An Open Label Extension Study in Participants With Rheuma... | NCT00837811 | Trialant
NCT00837811
Sponsor
Eli Lilly and Company
Status
Completed
Last Update Posted
Apr 25, 2018Actual
Enrollment
182Actual
Phase
Phase 2
Conditions
Rheumatoid Arthritis
Interventions
LY2127399
Countries
United States
Australia
Austria
Belgium
Brazil
Canada
Chile
Germany
Hungary
India
Mexico
Poland
Puerto Rico
Romania
Protocol Section
Identification Module
NCT ID
NCT00837811
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
11768
Secondary IDs
ID
Type
Description
Link
H9B-MC-BCDI
Other Identifier
Eli Lilly and Company
CTRI/2009/091/000765
Registry Identifier
India
Brief Title
An Open Label Extension Study in Participants With Rheumatoid Arthritis
Official Title
An Open Label Extension Study of Multiple Subcutaneous Doses of LY2127399 in Patients With Rheumatoid Arthritis.
Acronym
Not provided
Organization
Eli Lilly and CompanyINDUSTRY
Status Module
Record Verification Date
Mar 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
Feb 2009
Primary Completion Date
Jan 2011Actual
Completion Date
Jan 2012Actual
First Submitted Date
Feb 3, 2009
First Submission Date that Met QC Criteria
Feb 3, 2009
First Posted Date
Feb 5, 2009Estimated
Results Waived
Not provided
Results First Submitted Date
Mar 24, 2018
Results First Submitted that Met QC Criteria
Mar 24, 2018
Results First Posted Date
Apr 25, 2018Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Apr 5, 2011
Certification/Extension First Submitted that Passed QC Review
Apr 5, 2011
Certification/Extension First Posted Date
Apr 13, 2011Estimated
Last Update Submitted Date
Mar 24, 2018
Last Update Posted Date
Apr 25, 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)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
To evaluate the safety and tolerability of LY2127399 administered as subcutaneous injections for 48 weeks in participants with Rheumatoid Arthritis
Detailed Description
Not provided
Conditions Module
Conditions
Rheumatoid Arthritis
Keywords
Arthritis
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
182Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
LY2127399
Experimental
Biological: LY2127399
Interventions
Name
Type
Description
Arm Group Labels
Other Names
LY2127399
Biological
60 milligrams [(mg) with potential for dose escalation to 120 mg] subcutaneously every 4 weeks for 48 weeks
LY2127399
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants Who Had Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
A TEAE started on or after the date and time of the first dose of study drug administered in this study, or started prior to the study drug administration but worsened after the study drug started. Clinically significant events were defined as SAEs and other non-serious adverse events (AEs). A summary of SAEs and other non-serious AEs is located in the Reported Adverse Events module. Participants were on treatment up to 48 weeks. If a participant completed 48 weeks of treatment, the post-study treatment follow-up started at the next visit, 4 weeks later (Week 52). If a participant discontinued treatment early [early discontinuation (ED)], the post-study treatment follow-up started immediately afterwards. Baseline was defined as Week 0 in this study [which is equivalent to Week 24 of the participant's prior study: Study H9B-MC-BCDG (NCT00689728) or Study H9B-MC-BCDH (NCT00785928)].
Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52)
Number of Participants With Planned Laboratory Evaluations (Including Hematology, Clinical Chemistry, and Urinalysis) Reported as AEs
For each planned laboratory evaluation, the range of values to be reported as AEs, regardless of causality, was pre-specified. A summary of SAEs and other non-serious AEs regardless of causality is located in the Reported Adverse Events module. Baseline was defined as Week 0 in this study [which is equivalent to Week 24 of the participant's prior study: Study H9B-MC-BCDG (NCT00689728) or Study H9B-MC-BCDH (NCT00785928)].
Baseline through Week 112
Secondary Outcomes
Measure
Description
Time Frame
Change From Baseline in Tender Joint Count [Individual Component of the American College of Rheumatology (ACR) Core Set]
The number of tender and painful joints was determined by examination of 28 joints (14 on each side) which included: the 2 shoulders, the 2 elbows, the 2 wrists, the 10 metacarpophalangeal joints, the 2 interphalangeal joints of the thumb, the 8 proximal interphalangeal joints, and the 2 knees. Joints were assessed by pressure and joint manipulation on physical examination. The participant was asked for pain sensations on these manipulations and the investigator watched for spontaneous pain reactions. Any positive response on pressure, movement, or both was translated into a single tender-versus-nontender dichotomy. Baseline was defined as the last assessment prior to the participant's first dose of LY2127399 in Study H9B-MC-BCDG (NCT00689728), Study H9B-MC-BCDH (NCT00785928), or this study. A decrease in tender joint count indicated an improvement in the participant's condition.
Other Outcomes
Measure
Description
Time Frame
Number of Participants Who Died, Any Cause
A summary of serious and other non-serious AEs regardless of causality is located in the Reported Adverse Events module. Baseline was defined as Week 0 in this study [which is equivalent to Week 24 of the participant's prior study: Study H9B-MC-BCDG (NCT00689728) or Study H9B-MC-BCDH (NCT00785928)]. Participants were on treatment up to 48 weeks. If a participant completed 48 weeks of treatment, the post-study treatment follow-up started at the next visit, 4 weeks later (Week 52). If a participant discontinued treatment early, the post-study treatment follow-up started immediately afterwards. After treatment discontinuation, participants could be followed beyond Week 72 for B cell recovery (up to Week 112).
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Have given written informed consent
Women must not be pregnant, breastfeeding or be at risk to become pregnant during study participation
Have participated in either Study H9B-MC-BCDG (NCT00689728) or Study H9B-MC-BCDH (NCT00785928)
Exclusion Criteria:
Have had, during Study H9B-MC-BCDG (NCT00689728) or Study H9B-MC-BCDH (NCT00785928), any safety event, [including having a recent, ongoing, or serious infection, a serious drug reaction, or any adverse event (AE) that caused discontinuation from treatment] that in the opinion of the investigator poses an unacceptable risk to participation in the study.
Have received, during Study H9B-MC-BCDG (NCT00689728) or Study H9B-MC-BCDH (NCT00785928), any drug not allowed by the study protocol including unapproved drugs, biologic disease-modifying anti-rheumatic drugs (DMARDs), or live vaccines.
Enrollment in any other clinical trial involving off-label use of an investigational drug or device, or enrollment in any other type of medical research.
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Call 1-877-CTLILLY(1-877-285-4559) or 1-317-615-4559 Mon-Fri 9AM - 5PM Eastern time (UCT/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.
Greenwald M, Szczepanski L, Kennedy A, Veenhuizen M, Komocsar WJ, Polasek E, Guerrettaz K, Berclaz PY, Lee C. A 52-week, open-label study evaluating the safety and efficacy of tabalumab, an anti-B-cell-activating factor monoclonal antibody, for rheumatoid arthritis. Arthritis Res Ther. 2014 Aug 29;16(4):415. doi: 10.1186/s13075-014-0415-2.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
After ≥3 months treatment, investigator could choose 1-time dose increase [120 milligrams (mg) LY2127399 (LY)] for participants (pts) with ≥4 tender and ≥4 swollen joints. Additionally, 1-time dose decrease back to 60 mg LY permitted. Pts completing Week 72 completed study, but could be followed beyond Week 72 for B cell recovery (up to Week 112).
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
60 mg LY2127399
LY2127399: 60 mg subcutaneous injections every 4 weeks for 48 weeks.
FG001
60/120 mg LY2127399
LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, participants had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Participants remained at this dose level for the remainder of study treatment (48 weeks in total).
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
0
More Info Module
Limitations and Caveats
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Argentina
Czechia
France
Slovakia
Ukraine
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
N/A
Intervention Model
Single Group Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Baseline, up to and through Week 52
Change From Baseline in Swollen Joint Count (Individual Component of the ACR Core Set)
The number of swollen joints was determined by examination of 28 joints (14 on each side) which included: the 2 shoulders, the 2 elbows, the 2 wrists, the 10 metacarpophalangeal joints, the 2 interphalangeal joints of the thumb, the 8 proximal interphalangeal joints, and the 2 knees. Joints were classified as either swollen or not swollen. Swelling was defined as palpable fluctuating synovitis of the joint. Baseline was defined as the last assessment prior to the participant's first dose of LY2127399 in Study H9B-MC-BCDG (NCT00689728), Study H9B-MC-BCDH (NCT00785928), or this study. A decrease in swollen joint count indicated an improvement in the participant's condition.
Baseline, up to and through Week 52
Change From Baseline in Participant's Assessment of Disease Activity (Individual Component of the ACR Core Set)
Participant's assessment of their current arthritis disease activity using a visual analog scale (VAS), which ranged from 0 millimeters (mm) (no arthritis activity) to 100 mm (extremely active arthritis). Baseline was defined as the last assessment prior to the participant's first dose of LY2127399 in Study H9B-MC-BCDG (NCT00689728), Study H9B-MC-BCDH (NCT00785928), or this study. A decrease in disease activity score indicated an improvement in the participant's condition.
Baseline, up to and through Week 52
Change From Baseline in Physician's Global Assessment of Disease Activity (Individual Component of the ACR Core Set)
Physician's assessment of disease activity using a VAS that ranged from 0 mm (no arthritis activity) to 100 mm (extremely active arthritis). Baseline was defined as the last assessment prior to the participant's first dose of LY2127399 in Study H9B-MC-BCDG (NCT00689728), Study H9B-MC-BCDH (NCT00785928), or this study. A decrease in disease activity score indicated an improvement in the participant's condition.
Baseline, up to and through Week 52
Change From Baseline in Health Assessment Questionnaire-Disability Index [(HAQ-DI) Individual Component of the ACR Core Set]
The disability section of the health assessment questionnaire scored the participant's self-perception on the degree of difficulty [0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do)] when dressing and grooming, arising, eating, walking, hygiene, reaching, gripping, and performing other daily activities. Scores for each functional area, which ranged from 0 (no disability) to 3 (severe disability), were averaged to calculate HAQ-DI. Baseline was defined as the last assessment prior to the participant's first dose of LY2127399 in Study H9B-MC-BCDG (NCT00689728), Study H9B-MC-BCDH (NCT00785928), or this study. A decrease in HAQ-DI score indicated an improvement in the participant's condition.
Baseline, up to and through Week 52
Change From Baseline in Participant's Assessment of Joint Pain (Individual Component of the ACR Core Set)
Participant's assessment of joint pain using a VAS, which ranged from 0 mm (no pain) to 100 mm (worst possible pain). Baseline was defined as the last assessment prior to the participant's first dose of LY2127399 in Study H9B-MC-BCDG (NCT00689728), Study H9B-MC-BCDH (NCT00785928), or this study. A decrease in joint pain indicated an improvement in the participant's condition.
Baseline, up to and through Week 52
Percent Change From Baseline in C-Reactive Protein [(CRP) Individual Component of the ACR Core Set]
CRP is an indicator of inflammation. The percentage of change in CRP from baseline=[(post-baseline CRP-baseline CRP)/baseline CRP]*100. Baseline was defined as the last assessment prior to the participant's first dose of LY2127399 in Study H9B-MC-BCDG (NCT00689728), Study H9B-MC-BCDH (NCT00785928), or this study. A negative change indicated an improvement in the participant's condition.
Baseline, up to and through Week 52
Percentage of Participants Achieving ACR20 Response
ACR20 Responder Index: Composite of clinical, laboratory, and functional measures of rheumatoid arthritis. ACR20 Responder: had ≥20% improvement from baseline in both tender and swollen joint counts and ≥20% improvement in at least 3 of 5 criteria: participant's and physician's global assessment of disease activity, HAQ-DI (which measured participants' perceived degree of difficulty performing daily activities), joint pain, and CRP. Percentage of participants achieving ACR20 response=(number of ACR20 responders/number of participants treated)*100. Participants who discontinued from study prior to Week 52 were imputed as non-responders. Participants who reached Week 52 but had ≥1 of 7 components missing had missing components imputed by LOCF. This composite data imputation was denoted as non-responder imputation (NRI)/LOCF. Baseline: the last assessment prior to the participant's first dose of LY2127399 in Study H9B-MC-BCDG (NCT00689728), Study H9B-MC-BCDH (NCT00785928), or this study.
Baseline, up to and through Week 52
Percentage of Participants ACR50 Response
ACR50 Responder Index: Composite of clinical, laboratory, and functional measures of rheumatoid arthritis. ACR50 Responder: had ≥50% improvement from baseline in both tender and swollen joint counts and ≥50% improvement in at least 3 of 5 criteria: participant's and physician's global assessment of disease activity, HAQ-DI (which measured participants' perceived degree of difficulty performing daily activities), joint pain, and CRP. Percentage of participants achieving ACR50 response=(number of ACR50 responders/number of participants treated)*100. Participants who discontinued from study prior to Week 52 were imputed as non-responders. Participants who reached Week 52 but had ≥1 of 7 components missing had missing components imputed by LOCF. This composite data imputation was denoted as NRI/LOCF. Baseline was defined as the last assessment prior to the participant's first dose of LY2127399 in Study H9B-MC-BCDG (NCT00689728), Study H9B-MC-BCDH (NCT00785928), or this study.
Baseline, up to and through Week 52
Percentage of Participants Achieving ACR70 Response
ACR70 Responder Index: Composite of clinical, laboratory, and functional measures of rheumatoid arthritis. ACR70 Responder: had ≥70% improvement from baseline in both tender and swollen joint counts and ≥70% improvement in at least 3 of 5 criteria: participant's and physician's global assessment of disease activity, HAQ-DI (which measured participants' perceived degree of difficulty performing daily activities), joint pain, and CRP. Percentage of participants achieving ACR70 response=(number of ACR70 responders/number of participants treated)*100. Participants who discontinued from study prior to Week 52 were imputed as non-responders. Participants who reached Week 52 but had ≥1 of 7 components missing had missing components imputed by LOCF. This composite data imputation was denoted as NRI/LOCF. Baseline was defined as the last assessment prior to the participant's first dose of LY2127399 in Study H9B-MC-BCDG (NCT00689728), Study H9B-MC-BCDH (NCT00785928), or this study.
Baseline, up to and through Week 52
ACR-N Response
The ACR-N Responder Index was a composite of clinical, laboratory, and functional measures of rheumatoid arthritis. This index was defined as the lowest of either a) percent change in tender joint count, b) percent change in swollen joint count, or c) median percent change in 5 core ACR criteria: participant global assessment of disease activity, physician global assessment of disease activity, HAQ-DI (which measured participants' perceived degree of difficulty performing daily activities), joint pain, and CRP. For example, a participant with an ACR-N of X had an improvement ≥X% in both tender and swollen joint counts and a median improvement ≥X% in the 5 criteria previously mentioned. Baseline was the last assessment prior to the participant's first dose of LY2127399 in Study H9B-MC-BCDG (NCT00689728), Study H9B-MC-BCDH (NCT00785928), or this study. Results for the 60/120/60 mg LY2127399 treatment arm were not analyzed as the participant did not have an ACR assessment.
Baseline, up to and through Week 52
Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Score
The FACIT Fatigue Scale was a brief participant-reported measure of fatigue and consisted of 13 items. Scores ranged from 0 to 52, where higher scores indicated less fatigue. Baseline was defined as the last assessment prior to the participant's first dose of LY2127399 in Study H9B-MC-BCDG (NCT00689728), Study H9B-MC-BCDH (NCT00785928), or this study. An increase in FACIT fatigue score indicated an improvement of the participant's condition.
Baseline, up to and through Week 52
Change From Baseline in Disease Activity Score Based on 28 Joint Count (DAS28)
The DAS28 consisted of a composite score of the following variables: tender joint count (TJC28), swollen joint count (SJC28), CRP (milligrams per liter [mg/L]), and participant global assessment of his or her disease activity using a VAS (participant global VAS). The DAS28 was calculated by using the following formula: DAS28-CRP=0.56*square root(TJC28)+0.28*square root(SJC28)+0.36*natural log(CRP+1)+0.014*participant global VAS+0.96. Scores ranged from 1.0 to 9.4 where lower scores indicated less disease activity and remission is DAS28 <2.6. Baseline was defined as the last assessment prior to the participant's first dose of LY2127399 in Study H9B-MC-BCDG (NCT00689728), Study H9B-MC-BCDH (NCT00785928), or this study. A decrease in DAS28 indicated an improvement in the participant's condition.
Baseline, up to and through Week 52
Percentage of Participants With Response Based on European League Against Rheumatism Responder Index, 28 Joint Count (EULAR28)
EULAR28 was defined by the participant's change from baseline in DAS28 score and the absolute DAS28 score achieved. DAS28 consisted of composite score of the following: tender joint count, swollen joint count, CRP, and participant global assessment of his\her disease activity (participant global VAS). EULAR28 categories included: No Response [improvement in DAS28 ≤0.6 units (u) or post-baseline DAS28 score >5.1 with improvement ≤1.2 u], Moderate Response (post-baseline DAS28 score ≤5.1 with improvement >0.6 u but <1.2 u or post-baseline DAS28 score >3.2 with improvement >1.2 u), and Good Response (post-baseline DAS28 score ≤3.2 with improvement >1.2 u). Baseline was the last assessment prior to the participant's first dose of LY2127399 in Study H9B-MC-BCDG (NCT00689728), Study H9B-MC-BCDH (NCT00785928), or this study. Percentage of participants=(number of participants with specific response/participants assessed)*100. Displayed percentages may not add up to 100% because of rounding.
Baseline, up to and through Week 52
Change From Baseline in Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) Component Scores
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 calculated by summing individual items for each domain and transforming scores into 0 to 100 scale; higher scores indicated better health status. 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). Baseline: last assessment prior to participant's first dose of LY2127399 in Study H9B-MC-BCDG (NCT00689728), Study H9B-MC-BCDH (NCT00785928), or this study.
Baseline, up to and through Week 52
Pharmacodynamics: Change From Baseline in Total B Cells [Cluster Designation 20+ (CD20+)] Absolute Cell Counts
B-lymphocyte antigen CD20+ is an activated-glycosylated phosphoprotein expressed on the surface of all mature B cells. Baseline was defined as the last measurement prior to randomization to any treatment in either Study H9B-MC-BCDG (NCT00689728) or Study H9B-MC-BCDH (NCT00785928). A negative change indicated a decrease in cell count.
Baseline, Weeks 52, 60, 72, 80, 88, and 100
Pharmacodynamics: Change From Baseline in Peripheral Blood B Cell Subsets (Absolute Cell Counts)
Cell surface marker CD19, 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 cells (CD19+IgD+CD27-); immature/transitional cells (CD19+IgD-CD27-); switched memory (CD19+IgD-CD27+); and non-switched memory (CD19+IgD+CD27+). Baseline was defined as the last measurement prior to randomization to any treatment in either Study H9B-MC-BCDG (NCT00689728) or Study H9B-MC-BCDH (NCT00785928). A negative change indicated a decrease in cell count.
Baseline, Weeks 52, 60, 72, 80, 88, and 100
Pharmacodynamics: Change From Baseline in Serum Immunoglobulin
Immunoglobulins, or antibodies, are large proteins used by the immune system to identify and neutralize foreign particles such as bacteria and viruses. Their normal blood levels indicate proper immune status. Change from baseline serum immunoglobulin G (IgG), immunoglobulin M (IgM), and immunoglobulin A (IgA) levels are reported. Baseline was defined as the last measurement prior to randomization to any treatment in either Study H9B-MC-BCDG (NCT00689728) or Study H9B-MC-BCDH (NCT00785928). A negative change indicated a decrease in immunoglobulin levels.
Baseline, up to Week 52
Pharmacodynamics: Change From Baseline in Rheumatoid Factor (RF) Levels at Week 52
RF is an autoantibody (antibody directed against an organism's own tissues) most relevant in rheumatoid arthritis. Higher RF levels indicate an aggressive rheumatoid arthritis and a higher risk of joint damage. Baseline was defined as Week 0 in this study [which is equivalent to Week 24 of the participant's prior study: Study H9B-MC-BCDG (NCT00689728) or Study H9B-MC-BCDH (NCT00785928)]. A decrease in RF levels indicated an improvement in the participant's condition. Results for the 60/120/60 mg LY2127399 treatment arm were not analyzed as the participant did not have a Week 52 RF level assessment.
Baseline, Week 52
Pharmacodynamics: Change From Baseline in Serum Anti-Cyclic Citrullinated Peptide (Anti-CCP) Antibodies
Anti-CCP antibodies were measured using an enzyme-linked immunosorbent assay (ELISA) method. In general, high levels of the antibody indicated an aggressive rheumatoid arthritis and a higher risk of joint damage. Baseline was defined as Week 0 in this study [which is equivalent to Week 24 of the participant's prior study: Study H9B-MC-BCDG (NCT00689728) or Study H9B-MC-BCDH (NCT00785928)]. A decrease in anti-CCP antibodies indicated an improvement in the participant's condition.
Baseline, up to Week 52
Pharmacodynamics: Percent Change From Baseline in Erythrocyte Sedimentation Rate (ESR)
ESR is a laboratory test that provides a non-specific measure of inflammation. The test assessed the rate at which red blood cells fell in a test tube. Normal range was considered to be 0 to 20 or 0 to 30 millimeters per hour (mm/h), depending on the reference range used by the laboratory. Higher scores indicated greater inflammation. Percent change from baseline ESR=[(post-baseline ESR- baseline ESR)/baseline ESR]*100. Baseline was defined as Week 0 in this study [which is equivalent to Week 24 of the participant's prior study: Study H9B-MC-BCDG (NCT00689728) or Study H9B-MC-BCDH (NCT00785928)]. A decrease in ESR indicated an improvement in the participant's condition.
Baseline, up to Week 52
Number of Participants With LY2127399 Immunogenicity (Anti-LY2127399 Antibodies)
The number of participants who had treatment-emergent or follow-up emergent anti-LY2127399 antibodies [anti-drug antibodies (ADA)] is reported. Treatment-emergent was defined as participants who had any sample from baseline through Week 52 that was a 4-fold increase (2 dilution increase) in immunogenicity titer over the baseline titer, or participants who tested negative at baseline and positive post-baseline (at titer of ≥1:20). Follow-up emergent was defined as any sample during follow-up that was a 4-fold increase (2 dilution increase) in immunogenicity titer over the baseline titer. The number of participants with baseline positive ADA data is also reported. Baseline was defined as the last measurement prior to randomization to any treatment in either Study H9B-MC-BCDG (NCT00689728) or Study H9B-MC-BCDH (NCT00785928).
Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post-study treatment follow-up (start of Week 53 or ED up to and through Week 112)
Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post-study treatment follow-up (start of Week 53 or ED up to and through Week 72 and start of Week 73 up to and through Week 112)
United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Huntsville
Alabama
35801
United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Mesa
Arizona
85208
United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Palm Desert
California
92260
United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Riverside
California
92501
United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Santa Maria
California
93454
United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Upland
California
91786
United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Jupiter
Florida
33458
United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Vero Beach
Florida
32960
United States
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Zephyrhills
Florida
33542
United States
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Baltimore
Maryland
21239
United States
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St Louis
Missouri
63141
United States
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Hickory
North Carolina
28601
United States
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Middleburg Heights
Ohio
44130
United States
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Philadelphia
Pennsylvania
19152
United States
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Orangeburg
South Carolina
29118
United States
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Memphis
Tennessee
38119
United States
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Dallas
Texas
75231
United States
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Mesquite
Texas
75150
United States
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Elizabeth Vale
South Australia
5112
Australia
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Vienna
1100
Austria
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Liège
4000
Belgium
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Campinas
13015-011
Brazil
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Curitiba
80060-240
Brazil
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Goiânia
74605-050
Brazil
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Porto Alegre
90610-970
Brazil
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Setor Oeste/Goiania
74100-125
Brazil
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Winnipeg
Manitoba
R3A 1M4
Canada
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Hamilton
Ontario
N2M 5N6
Canada
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Kitchener
Ontario
N2M 5N6
Canada
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Santiago
Chile
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Valdivia
Chile
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Viña del Mar
Chile
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Hildesheim
31134
Germany
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Leipzig
04103
Germany
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Budapest
1023
Hungary
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Esztergom
2500
Hungary
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Kistarcsa
2143
Hungary
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Szolnok
5000
Hungary
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Lucknow
226018
India
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Pune
411001
India
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Secunderabad
500003
India
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Chihuahua City
31000
Mexico
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Cuernavaca
62270
Mexico
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Guadalajara
44100
Mexico
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Mexico City
06700
Mexico
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Monterrey
64000
Mexico
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San Luis Potosí City
78210
Mexico
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Tampico
89000
Mexico
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Bialystok
15-337
Poland
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Chełm Śląski
41-403
Poland
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Elblag
82-300
Poland
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Krakow
30-510
Poland
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Lubin
20-022
Poland
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Lublin
20-954
Poland
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Poznan
60-356
Poland
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Torun
87-100
Poland
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Warsaw
00-235
Poland
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Wroclaw
50-088
Poland
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San Juan
00918
Puerto Rico
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Brasov
500365
Romania
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Târgu Mureş
540136
Romania
FG002
60/120/60 mg LY2127399
LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, the participant had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Subsequently, the participant had a dose decrease back to 60 mg LY2127399, administered once every 4 weeks for the remainder of study treatment (48 weeks in total).
FG00060 subjects
FG001121 subjects
FG0021 subjects
Received Any Amount of Study Drug
FG00060 subjects
FG001121 subjects
FG0021 subjects
Had at Least 1 Efficacy Assessment
FG00059 subjects
FG001121 subjects
FG0021 subjects
Included in Efficacy Analyses
FG00059 subjects
FG001120 subjectsExcludes participant from site with Good Clinical Practice (GCP) violations.
FG0021 subjects
COMPLETED
FG00053 subjects
FG00187 subjects
FG0020 subjects
NOT COMPLETED
FG0007 subjects
FG00134 subjects
FG0021 subjects
Type
Comment
Reasons
Adverse Event
FG0004 subjects
FG0016 subjects
FG0020 subjects
Death
FG0001 subjects
FG0011 subjects
FG0020 subjects
Lack of Efficacy
FG0000 subjects
FG00111 subjects
FG0020 subjects
Lost to Follow-up
FG0001 subjects
FG0013 subjects
FG0020 subjects
Physician Decision
FG0000 subjects
FG0012 subjects
FG0021 subjects
Withdrawal by Subject
FG0001 subjects
FG0019 subjects
FG0020 subjects
Sponsor Decision
FG0000 subjects
FG0012 subjects
FG0020 subjects
Baseline was defined as Week 0 in this study [which is equivalent to Week 24 of the participant's prior study: Study H9B-MC-BCDG (NCT00689728) or Study H9B-MC-BCDH (NCT00785928)]. The baseline characteristics of participants who received any amount of study drug and had at least 1 post-baseline efficacy assessment were analyzed.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
60 mg LY2127399
LY2127399: 60 mg subcutaneous injections every 4 weeks for 48 weeks.
BG001
60/120 mg LY2127399
LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, participants had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Participants remained at this dose level for the remainder of study treatment (48 weeks in total).
BG002
60/120/60 mg LY2127399
LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, the participant had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Subsequently, the participant had a dose decrease back to 60 mg LY2127399, administered once every 4 weeks for the remainder of study treatment (48 weeks in total).
BG003
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00059
BG001121
BG0021
BG003181
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
BG00053.4± 11.86
BG00151.5± 12.20
BG00261.5± NAOnly 1 participant in the analysis, therefore standard deviation is not calculable.
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00050
BG00199
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
White
Title
Measurements
BG00034
BG00180
BG002
Region of Enrollment
Count of Participants
Participants
Title
Denominators
Categories
Austria
Title
Measurements
BG0003
BG0013
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Number of Participants Who Had Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
A TEAE started on or after the date and time of the first dose of study drug administered in this study, or started prior to the study drug administration but worsened after the study drug started. Clinically significant events were defined as SAEs and other non-serious adverse events (AEs). A summary of SAEs and other non-serious AEs is located in the Reported Adverse Events module. Participants were on treatment up to 48 weeks. If a participant completed 48 weeks of treatment, the post-study treatment follow-up started at the next visit, 4 weeks later (Week 52). If a participant discontinued treatment early [early discontinuation (ED)], the post-study treatment follow-up started immediately afterwards. Baseline was defined as Week 0 in this study [which is equivalent to Week 24 of the participant's prior study: Study H9B-MC-BCDG (NCT00689728) or Study H9B-MC-BCDH (NCT00785928)].
Participants who received any amount of study drug.
Posted
Count of Participants
Participants
No
Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52)
ID
Title
Description
OG000
60 mg LY2127399
LY2127399: 60 mg subcutaneous injections every 4 weeks for 48 weeks.
OG001
60/120 mg LY2127399
LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, participants had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Participants remained at this dose level for the remainder of study treatment (48 weeks in total).
OG002
60/120/60 mg LY2127399
LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, the participant had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Subsequently, the participant had a dose decrease back to 60 mg LY2127399, administered once every 4 weeks for the remainder of study treatment (48 weeks in total).
Units
Counts
Participants
OG00060
OG001121
OG0021
Title
Denominators
Categories
Any TEAE
Title
Measurements
OG00038
OG00195
OG0021
Any SAE
Primary
Number of Participants With Planned Laboratory Evaluations (Including Hematology, Clinical Chemistry, and Urinalysis) Reported as AEs
For each planned laboratory evaluation, the range of values to be reported as AEs, regardless of causality, was pre-specified. A summary of SAEs and other non-serious AEs regardless of causality is located in the Reported Adverse Events module. Baseline was defined as Week 0 in this study [which is equivalent to Week 24 of the participant's prior study: Study H9B-MC-BCDG (NCT00689728) or Study H9B-MC-BCDH (NCT00785928)].
Participants who received any amount of study drug.
Posted
Count of Participants
Participants
No
Baseline through Week 112
ID
Title
Description
OG000
60 mg LY2127399 Treatment
AEs reported while on study treatment (baseline up to Week 48) plus up to 3 weeks after discontinuation of study treatment (until next study visit).
LY2127399: 60 mg subcutaneous injections every 4 weeks for 48 weeks.
OG001
60/120 mg LY2127399 Treatment
AEs reported while on study treatment (baseline up to Week 48) plus up to 3 weeks after discontinuation of study treatment (until next study visit).
LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, participants had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Participants remained at this dose level for the remainder of study treatment (48 weeks in total).
Secondary
Change From Baseline in Tender Joint Count [Individual Component of the American College of Rheumatology (ACR) Core Set]
The number of tender and painful joints was determined by examination of 28 joints (14 on each side) which included: the 2 shoulders, the 2 elbows, the 2 wrists, the 10 metacarpophalangeal joints, the 2 interphalangeal joints of the thumb, the 8 proximal interphalangeal joints, and the 2 knees. Joints were assessed by pressure and joint manipulation on physical examination. The participant was asked for pain sensations on these manipulations and the investigator watched for spontaneous pain reactions. Any positive response on pressure, movement, or both was translated into a single tender-versus-nontender dichotomy. Baseline was defined as the last assessment prior to the participant's first dose of LY2127399 in Study H9B-MC-BCDG (NCT00689728), Study H9B-MC-BCDH (NCT00785928), or this study. A decrease in tender joint count indicated an improvement in the participant's condition.
Participants who received any amount of study drug and had at least 1 post-baseline tender joint assessment; excludes site with GCP issues; Last observation carried forward (LOCF).
Posted
Mean
Standard Deviation
tender joints
Baseline, up to and through Week 52
ID
Title
Description
OG000
60 mg LY2127399
LY2127399: 60 mg subcutaneous injections every 4 weeks for 48 weeks.
OG001
60/120 mg LY2127399
LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, participants had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Participants remained at this dose level for the remainder of study treatment (48 weeks in total).
Secondary
Change From Baseline in Swollen Joint Count (Individual Component of the ACR Core Set)
The number of swollen joints was determined by examination of 28 joints (14 on each side) which included: the 2 shoulders, the 2 elbows, the 2 wrists, the 10 metacarpophalangeal joints, the 2 interphalangeal joints of the thumb, the 8 proximal interphalangeal joints, and the 2 knees. Joints were classified as either swollen or not swollen. Swelling was defined as palpable fluctuating synovitis of the joint. Baseline was defined as the last assessment prior to the participant's first dose of LY2127399 in Study H9B-MC-BCDG (NCT00689728), Study H9B-MC-BCDH (NCT00785928), or this study. A decrease in swollen joint count indicated an improvement in the participant's condition.
Participants who received any amount of study drug and had at least 1 post-baseline swollen joint assessment; excludes site with GCP issues; LOCF.
Posted
Mean
Standard Deviation
swollen joints
Baseline, up to and through Week 52
ID
Title
Description
OG000
60 mg LY2127399
LY2127399: 60 mg subcutaneous injections every 4 weeks for 48 weeks.
OG001
60/120 mg LY2127399
LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, participants had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Participants remained at this dose level for the remainder of study treatment (48 weeks in total).
Secondary
Change From Baseline in Participant's Assessment of Disease Activity (Individual Component of the ACR Core Set)
Participant's assessment of their current arthritis disease activity using a visual analog scale (VAS), which ranged from 0 millimeters (mm) (no arthritis activity) to 100 mm (extremely active arthritis). Baseline was defined as the last assessment prior to the participant's first dose of LY2127399 in Study H9B-MC-BCDG (NCT00689728), Study H9B-MC-BCDH (NCT00785928), or this study. A decrease in disease activity score indicated an improvement in the participant's condition.
Participants who received any amount of study drug and had at least 1 post-baseline self-rated assessment of disease activity; excludes site with GCP issues; LOCF.
Posted
Mean
Standard Deviation
mm
Baseline, up to and through Week 52
ID
Title
Description
OG000
60 mg LY2127399
LY2127399: 60 mg subcutaneous injections every 4 weeks for 48 weeks.
OG001
60/120 mg LY2127399
LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, participants had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Participants remained at this dose level for the remainder of study treatment (48 weeks in total).
OG002
60/120/60 mg LY2127399
Secondary
Change From Baseline in Physician's Global Assessment of Disease Activity (Individual Component of the ACR Core Set)
Physician's assessment of disease activity using a VAS that ranged from 0 mm (no arthritis activity) to 100 mm (extremely active arthritis). Baseline was defined as the last assessment prior to the participant's first dose of LY2127399 in Study H9B-MC-BCDG (NCT00689728), Study H9B-MC-BCDH (NCT00785928), or this study. A decrease in disease activity score indicated an improvement in the participant's condition.
Participants who received any amount of study drug and had at least 1 post-baseline physician's global assessment of disease activity; excludes site with GCP issues; LOCF.
Posted
Mean
Standard Deviation
mm
Baseline, up to and through Week 52
ID
Title
Description
OG000
60 mg LY2127399
LY2127399: 60 mg subcutaneous injections every 4 weeks for 48 weeks.
OG001
60/120 mg LY2127399
LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, participants had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Participants remained at this dose level for the remainder of study treatment (48 weeks in total).
OG002
60/120/60 mg LY2127399
Secondary
Change From Baseline in Health Assessment Questionnaire-Disability Index [(HAQ-DI) Individual Component of the ACR Core Set]
The disability section of the health assessment questionnaire scored the participant's self-perception on the degree of difficulty [0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do)] when dressing and grooming, arising, eating, walking, hygiene, reaching, gripping, and performing other daily activities. Scores for each functional area, which ranged from 0 (no disability) to 3 (severe disability), were averaged to calculate HAQ-DI. Baseline was defined as the last assessment prior to the participant's first dose of LY2127399 in Study H9B-MC-BCDG (NCT00689728), Study H9B-MC-BCDH (NCT00785928), or this study. A decrease in HAQ-DI score indicated an improvement in the participant's condition.
Participants who received any amount of study drug and had at least 1 post-baseline HAQ-DI assessment; excludes site with GCP issues; LOCF.
Posted
Mean
Standard Deviation
units on a scale
Baseline, up to and through Week 52
ID
Title
Description
OG000
60 mg LY2127399
LY2127399: 60 mg subcutaneous injections every 4 weeks for 48 weeks.
OG001
60/120 mg LY2127399
LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, participants had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Participants remained at this dose level for the remainder of study treatment (48 weeks in total).
Secondary
Change From Baseline in Participant's Assessment of Joint Pain (Individual Component of the ACR Core Set)
Participant's assessment of joint pain using a VAS, which ranged from 0 mm (no pain) to 100 mm (worst possible pain). Baseline was defined as the last assessment prior to the participant's first dose of LY2127399 in Study H9B-MC-BCDG (NCT00689728), Study H9B-MC-BCDH (NCT00785928), or this study. A decrease in joint pain indicated an improvement in the participant's condition.
Participants who received any amount of study drug and had at least 1 post-baseline self-rated assessment of joint pain; excludes site with GCP issues; LOCF.
Posted
Mean
Standard Deviation
mm
Baseline, up to and through Week 52
ID
Title
Description
OG000
60 mg LY2127399
LY2127399: 60 mg subcutaneous injections every 4 weeks for 48 weeks.
OG001
60/120 mg LY2127399
LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, participants had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Participants remained at this dose level for the remainder of study treatment (48 weeks in total).
OG002
60/120/60 mg LY2127399
LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, the participant had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Subsequently, the participant had a dose decrease back to 60 mg LY2127399, administered once every 4 weeks for the remainder of study treatment (48 weeks in total).
Secondary
Percent Change From Baseline in C-Reactive Protein [(CRP) Individual Component of the ACR Core Set]
CRP is an indicator of inflammation. The percentage of change in CRP from baseline=[(post-baseline CRP-baseline CRP)/baseline CRP]*100. Baseline was defined as the last assessment prior to the participant's first dose of LY2127399 in Study H9B-MC-BCDG (NCT00689728), Study H9B-MC-BCDH (NCT00785928), or this study. A negative change indicated an improvement in the participant's condition.
Participants who received any amount of study drug and had at least 1 post-baseline CRP assessment; excludes site with GCP issues; LOCF.
Posted
Mean
Standard Deviation
percent change
Baseline, up to and through Week 52
ID
Title
Description
OG000
60 mg LY2127399
LY2127399: 60 mg subcutaneous injections every 4 weeks for 48 weeks.
OG001
60/120 mg LY2127399
LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, participants had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Participants remained at this dose level for the remainder of study treatment (48 weeks in total).
OG002
60/120/60 mg LY2127399
LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, the participant had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Subsequently, the participant had a dose decrease back to 60 mg LY2127399, administered once every 4 weeks for the remainder of study treatment (48 weeks in total).
Secondary
Percentage of Participants Achieving ACR20 Response
ACR20 Responder Index: Composite of clinical, laboratory, and functional measures of rheumatoid arthritis. ACR20 Responder: had ≥20% improvement from baseline in both tender and swollen joint counts and ≥20% improvement in at least 3 of 5 criteria: participant's and physician's global assessment of disease activity, HAQ-DI (which measured participants' perceived degree of difficulty performing daily activities), joint pain, and CRP. Percentage of participants achieving ACR20 response=(number of ACR20 responders/number of participants treated)*100. Participants who discontinued from study prior to Week 52 were imputed as non-responders. Participants who reached Week 52 but had ≥1 of 7 components missing had missing components imputed by LOCF. This composite data imputation was denoted as non-responder imputation (NRI)/LOCF. Baseline: the last assessment prior to the participant's first dose of LY2127399 in Study H9B-MC-BCDG (NCT00689728), Study H9B-MC-BCDH (NCT00785928), or this study.
Participants who received any amount of study drug and had at least 1 post-baseline ACR20 assessment; excludes site with GCP issues; missing data imputed by NRI/LOCF. Four (4), 29, and 1 participants were imputed as non-responders for the 60 mg, 60/120 mg, and 60/120/60 mg LY2127399 groups, respectively.
Posted
Number
percentage of participants
Baseline, up to and through Week 52
ID
Title
Description
OG000
60 mg LY2127399
LY2127399: 60 mg subcutaneous injections every 4 weeks for 48 weeks.
OG001
60/120 mg LY2127399
Secondary
Percentage of Participants ACR50 Response
ACR50 Responder Index: Composite of clinical, laboratory, and functional measures of rheumatoid arthritis. ACR50 Responder: had ≥50% improvement from baseline in both tender and swollen joint counts and ≥50% improvement in at least 3 of 5 criteria: participant's and physician's global assessment of disease activity, HAQ-DI (which measured participants' perceived degree of difficulty performing daily activities), joint pain, and CRP. Percentage of participants achieving ACR50 response=(number of ACR50 responders/number of participants treated)*100. Participants who discontinued from study prior to Week 52 were imputed as non-responders. Participants who reached Week 52 but had ≥1 of 7 components missing had missing components imputed by LOCF. This composite data imputation was denoted as NRI/LOCF. Baseline was defined as the last assessment prior to the participant's first dose of LY2127399 in Study H9B-MC-BCDG (NCT00689728), Study H9B-MC-BCDH (NCT00785928), or this study.
Participants who received any amount of study drug and had at least 1 post-baseline ACR50 assessment; excludes site with GCP issues; missing data imputed by NRI/LOCF. Four (4), 29, and 1 participants were imputed as non-responders for the 60 mg, 60/120 mg, and 60/120/60 mg LY2127399 groups, respectively.
Posted
Number
percentage of participants
Baseline, up to and through Week 52
ID
Title
Description
OG000
60 mg LY2127399
LY2127399: 60 mg subcutaneous injections every 4 weeks for 48 weeks.
OG001
60/120 mg LY2127399
Secondary
Percentage of Participants Achieving ACR70 Response
ACR70 Responder Index: Composite of clinical, laboratory, and functional measures of rheumatoid arthritis. ACR70 Responder: had ≥70% improvement from baseline in both tender and swollen joint counts and ≥70% improvement in at least 3 of 5 criteria: participant's and physician's global assessment of disease activity, HAQ-DI (which measured participants' perceived degree of difficulty performing daily activities), joint pain, and CRP. Percentage of participants achieving ACR70 response=(number of ACR70 responders/number of participants treated)*100. Participants who discontinued from study prior to Week 52 were imputed as non-responders. Participants who reached Week 52 but had ≥1 of 7 components missing had missing components imputed by LOCF. This composite data imputation was denoted as NRI/LOCF. Baseline was defined as the last assessment prior to the participant's first dose of LY2127399 in Study H9B-MC-BCDG (NCT00689728), Study H9B-MC-BCDH (NCT00785928), or this study.
Participants who received any amount of study drug and had at least 1 post-baseline ACR70 assessment; excludes site with GCP issues; missing data imputed by NRI/LOCF. Four (4), 29, and 1 participants were imputed as non-responders for the 60 mg, 60/120 mg, and 60/120/60 mg LY2127399 groups, respectively.
Posted
Number
percentage of participants
Baseline, up to and through Week 52
ID
Title
Description
OG000
60 mg LY2127399
LY2127399: 60 mg subcutaneous injections every 4 weeks for 48 weeks.
OG001
60/120 mg LY2127399
Secondary
ACR-N Response
The ACR-N Responder Index was a composite of clinical, laboratory, and functional measures of rheumatoid arthritis. This index was defined as the lowest of either a) percent change in tender joint count, b) percent change in swollen joint count, or c) median percent change in 5 core ACR criteria: participant global assessment of disease activity, physician global assessment of disease activity, HAQ-DI (which measured participants' perceived degree of difficulty performing daily activities), joint pain, and CRP. For example, a participant with an ACR-N of X had an improvement ≥X% in both tender and swollen joint counts and a median improvement ≥X% in the 5 criteria previously mentioned. Baseline was the last assessment prior to the participant's first dose of LY2127399 in Study H9B-MC-BCDG (NCT00689728), Study H9B-MC-BCDH (NCT00785928), or this study. Results for the 60/120/60 mg LY2127399 treatment arm were not analyzed as the participant did not have an ACR assessment.
Participants who received any amount of study drug and had at least 1 post-baseline ACR-N assessment; excludes site with GCP issues; LOCF. No participant was analyzed in the 60/120/60 mg LY2127399 treatment arm.
Posted
Mean
Standard Deviation
units on a scale
Baseline, up to and through Week 52
ID
Title
Description
OG000
60 mg LY2127399
LY2127399: 60 mg subcutaneous injections every 4 weeks for 48 weeks.
OG001
60/120 mg LY2127399
LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, participants had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Participants remained at this dose level for the remainder of study treatment (48 weeks in total).
Secondary
Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Score
The FACIT Fatigue Scale was a brief participant-reported measure of fatigue and consisted of 13 items. Scores ranged from 0 to 52, where higher scores indicated less fatigue. Baseline was defined as the last assessment prior to the participant's first dose of LY2127399 in Study H9B-MC-BCDG (NCT00689728), Study H9B-MC-BCDH (NCT00785928), or this study. An increase in FACIT fatigue score indicated an improvement of the participant's condition.
Participants who received any amount of study drug and had at least 1 post-baseline FACIT assessment; excludes site with GCP issues; LOCF.
Posted
Mean
Standard Deviation
units on a scale
Baseline, up to and through Week 52
ID
Title
Description
OG000
60 mg LY2127399
LY2127399: 60 mg subcutaneous injections every 4 weeks for 48 weeks.
OG001
60/120 mg LY2127399
LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, participants had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Participants remained at this dose level for the remainder of study treatment (48 weeks in total).
OG002
60/120/60 mg LY2127399
Secondary
Change From Baseline in Disease Activity Score Based on 28 Joint Count (DAS28)
The DAS28 consisted of a composite score of the following variables: tender joint count (TJC28), swollen joint count (SJC28), CRP (milligrams per liter [mg/L]), and participant global assessment of his or her disease activity using a VAS (participant global VAS). The DAS28 was calculated by using the following formula: DAS28-CRP=0.56*square root(TJC28)+0.28*square root(SJC28)+0.36*natural log(CRP+1)+0.014*participant global VAS+0.96. Scores ranged from 1.0 to 9.4 where lower scores indicated less disease activity and remission is DAS28 <2.6. Baseline was defined as the last assessment prior to the participant's first dose of LY2127399 in Study H9B-MC-BCDG (NCT00689728), Study H9B-MC-BCDH (NCT00785928), or this study. A decrease in DAS28 indicated an improvement in the participant's condition.
Participants who received any amount of study drug and had at least 1 post-baseline DAS28 assessment; excludes site with GCP issues; LOCF.
Posted
Mean
Standard Deviation
units on a scale
Baseline, up to and through Week 52
ID
Title
Description
OG000
60 mg LY2127399
LY2127399: 60 mg subcutaneous injections every 4 weeks for 48 weeks.
OG001
60/120 mg LY2127399
LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, participants had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Participants remained at this dose level for the remainder of study treatment (48 weeks in total).
Secondary
Percentage of Participants With Response Based on European League Against Rheumatism Responder Index, 28 Joint Count (EULAR28)
EULAR28 was defined by the participant's change from baseline in DAS28 score and the absolute DAS28 score achieved. DAS28 consisted of composite score of the following: tender joint count, swollen joint count, CRP, and participant global assessment of his\her disease activity (participant global VAS). EULAR28 categories included: No Response [improvement in DAS28 ≤0.6 units (u) or post-baseline DAS28 score >5.1 with improvement ≤1.2 u], Moderate Response (post-baseline DAS28 score ≤5.1 with improvement >0.6 u but <1.2 u or post-baseline DAS28 score >3.2 with improvement >1.2 u), and Good Response (post-baseline DAS28 score ≤3.2 with improvement >1.2 u). Baseline was the last assessment prior to the participant's first dose of LY2127399 in Study H9B-MC-BCDG (NCT00689728), Study H9B-MC-BCDH (NCT00785928), or this study. Percentage of participants=(number of participants with specific response/participants assessed)*100. Displayed percentages may not add up to 100% because of rounding.
Participants who received any amount of study drug and had at least 1 post-baseline EULAR28 assessment; excludes site with GCP issues; LOCF.
Posted
Number
percentage of participants
Baseline, up to and through Week 52
ID
Title
Description
OG000
60 mg LY2127399
LY2127399: 60 mg subcutaneous injections every 4 weeks for 48 weeks.
OG001
60/120 mg LY2127399
Secondary
Change From Baseline in Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) Component Scores
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 calculated by summing individual items for each domain and transforming scores into 0 to 100 scale; higher scores indicated better health status. 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). Baseline: last assessment prior to participant's first dose of LY2127399 in Study H9B-MC-BCDG (NCT00689728), Study H9B-MC-BCDH (NCT00785928), or this study.
Participants who received any amount of study drug and had at least 1 post-baseline SF-36 assessment; excludes site with GCP issues; LOCF.
Posted
Mean
Standard Deviation
units on a scale
Baseline, up to and through Week 52
ID
Title
Description
OG000
60 mg LY2127399
LY2127399: 60 mg subcutaneous injections every 4 weeks for 48 weeks.
OG001
60/120 mg LY2127399
Secondary
Pharmacodynamics: Change From Baseline in Total B Cells [Cluster Designation 20+ (CD20+)] Absolute Cell Counts
B-lymphocyte antigen CD20+ is an activated-glycosylated phosphoprotein expressed on the surface of all mature B cells. Baseline was defined as the last measurement prior to randomization to any treatment in either Study H9B-MC-BCDG (NCT00689728) or Study H9B-MC-BCDH (NCT00785928). A negative change indicated a decrease in cell count.
Participants who received any amount of study drug and a post-baseline total B cell assessment at the specified time points.
Posted
Mean
Standard Deviation
cells per microliter (cells/µL)
Baseline, Weeks 52, 60, 72, 80, 88, and 100
ID
Title
Description
OG000
60 mg LY2127399
LY2127399: 60 mg subcutaneous injections every 4 weeks for 48 weeks.
OG001
60/120 mg LY2127399
LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, participants had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Participants remained at this dose level for the remainder of study treatment (48 weeks in total).
OG002
60/120/60 mg LY2127399
LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, the participant had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Subsequently, the participant had a dose decrease back to 60 mg LY2127399, administered once every 4 weeks for the remainder of study treatment (48 weeks in total).
Secondary
Pharmacodynamics: Change From Baseline in Peripheral Blood B Cell Subsets (Absolute Cell Counts)
Cell surface marker CD19, 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 cells (CD19+IgD+CD27-); immature/transitional cells (CD19+IgD-CD27-); switched memory (CD19+IgD-CD27+); and non-switched memory (CD19+IgD+CD27+). Baseline was defined as the last measurement prior to randomization to any treatment in either Study H9B-MC-BCDG (NCT00689728) or Study H9B-MC-BCDH (NCT00785928). A negative change indicated a decrease in cell count.
Participants who received any amount of study drug and had the specified peripheral blood B cell subset assessment post-baseline at the specified time points.
Posted
Mean
Standard Deviation
cells/µL
Baseline, Weeks 52, 60, 72, 80, 88, and 100
ID
Title
Description
OG000
60 mg LY2127399
LY2127399: 60 mg subcutaneous injections every 4 weeks for 48 weeks.
OG001
60/120 mg LY2127399
LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, participants had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Participants remained at this dose level for the remainder of study treatment (48 weeks in total).
Secondary
Pharmacodynamics: Change From Baseline in Serum Immunoglobulin
Immunoglobulins, or antibodies, are large proteins used by the immune system to identify and neutralize foreign particles such as bacteria and viruses. Their normal blood levels indicate proper immune status. Change from baseline serum immunoglobulin G (IgG), immunoglobulin M (IgM), and immunoglobulin A (IgA) levels are reported. Baseline was defined as the last measurement prior to randomization to any treatment in either Study H9B-MC-BCDG (NCT00689728) or Study H9B-MC-BCDH (NCT00785928). A negative change indicated a decrease in immunoglobulin levels.
Participants who received any amount of study drug and had at least 1 post-baseline serum immunoglobulin assessment; LOCF.
Posted
Mean
Standard Deviation
grams per liter (g/L)
Baseline, up to Week 52
ID
Title
Description
OG000
60 mg LY2127399
LY2127399: 60 mg subcutaneous injections every 4 weeks for 48 weeks.
OG001
60/120 mg LY2127399
LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, participants had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Participants remained at this dose level for the remainder of study treatment (48 weeks in total).
OG002
60/120/60 mg LY2127399
Other Pre-specified
Number of Participants Who Died, Any Cause
A summary of serious and other non-serious AEs regardless of causality is located in the Reported Adverse Events module. Baseline was defined as Week 0 in this study [which is equivalent to Week 24 of the participant's prior study: Study H9B-MC-BCDG (NCT00689728) or Study H9B-MC-BCDH (NCT00785928)]. Participants were on treatment up to 48 weeks. If a participant completed 48 weeks of treatment, the post-study treatment follow-up started at the next visit, 4 weeks later (Week 52). If a participant discontinued treatment early, the post-study treatment follow-up started immediately afterwards. After treatment discontinuation, participants could be followed beyond Week 72 for B cell recovery (up to Week 112).
Participants who received any amount of study drug.
Posted
Count of Participants
Participants
No
Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post-study treatment follow-up (start of Week 53 or ED up to and through Week 72 and start of Week 73 up to and through Week 112)
ID
Title
Description
OG000
60 mg LY2127399
LY2127399: 60 mg subcutaneous injections every 4 weeks for 48 weeks.
OG001
60/120 mg LY2127399
LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, participants had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Participants remained at this dose level for the remainder of study treatment (48 weeks in total).
Secondary
Pharmacodynamics: Change From Baseline in Rheumatoid Factor (RF) Levels at Week 52
RF is an autoantibody (antibody directed against an organism's own tissues) most relevant in rheumatoid arthritis. Higher RF levels indicate an aggressive rheumatoid arthritis and a higher risk of joint damage. Baseline was defined as Week 0 in this study [which is equivalent to Week 24 of the participant's prior study: Study H9B-MC-BCDG (NCT00689728) or Study H9B-MC-BCDH (NCT00785928)]. A decrease in RF levels indicated an improvement in the participant's condition. Results for the 60/120/60 mg LY2127399 treatment arm were not analyzed as the participant did not have a Week 52 RF level assessment.
Participants who received any amount of study drug and had Week 52 post-baseline RF level assessment, excluding the site with GCP issues. No participant was analyzed in the 60/120/60 mg LY2127399 treatment arm.
Posted
Mean
Standard Deviation
international units/milliliter (IU/mL)
Baseline, Week 52
ID
Title
Description
OG000
60 mg LY2127399
LY2127399: 60 mg subcutaneous injections every 4 weeks for 48 weeks.
OG001
60/120 mg LY2127399
LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, participants had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Participants remained at this dose level for the remainder of study treatment (48 weeks in total).
Secondary
Pharmacodynamics: Change From Baseline in Serum Anti-Cyclic Citrullinated Peptide (Anti-CCP) Antibodies
Anti-CCP antibodies were measured using an enzyme-linked immunosorbent assay (ELISA) method. In general, high levels of the antibody indicated an aggressive rheumatoid arthritis and a higher risk of joint damage. Baseline was defined as Week 0 in this study [which is equivalent to Week 24 of the participant's prior study: Study H9B-MC-BCDG (NCT00689728) or Study H9B-MC-BCDH (NCT00785928)]. A decrease in anti-CCP antibodies indicated an improvement in the participant's condition.
Participants who received any amount of study drug and had at least 1 post-baseline anti-CCP assessment, excluding site with GCP issues; LOCF.
Posted
Mean
Standard Deviation
units per milliliter (U/mL)
Baseline, up to Week 52
ID
Title
Description
OG000
60 mg LY2127399
LY2127399: 60 mg subcutaneous injections every 4 weeks for 48 weeks.
OG001
60/120 mg LY2127399
LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, participants had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Participants remained at this dose level for the remainder of study treatment (48 weeks in total).
OG002
60/120/60 mg LY2127399
Secondary
Pharmacodynamics: Percent Change From Baseline in Erythrocyte Sedimentation Rate (ESR)
ESR is a laboratory test that provides a non-specific measure of inflammation. The test assessed the rate at which red blood cells fell in a test tube. Normal range was considered to be 0 to 20 or 0 to 30 millimeters per hour (mm/h), depending on the reference range used by the laboratory. Higher scores indicated greater inflammation. Percent change from baseline ESR=[(post-baseline ESR- baseline ESR)/baseline ESR]*100. Baseline was defined as Week 0 in this study [which is equivalent to Week 24 of the participant's prior study: Study H9B-MC-BCDG (NCT00689728) or Study H9B-MC-BCDH (NCT00785928)]. A decrease in ESR indicated an improvement in the participant's condition.
Participants who received any amount of study drug and had at least 1 post-baseline ESR assessment, excluding site with GCP issues; LOCF.
Posted
Mean
Standard Deviation
percent change
Baseline, up to Week 52
ID
Title
Description
OG000
60 mg LY2127399
LY2127399: 60 mg subcutaneous injections every 4 weeks for 48 weeks.
OG001
60/120 mg LY2127399
LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, participants had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Participants remained at this dose level for the remainder of study treatment (48 weeks in total).
Secondary
Number of Participants With LY2127399 Immunogenicity (Anti-LY2127399 Antibodies)
The number of participants who had treatment-emergent or follow-up emergent anti-LY2127399 antibodies [anti-drug antibodies (ADA)] is reported. Treatment-emergent was defined as participants who had any sample from baseline through Week 52 that was a 4-fold increase (2 dilution increase) in immunogenicity titer over the baseline titer, or participants who tested negative at baseline and positive post-baseline (at titer of ≥1:20). Follow-up emergent was defined as any sample during follow-up that was a 4-fold increase (2 dilution increase) in immunogenicity titer over the baseline titer. The number of participants with baseline positive ADA data is also reported. Baseline was defined as the last measurement prior to randomization to any treatment in either Study H9B-MC-BCDG (NCT00689728) or Study H9B-MC-BCDH (NCT00785928).
Participants who received any amount of study drug.
Posted
Count of Participants
Participants
No
Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post-study treatment follow-up (start of Week 53 or ED up to and through Week 112)
ID
Title
Description
OG000
60 mg LY2127399
LY2127399: 60 mg subcutaneous injections every 4 weeks for 48 weeks.
OG001
60/120 mg LY2127399
LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, participants had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Participants remained at this dose level for the remainder of study treatment (48 weeks in total).
Time Frame
Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112)
Description
Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112).
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
60 mg LY2127399 Treatment
AEs reported while on study treatment (baseline up to Week 48) plus up to 3 weeks after discontinuation of study treatment (until next study visit).
LY2127399: 60 mg subcutaneous injections every 4 weeks for 48 weeks.
4
60
36
60
EG001
60/120 mg LY2127399 Treatment
AEs reported while on study treatment (baseline up to Week 48) plus up to 3 weeks after discontinuation of study treatment (until next study visit).
LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, participants had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Participants remained at this dose level for the remainder of study treatment (48 weeks in total).
16
121
93
121
EG002
60/120/60 mg LY2127399 Treatment
AEs reported while on study treatment (baseline up to Week 48) plus up to 3 weeks after discontinuation of study treatment (until next study visit).
LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, the participant had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Subsequently, the participant had a dose decrease back to 60 mg LY2127399, administered once every 4 weeks for the remainder of study treatment (48 weeks in total).
1
1
1
1
EG003
60 mg LY2127399 Post-Study Treatment Follow-Up
AEs that started or worsened after discontinuation of study treatment (Week 52 or ED) through end of study (Week 72) plus 28 weeks, for participants who received only the 60 mg LY2127399 dose during study treatment.
No study drug was administered during the post-study treatment follow-up.
AEs that started or worsened after discontinuation of study treatment (Week 52 or ED) through end of study (Week 72) plus 28 weeks, for participants who had a dose increase to 120 mg LY2127399 during study treatment.
No study drug was administered during the post-study treatment follow-up.
AEs that started or worsened after discontinuation of study treatment (Week 52 or ED) through end of study (Week 72) plus 28 weeks, for participants who had a dose increase to 120 mg LY2127399 and a dose decrease back to 60 mg LY2127399 during study treatment.
No study drug was administered during the post-study treatment follow-up.
0
1
0
1
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
PANCYTOPENIA
Blood and lymphatic system disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected121 at risk
EG0021 events1 affected1 at risk
EG0030 events0 affected60 at risk
EG0040 events0 affected121 at risk
EG0050 events0 affected1 at risk
HYPERTROPHIC CARDIOMYOPATHY
Cardiac disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0011 events1 affected121 at risk
EG0020 events0 affected1 at risk
EG003
MYOCARDIAL INFARCTION
Cardiac disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0011 events1 affected121 at risk
EG0020 events0 affected1 at risk
EG003
MYOCARDIAL ISCHAEMIA
Cardiac disorders
MedDRA 14.0
Systematic Assessment
EG0001 events1 affected60 at risk
EG0010 events0 affected121 at risk
EG0020 events0 affected1 at risk
EG003
GASTRIC ULCER
Gastrointestinal disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0011 events1 affected121 at risk
EG0020 events0 affected1 at risk
EG003
PANCREATITIS ACUTE
Gastrointestinal disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected121 at risk
EG0020 events0 affected1 at risk
EG003
DEVICE DISLOCATION
General disorders
MedDRA 14.0
Systematic Assessment
EG0001 events1 affected60 at risk
EG0010 events0 affected121 at risk
EG0020 events0 affected1 at risk
EG003
GASTROENTERITIS VIRAL
Infections and infestations
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0011 events1 affected121 at risk
EG0020 events0 affected1 at risk
EG003
HEPATITIS A
Infections and infestations
MedDRA 14.0
Systematic Assessment
EG0001 events1 affected60 at risk
EG0010 events0 affected121 at risk
EG0020 events0 affected1 at risk
EG003
INTERVERTEBRAL DISCITIS
Infections and infestations
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0011 events1 affected121 at risk
EG0020 events0 affected1 at risk
EG003
OSTEOMYELITIS
Infections and infestations
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0011 events1 affected121 at risk
EG0020 events0 affected1 at risk
EG003
PNEUMONIA
Infections and infestations
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0011 events1 affected121 at risk
EG0020 events0 affected1 at risk
EG003
PNEUMONIA NECROTISING
Infections and infestations
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected121 at risk
EG0020 events0 affected1 at risk
EG003
PSOAS ABSCESS
Infections and infestations
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0011 events1 affected121 at risk
EG0020 events0 affected1 at risk
EG003
BRAIN CONTUSION
Injury, poisoning and procedural complications
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0011 events1 affected121 at risk
EG0020 events0 affected1 at risk
EG003
FALL
Injury, poisoning and procedural complications
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0011 events1 affected121 at risk
EG0020 events0 affected1 at risk
EG003
POST PROCEDURAL HAEMORRHAGE
Injury, poisoning and procedural complications
MedDRA 14.0
Systematic Assessment
EG0001 events1 affected60 at risk
EG0010 events0 affected121 at risk
EG0020 events0 affected1 at risk
EG003
RIB FRACTURE
Injury, poisoning and procedural complications
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected121 at risk
EG0020 events0 affected1 at risk
EG003
TRACHEAL OBSTRUCTION
Injury, poisoning and procedural complications
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected121 at risk
EG0020 events0 affected1 at risk
EG003
DIABETIC KETOACIDOSIS
Metabolism and nutrition disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0011 events1 affected121 at risk
EG0020 events0 affected1 at risk
EG003
OSTEONECROSIS
Musculoskeletal and connective tissue disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0011 events1 affected121 at risk
EG0020 events0 affected1 at risk
EG003
RHEUMATOID ARTHRITIS
Musculoskeletal and connective tissue disorders
MedDRA 14.0
Systematic Assessment
EG0001 events1 affected60 at risk
EG0014 events4 affected121 at risk
EG0020 events0 affected1 at risk
EG003
BENIGN LUNG NEOPLASM
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0011 events1 affected121 at risk
EG0020 events0 affected1 at risk
EG003
BREAST CANCER
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0011 events1 affected121 at risk
EG0020 events0 affected1 at risk
EG003
COLON CANCER METASTATIC
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected121 at risk
EG0020 events0 affected1 at risk
EG003
OVARIAN EPITHELIAL CANCER
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected51 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected1 at risk
EG003
CEREBROVASCULAR ACCIDENT
Nervous system disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0011 events1 affected121 at risk
EG0020 events0 affected1 at risk
EG003
ISCHAEMIC STROKE
Nervous system disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected121 at risk
EG0021 events1 affected1 at risk
EG003
ASTHMA
Respiratory, thoracic and mediastinal disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected121 at risk
EG0020 events0 affected1 at risk
EG003
PULMONARY FIBROSIS
Respiratory, thoracic and mediastinal disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0012 events2 affected121 at risk
EG0020 events0 affected1 at risk
EG003
RESPIRATORY FAILURE
Respiratory, thoracic and mediastinal disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected121 at risk
EG0020 events0 affected1 at risk
EG003
RHEUMATOID LUNG
Respiratory, thoracic and mediastinal disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected121 at risk
EG0020 events0 affected1 at risk
EG003
ARTERIOSCLEROSIS
Vascular disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0011 events1 affected121 at risk
EG0020 events0 affected1 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
ANAEMIA
Blood and lymphatic system disorders
MedDRA 14.0
Systematic Assessment
EG0002 events2 affected60 at risk
EG0017 events7 affected121 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected60 at risk
EG0041 events1 affected121 at risk
EG0050 events0 affected1 at risk
IRON DEFICIENCY ANAEMIA
Blood and lymphatic system disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected121 at risk
EG0020 events0 affected1 at risk
EG003
LEUKOCYTOSIS
Blood and lymphatic system disorders
MedDRA 14.0
Systematic Assessment
EG0001 events1 affected60 at risk
EG0010 events0 affected121 at risk
EG0020 events0 affected1 at risk
EG003
LYMPHADENOPATHY
Blood and lymphatic system disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0012 events2 affected121 at risk
EG0020 events0 affected1 at risk
EG003
MICROCYTIC ANAEMIA
Blood and lymphatic system disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected121 at risk
EG0020 events0 affected1 at risk
EG003
THROMBOCYTOPENIA
Blood and lymphatic system disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected121 at risk
EG0020 events0 affected1 at risk
EG003
BUNDLE BRANCH BLOCK LEFT
Cardiac disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0011 events1 affected121 at risk
EG0020 events0 affected1 at risk
EG003
CORONARY ARTERY DISEASE
Cardiac disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0011 events1 affected121 at risk
EG0020 events0 affected1 at risk
EG003
MYOCARDIAL ISCHAEMIA
Cardiac disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0011 events1 affected121 at risk
EG0020 events0 affected1 at risk
EG003
PALPITATIONS
Cardiac disorders
MedDRA 14.0
Systematic Assessment
EG0002 events2 affected60 at risk
EG0012 events2 affected121 at risk
EG0020 events0 affected1 at risk
EG003
SPLINTER HAEMORRHAGES
Cardiac disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0011 events1 affected121 at risk
EG0020 events0 affected1 at risk
EG003
TACHYCARDIA
Cardiac disorders
MedDRA 14.0
Systematic Assessment
EG0001 events1 affected60 at risk
EG0010 events0 affected121 at risk
EG0020 events0 affected1 at risk
EG003
VENTRICULAR EXTRASYSTOLES
Cardiac disorders
MedDRA 14.0
Systematic Assessment
EG0001 events1 affected60 at risk
EG0010 events0 affected121 at risk
EG0020 events0 affected1 at risk
EG003
CERUMEN IMPACTION
Ear and labyrinth disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected121 at risk
EG0020 events0 affected1 at risk
EG003
EXTERNAL EAR INFLAMMATION
Ear and labyrinth disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0011 events1 affected121 at risk
EG0020 events0 affected1 at risk
EG003
TYMPANIC MEMBRANE PERFORATION
Ear and labyrinth disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected121 at risk
EG0020 events0 affected1 at risk
EG003
VERTIGO
Ear and labyrinth disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0012 events2 affected121 at risk
EG0020 events0 affected1 at risk
EG003
HYPOTHYROIDISM
Endocrine disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected121 at risk
EG0020 events0 affected1 at risk
EG003
CATARACT
Eye disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0011 events1 affected121 at risk
EG0020 events0 affected1 at risk
EG003
CONJUNCTIVAL HAEMORRHAGE
Eye disorders
MedDRA 14.0
Systematic Assessment
EG0002 events2 affected60 at risk
EG0010 events0 affected121 at risk
EG0020 events0 affected1 at risk
EG003
CONJUNCTIVITIS
Eye disorders
MedDRA 14.0
Systematic Assessment
EG0001 events1 affected60 at risk
EG0011 events1 affected121 at risk
EG0020 events0 affected1 at risk
EG003
OPEN ANGLE GLAUCOMA
Eye disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected121 at risk
EG0020 events0 affected1 at risk
EG003
RETINAL DETACHMENT
Eye disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected121 at risk
EG0020 events0 affected1 at risk
EG003
ULCERATIVE KERATITIS
Eye disorders
MedDRA 14.0
Systematic Assessment
EG0001 events1 affected60 at risk
EG0010 events0 affected121 at risk
EG0020 events0 affected1 at risk
EG003
ABDOMINAL PAIN
Gastrointestinal disorders
MedDRA 14.0
Systematic Assessment
EG0001 events1 affected60 at risk
EG0010 events0 affected121 at risk
EG0020 events0 affected1 at risk
EG003
ABDOMINAL PAIN UPPER
Gastrointestinal disorders
MedDRA 14.0
Systematic Assessment
EG0002 events2 affected60 at risk
EG0011 events1 affected121 at risk
EG0020 events0 affected1 at risk
EG003
ABDOMINAL TENDERNESS
Gastrointestinal disorders
MedDRA 14.0
Systematic Assessment
EG0001 events1 affected60 at risk
EG0010 events0 affected121 at risk
EG0020 events0 affected1 at risk
EG003
CONSTIPATION
Gastrointestinal disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected121 at risk
EG0020 events0 affected1 at risk
EG003
DENTAL CARIES
Gastrointestinal disorders
MedDRA 14.0
Systematic Assessment
EG0002 events2 affected60 at risk
EG0010 events0 affected121 at risk
EG0020 events0 affected1 at risk
EG003
DIARRHOEA
Gastrointestinal disorders
MedDRA 14.0
Systematic Assessment
EG0001 events1 affected60 at risk
EG0011 events1 affected121 at risk
EG0020 events0 affected1 at risk
EG003
DYSPEPSIA
Gastrointestinal disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0012 events2 affected121 at risk
EG0020 events0 affected1 at risk
EG003
DYSPHAGIA
Gastrointestinal disorders
MedDRA 14.0
Systematic Assessment
EG0001 events1 affected60 at risk
EG0010 events0 affected121 at risk
EG0020 events0 affected1 at risk
EG003
GASTRITIS
Gastrointestinal disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0013 events3 affected121 at risk
EG0020 events0 affected1 at risk
EG003
GASTROOESOPHAGEAL REFLUX DISEASE
Gastrointestinal disorders
MedDRA 14.0
Systematic Assessment
EG0001 events1 affected60 at risk
EG0011 events1 affected121 at risk
EG0021 events1 affected1 at risk
EG003
IRRITABLE BOWEL SYNDROME
Gastrointestinal disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0011 events1 affected121 at risk
EG0020 events0 affected1 at risk
EG003
MOUTH ULCERATION
Gastrointestinal disorders
MedDRA 14.0
Systematic Assessment
EG0001 events1 affected60 at risk
EG0010 events0 affected121 at risk
EG0021 events1 affected1 at risk
EG003
NAUSEA
Gastrointestinal disorders
MedDRA 14.0
Systematic Assessment
EG0001 events1 affected60 at risk
EG0011 events1 affected121 at risk
EG0021 events1 affected1 at risk
EG003
ORAL MUCOSAL ERUPTION
Gastrointestinal disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0011 events1 affected121 at risk
EG0020 events0 affected1 at risk
EG003
PANCREATITIS
Gastrointestinal disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0011 events1 affected121 at risk
EG0020 events0 affected1 at risk
EG003
SALIVARY GLAND ENLARGEMENT
Gastrointestinal disorders
MedDRA 14.0
Systematic Assessment
EG0001 events1 affected60 at risk
EG0010 events0 affected121 at risk
EG0020 events0 affected1 at risk
EG003
UMBILICAL HERNIA
Gastrointestinal disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected121 at risk
EG0020 events0 affected1 at risk
EG003
VOMITING
Gastrointestinal disorders
MedDRA 14.0
Systematic Assessment
EG0001 events1 affected60 at risk
EG0012 events2 affected121 at risk
EG0020 events0 affected1 at risk
EG003
ASTHENIA
General disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0012 events2 affected121 at risk
EG0020 events0 affected1 at risk
EG003
CHEST PAIN
General disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0012 events2 affected121 at risk
EG0020 events0 affected1 at risk
EG003
DRUG INTOLERANCE
General disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0011 events1 affected121 at risk
EG0020 events0 affected1 at risk
EG003
FATIGUE
General disorders
MedDRA 14.0
Systematic Assessment
EG0001 events1 affected60 at risk
EG0011 events1 affected121 at risk
EG0020 events0 affected1 at risk
EG003
INJECTION SITE HAEMORRHAGE
General disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0011 events1 affected121 at risk
EG0020 events0 affected1 at risk
EG003
INJECTION SITE NODULE
General disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0011 events1 affected121 at risk
EG0020 events0 affected1 at risk
EG003
INJECTION SITE PAIN
General disorders
MedDRA 14.0
Systematic Assessment
EG0002 events2 affected60 at risk
EG00112 events12 affected121 at risk
EG0020 events0 affected1 at risk
EG003
INJECTION SITE PARAESTHESIA
General disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0011 events1 affected121 at risk
EG0020 events0 affected1 at risk
EG003
INJECTION SITE RASH
General disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0011 events1 affected121 at risk
EG0020 events0 affected1 at risk
EG003
MALAISE
General disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0011 events1 affected121 at risk
EG0020 events0 affected1 at risk
EG003
OEDEMA PERIPHERAL
General disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0012 events2 affected121 at risk
EG0020 events0 affected1 at risk
EG003
PYREXIA
General disorders
MedDRA 14.0
Systematic Assessment
EG0001 events1 affected60 at risk
EG0014 events4 affected121 at risk
EG0020 events0 affected1 at risk
EG003
CHOLELITHIASIS
Hepatobiliary disorders
MedDRA 14.0
Systematic Assessment
EG0001 events1 affected60 at risk
EG0010 events0 affected121 at risk
EG0020 events0 affected1 at risk
EG003
CHOLESTASIS
Hepatobiliary disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected121 at risk
EG0020 events0 affected1 at risk
EG003
DRUG HYPERSENSITIVITY
Immune system disorders
MedDRA 14.0
Systematic Assessment
EG0001 events1 affected60 at risk
EG0010 events0 affected121 at risk
EG0020 events0 affected1 at risk
EG003
ABSCESS LIMB
Infections and infestations
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected121 at risk
EG0020 events0 affected1 at risk
EG003
BRONCHIOLITIS
Infections and infestations
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0011 events1 affected121 at risk
EG0020 events0 affected1 at risk
EG003
BRONCHITIS
Infections and infestations
MedDRA 14.0
Systematic Assessment
EG0007 events6 affected60 at risk
EG0018 events8 affected121 at risk
EG0020 events0 affected1 at risk
EG003
CELLULITIS
Infections and infestations
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0011 events1 affected121 at risk
EG0020 events0 affected1 at risk
EG003
CONJUNCTIVITIS BACTERIAL
Infections and infestations
MedDRA 14.0
Systematic Assessment
EG0001 events1 affected60 at risk
EG0010 events0 affected121 at risk
EG0020 events0 affected1 at risk
EG003
CYSTITIS
Infections and infestations
MedDRA 14.0
Systematic Assessment
EG0001 events1 affected60 at risk
EG0011 events1 affected121 at risk
EG0020 events0 affected1 at risk
EG003
FUNGAL SKIN INFECTION
Infections and infestations
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0011 events1 affected121 at risk
EG0020 events0 affected1 at risk
EG003
GASTROENTERITIS
Infections and infestations
MedDRA 14.0
Systematic Assessment
EG0002 events2 affected60 at risk
EG0013 events3 affected121 at risk
EG0020 events0 affected1 at risk
EG003
GASTROENTERITIS VIRAL
Infections and infestations
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0012 events2 affected121 at risk
EG0020 events0 affected1 at risk
EG003
GASTROINTESTINAL INFECTION
Infections and infestations
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0011 events1 affected121 at risk
EG0020 events0 affected1 at risk
EG003
HERPES ZOSTER
Infections and infestations
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected121 at risk
EG0020 events0 affected1 at risk
EG003
HORDEOLUM
Infections and infestations
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0011 events1 affected121 at risk
EG0020 events0 affected1 at risk
EG003
INFECTED BITES
Infections and infestations
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0011 events1 affected121 at risk
EG0020 events0 affected1 at risk
EG003
INFLUENZA
Infections and infestations
MedDRA 14.0
Systematic Assessment
EG0002 events2 affected60 at risk
EG0014 events4 affected121 at risk
EG0020 events0 affected1 at risk
EG003
LABYRINTHITIS
Infections and infestations
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0011 events1 affected121 at risk
EG0020 events0 affected1 at risk
EG003
LARYNGITIS
Infections and infestations
MedDRA 14.0
Systematic Assessment
EG0001 events1 affected60 at risk
EG0011 events1 affected121 at risk
EG0020 events0 affected1 at risk
EG003
NASOPHARYNGITIS
Infections and infestations
MedDRA 14.0
Systematic Assessment
EG0005 events5 affected60 at risk
EG0019 events9 affected121 at risk
EG0020 events0 affected1 at risk
EG003
ORAL HERPES
Infections and infestations
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0014 events4 affected121 at risk
EG0020 events0 affected1 at risk
EG003
OTITIS MEDIA
Infections and infestations
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0011 events1 affected121 at risk
EG0020 events0 affected1 at risk
EG003
PHARYNGITIS
Infections and infestations
MedDRA 14.0
Systematic Assessment
EG0003 events3 affected60 at risk
EG0016 events5 affected121 at risk
EG0020 events0 affected1 at risk
EG003
PHARYNGITIS BACTERIAL
Infections and infestations
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected121 at risk
EG0020 events0 affected1 at risk
EG003
PHARYNGOTONSILLITIS
Infections and infestations
MedDRA 14.0
Systematic Assessment
EG0001 events1 affected60 at risk
EG0010 events0 affected121 at risk
EG0020 events0 affected1 at risk
EG003
PNEUMONIA
Infections and infestations
MedDRA 14.0
Systematic Assessment
EG0001 events1 affected60 at risk
EG0011 events1 affected121 at risk
EG0020 events0 affected1 at risk
EG003
RESPIRATORY TRACT INFECTION
Infections and infestations
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0012 events2 affected121 at risk
EG0020 events0 affected1 at risk
EG003
RHINITIS
Infections and infestations
MedDRA 14.0
Systematic Assessment
EG0001 events1 affected60 at risk
EG0012 events2 affected121 at risk
EG0020 events0 affected1 at risk
EG003
SIALOADENITIS
Infections and infestations
MedDRA 14.0
Systematic Assessment
EG0001 events1 affected60 at risk
EG0010 events0 affected121 at risk
EG0020 events0 affected1 at risk
EG003
SINUSITIS
Infections and infestations
MedDRA 14.0
Systematic Assessment
EG0002 events2 affected60 at risk
EG0013 events3 affected121 at risk
EG0020 events0 affected1 at risk
EG003
SKIN INFECTION
Infections and infestations
MedDRA 14.0
Systematic Assessment
EG0001 events1 affected60 at risk
EG0010 events0 affected121 at risk
EG0020 events0 affected1 at risk
EG003
SOFT TISSUE INFECTION
Infections and infestations
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0011 events1 affected121 at risk
EG0020 events0 affected1 at risk
EG003
STAPHYLOCOCCAL INFECTION
Infections and infestations
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0011 events1 affected121 at risk
EG0020 events0 affected1 at risk
EG003
STAPHYLOCOCCAL PHARYNGITIS
Infections and infestations
MedDRA 14.0
Systematic Assessment
EG0001 events1 affected60 at risk
EG0010 events0 affected121 at risk
EG0020 events0 affected1 at risk
EG003
STAPHYLOCOCCAL SKIN INFECTION
Infections and infestations
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0011 events1 affected121 at risk
EG0020 events0 affected1 at risk
EG003
TOOTH ABSCESS
Infections and infestations
MedDRA 14.0
Systematic Assessment
EG0001 events1 affected60 at risk
EG0011 events1 affected121 at risk
EG0020 events0 affected1 at risk
EG003
TOOTH INFECTION
Infections and infestations
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0011 events1 affected121 at risk
EG0020 events0 affected1 at risk
EG003
TRACHEITIS
Infections and infestations
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected121 at risk
EG0020 events0 affected1 at risk
EG003
UPPER RESPIRATORY TRACT INFECTION
Infections and infestations
MedDRA 14.0
Systematic Assessment
EG0002 events2 affected60 at risk
EG00112 events12 affected121 at risk
EG0020 events0 affected1 at risk
EG003
URINARY TRACT INFECTION
Infections and infestations
MedDRA 14.0
Systematic Assessment
EG0002 events2 affected60 at risk
EG00113 events13 affected121 at risk
EG0020 events0 affected1 at risk
EG003
VAGINAL ABSCESS
Infections and infestations
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected51 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected1 at risk
EG003
VAGINAL INFECTION
Infections and infestations
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected51 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected1 at risk
EG003
VIRAL INFECTION
Infections and infestations
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0011 events1 affected121 at risk
EG0020 events0 affected1 at risk
EG003
VIRAL UPPER RESPIRATORY TRACT INFECTION
Infections and infestations
MedDRA 14.0
Systematic Assessment
EG0001 events1 affected60 at risk
EG0011 events1 affected121 at risk
EG0020 events0 affected1 at risk
EG003
VULVOVAGINAL MYCOTIC INFECTION
Infections and infestations
MedDRA 14.0
Systematic Assessment
EG0001 events1 affected51 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected1 at risk
EG003
ANAEMIA POSTOPERATIVE
Injury, poisoning and procedural complications
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0011 events1 affected121 at risk
EG0020 events0 affected1 at risk
EG003
ANIMAL BITE
Injury, poisoning and procedural complications
MedDRA 14.0
Systematic Assessment
EG0001 events1 affected60 at risk
EG0010 events0 affected121 at risk
EG0020 events0 affected1 at risk
EG003
ANKLE FRACTURE
Injury, poisoning and procedural complications
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0011 events1 affected121 at risk
EG0020 events0 affected1 at risk
EG003
CONTUSION
Injury, poisoning and procedural complications
MedDRA 14.0
Systematic Assessment
EG0001 events1 affected60 at risk
EG0012 events2 affected121 at risk
EG0020 events0 affected1 at risk
EG003
DRUG EXPOSURE DURING PREGNANCY
Injury, poisoning and procedural complications
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected51 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected1 at risk
EG003
EPICONDYLITIS
Injury, poisoning and procedural complications
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0011 events1 affected121 at risk
EG0020 events0 affected1 at risk
EG003
EXCORIATION
Injury, poisoning and procedural complications
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected121 at risk
EG0020 events0 affected1 at risk
EG003
FACIAL BONES FRACTURE
Injury, poisoning and procedural complications
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0011 events1 affected121 at risk
EG0020 events0 affected1 at risk
EG003
FALL
Injury, poisoning and procedural complications
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0011 events1 affected121 at risk
EG0020 events0 affected1 at risk
EG003
FIBULA FRACTURE
Injury, poisoning and procedural complications
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0011 events1 affected121 at risk
EG0020 events0 affected1 at risk
EG003
FOOT FRACTURE
Injury, poisoning and procedural complications
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0011 events1 affected121 at risk
EG0020 events0 affected1 at risk
EG003
JOINT SPRAIN
Injury, poisoning and procedural complications
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0011 events1 affected121 at risk
EG0020 events0 affected1 at risk
EG003
LACERATION
Injury, poisoning and procedural complications
MedDRA 14.0
Systematic Assessment
EG0001 events1 affected60 at risk
EG0010 events0 affected121 at risk
EG0020 events0 affected1 at risk
EG003
LIMB INJURY
Injury, poisoning and procedural complications
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0011 events1 affected121 at risk
EG0020 events0 affected1 at risk
EG003
MUSCLE RUPTURE
Injury, poisoning and procedural complications
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0011 events1 affected121 at risk
EG0020 events0 affected1 at risk
EG003
MUSCLE STRAIN
Injury, poisoning and procedural complications
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0011 events1 affected121 at risk
EG0020 events0 affected1 at risk
EG003
NAIL INJURY
Injury, poisoning and procedural complications
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0011 events1 affected121 at risk
EG0020 events0 affected1 at risk
EG003
RADIUS FRACTURE
Injury, poisoning and procedural complications
MedDRA 14.0
Systematic Assessment
EG0001 events1 affected60 at risk
EG0010 events0 affected121 at risk
EG0020 events0 affected1 at risk
EG003
TENDON INJURY
Injury, poisoning and procedural complications
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0011 events1 affected121 at risk
EG0020 events0 affected1 at risk
EG003
TENDON RUPTURE
Injury, poisoning and procedural complications
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0011 events1 affected121 at risk
EG0020 events0 affected1 at risk
EG003
THERMAL BURN
Injury, poisoning and procedural complications
MedDRA 14.0
Systematic Assessment
EG0001 events1 affected60 at risk
EG0011 events1 affected121 at risk
EG0020 events0 affected1 at risk
EG003
TOOTH FRACTURE
Injury, poisoning and procedural complications
MedDRA 14.0
Systematic Assessment
EG0001 events1 affected60 at risk
EG0010 events0 affected121 at risk
EG0020 events0 affected1 at risk
EG003
ALANINE AMINOTRANSFERASE INCREASED
Investigations
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0011 events1 affected121 at risk
EG0020 events0 affected1 at risk
EG003
ASPARTATE AMINOTRANSFERASE INCREASED
Investigations
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0011 events1 affected121 at risk
EG0020 events0 affected1 at risk
EG003
ASPIRATION JOINT
Investigations
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0011 events1 affected121 at risk
EG0020 events0 affected1 at risk
EG003
ASPIRATION PLEURAL CAVITY
Investigations
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected121 at risk
EG0020 events0 affected1 at risk
EG003
B-LYMPHOCYTE COUNT DECREASED
Investigations
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected121 at risk
EG0020 events0 affected1 at risk
EG003
BLOOD ALKALINE PHOSPHATASE INCREASED
Investigations
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0011 events1 affected121 at risk
EG0020 events0 affected1 at risk
EG003
BLOOD CHOLESTEROL INCREASED
Investigations
MedDRA 14.0
Systematic Assessment
EG0001 events1 affected60 at risk
EG0010 events0 affected121 at risk
EG0020 events0 affected1 at risk
EG003
BLOOD IMMUNOGLOBULIN M INCREASED
Investigations
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected121 at risk
EG0020 events0 affected1 at risk
EG003
BLOOD PRESSURE INCREASED
Investigations
MedDRA 14.0
Systematic Assessment
EG0001 events1 affected60 at risk
EG0010 events0 affected121 at risk
EG0020 events0 affected1 at risk
EG003
BODY TEMPERATURE INCREASED
Investigations
MedDRA 14.0
Systematic Assessment
EG0001 events1 affected60 at risk
EG0010 events0 affected121 at risk
EG0020 events0 affected1 at risk
EG003
ECG SIGNS OF VENTRICULAR HYPERTROPHY
Investigations
MedDRA 14.0
Systematic Assessment
EG0001 events1 affected60 at risk
EG0010 events0 affected121 at risk
EG0020 events0 affected1 at risk
EG003
ELECTROCARDIOGRAM ST SEGMENT ABNORMAL
Investigations
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0011 events1 affected121 at risk
EG0020 events0 affected1 at risk
EG003
GAMMA-GLUTAMYLTRANSFERASE INCREASED
Investigations
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0012 events2 affected121 at risk
EG0020 events0 affected1 at risk
EG003
HEART RATE INCREASED
Investigations
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0011 events1 affected121 at risk
EG0020 events0 affected1 at risk
EG003
HEPATIC ENZYME INCREASED
Investigations
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0011 events1 affected121 at risk
EG0020 events0 affected1 at risk
EG003
NEUTROPHIL COUNT INCREASED
Investigations
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected121 at risk
EG0020 events0 affected1 at risk
EG003
QRS AXIS ABNORMAL
Investigations
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0011 events1 affected121 at risk
EG0020 events0 affected1 at risk
EG003
VITAMIN D DECREASED
Investigations
MedDRA 14.0
Systematic Assessment
EG0001 events1 affected60 at risk
EG0010 events0 affected121 at risk
EG0020 events0 affected1 at risk
EG003
WEIGHT DECREASED
Investigations
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0011 events1 affected121 at risk
EG0020 events0 affected1 at risk
EG003
WEIGHT INCREASED
Investigations
MedDRA 14.0
Systematic Assessment
EG0001 events1 affected60 at risk
EG0011 events1 affected121 at risk
EG0020 events0 affected1 at risk
EG003
WHITE BLOOD CELL COUNT INCREASED
Investigations
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected121 at risk
EG0020 events0 affected1 at risk
EG003
DIABETES MELLITUS
Metabolism and nutrition disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0011 events1 affected121 at risk
EG0021 events1 affected1 at risk
EG003
DYSLIPIDAEMIA
Metabolism and nutrition disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0011 events1 affected121 at risk
EG0020 events0 affected1 at risk
EG003
GOUT
Metabolism and nutrition disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0011 events1 affected121 at risk
EG0020 events0 affected1 at risk
EG003
HYPERCHOLESTEROLAEMIA
Metabolism and nutrition disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0012 events2 affected121 at risk
EG0021 events1 affected1 at risk
EG003
HYPERGLYCAEMIA
Metabolism and nutrition disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0011 events1 affected121 at risk
EG0020 events0 affected1 at risk
EG003
HYPERLIPIDAEMIA
Metabolism and nutrition disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected121 at risk
EG0020 events0 affected1 at risk
EG003
HYPOKALAEMIA
Metabolism and nutrition disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected121 at risk
EG0021 events1 affected1 at risk
EG003
VITAMIN B12 DEFICIENCY
Metabolism and nutrition disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0011 events1 affected121 at risk
EG0020 events0 affected1 at risk
EG003
VITAMIN D DEFICIENCY
Metabolism and nutrition disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected121 at risk
EG0020 events0 affected1 at risk
EG003
ARTHRALGIA
Musculoskeletal and connective tissue disorders
MedDRA 14.0
Systematic Assessment
EG0002 events2 affected60 at risk
EG0011 events1 affected121 at risk
EG0020 events0 affected1 at risk
EG003
ATLANTOAXIAL INSTABILITY
Musculoskeletal and connective tissue disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected121 at risk
EG0020 events0 affected1 at risk
EG003
BACK PAIN
Musculoskeletal and connective tissue disorders
MedDRA 14.0
Systematic Assessment
EG0002 events2 affected60 at risk
EG0015 events5 affected121 at risk
EG0020 events0 affected1 at risk
EG003
BURSITIS
Musculoskeletal and connective tissue disorders
MedDRA 14.0
Systematic Assessment
EG0001 events1 affected60 at risk
EG0011 events1 affected121 at risk
EG0020 events0 affected1 at risk
EG003
ENTHESOPATHY
Musculoskeletal and connective tissue disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected121 at risk
EG0020 events0 affected1 at risk
EG003
EXOSTOSIS
Musculoskeletal and connective tissue disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0011 events1 affected121 at risk
EG0020 events0 affected1 at risk
EG003
FASCIITIS
Musculoskeletal and connective tissue disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0011 events1 affected121 at risk
EG0020 events0 affected1 at risk
EG003
FIBROMYALGIA
Musculoskeletal and connective tissue disorders
MedDRA 14.0
Systematic Assessment
EG0002 events2 affected60 at risk
EG0010 events0 affected121 at risk
EG0020 events0 affected1 at risk
EG003
FOOT DEFORMITY
Musculoskeletal and connective tissue disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0011 events1 affected121 at risk
EG0020 events0 affected1 at risk
EG003
INTERVERTEBRAL DISC DEGENERATION
Musculoskeletal and connective tissue disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0011 events1 affected121 at risk
EG0020 events0 affected1 at risk
EG003
INTERVERTEBRAL DISC PROTRUSION
Musculoskeletal and connective tissue disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0011 events1 affected121 at risk
EG0020 events0 affected1 at risk
EG003
MUSCLE SPASMS
Musculoskeletal and connective tissue disorders
MedDRA 14.0
Systematic Assessment
EG0001 events1 affected60 at risk
EG0011 events1 affected121 at risk
EG0020 events0 affected1 at risk
EG003
MUSCULOSKELETAL CHEST PAIN
Musculoskeletal and connective tissue disorders
MedDRA 14.0
Systematic Assessment
EG0001 events1 affected60 at risk
EG0012 events2 affected121 at risk
EG0020 events0 affected1 at risk
EG003
MUSCULOSKELETAL PAIN
Musculoskeletal and connective tissue disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0011 events1 affected121 at risk
EG0020 events0 affected1 at risk
EG003
MYOFASCIAL PAIN SYNDROME
Musculoskeletal and connective tissue disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0011 events1 affected121 at risk
EG0020 events0 affected1 at risk
EG003
OSTEOARTHRITIS
Musculoskeletal and connective tissue disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0012 events2 affected121 at risk
EG0020 events0 affected1 at risk
EG003
OSTEOCHONDROSIS
Musculoskeletal and connective tissue disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0011 events1 affected121 at risk
EG0020 events0 affected1 at risk
EG003
OSTEOPOROSIS
Musculoskeletal and connective tissue disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected121 at risk
EG0020 events0 affected1 at risk
EG003
PAIN IN EXTREMITY
Musculoskeletal and connective tissue disorders
MedDRA 14.0
Systematic Assessment
EG0001 events1 affected60 at risk
EG0012 events2 affected121 at risk
EG0020 events0 affected1 at risk
EG003
RHEUMATOID ARTHRITIS
Musculoskeletal and connective tissue disorders
MedDRA 14.0
Systematic Assessment
EG00011 events10 affected60 at risk
EG00130 events28 affected121 at risk
EG0020 events0 affected1 at risk
EG003
TENDONITIS
Musculoskeletal and connective tissue disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0011 events1 affected121 at risk
EG0020 events0 affected1 at risk
EG003
BENIGN NEOPLASM OF THYROID GLAND
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected121 at risk
EG0020 events0 affected1 at risk
EG003
CARPAL TUNNEL SYNDROME
Nervous system disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected121 at risk
EG0020 events0 affected1 at risk
EG003
DIZZINESS
Nervous system disorders
MedDRA 14.0
Systematic Assessment
EG0001 events1 affected60 at risk
EG0012 events2 affected121 at risk
EG0020 events0 affected1 at risk
EG003
HEADACHE
Nervous system disorders
MedDRA 14.0
Systematic Assessment
EG0002 events2 affected60 at risk
EG0013 events3 affected121 at risk
EG0020 events0 affected1 at risk
EG003
HYPERAESTHESIA
Nervous system disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0011 events1 affected121 at risk
EG0020 events0 affected1 at risk
EG003
MIGRAINE
Nervous system disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected121 at risk
EG0020 events0 affected1 at risk
EG003
NEUROPATHY PERIPHERAL
Nervous system disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected121 at risk
EG0020 events0 affected1 at risk
EG003
PARAESTHESIA
Nervous system disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0012 events2 affected121 at risk
EG0020 events0 affected1 at risk
EG003
RADICULAR SYNDROME
Nervous system disorders
MedDRA 14.0
Systematic Assessment
EG0001 events1 affected60 at risk
EG0010 events0 affected121 at risk
EG0020 events0 affected1 at risk
EG003
SOMNOLENCE
Nervous system disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0011 events1 affected121 at risk
EG0020 events0 affected1 at risk
EG003
SYNCOPE
Nervous system disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0011 events1 affected121 at risk
EG0020 events0 affected1 at risk
EG003
VASCULAR DEMENTIA
Nervous system disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0011 events1 affected121 at risk
EG0020 events0 affected1 at risk
EG003
VITH NERVE PARALYSIS
Nervous system disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0011 events1 affected121 at risk
EG0020 events0 affected1 at risk
EG003
ANXIETY
Psychiatric disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected121 at risk
EG0020 events0 affected1 at risk
EG003
DEPRESSION
Psychiatric disorders
MedDRA 14.0
Systematic Assessment
EG0001 events1 affected60 at risk
EG0014 events4 affected121 at risk
EG0020 events0 affected1 at risk
EG003
INSOMNIA
Psychiatric disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected121 at risk
EG0021 events1 affected1 at risk
EG003
DYSURIA
Renal and urinary disorders
MedDRA 14.0
Systematic Assessment
EG0001 events1 affected60 at risk
EG0010 events0 affected121 at risk
EG0020 events0 affected1 at risk
EG003
NEPHROLITHIASIS
Renal and urinary disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0011 events1 affected121 at risk
EG0020 events0 affected1 at risk
EG003
NEPHROPATHY
Renal and urinary disorders
MedDRA 14.0
Systematic Assessment
EG0001 events1 affected60 at risk
EG0010 events0 affected121 at risk
EG0020 events0 affected1 at risk
EG003
RENAL COLIC
Renal and urinary disorders
MedDRA 14.0
Systematic Assessment
EG0001 events1 affected60 at risk
EG0010 events0 affected121 at risk
EG0020 events0 affected1 at risk
EG003
BREAST CYST
Reproductive system and breast disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0011 events1 affected121 at risk
EG0020 events0 affected1 at risk
EG003
MENORRHAGIA
Reproductive system and breast disorders
MedDRA 14.0
Systematic Assessment
EG0001 events1 affected51 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected1 at risk
EG003
METRORRHAGIA
Reproductive system and breast disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected51 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected1 at risk
EG003
POSTMENOPAUSAL HAEMORRHAGE
Reproductive system and breast disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected51 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected1 at risk
EG003
UTERINE POLYP
Reproductive system and breast disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected51 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected1 at risk
EG003
VAGINAL HAEMORRHAGE
Reproductive system and breast disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected51 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected1 at risk
EG003
ALLERGIC COUGH
Respiratory, thoracic and mediastinal disorders
MedDRA 14.0
Systematic Assessment
EG0001 events1 affected60 at risk
EG0010 events0 affected121 at risk
EG0020 events0 affected1 at risk
EG003
ASTHMA
Respiratory, thoracic and mediastinal disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0011 events1 affected121 at risk
EG0020 events0 affected1 at risk
EG003
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
Respiratory, thoracic and mediastinal disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0012 events2 affected121 at risk
EG0020 events0 affected1 at risk
EG003
COUGH
Respiratory, thoracic and mediastinal disorders
MedDRA 14.0
Systematic Assessment
EG0003 events3 affected60 at risk
EG0013 events3 affected121 at risk
EG0020 events0 affected1 at risk
EG003
DYSPHONIA
Respiratory, thoracic and mediastinal disorders
MedDRA 14.0
Systematic Assessment
EG0001 events1 affected60 at risk
EG0010 events0 affected121 at risk
EG0020 events0 affected1 at risk
EG003
EMPHYSEMA
Respiratory, thoracic and mediastinal disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0011 events1 affected121 at risk
EG0020 events0 affected1 at risk
EG003
EPISTAXIS
Respiratory, thoracic and mediastinal disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected121 at risk
EG0020 events0 affected1 at risk
EG003
HYDROPNEUMOTHORAX
Respiratory, thoracic and mediastinal disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0011 events1 affected121 at risk
EG0020 events0 affected1 at risk
EG003
PULMONARY EMBOLISM
Respiratory, thoracic and mediastinal disorders
MedDRA 14.0
Systematic Assessment
EG0001 events1 affected60 at risk
EG0010 events0 affected121 at risk
EG0020 events0 affected1 at risk
EG003
RALES
Respiratory, thoracic and mediastinal disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0012 events2 affected121 at risk
EG0020 events0 affected1 at risk
EG003
RHINORRHOEA
Respiratory, thoracic and mediastinal disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0011 events1 affected121 at risk
EG0020 events0 affected1 at risk
EG003
SINUS CONGESTION
Respiratory, thoracic and mediastinal disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0012 events2 affected121 at risk
EG0020 events0 affected1 at risk
EG003
ACNE
Skin and subcutaneous tissue disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0011 events1 affected121 at risk
EG0020 events0 affected1 at risk
EG003
ALOPECIA
Skin and subcutaneous tissue disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0013 events3 affected121 at risk
EG0020 events0 affected1 at risk
EG003
DERMATITIS
Skin and subcutaneous tissue disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0011 events1 affected121 at risk
EG0020 events0 affected1 at risk
EG003
DERMATITIS ALLERGIC
Skin and subcutaneous tissue disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0011 events1 affected121 at risk
EG0020 events0 affected1 at risk
EG003
DERMATOSIS
Skin and subcutaneous tissue disorders
MedDRA 14.0
Systematic Assessment
EG0001 events1 affected60 at risk
EG0010 events0 affected121 at risk
EG0020 events0 affected1 at risk
EG003
ECCHYMOSIS
Skin and subcutaneous tissue disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0011 events1 affected121 at risk
EG0020 events0 affected1 at risk
EG003
ECZEMA NUMMULAR
Skin and subcutaneous tissue disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0011 events1 affected121 at risk
EG0020 events0 affected1 at risk
EG003
ERYTHEMA
Skin and subcutaneous tissue disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected121 at risk
EG0020 events0 affected1 at risk
EG003
ERYTHEMA NODOSUM
Skin and subcutaneous tissue disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0011 events1 affected121 at risk
EG0020 events0 affected1 at risk
EG003
HYPERKERATOSIS
Skin and subcutaneous tissue disorders
MedDRA 14.0
Systematic Assessment
EG0001 events1 affected60 at risk
EG0010 events0 affected121 at risk
EG0020 events0 affected1 at risk
EG003
INCREASED TENDENCY TO BRUISE
Skin and subcutaneous tissue disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0011 events1 affected121 at risk
EG0020 events0 affected1 at risk
EG003
INGROWING NAIL
Skin and subcutaneous tissue disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected121 at risk
EG0020 events0 affected1 at risk
EG003
MACULE
Skin and subcutaneous tissue disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected121 at risk
EG0020 events0 affected1 at risk
EG003
PETECHIAE
Skin and subcutaneous tissue disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0011 events1 affected121 at risk
EG0020 events0 affected1 at risk
EG003
RASH
Skin and subcutaneous tissue disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0013 events3 affected121 at risk
EG0020 events0 affected1 at risk
EG003
RASH GENERALISED
Skin and subcutaneous tissue disorders
MedDRA 14.0
Systematic Assessment
EG0001 events1 affected60 at risk
EG0011 events1 affected121 at risk
EG0020 events0 affected1 at risk
EG003
RASH PAPULAR
Skin and subcutaneous tissue disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected121 at risk
EG0020 events0 affected1 at risk
EG003
SKIN INDURATION
Skin and subcutaneous tissue disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected121 at risk
EG0020 events0 affected1 at risk
EG003
SKIN LESION
Skin and subcutaneous tissue disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0011 events1 affected121 at risk
EG0020 events0 affected1 at risk
EG003
SKIN ULCER
Skin and subcutaneous tissue disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected121 at risk
EG0020 events0 affected1 at risk
EG003
ARTHRODESIS
Surgical and medical procedures
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0011 events1 affected121 at risk
EG0020 events0 affected1 at risk
EG003
CATARACT OPERATION
Surgical and medical procedures
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0012 events2 affected121 at risk
EG0020 events0 affected1 at risk
EG003
DEBRIDEMENT
Surgical and medical procedures
MedDRA 14.0
Systematic Assessment
EG0001 events1 affected60 at risk
EG0010 events0 affected121 at risk
EG0020 events0 affected1 at risk
EG003
HIP ARTHROPLASTY
Surgical and medical procedures
MedDRA 14.0
Systematic Assessment
EG0001 events1 affected60 at risk
EG0011 events1 affected121 at risk
EG0020 events0 affected1 at risk
EG003
KNEE ARTHROPLASTY
Surgical and medical procedures
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0012 events2 affected121 at risk
EG0020 events0 affected1 at risk
EG003
SYNOVECTOMY
Surgical and medical procedures
MedDRA 14.0
Systematic Assessment
EG0001 events1 affected60 at risk
EG0010 events0 affected121 at risk
EG0020 events0 affected1 at risk
EG003
TOOTH EXTRACTION
Surgical and medical procedures
MedDRA 14.0
Systematic Assessment
EG0001 events1 affected60 at risk
EG0012 events2 affected121 at risk
EG0020 events0 affected1 at risk
EG003
AORTIC ARTERIOSCLEROSIS
Vascular disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0011 events1 affected121 at risk
EG0020 events0 affected1 at risk
EG003
HAEMATOMA
Vascular disorders
MedDRA 14.0
Systematic Assessment
EG0001 events1 affected60 at risk
EG0010 events0 affected121 at risk
EG0020 events0 affected1 at risk
EG003
HOT FLUSH
Vascular disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected121 at risk
EG0020 events0 affected1 at risk
EG003
HYPERTENSION
Vascular disorders
MedDRA 14.0
Systematic Assessment
EG0004 events4 affected60 at risk
EG0018 events8 affected121 at risk
EG0021 events1 affected1 at risk
EG003
HYPERTENSIVE CRISIS
Vascular disorders
MedDRA 14.0
Systematic Assessment
EG0001 events1 affected60 at risk
EG0010 events0 affected121 at risk
EG0020 events0 affected1 at risk
EG003
HYPOTENSION
Vascular disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0011 events1 affected121 at risk
EG0020 events0 affected1 at risk
EG003
PHLEBITIS SUPERFICIAL
Vascular disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0011 events1 affected121 at risk
EG0020 events0 affected1 at risk
EG003
VENOUS INSUFFICIENCY
Vascular disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected121 at risk
EG0020 events0 affected1 at risk
EG003
Data integrity issues were identified at 1 study site involving 1 participant. Therefore, this site/participant is excluded from all efficacy analyses/results.
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
D001172
Arthritis, Rheumatoid
D001168
Arthritis
Ancestor Terms
ID
Term
D007592
Joint Diseases
D009140
Musculoskeletal Diseases
D012216
Rheumatic Diseases
D003240
Connective Tissue Diseases
D017437
Skin and Connective Tissue Diseases
D001327
Autoimmune Diseases
D007154
Immune System Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C575974
tabalumab
Ancestor Terms
Not provided
Browse Leaves
Not provided
Browse Branches
Not provided
BG00352.2± 12.08
1
BG003150
Male
BG0009
BG00122
BG0020
BG00331
1
BG003115
Black or African American
Title
Measurements
BG0001
BG00112
BG0020
BG00313
Hispanic
Title
Measurements
BG00019
BG00124
BG0020
BG00343
East Asian
Title
Measurements
BG0005
BG0014
BG0020
BG0039
West Asian
Title
Measurements
BG0000
BG0011
BG0020
BG0031
0
BG0036
Australia
Title
Measurements
BG0001
BG0010
BG0020
BG0031
Belgium
Title
Measurements
BG0000
BG0011
BG0020
BG0031
Brazil
Title
Measurements
BG0004
BG0019
BG0020
BG00313
Canada
Title
Measurements
BG0000
BG0014
BG0020
BG0034
Chile
Title
Measurements
BG0005
BG0018
BG0020
BG00313
Germany
Title
Measurements
BG0001
BG0011
BG0020
BG0032
Hungary
Title
Measurements
BG0006
BG0016
BG0020
BG00312
India
Title
Measurements
BG0005
BG0014
BG0020
BG0039
Mexico
Title
Measurements
BG00012
BG00112
BG0020
BG00324
Poland
Title
Measurements
BG00012
BG00130
BG0020
BG00342
Puerto Rico
Title
Measurements
BG0000
BG0011
BG0020
BG0031
Romania
Title
Measurements
BG0003
BG0013
BG0020
BG0036
United States
Title
Measurements
BG0007
BG00139
BG0021
BG00347
Title
Measurements
OG0004
OG00116
OG0021
OG002
60/120/60 mg LY2127399 Treatment
AEs reported while on study treatment (baseline up to Week 48) plus up to 3 weeks after discontinuation of study treatment (until next study visit).
LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, the participant had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Subsequently, the participant had a dose decrease back to 60 mg LY2127399, administered once every 4 weeks for the remainder of study treatment (48 weeks in total).
OG003
60 mg LY2127399 Post-Study Treatment Follow-Up
AEs that started or worsened after discontinuation of study treatment (Week 52 or ED) through end of study (Week 72) plus 28 weeks, for participants who received only the 60 mg LY2127399 dose during study treatment.
No study drug was administered during the post-study treatment follow-up.
AEs that started or worsened after discontinuation of study treatment (Week 52 or ED) through end of study (Week 72) plus 28 weeks, for participants who had a dose increase to 120 mg LY2127399 during study treatment.
No study drug was administered during the post-study treatment follow-up.
AEs that started or worsened after discontinuation of study treatment (Week 52 or ED) through end of study (Week 72) plus 28 weeks, for participants who had a dose increase to 120 mg LY2127399 and subsequently, a dose decrease back to 60 mg LY2127399 during study treatment.
No study drug was administered during the post-study treatment follow-up.
Units
Counts
Participants
OG00060
OG001121
OG0021
OG00360
OG004121
OG0051
Title
Denominators
Categories
Alanine Aminotransferase (ALT) Increased
Title
Measurements
OG0000
OG0011
OG0020
OG0030
OG0041
OG0050
Aspartate Aminotransferase (AST) Increased
Title
Measurements
OG0000
OG0011
OG0020
OG003
B-Lymphocyte Count Decreased
Title
Measurements
OG0000
OG0010
OG0020
OG003
Blood Alkaline Phosphatase Increased
Title
Measurements
OG0000
OG0011
OG0020
OG003
Blood Cholesterol Increased
Title
Measurements
OG0001
OG0010
OG0020
OG003
Blood Immunoglobulin M (IgM) Increased
Title
Measurements
OG0000
OG0010
OG0020
OG003
Gamma-Glutamyltransferase (GGT) Increased
Title
Measurements
OG0000
OG0012
OG0020
OG003
Hepatic Enzyme Increased
Title
Measurements
OG0000
OG0011
OG0020
OG003
Neutrophil Count Increased
Title
Measurements
OG0000
OG0010
OG0020
OG003
Vitamin D Decreased
Title
Measurements
OG0001
OG0010
OG0020
OG003
White Blood Cell Count Increased
Title
Measurements
OG0000
OG0010
OG0020
OG003
Dyslipidaemia
Title
Measurements
OG0000
OG0011
OG0020
OG003
Hypercholesterolaemia
Title
Measurements
OG0000
OG0012
OG0021
OG003
Hyperglycaemia
Title
Measurements
OG0000
OG0011
OG0020
OG003
Hyperlipidaemia
Title
Measurements
OG0000
OG0010
OG0020
OG003
Hypokalaemia
Title
Measurements
OG0000
OG0010
OG0021
OG003
Vitamin B12 Deficiency
Title
Measurements
OG0000
OG0011
OG0020
OG003
Vitamin D Deficiency
Title
Measurements
OG0000
OG0010
OG0020
OG003
OG002
60/120/60 mg LY2127399
LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, the participant had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Subsequently, the participant had a dose decrease back to 60 mg LY2127399, administered once every 4 weeks for the remainder of study treatment (48 weeks in total).
Units
Counts
Participants
OG00059
OG001120
OG0021
Title
Denominators
Categories
Title
Measurements
OG000-9.2± 8.0
OG001-6.5± 8.2
OG002-12.0± NAOnly 1 participant in the analysis, therefore standard deviation is not calculable.
OG002
60/120/60 mg LY2127399
LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, the participant had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Subsequently, the participant had a dose decrease back to 60 mg LY2127399, administered once every 4 weeks for the remainder of study treatment (48 weeks in total).
Units
Counts
Participants
OG00059
OG001120
OG0021
Title
Denominators
Categories
Title
Measurements
OG000-7.6± 6.8
OG001-5.3± 6.6
OG0022.0± NAOnly 1 participant in the analysis, therefore standard deviation is not calculable.
LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, the participant had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Subsequently, the participant had a dose decrease back to 60 mg LY2127399, administered once every 4 weeks for the remainder of study treatment (48 weeks in total).
Units
Counts
Participants
OG00057
OG001117
OG0021
Title
Denominators
Categories
Title
Measurements
OG000-26.1± 27.1
OG001-16.7± 30.7
OG002-68.0± NAOnly 1 participant in the analysis, therefore standard deviation is not calculable.
LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, the participant had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Subsequently, the participant had a dose decrease back to 60 mg LY2127399, administered once every 4 weeks for the remainder of study treatment (48 weeks in total).
Units
Counts
Participants
OG00058
OG001120
OG0021
Title
Denominators
Categories
Title
Measurements
OG000-29.1± 23.6
OG001-18.4± 26.9
OG002-38.0± NAOnly 1 participant in the analysis, therefore standard deviation is not calculable.
OG002
60/120/60 mg LY2127399
LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, the participant had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Subsequently, the participant had a dose decrease back to 60 mg LY2127399, administered once every 4 weeks for the remainder of study treatment (48 weeks in total).
Units
Counts
Participants
OG00059
OG001118
OG0021
Title
Denominators
Categories
Title
Measurements
OG000-0.3± 0.5
OG001-0.3± 0.6
OG002-0.5± NAOnly 1 participant in the analysis, therefore standard deviation is not calculable.
Units
Counts
Participants
OG00059
OG001118
OG0021
Title
Denominators
Categories
Title
Measurements
OG000-26.9± 26.4
OG001-13.4± 30.2
OG002-68.0± NAOnly 1 participant in the analysis, therefore standard deviation is not calculable.
Units
Counts
Participants
OG00058
OG001120
OG0021
Title
Denominators
Categories
Title
Measurements
OG000-11.1± 164.6
OG00150.7± 214.4
OG002241.4± NAOnly 1 participant in the analysis, therefore standard deviation is not calculable.
LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, participants had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Participants remained at this dose level for the remainder of study treatment (48 weeks in total).
OG002
60/120/60 mg LY2127399
LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, the participant had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Subsequently, the participant had a dose decrease back to 60 mg LY2127399, administered once every 4 weeks for the remainder of study treatment (48 weeks in total).
Units
Counts
Participants
OG00059
OG001120
OG0021
Title
Denominators
Categories
Title
Measurements
OG00066.1(52.6 to 77.9)
OG00132.5(24.2 to 41.7)
OG0020.0(0.0 to 97.5)
LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, participants had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Participants remained at this dose level for the remainder of study treatment (48 weeks in total).
OG002
60/120/60 mg LY2127399
LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, the participant had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Subsequently, the participant had a dose decrease back to 60 mg LY2127399, administered once every 4 weeks for the remainder of study treatment (48 weeks in total).
Units
Counts
Participants
OG00059
OG001120
OG0021
Title
Denominators
Categories
Title
Measurements
OG00033.9
OG00113.3
OG0020.0
LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, participants had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Participants remained at this dose level for the remainder of study treatment (48 weeks in total).
OG002
60/120/60 mg LY2127399
LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, the participant had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Subsequently, the participant had a dose decrease back to 60 mg LY2127399, administered once every 4 weeks for the remainder of study treatment (48 weeks in total).
Units
Counts
Participants
OG00059
OG001120
OG0021
Title
Denominators
Categories
Title
Measurements
OG00018.6
OG0016.7
OG0020.0
OG002
60/120/60 mg LY2127399
LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, the participant had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Subsequently, the participant had a dose decrease back to 60 mg LY2127399, administered once every 4 weeks for the remainder of study treatment (48 weeks in total).
Units
Counts
Participants
OG00059
OG001120
OG0020
Title
Denominators
Categories
Title
Measurements
OG00031.9± 47.6
OG00111.3± 46.4
LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, the participant had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Subsequently, the participant had a dose decrease back to 60 mg LY2127399, administered once every 4 weeks for the remainder of study treatment (48 weeks in total).
Units
Counts
Participants
OG00059
OG001118
OG0021
Title
Denominators
Categories
Title
Measurements
OG0005.2± 10.4
OG0015.1± 10.5
OG002-6.0± NAOnly 1 participant in the analysis, therefore standard deviation is not calculable.
OG002
60/120/60 mg LY2127399
LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, the participant had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Subsequently, the participant had a dose decrease back to 60 mg LY2127399, administered once every 4 weeks for the remainder of study treatment (48 weeks in total).
Units
Counts
Participants
OG00056
OG001117
OG0021
Title
Denominators
Categories
Title
Measurements
OG000-2.0± 1.5
OG001-1.3± 1.5
OG002-1.3± NAOnly 1 participant in the analysis, therefore standard deviation is not calculable.
LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, participants had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Participants remained at this dose level for the remainder of study treatment (48 weeks in total).
OG002
60/120/60 mg LY2127399
LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, the participant had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Subsequently, the participant had a dose decrease back to 60 mg LY2127399, administered once every 4 weeks for the remainder of study treatment (48 weeks in total).
Units
Counts
Participants
OG00056
OG001117
OG0021
Title
Denominators
Categories
No response
Title
Measurements
OG00016.1
OG00144.4
OG0020
Moderate response
Title
Measurements
OG00048.2
OG00139.3
OG002100.0
Good response
Title
Measurements
OG00035.7
OG00116.2
OG0020
LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, participants had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Participants remained at this dose level for the remainder of study treatment (48 weeks in total).
OG002
60/120/60 mg LY2127399
LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, the participant had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Subsequently, the participant had a dose decrease back to 60 mg LY2127399, administered once every 4 weeks for the remainder of study treatment (48 weeks in total).
Units
Counts
Participants
OG00059
OG001117
OG0021
Title
Denominators
Categories
Physical Health Component Summary Score
Title
Measurements
OG0005.7± 8.0
OG0014.1± 9.6
OG0021.4± NAOnly 1 participant in the analysis, therefore standard deviation is not calculable.
Mental Health Component Summary Score
Title
Measurements
OG0004.7± 12.2
OG0012.9± 10.1
OG002-2.9± NAOnly 1 participant in the analysis, therefore standard deviation is not calculable.
Units
Counts
Participants
OG00053
OG00183
OG0021
Title
Denominators
Categories
Week 52
ParticipantsOG00052
ParticipantsOG00183
ParticipantsOG0020
Title
Measurements
OG000-113.1± 103.4
OG001-110.3± 121.7
Week 60
ParticipantsOG00053
ParticipantsOG00182
ParticipantsOG0020
Title
Measurements
OG000
Week 72
ParticipantsOG00051
ParticipantsOG00179
ParticipantsOG0020
Title
Measurements
OG000
Week 80
ParticipantsOG00031
ParticipantsOG00160
ParticipantsOG0021
Title
Measurements
OG000
Week 88
ParticipantsOG00022
ParticipantsOG00145
ParticipantsOG0021
Title
Measurements
OG000
Week 100
ParticipantsOG00013
ParticipantsOG00124
ParticipantsOG0021
Title
Measurements
OG000
OG002
60/120/60 mg LY2127399
LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, the participant had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Subsequently, the participant had a dose decrease back to 60 mg LY2127399, administered once every 4 weeks for the remainder of study treatment (48 weeks in total).
Units
Counts
Participants
OG00052
OG00182
OG0021
Title
Denominators
Categories
Mature Naive Cells, Week 52
ParticipantsOG00052
ParticipantsOG00182
ParticipantsOG0020
Title
Measurements
OG000-115.0± 79.9
OG001-109.2± 92.2
Mature Naive Cells, Week 60
ParticipantsOG0004
ParticipantsOG0010
ParticipantsOG0020
Title
Measurements
OG000
Mature Naive Cells, Week 72
ParticipantsOG00050
ParticipantsOG00176
ParticipantsOG0020
Title
Measurements
OG000
Mature Naive Cells, Week 80
ParticipantsOG0001
ParticipantsOG0018
ParticipantsOG0021
Title
Measurements
OG000
Mature Naive Cells, Week 88
ParticipantsOG0002
ParticipantsOG0016
ParticipantsOG0020
Title
Measurements
OG000
Mature Naive Cells, Week 100
ParticipantsOG0000
ParticipantsOG0012
ParticipantsOG0020
Title
Measurements
OG001
Immature/Transitional Cells, Week 52
ParticipantsOG00051
ParticipantsOG00179
ParticipantsOG0020
Title
Measurements
OG000
Immature/Transitional Cells, Week 60
ParticipantsOG0004
ParticipantsOG0010
ParticipantsOG0020
Title
Measurements
OG000
Immature/Transitional Cells, Week 72
ParticipantsOG00050
ParticipantsOG00174
ParticipantsOG0020
Title
Measurements
OG000
Immature/Transitional Cells, Week 80
ParticipantsOG0001
ParticipantsOG0017
ParticipantsOG0021
Title
Measurements
OG000
Immature/Transitional Cells, Week 88
ParticipantsOG0002
ParticipantsOG0016
ParticipantsOG0020
Title
Measurements
OG000
Immature/Transitional Cells, Week 100
ParticipantsOG0000
ParticipantsOG0012
ParticipantsOG0020
Title
Measurements
OG001
Switched Memory Cells, Week 52
ParticipantsOG00052
ParticipantsOG00182
ParticipantsOG0020
Title
Measurements
OG000
Switched Memory Cells, Week 60
ParticipantsOG0004
ParticipantsOG0010
ParticipantsOG0020
Title
Measurements
OG000
Switched Memory Cells, Week 72
ParticipantsOG00050
ParticipantsOG00176
ParticipantsOG0020
Title
Measurements
OG000
Switched Memory Cells, Week 80
ParticipantsOG0001
ParticipantsOG0018
ParticipantsOG0021
Title
Measurements
OG000
Switched Memory Cells, Week 88
ParticipantsOG0002
ParticipantsOG0016
ParticipantsOG0020
Title
Measurements
OG000
Switched Memory Cells, Week 100
ParticipantsOG0000
ParticipantsOG0012
ParticipantsOG0020
Title
Measurements
OG001
Non-Switched Memory Cells, Week 52
ParticipantsOG00051
ParticipantsOG00179
ParticipantsOG0020
Title
Measurements
OG000
Non-Switched Memory Cells, Week 60
ParticipantsOG0004
ParticipantsOG0010
ParticipantsOG0020
Title
Measurements
OG000
Non-Switched Memory Cells, Week 72
ParticipantsOG00050
ParticipantsOG00174
ParticipantsOG0020
Title
Measurements
OG000
Non-Switched Memory Cells, Week 80
ParticipantsOG0001
ParticipantsOG0017
ParticipantsOG0021
Title
Measurements
OG000
Non-Switched Memory Cells, Week 88
ParticipantsOG0002
ParticipantsOG0016
ParticipantsOG0020
Title
Measurements
OG000
Non-Switched Memory Cells, Week 100
ParticipantsOG0000
ParticipantsOG0012
ParticipantsOG0020
Title
Measurements
OG001
LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, the participant had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Subsequently, the participant had a dose decrease back to 60 mg LY2127399, administered once every 4 weeks for the remainder of study treatment (48 weeks in total).
Units
Counts
Participants
OG00059
OG001121
OG0021
Title
Denominators
Categories
IgG
Title
Measurements
OG000-1.8± 2.1
OG001-2.0± 3.8
OG002-1.9± NAOnly 1 participant in the analysis, therefore standard deviation is not calculable.
IgM
Title
Measurements
OG000-0.3± 0.4
OG001-0.3± 0.5
OG002-0.2± NAOnly 1 participant in the analysis, therefore standard deviation is not calculable.
IgA
Title
Measurements
OG000-0.6± 0.8
OG001-0.5± 0.7
OG002-0.8± NAOnly 1 participant in the analysis, therefore standard deviation is not calculable.
OG002
60/120/60 mg LY2127399
LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, the participant had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Subsequently, the participant had a dose decrease back to 60 mg LY2127399, administered once every 4 weeks for the remainder of study treatment (48 weeks in total).
Units
Counts
Participants
OG00060
OG001121
OG0021
Title
Denominators
Categories
Died on study treatment [up to Week (Wk) 52]
Title
Measurements
OG0000
OG0011
OG0020
Died post-study treatment Wk 53/ED through Wk 72
Title
Measurements
OG0001
OG0010
OG0020
Died post-study treatment Wk 73 through Wk 100
Title
Measurements
OG0001
OG0011
OG0020
Units
Counts
Participants
OG00050
OG00187
Title
Denominators
Categories
Title
Measurements
OG000-26.9± 241.4
OG001-53.8± 312.6
LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, the participant had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Subsequently, the participant had a dose decrease back to 60 mg LY2127399, administered once every 4 weeks for the remainder of study treatment (48 weeks in total).
Units
Counts
Participants
OG00052
OG001113
OG0021
Title
Denominators
Categories
Title
Measurements
OG0006.9± 241.9
OG001-19.4± 358.7
OG0020.0± NAOnly 1 participant in the analysis, therefore standard deviation is not calculable.
OG002
60/120/60 mg LY2127399
LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, the participant had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Subsequently, the participant had a dose decrease back to 60 mg LY2127399, administered once every 4 weeks for the remainder of study treatment (48 weeks in total).
Units
Counts
Participants
OG00057
OG001116
OG0021
Title
Denominators
Categories
Title
Measurements
OG0005.0± 63.7
OG00120.9± 103.9
OG002-25.0± NAOnly 1 participant in the analysis, therefore standard deviation is not calculable.
OG002
60/120/60 mg LY2127399
LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, the participant had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Subsequently, the participant had a dose decrease back to 60 mg LY2127399, administered once every 4 weeks for the remainder of study treatment (48 weeks in total).
Units
Counts
Participants
OG00060
OG001121
OG0021
Title
Denominators
Categories
Baseline Positive ADA
ParticipantsOG00060
ParticipantsOG001121
ParticipantsOG0021
Title
Measurements
OG0002
OG0011
OG0020
Treatment-Emergent ADA
ParticipantsOG00060
ParticipantsOG001121
ParticipantsOG0021
Title
Measurements
OG000
Follow-Up Emergent ADA
ParticipantsOG00050
ParticipantsOG00191
ParticipantsOG0021
Title
Measurements
OG000
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0 affected
60 at risk
EG0040 events0 affected121 at risk
EG0050 events0 affected1 at risk
0 events
0 affected
60 at risk
EG0040 events0 affected121 at risk
EG0050 events0 affected1 at risk
0 events
0 affected
60 at risk
EG0040 events0 affected121 at risk
EG0050 events0 affected1 at risk
0 events
0 affected
60 at risk
EG0040 events0 affected121 at risk
EG0050 events0 affected1 at risk
1 events
1 affected
60 at risk
EG0040 events0 affected121 at risk
EG0050 events0 affected1 at risk
0 events
0 affected
60 at risk
EG0040 events0 affected121 at risk
EG0050 events0 affected1 at risk
1 events
1 affected
60 at risk
EG0040 events0 affected121 at risk
EG0050 events0 affected1 at risk
0 events
0 affected
60 at risk
EG0040 events0 affected121 at risk
EG0050 events0 affected1 at risk
0 events
0 affected
60 at risk
EG0040 events0 affected121 at risk
EG0050 events0 affected1 at risk
0 events
0 affected
60 at risk
EG0041 events1 affected121 at risk
EG0050 events0 affected1 at risk
0 events
0 affected
60 at risk
EG0040 events0 affected121 at risk
EG0050 events0 affected1 at risk
0 events
0 affected
60 at risk
EG0040 events0 affected121 at risk
EG0050 events0 affected1 at risk
0 events
0 affected
60 at risk
EG0040 events0 affected121 at risk
EG0050 events0 affected1 at risk
1 events
1 affected
60 at risk
EG0041 events1 affected121 at risk
EG0050 events0 affected1 at risk
0 events
0 affected
60 at risk
EG0041 events1 affected121 at risk
EG0050 events0 affected1 at risk
1 events
1 affected
60 at risk
EG0040 events0 affected121 at risk
EG0050 events0 affected1 at risk
0 events
0 affected
60 at risk
EG0040 events0 affected121 at risk
EG0050 events0 affected1 at risk
0 events
0 affected
60 at risk
EG0040 events0 affected121 at risk
EG0050 events0 affected1 at risk
0 events
0 affected
60 at risk
EG0041 events1 affected121 at risk
EG0050 events0 affected1 at risk
0 events
0 affected
60 at risk
EG0041 events1 affected121 at risk
EG0050 events0 affected1 at risk
0 events
0 affected
60 at risk
EG0040 events0 affected121 at risk
EG0050 events0 affected1 at risk
0 events
0 affected
60 at risk
EG0041 events1 affected121 at risk
EG0050 events0 affected1 at risk
0 events
0 affected
60 at risk
EG0041 events1 affected121 at risk
EG0050 events0 affected1 at risk
0 events
0 affected
60 at risk
EG0040 events0 affected121 at risk
EG0050 events0 affected1 at risk
0 events
0 affected
60 at risk
EG0040 events0 affected121 at risk
EG0050 events0 affected1 at risk
0 events
0 affected
60 at risk
EG0040 events0 affected121 at risk
EG0050 events0 affected1 at risk
0 events
0 affected
60 at risk
EG0040 events0 affected121 at risk
EG0050 events0 affected1 at risk
0 events
0 affected
60 at risk
EG0040 events0 affected121 at risk
EG0050 events0 affected1 at risk
0 events
0 affected
60 at risk
EG0040 events0 affected121 at risk
EG0050 events0 affected1 at risk
0 events
0 affected
60 at risk
EG0040 events0 affected121 at risk
EG0050 events0 affected1 at risk
0 events
0 affected
60 at risk
EG0040 events0 affected121 at risk
EG0050 events0 affected1 at risk
0 events
0 affected
60 at risk
EG0041 events1 affected121 at risk
EG0050 events0 affected1 at risk
0 events
0 affected
60 at risk
EG0041 events1 affected121 at risk
EG0050 events0 affected1 at risk
0 events
0 affected
60 at risk
EG0040 events0 affected121 at risk
EG0050 events0 affected1 at risk
0 events
0 affected
60 at risk
EG0040 events0 affected121 at risk
EG0050 events0 affected1 at risk
0 events
0 affected
60 at risk
EG0040 events0 affected121 at risk
EG0050 events0 affected1 at risk
1 events
1 affected
60 at risk
EG0040 events0 affected121 at risk
EG0050 events0 affected1 at risk
0
OG0041
OG0050
0
OG0041
OG0050
0
OG0040
OG0050
0
OG0040
OG0050
0
OG0041
OG0050
1
OG0040
OG0050
1
OG0040
OG0050
0
OG0041
OG0050
0
OG0040
OG0050
0
OG0041
OG0050
0
OG0040
OG0050
0
OG0040
OG0050
0
OG0040
OG0050
0
OG0041
OG0050
0
OG0041
OG0050
0
OG0040
OG0050
0
OG0041
OG0050
-135.9
± 119.0
OG001-143.1± 135.3
-141.0
± 105.4
OG001-151.6± 117.8
-137.6
± 85.7
OG001-150.9± 127.7
OG002-262.0± NAOnly 1 participant in the analysis, therefore standard deviation is not calculable.
-109.9
± 83.8
OG001-148.6± 131.3
OG002-143.0± NAOnly 1 participant in the analysis, therefore standard deviation is not calculable.
-71.7
± 68.7
OG001-127.3± 121.4
OG002-95.0± NAOnly 1 participant in the analysis, therefore standard deviation is not calculable.
-138.8
± 67.1
-95.9
± 75.4
OG001-102.6± 90.4
-189.0
± NA
Only 1 participant in the analysis, therefore standard deviation is not calculable.
OG001-80.1± 62.8
OG002-123.0± NAOnly 1 participant in the analysis, therefore standard deviation is not calculable.
-116.5
± 99.7
OG001-111.7± 75.5
-89.0
± 108.9
-5.8
± 7.10
OG001-4.5± 13.2
-6.5
± 7.9
-8.6
± 8.9
OG001-8.5± 15.5
-5.0
± NA
Only 1 participant in the analysis, therefore standard deviation is not calculable.
OG001-9.0± 12.1
OG002-10.0± NAOnly 1 participant in the analysis, therefore standard deviation is not calculable.
-3.0
± 4.2
OG001-9.0± 10.5
-6.5
± 0.7
12.6
± 27.1
OG00113.1± 31.4
-6.5
± 16.3
-14.7
± 18.9
OG001-17.7± 36.1
-10.0
± NA
Only 1 participant in the analysis, therefore standard deviation is not calculable.
OG001-7.5± 17.3
OG002-23.0± NAOnly 1 participant in the analysis, therefore standard deviation is not calculable.
-10.0
± 5.7
OG001-9.0± 10.2
-13.0
± 22.6
6.0
± 22.0
OG0018.3± 22.2
-3.8
± 2.2
-10.5
± 18.0
OG001-7.3± 18.7
-4.0
± NA
Only 1 participant in the analysis, therefore standard deviation is not calculable.
OG001-3.6± 4.3
OG002-35.0± NAOnly 1 participant in the analysis, therefore standard deviation is not calculable.