A Study of Participants With Relapsing-Remitting Multiple... | NCT00882999 | Trialant
NCT00882999
Sponsor
Eli Lilly and Company
Status
Completed
Last Update Posted
Nov 15, 2018Actual
Enrollment
245Actual
Phase
Phase 2
Conditions
Relapsing-Remitting Multiple Sclerosis
Interventions
LY2127399
Placebo
Countries
United States
Bulgaria
Czechia
France
Germany
Hungary
Israel
Poland
Romania
Russia
Serbia
Slovakia
Ukraine
Protocol Section
Identification Module
NCT ID
NCT00882999
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
12778
Secondary IDs
ID
Type
Description
Link
H9B-MC-BCDJ
Other Identifier
Eli Lilly and Company
Brief Title
A Study of Participants With Relapsing-Remitting Multiple Sclerosis (RRMS)
Official Title
Multiple Subcutaneous Doses of LY2127399, an Anti-BAFF Human Antibody, in Subjects With Relapsing-Remitting Multiple Sclerosis
Acronym
Not provided
Organization
Eli Lilly and CompanyINDUSTRY
Status Module
Record Verification Date
Nov 2018
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
Apr 2009
Primary Completion Date
Feb 2011Actual
Completion Date
Jun 2012Actual
First Submitted Date
Apr 16, 2009
First Submission Date that Met QC Criteria
Apr 16, 2009
First Posted Date
Apr 17, 2009Estimated
Results Waived
Not provided
Results First Submitted Date
Mar 24, 2018
Results First Submitted that Met QC Criteria
Nov 10, 2018
Results First Posted Date
Nov 15, 2018Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Jun 13, 2011
Certification/Extension First Submitted that Passed QC Review
Jun 13, 2011
Certification/Extension First Posted Date
Jun 27, 2011Estimated
Last Update Submitted Date
Nov 10, 2018
Last Update Posted Date
Nov 15, 2018Actual
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)
Yes
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
To look at the ability of LY2127399 to reduce magnetic resonance imaging (MRI) lesions at 12, 16, 20, and 24 weeks compared to placebo.
Detailed Description
Not provided
Conditions Module
Conditions
Relapsing-Remitting Multiple Sclerosis
Keywords
Relapsing
Remitting
Multiple Sclerosis
Multiple
Sclerosis
MS
LY2127399
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
245Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Placebo
Placebo Comparator
Injection: Every 4 weeks in the placebo arm for 24 weeks (Weeks 0, 4, 8, 12, 16, and 20) for a total of 6 doses. Every 4 weeks in the LY2127399 arms [4 milligrams (mg) LY2127399 / 12 weeks and 120 mg LY2127399 / 12 weeks] for 24 weeks (except Week 0 and Week 12).
Drug: Placebo
4 mg LY2127399 / 4 weeks
Experimental
Injection: 6 doses, one every 4 weeks for 24 weeks.
Drug: LY2127399
40 mg LY2127399 / 4 weeks
Experimental
Injection: 6 doses, one every 4 weeks for 24 weeks.
Drug: LY2127399
120 mg LY2127399 / 4 weeks
Experimental
Injection: 6 doses, one every 4 weeks for 24 weeks.
Drug: LY2127399
4 mg LY2127399 / 12 weeks
Experimental
Drug: LY2127399 Injection: 2 doses, one every 12 weeks for 24 weeks.
Drug: Placebo Injection: Every 4 weeks for 24 weeks (except Week 0 and Week 12).
Drug: LY2127399
Drug: Placebo
120 mg LY2127399 / 12 weeks
Interventions
Name
Type
Description
Arm Group Labels
Other Names
LY2127399
Drug
Administered via Injection
12 mg LY2127399 / 4 weeks
120 mg LY2127399 / 12 weeks
120 mg LY2127399 / 4 weeks
4 mg LY2127399 / 12 weeks
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Total Number of Gd-Enhancing T1-Weighted MRI Lesions Per Scan Averaged During Weeks 12, 16, 20, and 24
Lesions were measured using Gd-enhancing T1-weighted MRI scans. The number of T1-weighted lesions per scan was obtained from the number of T1-weighted lesions observed during a specified week divided by the number of scans performed that same week. To obtain the number of T1-weighted lesions per scan averaged during Weeks 12, 16, 20, and 24, the number of lesions per scan at each week was summed and then divided by the number of visits with non-missing lesion counts.
Weeks 12, 16, 20, and 24
Secondary Outcomes
Measure
Description
Time Frame
Change From Baseline in Number of Gd-Enhancing T1-Weighted MRI Lesions Per Scan
Lesions were measured using Gd-enhancing T1-weighted MRI scans. The number of T1-weighted lesions per scan was obtained from the number of T1-weighted lesions observed during a specified week divided by the number of scans performed that same week. Least squares (LS) mean was calculated using an analysis of variance (ANOVA).
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
18 through 64 years of age diagnosed with RRMS, who can walk without aid or rest for at least 200 meters (approximately 1/10 of a mile).
Women who can become pregnant must use birth control.
Exclusion Criteria:
Have had a live vaccination within 12 weeks before randomization, or intend to have a live vaccination during the course of the study.
Have had had recent surgery or are scheduled to have surgery during the study.
Are immunocompromised or have evidence of active infection [such as hepatitis, tuberculosis or, human immunodeficiency virus (HIV)].
Have been on certain drugs that are being studied for RRMS or have recently received prescription drugs to treat RRMS.
Have had a recent serious infection.
Have serious or uncontrolled illnesses other than RRMS.
Have clinically significant blood test values.
Have multiple or severe drug allergies.
Have contraindications for MRI "scanning" or claustrophobia (fear of an enclosed space) that cannot be managed.
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
64 Years
Standard Ages
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
Eli Lilly and Company
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
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.
Phoenix
Arizona
85013
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.
Results Section
Participant Flow Module
Pre-assignment Details
The study included 24 weeks of treatment and 24 weeks of follow-up. If necessary, participants had additional long-term follow-up for peripheral blood B cell monitoring (up to Week 108). Participants who completed study treatment (24 weeks) and the initial study follow-up (24 weeks) were considered study completers.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
4 mg LY2127399 Q4W
LY2127399: 4 milligrams (mg) subcutaneous injection once every 4 weeks (Q4W) for 24 weeks (Weeks 0, 4, 8, 12, 16, and 20).
FG001
12 mg LY2127399 Q4W
LY2127399: 12 mg subcutaneous injection Q4W for 24 weeks.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
2
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Belgium
Canada
Denmark
Finland
Switzerland
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Double
Masking Description
Not provided
Who Masked
ParticipantInvestigator
Experimental
Drug: LY2127399 Injection: 2 doses, one every 12 weeks for 24 weeks.
Drug: Placebo Injection: Every 4 weeks for 24 weeks (except Week 0 and Week 12).
Drug: LY2127399
Drug: Placebo
12 mg LY2127399 / 4 weeks
Experimental
Injection: 6 doses, one every 4 weeks for 24 weeks.
Drug: LY2127399
4 mg LY2127399 / 4 weeks
40 mg LY2127399 / 4 weeks
Placebo
Drug
Administered via Injection
120 mg LY2127399 / 12 weeks
4 mg LY2127399 / 12 weeks
Placebo
Baseline, Weeks 4, 8, 12, 16, 20, 24, 36, and 48
Total Number of New Gd-Enhancing T1-Weighted MRI Lesions Per Scan
Lesions were measured using Gd-enhancing T1-weighted MRI scans. The number of new T1-weighted lesions per scan was obtained from the number new T1-weighted lesions observed during a specified week divided by the number of scans performed that same week.
Weeks 4, 8, 12, 16, 20, 24, 36, and 48
Total Number of New or Newly Enlarging T2-Weighted MRI Lesions
Lesions were measured using T2-weighted proton density MRI scans.
Weeks 4, 8, 12, 16, 20, 24, 36, and 48
Total Volume of T2-Weighted MRI Lesions
The total volume of T2-weighted lesions was measured using T2-weighted proton density MRI scans. LS mean was calculated using an ANOVA model.
Weeks 4, 8, 12, 16, 20, 24, 36, and 48
Expanded Disability Status Scale (EDSS)
The EDSS is a rating scale for quantifying disability in multiple sclerosis (MS) participants. The EDSS has 8 functional systems (pyramidal, cerebellar, brain stem, sensory, bowel and bladder, visual, cerebral, and other) each rated on a scale from 0 (normal) to 5 (severe disability) or 0 (normal) to 6 (severe disability). The EDSS score was computed based on an algorithm of these components, and scores ranged from 0.0 (normal neurological exam) to 10.0 (death due to MS) in increments of 0.5.
Weeks 12, 24, and 48
Time to First Relapse
A confirmed relapse was defined as the appearance of 1 or more new neurological symptom(s) attributable to MS or the worsening of 1 or more previously observed symptoms. This change in clinical state was to last at least 48 hours and be immediately preceded by an improving neurological state of at least 30 days from onset of previous relapse. New or worsening neurological symptoms were accompanied by objective EDSS changes on examination (an increase from baseline of at least 1 point on the EDSS, at least 1 point on 2 EDSS functional systems, or at least 2 points on 1 EDSS functional system). A relapse may or may not have required systemic corticosteroid treatment. If a relapse did not occur during the specified time frame, the time to the first confirmed relapse was censored to the date of the participant's last available visit at or prior to Week 24, Week 48, and Week 48 for the respective time frames.
Baseline through Week 24, Baseline through Week 48, and Week 24 through Week 48
Percentage of Relapse-Free Participants
A confirmed relapse was defined as the appearance of 1 or more new neurological symptom(s) attributable to MS or the worsening of 1 or more previously observed symptoms. This change in clinical state was to last at least 48 hours and be immediately preceded by an improving neurological state of at least 30 days from onset of previous relapse. New or worsening neurological symptoms were accompanied by objective EDSS changes on examination (an increase from baseline of at least 1 point on the EDSS, at least 1 point on 2 EDSS functional systems, or at least 2 points on 1 EDSS functional system). A relapse may or may not have required systemic corticosteroid treatment. Percentage of relapse-free participants=[(number of participants who did not relapse)/(number of pts assessed)]*100.
Week 24, Week 48, end of study treatment [Week 24 or early discontinuation (ED)], and end of follow-up (Week 48 or ED)
Annualized Relapse Rate (ARR) at Week 24 and Week 48
The number of confirmed relapses per year, ARR=[(number of relapses from baseline through Week 24 or baseline through Week 48)/(the time in days between the same interval)]*365.25. A confirmed relapse was defined as the appearance of 1 or more new neurological symptom(s) attributable to MS or the worsening of 1 or more previously observed symptoms. This change in clinical state was to last at least 48 hours and be immediately preceded by an improving neurological state of at least 30 days from onset of previous relapse. New or worsening neurological symptoms were accompanied by objective EDSS changes on examination (an increase from baseline of at least 1 point on the EDSS, at least 1 point on 2 EDSS functional systems, or at least 2 points on 1 EDSS functional system). A relapse may or may have not required systemic corticosteroid treatment.
Baseline through Week 24 and Baseline through Week 48
The MSFC is a composite scale consisting of 3 components [Timed 25-Foot Walk, 9-Hole Peg Test (9-HPT), and 3-Second Paced Auditory Serial Addition Test (PASAT-3)]. The Timed 25-Foot Walk was a quantitative measure of lower extremity function. The 9-HPT was a quantitative measure of upper extremity (arm and hand) function. The PASAT-3 was a measure of cognitive function that specifically assessed auditory information processing speed and flexibility, as well as calculation ability. Component scores ranged from 0 to 60 and were converted to standard scores (z-scores). The MSFC score was calculated as the average of the 3 standardized component scores. Higher MSFC scores reflected better neurological function.
Weeks 12, 24, and 48
Visual Analog Scale (VAS) of Wellbeing
The VAS is a 100-millimeter (mm) horizontal line marked with 0 mm = "poor" and 100 mm = "excellent." Participants were asked to assess their wellbeing by making a vertical mark on the scale. The score was computed as the distance from 0 mm to the vertical mark.
Weeks 12, 24, and 48
16-Item Quick Inventory for Depressive Symptomatology Self Report (QIDS-SR16)
The QIDS-SR16 is a 16-item participant-rated measure of depressive symptomatology. Each item corresponds to 1 of 9 criterion domains for depression: change in sleep disturbance [question (Q) 1 through Q4], sad mood (Q5), decrease or increase in appetite and weight (Q6 through Q9), concentration (Q10), self-criticism (Q11), suicidal ideation (Q12), interest (Q13), energy/fatigue (Q14), and psychomotor agitation and retardation (Q15 and Q16). Each question was scored 0 (no problems) to 3 (increased symptoms). The total score=(the highest score from Q1 through Q4)+(Q5 score)+(the highest score from Q6 through Q9)+(the total score for each Q10 through Q14)+(the highest score from Q15 and Q16). A total score of 0 through 5 was considered no depression likely, 6 through 10 was mild depression, 11 through 15 was moderate depression, 16 through 20 was severe depression, and 21 or over was very severe depression.
Weeks 12, 24, and 48
Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) Component Scores
The SF-36 was a 36-item, health-related survey that assessed participant's quality of life on 8 domains: physical functioning, bodily pain, role limitations due to physical problems, role limitations due to emotional problems, general health, mental health, social functioning, vitality and 2 component scores (mental and physical health). Domain scores were calculated by summing individual items for each domain and transforming scores into 0 to 100 scale; higher scores indicated better health status or function. The mental component summary (MCS) score, based on SF-36 domains, consisted of social functioning, vitality, mental health, and role-emotional scales (range: 0 to 100). The physical component summary (PCS) score, based on SF-36 domains, consisted of physical functioning, bodily pain, role-physical, and general health scales (range: 0 to 100).
Weeks 12, 24, and 48
Pharmacokinetics (PK): Area Under the Concentration-Time Curve for Dosing Interval at Steady State (AUCtau,ss)
AUCtau,ss was obtained by conducting a simulation consisting of 1000 participants, which were then used to determine the noncompartmental PK parameters for each regimen.
Week 0: Day 1, 2, or 3 and Weeks 1, 4, 8, 12, 16, 20, 24, 30, 36, and 40.
Percentage of Participants With Anti-LY2127399 Antibodies [Anti-Drug Antibodies (ADA)]
The percentage of participants with ADA=[(number of participants who had ADA)/(number of participants assessed)]*100.
Pharmacodynamics: Change From Baseline in Peripheral Blood B Cell Subsets (Absolute Cell Counts)
Cell surface marker cluster designation (CD)19, CD27, and immunoglobulin D (IgD) expression levels were used to define the various B cell subsets. Cell surface markers were defined as being either present (+) or absent (-). Peripheral blood B cell subsets included: mature naive B cells (CD19+IgD+CD27-); immature/transitional (immature/tran) B cells (CD19+IgD-CD27-); switched memory B cells (CD19+IgD-CD27+); and non-switched memory B cells (CD19+IgD+CD27+). A positive or negative change indicated an increase or decrease, respectively in B cell count.
Baseline, Day 2, Weeks (Wks) 1, 4, 12, 24, 36, and 48
United States
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Tucson
Arizona
85741
United States
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Fullerton
California
92835
United States
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Denver
Colorado
80220
United States
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Naples
Florida
34102
United States
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Plantation
Florida
33324
United States
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Sarasota
Florida
34239
United States
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Northbrook
Illinois
60062
United States
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Indianapolis
Indiana
46202
United States
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Kansas City
Kansas
66160
United States
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Lexington
Kentucky
40513
United States
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Biddeford
Maine
04005
United States
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Farmington Hills
Michigan
48334
United States
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Toms River
New Jersey
08755
United States
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Schenectady
New York
12308
United States
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Charlotte
North Carolina
28207
United States
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Raleigh
North Carolina
27607
United States
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Akron
Ohio
44320
United States
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Green
Ohio
44685
United States
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Greensburg
Pennsylvania
15601
United States
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Greenville
South Carolina
29615
United States
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Franklin
Tennessee
37064
United States
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Memphis
Tennessee
38120
United States
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Lubbock
Texas
79410
United States
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Round Rock
Texas
78681
United States
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Newport News
Virginia
23601
United States
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Roanoke
Virginia
24018
United States
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Sofia
1407
Bulgaria
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Brno
62500
Czechia
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Pardubice
500 05
Czechia
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Prague
140 59
Czechia
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Caen
14033
France
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Montpellier
34295
France
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Nîmes
30900
France
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Strasbourg
67091
France
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Berlin
13156
Germany
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Ulm
89075
Germany
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Budapest
1095
Hungary
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Győr
9023
Hungary
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Gyula
5700
Hungary
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Tel Litwinsky
52621
Israel
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Gdansk
80-952
Poland
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Gliwice
44-100
Poland
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Grodzisk Mazowiecki
05-825
Poland
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Krakow-Nowa Huta
PL-31-826
Poland
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Lodz
90-549
Poland
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Lublin
20-090
Poland
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Târgu Mureş
540136
Romania
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Kazan'
4420029
Russia
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Kemerovo
650066
Russia
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Moscow
119435
Russia
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Belgrade
11000
Serbia
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Niš
18000
Serbia
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Bratislava
833 05
Slovakia
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Košice
04011
Slovakia
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Spišská Nová Ves
05201
Slovakia
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Žilina
01001
Slovakia
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Dnipro
49027
Ukraine
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Donetsk
83037
Ukraine
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Ivano-Frankivsk
76008
Ukraine
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Kharkiv
61000
Ukraine
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Vinnytsia
21005
Ukraine
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Zaporizhzhya
69057
Ukraine
FG002
40 mg LY2127399 Q4W
LY2127399: 40 mg subcutaneous injection Q4W for 24 weeks.
FG003
120 mg LY2127399 Q4W
LY2127399: 120 mg subcutaneous injection Q4W for 24 weeks.
FG004
4 mg LY2127399 Q12W
LY2127399: 4 mg subcutaneous injection every 12 weeks (Q12W) for 24 weeks (Weeks 0 and 12).
Placebo: Subcutaneous injection Q4W for 24 weeks except (Weeks 0 and 12).
FG005
120 mg LY2127399 Q12W
LY2127399: 120 mg subcutaneous injection Q12W for 24 weeks (Weeks 0 and 12).
Placebo: Subcutaneous injection Q4W for 24 weeks except (Weeks 0 and 12).
FG006
Placebo
Placebo: Subcutaneous injection Q4W for 24 weeks.
FG00035 subjects
FG00134 subjects
FG00234 subjects
FG00336 subjects
FG00436 subjects
FG00535 subjects
FG00635 subjects
Received Any Amount of Study Drug
FG00035 subjects
FG00134 subjects
FG00234 subjects
FG00336 subjects
FG00436 subjects
FG00535 subjects
FG00635 subjects
Completed Study Treatment
FG00029 subjects
FG00129 subjects
FG00231 subjects
FG00333 subjects
FG00429 subjects
FG00530 subjects
FG00631 subjects
COMPLETED
FG00027 subjects
FG00126 subjects
FG00230 subjects
FG00331 subjects
FG00428 subjects
FG00528 subjects
FG00627 subjects
NOT COMPLETED
FG0008 subjects
FG0018 subjects
FG0024 subjects
FG0035 subjects
FG0048 subjects
FG0057 subjects
FG0068 subjects
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0041 subjects
FG0050 subjects
FG0060 subjects
Death
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0007 subjects
FG0016 subjects
FG0023 subjects
FG0033 subjects
FG004
Lost to Follow-up
FG0000 subjects
FG0011 subjects
FG0021 subjects
FG0032 subjects
FG004
Physician Decision
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
All randomized participants.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
4 mg LY2127399 Q4W
LY2127399: 4 mg subcutaneous injection Q4W for 24 weeks (Weeks 0, 4, 8, 12, 16, and 20).
BG001
12 mg LY2127399 Q4W
LY2127399: 12 mg subcutaneous injection Q4W for 24 weeks.
BG002
40 mg LY2127399 Q4W
LY2127399: 40 mg subcutaneous injection Q4W for 24 weeks.
BG003
120 mg LY2127399 Q4W
LY2127399: 120 mg subcutaneous injection Q4W for 24 weeks.
BG004
4 mg LY2127399 Q12W
LY2127399: 4 mg subcutaneous injection Q12W for 24 weeks (Weeks 0 and 12).
Placebo: Subcutaneous injection Q4W for 24 weeks (except Weeks 0 and 12).
BG005
120 mg LY2127399 Q12W
LY2127399: 120 mg subcutaneous injection Q12W for 24 weeks (Weeks 0 and 12).
Placebo: Subcutaneous injection Q4W for 24 weeks (except Weeks 0 and 12).
BG006
Placebo
Placebo: Subcutaneous injection Q4W for 24 weeks.
BG007
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00035
BG00134
BG00234
BG00336
BG00436
BG00535
BG00635
BG007245
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00041.7± 10.23
BG00143.1± 10.06
BG00240.8± 10.78
BG003
Sex: Female, Male
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Female
BG00024
BG00122
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0000
BG0010
BG002
Race (NIH/OMB)
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Region of Enrollment
Count of Participants
Participants
No
Title
Denominators
Categories
United States
Title
Measurements
BG00014
BG00110
BG002
Time Since Onset Of First Symptoms
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG0008.5± 7.81
BG0019.4± 6.96
BG002
Time Since First Diagnosis
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG0005.9± 7.19
BG0016.3± 6.19
BG002
Number Of Relapses In Past Year
Mean
Standard Deviation
relapses
Title
Denominators
Categories
Title
Measurements
BG0001.4± 1.26
BG0011.3± 0.51
BG002
Number of Gadolinium (Gd)-Enhancing T1-Weighted Lesions
Lesions were measured through Gd-enhancing T1-weighted magnetic resonance imaging (MRI) scans.
Mean
Standard Deviation
lesions
Title
Denominators
Categories
Title
Measurements
BG0001.1± 2.64
BG0010.5
Volume of T2-Weighted Lesions
Lesions were measured through T2-weighted proton density MRI scans.
Mean
Standard Deviation
milliliters (mL)
Title
Denominators
Categories
Title
Measurements
BG0008.5± 10.53
BG0017.8± 9.21
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
Total Number of Gd-Enhancing T1-Weighted MRI Lesions Per Scan Averaged During Weeks 12, 16, 20, and 24
Lesions were measured using Gd-enhancing T1-weighted MRI scans. The number of T1-weighted lesions per scan was obtained from the number of T1-weighted lesions observed during a specified week divided by the number of scans performed that same week. To obtain the number of T1-weighted lesions per scan averaged during Weeks 12, 16, 20, and 24, the number of lesions per scan at each week was summed and then divided by the number of visits with non-missing lesion counts.
Randomized participants who had a Gd-enhancing T1-weighted MRI lesion for at least 1 time point among Weeks 12, 16, 20, or 24.
Posted
Mean
Standard Deviation
lesions per scan
Weeks 12, 16, 20, and 24
ID
Title
Description
OG000
4 mg LY2127399 Q4W
LY2127399: 4 mg subcutaneous injection Q4W for 24 weeks (Weeks 0, 4, 8, 12, 16, and 20).
OG001
12 mg LY2127399 Q4W
LY2127399: 12 mg subcutaneous injection Q4W for 24 weeks.
OG002
40 mg LY2127399 Q4W
LY2127399: 40 mg subcutaneous injection Q4W for 24 weeks.
OG003
120 mg LY2127399 Q4W
LY2127399: 120 mg subcutaneous injection Q4W for 24 weeks.
OG004
4 mg LY2127399 Q12W
LY2127399: 4 mg subcutaneous injection Q12W for 24 weeks (Weeks 0 and 12).
Placebo: Subcutaneous injection Q4W for 24 weeks (except Weeks 0 and 12).
OG005
120 mg LY2127399 Q12W
LY2127399: 120 mg subcutaneous injection Q12W for 24 weeks (Weeks 0 and 12).
Placebo: Subcutaneous injection Q4W for 24 weeks (except Weeks 0 and 12).
OG006
Placebo
Placebo: Subcutaneous injection Q4W for 24 weeks.
Units
Counts
Participants
OG00034
OG00131
OG00231
OG003
Title
Denominators
Categories
Title
Measurements
OG0001.819± 3.312
OG0010.710± 1.103
OG0021.237± 1.999
OG003
Secondary
Change From Baseline in Number of Gd-Enhancing T1-Weighted MRI Lesions Per Scan
Lesions were measured using Gd-enhancing T1-weighted MRI scans. The number of T1-weighted lesions per scan was obtained from the number of T1-weighted lesions observed during a specified week divided by the number of scans performed that same week. Least squares (LS) mean was calculated using an analysis of variance (ANOVA).
Randomized participants who had a Gd-enhancing T1-weighted MRI assessment at the specified time points.
Posted
Least Squares Mean
Standard Error
lesions per scan
Baseline, Weeks 4, 8, 12, 16, 20, 24, 36, and 48
ID
Title
Description
OG000
4 mg LY2127399 Q4W
LY2127399: 4 mg subcutaneous injection Q4W for 24 weeks (Weeks 0, 4, 8, 12, 16, and 20).
OG001
12 mg LY2127399 Q4W
LY2127399: 12 mg subcutaneous injection Q4W for 24 weeks.
OG002
40 mg LY2127399 Q4W
LY2127399: 40 mg subcutaneous injection Q4W for 24 weeks.
OG003
120 mg LY2127399 Q4W
Secondary
Total Number of New Gd-Enhancing T1-Weighted MRI Lesions Per Scan
Lesions were measured using Gd-enhancing T1-weighted MRI scans. The number of new T1-weighted lesions per scan was obtained from the number new T1-weighted lesions observed during a specified week divided by the number of scans performed that same week.
Randomized participants who had a Gd-enhancing T1-weighted MRI assessment at the specified time points.
Posted
Mean
Standard Deviation
lesions per scan
Weeks 4, 8, 12, 16, 20, 24, 36, and 48
ID
Title
Description
OG000
4 mg LY2127399 Q4W
LY2127399: 4 mg subcutaneous injection Q4W for 24 weeks (Weeks 0, 4, 8, 12, 16, and 20).
OG001
12 mg LY2127399 Q4W
LY2127399: 12 mg subcutaneous injection Q4W for 24 weeks.
OG002
40 mg LY2127399 Q4W
LY2127399: 40 mg subcutaneous injection Q4W for 24 weeks.
OG003
120 mg LY2127399 Q4W
LY2127399: 120 mg subcutaneous injection Q4W for 24 weeks.
Secondary
Total Number of New or Newly Enlarging T2-Weighted MRI Lesions
Lesions were measured using T2-weighted proton density MRI scans.
Randomized participants who had a T2-weighted MRI assessment at the specified time points.
Posted
Mean
Standard Deviation
lesions
Weeks 4, 8, 12, 16, 20, 24, 36, and 48
ID
Title
Description
OG000
4 mg LY2127399 Q4W
LY2127399: 4 mg subcutaneous injection Q4W for 24 weeks (Weeks 0, 4, 8, 12, 16, and 20).
OG001
12 mg LY2127399 Q4W
LY2127399: 12 mg subcutaneous injection Q4W for 24 weeks.
OG002
40 mg LY2127399 Q4W
LY2127399: 40 mg subcutaneous injection Q4W for 24 weeks.
OG003
120 mg LY2127399 Q4W
LY2127399: 120 mg subcutaneous injection Q4W for 24 weeks.
OG004
4 mg LY2127399 Q12W
Secondary
Total Volume of T2-Weighted MRI Lesions
The total volume of T2-weighted lesions was measured using T2-weighted proton density MRI scans. LS mean was calculated using an ANOVA model.
Randomized participants who had a T2-weighted MRI assessment at the specified time points.
Posted
Least Squares Mean
Standard Error
mL
Weeks 4, 8, 12, 16, 20, 24, 36, and 48
ID
Title
Description
OG000
4 mg LY2127399 Q4W
LY2127399: 4 mg subcutaneous injection Q4W for 24 weeks (Weeks 0, 4, 8, 12, 16, and 20).
OG001
12 mg LY2127399 Q4W
LY2127399: 12 mg subcutaneous injection Q4W for 24 weeks.
OG002
40 mg LY2127399 Q4W
LY2127399: 40 mg subcutaneous injection Q4W for 24 weeks.
OG003
120 mg LY2127399 Q4W
LY2127399: 120 mg subcutaneous injection Q4W for 24 weeks.
OG004
4 mg LY2127399 Q12W
Secondary
Expanded Disability Status Scale (EDSS)
The EDSS is a rating scale for quantifying disability in multiple sclerosis (MS) participants. The EDSS has 8 functional systems (pyramidal, cerebellar, brain stem, sensory, bowel and bladder, visual, cerebral, and other) each rated on a scale from 0 (normal) to 5 (severe disability) or 0 (normal) to 6 (severe disability). The EDSS score was computed based on an algorithm of these components, and scores ranged from 0.0 (normal neurological exam) to 10.0 (death due to MS) in increments of 0.5.
Randomized participants who had EDSS scores at the specified time points.
Posted
Mean
Standard Deviation
units on a scale
Weeks 12, 24, and 48
ID
Title
Description
OG000
4 mg LY2127399 Q4W
LY2127399: 4 mg subcutaneous injection Q4W for 24 weeks (Weeks 0, 4, 8, 12, 16, and 20).
OG001
12 mg LY2127399 Q4W
LY2127399: 12 mg subcutaneous injection Q4W for 24 weeks.
OG002
40 mg LY2127399 Q4W
LY2127399: 40 mg subcutaneous injection Q4W for 24 weeks.
OG003
120 mg LY2127399 Q4W
Secondary
Time to First Relapse
A confirmed relapse was defined as the appearance of 1 or more new neurological symptom(s) attributable to MS or the worsening of 1 or more previously observed symptoms. This change in clinical state was to last at least 48 hours and be immediately preceded by an improving neurological state of at least 30 days from onset of previous relapse. New or worsening neurological symptoms were accompanied by objective EDSS changes on examination (an increase from baseline of at least 1 point on the EDSS, at least 1 point on 2 EDSS functional systems, or at least 2 points on 1 EDSS functional system). A relapse may or may not have required systemic corticosteroid treatment. If a relapse did not occur during the specified time frame, the time to the first confirmed relapse was censored to the date of the participant's last available visit at or prior to Week 24, Week 48, and Week 48 for the respective time frames.
Randomized participants who had a relapse assessment for the specified time periods. Twenty-one (21), 24, 24, 28, 23, 26, and 26 participants were censored in the following arms respectively: 4 mg, 12 mg, 40 mg, and 120 mg LY2127399 Q4W, 4 mg and 120 mg LY2127399 Q12W, and placebo.
Posted
Mean
Standard Deviation
days
Baseline through Week 24, Baseline through Week 48, and Week 24 through Week 48
ID
Title
Description
OG000
4 mg LY2127399 Q4W
LY2127399: 4 mg subcutaneous injection Q4W for 24 weeks (Weeks 0, 4, 8, 12, 16, and 20).
OG001
12 mg LY2127399 Q4W
Secondary
Percentage of Relapse-Free Participants
A confirmed relapse was defined as the appearance of 1 or more new neurological symptom(s) attributable to MS or the worsening of 1 or more previously observed symptoms. This change in clinical state was to last at least 48 hours and be immediately preceded by an improving neurological state of at least 30 days from onset of previous relapse. New or worsening neurological symptoms were accompanied by objective EDSS changes on examination (an increase from baseline of at least 1 point on the EDSS, at least 1 point on 2 EDSS functional systems, or at least 2 points on 1 EDSS functional system). A relapse may or may not have required systemic corticosteroid treatment. Percentage of relapse-free participants=[(number of participants who did not relapse)/(number of pts assessed)]*100.
Randomized participants who had a relapse assessment at the specified time points.
Posted
Number
percentage of participants
Week 24, Week 48, end of study treatment [Week 24 or early discontinuation (ED)], and end of follow-up (Week 48 or ED)
ID
Title
Description
OG000
4 mg LY2127399 Q4W
LY2127399: 4 mg subcutaneous injection Q4W for 24 weeks (Weeks 0, 4, 8, 12, 16, and 20).
OG001
12 mg LY2127399 Q4W
LY2127399: 12 mg subcutaneous injection Q4W for 24 weeks.
OG002
Secondary
Annualized Relapse Rate (ARR) at Week 24 and Week 48
The number of confirmed relapses per year, ARR=[(number of relapses from baseline through Week 24 or baseline through Week 48)/(the time in days between the same interval)]*365.25. A confirmed relapse was defined as the appearance of 1 or more new neurological symptom(s) attributable to MS or the worsening of 1 or more previously observed symptoms. This change in clinical state was to last at least 48 hours and be immediately preceded by an improving neurological state of at least 30 days from onset of previous relapse. New or worsening neurological symptoms were accompanied by objective EDSS changes on examination (an increase from baseline of at least 1 point on the EDSS, at least 1 point on 2 EDSS functional systems, or at least 2 points on 1 EDSS functional system). A relapse may or may have not required systemic corticosteroid treatment.
Randomized participants who had a relapse assessment for the specified time periods.
Posted
Mean
Standard Deviation
relapses per year
Baseline through Week 24 and Baseline through Week 48
ID
Title
Description
OG000
4 mg LY2127399 Q4W
LY2127399: 4 mg subcutaneous injection Q4W for 24 weeks (Weeks 0, 4, 8, 12, 16, and 20).
OG001
12 mg LY2127399 Q4W
LY2127399: 12 mg subcutaneous injection Q4W for 24 weeks.
The MSFC is a composite scale consisting of 3 components [Timed 25-Foot Walk, 9-Hole Peg Test (9-HPT), and 3-Second Paced Auditory Serial Addition Test (PASAT-3)]. The Timed 25-Foot Walk was a quantitative measure of lower extremity function. The 9-HPT was a quantitative measure of upper extremity (arm and hand) function. The PASAT-3 was a measure of cognitive function that specifically assessed auditory information processing speed and flexibility, as well as calculation ability. Component scores ranged from 0 to 60 and were converted to standard scores (z-scores). The MSFC score was calculated as the average of the 3 standardized component scores. Higher MSFC scores reflected better neurological function.
Randomized participants who had MSFC scores at the specified time points.
Posted
Mean
Standard Deviation
units on a scale
Weeks 12, 24, and 48
ID
Title
Description
OG000
4 mg LY2127399 Q4W
LY2127399: 4 mg subcutaneous injection Q4W for 24 weeks (Weeks 0, 4, 8, 12, 16, and 20).
OG001
12 mg LY2127399 Q4W
LY2127399: 12 mg subcutaneous injection Q4W for 24 weeks.
OG002
40 mg LY2127399 Q4W
LY2127399: 40 mg subcutaneous injection Q4W for 24 weeks.
Secondary
Visual Analog Scale (VAS) of Wellbeing
The VAS is a 100-millimeter (mm) horizontal line marked with 0 mm = "poor" and 100 mm = "excellent." Participants were asked to assess their wellbeing by making a vertical mark on the scale. The score was computed as the distance from 0 mm to the vertical mark.
Randomized participants who had VAS of Wellbeing scores at the specified time points.
Posted
Mean
Standard Deviation
mm
Weeks 12, 24, and 48
ID
Title
Description
OG000
4 mg LY2127399 Q4W
LY2127399: 4 mg subcutaneous injection Q4W for 24 weeks (Weeks 0, 4, 8, 12, 16, and 20).
OG001
12 mg LY2127399 Q4W
LY2127399: 12 mg subcutaneous injection Q4W for 24 weeks.
OG002
40 mg LY2127399 Q4W
LY2127399: 40 mg subcutaneous injection Q4W for 24 weeks.
OG003
120 mg LY2127399 Q4W
LY2127399: 120 mg subcutaneous injection Q4W for 24 weeks.
Secondary
16-Item Quick Inventory for Depressive Symptomatology Self Report (QIDS-SR16)
The QIDS-SR16 is a 16-item participant-rated measure of depressive symptomatology. Each item corresponds to 1 of 9 criterion domains for depression: change in sleep disturbance [question (Q) 1 through Q4], sad mood (Q5), decrease or increase in appetite and weight (Q6 through Q9), concentration (Q10), self-criticism (Q11), suicidal ideation (Q12), interest (Q13), energy/fatigue (Q14), and psychomotor agitation and retardation (Q15 and Q16). Each question was scored 0 (no problems) to 3 (increased symptoms). The total score=(the highest score from Q1 through Q4)+(Q5 score)+(the highest score from Q6 through Q9)+(the total score for each Q10 through Q14)+(the highest score from Q15 and Q16). A total score of 0 through 5 was considered no depression likely, 6 through 10 was mild depression, 11 through 15 was moderate depression, 16 through 20 was severe depression, and 21 or over was very severe depression.
Randomized participants who had QIDS-SR16 scores at the specified time points.
Posted
Mean
Standard Deviation
units on a scale
Weeks 12, 24, and 48
ID
Title
Description
OG000
4 mg LY2127399 Q4W
LY2127399: 4 mg subcutaneous injection Q4W for 24 weeks (Weeks 0, 4, 8, 12, 16, and 20).
OG001
12 mg LY2127399 Q4W
LY2127399: 12 mg subcutaneous injection Q4W for 24 weeks.
Secondary
Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) Component Scores
The SF-36 was a 36-item, health-related survey that assessed participant's quality of life on 8 domains: physical functioning, bodily pain, role limitations due to physical problems, role limitations due to emotional problems, general health, mental health, social functioning, vitality and 2 component scores (mental and physical health). Domain scores were calculated by summing individual items for each domain and transforming scores into 0 to 100 scale; higher scores indicated better health status or function. The mental component summary (MCS) score, based on SF-36 domains, consisted of social functioning, vitality, mental health, and role-emotional scales (range: 0 to 100). The physical component summary (PCS) score, based on SF-36 domains, consisted of physical functioning, bodily pain, role-physical, and general health scales (range: 0 to 100).
Randomized participants who had SF-36 component scores at the specified time points.
Posted
Mean
Standard Deviation
units on a scale
Weeks 12, 24, and 48
ID
Title
Description
OG000
4 mg LY2127399 Q4W
LY2127399: 4 mg subcutaneous injection Q4W for 24 weeks (Weeks 0, 4, 8, 12, 16, and 20).
OG001
12 mg LY2127399 Q4W
LY2127399: 12 mg subcutaneous injection Q4W for 24 weeks.
OG002
Secondary
Pharmacokinetics (PK): Area Under the Concentration-Time Curve for Dosing Interval at Steady State (AUCtau,ss)
AUCtau,ss was obtained by conducting a simulation consisting of 1000 participants, which were then used to determine the noncompartmental PK parameters for each regimen.
Randomized participants who had evaluable PK data.
Posted
Median
Standard Deviation
micrograms/milliliter*hours (mcg/mL*h)
Week 0: Day 1, 2, or 3 and Weeks 1, 4, 8, 12, 16, 20, 24, 30, 36, and 40.
ID
Title
Description
OG000
4 mg LY2127399 Q4W
LY2127399: 4 mg subcutaneous injection Q4W for 24 weeks (Weeks 0, 4, 8, 12, 16, and 20).
OG001
12 mg LY2127399 Q4W
LY2127399: 12 mg subcutaneous injection Q4W for 24 weeks.
OG002
40 mg LY2127399 Q4W
LY2127399: 40 mg subcutaneous injection Q4W for 24 weeks.
OG003
120 mg LY2127399 Q4W
LY2127399: 120 mg subcutaneous injection Q4W for 24 weeks.
Secondary
Percentage of Participants With Anti-LY2127399 Antibodies [Anti-Drug Antibodies (ADA)]
The percentage of participants with ADA=[(number of participants who had ADA)/(number of participants assessed)]*100.
Randomized participants who had an ADA assessment at the specified time periods.
LY2127399: 4 mg subcutaneous injection Q4W for 24 weeks (Weeks 0, 4, 8, 12, 16, and 20).
OG001
12 mg LY2127399 Q4W
LY2127399: 12 mg subcutaneous injection Q4W for 24 weeks.
OG002
40 mg LY2127399 Q4W
LY2127399: 40 mg subcutaneous injection Q4W for 24 weeks.
OG003
120 mg LY2127399 Q4W
LY2127399: 120 mg subcutaneous injection Q4W for 24 weeks.
OG004
Secondary
Pharmacodynamics: Change From Baseline in Peripheral Blood B Cell Subsets (Absolute Cell Counts)
Cell surface marker cluster designation (CD)19, CD27, and immunoglobulin D (IgD) expression levels were used to define the various B cell subsets. Cell surface markers were defined as being either present (+) or absent (-). Peripheral blood B cell subsets included: mature naive B cells (CD19+IgD+CD27-); immature/transitional (immature/tran) B cells (CD19+IgD-CD27-); switched memory B cells (CD19+IgD-CD27+); and non-switched memory B cells (CD19+IgD+CD27+). A positive or negative change indicated an increase or decrease, respectively in B cell count.
Randomized participants who had peripheral blood B cell subset cell counts at the specified time points.
Posted
Mean
Standard Deviation
cells per microliter (cells/µL)
Baseline, Day 2, Weeks (Wks) 1, 4, 12, 24, 36, and 48
ID
Title
Description
OG000
4 mg LY2127399 Q4W
LY2127399: 4 mg subcutaneous injection Q4W for 24 weeks (Weeks 0, 4, 8, 12, 16, and 20).
OG001
12 mg LY2127399 Q4W
LY2127399: 12 mg subcutaneous injection Q4W for 24 weeks.
OG002
40 mg LY2127399 Q4W
LY2127399: 40 mg subcutaneous injection Q4W for 24 weeks.
Time Frame
Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Description
Randomized participants who received any amount of study drug.
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
4 mg LY2127399 Q4W, Treatment
Adverse Events (AEs) reported during study treatment (up to Week 24).
LY2127399: 4 mg subcutaneous injection Q4W for 24 weeks (Weeks 0, 4, 8, 12, 16, and 20).
2
35
21
35
EG001
12 mg LY2127399 Q4W, Treatment
AEs reported during study treatment (up to Week 24).
LY2127399: 12 mg subcutaneous injection Q4W for 24 weeks.
4
34
22
34
EG002
40 mg LY2127399 Q4W, Treatment
AEs reported during study treatment (up to Week 24).
LY2127399: 40 mg subcutaneous injection Q4W for 24 weeks.
2
34
25
34
EG003
120 mg LY2127399 Q4W, Treatment
AEs reported during study treatment (up to Week 24).
LY2127399: 120 mg subcutaneous injection Q4W for 24 weeks.
3
36
19
36
EG004
4 mg LY2127399 Q12W, Treatment
AEs reported during study treatment (up to Week 24).
LY2127399: 4 mg subcutaneous injection Q12W for 24 weeks (Weeks 0 and 12).
Placebo: Subcutaneous injection Q4W for 24 weeks (except Weeks 0 and 12).
3
36
28
36
EG005
120 mg LY2127399 Q12W, Treatment
AEs reported during study treatment (up to Week 24).
LY2127399: 120 mg subcutaneous injection Q12W for 24 weeks (Weeks 0 and 12).
Placebo: Subcutaneous injection every Q4W for 24 weeks (except Weeks 0 and 12).
2
35
25
35
EG006
Placebo, Treatment
AEs reported during study treatment (up to Week 24).
AEs that started or worsened after Week 24 or ED through long-term follow-up (up to Week 108) for participants who received a 4 mg LY2127399 subcutaneous injection Q4W for 24 weeks.
No study drug was administered during the post-study treatment follow-up.
AEs that started or worsened after Week 24 or ED through long-term follow-up (up to Week 108) for participants who received a 12 mg LY2127399 subcutaneous injection Q4W for 24 weeks.
No study drug was administered during the post-study treatment follow-up.
AEs that started or worsened after Week 24 or ED through long-term follow-up (up to Week 108) for participants who received a 40 mg LY2127399 subcutaneous injection Q4W for 24 weeks.
No study drug was administered during the post-study treatment follow-up.
AEs that started or worsened after Week 24 or ED through long-term follow-up (up to Week 108) for participants who received a 120 mg LY2127399 subcutaneous injection Q4W for 24 weeks.
No study drug was administered during the post-study treatment follow-up.
AEs that started or worsened after Week 24 or ED through long-term follow-up (up to Week 108) for participants who received a 4 mg LY2127399 subcutaneous injection Q12W for 24 weeks (Weeks 0 and 12) and a placebo subcutaneous injection Q4W for 24 weeks (except Weeks 0 and 12).
No study drug was administered during the post-study treatment follow-up.
AEs that started or worsened after Week 24 or ED through long-term follow-up (up to Week 108) for participants who received a120 mg LY2127399 subcutaneous injection Q12W for 24 weeks (Weeks 0 and 12) and a placebo subcutaneous injection Q4W for 24 weeks (except Weeks 0 and 12).
No study drug was administered during the post-study treatment follow-up.
5
35
14
35
EG013
Placebo, Post-Study Treatment Follow-Up
AEs that started or worsened after Week 24 or ED through long-term follow-up (up to Week 108) for participants who received a placebo subcutaneous injection Q4W for 24 weeks.
No study drug was administered during the post-study treatment follow-up.
2
35
12
35
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
LEFT VENTRICULAR DYSFUNCTION
Cardiac disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG0030 events0 affected36 at risk
EG0040 events0 affected36 at risk
EG0050 events0 affected35 at risk
EG0060 events0 affected35 at risk
EG0070 events0 affected35 at risk
EG0080 events0 affected34 at risk
EG0091 events1 affected34 at risk
EG0100 events0 affected36 at risk
EG0110 events0 affected36 at risk
EG0120 events0 affected35 at risk
EG0130 events0 affected35 at risk
MYOCARDIAL INFARCTION
Cardiac disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
HEART DISEASE CONGENITAL
Congenital, familial and genetic disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
CHEST PAIN
General disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
URINARY TRACT INFECTION
Infections and infestations
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
SUBDURAL HAEMATOMA
Injury, poisoning and procedural complications
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
BREAST CANCER
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
BREAST CANCER IN SITU
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
AXONAL NEUROPATHY
Nervous system disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0021 events1 affected34 at risk
EG003
BALANCE DISORDER
Nervous system disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
MULTIPLE SCLEROSIS
Nervous system disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0011 events1 affected34 at risk
EG0020 events0 affected34 at risk
EG003
MULTIPLE SCLEROSIS RELAPSE
Nervous system disorders
15.0
Systematic Assessment
EG0001 events1 affected35 at risk
EG0014 events3 affected34 at risk
EG0021 events1 affected34 at risk
EG003
PARESIS
Nervous system disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
ACUTE PSYCHOSIS
Psychiatric disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
DEPRESSION
Psychiatric disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
SCHIZOPHRENIA
Psychiatric disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
NEPHROLITHIASIS
Renal and urinary disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
TOXIC SKIN ERUPTION
Skin and subcutaneous tissue disorders
15.0
Systematic Assessment
EG0001 events1 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
ANAEMIA
Blood and lymphatic system disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0021 events1 affected34 at risk
EG0030 events0 affected36 at risk
EG0040 events0 affected36 at risk
EG0050 events0 affected35 at risk
EG0060 events0 affected35 at risk
EG0070 events0 affected35 at risk
EG0080 events0 affected34 at risk
EG0090 events0 affected34 at risk
EG0100 events0 affected36 at risk
EG0110 events0 affected36 at risk
EG0120 events0 affected35 at risk
EG0130 events0 affected35 at risk
IRON DEFICIENCY ANAEMIA
Blood and lymphatic system disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
LEUKOCYTOSIS
Blood and lymphatic system disorders
15.0
Systematic Assessment
EG0001 events1 affected35 at risk
EG0010 events0 affected34 at risk
EG0021 events1 affected34 at risk
EG003
ARTERIOSCLEROSIS CORONARY ARTERY
Cardiac disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
ATRIOVENTRICULAR BLOCK FIRST DEGREE
Cardiac disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
BRADYCARDIA
Cardiac disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
BUNDLE BRANCH BLOCK LEFT
Cardiac disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
LEFT VENTRICULAR HYPERTROPHY
Cardiac disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
PALPITATIONS
Cardiac disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
TACHYCARDIA
Cardiac disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0011 events1 affected34 at risk
EG0020 events0 affected34 at risk
EG003
EUSTACHIAN TUBE DYSFUNCTION
Ear and labyrinth disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
EUSTACHIAN TUBE OBSTRUCTION
Ear and labyrinth disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
HYPOACUSIS
Ear and labyrinth disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
TINNITUS
Ear and labyrinth disorders
15.0
Systematic Assessment
EG0001 events1 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
VERTIGO
Ear and labyrinth disorders
15.0
Systematic Assessment
EG0001 events1 affected35 at risk
EG0011 events1 affected34 at risk
EG0020 events0 affected34 at risk
EG003
VERTIGO POSITIONAL
Ear and labyrinth disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
GOITRE
Endocrine disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
HYPERTHYROIDISM
Endocrine disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
CONJUNCTIVITIS
Eye disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0021 events1 affected34 at risk
EG003
DIPLOPIA
Eye disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0011 events1 affected34 at risk
EG0020 events0 affected34 at risk
EG003
DRY EYE
Eye disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
EYE ALLERGY
Eye disorders
15.0
Systematic Assessment
EG0001 events1 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
EYE MOVEMENT DISORDER
Eye disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
EYE PAIN
Eye disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
OPTIC NERVE DISORDER
Eye disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0021 events1 affected34 at risk
EG003
PHOTOPHOBIA
Eye disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
UVEITIS
Eye disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
VISION BLURRED
Eye disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0021 events1 affected34 at risk
EG003
VISUAL ACUITY REDUCED
Eye disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0011 events1 affected34 at risk
EG0020 events0 affected34 at risk
EG003
VISUAL IMPAIRMENT
Eye disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
ABDOMINAL DISCOMFORT
Gastrointestinal disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
ABDOMINAL DISTENSION
Gastrointestinal disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
ABDOMINAL PAIN
Gastrointestinal disorders
15.0
Systematic Assessment
EG0001 events1 affected35 at risk
EG0010 events0 affected34 at risk
EG0022 events2 affected34 at risk
EG003
ABDOMINAL PAIN LOWER
Gastrointestinal disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
ABDOMINAL PAIN UPPER
Gastrointestinal disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0011 events1 affected34 at risk
EG0020 events0 affected34 at risk
EG003
APHTHOUS STOMATITIS
Gastrointestinal disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
COLITIS
Gastrointestinal disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
CONSTIPATION
Gastrointestinal disorders
15.0
Systematic Assessment
EG0002 events2 affected35 at risk
EG0010 events0 affected34 at risk
EG0021 events1 affected34 at risk
EG003
DIARRHOEA
Gastrointestinal disorders
15.0
Systematic Assessment
EG0004 events3 affected35 at risk
EG0012 events2 affected34 at risk
EG0020 events0 affected34 at risk
EG003
DIVERTICULUM
Gastrointestinal disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
DRY MOUTH
Gastrointestinal disorders
15.0
Systematic Assessment
EG0001 events1 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
DYSPEPSIA
Gastrointestinal disorders
15.0
Systematic Assessment
EG0001 events1 affected35 at risk
EG0010 events0 affected34 at risk
EG0021 events1 affected34 at risk
EG003
DYSPHAGIA
Gastrointestinal disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0021 events1 affected34 at risk
EG003
FAECAL INCONTINENCE
Gastrointestinal disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
GASTROINTESTINAL MOTILITY DISORDER
Gastrointestinal disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
HAEMORRHOIDS
Gastrointestinal disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
INGUINAL HERNIA
Gastrointestinal disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
MOUTH HAEMORRHAGE
Gastrointestinal disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
NAUSEA
Gastrointestinal disorders
15.0
Systematic Assessment
EG0006 events4 affected35 at risk
EG0011 events1 affected34 at risk
EG0025 events3 affected34 at risk
EG003
ORAL PAIN
Gastrointestinal disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0021 events1 affected34 at risk
EG003
PARAESTHESIA ORAL
Gastrointestinal disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
TOOTHACHE
Gastrointestinal disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
VOMITING
Gastrointestinal disorders
15.0
Systematic Assessment
EG0002 events2 affected35 at risk
EG0011 events1 affected34 at risk
EG0020 events0 affected34 at risk
EG003
ASTHENIA
General disorders
15.0
Systematic Assessment
EG0001 events1 affected35 at risk
EG0011 events1 affected34 at risk
EG0020 events0 affected34 at risk
EG003
CHEST DISCOMFORT
General disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
CHEST PAIN
General disorders
15.0
Systematic Assessment
EG0001 events1 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
CHILLS
General disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
CYST
General disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
ENERGY INCREASED
General disorders
15.0
Systematic Assessment
EG0001 events1 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
FACIAL PAIN
General disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
FATIGUE
General disorders
15.0
Systematic Assessment
EG0004 events4 affected35 at risk
EG0014 events4 affected34 at risk
EG0023 events3 affected34 at risk
EG003
FEELING COLD
General disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
FEELING HOT
General disorders
15.0
Systematic Assessment
EG0002 events2 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
GAIT DISTURBANCE
General disorders
15.0
Systematic Assessment
EG0001 events1 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
HYPERPYREXIA
General disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
INFLUENZA LIKE ILLNESS
General disorders
15.0
Systematic Assessment
EG0001 events1 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
INJECTION SITE ERYTHEMA
General disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
INJECTION SITE HAEMATOMA
General disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0021 events1 affected34 at risk
EG003
INJECTION SITE OEDEMA
General disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
INJECTION SITE PAIN
General disorders
15.0
Systematic Assessment
EG0002 events1 affected35 at risk
EG0018 events4 affected34 at risk
EG0028 events3 affected34 at risk
EG003
INJECTION SITE REACTION
General disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0011 events1 affected34 at risk
EG0020 events0 affected34 at risk
EG003
IRRITABILITY
General disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0013 events1 affected34 at risk
EG0021 events1 affected34 at risk
EG003
MALAISE
General disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
OEDEMA
General disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
OEDEMA PERIPHERAL
General disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0011 events1 affected34 at risk
EG0020 events0 affected34 at risk
EG003
PAIN
General disorders
15.0
Systematic Assessment
EG0001 events1 affected35 at risk
EG0010 events0 affected34 at risk
EG0021 events1 affected34 at risk
EG003
PYREXIA
General disorders
15.0
Systematic Assessment
EG0001 events1 affected35 at risk
EG0011 events1 affected34 at risk
EG0021 events1 affected34 at risk
EG003
SENSATION OF FOREIGN BODY
General disorders
15.0
Systematic Assessment
EG0001 events1 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
TEMPERATURE INTOLERANCE
General disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
CONTRAST MEDIA ALLERGY
Immune system disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0021 events1 affected34 at risk
EG003
DRUG HYPERSENSITIVITY
Immune system disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
HYPERSENSITIVITY
Immune system disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
SEASONAL ALLERGY
Immune system disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
ACUTE SINUSITIS
Infections and infestations
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
BRONCHITIS
Infections and infestations
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0021 events1 affected34 at risk
EG003
BRONCHITIS VIRAL
Infections and infestations
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0021 events1 affected34 at risk
EG003
CELLULITIS
Infections and infestations
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
CERVICITIS
Infections and infestations
15.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected27 at risk
EG003
CYSTITIS
Infections and infestations
15.0
Systematic Assessment
EG0001 events1 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
DERMATITIS INFECTED
Infections and infestations
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
DIVERTICULITIS
Infections and infestations
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
EAR INFECTION
Infections and infestations
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
EYE INFECTION
Infections and infestations
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0011 events1 affected34 at risk
EG0020 events0 affected34 at risk
EG003
FUNGAL INFECTION
Infections and infestations
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
FURUNCLE
Infections and infestations
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
GASTROENTERITIS
Infections and infestations
15.0
Systematic Assessment
EG0001 events1 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
GASTROENTERITIS VIRAL
Infections and infestations
15.0
Systematic Assessment
EG0001 events1 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
HEPATITIS B
Infections and infestations
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
HERPES SIMPLEX
Infections and infestations
15.0
Systematic Assessment
EG0002 events1 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
HERPES ZOSTER
Infections and infestations
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
INFLUENZA
Infections and infestations
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0022 events2 affected34 at risk
EG003
LARYNGITIS
Infections and infestations
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0012 events1 affected34 at risk
EG0020 events0 affected34 at risk
EG003
LOCALISED INFECTION
Infections and infestations
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
NASOPHARYNGITIS
Infections and infestations
15.0
Systematic Assessment
EG0003 events3 affected35 at risk
EG0011 events1 affected34 at risk
EG0021 events1 affected34 at risk
EG003
ORAL CANDIDIASIS
Infections and infestations
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
ORAL HERPES
Infections and infestations
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0023 events2 affected34 at risk
EG003
OTITIS EXTERNA
Infections and infestations
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0011 events1 affected34 at risk
EG0020 events0 affected34 at risk
EG003
OTITIS MEDIA
Infections and infestations
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
PARONYCHIA
Infections and infestations
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
PHARYNGITIS
Infections and infestations
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0011 events1 affected34 at risk
EG0021 events1 affected34 at risk
EG003
PHARYNGITIS STREPTOCOCCAL
Infections and infestations
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
POSTOPERATIVE WOUND INFECTION
Infections and infestations
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
RESPIRATORY TRACT INFECTION
Infections and infestations
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
RESPIRATORY TRACT INFECTION VIRAL
Infections and infestations
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0022 events1 affected34 at risk
EG003
RHINITIS
Infections and infestations
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
RHINOTRACHEITIS
Infections and infestations
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
SINUSITIS
Infections and infestations
15.0
Systematic Assessment
EG0001 events1 affected35 at risk
EG0015 events5 affected34 at risk
EG0023 events3 affected34 at risk
EG003
STAPHYLOCOCCAL INFECTION
Infections and infestations
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
TOOTH ABSCESS
Infections and infestations
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0012 events1 affected34 at risk
EG0021 events1 affected34 at risk
EG003
UPPER RESPIRATORY TRACT INFECTION
Infections and infestations
15.0
Systematic Assessment
EG0002 events2 affected35 at risk
EG0010 events0 affected34 at risk
EG0021 events1 affected34 at risk
EG003
URINARY TRACT INFECTION
Infections and infestations
15.0
Systematic Assessment
EG0001 events1 affected35 at risk
EG0010 events0 affected34 at risk
EG0025 events4 affected34 at risk
EG003
VAGINAL INFECTION
Infections and infestations
15.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected27 at risk
EG003
VAGINITIS BACTERIAL
Infections and infestations
15.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected27 at risk
EG003
VIRAL INFECTION
Infections and infestations
15.0
Systematic Assessment
EG0001 events1 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
VIRAL RHINITIS
Infections and infestations
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
ALLERGIC TRANSFUSION REACTION
Injury, poisoning and procedural complications
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0011 events1 affected34 at risk
EG0020 events0 affected34 at risk
EG003
ANIMAL BITE
Injury, poisoning and procedural complications
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
ARTHROPOD BITE
Injury, poisoning and procedural complications
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
ARTHROPOD STING
Injury, poisoning and procedural complications
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0021 events1 affected34 at risk
EG003
CONTUSION
Injury, poisoning and procedural complications
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0021 events1 affected34 at risk
EG003
EXCORIATION
Injury, poisoning and procedural complications
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
FALL
Injury, poisoning and procedural complications
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0021 events1 affected34 at risk
EG003
FOOT FRACTURE
Injury, poisoning and procedural complications
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
FOREIGN BODY
Injury, poisoning and procedural complications
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
LACERATION
Injury, poisoning and procedural complications
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0021 events1 affected34 at risk
EG003
LIGAMENT SPRAIN
Injury, poisoning and procedural complications
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
LIMB INJURY
Injury, poisoning and procedural complications
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
MENISCUS LESION
Injury, poisoning and procedural complications
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
MUSCLE STRAIN
Injury, poisoning and procedural complications
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
POST-TRAUMATIC PAIN
Injury, poisoning and procedural complications
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
PROCEDURAL PAIN
Injury, poisoning and procedural complications
15.0
Systematic Assessment
EG0006 events1 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
PUBIS FRACTURE
Injury, poisoning and procedural complications
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
SOFT TISSUE INJURY
Injury, poisoning and procedural complications
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
THERMAL BURN
Injury, poisoning and procedural complications
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
TOOTH FRACTURE
Injury, poisoning and procedural complications
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
TRAUMATIC HAEMATOMA
Injury, poisoning and procedural complications
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
ALANINE AMINOTRANSFERASE INCREASED
Investigations
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
AMYLASE INCREASED
Investigations
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
ASPARTATE AMINOTRANSFERASE INCREASED
Investigations
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
BLOOD BILIRUBIN INCREASED
Investigations
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
BLOOD CHOLESTEROL INCREASED
Investigations
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
BLOOD PRESSURE INCREASED
Investigations
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
BODY TEMPERATURE INCREASED
Investigations
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
CREATININE RENAL CLEARANCE DECREASED
Investigations
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0021 events1 affected34 at risk
EG003
ELECTROCARDIOGRAM ABNORMAL
Investigations
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0021 events1 affected34 at risk
EG003
ELECTROCARDIOGRAM QT INTERVAL ABNORMAL
Investigations
15.0
Systematic Assessment
EG0001 events1 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
ELECTROCARDIOGRAM QT PROLONGED
Investigations
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0021 events1 affected34 at risk
EG003
HAEMOGLOBIN A PRESENT
Investigations
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
HEPATIC ENZYME INCREASED
Investigations
15.0
Systematic Assessment
EG0001 events1 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
HEPATITIS B CORE ANTIBODY POSITIVE
Investigations
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
HEPATITIS B SURFACE ANTIBODY POSITIVE
Investigations
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
LIPASE INCREASED
Investigations
15.0
Systematic Assessment
EG0001 events1 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
LIVER FUNCTION TEST ABNORMAL
Investigations
15.0
Systematic Assessment
EG0001 events1 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
NEUTROPHIL COUNT DECREASED
Investigations
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
NEUTROPHIL COUNT INCREASED
Investigations
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
URINE LEUKOCYTE ESTERASE POSITIVE
Investigations
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0021 events1 affected34 at risk
EG003
WEIGHT DECREASED
Investigations
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
DECREASED APPETITE
Metabolism and nutrition disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0011 events1 affected34 at risk
EG0020 events0 affected34 at risk
EG003
DIABETES MELLITUS
Metabolism and nutrition disorders
15.0
Systematic Assessment
EG0001 events1 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
FLUID RETENTION
Metabolism and nutrition disorders
15.0
Systematic Assessment
EG0001 events1 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
HYPERCHOLESTEROLAEMIA
Metabolism and nutrition disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
HYPERGLYCAEMIA
Metabolism and nutrition disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
HYPOCALCAEMIA
Metabolism and nutrition disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
OBESITY
Metabolism and nutrition disorders
15.0
Systematic Assessment
EG0001 events1 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
VITAMIN D DEFICIENCY
Metabolism and nutrition disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
ARTHRALGIA
Musculoskeletal and connective tissue disorders
15.0
Systematic Assessment
EG0001 events1 affected35 at risk
EG0011 events1 affected34 at risk
EG0023 events2 affected34 at risk
EG003
BACK PAIN
Musculoskeletal and connective tissue disorders
15.0
Systematic Assessment
EG0002 events2 affected35 at risk
EG0012 events1 affected34 at risk
EG0022 events2 affected34 at risk
EG003
FIBROMYALGIA
Musculoskeletal and connective tissue disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
FLANK PAIN
Musculoskeletal and connective tissue disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
JOINT EFFUSION
Musculoskeletal and connective tissue disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
JOINT STIFFNESS
Musculoskeletal and connective tissue disorders
15.0
Systematic Assessment
EG0001 events1 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
JOINT SWELLING
Musculoskeletal and connective tissue disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0021 events1 affected34 at risk
EG003
MUSCLE SPASMS
Musculoskeletal and connective tissue disorders
15.0
Systematic Assessment
EG0001 events1 affected35 at risk
EG0012 events2 affected34 at risk
EG0021 events1 affected34 at risk
EG003
MUSCLE TIGHTNESS
Musculoskeletal and connective tissue disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
MUSCLE TWITCHING
Musculoskeletal and connective tissue disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
MUSCULAR WEAKNESS
Musculoskeletal and connective tissue disorders
15.0
Systematic Assessment
EG0001 events1 affected35 at risk
EG0011 events1 affected34 at risk
EG0022 events2 affected34 at risk
EG003
MUSCULOSKELETAL PAIN
Musculoskeletal and connective tissue disorders
15.0
Systematic Assessment
EG0001 events1 affected35 at risk
EG0011 events1 affected34 at risk
EG0021 events1 affected34 at risk
EG003
MUSCULOSKELETAL STIFFNESS
Musculoskeletal and connective tissue disorders
15.0
Systematic Assessment
EG0002 events2 affected35 at risk
EG0011 events1 affected34 at risk
EG0020 events0 affected34 at risk
EG003
MYALGIA
Musculoskeletal and connective tissue disorders
15.0
Systematic Assessment
EG0001 events1 affected35 at risk
EG0011 events1 affected34 at risk
EG0020 events0 affected34 at risk
EG003
NECK PAIN
Musculoskeletal and connective tissue disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0021 events1 affected34 at risk
EG003
OSTEOARTHRITIS
Musculoskeletal and connective tissue disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0022 events2 affected34 at risk
EG003
OSTEOPOROSIS
Musculoskeletal and connective tissue disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0021 events1 affected34 at risk
EG003
PAIN IN EXTREMITY
Musculoskeletal and connective tissue disorders
15.0
Systematic Assessment
EG0001 events1 affected35 at risk
EG0010 events0 affected34 at risk
EG0022 events2 affected34 at risk
EG003
PERIARTHRITIS
Musculoskeletal and connective tissue disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
ROTATOR CUFF SYNDROME
Musculoskeletal and connective tissue disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
SENSATION OF HEAVINESS
Musculoskeletal and connective tissue disorders
15.0
Systematic Assessment
EG0001 events1 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
SYNOVIAL CYST
Musculoskeletal and connective tissue disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
TENDONITIS
Musculoskeletal and connective tissue disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
BASAL CELL CARCINOMA
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0011 events1 affected34 at risk
EG0020 events0 affected34 at risk
EG003
BENIGN UTERINE NEOPLASM
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
LIPOMA
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0021 events1 affected34 at risk
EG003
SEBORRHOEIC KERATOSIS
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
SKIN PAPILLOMA
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
THYROID NEOPLASM
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
UTERINE LEIOMYOMA
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
15.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected27 at risk
EG003
APHASIA
Nervous system disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
AREFLEXIA
Nervous system disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
ATAXIA
Nervous system disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
BALANCE DISORDER
Nervous system disorders
15.0
Systematic Assessment
EG0002 events2 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
BURNING SENSATION
Nervous system disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
COGNITIVE DISORDER
Nervous system disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
DISTURBANCE IN ATTENTION
Nervous system disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
DIZZINESS
Nervous system disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0011 events1 affected34 at risk
EG0022 events2 affected34 at risk
EG003
DROOLING
Nervous system disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0011 events1 affected34 at risk
EG0020 events0 affected34 at risk
EG003
DYSKINESIA
Nervous system disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0021 events1 affected34 at risk
EG003
FACIAL SPASM
Nervous system disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
HEAD DISCOMFORT
Nervous system disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
HEADACHE
Nervous system disorders
15.0
Systematic Assessment
EG00012 events5 affected35 at risk
EG0015 events3 affected34 at risk
EG0025 events4 affected34 at risk
EG003
HYPOAESTHESIA
Nervous system disorders
15.0
Systematic Assessment
EG0001 events1 affected35 at risk
EG0013 events1 affected34 at risk
EG0020 events0 affected34 at risk
EG003
LETHARGY
Nervous system disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
MEMORY IMPAIRMENT
Nervous system disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
MIGRAINE
Nervous system disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
MONOPARESIS
Nervous system disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0021 events1 affected34 at risk
EG003
MULTIPLE SCLEROSIS RELAPSE
Nervous system disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
NEURALGIA
Nervous system disorders
15.0
Systematic Assessment
EG0002 events2 affected35 at risk
EG0012 events1 affected34 at risk
EG0021 events1 affected34 at risk
EG003
NEUROPATHY PERIPHERAL
Nervous system disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0021 events1 affected34 at risk
EG003
NYSTAGMUS
Nervous system disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
OPTIC NEURITIS
Nervous system disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
PARAESTHESIA
Nervous system disorders
15.0
Systematic Assessment
EG0003 events2 affected35 at risk
EG0011 events1 affected34 at risk
EG0020 events0 affected34 at risk
EG003
PRESYNCOPE
Nervous system disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0011 events1 affected34 at risk
EG0020 events0 affected34 at risk
EG003
RADICULOPATHY
Nervous system disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0011 events1 affected34 at risk
EG0020 events0 affected34 at risk
EG003
RESTLESS LEGS SYNDROME
Nervous system disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0021 events1 affected34 at risk
EG003
SCIATICA
Nervous system disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0011 events1 affected34 at risk
EG0020 events0 affected34 at risk
EG003
SENSORY DISTURBANCE
Nervous system disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0022 events1 affected34 at risk
EG003
SENSORY LOSS
Nervous system disorders
15.0
Systematic Assessment
EG0001 events1 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
SYNCOPE
Nervous system disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0011 events1 affected34 at risk
EG0021 events1 affected34 at risk
EG003
TENSION HEADACHE
Nervous system disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
TREMOR
Nervous system disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0011 events1 affected34 at risk
EG0020 events0 affected34 at risk
EG003
AFFECT LABILITY
Psychiatric disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0021 events1 affected34 at risk
EG003
ALCOHOL ABUSE
Psychiatric disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
ANXIETY
Psychiatric disorders
15.0
Systematic Assessment
EG0001 events1 affected35 at risk
EG0010 events0 affected34 at risk
EG0022 events2 affected34 at risk
EG003
CLAUSTROPHOBIA
Psychiatric disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
DEPRESSED MOOD
Psychiatric disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0021 events1 affected34 at risk
EG003
DEPRESSION
Psychiatric disorders
15.0
Systematic Assessment
EG0001 events1 affected35 at risk
EG0015 events3 affected34 at risk
EG0021 events1 affected34 at risk
EG003
HALLUCINATION, VISUAL
Psychiatric disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
INSOMNIA
Psychiatric disorders
15.0
Systematic Assessment
EG0001 events1 affected35 at risk
EG0012 events2 affected34 at risk
EG0021 events1 affected34 at risk
EG003
NERVOUSNESS
Psychiatric disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
PANIC ATTACK
Psychiatric disorders
15.0
Systematic Assessment
EG0001 events1 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
SLEEP DISORDER
Psychiatric disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0011 events1 affected34 at risk
EG0020 events0 affected34 at risk
EG003
BLADDER IRRITATION
Renal and urinary disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0021 events1 affected34 at risk
EG003
DYSURIA
Renal and urinary disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
HAEMATURIA
Renal and urinary disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0021 events1 affected34 at risk
EG003
INCONTINENCE
Renal and urinary disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
MICTURITION URGENCY
Renal and urinary disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0021 events1 affected34 at risk
EG003
NEUROGENIC BLADDER
Renal and urinary disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
URETHRAL POLYP
Renal and urinary disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
URINARY INCONTINENCE
Renal and urinary disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
URINARY RETENTION
Renal and urinary disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
URINE FLOW DECREASED
Renal and urinary disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
ATROPHIC VULVOVAGINITIS
Reproductive system and breast disorders
15.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected27 at risk
EG003
CYSTOCELE
Reproductive system and breast disorders
15.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected27 at risk
EG003
ENDOMETRIOSIS
Reproductive system and breast disorders
15.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected27 at risk
EG003
EPIDIDYMITIS
Reproductive system and breast disorders
15.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected7 at risk
EG003
MENORRHAGIA
Reproductive system and breast disorders
15.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected27 at risk
EG003
MENSTRUATION DELAYED
Reproductive system and breast disorders
15.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected22 at risk
EG0021 events1 affected27 at risk
EG003
MENSTRUATION IRREGULAR
Reproductive system and breast disorders
15.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected27 at risk
EG003
OVARIAN ADHESION
Reproductive system and breast disorders
15.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected27 at risk
EG003
OVARIAN CYST
Reproductive system and breast disorders
15.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected27 at risk
EG003
VULVOVAGINAL DISCOMFORT
Reproductive system and breast disorders
15.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected27 at risk
EG003
COUGH
Respiratory, thoracic and mediastinal disorders
15.0
Systematic Assessment
EG0002 events2 affected35 at risk
EG0011 events1 affected34 at risk
EG0020 events0 affected34 at risk
EG003
DYSPHONIA
Respiratory, thoracic and mediastinal disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0021 events1 affected34 at risk
EG003
EPISTAXIS
Respiratory, thoracic and mediastinal disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0011 events1 affected34 at risk
EG0020 events0 affected34 at risk
EG003
NASAL CONGESTION
Respiratory, thoracic and mediastinal disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0011 events1 affected34 at risk
EG0020 events0 affected34 at risk
EG003
OROPHARYNGEAL PAIN
Respiratory, thoracic and mediastinal disorders
15.0
Systematic Assessment
EG0009 events3 affected35 at risk
EG0010 events0 affected34 at risk
EG0021 events1 affected34 at risk
EG003
PRODUCTIVE COUGH
Respiratory, thoracic and mediastinal disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
PULMONARY HYPERTENSION
Respiratory, thoracic and mediastinal disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
RESPIRATION ABNORMAL
Respiratory, thoracic and mediastinal disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
RESPIRATORY TRACT CONGESTION
Respiratory, thoracic and mediastinal disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0021 events1 affected34 at risk
EG003
RHINITIS ALLERGIC
Respiratory, thoracic and mediastinal disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0011 events1 affected34 at risk
EG0021 events1 affected34 at risk
EG003
RHINORRHOEA
Respiratory, thoracic and mediastinal disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
SINUS CONGESTION
Respiratory, thoracic and mediastinal disorders
15.0
Systematic Assessment
EG0001 events1 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
THROAT TIGHTNESS
Respiratory, thoracic and mediastinal disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0021 events1 affected34 at risk
EG003
ACNE
Skin and subcutaneous tissue disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0021 events1 affected34 at risk
EG003
ALOPECIA
Skin and subcutaneous tissue disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
BLISTER
Skin and subcutaneous tissue disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
DERMATITIS
Skin and subcutaneous tissue disorders
15.0
Systematic Assessment
EG0001 events1 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
DERMATITIS ALLERGIC
Skin and subcutaneous tissue disorders
15.0
Systematic Assessment
EG0001 events1 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
ECCHYMOSIS
Skin and subcutaneous tissue disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0021 events1 affected34 at risk
EG003
HAIR TEXTURE ABNORMAL
Skin and subcutaneous tissue disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
LICHEN PLANUS
Skin and subcutaneous tissue disorders
15.0
Systematic Assessment
EG0001 events1 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
NIGHT SWEATS
Skin and subcutaneous tissue disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
PRURITUS
Skin and subcutaneous tissue disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
RASH
Skin and subcutaneous tissue disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0011 events1 affected34 at risk
EG0020 events0 affected34 at risk
EG003
RASH MACULAR
Skin and subcutaneous tissue disorders
15.0
Systematic Assessment
EG0001 events1 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
RASH MACULO-PAPULAR
Skin and subcutaneous tissue disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0021 events1 affected34 at risk
EG003
RASH PAPULAR
Skin and subcutaneous tissue disorders
15.0
Systematic Assessment
EG0001 events1 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
SCAR
Skin and subcutaneous tissue disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0021 events1 affected34 at risk
EG003
SKIN DISORDER
Skin and subcutaneous tissue disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0011 events1 affected34 at risk
EG0020 events0 affected34 at risk
EG003
SKIN SWELLING
Skin and subcutaneous tissue disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
URTICARIA
Skin and subcutaneous tissue disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0021 events1 affected34 at risk
EG003
FLUSHING
Vascular disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0021 events1 affected34 at risk
EG003
HAEMATOMA
Vascular disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
HYPERTENSION
Vascular disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0011 events1 affected34 at risk
EG0020 events0 affected34 at risk
EG003
PERIPHERAL COLDNESS
Vascular disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
PHLEBITIS
Vascular disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
VENOUS INSUFFICIENCY
Vascular disorders
15.0
Systematic Assessment
EG0001 events1 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
VENOUS STENOSIS
Vascular disorders
15.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
GT60
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Not provided
Point of Contact
Title
Organization
Phone
Extension
Email
Chief Medical Officer
Eli Lilly and Company
800-545-5979
ID
Term
D020529
Multiple Sclerosis, Relapsing-Remitting
D012008
Recurrence
D009103
Multiple Sclerosis
D012598
Sclerosis
Ancestor Terms
ID
Term
D020278
Demyelinating Autoimmune Diseases, CNS
D020274
Autoimmune Diseases of the Nervous System
D009422
Nervous System Diseases
D003711
Demyelinating Diseases
D001327
Autoimmune Diseases
D007154
Immune System Diseases
D020969
Disease Attributes
D010335
Pathologic Processes
D013568
Pathological Conditions, Signs and Symptoms
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C575974
tabalumab
Ancestor Terms
Not provided
Browse Leaves
Not provided
Browse Branches
Not provided
0 subjects
FG0050 subjects
FG0060 subjects
6 subjects
FG0055 subjects
FG0065 subjects
1 subjects
FG0051 subjects
FG0062 subjects
0 subjects
FG0051 subjects
FG0061 subjects
40.8
± 11.10
BG00443.1± 10.62
BG00539.0± 10.16
BG00640.3± 12.02
BG00741.3± 10.69
27
BG00321
BG00427
BG00524
BG00624
BG007169
Male
BG00011
BG00112
BG0027
BG00315
BG0049
BG00511
BG00611
BG00776
0
BG0031
BG0042
BG0050
BG0061
BG0074
Not Hispanic or Latino
BG00035
BG00134
BG00234
BG00335
BG00434
BG00535
BG00634
BG007241
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
0
BG0030
BG0040
BG0050
BG0060
BG0070
Asian
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
Native Hawaiian or Other Pacific Islander
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
Black or African American
BG0004
BG0010
BG0020
BG0032
BG0046
BG0052
BG0063
BG00717
White
BG00031
BG00134
BG00234
BG00334
BG00430
BG00533
BG00632
BG007228
More than one race
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
15
BG00315
BG00422
BG00518
BG00614
BG007108
Slovakia
Title
Measurements
BG0005
BG0015
BG0023
BG0036
BG0043
BG0054
BG0066
BG00732
Ukraine
Title
Measurements
BG0002
BG0012
BG0021
BG0031
BG0040
BG0052
BG0060
BG0078
Israel
Title
Measurements
BG0000
BG0011
BG0020
BG0030
BG0040
BG0050
BG0061
BG0072
Russia
Title
Measurements
BG0002
BG0011
BG0024
BG0033
BG0041
BG0051
BG0061
BG00713
France
Title
Measurements
BG0000
BG0010
BG0021
BG0030
BG0041
BG0051
BG0061
BG0074
Czechia
Title
Measurements
BG0000
BG0012
BG0021
BG0030
BG0040
BG0052
BG0061
BG0076
Hungary
Title
Measurements
BG0002
BG0011
BG0020
BG0031
BG0040
BG0050
BG0061
BG0075
Poland
Title
Measurements
BG0003
BG0015
BG0022
BG0033
BG0045
BG0052
BG0063
BG00723
Romania
Title
Measurements
BG0001
BG0011
BG0021
BG0032
BG0040
BG0051
BG0062
BG0078
Bulgaria
Title
Measurements
BG0000
BG0011
BG0020
BG0031
BG0040
BG0051
BG0060
BG0073
Finland
Title
Measurements
BG0002
BG0012
BG0020
BG0030
BG0040
BG0050
BG0061
BG0075
Germany
Title
Measurements
BG0000
BG0011
BG0020
BG0031
BG0040
BG0050
BG0060
BG0072
Canada
Title
Measurements
BG0004
BG0012
BG0025
BG0033
BG0044
BG0053
BG0064
BG00725
9.2
± 7.49
BG0038.9± 9.52
BG0047.8± 5.93
BG0059.2± 8.48
BG0067.4± 6.70
BG0078.6± 7.58
5.4
± 6.67
BG0035.0± 7.50
BG0045.0± 5.03
BG0056.0± 5.73
BG0063.8± 4.88
BG0075.3± 6.21
1.4
± 0.73
BG0031.2± 0.56
BG0041.4± 1.11
BG0051.5± 0.89
BG0061.5± 1.38
BG0071.4± 0.97
± 0.93
BG0021.1± 1.91
BG0031.4± 2.60
BG0041.3± 2.41
BG0051.2± 2.11
BG0061.2± 2.08
BG0071.1± 2.16
BG002
6.6
± 7.92
BG0039.0± 11.90
BG00410.1± 13.90
BG0057.1± 7.66
BG0067.0± 8.07
BG0078.0± 10.10
36
OG00436
OG00534
OG00633
1.477
± 2.834
OG0042.319± 4.145
OG0051.422± 3.058
OG0061.758± 3.615
LY2127399: 120 mg subcutaneous injection Q4W for 24 weeks.
OG004
4 mg LY2127399 Q12W
LY2127399: 4 mg subcutaneous injection Q12W for 24 weeks (Weeks 0 and 12).
Placebo: Subcutaneous injection Q4W for 24 weeks (except Weeks 0 and 12).
OG005
120 mg LY2127399 Q12W
LY2127399: 120 mg subcutaneous injection Q12W for 24 weeks (Weeks 0 and 12).
Placebo: Subcutaneous injection Q4W for 24 weeks (except Weeks 0 and 12).
OG006
Placebo
Placebo: Subcutaneous injection Q4W for 24 weeks.
Units
Counts
Participants
OG00034
OG00133
OG00231
OG00336
OG00436
OG00534
OG00634
Title
Denominators
Categories
Week 4
ParticipantsOG00034
ParticipantsOG00131
ParticipantsOG00231
ParticipantsOG00336
ParticipantsOG00435
ParticipantsOG00534
ParticipantsOG00634
Title
Measurements
OG000-0.2± 0.09
OG001-0.3± 0.09
OG002-0.3± 0.09
OG003
Week 8
ParticipantsOG00033
ParticipantsOG00133
ParticipantsOG00231
ParticipantsOG00335
Week 12
ParticipantsOG00032
ParticipantsOG00128
ParticipantsOG00230
ParticipantsOG00335
Week 16
ParticipantsOG00033
ParticipantsOG00127
ParticipantsOG00230
ParticipantsOG00334
Week 20
ParticipantsOG00027
ParticipantsOG00128
ParticipantsOG00230
ParticipantsOG00334
Week 24
ParticipantsOG00028
ParticipantsOG00128
ParticipantsOG00229
ParticipantsOG00332
Week 36
ParticipantsOG00026
ParticipantsOG00126
ParticipantsOG00231
ParticipantsOG00332
Week 48
ParticipantsOG00026
ParticipantsOG00125
ParticipantsOG00227
ParticipantsOG00331
OG004
4 mg LY2127399 Q12W
LY2127399: 4 mg subcutaneous injection Q12W for 24 weeks (Weeks 0 and 12).
Placebo: Subcutaneous injection Q4W for 24 weeks (except Weeks 0 and 12).
OG005
120 mg LY2127399 Q12W
LY2127399: 120 mg subcutaneous injection Q12W for 24 weeks (Weeks 0 and 12).
Placebo: Subcutaneous injection Q4W for 24 weeks (except Weeks 0 and 12).
OG006
Placebo
Placebo: Subcutaneous injection Q4W for 24 weeks.
Units
Counts
Participants
OG00034
OG00133
OG00231
OG00336
OG00436
OG00534
OG00634
Title
Denominators
Categories
Week 4
ParticipantsOG00034
ParticipantsOG00131
ParticipantsOG00231
ParticipantsOG00336
ParticipantsOG00435
ParticipantsOG00534
ParticipantsOG00634
Title
Measurements
OG0001.1± 1.67
OG0010.6± 1.09
OG0020.6± 1.23
OG003
Week 8
ParticipantsOG00033
ParticipantsOG00133
ParticipantsOG00231
ParticipantsOG00335
Week 12
ParticipantsOG00032
ParticipantsOG00128
ParticipantsOG00230
ParticipantsOG00335
Week 16
ParticipantsOG00033
ParticipantsOG00127
ParticipantsOG00230
ParticipantsOG00334
Week 20
ParticipantsOG00027
ParticipantsOG00128
ParticipantsOG00230
ParticipantsOG00334
Week 24
ParticipantsOG00028
ParticipantsOG00128
ParticipantsOG00229
ParticipantsOG00332
Week 36
ParticipantsOG00026
ParticipantsOG00126
ParticipantsOG00231
ParticipantsOG00332
Week 48
ParticipantsOG00026
ParticipantsOG00125
ParticipantsOG00227
ParticipantsOG00331
LY2127399: 4 mg subcutaneous injection Q12W for 24 weeks (Weeks 0 and 12).
Placebo: Subcutaneous injection Q4W for 24 weeks (except Weeks 0 and 12).
OG005
120 mg LY2127399 Q12W
LY2127399: 120 mg subcutaneous injection Q12W for 24 weeks (Weeks 0 and 12).
Placebo: Subcutaneous injection Q4W for 24 weeks (except Weeks 0 and 12).
OG006
Placebo
Placebo: Subcutaneous injection Q4W for 24 weeks.
Units
Counts
Participants
OG00034
OG00133
OG00231
OG00336
OG00436
OG00534
OG00634
Title
Denominators
Categories
Week 4
ParticipantsOG00034
ParticipantsOG00131
ParticipantsOG00231
ParticipantsOG00336
ParticipantsOG00435
ParticipantsOG00534
ParticipantsOG00634
Title
Measurements
OG0001.5± 2.21
OG0010.7± 1.39
OG0020.7± 1.46
OG003
Week 8
ParticipantsOG00033
ParticipantsOG00133
ParticipantsOG00231
ParticipantsOG00335
Week 12
ParticipantsOG00032
ParticipantsOG00128
ParticipantsOG00230
ParticipantsOG00335
Week 16
ParticipantsOG00033
ParticipantsOG00127
ParticipantsOG00230
ParticipantsOG00334
Week 20
ParticipantsOG00027
ParticipantsOG00128
ParticipantsOG00230
ParticipantsOG00334
Week 24
ParticipantsOG00028
ParticipantsOG00128
ParticipantsOG00229
ParticipantsOG00332
Week 36
ParticipantsOG00026
ParticipantsOG00126
ParticipantsOG00231
ParticipantsOG00332
Week 48
ParticipantsOG00026
ParticipantsOG00125
ParticipantsOG00228
ParticipantsOG00331
LY2127399: 4 mg subcutaneous injection Q12W for 24 weeks (Weeks 0 and 12).
Placebo: Subcutaneous injection Q4W for 24 weeks (except Weeks 0 and 12).
OG005
120 mg LY2127399 Q12W
LY2127399: 120 mg subcutaneous injection Q12W for 24 weeks (Weeks 0 and 12).
Placebo: Subcutaneous injection Q4W for 24 weeks (except Weeks 0 and 12).
OG006
Placebo
Placebo: Subcutaneous injection Q4W for 24 weeks.
Units
Counts
Participants
OG00034
OG00133
OG00231
OG00336
OG00436
OG00534
OG00634
Title
Denominators
Categories
Week 4
ParticipantsOG00034
ParticipantsOG00131
ParticipantsOG00231
ParticipantsOG00336
ParticipantsOG00435
ParticipantsOG00534
ParticipantsOG00634
Title
Measurements
OG0008.7± 1.73
OG0017.6± 1.81
OG0026.3± 1.81
OG003
Week 8
ParticipantsOG00033
ParticipantsOG00133
ParticipantsOG00231
ParticipantsOG00335
Week 12
ParticipantsOG00032
ParticipantsOG00128
ParticipantsOG00230
ParticipantsOG00335
Week 16
ParticipantsOG00033
ParticipantsOG00127
ParticipantsOG00230
ParticipantsOG00334
Week 20
ParticipantsOG00027
ParticipantsOG00128
ParticipantsOG00230
ParticipantsOG00334
Week 24
ParticipantsOG00028
ParticipantsOG00128
ParticipantsOG00229
ParticipantsOG00332
Week 36
ParticipantsOG00026
ParticipantsOG00126
ParticipantsOG00231
ParticipantsOG00332
Week 48
ParticipantsOG00026
ParticipantsOG00125
ParticipantsOG00228
ParticipantsOG00331
LY2127399: 120 mg subcutaneous injection Q4W for 24 weeks.
OG004
4 mg LY2127399 Q12W
LY2127399: 4 mg subcutaneous injection Q12W for 24 weeks (Weeks 0 and 12).
Placebo: Subcutaneous injection Q4W for 24 weeks (except Weeks 0 and 12).
OG005
120 mg LY2127399 Q12W
LY2127399: 120 mg subcutaneous injection Q12W for 24 weeks (Weeks 0 and 12).
Placebo: Subcutaneous injection Q4W for 24 weeks (except Weeks 0 and 12).
OG006
Placebo
Placebo: Subcutaneous injection Q4W for 24 weeks.
Units
Counts
Participants
OG00035
OG00132
OG00230
OG00336
OG00436
OG00534
OG00633
Title
Denominators
Categories
Week 12
ParticipantsOG00035
ParticipantsOG00132
ParticipantsOG00230
ParticipantsOG00336
ParticipantsOG00436
ParticipantsOG00534
ParticipantsOG00633
Title
Measurements
OG0002.96± 1.146
OG0012.75± 1.397
OG0022.65± 1.212
OG003
Week 24
ParticipantsOG00029
ParticipantsOG00129
ParticipantsOG00230
ParticipantsOG00332
Week 48
ParticipantsOG00027
ParticipantsOG00126
ParticipantsOG00229
ParticipantsOG00331
LY2127399: 12 mg subcutaneous injection Q4W for 24 weeks.
OG002
40 mg LY2127399 Q4W
LY2127399: 40 mg subcutaneous injection Q4W for 24 weeks.
OG003
120 mg LY2127399 Q4W
LY2127399: 120 mg subcutaneous injection Q4W for 24 weeks.
OG004
4 mg LY2127399 Q12W
LY2127399: 4 mg subcutaneous injection Q12W for 24 weeks (Weeks 0 and 12).
Placebo: Subcutaneous injection Q4W for 24 weeks (except Weeks 0 and 12).
OG005
120 mg LY2127399 Q12W
LY2127399: 120 mg subcutaneous injection Q12W for 24 weeks (Weeks 0 and 12).
Placebo: Subcutaneous injection Q4W for 24 weeks (except Weeks 0 and 12).
OG006
Placebo
Placebo: Subcutaneous injection Q4W for 24 weeks.
Units
Counts
Participants
OG00035
OG00134
OG00233
OG00336
OG00436
OG00535
OG00635
Title
Denominators
Categories
Baseline through Week 24
ParticipantsOG00035
ParticipantsOG00134
ParticipantsOG00233
ParticipantsOG00336
ParticipantsOG00436
ParticipantsOG00535
ParticipantsOG00635
Title
Measurements
OG000139.54± 48.949
OG001141.56± 51.460
OG002154.73± 40.117
OG003
Baseline through Week 48
ParticipantsOG00035
ParticipantsOG00134
ParticipantsOG00233
ParticipantsOG00336
Week 24 through Week 48
ParticipantsOG00029
ParticipantsOG00128
ParticipantsOG00230
ParticipantsOG00333
40 mg LY2127399 Q4W
LY2127399: 40 mg subcutaneous injection Q4W for 24 weeks.
OG003
120 mg LY2127399 Q4W
LY2127399: 120 mg subcutaneous injection Q4W for 24 weeks.
OG004
4 mg LY2127399 Q12W
LY2127399: 4 mg subcutaneous injection Q12W for 24 weeks (Weeks 0 and 12).
Placebo: Subcutaneous injection Q4W for 24 weeks (except Weeks 0 and 12).
OG005
120 mg LY2127399 Q12W
LY2127399: 120 mg subcutaneous injection Q12W for 24 weeks (Weeks 0 and 12).
Placebo: Subcutaneous injection Q4W for 24 weeks (except Weeks 0 and 12).
OG006
Placebo
Placebo: Subcutaneous injection Q4W for 24 weeks.
Units
Counts
Participants
OG00035
OG00134
OG00233
OG00336
OG00436
OG00535
OG00635
Title
Denominators
Categories
Week 24
ParticipantsOG00029
ParticipantsOG00129
ParticipantsOG00231
ParticipantsOG00333
ParticipantsOG00429
ParticipantsOG00531
ParticipantsOG00631
Title
Measurements
OG00072.4
OG00182.8
OG00277.4
OG003
Week 48
ParticipantsOG00027
ParticipantsOG00126
ParticipantsOG00231
ParticipantsOG00332
End of Treatment
ParticipantsOG00035
ParticipantsOG00134
ParticipantsOG00233
ParticipantsOG00336
End of Follow-Up
ParticipantsOG00035
ParticipantsOG00134
ParticipantsOG00233
ParticipantsOG00336
40 mg LY2127399 Q4W
LY2127399: 40 mg subcutaneous injection Q4W for 24 weeks.
OG003
120 mg LY2127399 Q4W
LY2127399: 120 mg subcutaneous injection Q4W for 24 weeks.
OG004
4 mg LY2127399 Q12W
LY2127399: 4 mg subcutaneous injection Q12W for 24 weeks (Weeks 0 and 12).
Placebo: Subcutaneous injection Q4W for 24 weeks (except Weeks 0 and 12).
OG005
120 mg LY2127399 Q12W
LY2127399: 120 mg subcutaneous injection Q12W for 24 weeks (Weeks 0 and 12).
Placebo: Subcutaneous injection Q4W for 24 weeks (except Weeks 0 and 12).
OG006
Placebo
Placebo: Subcutaneous injection Q4W for 24 weeks.
Units
Counts
Participants
OG00035
OG00134
OG00233
OG00336
OG00436
OG00535
OG00635
Title
Denominators
Categories
Week 24
Title
Measurements
OG0000.75± 1.568
OG0010.80± 1.830
OG0020.33± 0.787
OG0030.38± 0.856
OG0040.67± 1.536
OG0050.51± 1.205
OG0060.71± 2.844
Week 48
Title
Measurements
OG0000.67± 1.463
OG0010.64± 1.284
OG0020.36± 0.645
OG003
OG003
120 mg LY2127399 Q4W
LY2127399: 120 mg subcutaneous injection Q4W for 24 weeks.
OG004
4 mg LY2127399 Q12W
LY2127399: 4 mg subcutaneous injection Q12W for 24 weeks (Weeks 0 and 12).
Placebo: Subcutaneous injection Q4W for 24 weeks (except Weeks 0 and 12).
OG005
120 mg LY2127399 Q12W
LY2127399: 120 mg subcutaneous injection Q12W for 24 weeks (Weeks 0 and 12).
Placebo: Subcutaneous injection Q4W for 24 weeks (except Weeks 0 and 12).
OG006
Placebo
Placebo: Subcutaneous injection Q4W for 24 weeks.
Units
Counts
Participants
OG00035
OG00132
OG00231
OG00335
OG00434
OG00534
OG00632
Title
Denominators
Categories
Week 12
ParticipantsOG00035
ParticipantsOG00132
ParticipantsOG00230
ParticipantsOG00335
ParticipantsOG00434
ParticipantsOG00534
ParticipantsOG00632
Title
Measurements
OG0000.11± 0.821
OG0010.08± 0.511
OG002-0.02± 0.385
OG003
Week 24
ParticipantsOG00028
ParticipantsOG00128
ParticipantsOG00231
ParticipantsOG00333
Week 48
ParticipantsOG00027
ParticipantsOG00125
ParticipantsOG00229
ParticipantsOG00331
OG004
4 mg LY2127399 Q12W
LY2127399: 4 mg subcutaneous injection Q12W for 24 weeks (Weeks 0 and 12).
Placebo: Subcutaneous injection Q4W for 24 weeks (except Weeks 0 and 12).
OG005
120 mg LY2127399 Q12W
LY2127399: 120 mg subcutaneous injection Q12W for 24 weeks (Weeks 0 and 12).
Placebo: Subcutaneous injection Q4W for 24 weeks (except Weeks 0 and 12).
OG006
Placebo
Placebo: Subcutaneous injection Q4W for 24 weeks.
Units
Counts
Participants
OG00035
OG00132
OG00231
OG00336
OG00436
OG00533
OG00633
Title
Denominators
Categories
Week 12
ParticipantsOG00035
ParticipantsOG00132
ParticipantsOG00230
ParticipantsOG00336
ParticipantsOG00436
ParticipantsOG00533
ParticipantsOG00633
Title
Measurements
OG00055.86± 24.686
OG00161.09± 20.934
OG00263.20± 24.864
OG003
Week 24
ParticipantsOG00028
ParticipantsOG00129
ParticipantsOG00231
ParticipantsOG00333
Week 48
ParticipantsOG00026
ParticipantsOG00126
ParticipantsOG00229
ParticipantsOG00331
OG002
40 mg LY2127399 Q4W
LY2127399: 40 mg subcutaneous injection Q4W for 24 weeks.
OG003
120 mg LY2127399 Q4W
LY2127399: 120 mg subcutaneous injection Q4W for 24 weeks.
OG004
4 mg LY2127399 Q12W
LY2127399: 4 mg subcutaneous injection Q12W for 24 weeks (Weeks 0 and 12).
Placebo: Subcutaneous injection Q4W for 24 weeks (except Weeks 0 and 12).
OG005
120 mg LY2127399 Q12W
LY2127399: 120 mg subcutaneous injection Q12W for 24 weeks (Weeks 0 and 12).
Placebo: Subcutaneous injection Q4W for 24 weeks (except Weeks 0 and 12).
OG006
Placebo
Placebo: Subcutaneous injection Q4W for 24 weeks.
Units
Counts
Participants
OG00034
OG00132
OG00231
OG00336
OG00436
OG00533
OG00632
Title
Denominators
Categories
Week 12
ParticipantsOG00034
ParticipantsOG00132
ParticipantsOG00230
ParticipantsOG00336
ParticipantsOG00436
ParticipantsOG00533
ParticipantsOG00632
Title
Measurements
OG0007.79± 4.766
OG0016.78± 4.668
OG0027.13± 5.322
OG003
Week 24
ParticipantsOG00028
ParticipantsOG00128
ParticipantsOG00231
ParticipantsOG00333
Week 48
ParticipantsOG00026
ParticipantsOG00126
ParticipantsOG00228
ParticipantsOG00331
40 mg LY2127399 Q4W
LY2127399: 40 mg subcutaneous injection Q4W for 24 weeks.
OG003
120 mg LY2127399 Q4W
LY2127399: 120 mg subcutaneous injection Q4W for 24 weeks.
OG004
4 mg LY2127399 Q12W
LY2127399: 4 mg subcutaneous injection Q12W for 24 weeks (Weeks 0 and 12).
Placebo: Subcutaneous injection Q4W for 24 weeks (except Weeks 0 and 12).
OG005
120 mg LY2127399 Q12W
LY2127399: 120 mg subcutaneous injection Q12W for 24 weeks (Weeks 0 and 12).
Placebo: Subcutaneous injection Q4W for 24 weeks (except Weeks 0 and 12).
OG006
Placebo
Placebo: Subcutaneous injection Q4W for 24 weeks.
Units
Counts
Participants
OG00035
OG00132
OG00231
OG00336
OG00436
OG00533
OG00633
Title
Denominators
Categories
PCS, Week 12
ParticipantsOG00035
ParticipantsOG00132
ParticipantsOG00230
ParticipantsOG00336
ParticipantsOG00436
ParticipantsOG00533
ParticipantsOG00633
Title
Measurements
OG00040.96± 10.673
OG00145.53± 9.511
OG00244.30± 10.298
OG003
MCS, Week 12
ParticipantsOG00035
ParticipantsOG00132
ParticipantsOG00230
ParticipantsOG00336
PCS, Week 24
ParticipantsOG00029
ParticipantsOG00129
ParticipantsOG00231
ParticipantsOG00333
MCS, Week 24
ParticipantsOG00029
ParticipantsOG00129
ParticipantsOG00231
ParticipantsOG00333
PCS, Week 48
ParticipantsOG00026
ParticipantsOG00126
ParticipantsOG00229
ParticipantsOG00331
MCS, Week 48
ParticipantsOG00026
ParticipantsOG00126
ParticipantsOG00229
ParticipantsOG00331
OG004
4 mg LY2127399 Q12W
LY2127399: 4 mg subcutaneous injection Q12W for 24 weeks (Weeks 0 and 12).
Placebo: Subcutaneous injection Q4W for 24 weeks (except Weeks 0 and 12).
OG005
120 mg LY2127399 Q12W
LY2127399: 120 mg subcutaneous injection Q12W for 24 weeks (Weeks 0 and 12).
Placebo: Subcutaneous injection Q4W for 24 weeks (except Weeks 0 and 12).
Units
Counts
Participants
OG00035
OG00134
OG00233
OG00336
OG00436
OG00535
Title
Denominators
Categories
Title
Measurements
OG000161± 127
OG001724± 569
OG0024405± 2010
OG00316603± 5444
OG004146± 108
OG00513608± 5746
4 mg LY2127399 Q12W
LY2127399: 4 mg subcutaneous injection Q12W for 24 weeks (Weeks 0 and 12).
Placebo: Subcutaneous injection Q4W for 24 weeks (except Weeks 0 and 12).
OG005
120 mg LY2127399 Q12W
LY2127399: 120 mg subcutaneous injection Q12W for 24 weeks (Weeks 0 and 12).
Placebo: Subcutaneous injection Q4W for 24 weeks (except Weeks 0 and 12).
OG006
Placebo
Placebo: Subcutaneous injection Q4W for 24 weeks.
Units
Counts
Participants
OG00035
OG00133
OG00233
OG00334
OG00436
OG00535
OG00635
Title
Denominators
Categories
Baseline, Positive ADA
ParticipantsOG00035
ParticipantsOG00133
ParticipantsOG00233
ParticipantsOG00334
ParticipantsOG00435
ParticipantsOG00534
ParticipantsOG00633
Title
Measurements
OG0000
OG0010
OG0020
OG003
Week 4, Positive ADA
ParticipantsOG00035
ParticipantsOG00133
ParticipantsOG00233
ParticipantsOG00334
Week 12, Positive ADA
ParticipantsOG00034
ParticipantsOG00132
ParticipantsOG00230
ParticipantsOG00333
Week 24, Positive ADA
ParticipantsOG00029
ParticipantsOG00129
ParticipantsOG00230
ParticipantsOG00333
Week 48, Positive ADA
ParticipantsOG00026
ParticipantsOG00126
ParticipantsOG00229
ParticipantsOG00331
Week 60, Positive ADA
ParticipantsOG00018
ParticipantsOG00124
ParticipantsOG00222
ParticipantsOG00326
Week 72, Positive ADA
ParticipantsOG00016
ParticipantsOG00123
ParticipantsOG00223
ParticipantsOG00326
Week 84, Positive ADA
ParticipantsOG0003
ParticipantsOG0017
ParticipantsOG0027
ParticipantsOG00312
Week 96, Positive ADA
ParticipantsOG0000
ParticipantsOG0017
ParticipantsOG0026
ParticipantsOG00312
Week 108, Positive ADA
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0031
OG003
120 mg LY2127399 Q4W
LY2127399: 120 mg subcutaneous injection Q4W for 24 weeks.
OG004
4 mg LY2127399 Q12W
LY2127399: 4 mg subcutaneous injection Q12W for 24 weeks (Weeks 0 and 12).
Placebo: Subcutaneous injection Q4W for 24 weeks (except Weeks 0 and 12).
OG005
120 mg LY2127399 Q12W
LY2127399: 120 mg subcutaneous injection Q12W for 24 weeks (Weeks 0 and 12).
Placebo: Subcutaneous injection Q4W for 24 weeks (except Weeks 0 and 12).