A Study of LY3002813 in Participants With Memory Damage D... | NCT02624778 | Trialant
NCT02624778
Sponsor
Eli Lilly and Company
Status
Completed
Last Update Posted
Oct 8, 2024Actual
Enrollment
61Actual
Phase
Phase 1
Conditions
Alzheimer Disease
Interventions
LY3002813
Placebo
Countries
United States
Japan
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
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Derived Section
Miscellaneous Info Module
Version Holder
NCT02624778
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
16233
Secondary IDs
ID
Type
Description
Link
I5T-MC-AACD
Other Identifier
Eli Lilly and Company
Brief Title
A Study of LY3002813 in Participants With Memory Damage Due to Alzheimer's Disease (AD) or AD
Official Title
A Single- and Multiple-Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Intravenous Doses of LY3002813 in Patients With Mild Cognitive Impairment Due to Alzheimer's Disease or Mild to Moderate Alzheimer's Disease
Acronym
Not provided
Organization
Eli Lilly and CompanyINDUSTRY
Status Module
Record Verification Date
Jul 2024
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Dec 22, 2015Actual
Primary Completion Date
Aug 28, 2019Actual
Completion Date
Aug 28, 2019Actual
First Submitted Date
Dec 4, 2015
First Submission Date that Met QC Criteria
Dec 4, 2015
First Posted Date
Dec 8, 2015Estimated
Results Waived
Not provided
Results First Submitted Date
Jul 8, 2024
Results First Submitted that Met QC Criteria
Jul 8, 2024
Results First Posted Date
Oct 8, 2024Actual
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
Jul 8, 2024
Last Update Posted Date
Oct 8, 2024Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Eli Lilly and CompanyINDUSTRY
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 study will evaluate the effect of LY3002813 on brain scans. The study will evaluate the safety of LY3002813 by looking at adverse events (side effects). The study will also look at the effect the body has on LY3002813. Study participants will have mild cognitive impairment (MCI) due to AD or mild to moderate AD.
The study involves 3 parts.
Part A in which participants will receive a single dose of LY3002813 or placebo (no drug).
Part B in which participants will receive multiple doses of LY3002813 or placebo for 24 weeks.
Part C in which participants will receive multiple doses of LY3002813 or placebo for up to 72 weeks.
Drug will be given as an intravenous infusion (injection into a vein). For Parts A, B and C, the study will last approximately 72 weeks, not including screening of approximately 56 days. The study is for research purposes only and is not intended to treat any medical condition.
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
61Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Part A: Placebo Single Dose (SD)
Placebo Comparator
Participants received single intravenous (IV) dose of placebo.
Drug: Placebo
Part A: 10 Milligram Per Kilogram (mg/kg) LY3002813 SD
Experimental
Participants received single IV dose of 10 mg/kg LY3002813.
Biological: LY3002813
Part A: 20 mg/kg LY3002813 SD
Experimental
Participants received single IV dose of 20 mg/kg LY3002813.
Biological: LY3002813
Part A: 40 mg/kg LY3002813 SD
Experimental
Participants received single IV dose of 40 mg/kg LY3002813.
Biological: LY3002813
Part B: Placebo Q2W
Placebo Comparator
Participants received multiple IV dose of placebo every 2 weeks (Q2W) for 24 weeks.
Drug: Placebo
Part B: 10 mg/kg LY3002813 Q2W
Experimental
Interventions
Name
Type
Description
Arm Group Labels
Other Names
LY3002813
Biological
Administered IV
Part A: 10 Milligram Per Kilogram (mg/kg) LY3002813 SD
Part A: 20 mg/kg LY3002813 SD
Part A: 40 mg/kg LY3002813 SD
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Change From Baseline in Florbetapir Positron Emission Tomography (PET) Scan Standard Uptake Value Ratio (SUVr)
Florbetapir PET imaging was used to confirm the presence of amyloid pathology consistent with AD. Change from baseline was done to test the hypothesis that amyloid burden was reduced in participants in the treatment group. The change from baseline to the postbaseline visit of the composite summary standard uptake value ratio of florbetapir F18 was calculated. Least square (LS) mean value was controlled for baseline value, baseline age, pooled investigator, treatment and visit. The composite summary measure is an unweighted average of the 6 smaller regions (anterior cingulate, frontal medial orbital, parietal, posterior cingulate, precuneus, and temporal) normalized to whole cerebellum or subject-specific white matter.
Baseline, Week 72
Secondary Outcomes
Measure
Description
Time Frame
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-tlast)] in Part A
Area under the curve from time zero to last quantifiable concentration [AUC (0-tlast)] at day 1 was reported.
Predose, end of infusion, 3, 24 and 48 hours postdose
Pharmacokinetics (PK): Area Under the Concentration Curve Versus Time at a Dosing Interval (AUCtau) at Day 1 of LY3002813 in Part B and Part C
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Present with mild cognitive impairment (MCI) due to Alzheimer's disease (AD) or mild-to-moderate AD
Men or nonfertile women, at least 50 years of age. Nonfertile is defined as hysterectomy and/or bilateral oophorectomy, or amenorrhea for at least 1 year
Have up to 2 partners who will provide a separate written informed consent to participate
Have adequate vision and hearing for neuropsychological testing in the opinion of the investigator
Positive florbetapir scan
Exclusion Criteria:
Do not have up to 2 reliable partners who are in frequent contact with the participant, who will accompany the participant to the office and/or be available by telephone at designated times, and will monitor administration of prescribed medications
Are being monitored for radiation due to occupational exposure to ionized radiation, or exposure to ionizing radiation within last 12 months from an investigational study
History of intracranial hemorrhage, cerebrovascular aneurysm or arteriovenous malformation, or carotid artery occlusion, or stroke or epilepsy
Have any contraindications for magnetic resonance imaging (MRI) studies, including claustrophobia, the presence of contraindicated metal (ferromagnetic) implants, cardiac pacemaker
Have allergies to humanized monoclonal antibodies, including proteins and diphenhydramine, epinephrine, and methylprednisolone
Have gamma globulin therapy within the last year
Previously dosed in any other study investigating active immunization against amyloid beta (Aβ)
Previously dosed in any other study investigating passive immunization against Aβ within the last 6 months
Have current serious or unstable illnesses
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
50 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Participants received single intravenous (IV) dose of placebo.
FG001
Part A: 10 Milligram Per Kilogram (mg/kg) LY3002813 SD
Participants received single IV dose of 10 mg/kg LY3002813.
FG002
Part A: 20 mg/kg LY3002813 SD
Participants received single IV dose of 20 mg/kg LY3002813.
FG003
Part A: 40 mg/kg LY3002813 SD
Participants received single IV dose of 40 mg/kg LY3002813.
FG004
Part B: Placebo Q2W
Participants received multiple IV doses of placebo every 2 weeks (Q2W) for 24 weeks.
FG005
Part B: 10 mg/kg LY3002813 Q2W
Participants received multiple IV doses of 10 mg/kg LY3002813 Q2W for 24 weeks.
FG006
Part C: Placebo Q4W
Participants received multiple IV doses of placebo every 4 weeks (Q4W) for 72 weeks.
FG007
Part C:10 mg/kg LY3002813 Q4W
Participants received multiple IV doses of 10 mg/kg LY3002813 Q4W for 72 weeks.
FG008
Part C:20 mg/kg LY3002813 Q4W
Participants received multiple IV doses of 20 mg/kg LY3002813 Q4W for 72 weeks.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
FG0007 subjects
FG0017 subjects
FG0027 subjects
FG0034 subjects
FG0043 subjects
FG00510 subjects
FG0065 subjects
FG0078 subjects
FG00810 subjects
Received at Least 1 Dose of Study Drug
FG0007 subjects
FG0017 subjects
FG0027 subjects
FG0034 subjects
COMPLETED
FG0007 subjects
FG0016 subjects
FG0026 subjects
FG0034 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0011 subjects
FG0021 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG003
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Part A: Placebo Single Dose (SD)
Participants received single intravenous (IV) dose of placebo.
BG001
Part A: 10 mg/kg LY3002813 SD
Participants received single IV dose of 10 mg/kg LY3002813.
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
Change From Baseline in Florbetapir Positron Emission Tomography (PET) Scan Standard Uptake Value Ratio (SUVr)
Florbetapir PET imaging was used to confirm the presence of amyloid pathology consistent with AD. Change from baseline was done to test the hypothesis that amyloid burden was reduced in participants in the treatment group. The change from baseline to the postbaseline visit of the composite summary standard uptake value ratio of florbetapir F18 was calculated. Least square (LS) mean value was controlled for baseline value, baseline age, pooled investigator, treatment and visit. The composite summary measure is an unweighted average of the 6 smaller regions (anterior cingulate, frontal medial orbital, parietal, posterior cingulate, precuneus, and temporal) normalized to whole cerebellum or subject-specific white matter.
All randomized participants who received at least 1 dose of study drug and had baseline and post baseline scan data.
Posted
Least Squares Mean
Standard Error
standard uptake value ratio (SUVr)
Baseline, Week 72
ID
Title
Description
Adverse Events Module
Frequency Threshold
5
Time Frame
Baseline Upto 584 Days
Description
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Participants received multiple IV dose of 10 mg/kg LY3002813 Q2W for 24 weeks.
Biological: LY3002813
Part C: Placebo Q4W
Placebo Comparator
Participants received multiple IV dose of placebo every 4 weeks (Q4W) for 72 weeks.
Drug: Placebo
Part C:10 mg/kg LY3002813 Q4W
Experimental
Participants received multiple IV dose of 10 mg/kg LY3002813 Q4W for 72 weeks.
Biological: LY3002813
Part C:20 mg/kg LY3002813 Q4W
Experimental
Participants received multiple IV dose of 20 mg/kg LY3002813 Q4W for 72 weeks.
Biological: LY3002813
Part B: 10 mg/kg LY3002813 Q2W
Part C:10 mg/kg LY3002813 Q4W
Part C:20 mg/kg LY3002813 Q4W
Placebo
Drug
Administered IV
Part A: Placebo Single Dose (SD)
Part B: Placebo Q2W
Part C: Placebo Q4W
Area under the concentration versus time curve during one dosing interval at day 1 was reported.
Predose, end of infusion, 3, 24, 48 and 72 hours postdose
PK:Area Under the Concentration Curve Versus Time at a Dosing Interval at Steady State (AUCtau,ss) of LY3002813 in Part B and C
AUCtau of LY3002813 at steady state (Day 127 [10 mg/kg Q2W] for part B and Day 141 [10 mg/kg and 20 mg/kg Q4W]) for Part C following multiple dose administration of LY3002813 was evaluated.
Part B (Day 127): predose, end of infusion, 3, 24, 48 and 72 hours postdose; Part C (Day 141): predose, end of infusion, 3, 24, 48 and 72 hours postdose
PK: Maximum Serum Concentration (Cmax) of LY3002813 at Day 1 of LY3002813
Maximum serum concentration of LY3002813 during one dosing interval at day 1 was reported.
Part A: Predose, end of infusion, 3, 24 and 48 hours postdose; Part B and C: Predose, end of infusion, 3, 24, 48 and 72 hours postdose
PK: Maximum Serum Concentration (Cmax) of LY3002813 at Steady State of LY3002813 in Part B and C
Cmax of LY3002813 at steady state (Day 127 [10 mg/kg Q2W] for part B and Day 141 [10 mg/kg and 20 mg/kg Q4W]) for Part C following multiple dose administration of LY3002813 was evaluated.
Part B (Day 127): predose, end of infusion, 3, 24, 48 and 72 hours postdose; Part C (Day 141): predose, end of infusion, 3, 24, 48 and 72 hours postdose
Percentage of Participants With Treatment-Emergent Anti-Drug Antibodies (TE-ADAs) to LY3002813
Blood samples were tested to determine if a participant reacted to LY3002813 by producing anti-LY3002813 antibodies. Samples were identified as TE-ADAs if the post-treatment sample had an increase of at least 4 fold in titer from pre-treatment values. If the pre-treatment value was not detected or was not present, a 1:20 post-treatment titer was required to indicate treatment emergence. The percentage of participants with TE ADA was calculated as: (the number of participants with TE ADA / total number of participants with at least 1 post-treatment immunogenicity sample analyzed)*100.
Predose up to Day 589
Orlando
Florida
32806
United States
Compass Research
The Villages
Florida
32162
United States
SNBL Clinical Pharmacology Center Inc
Baltimore
Maryland
21201
United States
St. Louis Clinical Trials, LC
St Louis
Missouri
63141
United States
PRA Health Sciences
Salt Lake City
Utah
84106
United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Shinjuku-Ku
162-0053
Japan
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
Shinjuku-Ku
169-0073
Japan
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
Sumida-ku
130-0004
Japan
FG004
3 subjects
FG00510 subjects
FG0065 subjects
FG0078 subjects
FG00810 subjects
3 subjects
FG0059 subjects
FG0063 subjects
FG0074 subjects
FG0084 subjects
0 subjects
FG0051 subjects
FG0062 subjects
FG0074 subjects
FG0086 subjects
0 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
Withdrawal by Subject
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0051 subjects
FG0061 subjects
FG0071 subjects
FG0081 subjects
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0082 subjects
Death
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0061 subjects
FG0070 subjects
FG0080 subjects
Physician Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0073 subjects
FG0083 subjects
BG002
Part A: 20 mg/kg LY3002813 SD
Participants received single IV dose of 20 mg/kg LY3002813.
BG003
Part A: 40 mg/kg LY3002813 SD
Participants received single IV dose of 40 mg/kg LY3002813.
BG004
Part B: Placebo Q2W
Participants received multiple IV doses of placebo every 2 weeks (Q2W) for 24 weeks.
BG005
Part B: 10 mg/kg LY3002813 Q2W
Participants received multiple IV doses of 10 mg/kg LY3002813 Q2W for 24 weeks.
BG006
Part C: Placebo Q4W
Participants received multiple IV doses of placebo every 4 weeks (Q4W) for 72 weeks.
BG007
Part C:10 mg/kg LY3002813 Q4W
Participants received multiple IV doses of 10 mg/kg LY3002813 Q4W for 72 weeks.
BG008
Part C:20 mg/kg LY3002813 Q4W
Participants received multiple IV doses of 20 mg/kg LY3002813 Q4W for 72 weeks.
BG009
Total
Total of all reporting groups
7
BG0017
BG0027
BG0034
BG0043
BG00510
BG0065
BG0078
BG00810
BG00961
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00079.6± 7.7
BG00178.3± 8.4
BG00275.6± 6.4
BG00375.3± 6.7
BG00465.7± 4.9
BG00566.8± 8.6
BG00672.6± 12.2
BG00773.0± 7.8
BG00871.7± 9.2
BG00973.2± 8.9
Sex: Female, Male
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Female
BG0006
BG0014
BG0023
BG0032
BG0042
BG0054
BG0063
BG0074
BG0086
BG00934
Male
BG0001
BG0013
BG0024
BG0032
BG004
Ethnicity (NIH/OMB)
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0000
BG0010
BG0020
BG0030
BG0040
BG0051
BG0060
BG0070
BG0081
BG0092
Not Hispanic or Latino
BG0007
BG0017
BG0027
BG0034
BG004
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG004
Race (NIH/OMB)
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
Asian
BG0002
BG0012
BG0021
BG0032
BG004
Native Hawaiian or Other Pacific Islander
BG0000
BG0010
BG0020
BG0030
BG004
Black or African American
BG0001
BG0010
BG0020
BG0031
BG004
White
BG0004
BG0015
BG0026
BG0031
BG004
More than one race
BG0000
BG0010
BG0020
BG0030
BG004
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG004
Region of Enrollment
Count of Participants
Participants
No
Title
Denominators
Categories
United States
Title
Measurements
BG0005
BG0015
BG0026
BG0032
BG0042
BG0057
BG0063
BG0075
BG0088
BG00943
Japan
Title
Measurements
BG0002
BG0012
BG0021
BG003
OG000
Part A,B and C: Placebo
Participants received single or multiple IV doses of placebo.
OG001
Part A: 10 mg/kg LY3002813 SD
Participants received single IV dose of 10 mg/kg LY3002813.
OG002
Part A: 20 mg/kg LY3002813 SD
Participants received single IV dose of 20 mg/kg LY3002813.
OG003
Part A: 40 mg/kg LY3002813 SD
Participants received single IV dose of 40 mg/kg LY3002813.
OG004
Part B: 10 mg/kg LY3002813 Q2W
Participants received multiple IV doses of 10 mg/kg LY3002813 Q2W for 24 weeks.
OG005
Part C:10 mg/kg LY3002813 Q4W
Participants received multiple IV doses of 10 mg/kg LY3002813 Q4W for 72 weeks.
OG006
Part C:20 mg/kg LY3002813 Q4W
Participants received multiple IV doses of 20 mg/kg LY3002813 Q4W for 72 weeks.
Units
Counts
Participants
OG00011
OG0016
OG0026
OG0031
OG0049
OG0054
OG0064
Title
Denominators
Categories
Title
Measurements
OG000-0.050± 0.04
OG001-0.122± 0.06
OG002-0.183± 0.06
OG003-0.255± 0.10
OG004-0.305± 0.05
OG005-0.419± 0.06
OG006-0.379± 0.05
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Mixed Models Analysis
0.309
LS Mean
-0.071
Standard Error of the Mean
0.07
2-Sided
95
-0.21
0.07
Superiority
OG000
OG002
Mixed Models Analysis
0.061
LS Mean
-0.133
Standard Error of the Mean
0.07
2-Sided
95
-0.27
0.01
Superiority
OG000
OG003
Mixed Models Analysis
0.053
LS Mean
-0.205
Standard Error of the Mean
0.10
2-Sided
95
-0.41
0.00
Superiority
OG000
OG004
Mixed Models Analysis
<0.001
LS Mean
-0.255
Standard Error of the Mean
0.06
2-Sided
95
-0.38
-0.13
Superiority
OG000
OG005
Mixed Models Analysis
<0.001
LS Mean
-0.369
Standard Error of the Mean
0.07
2-Sided
95
-0.51
-0.23
Superiority
OG000
OG006
Mixed Models Analysis
<0.001
LS Mean
-0.329
Standard Error of the Mean
0.07
2-Sided
95
-0.46
-0.20
Superiority
Secondary
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-tlast)] in Part A
Area under the curve from time zero to last quantifiable concentration [AUC (0-tlast)] at day 1 was reported.
All randomized participants from part A who received at least one dose of study drug and had evaluable PK data.
Posted
Geometric Mean
Geometric Coefficient of Variation
microgram*hour per milliliter(μg*hr/mL)
Predose, end of infusion, 3, 24 and 48 hours postdose
ID
Title
Description
OG000
Part A: 10 mg/kg LY3002813 SD
Participants received single IV dose of 10 mg/kg LY3002813.
OG001
Part A: 20 mg/kg LY3002813 SD
Participants received single IV dose of 20 mg/kg LY3002813.
OG002
Part A: 40 mg/kg LY3002813 SD
Participants received single IV dose of 40 mg/kg LY3002813.
Units
Counts
Participants
OG0007
OG0017
OG0024
Title
Denominators
Categories
Title
Measurements
OG00025700± 20
OG00159400± 19
OG002110000± 32
Secondary
Pharmacokinetics (PK): Area Under the Concentration Curve Versus Time at a Dosing Interval (AUCtau) at Day 1 of LY3002813 in Part B and Part C
Area under the concentration versus time curve during one dosing interval at day 1 was reported.
All randomized participants from part B and part C who received at least one dose of study drug and had evaluable PK data.
Posted
Geometric Mean
Geometric Coefficient of Variation
microgram*hour per milliliter (μg*hr/mL)
Predose, end of infusion, 3, 24, 48 and 72 hours postdose
ID
Title
Description
OG000
Part B: 10 mg/kg LY3002813 Q2W
Participants received multiple IV doses of 10 mg/kg LY3002813 Q2W for 24 weeks.
OG001
Part C:10 mg/kg LY3002813 Q4W
Participants received multiple IV doses of 10 mg/kg LY3002813 Q4W for 72 weeks.
OG002
Part C:20 mg/kg LY3002813 Q4W
Participants received multiple IV doses of 20 mg/kg LY3002813 Q4W for 72 weeks.
Units
Counts
Participants
OG0009
OG0018
OG00210
Title
Denominators
Categories
Title
Measurements
OG00023000± 22
OG00132900± 35
OG00258900± 22
Secondary
PK:Area Under the Concentration Curve Versus Time at a Dosing Interval at Steady State (AUCtau,ss) of LY3002813 in Part B and C
AUCtau of LY3002813 at steady state (Day 127 [10 mg/kg Q2W] for part B and Day 141 [10 mg/kg and 20 mg/kg Q4W]) for Part C following multiple dose administration of LY3002813 was evaluated.
All randomized participants from part B and part C who received at least one dose of study drug and had evaluable PK data.
Posted
Geometric Mean
Geometric Coefficient of Variation
μg*hr/mL
Part B (Day 127): predose, end of infusion, 3, 24, 48 and 72 hours postdose; Part C (Day 141): predose, end of infusion, 3, 24, 48 and 72 hours postdose
ID
Title
Description
OG000
Part B: 10 mg/kg LY3002813 Q2W
Participants received multiple IV doses of 10 mg/kg LY3002813 Q2W for 24 weeks.
OG001
Part C:10 mg/kg LY3002813 Q4W
Participants received multiple IV doses of 10 mg/kg LY3002813 Q4W for 72 weeks.
OG002
Part C:20 mg/kg LY3002813 Q4W
Participants received multiple IV doses of 20 mg/kg LY3002813 Q4W for 72 weeks.
Units
Counts
Participants
OG0004
OG0016
OG0027
Title
Denominators
Categories
Title
Measurements
OG00029700± 68
OG00135800± 61
OG00268400± 37
Secondary
PK: Maximum Serum Concentration (Cmax) of LY3002813 at Day 1 of LY3002813
Maximum serum concentration of LY3002813 during one dosing interval at day 1 was reported.
All randomized participants who received at least one dose of study drug and had evaluable PK data.
Posted
Geometric Mean
Geometric Coefficient of Variation
microgram per milliliter (μg/mL)
Part A: Predose, end of infusion, 3, 24 and 48 hours postdose; Part B and C: Predose, end of infusion, 3, 24, 48 and 72 hours postdose
ID
Title
Description
OG000
Part A: 10 mg/kg LY3002813 SD
Participants received single IV dose of 10 mg/kg LY3002813.
OG001
Part A: 20 mg/kg LY3002813 SD
Participants received single IV dose of 20 mg/kg LY3002813.
OG002
Part A: 40 mg/kg LY3002813 SD
Participants received single IV dose of 40 mg/kg LY3002813.
OG003
Part B: 10 mg/kg LY3002813 Q2W
Participants received multiple IV doses of 10 mg/kg LY3002813 Q2W for 24 weeks.
OG004
Part C:10 mg/kg LY3002813 Q4W
Participants received multiple IV doses of 10 mg/kg LY3002813 Q4W for 72 weeks.
OG005
Part C:20 mg/kg LY3002813 Q4W
Participants received multiple IV doses of 20 mg/kg LY3002813 Q4W for 72 weeks.
Units
Counts
Participants
OG0007
OG0017
OG0024
OG003
Title
Denominators
Categories
Title
Measurements
OG000196± 17
OG001413± 17
OG002910± 15
OG003
Secondary
PK: Maximum Serum Concentration (Cmax) of LY3002813 at Steady State of LY3002813 in Part B and C
Cmax of LY3002813 at steady state (Day 127 [10 mg/kg Q2W] for part B and Day 141 [10 mg/kg and 20 mg/kg Q4W]) for Part C following multiple dose administration of LY3002813 was evaluated.
All randomized participants from part B and C who received at least one dose of study drug and had evaluable PK data.
Posted
Geometric Mean
Geometric Coefficient of Variation
μg/mL
Part B (Day 127): predose, end of infusion, 3, 24, 48 and 72 hours postdose; Part C (Day 141): predose, end of infusion, 3, 24, 48 and 72 hours postdose
ID
Title
Description
OG000
Part B: 10 mg/kg LY3002813 Q2W
Participants received multiple IV doses of 10 mg/kg LY3002813 Q2W for 24 weeks.
OG001
Part C:10 mg/kg LY3002813 Q4W
Participants received multiple IV doses of 10 mg/kg LY3002813 Q4W for 72 weeks.
OG002
Part C:20 mg/kg LY3002813 Q4W
Participants received multiple IV doses of 20 mg/kg LY3002813 Q4W for 72 weeks.
Units
Counts
Participants
OG0004
OG0016
OG0027
Title
Denominators
Categories
Title
Measurements
OG000273± 23
OG001366± 44
OG002598± 23
Secondary
Percentage of Participants With Treatment-Emergent Anti-Drug Antibodies (TE-ADAs) to LY3002813
Blood samples were tested to determine if a participant reacted to LY3002813 by producing anti-LY3002813 antibodies. Samples were identified as TE-ADAs if the post-treatment sample had an increase of at least 4 fold in titer from pre-treatment values. If the pre-treatment value was not detected or was not present, a 1:20 post-treatment titer was required to indicate treatment emergence. The percentage of participants with TE ADA was calculated as: (the number of participants with TE ADA / total number of participants with at least 1 post-treatment immunogenicity sample analyzed)*100.
All randomized participants who received at least one dose of study drug & had least one non-missing test result for ADA for each of the baseline period and the post-baseline period.
Posted
Number
percentage of participants
Predose up to Day 589
ID
Title
Description
OG000
Part A,B and C: Placebo
Participants received single or multiple IV doses of placebo.
OG001
10 mg/kg LY3002813 IV SD
Participants received single IV dose of 10 mg/kg LY3002813.
OG002
20 mg/kg LY3002813 IV SD
Participants received single IV dose of 20 mg/kg LY3002813.
OG003
40 mg/kg LY3002813 IV SD
Participants received single IV dose of 40 mg/kg LY3002813.
OG004
10 mg/kg LY3002813 IV Q2W
Participants received multiple IV doses of 10 mg/kg LY3002813 Q2W for 24 weeks.
OG005
10 mg/kg LY3002813 IV Q4W
Participants received multiple IV doses of 10 mg/kg LY3002813 Q4W for 72 weeks.
OG006
20 mg/kg LY3002813 IV Q4W
Participants received multiple IV doses of 20 mg/kg LY3002813 Q4W for 72 weeks.
Units
Counts
Participants
OG00015
OG0017
OG0027
OG003
Title
Denominators
Categories
Title
Measurements
OG00013.3
OG00185.7
OG002100.0
OG003
7
2
7
5
7
EG001
Part A: 10 mg/kg LY3002813 SD
Participants received single IV dose of 10 mg/kg LY3002813.
0
7
0
7
7
7
EG002
Part A: 20 mg/kg LY3002813 SD
Participants received single IV dose of 20 mg/kg LY3002813.
0
7
0
7
6
7
EG003
Part A: 40 mg/kg LY3002813 SD
Participants received single IV dose of 40 mg/kg LY3002813.
0
4
0
4
4
4
EG004
Part B: Placebo Q2W
Participants received multiple IV doses of placebo Q2W for 24 weeks.
0
3
0
3
2
3
EG005
Part B: 10 mg/kg LY3002813 Q2W
Participants received multiple IV doses of 10 mg/kg LY3002813 Q2W for 24 weeks.
0
10
0
10
10
10
EG006
Part C: Placebo Q4W
Participants received multiple IV doses of placebo Q4W for 72 weeks.
1
5
1
5
4
5
EG007
Part C:10 mg/kg LY3002813 Q4W
Participants received multiple IV doses of 10 mg/kg LY3002813 Q4W for 72 weeks
0
8
1
8
8
8
EG008
Part C:20 mg/kg LY3002813 Q4W
Participants received multiple IV doses of 20 mg/kg LY3002813 Q4W for 72 weeks.
0
10
2
10
9
10
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected10 at risk
EG0061 events1 affected5 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected10 at risk
Decreased activity
General disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected10 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected8 at risk
EG0081 events1 affected10 at risk
Urinary tract infection
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected10 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected8 at risk
EG0081 events1 affected10 at risk
Hip fracture
Injury, poisoning and procedural complications
MedDRA 18.1
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected10 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected10 at risk
Invasive lobular breast carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected2 at risk
EG0040 events0 affected2 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected6 at risk
Vasogenic cerebral oedema
Nervous system disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected10 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected8 at risk
EG0081 events1 affected10 at risk
Anger
Psychiatric disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected10 at risk
EG0060 events0 affected5 at risk
EG0071 events1 affected8 at risk
EG0080 events0 affected10 at risk
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected10 at risk
EG0060 events0 affected5 at risk
EG0071 events1 affected8 at risk
EG0080 events0 affected10 at risk
Lymphadenopathy
Blood and lymphatic system disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected10 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected8 at risk
EG0081 events1 affected10 at risk
Atrial fibrillation
Cardiac disorders
MedDRA 18.1
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected10 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected10 at risk
Bradycardia
Cardiac disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected10 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected8 at risk
EG0082 events1 affected10 at risk
Bundle branch block right
Cardiac disorders
MedDRA 18.1
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected10 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected10 at risk
Nodal rhythm
Cardiac disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected10 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected10 at risk
Supraventricular extrasystoles
Cardiac disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected10 at risk
EG0060 events0 affected5 at risk
EG0071 events1 affected8 at risk
EG0080 events0 affected10 at risk
Tachycardia
Cardiac disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected10 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected10 at risk
Deafness bilateral
Ear and labyrinth disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected7 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected10 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected10 at risk
Conjunctival haemorrhage
Eye disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected10 at risk
EG0060 events0 affected5 at risk
EG0071 events1 affected8 at risk
EG0080 events0 affected10 at risk
Diabetic retinopathy
Eye disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected10 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected10 at risk
Vitreous floaters
Eye disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected10 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected10 at risk
Dental caries
Gastrointestinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected10 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected10 at risk
Faecal incontinence
Gastrointestinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected10 at risk
EG0060 events0 affected5 at risk
EG0071 events1 affected8 at risk
EG0080 events0 affected10 at risk
Haemorrhoidal haemorrhage
Gastrointestinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected10 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected10 at risk
Haemorrhoids thrombosed
Gastrointestinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected10 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected8 at risk
EG0081 events1 affected10 at risk
Large intestine polyp
Gastrointestinal disorders
MedDRA 18.1
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected10 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected10 at risk
Melaena
Gastrointestinal disorders
MedDRA 18.1
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected10 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected10 at risk
Nausea
Gastrointestinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected10 at risk
EG0061 events1 affected5 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected10 at risk
Vomiting
Gastrointestinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected3 at risk
EG0052 events1 affected10 at risk
EG0060 events0 affected5 at risk
EG0071 events1 affected8 at risk
EG0082 events1 affected10 at risk
Asthenia
General disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected7 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected10 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected10 at risk
Chest pain
General disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected10 at risk
EG0061 events1 affected5 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected10 at risk
Decreased activity
General disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected10 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected8 at risk
EG0081 events1 affected10 at risk
Fatigue
General disorders
MedDRA 18.1
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected3 at risk
EG0052 events2 affected10 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected10 at risk
Influenza like illness
General disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected10 at risk
EG0060 events0 affected5 at risk
EG0071 events1 affected8 at risk
EG0080 events0 affected10 at risk
Infusion site bruising
General disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected10 at risk
EG0060 events0 affected5 at risk
EG0071 events1 affected8 at risk
EG0080 events0 affected10 at risk
Infusion site extravasation
General disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected10 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected10 at risk
Infusion site oedema
General disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected10 at risk
EG0060 events0 affected5 at risk
EG0072 events1 affected8 at risk
EG0080 events0 affected10 at risk
Infusion site reaction
General disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected3 at risk
EG0052 events1 affected10 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected10 at risk
Oedema
General disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected10 at risk
EG0060 events0 affected5 at risk
EG0071 events1 affected8 at risk
EG0080 events0 affected10 at risk
Oedema peripheral
General disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected10 at risk
EG0060 events0 affected5 at risk
EG0071 events1 affected8 at risk
EG0081 events1 affected10 at risk
Seasonal allergy
Immune system disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected10 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected10 at risk
Bronchitis
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected10 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected10 at risk
Cellulitis
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected10 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected10 at risk
Conjunctivitis
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected10 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected8 at risk
EG0081 events1 affected10 at risk
Dermatophytosis of nail
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected10 at risk
EG0060 events0 affected5 at risk
EG0071 events1 affected8 at risk
EG0080 events0 affected10 at risk
Gastroenteritis
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected4 at risk
EG0041 events1 affected3 at risk
EG0050 events0 affected10 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected10 at risk
Influenza
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected10 at risk
EG0060 events0 affected5 at risk
EG0071 events1 affected8 at risk
EG0080 events0 affected10 at risk
Mastoiditis
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected10 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected10 at risk
Nasopharyngitis
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected10 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected10 at risk
Pneumonia
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected10 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected10 at risk
Respiratory tract infection viral
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected10 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected10 at risk
Rhinitis
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected10 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected8 at risk
EG0081 events1 affected10 at risk
Sinusitis
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected10 at risk
EG0061 events1 affected5 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected10 at risk
Upper respiratory tract infection
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0002 events2 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected10 at risk
EG0061 events1 affected5 at risk
EG0072 events2 affected8 at risk
EG0081 events1 affected10 at risk
Urinary tract infection
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected7 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected10 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected10 at risk
Viral upper respiratory tract infection
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected7 at risk
EG0031 events1 affected4 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected10 at risk
EG0060 events0 affected5 at risk
EG0071 events1 affected8 at risk
EG0080 events0 affected10 at risk
Contusion
Injury, poisoning and procedural complications
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected10 at risk
EG0060 events0 affected5 at risk
EG0071 events1 affected8 at risk
EG0080 events0 affected10 at risk
Eye contusion
Injury, poisoning and procedural complications
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected10 at risk
EG0060 events0 affected5 at risk
EG0071 events1 affected8 at risk
EG0080 events0 affected10 at risk
Fall
Injury, poisoning and procedural complications
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected3 at risk
EG0052 events1 affected10 at risk
EG0060 events0 affected5 at risk
EG0071 events1 affected8 at risk
EG0080 events0 affected10 at risk
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected10 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected10 at risk
Laceration
Injury, poisoning and procedural complications
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected10 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected10 at risk
Post lumbar puncture syndrome
Injury, poisoning and procedural complications
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected7 at risk
EG0031 events1 affected4 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected10 at risk
EG0061 events1 affected5 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected10 at risk
Procedural anxiety
Injury, poisoning and procedural complications
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected10 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected8 at risk
EG0081 events1 affected10 at risk
Procedural complication
Injury, poisoning and procedural complications
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected10 at risk
EG0060 events0 affected5 at risk
EG0072 events1 affected8 at risk
EG0080 events0 affected10 at risk
Procedural dizziness
Injury, poisoning and procedural complications
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected10 at risk
EG0060 events0 affected5 at risk
EG0071 events1 affected8 at risk
EG0080 events0 affected10 at risk
Procedural haemorrhage
Injury, poisoning and procedural complications
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected10 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected10 at risk
Procedural pain
Injury, poisoning and procedural complications
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected10 at risk
EG0060 events0 affected5 at risk
EG0071 events1 affected8 at risk
EG0080 events0 affected10 at risk
Road traffic accident
Injury, poisoning and procedural complications
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected7 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected10 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected10 at risk
Skin abrasion
Injury, poisoning and procedural complications
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected10 at risk
EG0060 events0 affected5 at risk
EG0071 events1 affected8 at risk
EG0080 events0 affected10 at risk
Soft tissue injury
Injury, poisoning and procedural complications
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected7 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected10 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected10 at risk
Spinal compression fracture
Injury, poisoning and procedural complications
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected10 at risk
EG0060 events0 affected5 at risk
EG0071 events1 affected8 at risk
EG0080 events0 affected10 at risk
Subdural haematoma
Injury, poisoning and procedural complications
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected10 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected10 at risk
Tooth fracture
Injury, poisoning and procedural complications
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected10 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected10 at risk
Blood creatinine increased
Investigations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected10 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected10 at risk
Electrocardiogram qt prolonged
Investigations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected7 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected10 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected10 at risk
Glucose urine present
Investigations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected10 at risk
EG0060 events0 affected5 at risk
EG0071 events1 affected8 at risk
EG0080 events0 affected10 at risk
Hypocholesterolaemia
Metabolism and nutrition disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected7 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected10 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected10 at risk
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA 18.1
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected10 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected10 at risk
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 18.1
Systematic Assessment
EG0002 events1 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected10 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected10 at risk
Vitamin b12 deficiency
Metabolism and nutrition disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected10 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected10 at risk
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected10 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected8 at risk
EG0081 events1 affected10 at risk
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0011 events1 affected7 at risk
EG0021 events1 affected7 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected10 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected8 at risk
EG0081 events1 affected10 at risk
Limb discomfort
Musculoskeletal and connective tissue disorders
MedDRA 18.1
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected10 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected10 at risk
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected10 at risk
EG0060 events0 affected5 at risk
EG0071 events1 affected8 at risk
EG0081 events1 affected10 at risk
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected4 at risk
EG0041 events1 affected3 at risk
EG0050 events0 affected10 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected10 at risk
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected10 at risk
EG0060 events0 affected5 at risk
EG0071 events1 affected8 at risk
EG0080 events0 affected10 at risk
Soft tissue disorder
Musculoskeletal and connective tissue disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected10 at risk
EG0061 events1 affected5 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected10 at risk
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0022 events1 affected7 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected10 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected8 at risk
EG0081 events1 affected10 at risk
Squamous cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected7 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected10 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected10 at risk
Cerebral infarction
Nervous system disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected7 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected10 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected10 at risk
Cerebral microhaemorrhage
Nervous system disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0012 events1 affected7 at risk
EG0023 events1 affected7 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected3 at risk
EG0052 events2 affected10 at risk
EG0061 events1 affected5 at risk
EG0070 events0 affected8 at risk
EG0083 events2 affected10 at risk
Cognitive disorder
Nervous system disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected10 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected8 at risk
EG0081 events1 affected10 at risk
Decreased vibratory sense
Nervous system disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected10 at risk
EG0060 events0 affected5 at risk
EG0071 events1 affected8 at risk
EG0080 events0 affected10 at risk
Dementia alzheimer's type
Nervous system disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected10 at risk
EG0060 events0 affected5 at risk
EG0071 events1 affected8 at risk
EG0080 events0 affected10 at risk
Dizziness
Nervous system disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected7 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected10 at risk
EG0060 events0 affected5 at risk
EG0071 events1 affected8 at risk
EG0080 events0 affected10 at risk
Dizziness exertional
Nervous system disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0022 events1 affected7 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected10 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected10 at risk
Dizziness postural
Nervous system disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected10 at risk
EG0060 events0 affected5 at risk
EG0071 events1 affected8 at risk
EG0080 events0 affected10 at risk
Headache
Nervous system disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0014 events1 affected7 at risk
EG0022 events2 affected7 at risk
EG0030 events0 affected4 at risk
EG0041 events1 affected3 at risk
EG0051 events1 affected10 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected8 at risk
EG0083 events1 affected10 at risk
Lethargy
Nervous system disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected10 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected10 at risk
Paraesthesia
Nervous system disorders
MedDRA 18.1
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected10 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected10 at risk
Somnolence
Nervous system disorders
MedDRA 18.1
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected7 at risk
EG0031 events1 affected4 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected10 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected10 at risk
Subarachnoid haemorrhage
Nervous system disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected10 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected10 at risk
Superficial siderosis of central nervous system
Nervous system disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected10 at risk
EG0060 events0 affected5 at risk
EG0071 events1 affected8 at risk
EG0081 events1 affected10 at risk
Syncope
Nervous system disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected10 at risk
EG0061 events1 affected5 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected10 at risk
Vasogenic cerebral oedema
Nervous system disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0022 events2 affected7 at risk
EG0032 events2 affected4 at risk
EG0040 events0 affected3 at risk
EG0052 events2 affected10 at risk
EG0060 events0 affected5 at risk
EG0073 events3 affected8 at risk
EG0082 events2 affected10 at risk
Abnormal behaviour
Psychiatric disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected10 at risk
EG0060 events0 affected5 at risk
EG0071 events1 affected8 at risk
EG0080 events0 affected10 at risk
Agitation
Psychiatric disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected10 at risk
EG0060 events0 affected5 at risk
EG0071 events1 affected8 at risk
EG0080 events0 affected10 at risk
Anger
Psychiatric disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected10 at risk
EG0060 events0 affected5 at risk
EG0072 events2 affected8 at risk
EG0080 events0 affected10 at risk
Anxiety
Psychiatric disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected7 at risk
EG0031 events1 affected4 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected10 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected10 at risk
Delusional perception
Psychiatric disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0022 events1 affected7 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected10 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected10 at risk
Depression
Psychiatric disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected10 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected8 at risk
EG0081 events1 affected10 at risk
Depressive symptom
Psychiatric disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected10 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected10 at risk
Hallucination, visual
Psychiatric disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected10 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected10 at risk
Hypersomnia related to another mental condition
Psychiatric disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected10 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected8 at risk
EG0081 events1 affected10 at risk
Irritability
Psychiatric disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected10 at risk
EG0060 events0 affected5 at risk
EG0071 events1 affected8 at risk
EG0080 events0 affected10 at risk
Mental status changes
Psychiatric disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected7 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected10 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected10 at risk
Restlessness
Psychiatric disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected10 at risk
EG0060 events0 affected5 at risk
EG0071 events1 affected8 at risk
EG0080 events0 affected10 at risk
Sleep disorder
Psychiatric disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected10 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected10 at risk
Suicidal ideation
Psychiatric disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected7 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected10 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected10 at risk
Pollakiuria
Renal and urinary disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected4 at risk
EG0041 events1 affected3 at risk
EG0050 events0 affected10 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected10 at risk
Renal injury
Renal and urinary disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected10 at risk
EG0060 events0 affected5 at risk
EG0073 events1 affected8 at risk
EG0080 events0 affected10 at risk
Sterile pyuria
Renal and urinary disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected10 at risk
EG0060 events0 affected5 at risk
EG0071 events1 affected8 at risk
EG0080 events0 affected10 at risk
Urinary incontinence
Renal and urinary disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected7 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected10 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected10 at risk
Atrophic vulvovaginitis
Reproductive system and breast disorders
MedDRA 18.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected2 at risk
EG0041 events1 affected2 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected6 at risk
Breast pain
Reproductive system and breast disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected2 at risk
EG0040 events0 affected2 at risk
EG0051 events1 affected4 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected6 at risk
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected10 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected8 at risk
EG0081 events1 affected10 at risk
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected10 at risk
EG0060 events0 affected5 at risk
EG0071 events1 affected8 at risk
EG0080 events0 affected10 at risk
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected3 at risk
EG0052 events1 affected10 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected10 at risk
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected4 at risk
EG0041 events1 affected3 at risk
EG0050 events0 affected10 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected10 at risk
Pneumonia aspiration
Respiratory, thoracic and mediastinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected10 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected8 at risk
EG0081 events1 affected10 at risk
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected10 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected10 at risk
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected7 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected10 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected10 at risk
Upper-airway cough syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected10 at risk
EG0060 events0 affected5 at risk
EG0071 events1 affected8 at risk
EG0080 events0 affected10 at risk
Actinic keratosis
Skin and subcutaneous tissue disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected10 at risk
EG0060 events0 affected5 at risk
EG0071 events1 affected8 at risk
EG0080 events0 affected10 at risk
Dermatitis contact
Skin and subcutaneous tissue disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected10 at risk
EG0060 events0 affected5 at risk
EG0071 events1 affected8 at risk
EG0080 events0 affected10 at risk
Ecchymosis
Skin and subcutaneous tissue disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected10 at risk
EG0060 events0 affected5 at risk
EG0071 events1 affected8 at risk
EG0080 events0 affected10 at risk
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected4 at risk
EG0042 events1 affected3 at risk
EG0050 events0 affected10 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected10 at risk
Rash
Skin and subcutaneous tissue disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected4 at risk
EG0042 events2 affected3 at risk
EG0050 events0 affected10 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected10 at risk
Rash erythematous
Skin and subcutaneous tissue disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected10 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected10 at risk
Retinal operation
Surgical and medical procedures
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected10 at risk
EG0060 events0 affected5 at risk
EG0071 events1 affected8 at risk
EG0080 events0 affected10 at risk
Haematoma
Vascular disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected4 at risk
EG0041 events1 affected3 at risk
EG0050 events0 affected10 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected10 at risk
Hypertension
Vascular disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected10 at risk
EG0060 events0 affected5 at risk
EG0071 events1 affected8 at risk
EG0080 events0 affected10 at risk
Hypertensive crisis
Vascular disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected10 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected8 at risk
EG0081 events1 affected10 at risk
Hypertensive emergency
Vascular disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected10 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected8 at risk
EG0081 events1 affected10 at risk
Systolic hypertension
Vascular disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected10 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected10 at risk
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
The sponsor cannot use results communications, embargo communications regarding trial results for at least 5 years from the date of disclosure.