A Study of V950 in People With Alzheimer Disease (V950-00... | NCT00464334 | Trialant
NCT00464334
Sponsor
Merck Sharp & Dohme LLC
Status
Completed
Last Update Posted
Sep 25, 2015Estimated
Enrollment
86Actual
Phase
Phase 1
Conditions
Alzheimer Disease
Interventions
V950
ISCOMATRIXâ„¢
Placebo to V950
Countries
Not provided
Protocol Section
Identification Module
NCT ID
Results Section
Participant Flow Module
Pre-assignment Details
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
NCT00464334
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
V950-001
Secondary IDs
ID
Type
Description
Link
2007_518
Other Identifier
Merck Registration ID
Brief Title
A Study of V950 in People With Alzheimer Disease (V950-001 AM7)
Official Title
A Double-Blind, Randomized, Placebo-Controlled, Dose Escalating Study to Evaluate the Safety, Tolerability, and Immunogenicity of V950 Formulated on Aluminum-Containing Adjuvant With or Without ISCOMATRIXâ„¢ in Patients With Alzheimer Disease
Acronym
Not provided
Organization
Merck Sharp & Dohme LLCINDUSTRY
Status Module
Record Verification Date
Sep 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
Mar 2007
Primary Completion Date
Jan 2012Actual
Completion Date
Jan 2012Actual
First Submitted Date
Apr 20, 2007
First Submission Date that Met QC Criteria
Apr 20, 2007
First Posted Date
Apr 23, 2007Estimated
Results Waived
Not provided
Results First Submitted Date
Nov 19, 2012
Results First Submitted that Met QC Criteria
Nov 19, 2012
Results First Posted Date
Dec 18, 2012Estimated
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
Sep 24, 2015
Last Update Posted Date
Sep 25, 2015Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Merck Sharp & Dohme LLCINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
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 study is to test the safety, tolerability and the immune response to an investigational vaccine, V950, with or without ISCOMATRIXâ„¢ (IMX).
Detailed Description
Not provided
Conditions Module
Conditions
Alzheimer 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 1
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
Placebo to V950/IMX 0 mcg
Experimental
Participants receive Placebo to V950/IMX 0 mcg, 0.5 mL intramuscular injection at Months 0, 2 and 6.
Biological: ISCOMATRIXâ„¢
Biological: Placebo to V950
Placebo to V950/IMX 16 mcg
Experimental
Participants receive Placebo to V950/IMX 16 mcg, 0.5 mL intramuscular injection at Months 0, 2 and 6.
Biological: ISCOMATRIXâ„¢
Biological: Placebo to V950
V950 0.5 mcg/IMX 0 mcg
Experimental
Participants receive V950 0.5 mcg/IMX 0 mcg, 0.5 mL intramuscular injection at Months 0, 2 and 6.
Biological: V950
Biological: ISCOMATRIXâ„¢
V950 0.5 mcg/IMX 16 mcg
Experimental
Participants receive V950 0.5 mcg/IMX 16 mcg, 0.5 mL intramuscular injection at Months 0, 2 and 6.
Biological: V950
Biological: ISCOMATRIXâ„¢
V950 0.5 mcg/IMX 47 mcg
Experimental
Participants receive V950 0.5 mcg/IMX 47 mcg, 0.5 mL intramuscular injection at Months 0, 2 and 6.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
V950
Biological
V950 will be given in doses of 0.5, 5 or 50 mcg depending on arm assignment.
V950 0.5 mcg/IMX 0 mcg
V950 0.5 mcg/IMX 16 mcg
V950 0.5 mcg/IMX 47 mcg
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants Who Experienced at Least One Adverse Event
An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product.
Up to 4 years after first dose of vaccine
Number of Participants Who Discontinued Study Drug Due to an Adverse Event
This is a measure of the number of participants who discontinued study drug because of an adverse event. An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product.
Up to 6 months after first dose of vaccine
Geometric Mean Titer (GMT) of Amyloid Beta (Aβ) Peptide 1-40 Specific Antibodies at Month 7
The level of Aβ Peptide 1-40 specific antibodies was measured as the geometric mean titer (GMT) one month after the third dose (Month 7) of vaccine using an enzyme-linked immunosorbent assay (ELISA).
Month 7
Mean Fold Change From Baseline in GMT of Aβ Peptide 1-40 Specific Antibodies
The Aβ Peptide 1-40 specific immunogenicity of 3-dose regimen of V950 was measured one month after the third dose (Month 7) of vaccine by the GMT fold change of Aβ 1-40 specific antibodies compared to Baseline (Month 0) using ELISA.
Baseline and Month 7
Secondary Outcomes
Not provided
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Patient has mild to moderate Alzheimer Disease
Women cannot be able to get pregnant
Patient has a reliable caregiver, who will attend all visits and answer questions about the patient
Exclusion Criteria:
Patient lives in a nursing home or facility
Patient has another neurological or neurodegenerative disorder
Patient has a history of stroke
Patient uses illicit drugs or has a history of drug/alcohol abuse
Patient has received blood or blood derived products within 6 months
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
55 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Medical Monitor
Merck Sharp & Dohme LLC
Study Director
Locations
Not provided
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
Not provided
Recruitment Details
Participants were recruited from 51 sites in Europe, South America and the United States. The primary treatment period was from June 2007 to August 2010, with follow up through January 2012.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Placebo to V950/IMX 0 mcg
Participants receive Placebo to V950/ISCOMATRIXâ„¢ (IMX) 0 mcg
FG001
Placebo to V950/IMX 16 mcg
Participants receive Placebo to V950/IMX 16 mcg
FG002
V950 0.5 mcg/IMX 0 mcg
Participants receive V950 0.5 mcg/IMX 0 mcg
FG003
V950 0.5 mcg/IMX 16 mcg
Participants receive V950 0.5 mcg/IMX 16 mcg
FG004
V950 0.5 mcg/IMX 47 mcg
Participants receive V950 0.5 mcg/IMX 47 mcg
FG005
V950 0.5 mcg/IMX 94 mcg
Participants receive V950 0.5 mcg/IMX 94 mcg
FG006
V950 5 mcg/IMX 0 mcg
Participants receive V950 5 mcg/IMX 0 mcg
FG007
V950 5 mcg/IMX 16 mcg
Participants receive V950 5 mcg/IMX 16 mcg
FG008
V950 5 mcg/IMX 47 mcg
Participants receive V950 5 mcg/IMX 47 mcg
FG009
V950 50 mcg/IMX 0 mcg
Participants receive V950 50 mcg/IMX 0 mcg
FG010
V950 50 mcg/IMX 16 mcg
Participants receive V950 50 mcg/IMX 16 mcg
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
FG0005 subjects
FG00113 subjects
FG0028 subjects
FG0038 subjects
FG0047 subjects
FG0057 subjects
FG0069 subjects
FG0078 subjects
FG0088 subjects
FG0095 subjects
FG0108 subjects
COMPLETED
FG0004 subjects
FG0015 subjects
FG0023 subjects
FG0034 subjects
FG004
NOT COMPLETED
FG0001 subjects
FG0018 subjects
FG0025 subjects
FG0034 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Placebo to V950/IMX 0 mcg
Participants receive Placebo to V950/IMX 0 mcg
BG001
Placebo to V950/IMX 16 mcg
Participants receive Placebo to V950/IMX 16 mcg
Denominators
Units
Counts
Participants
BG000
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Outcome Measures Module
Outcome Measures
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Number of Participants Who Experienced at Least One Adverse Event
An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product.
Population consists of all participants who received at least one dose of vaccine.
Posted
Number
participants
Up to 4 years after first dose of vaccine
ID
Title
Description
OG000
Placebo to V950/ IMX 0 mcg
Participants receive Placebo to V950/IMX 0 mcg
OG001
Placebo to V950/ IMX 16 mcg
Participants receive Placebo to V950/IMX 16 mcg
Adverse Events Module
Frequency Threshold
5
Time Frame
Up to 4 years after first dose of vaccine
Description
The Safety Population consisted of all participants who received at least one dose of vaccine.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Placebo to V950/ IMX 0 mcg
Participants receive Placebo to V950/IMX 0 mcg
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Arrhythmia
Cardiac disorders
MedDRA 14.1
Systematic Assessment
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 14.1
Systematic Assessment
More Info Module
Limitations and Caveats
Not provided
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
Point of Contact
Title
Organization
Phone
Extension
Email
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp
1-800-672-6372
ClinicalTrialsDisclosure@merck.com
Jul 10, 2026
Removed Countries
France
Sweden
United States
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
ID
Term
D000544
Alzheimer Disease
Ancestor Terms
ID
Term
D003704
Dementia
D001927
Brain Diseases
D002493
Central Nervous System Diseases
D009422
Nervous System Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
Intervention Browse Module
MeSH Terms
ID
Term
C493786
ISCOMATRIX
Ancestor Terms
Not provided
Browse Leaves
Not provided
Browse Branches
Not provided
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Diagnostic
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Double
Masking Description
Not provided
Who Masked
ParticipantInvestigator
Biological: V950
Biological: ISCOMATRIXâ„¢
V950 0.5 mcg/IMX 94 mcg
Experimental
Participants receive V950 0.5 mcg/IMX 94 mcg, 0.5 mL intramuscular injection at Months 0, 2 and 6.
Biological: V950
Biological: ISCOMATRIXâ„¢
V950 5 mcg/IMX 0 mcg
Experimental
Participants receive V950 5 mcg/IMX 0 mcg, 0.5 mL intramuscular injection at Months 0, 2 and 6.
Biological: V950
Biological: ISCOMATRIXâ„¢
V950 5 mcg/IMX 16 mcg
Experimental
Participants receive V950 5 mcg/IMX 16 mcg, 0.5 mL intramuscular injection at Months 0, 2 and 6.
Biological: V950
Biological: ISCOMATRIXâ„¢
V950 5 mcg/IMX 47 mcg
Experimental
Participants receive V950 5 mcg/IMX 47 mcg, 0.5 mL intramuscular injection at Months 0, 2 and 6.
Biological: V950
Biological: ISCOMATRIXâ„¢
V950 50 mcg/IMX 0 mcg
Experimental
Participants receive V950 50 mcg/IMX 0 mcg, 0.5 mL intramuscular injection at Months 0, 2 and 6.
Biological: V950
Biological: ISCOMATRIXâ„¢
V950 50 mcg/IMX 16 mcg
Experimental
Participants receive V950 50 mcg/IMX 16 mcg, 0.5 mL intramuscular injection at Months 0, 2 and 6.
Biological: V950
Biological: ISCOMATRIXâ„¢
V950 0.5 mcg/IMX 94 mcg
V950 5 mcg/IMX 0 mcg
V950 5 mcg/IMX 16 mcg
V950 5 mcg/IMX 47 mcg
V950 50 mcg/IMX 0 mcg
V950 50 mcg/IMX 16 mcg
ISCOMATRIXâ„¢
Biological
ISCOMATRIX will be given in doses of 0, 16, 47 or 94 mcg depending on arm assignment.
Placebo to V950/IMX 0 mcg
Placebo to V950/IMX 16 mcg
V950 0.5 mcg/IMX 0 mcg
V950 0.5 mcg/IMX 16 mcg
V950 0.5 mcg/IMX 47 mcg
V950 0.5 mcg/IMX 94 mcg
V950 5 mcg/IMX 0 mcg
V950 5 mcg/IMX 16 mcg
V950 5 mcg/IMX 47 mcg
V950 50 mcg/IMX 0 mcg
V950 50 mcg/IMX 16 mcg
Placebo to V950
Biological
Placebo to V950/IMX 0 mcg
Placebo to V950/IMX 16 mcg
3 subjects
FG0053 subjects
FG0066 subjects
FG0077 subjects
FG0082 subjects
FG0094 subjects
FG0104 subjects
4 subjects
FG0054 subjects
FG0063 subjects
FG0071 subjects
FG0086 subjects
FG0091 subjects
FG0104 subjects
1 subjects
FG0041 subjects
FG0051 subjects
FG0060 subjects
FG0070 subjects
FG0082 subjects
FG0091 subjects
FG0102 subjects
Lack of Efficacy
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG0041 subjects
FG0050 subjects
FG0061 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0102 subjects
Progressive Disease
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0051 subjects
FG0060 subjects
FG0070 subjects
FG0081 subjects
FG0090 subjects
FG0100 subjects
Study Terminated by Sponsor
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
Withdrawal by Subject
FG0001 subjects
FG0017 subjects
FG0024 subjects
FG0032 subjects
FG0042 subjects
FG0052 subjects
FG0062 subjects
FG0071 subjects
FG0083 subjects
FG0090 subjects
FG0100 subjects
BG002
V950 0.5 mcg/IMX 0 mcg
Participants receive V950 0.5 mcg/IMX 0 mcg
BG003
V950 0.5 mcg/IMX 16 mcg
Participants receive V950 0.5 mcg/IMX 16 mcg
BG004
V950 0.5 mcg/IMX 47 mcg
Participants receive V950 0.5 mcg/IMX 47 mcg
BG005
V950 0.5 mcg/IMX 94 mcg
Participants receive V950 0.5 mcg/IMX 94 mcg
BG006
V950 5 mcg/IMX 0 mcg
Participants receive V950 5 mcg/IMX 0 mcg
BG007
V950 5 mcg/IMX 16 mcg
Participants receive V950 5 mcg/IMX 16 mcg
BG008
V950 5 mcg/IMX 47 mcg
Participants receive V950 5 mcg/IMX 47 mcg
BG009
V950 50 mcg/IMX 0 mcg
Participants receive V950 50 mcg/IMX 0 mcg
BG010
V950 50 mcg/IMX 16 mcg
Participants receive V950 50 mcg/IMX 16 mcg
BG011
Total
Total of all reporting groups
5
BG00113
BG0028
BG0038
BG0047
BG0057
BG0069
BG0078
BG0088
BG0095
BG0108
BG01186
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00073.6± 10.69
BG00170.7± 9.6
BG00276.9± 4.39
BG00373.6± 8.07
BG00476.1± 8.01
BG00573.4± 10.89
BG00672.6± 9.26
BG00772.5± 10.10
BG00881.5± 5.48
BG00970.6± 8.38
BG01075.5± 10.04
BG01174.2± 8.85
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0003
BG0017
BG0023
BG0035
BG0045
BG0056
BG0064
BG0075
BG0081
BG0093
BG0103
BG01145
Male
BG0002
BG0016
BG0025
BG0033
BG004
OG002
V950 0.5 mcg / IMX 0 mcg
Participants receive V950 0.5 mcg/IMX 0 mcg
OG003
V950 0.5 mcg / IMX 16 mcg
Participants receive V950 0.5 mcg/IMX 16 mcg
OG004
V950 0.5 mcg / IMX 47 mcg
Participants receive V950 0.5 mcg/IMX 47 mcg
OG005
V950 0.5 mcg / IMX 94 mcg
Participants receive V950 0.5 mcg/IMX 94 mcg
OG006
V950 5 mcg / IMX 0 mcg
Participants receive V950 5 mcg/IMX 0 mcg
OG007
V950 5 mcg / IMX 16 mcg
Participants receive V950 5 mcg/IMX 16 mcg
OG008
V950 5 mcg / IMX 47 mcg
Participants receive V950 5 mcg/IMX 47 mcg
OG009
V950 50 mcg / IMX 0 mcg
Participants receive V950 50 mcg/IMX 0 mcg
OG010
V950 50 mcg / IMX 16 mcg
Participants receive V950 50 mcg/IMX 16 mcg
Units
Counts
Participants
OG0005
OG00113
OG0028
OG0038
OG0047
OG0057
OG0069
OG0078
OG0088
OG0095
OG0108
Title
Denominators
Categories
Title
Measurements
OG0004
OG00111
OG0027
OG0038
OG0046
OG0057
OG0069
OG0078
OG0088
OG0095
OG0108
Primary
Number of Participants Who Discontinued Study Drug Due to an Adverse Event
This is a measure of the number of participants who discontinued study drug because of an adverse event. An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product.
Population consists of all participants who received at least one dose of vaccine.
Posted
Number
participants
Up to 6 months after first dose of vaccine
ID
Title
Description
OG000
Placebo to V950/ IMX 0 mcg
Participants receive Placebo to V950/IMX 0 mcg
OG001
Placebo to V950/ IMX 16 mcg
Participants receive Placebo to V950/IMX 16 mcg
OG002
V950 0.5 mcg / IMX 0 mcg
Participants receive V950 0.5 mcg/IMX 0 mcg
OG003
V950 0.5 mcg / IMX 16 mcg
Participants receive V950 0.5 mcg/IMX 16 mcg
OG004
V950 0.5 mcg / IMX 47 mcg
Participants receive V950 0.5 mcg/IMX 47 mcg
OG005
V950 0.5 mcg / IMX 94 mcg
Participants receive V950 0.5 mcg/IMX 94 mcg
OG006
V950 5 mcg / IMX 0 mcg
Participants receive V950 5 mcg/IMX 0 mcg
OG007
V950 5 mcg / IMX 16 mcg
Participants receive V950 5 mcg/IMX 16 mcg
OG008
V950 5 mcg / IMX 47 mcg
Participants receive V950 5 mcg/IMX 47 mcg
OG009
V950 50 mcg / IMX 0 mcg
Participants receive V950 50 mcg/IMX 0 mcg
OG010
V950 50 mcg / IMX 16 mcg
Participants receive V950 50 mcg/IMX 16 mcg
Units
Counts
Participants
OG0005
OG00113
OG0028
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG003
Primary
Geometric Mean Titer (GMT) of Amyloid Beta (Aβ) Peptide 1-40 Specific Antibodies at Month 7
The level of Aβ Peptide 1-40 specific antibodies was measured as the geometric mean titer (GMT) one month after the third dose (Month 7) of vaccine using an enzyme-linked immunosorbent assay (ELISA).
Population consists of all participants who received three doses of vaccine and had no protocol violations. No participants in the V950 50 mcg/IMX 0 mcg group had data for the Month 7 evaluation.
Posted
Geometric Mean
95% Confidence Interval
ng/mL
Month 7
ID
Title
Description
OG000
Placebo to V950/IMX 0 mcg
Participants receive Placebo to V950/IMX 0 mcg
OG001
Placebo to V950/IMX 16 mcg
Participants receive Placebo to V950/IMX 16 mcg
OG002
V950 0.5 mcg/IMX 0 mcg
Participants receive V950 0.5 mcg/IMX 0 mcg
OG003
V950 0.5 mcg/IMX 16 mcg
Participants receive V950 0.5 mcg/IMX 16 mcg
OG004
V950 0.5 mcg/IMX 47 mcg
Participants receive V950 0.5 mcg/IMX 47 mcg
OG005
V950 0.5 mcg/IMX 94 mcg
Participants receive V950 0.5 mcg/IMX 94 mcg
OG006
V950 5 mcg/IMX 0 mcg
Participants receive V950 5 mcg/IMX 0 mcg
OG007
V950 5 mcg/IMX 16 mcg
Participants receive V950 5 mcg/IMX 16 mcg
OG008
V950 5 mcg/IMX 47 mcg
Participants receive V950 5 mcg/IMX 47 mcg
OG009
V950 50 mcg/IMX 0 mcg
Participants receive V950 50 mcg/IMX 0 mcg
OG010
V950 50 mcg/IMX 16 mcg
Participants receive V950 50 mcg/IMX 16 mcg
Units
Counts
Participants
OG0004
OG0014
OG0028
OG003
Title
Denominators
Categories
Title
Measurements
OG000363(161 to 729)
OG001542.08(310.16 to 818.02)
OG002855(575 to 1275)
OG003
Primary
Mean Fold Change From Baseline in GMT of Aβ Peptide 1-40 Specific Antibodies
The Aβ Peptide 1-40 specific immunogenicity of 3-dose regimen of V950 was measured one month after the third dose (Month 7) of vaccine by the GMT fold change of Aβ 1-40 specific antibodies compared to Baseline (Month 0) using ELISA.
Population consists of all participants who received three doses of vaccine and had no protocol violations. No participants in the V950 50 mcg/IMX 0 mcg group had data for the Month 7 evaluation.
Posted
Geometric Mean
95% Confidence Interval
fold change
Baseline and Month 7
ID
Title
Description
OG000
Placebo to V950/ IMX 0 mcg
Participants receive Placebo to V950/IMX 0 mcg
OG001
Placebo to V950/ IMX 16 mcg
Participants receive Placebo to V950/IMX 16 mcg
OG002
V950 0.5 mcg / IMX 0 mcg
Participants receive V950 0.5 mcg/IMX 0 mcg
OG003
V950 0.5 mcg / IMX 16 mcg
Participants receive V950 0.5 mcg/IMX 16 mcg
OG004
V950 0.5 mcg / IMX 47 mcg
Participants receive V950 0.5 mcg/IMX 47 mcg
OG005
V950 0.5 mcg / IMX 94 mcg
Participants receive V950 0.5 mcg/IMX 94 mcg
OG006
V950 5 mcg / IMX 0 mcg
Participants receive V950 5 mcg/IMX 0 mcg
OG007
V950 5 mcg / IMX 16 mcg
Participants receive V950 5 mcg/IMX 16 mcg
OG008
V950 5 mcg / IMX 47 mcg
Participants receive V950 5 mcg/IMX 47 mcg
OG009
V950 50 mcg / IMX 0 mcg
Participants receive V950 50 mcg/IMX 0 mcg
OG010
V950 50 mcg / IMX 16 mcg
Participants receive V950 50 mcg/IMX 16 mcg
Units
Counts
Participants
OG0004
OG0014
OG0028
OG003
Title
Denominators
Categories
Title
Measurements
OG0000.89(0.70 to 1.16)
OG0010.76(0.49 to 1.06)
OG0020.98(0.79 to 1.17)
OG003
1
5
4
5
EG001
Placebo to V950/ IMX 16 mcg
Participants receive Placebo to V950/IMX 16 mcg
0
13
11
13
EG002
V950 0.5 mcg / IMX 0 mcg
Participants receive V950 0.5 mcg/IMX 0 mcg
2
8
7
8
EG003
V950 0.5 mcg / IMX 16 mcg
Participants receive V950 0.5 mcg/IMX 16 mcg
2
8
8
8
EG004
V950 0.5 mcg / IMX 47 mcg
Participants receive V950 0.5 mcg/IMX 47 mcg
3
7
6
7
EG005
V950 0.5 mcg / IMX 94 mcg
Participants receive V950 0.5 mcg/IMX 94 mcg
1
7
7
7
EG006
V950 5 mcg / IMX 0 mcg
Participants receive V950 5 mcg/IMX 0 mcg
4
9
9
9
EG007
V950 5 mcg / IMX 16 mcg
Participants receive V950 5 mcg/IMX 16 mcg
1
8
8
8
EG008
V950 5 mcg / IMX 47 mcg
Participants receive V950 5 mcg/IMX 47 mcg
2
8
8
8
EG009
V950 50 mcg / IMX 0 mcg
Participants receive V950 50 mcg/IMX 0 mcg
1
5
5
5
EG010
V950 50 mcg / IMX 16 mcg
Participants receive V950 50 mcg/IMX 16 mcg
0
8
8
8
EG0000 events0 affected5 at risk
EG0010 events0 affected13 at risk
EG0022 events2 affected8 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Cardiac arrest
Cardiac disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected8 at risk
EG0041 events1 affected7 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Dysphagia
Gastrointestinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected8 at risk
EG0041 events1 affected7 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Chest pain
General disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected8 at risk
EG0081 events1 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Urinary tract infection
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected8 at risk
EG0041 events1 affected7 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Contusion
Injury, poisoning and procedural complications
MedDRA 14.1
Systematic Assessment
EG0001 events1 affected5 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Hip fracture
Injury, poisoning and procedural complications
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0061 events1 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Bursitis
Musculoskeletal and connective tissue disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0061 events1 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Osteonecrosis
Musculoskeletal and connective tissue disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0061 events1 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Bladder cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected8 at risk
EG0041 events1 affected7 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Squamous cell carcinoma of skin
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected9 at risk
EG0071 events1 affected8 at risk
EG0080 events0 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Cerebrovascular accident
Nervous system disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected7 at risk
EG0052 events1 affected7 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Syncope
Nervous system disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected13 at risk
EG0023 events1 affected8 at risk
EG0031 events1 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected8 at risk
EG0081 events1 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Transient ischaemic attack
Nervous system disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected8 at risk
EG0031 events1 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0061 events1 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Depression
Psychiatric disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0091 events1 affected5 at risk
EG0100 events0 affected8 at risk
Suicidal ideation
Psychiatric disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected8 at risk
EG0081 events1 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Haematuria
Renal and urinary disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected8 at risk
EG0041 events1 affected7 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Lung disorder
Respiratory, thoracic and mediastinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0061 events1 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected8 at risk
EG0041 events1 affected7 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Orthostatic hypotension
Vascular disorders
MedDRA 14.1
Systematic Assessment
EG0001 events1 affected5 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
EG0000 events0 affected5 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0062 events2 affected9 at risk
EG0070 events0 affected8 at risk
EG0082 events2 affected8 at risk
EG0090 events0 affected5 at risk
EG0101 events1 affected8 at risk
Leukocytosis
Blood and lymphatic system disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0061 events1 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Atrial fibrillation
Cardiac disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected8 at risk
EG0041 events1 affected7 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Tachycardia paroxysmal
Cardiac disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected13 at risk
EG0022 events1 affected8 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Middle ear effusion
Ear and labyrinth disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0091 events1 affected5 at risk
EG0100 events0 affected8 at risk
Tinnitus
Ear and labyrinth disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Hypothyroidism
Endocrine disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected8 at risk
EG0031 events1 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0091 events1 affected5 at risk
EG0100 events0 affected8 at risk
Conjunctivitis
Eye disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0061 events1 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Glaucoma
Eye disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected7 at risk
EG0051 events1 affected7 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Macular degeneration
Eye disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0061 events1 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Visual impairment
Eye disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0091 events1 affected5 at risk
EG0100 events0 affected8 at risk
Vitreous floaters
Eye disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Abdominal discomfort
Gastrointestinal disorders
MedDRA 14.1
Systematic Assessment
EG0001 events1 affected5 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Abdominal pain
Gastrointestinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected8 at risk
EG0081 events1 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Abdominal pain lower
Gastrointestinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected13 at risk
EG0021 events1 affected8 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Constipation
Gastrointestinal disorders
MedDRA 14.1
Systematic Assessment
EG0001 events1 affected5 at risk
EG0010 events0 affected13 at risk
EG0021 events1 affected8 at risk
EG0031 events1 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0061 events1 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Diarrhoea
Gastrointestinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0013 events3 affected13 at risk
EG0021 events1 affected8 at risk
EG0031 events1 affected8 at risk
EG0042 events2 affected7 at risk
EG0050 events0 affected7 at risk
EG0062 events2 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0091 events1 affected5 at risk
EG0100 events0 affected8 at risk
Diverticulum
Gastrointestinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0061 events1 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Dyspepsia
Gastrointestinal disorders
MedDRA 14.1
Systematic Assessment
EG0001 events1 affected5 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected8 at risk
EG0031 events1 affected8 at risk
EG0041 events1 affected7 at risk
EG0051 events1 affected7 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Dysphagia
Gastrointestinal disorders
MedDRA 14.1
Systematic Assessment
EG0001 events1 affected5 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Flatulence
Gastrointestinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected8 at risk
EG0031 events1 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Gastritis
Gastrointestinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Gingival bleeding
Gastrointestinal disorders
MedDRA 14.1
Systematic Assessment
EG0001 events1 affected5 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Gingivitis
Gastrointestinal disorders
MedDRA 14.1
Systematic Assessment
EG0001 events1 affected5 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Haemorrhoids
Gastrointestinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected8 at risk
EG0032 events1 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0061 events1 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Hyperchlorhydria
Gastrointestinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected8 at risk
EG0031 events1 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Lip swelling
Gastrointestinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Nausea
Gastrointestinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected8 at risk
EG0041 events1 affected7 at risk
EG0052 events2 affected7 at risk
EG0062 events2 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Oral mucosal erythema
Gastrointestinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0091 events1 affected5 at risk
EG0100 events0 affected8 at risk
Peptic ulcer
Gastrointestinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0061 events1 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Proctalgia
Gastrointestinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0061 events1 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Rectal haemorrhage
Gastrointestinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected8 at risk
EG0031 events1 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0061 events1 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Salivary hypersecretion
Gastrointestinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Stomatitis
Gastrointestinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected9 at risk
EG0071 events1 affected8 at risk
EG0080 events0 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Toothache
Gastrointestinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected13 at risk
EG0021 events1 affected8 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Vomiting
Gastrointestinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected8 at risk
EG0041 events1 affected7 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Adverse drug reaction
General disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected8 at risk
EG0081 events1 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Asthenia
General disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0012 events1 affected13 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Fatigue
General disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected8 at risk
EG0033 events2 affected8 at risk
EG0040 events0 affected7 at risk
EG0051 events1 affected7 at risk
EG0062 events2 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Feeling cold
General disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected9 at risk
EG0071 events1 affected8 at risk
EG0080 events0 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Gait disturbance
General disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0091 events1 affected5 at risk
EG0100 events0 affected8 at risk
Influenza like illness
General disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0090 events0 affected5 at risk
EG0101 events1 affected8 at risk
Injection site discomfort
General disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected7 at risk
EG0051 events1 affected7 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Injection site erythema
General disorders
MedDRA 14.1
Systematic Assessment
EG0002 events1 affected5 at risk
EG0012 events2 affected13 at risk
EG0020 events0 affected8 at risk
EG0032 events1 affected8 at risk
EG0043 events2 affected7 at risk
EG0053 events3 affected7 at risk
EG0062 events2 affected9 at risk
EG0074 events2 affected8 at risk
EG0085 events3 affected8 at risk
EG0094 events2 affected5 at risk
EG01011 events6 affected8 at risk
Injection site haematoma
General disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected8 at risk
EG0031 events1 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0091 events1 affected5 at risk
EG0100 events0 affected8 at risk
Injection site hypersensitivity
General disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0061 events1 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Injection site mass
General disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0090 events0 affected5 at risk
EG0101 events1 affected8 at risk
Injection site pain
General disorders
MedDRA 14.1
Systematic Assessment
EG0003 events1 affected5 at risk
EG0014 events3 affected13 at risk
EG0022 events1 affected8 at risk
EG0039 events4 affected8 at risk
EG0042 events1 affected7 at risk
EG00510 events7 affected7 at risk
EG0066 events4 affected9 at risk
EG0074 events3 affected8 at risk
EG0089 events4 affected8 at risk
EG00913 events5 affected5 at risk
EG01013 events5 affected8 at risk
Injection site pruritus
General disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected8 at risk
EG0031 events1 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Injection site rash
General disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0061 events1 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Injection site swelling
General disorders
MedDRA 14.1
Systematic Assessment
EG0002 events1 affected5 at risk
EG0012 events2 affected13 at risk
EG0021 events1 affected8 at risk
EG0034 events3 affected8 at risk
EG0043 events2 affected7 at risk
EG0053 events2 affected7 at risk
EG0060 events0 affected9 at risk
EG0073 events2 affected8 at risk
EG0086 events3 affected8 at risk
EG0096 events3 affected5 at risk
EG0105 events5 affected8 at risk
Malaise
General disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected13 at risk
EG0021 events1 affected8 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Oedema peripheral
General disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0062 events1 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Pain
General disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected8 at risk
EG0081 events1 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Pyrexia
General disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0011 events1 affected13 at risk
EG0023 events3 affected8 at risk
EG0031 events1 affected8 at risk
EG0041 events1 affected7 at risk
EG0050 events0 affected7 at risk
EG0061 events1 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Bronchitis
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected8 at risk
EG0041 events1 affected7 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected9 at risk
EG0071 events1 affected8 at risk
EG0080 events0 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Cellulitis
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0012 events1 affected13 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0061 events1 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Cystitis
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected8 at risk
EG0031 events1 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Diverticulitis
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected13 at risk
EG0021 events1 affected8 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Fungal skin infection
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0090 events0 affected5 at risk
EG0101 events1 affected8 at risk
Herpes zoster
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected7 at risk
EG0051 events1 affected7 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Localised infection
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0001 events1 affected5 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Nasopharyngitis
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0011 events1 affected13 at risk
EG0021 events1 affected8 at risk
EG0031 events1 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0061 events1 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0091 events1 affected5 at risk
EG0100 events0 affected8 at risk
Otitis externa
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Pneumonia
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0091 events1 affected5 at risk
EG0100 events0 affected8 at risk
Prostate infection
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0090 events0 affected5 at risk
EG0101 events1 affected8 at risk
Rhinitis
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected7 at risk
EG0051 events1 affected7 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Sinusitis
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0001 events1 affected5 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected8 at risk
EG0031 events1 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected8 at risk
EG0081 events1 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Tooth abscess
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0091 events1 affected5 at risk
EG0100 events0 affected8 at risk
Tooth infection
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected13 at risk
EG0021 events1 affected8 at risk
EG0030 events0 affected8 at risk
EG0041 events1 affected7 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Upper respiratory tract infection
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0001 events1 affected5 at risk
EG0011 events1 affected13 at risk
EG0021 events1 affected8 at risk
EG0030 events0 affected8 at risk
EG0042 events2 affected7 at risk
EG0051 events1 affected7 at risk
EG0061 events1 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Urinary tract infection
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected13 at risk
EG0021 events1 affected8 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected7 at risk
EG0051 events1 affected7 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0091 events1 affected5 at risk
EG0100 events0 affected8 at risk
Wound infection
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected13 at risk
EG0021 events1 affected8 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Arthropod bite
Injury, poisoning and procedural complications
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected8 at risk
EG0041 events1 affected7 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Concussion
Injury, poisoning and procedural complications
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0091 events1 affected5 at risk
EG0100 events0 affected8 at risk
Contusion
Injury, poisoning and procedural complications
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected13 at risk
EG0024 events2 affected8 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Documented hypersensitivity to administered drug
Injury, poisoning and procedural complications
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected13 at risk
EG0021 events1 affected8 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Excoriation
Injury, poisoning and procedural complications
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected8 at risk
EG0032 events1 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Fall
Injury, poisoning and procedural complications
MedDRA 14.1
Systematic Assessment
EG0002 events2 affected5 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected8 at risk
EG0032 events1 affected8 at risk
EG0040 events0 affected7 at risk
EG0051 events1 affected7 at risk
EG0061 events1 affected9 at risk
EG0070 events0 affected8 at risk
EG0081 events1 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Foot fracture
Injury, poisoning and procedural complications
MedDRA 14.1
Systematic Assessment
EG0001 events1 affected5 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected8 at risk
EG0031 events1 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Laceration
Injury, poisoning and procedural complications
MedDRA 14.1
Systematic Assessment
EG0001 events1 affected5 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Ligament sprain
Injury, poisoning and procedural complications
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Procedural headache
Injury, poisoning and procedural complications
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected13 at risk
EG0021 events1 affected8 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Rib fracture
Injury, poisoning and procedural complications
MedDRA 14.1
Systematic Assessment
EG0001 events1 affected5 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected8 at risk
EG0031 events1 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0061 events1 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Road traffic accident
Injury, poisoning and procedural complications
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0061 events1 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0091 events1 affected5 at risk
EG0100 events0 affected8 at risk
Spinal fracture
Injury, poisoning and procedural complications
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected8 at risk
EG0041 events1 affected7 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Tooth fracture
Injury, poisoning and procedural complications
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected13 at risk
EG0021 events1 affected8 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Blood alkaline phosphatase increased
Investigations
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected8 at risk
EG0031 events1 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Blood amylase increased
Investigations
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected8 at risk
EG0041 events1 affected7 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
CSF glucose increased
Investigations
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected7 at risk
EG0051 events1 affected7 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
CSF protein increased
Investigations
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected7 at risk
EG0051 events1 affected7 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Haemoglobin decreased
Investigations
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected8 at risk
EG0081 events1 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Neurological examination abnormal
Investigations
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected8 at risk
EG0031 events1 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Temperature perception test decreased
Investigations
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected8 at risk
EG0081 events1 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Weight decreased
Investigations
MedDRA 14.1
Systematic Assessment
EG0001 events1 affected5 at risk
EG0010 events0 affected13 at risk
EG0021 events1 affected8 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected9 at risk
EG0072 events2 affected8 at risk
EG0080 events0 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Decreased appetite
Metabolism and nutrition disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected13 at risk
EG0021 events1 affected8 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected9 at risk
EG0071 events1 affected8 at risk
EG0080 events0 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Dehydration
Metabolism and nutrition disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected8 at risk
EG0041 events1 affected7 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected8 at risk
EG0081 events1 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Diabetes mellitus
Metabolism and nutrition disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0090 events0 affected5 at risk
EG0101 events1 affected8 at risk
Hypercholesterolaemia
Metabolism and nutrition disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected8 at risk
EG0031 events1 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0061 events1 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected8 at risk
EG0081 events1 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected8 at risk
EG0041 events1 affected7 at risk
EG0050 events0 affected7 at risk
EG0061 events1 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected8 at risk
EG0081 events1 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Salt craving
Metabolism and nutrition disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected13 at risk
EG0022 events2 affected8 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected7 at risk
EG0052 events1 affected7 at risk
EG0061 events1 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected13 at risk
EG0021 events1 affected8 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected8 at risk
EG0041 events1 affected7 at risk
EG0052 events1 affected7 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Bursitis
Musculoskeletal and connective tissue disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected8 at risk
EG0031 events1 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0061 events1 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Intervertebral disc protrusion
Musculoskeletal and connective tissue disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected8 at risk
EG0041 events1 affected7 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0091 events1 affected5 at risk
EG0100 events0 affected8 at risk
Joint swelling
Musculoskeletal and connective tissue disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected8 at risk
EG0031 events1 affected8 at risk
EG0041 events1 affected7 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Monarthritis
Musculoskeletal and connective tissue disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0091 events1 affected5 at risk
EG0100 events0 affected8 at risk
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 14.1
Systematic Assessment
EG0001 events1 affected5 at risk
EG0012 events2 affected13 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected13 at risk
EG0021 events1 affected8 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected8 at risk
EG0031 events1 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0061 events1 affected9 at risk
EG0070 events0 affected8 at risk
EG0081 events1 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected9 at risk
EG0071 events1 affected8 at risk
EG0080 events0 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 14.1
Systematic Assessment
EG0001 events1 affected5 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0091 events1 affected5 at risk
EG0100 events0 affected8 at risk
Plantar fasciitis
Musculoskeletal and connective tissue disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Melanocytic naevus
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Seborrhoeic keratosis
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected9 at risk
EG0071 events1 affected8 at risk
EG0080 events0 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Balance disorder
Nervous system disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected13 at risk
EG0021 events1 affected8 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected7 at risk
EG0052 events1 affected7 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Cerebral haemorrhage
Nervous system disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0061 events1 affected9 at risk
EG0070 events0 affected8 at risk
EG0081 events1 affected8 at risk
EG0090 events0 affected5 at risk
EG0101 events1 affected8 at risk
Cerebral microhaemorrhage
Nervous system disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0061 events1 affected9 at risk
EG0070 events0 affected8 at risk
EG0081 events1 affected8 at risk
EG0091 events1 affected5 at risk
EG0101 events1 affected8 at risk
Decreased vibratory sense
Nervous system disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected8 at risk
EG0081 events1 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Dizziness
Nervous system disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected8 at risk
EG0031 events1 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0062 events2 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0093 events1 affected5 at risk
EG0100 events0 affected8 at risk
Glabellar reflex abnormal
Nervous system disorders
MedDRA 14.1
Systematic Assessment
EG0001 events1 affected5 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Headache
Nervous system disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected13 at risk
EG0021 events1 affected8 at risk
EG0032 events1 affected8 at risk
EG0041 events1 affected7 at risk
EG0056 events3 affected7 at risk
EG0063 events3 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0095 events3 affected5 at risk
EG0100 events0 affected8 at risk
Hyporeflexia
Nervous system disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected8 at risk
EG0081 events1 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Intention tremor
Nervous system disorders
MedDRA 14.1
Systematic Assessment
EG0001 events1 affected5 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected8 at risk
EG0031 events1 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Mental impairment
Nervous system disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected13 at risk
EG0022 events2 affected8 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Neuropathy peripheral
Nervous system disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0090 events0 affected5 at risk
EG0101 events1 affected8 at risk
Parosmia
Nervous system disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected8 at risk
EG0031 events1 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Restless legs syndrome
Nervous system disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected8 at risk
EG0081 events1 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Sinus headache
Nervous system disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected8 at risk
EG0031 events1 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Somnolence
Nervous system disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0091 events1 affected5 at risk
EG0100 events0 affected8 at risk
Syncope
Nervous system disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected8 at risk
EG0081 events1 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Tremor
Nervous system disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected13 at risk
EG0021 events1 affected8 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Abnormal dreams
Psychiatric disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0061 events1 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Agitation
Psychiatric disorders
MedDRA 14.1
Systematic Assessment
EG0001 events1 affected5 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected8 at risk
EG0031 events1 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0061 events1 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0091 events1 affected5 at risk
EG0100 events0 affected8 at risk
Anxiety
Psychiatric disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0012 events2 affected13 at risk
EG0021 events1 affected8 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0062 events2 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0092 events1 affected5 at risk
EG0101 events1 affected8 at risk
Confusional state
Psychiatric disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected13 at risk
EG0021 events1 affected8 at risk
EG0031 events1 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected8 at risk
EG0082 events2 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Daydreaming
Psychiatric disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected9 at risk
EG0071 events1 affected8 at risk
EG0080 events0 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Delirium
Psychiatric disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected13 at risk
EG0021 events1 affected8 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0061 events1 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Depressed mood
Psychiatric disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected8 at risk
EG0031 events1 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Depression
Psychiatric disorders
MedDRA 14.1
Systematic Assessment
EG0001 events1 affected5 at risk
EG0011 events1 affected13 at risk
EG0021 events1 affected8 at risk
EG0032 events2 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0061 events1 affected9 at risk
EG0071 events1 affected8 at risk
EG0081 events1 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Depressive symptom
Psychiatric disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Hallucination
Psychiatric disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected13 at risk
EG0021 events1 affected8 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Hallucination, visual
Psychiatric disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Insomnia
Psychiatric disorders
MedDRA 14.1
Systematic Assessment
EG0001 events1 affected5 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected8 at risk
EG0041 events1 affected7 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected9 at risk
EG0071 events1 affected8 at risk
EG0080 events0 affected8 at risk
EG0090 events0 affected5 at risk
EG0101 events1 affected8 at risk
Mental status changes
Psychiatric disorders
MedDRA 14.1
Systematic Assessment
EG0001 events1 affected5 at risk
EG0010 events0 affected13 at risk
EG0021 events1 affected8 at risk
EG0031 events1 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0092 events2 affected5 at risk
EG0100 events0 affected8 at risk
Psychotic disorder
Psychiatric disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected8 at risk
EG0081 events1 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Restlessness
Psychiatric disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected9 at risk
EG0071 events1 affected8 at risk
EG0081 events1 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Acute prerenal failure
Renal and urinary disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0061 events1 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Pollakiuria
Renal and urinary disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected13 at risk
EG0021 events1 affected8 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Renal failure chronic
Renal and urinary disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected8 at risk
EG0081 events1 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Urinary incontinence
Renal and urinary disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0091 events1 affected5 at risk
EG0100 events0 affected8 at risk
Benign prostatic hyperplasia
Reproductive system and breast disorders
MedDRA 14.1
Systematic Assessment
EG0001 events1 affected5 at risk
EG0010 events0 affected13 at risk
EG0021 events1 affected8 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Erectile dysfunction
Reproductive system and breast disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Allergic sinusitis
Respiratory, thoracic and mediastinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected13 at risk
EG0022 events1 affected8 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0061 events1 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected8 at risk
EG0031 events1 affected8 at risk
EG0041 events1 affected7 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected9 at risk
EG0071 events1 affected8 at risk
EG0080 events0 affected8 at risk
EG0091 events1 affected5 at risk
EG0100 events0 affected8 at risk
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected13 at risk
EG0021 events1 affected8 at risk
EG0031 events1 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Hiccups
Respiratory, thoracic and mediastinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected13 at risk
EG0021 events1 affected8 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0091 events1 affected5 at risk
EG0100 events0 affected8 at risk
Nasal discomfort
Respiratory, thoracic and mediastinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0061 events1 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0091 events1 affected5 at risk
EG0100 events0 affected8 at risk
Respiratory tract congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected8 at risk
EG0041 events1 affected7 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected8 at risk
EG0081 events1 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
MedDRA 14.1
Systematic Assessment
EG0001 events1 affected5 at risk
EG0010 events0 affected13 at risk
EG0021 events1 affected8 at risk
EG0031 events1 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected8 at risk
EG0031 events1 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected9 at risk
EG0071 events1 affected8 at risk
EG0080 events0 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Sinus congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0012 events1 affected13 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0093 events1 affected5 at risk
EG0100 events0 affected8 at risk
Upper respiratory tract congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 14.1
Systematic Assessment
EG0001 events1 affected5 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Upper-airway cough syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0061 events1 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Alopecia
Skin and subcutaneous tissue disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0061 events1 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Dermatitis
Skin and subcutaneous tissue disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Dermatitis contact
Skin and subcutaneous tissue disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected9 at risk
EG0071 events1 affected8 at risk
EG0080 events0 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Dry skin
Skin and subcutaneous tissue disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected8 at risk
EG0081 events1 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Ecchymosis
Skin and subcutaneous tissue disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0061 events1 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0092 events1 affected5 at risk
EG0100 events0 affected8 at risk
Hair disorder
Skin and subcutaneous tissue disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Hypertrichosis
Skin and subcutaneous tissue disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Petechiae
Skin and subcutaneous tissue disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0061 events1 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Pruritus generalised
Skin and subcutaneous tissue disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Psoriasis
Skin and subcutaneous tissue disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0061 events1 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Rash
Skin and subcutaneous tissue disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected8 at risk
EG0031 events1 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Rash papular
Skin and subcutaneous tissue disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected7 at risk
EG0051 events1 affected7 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Skin lesion
Skin and subcutaneous tissue disorders
MedDRA 14.1
Systematic Assessment
EG0001 events1 affected5 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Urticaria
Skin and subcutaneous tissue disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0061 events1 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Haematoma
Vascular disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected9 at risk
EG0071 events1 affected8 at risk
EG0080 events0 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Hot flush
Vascular disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
Hypertension
Vascular disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected8 at risk
EG0041 events1 affected7 at risk
EG0050 events0 affected7 at risk
EG0062 events2 affected9 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected8 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected8 at risk
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
The Sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the SPONSOR as confidential must be deleted prior to submission.