A Study to Test Safety and Efficacy of Baricitinib in Par... | NCT01683409 | Trialant
NCT01683409
Sponsor
Eli Lilly and Company
Status
Completed
Last Update Posted
Sep 30, 2019Actual
Enrollment
130Actual
Phase
Phase 2
Conditions
Diabetic Kidney Disease
Interventions
Baricitinib
Placebo
Countries
United States
Japan
Mexico
Puerto Rico
Protocol Section
Identification Module
NCT ID
NCT01683409
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
14734
Secondary IDs
ID
Type
Description
Link
I4V-MC-JAGQ
Other Identifier
Eli Lilly and Company
Brief Title
A Study to Test Safety and Efficacy of Baricitinib in Participants With Diabetic Kidney Disease
Official Title
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Phase 2 Study to Evaluate the Safety and Renal Efficacy of Baricitinib in Patients With Diabetic Kidney Disease
Acronym
Not provided
Organization
Eli Lilly and CompanyINDUSTRY
Status Module
Record Verification Date
Sep 2019
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
Aug 2012
Primary Completion Date
Sep 2014Actual
Completion Date
Nov 2014Actual
First Submitted Date
Sep 7, 2012
First Submission Date that Met QC Criteria
Sep 7, 2012
First Posted Date
Sep 11, 2012Estimated
Results Waived
Not provided
Results First Submitted Date
Mar 10, 2017
Results First Submitted that Met QC Criteria
Jun 2, 2017
Results First Posted Date
Jul 2, 2017Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Jan 16, 2015
Certification/Extension First Submitted that Passed QC Review
Jan 16, 2015
Certification/Extension First Posted Date
Jan 29, 2015Estimated
Last Update Submitted Date
Sep 10, 2019
Last Update Posted Date
Sep 30, 2019Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Eli Lilly and CompanyINDUSTRY
Collaborators
Name
Class
Incyte Corporation
INDUSTRY
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
This is a dose ranging study to evaluate the safety and efficacy of baricitinib in the treatment of participants with mild to moderate diabetic kidney disease.
Detailed Description
Not provided
Conditions Module
Conditions
Diabetic Kidney Disease
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
130Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Placebo
Placebo Comparator
Administered orally, given as three placebo tablets in the morning and one placebo tablet in the evening for 24 weeks.
Drug: Placebo
Baricitinib 0.75 mg/0.5 mg QD
Experimental
Administered orally, 0.75 mg given as one 0.75 mg tablets and two placebo tablets in the morning and one placebo tablet in the evening for 24 weeks or 0.5 mg given as one 0.5 mg tablet and two placebo tablets in the morning and one placebo tablet in the evening for 24 weeks. Placebo tablets given to maintain blind.
Drug: Baricitinib
Drug: Placebo
Baricitinib 0.75 mg/0.5 mg BID
Experimental
Administered orally, 0.75 mg given as one 0.75 tablet and 2 placebo in the morning and one 0.75 mg tablet in the evening for 24 weeks or 0.5 mg given as one 0.5 mg tablet and two placebo tablets in the morning and one 0.5 mg tablet in the evening. Placebo tablets given to maintain blind.
Drug: Baricitinib
Drug: Placebo
Baricitinib 1.5 mg/1 mg
Experimental
Administered orally, 1.5 mg given as two 0.75 mg tablets and 1 placebo tablet in the morning and one placebo tablet in the evening for 24 weeks or 1 mg tablet and two placebo tablets in the morning and one placebo tablet in the evening for 24 weeks. Placebo tablets given to maintain blind.
Drug: Baricitinib
Drug: Placebo
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Baricitinib
Drug
Administered orally
Baricitinib 0.75 mg/0.5 mg BID
Baricitinib 0.75 mg/0.5 mg QD
Baricitinib 1.5 mg/1 mg
Baricitinib 4 mg/2.75 mg
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Change From Baseline in Urinary Albumin/Creatinine Ratio (UACR) at Week 24
UACR is a potential marker of chronic kidney disease, calculated as a ratio of Urinary Albumin and Urinary Creatinine. The least squares mean (LS mean) are from mixed model repeated measures (MMRM) analyses which include treatment, baseline estimated Glomerular Filtration Rate (eGFR) group (higher: 50 to 70 mL/min/1.73m² and lower: 25 to <50 mL/min/1.73m²), visit, treatment-by-visit interaction, baseline UACR, and baseline UACR-by-visit interaction.
Baseline, Week 24
Secondary Outcomes
Measure
Description
Time Frame
Change From Baseline in Urinary Monocyte Chemotactic Protein 1 (MCP-1)/Creatinine Ratio
Baseline, Week 24
Change From Baseline in Creatinine Clearance at Week 24
Creatinine clearance is the amount of creatinine cleared from kidney within 24 hours. The LS mean was from MMRM analyses which included treatment, baseline eGRF group, visit, treatment-by-visit interaction, baseline Creatinine Clearance, and baseline Creatinine Clearance-by-visit interaction.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Participants with Type 2 diabetes treated with at least one antihyperglycemic medicine for 12 months
Have diabetic kidney disease and receiving one of two specific medicines used to treat high blood pressure or diabetic kidney disease for at least 3 months
Estimated Glomerular Filtration Rate (eGFR) of 25 to 70 milliliter per minute per 1.73 square meter (mL/min/1.73 m²) (as determined by the Chronic Kidney Disease Epidemiology Collaboration equation) and a urinary albumin/creatinine ratio (UACR) >300 milligram per gram (mg/g) and <5000 mg/g
Exclusion Criteria:
Too high blood pressure when you enter the study
Some specific medicines used to treat high blood pressure or diabetic kidney disease
Frequent high blood glucose levels
Renal transplant or past history of dialysis
Nonsteroidal anti-inflammatory drugs (NSAIDs)
Had a special X-ray in the past 30 days which involved also receiving an injection of dye into the vein
Major surgery within 8 weeks of study entry or will require major surgery during the study
Some types of vaccination
Shingles or currently have symptoms of a cold sore
Serious viral, bacterial, fungal, or parasitic infection, or a urinary infection, Tuberculosis (TB)
Human immunodeficiency virus (HIV) infection- the virus that causes Acquired immunodeficiency syndrome (AIDS)
Have or had some blood disorders, enlarged lymph glands or spleen, or some cancers.
Serious circulatory, breathing, liver, stomach or bowel problems, neurological or psychiatric disorders
Heart attack or heart failure, or a stroke
Other serious disorders or illnesses
Electrocardiogram (ECG) heart trace abnormalities
Alcohol or illegal drug abuse
Donated more than 500 mL of blood in the last 30 days (no blood donations allowed during the study)
Pregnant or breastfeeding
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 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Hu S, Lee K, He JC, Fan Y. Current Landscape and Emerging Therapeutic Targets in Diabetic Kidney Disease. Clin J Am Soc Nephrol. 2026 Mar 10. doi: 10.2215/CJN.0000001053. Online ahead of print.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
Plan to Share IPD
Yes
Description
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Types
Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Access Criteria
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Participants in each baricitinib dose group were classified by their baseline estimated glomerular filtration rate (eGFR) into higher (50 to 70 milliliter [mL]/minute [min]/1.73 meters squared [m²]) and lower (25 to <50 mL/min/1.73 m²) eGFR strata. Participants in the lower strata had their dose adjusted to a lower dose.
Recruitment Details
The study included a 24-week treatment period and a 4- to 8-week washout period where study drug was discontinued. Time to loss-of-treatment benefit (defined as a failure to maintain a 30% decrease in UACR from baseline) was evaluated at Week 28. Participants who maintained treatment benefit were followed for an additional 4 weeks.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Placebo
Placebo administered orally (PO) once a day (QD).
FG001
Baricitinib 0.75 mg/0.5 mg QD
Baricitinib 0.75 mg or 0.5 mg administered PO QD.
Periods
Title
Milestones
Reasons Not Completed
Treatment Period (Weeks 1-24)
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
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Double
Masking Description
Not provided
Who Masked
ParticipantInvestigator
Baricitinib 4 mg/2.75 mg
Experimental
Administered orally, 4 mg given as one tablet and 2 placebo tablets in the morning and one placebo tablet in the evening for 24 weeks or 2.75 mg given as two 1 mg tablets and one 0.75 mg tablet in the morning and one placebo tablet in the evening for 24 weeks. Placebo tablets given to maintain blind.
Drug: Baricitinib
Drug: Placebo
LY3009104
INCB28050
Placebo
Drug
Administered orally
Baricitinib 0.75 mg/0.5 mg BID
Baricitinib 0.75 mg/0.5 mg QD
Baricitinib 1.5 mg/1 mg
Baricitinib 4 mg/2.75 mg
Placebo
Baseline, Week 24
Change From Baseline in European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) at Week 24
EQ-5D-5L is a 2-part measurement. The first part is comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The responses are used to derive the health state index scores using the United Kingdom (UK) algorithm, with scores ranging from -0.594 to 1, and the United States (US) algorithm, with scores ranging from -0.109 to 1. A higher score indicates better health state. The second part is assessed using a visual analog scale (VAS) that ranged from 0 to 100mm, where 0 is the worst health you can imagine and 100 is the best health you can imagine. The LS means are analyzed using an analysis of covariance (ANCOVA) model with treatment, baseline eGFR group, and baseline VAS score or baseline health state index score as covariates.
Baseline, Week 24
Pharmacokinetics (PK): Area Under the Concentration-Time Curve at Steady State (AUC,ss)
Evaluable pharmacokinetic concentrations from the 2-week, 4-week, 8-week, 12-week, 16-week, 20-week and 24-week time points were combined and utilized in a population approach to determine the population mean estimate and standard deviation at steady-state.
Weeks 2 and 4 (1-2 hours postdose), 8 (3-6 hours postdose), 12 (in fasted state), 16 and 20 (6-9 hours postdose), 24 (in fasted state)
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.
San Diego
California
92103
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.
Torrance
California
90502
United States
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Lakewood
Colorado
80227
United States
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Fort Lauderdale
Florida
33316
United States
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Jacksonville
Florida
32258
United States
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Miami
Florida
33173
United States
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Tampa
Florida
33614
United States
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Augusta
Georgia
30909
United States
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Honolulu
Hawaii
96814
United States
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Meridian
Idaho
83642
United States
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Gurnee
Illinois
60031
United States
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Peoria
Illinois
60603
United States
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Evansville
Indiana
47713
United States
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Topeka
Kansas
66606
United States
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Rockville
Maryland
20852
United States
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Ann Arbor
Michigan
48109
United States
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Detroit
Michigan
48236
United States
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Pontiac
Michigan
48341
United States
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Springfield
Missouri
65807
United States
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Billings
Montana
59101
United States
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Nashua
New Hampshire
03063
United States
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Albany
New York
12209
United States
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New York
New York
10021
United States
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Rosedale
New York
11422
United States
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Winston-Salem
North Carolina
27103
United States
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Bethlehem
Pennsylvania
18017
United States
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Philadelphia
Pennsylvania
19102
United States
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Sumter
South Carolina
29150
United States
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Chattanooga
Tennessee
37408
United States
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Houston
Texas
77030
United States
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San Antonio
Texas
78229
United States
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Seattle
Washington
98104
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.
Spokane
Washington
99204
United States
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Wenatchee
Washington
98801
United States
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Fukuoka
830-0011
Japan
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Hokkaido
004-0053
Japan
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Ibaraki
305-0812
Japan
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Ibaraki
311-0113
Japan
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Osaka
530-0001
Japan
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Tokyo
103-0027
Japan
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Mexico City
03300
Mexico
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Mérida
97070
Mexico
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Ponce
00716
Puerto Rico
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Rio Piedras
00936
Puerto Rico
FG002
Baricitinib 0.75 mg/0.5 mg BID
Baricitinib 0.75 mg or 0.5 mg administered PO twice a day (BID).
FG003
Baricitinib 1.5 mg/1 mg
Baricitinib 1.5 mg or 1 mg administered PO QD.
FG004
Baricitinib 4 mg/2.75 mg
Baricitinib 4 milligram (mg) or 2.75 mg administered PO QD.
FG00027 subjects
FG00125 subjects
FG00227 subjects
FG00326 subjects
FG00425 subjects
Received at Least One Dose of Study Drug
FG00027 subjects
FG00125 subjects
FG00226 subjects
FG00326 subjects
FG00425 subjects
COMPLETED
FG00027 subjects
FG00121 subjects
FG00226 subjects
FG00324 subjects
FG00423 subjects
NOT COMPLETED
FG0000 subjects
FG0014 subjects
FG0021 subjects
FG0032 subjects
FG0042 subjects
Type
Comment
Reasons
Inappropriately Enrolled
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG0040 subjects
Adverse Event
FG0000 subjects
FG0013 subjects
FG0020 subjects
FG0031 subjects
FG004
Lost to Follow-up
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Washout Period 1 (Weeks 25-28)
Type
Comment
Milestone Data
STARTED
FG00027 subjects
FG00121 subjects
FG00226 subjects
FG00324 subjects
FG00423 subjects
COMPLETED
FG00024 subjects
FG00117 subjects
FG00225 subjects
FG00322 subjects
FG004
NOT COMPLETED
FG0003 subjects
FG0014 subjects
FG0021 subjects
FG0032 subjects
FG004
Type
Comment
Reasons
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG003
Washout Period 2 (Weeks 29-32)
Type
Comment
Milestone Data
STARTED
FG0006 subjectsStudy was completed at Week 28 for 18 participants.
FG0016 subjectsStudy was completed at Week 28 for 11 participants.
FG0028 subjectsStudy was completed at Week 28 for 17 participants.
FG0036 subjectsStudy was completed at Week 28 for 16 participants.
FG00412 subjectsStudy was completed at Week 28 for 8 participants.
COMPLETED
FG0006 subjects
FG0016 subjects
FG0027 subjects
FG0036 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
All participants that received at least one dose of study drug.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Placebo
Placebo administered PO QD.
BG001
Baricitinib 0.75/0.5 mg QD
Baricitinib 0.75 mg or 0.5 mg administered PO QD.
BG002
Baricitinib 0.75 mg/0.5 mg BID
Baricitinib 0.75 mg or 0.5 mg administered PO BID.
BG003
Baricitinib 1.5 mg/1 mg QD
Baricitinib 1.5 mg or 1 mg administered PO QD.
BG004
Baricitinib 4 mg/2.75 mg
Baricitinib 4 mg or 2.75 administered PO QD.
BG005
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00027
BG00125
BG00226
BG00326
BG00425
BG005129
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
BG00064± 9.0
BG00161± 10.0
BG00264± 8.3
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0007
BG0018
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0004
BG0014
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0002
BG0012
BG002
Region of Enrollment
Count of Participants
Participants
Title
Denominators
Categories
Puerto Rico
Title
Measurements
BG0000
BG0011
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
Change From Baseline in Urinary Albumin/Creatinine Ratio (UACR) at Week 24
UACR is a potential marker of chronic kidney disease, calculated as a ratio of Urinary Albumin and Urinary Creatinine. The least squares mean (LS mean) are from mixed model repeated measures (MMRM) analyses which include treatment, baseline estimated Glomerular Filtration Rate (eGFR) group (higher: 50 to 70 mL/min/1.73m² and lower: 25 to <50 mL/min/1.73m²), visit, treatment-by-visit interaction, baseline UACR, and baseline UACR-by-visit interaction.
All randomized participants who received at least one dose of study drug.
Posted
Least Squares Mean
Standard Error
milligram/gram (mg/g)
Baseline, Week 24
ID
Title
Description
OG000
Placebo
Placebo administered PO QD.
OG001
Baricitinib 0.75 mg/0.5 mg QD
Baricitinib 0.75 mg or 0.5 mg administered PO QD.
OG002
Baricitinib 0.75 mg/0.5 mg BID
Baricitinib 0.75 mg or 0.5 mg administered PO BID.
OG003
Baricitinib 1.5 mg/1 mg
Baricitinib 1.5 mg or 1 mg administered PO QD.
OG004
Baricitinib 4 mg/2.75 mg
Baricitinib 4 mg or 2.75 mg administered PO QD.
Units
Counts
Participants
OG00027
OG00125
OG00226
OG003
Title
Denominators
Categories
Title
Measurements
OG0001.12± 0.172
OG0010.87± 0.155
OG0020.85± 0.131
OG003
Secondary
Change From Baseline in Urinary Monocyte Chemotactic Protein 1 (MCP-1)/Creatinine Ratio
Zero participants analyzed. No data analyzed due to urinary MCP-1 and creatinine being measured on different urine samples from different time points and thus not able to correlate.
Posted
Baseline, Week 24
ID
Title
Description
OG000
Placebo
Placebo administered PO QD.
OG001
Baricitinib 0.75 mg/0.5 mg QD
Baricitinib 0.75 mg or 0.5 mg administered PO QD.
OG002
Baricitinib 0.75 mg/0.5 mg BID
Baricitinib 0.75 mg or 0.5 mg administered PO BID.
OG003
Baricitinib 1.5 mg/1 mg
Baricitinib 1.5 mg or 1 mg administered PO QD.
OG004
Baricitinib 4 mg/2.75 mg
Baricitinib 4 mg or 2.75 mg administered PO QD.
Secondary
Change From Baseline in Creatinine Clearance at Week 24
Creatinine clearance is the amount of creatinine cleared from kidney within 24 hours. The LS mean was from MMRM analyses which included treatment, baseline eGRF group, visit, treatment-by-visit interaction, baseline Creatinine Clearance, and baseline Creatinine Clearance-by-visit interaction.
All randomized participants who received at least one dose of study drug.
Posted
Least Squares Mean
Standard Error
milliliter/minute (mL/min)
Baseline, Week 24
ID
Title
Description
OG000
Placebo
Placebo administered PO QD.
OG001
Baricitinib 0.75 mg/0.5 mg QD
Baricitinib 0.75 mg or 0.5 mg administered PO QD.
OG002
Baricitinib 0.75 mg/0.5 mg BID
Baricitinib 0.75 mg or 0.5 mg administered PO BID.
OG003
Baricitinib 1.5 mg/1 mg
Baricitinib 1.5 mg or 1 mg administered PO QD.
Secondary
Change From Baseline in European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) at Week 24
EQ-5D-5L is a 2-part measurement. The first part is comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The responses are used to derive the health state index scores using the United Kingdom (UK) algorithm, with scores ranging from -0.594 to 1, and the United States (US) algorithm, with scores ranging from -0.109 to 1. A higher score indicates better health state. The second part is assessed using a visual analog scale (VAS) that ranged from 0 to 100mm, where 0 is the worst health you can imagine and 100 is the best health you can imagine. The LS means are analyzed using an analysis of covariance (ANCOVA) model with treatment, baseline eGFR group, and baseline VAS score or baseline health state index score as covariates.
All randomized participants who received at least one dose of study drug. Missing values were imputed with the last observation carried forward (LOCF) method.
Posted
Least Squares Mean
Standard Error
Units on a Scale
Baseline, Week 24
ID
Title
Description
OG000
Placebo
Placebo administered PO QD.
OG001
Baricitinib 0.75 mg/0.5 mg QD
Baricitinib 0.75 mg or 0.5 mg administered PO QD.
Secondary
Pharmacokinetics (PK): Area Under the Concentration-Time Curve at Steady State (AUC,ss)
Evaluable pharmacokinetic concentrations from the 2-week, 4-week, 8-week, 12-week, 16-week, 20-week and 24-week time points were combined and utilized in a population approach to determine the population mean estimate and standard deviation at steady-state.
All randomized participants who received at least one dose of study drug and had evaluable PK data.
Posted
Mean
Standard Deviation
nanomole*hour (nM*hr)
Weeks 2 and 4 (1-2 hours postdose), 8 (3-6 hours postdose), 12 (in fasted state), 16 and 20 (6-9 hours postdose), 24 (in fasted state)
ID
Title
Description
OG000
Baricitinib 0.75 mg/0.5 mg QD
Baricitinib 0.75 mg or 0.5 mg administered PO QD.
OG001
Baricitinib 0.75 mg/0.5 mg BID
Baricitinib 0.75 mg or 0.5 mg administered PO BID.
OG002
Baricitinib 1.5 mg/1 mg
Baricitinib 1.5 mg or 1 mg administered PO QD.
OG003
Baricitinib 4 mg/2.75 mg
Time Frame
Not provided
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Placebo
Placebo administered PO QD.
2
27
18
27
EG001
Baricitinib 0.75 mg/0.5 mg QD
Baricitinib 0.75 mg or 0.5 mg administered PO QD.
0
25
18
25
EG002
Baricitinib 0.75 mg/0.5 mg BID
Baricitinib 0.75 mg or 0.5 mg administered PO BID.
2
26
17
26
EG003
Baricitinib 1.5 mg/1 mg
Baricitinib 1.5 mg or 1 mg administered PO QD.
2
26
19
26
EG004
Baricitinib 4 mg/2.75 mg
Baricitinib 4 mg or 2.75 mg administered PO QD.
6
25
23
25
EG005
Placebo - Washout 1
Placebo administered PO QD.
0
27
5
27
EG006
Baricitinib 0.75 mg/0.5 mg QD - Washout 1
Baricitinib 0.75 mg or 0.5 mg administered PO QD.
0
21
4
21
EG007
Baricitinib 0.75 mg/0.5 mg BID - Washout 1
Baricitinib 0.75 mg or 0.5 mg administered PO BID.
0
26
4
26
EG008
Baricitinib 1.5 mg/1 mg - Washout 1
Baricitinib 1.5 mg or 1 mg administered PO QD.
0
24
7
24
EG009
Baricitinib 4 mg/2.75 mg - Washout 1
Baricitinib 4 mg or 2.75 mg administered PO QD.
0
23
8
23
EG010
Placebo Washout 2
Placebo administered PO QD.
0
6
1
6
EG011
Baricitinib 0.75 mg/0.5 mg QD - Washout 2
Baricitinib 0.75 mg or 0.5 mg administered PO QD.
0
6
2
6
EG012
Baricitinib 0.75 mg/0.5 mg BID - Washout 2
Baricitinib 0.75 mg or 0.5 mg administered PO BID.
1
8
1
8
EG013
Baricitinib 1.5 mg/1 mg - Washout 2
Baricitinib 1.5 mg or 1 mg administered PO QD.
0
6
0
6
EG014
Baricitinib 4 mg/2.75 mg - Washout 2
Baricitinib 4 mg or 2.75 mg administered PO QD.
0
12
3
12
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected26 at risk
EG0030 events0 affected26 at risk
EG0041 events1 affected25 at risk
EG0050 affected27 at risk
EG0060 affected21 at risk
EG0070 affected26 at risk
EG0080 affected24 at risk
EG0090 affected23 at risk
EG0100 affected6 at risk
EG0110 affected6 at risk
EG0120 affected8 at risk
EG0130 affected6 at risk
EG0140 affected12 at risk
Aortic valve incompetence
Cardiac disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected26 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected27 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected26 at risk
EG003
Mitral valve incompetence
Cardiac disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected26 at risk
EG003
Pericardial effusion
Cardiac disorders
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected27 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected26 at risk
EG003
Vitreous haemorrhage
Eye disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0010 events0 affected25 at risk
EG0021 events1 affected26 at risk
EG003
Pancreatitis
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected27 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected26 at risk
EG003
Anaphylactic reaction
Immune system disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected26 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0010 events0 affected25 at risk
EG0021 events1 affected26 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected27 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected26 at risk
EG003
Staphylococcal infection
Infections and infestations
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected26 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected26 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected26 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected26 at risk
EG003
Renal failure acute
Renal and urinary disorders
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected27 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected26 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected27 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected26 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected27 at risk
EG0011 events1 affected25 at risk
EG0021 events1 affected26 at risk
EG0032 events2 affected26 at risk
EG0047 events7 affected25 at risk
EG0050 affected27 at risk
EG0060 affected21 at risk
EG0070 affected26 at risk
EG0080 affected24 at risk
EG0090 affected23 at risk
EG0100 affected6 at risk
EG0110 affected6 at risk
EG0120 affected8 at risk
EG0130 affected6 at risk
EG0140 affected12 at risk
Haemolytic anaemia
Blood and lymphatic system disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0011 events1 affected25 at risk
EG0020 events0 affected26 at risk
EG003
Nephrogenic anaemia
Blood and lymphatic system disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected26 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0011 events1 affected25 at risk
EG0020 events0 affected26 at risk
EG003
Angina unstable
Cardiac disorders
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected27 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected26 at risk
EG003
Bundle branch block left
Cardiac disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected27 at risk
EG0010 affected25 at risk
EG0020 affected26 at risk
EG003
Cardiac hypertrophy
Cardiac disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected26 at risk
EG003
Cardiomegaly
Cardiac disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected26 at risk
EG003
Coronary artery disease
Cardiac disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0011 events1 affected25 at risk
EG0020 events0 affected26 at risk
EG003
Palpitations
Cardiac disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected26 at risk
EG003
Cerumen impaction
Ear and labyrinth disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected26 at risk
EG003
Ear pain
Ear and labyrinth disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected27 at risk
EG0010 affected25 at risk
EG0020 affected26 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected27 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected26 at risk
EG003
Hyperparathyroidism
Endocrine disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0010 events0 affected25 at risk
EG0021 events1 affected26 at risk
EG003
Abnormal sensation in eye
Eye disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected26 at risk
EG003
Diabetic retinopathy
Eye disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected26 at risk
EG003
Dry eye
Eye disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected27 at risk
EG0010 affected25 at risk
EG0020 affected26 at risk
EG003
Eye pruritus
Eye disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected26 at risk
EG003
Vision blurred
Eye disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0011 events1 affected25 at risk
EG0020 events0 affected26 at risk
EG003
Visual acuity reduced
Eye disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected26 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected27 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected26 at risk
EG003
Diabetic gastroparesis
Gastrointestinal disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0010 events0 affected25 at risk
EG0021 events1 affected26 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0002 events2 affected27 at risk
EG0011 events1 affected25 at risk
EG0021 events1 affected26 at risk
EG003
Diverticulum
Gastrointestinal disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0010 events0 affected25 at risk
EG0021 events1 affected26 at risk
EG003
Diverticulum intestinal
Gastrointestinal disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0010 events0 affected25 at risk
EG0021 events1 affected26 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0011 events1 affected25 at risk
EG0020 events0 affected26 at risk
EG003
Epigastric discomfort
Gastrointestinal disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0011 events1 affected25 at risk
EG0020 events0 affected26 at risk
EG003
Food poisoning
Gastrointestinal disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected26 at risk
EG003
Gastric polyps
Gastrointestinal disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0011 events1 affected25 at risk
EG0020 events0 affected26 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0011 events1 affected25 at risk
EG0020 events0 affected26 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected26 at risk
EG003
Large intestine polyp
Gastrointestinal disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected26 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0012 events2 affected25 at risk
EG0020 events0 affected26 at risk
EG003
Oesophageal pain
Gastrointestinal disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0011 events1 affected25 at risk
EG0020 events0 affected26 at risk
EG003
Reflux gastritis
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected27 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected26 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected26 at risk
EG003
Umbilical hernia
Gastrointestinal disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0010 events0 affected25 at risk
EG0021 events1 affected26 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0011 events1 affected25 at risk
EG0020 events0 affected26 at risk
EG003
Chest pain
General disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0010 events0 affected25 at risk
EG0021 events1 affected26 at risk
EG003
Chills
General disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected26 at risk
EG003
Fatigue
General disorders
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0010 events0 affected25 at risk
EG0022 events2 affected26 at risk
EG003
Injection site nodule
General disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected27 at risk
EG0010 affected25 at risk
EG0020 affected26 at risk
EG003
Malaise
General disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected26 at risk
EG003
Oedema peripheral
General disorders
MedDRA 16.1
Systematic Assessment
EG0003 events2 affected27 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected26 at risk
EG003
Thirst
General disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected26 at risk
EG003
Hepatic steatosis
Hepatobiliary disorders
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected27 at risk
EG0011 events1 affected25 at risk
EG0021 events1 affected26 at risk
EG003
Drug hypersensitivity
Immune system disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0010 events0 affected25 at risk
EG0021 events1 affected26 at risk
EG003
Food allergy
Immune system disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected26 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected27 at risk
EG0012 events2 affected25 at risk
EG0020 events0 affected26 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected26 at risk
EG003
Cystitis
Infections and infestations
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0011 events1 affected25 at risk
EG0020 events0 affected26 at risk
EG003
Folliculitis
Infections and infestations
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected26 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected27 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected26 at risk
EG003
Helicobacter infection
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected27 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected26 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0011 events1 affected25 at risk
EG0020 events0 affected26 at risk
EG003
Infection parasitic
Infections and infestations
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0011 events1 affected25 at risk
EG0020 events0 affected26 at risk
EG003
Influenza
Infections and infestations
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected26 at risk
EG003
Localised infection
Infections and infestations
MedDRA 17.0
Systematic Assessment
EG0000 affected27 at risk
EG0010 affected25 at risk
EG0020 affected26 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MedDRA 16.0
Systematic Assessment
EG0000 affected27 at risk
EG0010 affected25 at risk
EG0020 affected26 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected27 at risk
EG0016 events4 affected25 at risk
EG0024 events4 affected26 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected26 at risk
EG003
Oral herpes
Infections and infestations
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected26 at risk
EG003
Otitis externa
Infections and infestations
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected26 at risk
EG003
Otitis media
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0000 affected27 at risk
EG0010 affected25 at risk
EG0020 affected26 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA 16.0
Systematic Assessment
EG0000 affected27 at risk
EG0010 affected25 at risk
EG0020 affected26 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected27 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected26 at risk
EG003
Pyelonephritis
Infections and infestations
MedDRA 17.0
Systematic Assessment
EG0000 affected27 at risk
EG0010 affected25 at risk
EG0020 affected26 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA 17.0
Systematic Assessment
EG0000 affected27 at risk
EG0010 affected25 at risk
EG0020 affected26 at risk
EG003
Rhinitis
Infections and infestations
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected26 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected27 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected26 at risk
EG003
Tinea pedis
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected27 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected26 at risk
EG003
Tooth abscess
Infections and infestations
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0010 events0 affected25 at risk
EG0021 events1 affected26 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0002 events1 affected27 at risk
EG0012 events2 affected25 at risk
EG0022 events2 affected26 at risk
EG003
Urethritis
Infections and infestations
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected26 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0010 events0 affected25 at risk
EG0022 events1 affected26 at risk
EG003
Viral upper respiratory tract infection
Infections and infestations
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0011 events1 affected25 at risk
EG0020 events0 affected26 at risk
EG003
Arthropod bite
Injury, poisoning and procedural complications
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0011 events1 affected25 at risk
EG0020 events0 affected26 at risk
EG003
Laceration
Injury, poisoning and procedural complications
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected26 at risk
EG003
Meniscus injury
Injury, poisoning and procedural complications
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0010 events0 affected25 at risk
EG0021 events1 affected26 at risk
EG003
Muscle strain
Injury, poisoning and procedural complications
MedDRA 16.1
Systematic Assessment
EG0002 events2 affected27 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected26 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected26 at risk
EG003
Wound secretion
Injury, poisoning and procedural complications
MedDRA 17.0
Systematic Assessment
EG0000 affected27 at risk
EG0010 affected25 at risk
EG0020 affected26 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRA 16.1
Systematic Assessment
EG0002 events2 affected27 at risk
EG0011 events1 affected25 at risk
EG0021 events1 affected26 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0012 events2 affected25 at risk
EG0020 events0 affected26 at risk
EG003
Glycosylated haemoglobin increased
Investigations
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected26 at risk
EG003
Haematocrit decreased
Investigations
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0011 events1 affected25 at risk
EG0020 events0 affected26 at risk
EG003
Haemoglobin decreased
Investigations
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0011 events1 affected25 at risk
EG0020 events0 affected26 at risk
EG003
Heart rate decreased
Investigations
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0010 events0 affected25 at risk
EG0021 events1 affected26 at risk
EG003
Lipase increased
Investigations
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0010 events0 affected25 at risk
EG0021 events1 affected26 at risk
EG003
Occult blood
Investigations
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected26 at risk
EG003
Occult blood positive
Investigations
MedDRA 17.0
Systematic Assessment
EG0000 affected27 at risk
EG0010 affected25 at risk
EG0020 affected26 at risk
EG003
Red blood cell count decreased
Investigations
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0011 events1 affected25 at risk
EG0020 events0 affected26 at risk
EG003
Vitamin D decreased
Investigations
MedDRA 16.1
Systematic Assessment
EG0000 affected27 at risk
EG0010 affected25 at risk
EG0020 affected26 at risk
EG003
White blood cells urine positive
Investigations
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0010 events0 affected25 at risk
EG0021 events1 affected26 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected27 at risk
EG0010 events0 affected25 at risk
EG0021 events1 affected26 at risk
EG003
Diabetes mellitus
Metabolism and nutrition disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0013 events3 affected25 at risk
EG0020 events0 affected26 at risk
EG003
Diabetes mellitus inadequate control
Metabolism and nutrition disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected27 at risk
EG0010 affected25 at risk
EG0020 affected26 at risk
EG003
Gout
Metabolism and nutrition disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0011 events1 affected25 at risk
EG0020 events0 affected26 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA 15.1
Systematic Assessment
EG0000 affected27 at risk
EG0010 affected25 at risk
EG0020 affected26 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected27 at risk
EG0010 affected25 at risk
EG0020 affected26 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected27 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected26 at risk
EG003
Hyperlipidaemia
Metabolism and nutrition disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0011 events1 affected25 at risk
EG0020 events0 affected26 at risk
EG003
Hyperuricaemia
Metabolism and nutrition disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected26 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA 17.0
Systematic Assessment
EG0005 events4 affected27 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected26 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0010 events0 affected25 at risk
EG0021 events1 affected26 at risk
EG003
Iron deficiency
Metabolism and nutrition disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected27 at risk
EG0010 affected25 at risk
EG0020 affected26 at risk
EG003
Metabolic acidosis
Metabolism and nutrition disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0010 events0 affected25 at risk
EG0021 events1 affected26 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected27 at risk
EG0012 events2 affected25 at risk
EG0020 events0 affected26 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected26 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 16.1
Systematic Assessment
EG0002 events1 affected27 at risk
EG0010 events0 affected25 at risk
EG0021 events1 affected26 at risk
EG003
Bursitis
Musculoskeletal and connective tissue disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected27 at risk
EG0010 affected25 at risk
EG0020 affected26 at risk
EG003
Exostosis
Musculoskeletal and connective tissue disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected27 at risk
EG0010 affected25 at risk
EG0020 affected26 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0011 events1 affected25 at risk
EG0020 events0 affected26 at risk
EG003
Joint swelling
Musculoskeletal and connective tissue disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected26 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected27 at risk
EG0010 events0 affected25 at risk
EG0023 events3 affected26 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0011 events1 affected25 at risk
EG0020 events0 affected26 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected27 at risk
EG0010 affected25 at risk
EG0020 affected26 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected26 at risk
EG003
Musculoskeletal stiffness
Musculoskeletal and connective tissue disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected27 at risk
EG0010 affected25 at risk
EG0020 affected26 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0011 events1 affected25 at risk
EG0020 events0 affected26 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0010 events0 affected25 at risk
EG0021 events1 affected26 at risk
EG003
Osteochondritis
Musculoskeletal and connective tissue disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected26 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected26 at risk
EG003
Sensation of heaviness
Musculoskeletal and connective tissue disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected26 at risk
EG003
Cerebral infarction
Nervous system disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0011 events1 affected25 at risk
EG0020 events0 affected26 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 16.1
Systematic Assessment
EG0003 events2 affected27 at risk
EG0012 events2 affected25 at risk
EG0020 events0 affected26 at risk
EG003
Headache
Nervous system disorders
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected27 at risk
EG0013 events3 affected25 at risk
EG0020 events0 affected26 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0011 events1 affected25 at risk
EG0020 events0 affected26 at risk
EG003
Somnolence
Nervous system disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0010 events0 affected25 at risk
EG0021 events1 affected26 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0012 events1 affected25 at risk
EG0020 events0 affected26 at risk
EG003
Depression
Psychiatric disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0010 events0 affected25 at risk
EG0021 events1 affected26 at risk
EG003
Head banging
Psychiatric disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected27 at risk
EG0010 affected25 at risk
EG0020 affected26 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0010 events0 affected25 at risk
EG0021 events1 affected26 at risk
EG003
Azotaemia
Renal and urinary disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected26 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected27 at risk
EG0010 affected25 at risk
EG0020 affected26 at risk
EG003
Pollakiuria
Renal and urinary disorders
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected27 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected26 at risk
EG003
Renal failure acute
Renal and urinary disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0010 events0 affected25 at risk
EG0021 events1 affected26 at risk
EG003
Renal impairment
Renal and urinary disorders
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected27 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected26 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0011 events1 affected25 at risk
EG0022 events2 affected26 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 17.0
Systematic Assessment
EG0001 events1 affected27 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected26 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected27 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected26 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0012 events1 affected25 at risk
EG0020 events0 affected26 at risk
EG003
Lung infiltration
Respiratory, thoracic and mediastinal disorders
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected27 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected26 at risk
EG003
Oropharyngeal discomfort
Respiratory, thoracic and mediastinal disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected27 at risk
EG0011 events1 affected25 at risk
EG0020 events0 affected26 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0011 events1 affected25 at risk
EG0020 events0 affected26 at risk
EG003
Respiratory tract congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected26 at risk
EG003
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected27 at risk
EG0010 events0 affected25 at risk
EG0021 events1 affected26 at risk
EG003
Sinus congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0010 events0 affected25 at risk
EG0021 events1 affected26 at risk
EG003
Sinus disorder
Respiratory, thoracic and mediastinal disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0011 events1 affected25 at risk
EG0020 events0 affected26 at risk
EG003
Sneezing
Respiratory, thoracic and mediastinal disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0010 events0 affected25 at risk
EG0021 events1 affected26 at risk
EG003
Upper respiratory tract inflammation
Respiratory, thoracic and mediastinal disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0010 events0 affected25 at risk
EG0021 events1 affected26 at risk
EG003
Diabetic bullosis
Skin and subcutaneous tissue disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0010 events0 affected25 at risk
EG0021 events1 affected26 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0011 events1 affected25 at risk
EG0020 events0 affected26 at risk
EG003
Ingrowing nail
Skin and subcutaneous tissue disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected26 at risk
EG003
Panniculitis
Skin and subcutaneous tissue disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected26 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected26 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 16.1
Systematic Assessment
EG0002 events2 affected27 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected26 at risk
EG003
Skin lesion
Skin and subcutaneous tissue disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected26 at risk
EG003
Xeroderma
Skin and subcutaneous tissue disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected26 at risk
EG003
Cataract operation
Surgical and medical procedures
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0010 events0 affected25 at risk
EG0022 events1 affected26 at risk
EG003
Tooth extraction
Surgical and medical procedures
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected26 at risk
EG003
Hot flush
Vascular disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected27 at risk
EG0010 affected25 at risk
EG0020 affected26 at risk
EG003
Hypertension
Vascular disorders
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected27 at risk
EG0011 events1 affected25 at risk
EG0021 events1 affected26 at risk
EG003
Microscopic polyangiitis
Vascular disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0010 events0 affected25 at risk
EG0020 events0 affected26 at risk
EG003
Orthostatic hypotension
Vascular disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0010 events0 affected25 at risk
EG0021 events1 affected26 at risk
EG003
Peripheral vascular disorder
Vascular disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0011 events1 affected25 at risk
EG0020 events0 affected26 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
GT60
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Not provided
Point of Contact
Title
Organization
Phone
Extension
Email
Chief Medical Officer
Eli Lilly and Company
800-545-5979
ID
Term
D003928
Diabetic Nephropathies
Ancestor Terms
ID
Term
D007674
Kidney Diseases
D014570
Urologic Diseases
D052776
Female Urogenital Diseases
D005261
Female Urogenital Diseases and Pregnancy Complications
D000091642
Urogenital Diseases
D052801
Male Urogenital Diseases
D048909
Diabetes Complications
D003920
Diabetes Mellitus
D004700
Endocrine System Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C000596027
baricitinib
Ancestor Terms
Not provided
Browse Leaves
Not provided
Browse Branches
Not provided
1 subjects
0 subjects
1 subjects
20 subjects
3 subjects
0 subjects
FG0040 subjects
Protocol Violation
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG0040 subjects
Withdrawal by Subject
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0041 subjects
Physician Decision
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
Adverse Event
FG0000 subjects
FG0014 subjects
FG0020 subjects
FG0031 subjects
FG0042 subjects
9 subjects
3 subjects
0 subjects
FG0043 subjects
Physician Decision
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG0040 subjects
61
± 10.4
BG00463± 7.8
BG00563± 9.1
5
BG0035
BG00410
BG00535
Male
BG00020
BG00117
BG00221
BG00321
BG00415
BG00594
6
BG0037
BG0044
BG00525
Not Hispanic or Latino
BG00023
BG00121
BG00220
BG00319
BG00421
BG005104
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
2
BG0032
BG0041
BG0059
Asian
BG00014
BG00112
BG00212
BG00311
BG00411
BG00560
Native Hawaiian or Other Pacific Islander
BG0000
BG0010
BG0020
BG0030
BG0041
BG0051
Black or African American
BG0002
BG0017
BG0023
BG0030
BG0043
BG00515
White
BG0008
BG0014
BG0029
BG00313
BG0049
BG00543
More than one race
BG0001
BG0010
BG0020
BG0030
BG0040
BG0051
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
0
BG0030
BG0040
BG0051
United States
Title
Measurements
BG00014
BG00113
BG00214
BG00314
BG00413
BG00568
Japan
Title
Measurements
BG00011
BG00110
BG00210
BG00310
BG00411
BG00552
Mexico
Title
Measurements
BG0002
BG0011
BG0022
BG0032
BG0041
BG0058
26
OG00425
0.91
± 0.143
OG0040.66± 0.111
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG004
Baricitinib 4 mg/2.75 mg
Baricitinib 4 mg or 2.75 mg administered PO QD.
Units
Counts
Participants
OG00027
OG00125
OG00226
OG00326
OG00425
Title
Denominators
Categories
Title
Measurements
OG0000.93± 0.070
OG0011.09± 0.104
OG0020.86± 0.069
OG0030.86± 0.069
OG0040.080± 0.066
OG002
Baricitinib 0.75 mg/0.5 mg BID
Baricitinib 0.75 mg or 0.5 mg administered PO BID.