected36 at risk
EG0010 affected60 at risk
EG0022 affected40 at risk
EG003
Weight decreased
Investigations
MedDRA 15.1
Non-systematic Assessment
EG0001 affected36 at risk
EG0014 affected60 at risk
EG0022 affected40 at risk
EG003
Weight increased
Investigations
MedDRA 15.1
Non-systematic Assessment
EG0001 affected36 at risk
EG0011 affected60 at risk
EG0021 affected40 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRA 15.1
Non-systematic Assessment
EG0003 affected36 at risk
EG0011 affected60 at risk
EG0020 affected40 at risk
EG003
Blood urea increased
Investigations
MedDRA 15.1
Non-systematic Assessment
EG0000 affected36 at risk
EG0010 affected60 at risk
EG0021 affected40 at risk
EG003
Blood albumin decreased
Investigations
MedDRA 15.1
Non-systematic Assessment
EG0000 affected36 at risk
EG0010 affected60 at risk
EG0020 affected40 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 15.1
Non-systematic Assessment
EG0000 affected36 at risk
EG0010 affected60 at risk
EG0020 affected40 at risk
EG003
Haematocrit decreased
Investigations
MedDRA 15.1
Non-systematic Assessment
EG0000 affected36 at risk
EG0010 affected60 at risk
EG0020 affected40 at risk
EG003
Haemoglobin decreased
Investigations
MedDRA 15.1
Non-systematic Assessment
EG0000 affected36 at risk
EG0010 affected60 at risk
EG0020 affected40 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 15.1
Non-systematic Assessment
EG0003 affected36 at risk
EG0011 affected60 at risk
EG0021 affected40 at risk
EG003
Skin lesion
Skin and subcutaneous tissue disorders
MedDRA 15.1
Non-systematic Assessment
EG0004 affected36 at risk
EG0013 affected60 at risk
EG0020 affected40 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA 15.1
Non-systematic Assessment
EG0001 affected36 at risk
EG0010 affected60 at risk
EG0021 affected40 at risk
EG003
Ecchymosis
Skin and subcutaneous tissue disorders
MedDRA 15.1
Non-systematic Assessment
EG0000 affected36 at risk
EG0010 affected60 at risk
EG0020 affected40 at risk
EG003
Petechiae
Skin and subcutaneous tissue disorders
MedDRA 15.1
Non-systematic Assessment
EG0001 affected36 at risk
EG0010 affected60 at risk
EG0020 affected40 at risk
EG003
Intertrigo
Skin and subcutaneous tissue disorders
MedDRA 15.1
Non-systematic Assessment
EG0000 affected36 at risk
EG0010 affected60 at risk
EG0020 affected40 at risk
EG003
Rash pruritic
Skin and subcutaneous tissue disorders
MedDRA 15.1
Non-systematic Assessment
EG0000 affected36 at risk
EG0010 affected60 at risk
EG0020 affected40 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA 15.1
Non-systematic Assessment
EG0000 affected36 at risk
EG0010 affected60 at risk
EG0020 affected40 at risk
EG003
Urinary incontinence
Renal and urinary disorders
MedDRA 15.1
Non-systematic Assessment
EG0002 affected36 at risk
EG0011 affected60 at risk
EG0023 affected40 at risk
EG003
Incontinence
Renal and urinary disorders
MedDRA 15.1
Non-systematic Assessment
EG0000 affected36 at risk
EG0010 affected60 at risk
EG0020 affected40 at risk
EG003
Hydronephrosis
Renal and urinary disorders
MedDRA 15.1
Non-systematic Assessment
EG0000 affected36 at risk
EG0010 affected60 at risk
EG0020 affected40 at risk
EG003
Renal failure
Renal and urinary disorders
MedDRA 15.1
Non-systematic Assessment
EG0000 affected36 at risk
EG0010 affected60 at risk
EG0020 affected40 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA 15.1
Non-systematic Assessment
EG0001 affected36 at risk
EG0011 affected60 at risk
EG0021 affected40 at risk
EG003
Iron deficiency anaemia
Blood and lymphatic system disorders
MedDRA 15.1
Non-systematic Assessment
EG0000 affected36 at risk
EG0010 affected60 at risk
EG0020 affected40 at risk
EG003
Cataract
Eye disorders
MedDRA 15.1
Non-systematic Assessment
EG0000 affected36 at risk
EG0013 affected60 at risk
EG0021 affected40 at risk
EG003
Eye movement disorder
Eye disorders
MedDRA 15.1
Non-systematic Assessment
EG0000 affected36 at risk
EG0010 affected60 at risk
EG0020 affected40 at risk
EG003
Squamous cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 15.1
Non-systematic Assessment
EG0000 affected36 at risk
EG0011 affected60 at risk
EG0020 affected40 at risk
EG003
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 15.1
Non-systematic Assessment
EG0000 affected36 at risk
EG0011 affected60 at risk
EG0020 affected40 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 15.1
Non-systematic Assessment
EG0000 affected36 at risk
EG0010 affected60 at risk
EG0020 affected40 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 15.1
Non-systematic Assessment
EG0000 affected36 at risk
EG0010 affected60 at risk
EG0020 affected40 at risk
EG003
Breast swelling
Reproductive system and breast disorders
MedDRA 15.1
Non-systematic Assessment
EG0000 affected36 at risk
EG0010 affected60 at risk
EG0020 affected40 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
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
C078785
saponin QA-21V1
Ancestor Terms
Not provided
Browse Leaves
Not provided
Browse Branches
Not provided
0 subjects
FG0050 subjects
FG0060 subjects
0 subjects
FG0050 subjects
FG0060 subjects
0 subjects
FG0051 subjects
FG0060 subjects
2 subjects
FG0052 subjects
FG0061 subjects
1 subjects
FG0052 subjects
FG0060 subjects
0 subjects
FG0050 subjects
FG0060 subjects
1 subjects
FG0054 subjects
FG0061 subjects
0 subjects
FG0053 subjects
FG0060 subjects
71.9
± 8.96
BG00470.9± 9.59
BG00568.8± 8.07
BG00669.4± 7.82
BG00769.1± 8.87
22
BG00319
BG0048
BG00531
BG00614
BG007139
Male
BG00020
BG00132
BG00218
BG00316
BG0044
BG00513
BG0063
BG007106
0
BG0030
BG0041
BG0050
BG0060
BG0071
Black or African American
Title
Measurements
BG0001
BG0010
BG0021
BG0030
BG0040
BG0051
BG0060
BG0073
Other
Title
Measurements
BG0002
BG0011
BG0021
BG0031
BG0040
BG0050
BG0060
BG0075
White
Title
Measurements
BG00033
BG00160
BG00238
BG00334
BG00411
BG00543
BG00617
BG007236
21.4
± 3.38
BG00221.0± 2.92
BG00321.6± 3.16
BG00421.8± 3.60
BG00521.7± 3.11
BG00621.2± 3.17
BG00721.4± 3.13
40
BG00224
BG00323
BG0048
BG00529
BG00611
BG007161
Low (16 - 20)
Title
Measurements
BG00010
BG00121
BG00216
BG00312
BG0044
BG00515
BG0066
BG00784
35
OG00412
OG00544
OG00617
91.4
OG00483.3
OG00590.9
OG006100
Percentage of participants with SAEs
Title
Measurements
OG00016.7
OG00118.3
OG00217.5
OG00314.3
OG00441.7
OG00511.4
OG00617.6
OG003
ACC 10 µg
Participants received 10 µg of ACC. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
OG004
ACC 30 µg
Participants received 30 µg of ACC. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
OG005
QS-21 Alone
Participants received 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
OG006
Phosphate Buffered Saline
Participants received Phosphate buffered Saline (PBS). Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
Units
Counts
Participants
OG00036
OG00160
OG00240
OG00335
OG00412
OG00544
OG00617
Title
Denominators
Categories
Baseline (N: 36, 59, 40, 35, 12, 44, 17)
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)
OG00553.1(47.1 to 59.8)
OG00650.0(50.0 to 50.0)
Week 2 (N: 35, 60, 39, 35, 12, 43, 16)
Title
Measurements
OG00056.6(49.1 to 65.3)
OG00169.0(57.4 to 83.0)
OG00286.5(65.7 to 113.9)
OG003
Week 4 (N: 35, 57, 38, 31, 12, 43, 16)
Title
Measurements
OG00053.2(48.5 to 58.4)
OG00177.1(61.9 to 96.0)
OG00282.8(63.0 to 108.8)
OG003
Week 6 (N: 36, 58, 37, 33, 12, 41, 16)
Title
Measurements
OG000634.8(322.7 to 1248.5)
OG0011089.4(646.0 to 1837.2)
OG0021343.5(716.0 to 2521.1)
OG003
Week 8 (N: 33, 57, 39, 33, 12, 41, 17)
Title
Measurements
OG000497.4(253.5 to 976.1)
OG001885.2(530.0 to 1478.7)
OG0021098.2(626.9 to 1924.0)
OG003
Week 10 (N: 34, 59, 40, 33, 12, 43, 17)
Title
Measurements
OG000292.3(156.5 to 546.0)
OG001762.8(468.5 to 1242.2)
OG002878.5(531.3 to 1452.6)
OG003
Week 14 (N: 33, 52, 39, 31, 11, 33, 14)
Title
Measurements
OG000907.5(474.6 to 1735.6)
OG0012892.3(1705.9 to 4903.8)
OG0023136.8(1877.6 to 5240.7)
OG003
Week 16 (N: 33, 59, 38, 34, 12, 41, 16)
Title
Measurements
OG000996.1(487.1 to 2037.1)
OG0013273.2(2083.9 to 5141.4)
OG0023324.7(1959.4 to 5641.3)
OG003
Week 24 (N: 34, 58, 37, 33, 10, 40, 16)
Title
Measurements
OG000547.8(278.8 to 1076.3)
OG0011827.6(1145.3 to 2916.1)
OG0021231.3(712.2 to 2128.6)
OG003
Week 28 (N: 31, 51, 33, 29, 8, 36, 16)
Title
Measurements
OG0002011.2(986.9 to 4098.8)
OG0014299.6(2843.8 to 6500.8)
OG0025407.7(3676.0 to 7955.3)
OG003
Week 30 (N: 33, 56, 36, 32, 10, 38, 16)
Title
Measurements
OG0002028.9(1035.8 to 3973.8)
OG0014316.8(2900.2 to 6425.2)
OG0024713.0(3076.0 to 7221.2)
OG003
Week 40 (N: 32, 54, 33, 33, 9, 37, 15)
Title
Measurements
OG0001167.3(609.1 to 2237.1)
OG0012147.2(1407.6 to 3275.3)
OG0022292.9(1436.6 to 3659.8)
OG003
Week 50 (N: 29, 53, 33, 33, 9, 36, 16)
Title
Measurements
OG000937.3(482.0 to 1822.6)
OG0011364.4(911.9 to 2041.4)
OG0021262.3(828.5 to 1923.2)
OG003
Week 54 (N: 27, 51, 30, 29, 9, 29, 14)
Title
Measurements
OG0002031.6(1024.2 to 4029.7)
OG0015744.6(3609.1 to 9143.7)
OG0026677.3(3678.7 to 12120.1)
OG003
Week 56 (N: 31, 52, 34, 32, 9, 34, 15)
Title
Measurements
OG0002635.7(1355.5 to 5125.2)
OG0015906.1(4058.8 to 8594.2)
OG0027642.5(5057.9 to 11547.9)
OG003
Week 66 (N: 31, 54,34, 31, 9, 33, 15)
Title
Measurements
OG0001372.0(717.1 to 2625.1)
OG0012867.4(1835.9 to 4478.5)
OG0022882.2(1793.1 to 4632.8)
OG003
Week 78 (N: 31, 52, 32, 32, 8, 32, 14)
Title
Measurements
OG0001108.4(585.1 to 2099.4)
OG0011867.5(1197.4 to 2912.5)
OG0021338.1(827.3 to 2164.4)
OG003
Week 91 (N: 15, 9, 3, 8, 2, 6, 2)
Title
Measurements
OG0001824.6(1063.2 to 3131.2)
OG0012497.0(644.8 to 9670.1)
OG002543.0(33.6 to 8767.8)
OG003
Week 104 (N: 15, 9, 4, 7, 1, 6, 2)
Title
Measurements
OG0001326.1(785.0 to 2240.2)
OG0012212.7(406.4 to 12048.4)
OG002243.3(28.8 to 2052.4)
OG003
OG003
ACC 10 µg
Participants received 10 µg of ACC. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
OG004
ACC 30 µg
Participants received 30 µg of ACC. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
OG005
QS-21 Alone
Participants received 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
OG006
Phosphate Buffered Saline
Participants received Phosphate buffered Saline (PBS). Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
Units
Counts
Participants
OG00036
OG00160
OG00240
OG00335
OG00412
OG00544
OG00617
Title
Denominators
Categories
Baseline (N: 36, 59, 40, 35, 12, 44, 17)
Title
Measurements
OG00032.3(24.6 to 42.4)
OG00138.2(30.8 to 47.2)
OG00234.2(27.7 to 42.2)
OG00332.9(28.1 to 38.5)
OG00440.3(27.1 to 59.9)
OG00530.8(26.4 to 36.0)
OG00625.0(25.0 to 25.0)
Week 2 (N: 35, 60, 39, 35, 12,43, 16)
Title
Measurements
OG00085.1(54.2 to 133.8)
OG001127.7(79.5 to 205.0)
OG002254.5(133.6 to 484.9)
OG003
Week 4 (N: 35, 57, 38, 31, 12, 43, 16)
Title
Measurements
OG00082.3(52.8 to 128.4)
OG001123.4(75.9 to 200.7)
OG002276.6(143.3 to 533.6)
OG003
Week 6 (M: 36, 58, 37, 33, 12, 41, 16)
Title
Measurements
OG000626.5(340.5 to 1152.8)
OG0011283.8(742.6 to 2219.4)
OG0021736.6(906.4 to 3327.1)
OG003
Week 8 (N: 33, 57, 39, 33, 12, 41, 17)
Title
Measurements
OG000758.9(388.6 to 1482.4)
OG0011903.8(1097.7 to 3301.9)
OG0022769.5(1407.2 to 5450.9)
OG003
Week 10 (N: 34, 59, 40, 33, 12, 43, 17)
Title
Measurements
OG000595.2(310.0 to 1143.0)
OG0011697.7(980.8 to 2938.6)
OG0022598.1(1382.6 to 4882.0)
OG003
Week 14 (N: 33, 52, 39, 31, 11, 33, 14)
Title
Measurements
OG000770.2(416.1 to 1425.6)
OG0012721.0(1608.3 to 4603.4)
OG0025271.3(2904.4 to 9567.3)
OG003
Week 16 (N: 33, 59, 38, 34, 12, 41, 16)
Title
Measurements
OG000727.3(395.0 to 1339.0)
OG0013098.3(1904.1 to 5041.2)
OG0025666.4(3264.6 to 9835.3)
OG003
Week 24 (N: 34, 58, 37, 33, 10, 40, 16)
Title
Measurements
OG000461.3(260.4 to 817.2)
OG0011862.5(1137.9 to 3048.3)
OG0022672.4(1553.6 to 4597.0)
OG003
Week 28 (N: 31, 51, 33, 29, 8, 36, 16)
Title
Measurements
OG000669.0(388.0 to 1153.6)
OG0011915.3(1256.2 to 2920.0)
OG0023593.2(2050.4 to 6296.9)
OG003
Week 30 (N: 33, 56, 36, 32, 10, 38, 16)
Title
Measurements
OG000717.3(432.6 to 1189.5)
OG0012259.4(1524.0 to 3349.6)
OG0024147.2(2423.1 to 7098.1)
OG003
Week 40 (N: 32, 54, 33, 33, 9, 37, 15)
Title
Measurements
OG000559.0(350.7 to 891.0)
OG0011351.6(885.3 to 2063.3)
OG0021855.9(1074.3 to 3206.1)
OG003
Week 50 (N: 29, 53, 33, 33, 9, 36, 16)
Title
Measurements
OG000351.3(210.2 to 587.2)
OG0011049.6(701.4 to 1570.8)
OG0021246.4(707.2 to 2196.7)
OG003
Week 54 (N: 27, 51, 30, 29, 9, 29, 14)
Title
Measurements
OG000477.7(305.2 to 747.7)
OG0011529.1(1045.4 to 2236.7)
OG0022479.5(1373.5 to 4476.4)
OG003
Week 56 (N: 31, 52, 34, 32, 9, 34, 15)
Title
Measurements
OG000598.7(375.1 to 955.5)
OG0011696.1(1173.6 to 2451.3)
OG0022681.8(1480.7 to 4857.0)
OG003
Week 66 (N: 31, 54, 34, 31, 9, 33, 15)
Title
Measurements
OG000457.6(282.2 to 742.1)
OG0011422.0(980.7 to 2061.9)
OG0021637.2(961.9 to 2786.6)
OG003
Week 78 (N: 31, 52, 32, 32, 8, 32, 14)
Title
Measurements
OG000368.2(238.4 to 568.7)
OG0011204.4(815.6 to 1778.6)
OG0021217.7(706.1 to 2100.1)
OG003
Week 91 (N: 15, 9, 3, 8, 2, 6, 2)
Title
Measurements
OG000391.2(205.6 to 744.2)
OG0011203.4(399.9 to 3621.9)
OG002679.2(28.5 to 16208.4)
OG003
Week 104 (N: 15, 9, 4, 7, 1, 6, 2)
Title
Measurements
OG000299.1(144.2 to 620.8)
OG0011561.8(438.0 to 5569.0)
OG002620.3(78.8 to 4882.2)
OG003
OG004
ACC 30 μg
Participants received 30 μg of ACC. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
OG005
QS-21 Alone
Participants received 50 μg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
OG006
Phosphate Buffered Saline
Participants received Phosphate buffered Saline (PBS). Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.