Oral Baricitinib (LY3009104)Treatment in Japanese Partici... | NCT01469013 | Trialant
NCT01469013
Sponsor
Eli Lilly and Company
Status
Completed
Last Update Posted
Sep 20, 2019Actual
Enrollment
145Actual
Phase
Phase 2
Conditions
Arthritis, Rheumatoid
Interventions
Placebo
Baricitinib
Baricitinib
Baricitinib
Methotrexate
Countries
Japan
Protocol Section
Identification Module
NCT ID
NCT01469013
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
14116
Secondary IDs
ID
Type
Description
Link
I4V-JE-JADN
Other Identifier
Eli Lilly and Company
Brief Title
Oral Baricitinib (LY3009104)Treatment in Japanese Participants With Active Rheumatoid Arthritis on Background Methotrexate Therapy
Official Title
A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Parallel-Group, Phase 2 Study of Baricitinib (LY3009104) in Japanese Patients With Active Rheumatoid Arthritis on Background Methotrexate Therapy
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
Nov 2011
Primary Completion Date
Nov 2012Actual
Completion Date
Dec 2013Actual
First Submitted Date
Nov 8, 2011
First Submission Date that Met QC Criteria
Nov 8, 2011
First Posted Date
Nov 10, 2011Estimated
Results Waived
Not provided
Results First Submitted Date
Mar 10, 2017
Results First Submitted that Met QC Criteria
Feb 20, 2018
Results First Posted Date
Nov 1, 2018Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Jan 11, 2013
Certification/Extension First Submitted that Passed QC Review
Jan 11, 2013
Certification/Extension First Posted Date
Jan 21, 2013Estimated
Last Update Submitted Date
Sep 5, 2019
Last Update Posted Date
Sep 20, 2019Actual
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
This is a Phase 2b, outpatient, randomized, double-blinded (with a single-blind extension), placebo-controlled, dose-ranging, parallel-group study of baricitinib (LY3009104) in Japanese participants with active rheumatoid arthritis (RA) on background methotrexate (MTX) therapy. Baricitinib will be orally administered once a day with background methotrexate [6 to 16 milligrams (mg)/week] therapy for 12 weeks in the double-blind treatment period (1, 2, 4 or 8 mg/day, or placebo), and for 52 weeks in the single-blind extension period (4 or 8 mg/day).
Detailed Description
Not provided
Conditions Module
Conditions
Arthritis, Rheumatoid
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
145Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Placebo
Placebo Comparator
2 placebo capsules administered orally once daily for 12 weeks. Participants who complete this treatment arm will be randomized in a 1:1 ratio to either the 4-mg baricitinib or 8-mg baricitinib arms. Participants rerandomized to 8-mg baricitinib arm at Week12 will switch to 4-mg baricitinib once a day after the approval of protocol amendment (d) and will receive that switched dose until Week 64.
The dosage form changed from capsule in treatment period (up to Week 12) to tablet in extension period (Week 13 to 64) per protocol amendment (b).
Drug: Placebo
Drug: Methotrexate
1-mg Baricitinib (LY3009104)
Experimental
1 x 1-mg baricitinib capsule + 1 identical placebo capsule, both administered orally once daily for 12 weeks. Participants who complete this treatment arm will be randomized in a 1:1 ratio to either the 4-mg baricitinib or 8-mg baricitinib arms. Participants rerandomized to 8-mg baricitinib arm at Week 12 will switch to 4-mg baricitinib once a day after the approval of protocol amendment (d) and will receive that switched dose until Week 64.
The dosage form changed from capsule in treatment period (up to Week 12) to tablet in extension period (Week 13 to 64) per protocol amendment (b).
Drug: Placebo
Drug: Baricitinib
Drug: Methotrexate
2-mg Baricitinib (LY3009104)
Experimental
2 x 1-mg baricitinib capsules administered orally once daily for 12 weeks. Participants who complete this treatment arm will be randomized in a 1:1 ratio to either the 4-mg baricitinib or 8-mg baricitinib arms. Participants rerandomized to 8-mg baricitinib arm at Week 12 will switch to 4-mg baricitinib once a day after the approval of protocol amendment (d) and will receive that switched dose until Week 64.
The dosage form changed from capsule in treatment period (up to Week 12) to tablet in extension period (Week 13 to 64) per protocol amendment (b).
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Placebo
Drug
1-mg Baricitinib (LY3009104)
4-mg Baricitinib (LY3009104)
Placebo
Sugar pill
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentage of Participants in the 4 mg and 8 mg Dose Groups Who Achieved an American College of Rheumatology 20 (ACR20) Responder Index Response Baseline Through Week 12 .
ACR20 responders are participants with at least 20% improvement from baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: Health Assessment Questionnaire-Disability Index (HAQ-DI) which measured participants perceived degree of difficulty performing daily activities, C-reactive Protein (CRP) and erythrocyte sedimentation rate (ESR), Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS) , Patient's Global Assessment of Disease Activity-VAS (PtGADA-VAS), and Physician's Global Assessment of Disease Activity-VAS (PhGA-VAS). Missing values were imputed using Non-Responder Imputation (NRI), where non-responders were participants who discontinued the study prior to the completion of Part A. Percentage of participants achieving ACR20 response = (number of ACR20 responders) /(number of participants treated) * 100.
12 weeks
Secondary Outcomes
Measure
Description
Time Frame
Percentage of Participants Who Achieved an ACR20 Response at 64 Weeks
ACR20 responders are participants with at least 20% improvement from baseline for TJC, SJC, and at least 3 of the 5 remaining core set measures: HAQ-DI which measured participants perceived degree of difficulty performing daily activities, CRP and ESR, PAAP-VAS, PtGADA-VAS, or PhGA-VAS. Missing values were imputed using NRI, where non-responders were participants who discontinued the study prior to the completion of Part B. Percentage of participants achieving ACR20 response = (number of ACR20 responders) / (number of participants treated) * 100.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Ambulatory males or females between the ages of 20 and 75 years, inclusive, at time of study entry
Diagnosis of adult-onset RA (of at least 6 months duration but not longer than 15 years prior to screening) according to the 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) Responder Index classification criteria for RA
Have active RA defined as at least 6 swollen and at least 6 tender joints based on the 66/68 joint count
Regular use of MTX for at least 12 weeks, and treatment at a stable dose of 6 to 16 mg/week (2 or 3 times a week) for at least 8 weeks prior to the treatment period. The dose of MTX should remain stable throughout the study, but may be adjusted for safety reasons.
For participants receiving corticosteroids, they must be on a dose not to exceed 10 mg of prednisone daily (or equivalent) and have been on the same dosing regimen for at least 6 weeks prior to the treatment period
Have C-Reactive Protein (CRP) measurement > 0.5 milligrams/deciliter (mg/dL) or Erythrocyte Sedimentation Rate (ESR) > 28 millimeters/hour (mm/hr). The CRP and ESR may be repeated once during the screening period at the discretion of the investigator, and the repeat results may be accepted for study eligibility purposes
Exclusion Criteria:
Use of nonsteroidal anti-inflammatories (NSAIDs) for less than 4 weeks prior to the treatment period. If on NSAIDs, must be on a stable dose of the drug for at least 4 weeks prior to the treatment period and must remain on a stable dose throughout the study
Received prior treatment with an oral Janus Kinase (JAK) inhibitor regardless of when they received it
Have a diagnosis of Felty's syndrome
Evidence of human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies
Have hepatitis C virus (HCV; positive for anti-hepatitis C antibody with confirmed presence of HCV)
Positive for hepatitis B surface antigen (HBsAg+), OR negative for hepatitis B surface antigen (HBsAg-), but positive for hepatitis B core antibody (HBcAb+) and/or positive for hepatitis B surface antibody (HBsAb+) with positive Hepatitis B virus (HBV)-deoxyribonucleic acid (DNA) [≥2.1 Log copy/mL by Polymerase Chain Reaction (PCR) method] detected in the serum
Have a positive result of the QuantiFERON®-tuberculosis (TB) Gold test (QFT-G) or a purified protein derivative (PPD) test
Have estimated Glomerular Filtration Rate (GFR) from serum creatinine using the Modification of Diet in Renal Disease (MDRD) method of <50 milliliter/minute (mL/min)
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
20 Years
Maximum Age
75 Years
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.
Taylor PC, Takeuchi T, Burmester GR, Durez P, Smolen JS, Deberdt W, Issa M, Terres JR, Bello N, Winthrop KL. Safety of baricitinib for the treatment of rheumatoid arthritis over a median of 4.6 and up to 9.3 years of treatment: final results from long-term extension study and integrated database. Ann Rheum Dis. 2022 Mar;81(3):335-343. doi: 10.1136/annrheumdis-2021-221276. Epub 2021 Oct 27.
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 on background methotrexate therapy were assigned to a dose of 1, 2, 4, 8 mg baricitinib (LY3009104) or placebo capsule once daily in a double blind manner for 12 weeks followed by single blind treatment of 4 mg or 8 mg baricitinib (LY3009104) tablet once daily for 52 weeks extension period.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Part A: 1 mg Baricitinib (LY3009104)
Participants on background methotrexate therapy administered 1 x 1-mg baricitinib (LY3009104) capsule + 1 identical placebo capsule, orally once daily for 12 weeks.
1 x 4-mg baricitinib capsule + 1 identical placebo capsule, both administered orally once daily for 12 weeks. Participants who complete this 12-week period will remain on this treatment regimen in tablet form.
Drug: Placebo
Drug: Baricitinib
Drug: Methotrexate
8-mg Baricitinib (LY3009104)
Experimental
2 x 4-mg baricitinib capsules administered orally once daily for 12 weeks. Participants who complete this 12-week period will remain on this treatment regimen in tablet form. Participants taking 8-mg baricitinib tablet form will switch to 4-mg baricitinib once a day after the approval of protocol amendment (d) and will receive that switched dose until Week 64.
Drug: Baricitinib
Drug: Methotrexate
Baricitinib
Drug
8-mg Baricitinib (LY3009104)
JAK1/JAK2 inhibitor
JAK1 inhibitor
JAK2 inhibitor
NCB028050
LY3009104
Baricitinib
Drug
4-mg Baricitinib (LY3009104)
JAK1/JAK2 inhibitor
JAK1 inhibitor
JAK2 inhibitor
NCB028050
LY3009104
Baricitinib
Drug
1-mg Baricitinib (LY3009104)
2-mg Baricitinib (LY3009104)
4-mg Baricitinib (LY3009104)
8-mg Baricitinib (LY3009104)
JAK1/JAK2 inhibitor
JAK1 inhibitor
JAK2 inhibitor
NCB028050
LY3009104
Methotrexate
Drug
Administered orally as background therapy
1-mg Baricitinib (LY3009104)
2-mg Baricitinib (LY3009104)
4-mg Baricitinib (LY3009104)
8-mg Baricitinib (LY3009104)
Placebo
Baseline up to 64 weeks
Percentage of Participants Who Achieved an ACR70 Response at 12 Weeks (Part A)
ACR70 responders were participants with at least 70% improvement from baseline for TJC, SJC, and at least 3 of the 5 remaining core set measures: HAQ-DI, CRP, PAAP-VAS, PtGADA-VAS, or PhGA-VAS. Missing values were imputed using NRI, where non-responders were participants who discontinued the study prior to the completion of Part A. Percentage of participants achieving ACR70 response=(number of ACR70 responders / number of participants treated) * 100.
Baseline up to 12 weeks
Percentage of Participants Who Achieved an ACR70 Response at 64 Weeks (Part B)
ACR70 responders were participants with at least 70% improvement from baseline for TJC, SJC, and at least 3 of the 5 remaining core set measures: HAQ-DI, CRP, PAAP-VAS, PtGADA-VAS, or PhGA-VAS. Missing values were imputed using NRI, where non-responders were participants who discontinued the study prior to the completion of Part B. Percentage of participants achieving ACR70 response=(number of ACR70 responders) / (number of participants treated) * 100.
Baseline up to 64 weeks
Mean Change From Baseline to Week 12 in Disease Activity Score (DAS) Based on the 28 Diarthrodial Joint Count and CRP Level (DAS28-CRP)
DAS modified included the DAS28 that consisted of a composite score of the following variables: tender joint count out of 28 (TJC28), swollen joint count out of 28 (SJC28), CRP [milligrams per liter (mg/L)], and PtGADA on a 0 to 100 millimeter (mm) VAS (0mm=no arthritis activity to 100 mm= extremely active arthritis). DAS28 calculated as: DAS28-CRP = 0.56(square root of TJC28)+0.28(square root of SJC28)+0.36[ln(CRP +1)]+0.014(VAS)+0.96. A decrease in DAS28-CRP indicated an improvement in participant's condition.
Baseline, 12 weeks
Mean Change From Baseline to Week 64 in DAS Based on the 28 Diarthrodial Joint Count and CRP Level (DAS28-CRP)
DAS modified included the 28 diarthroidal joint count (DAS28) that consisted of a composite score of the following variables: TJC28, SJC28, CRP (mg/L), and PtGADA on a 0 to 100 mm VAS (0mm=no arthritis activity to 100 mm= extremely active arthritis). DAS28 calculated as: DAS28-CRP = 0.56(square root of TJC28)+0.28(square root of SJC28)+0.36[ln(CRP +1)]+0.014(VAS)+0.96. A decrease in DAS28-CRP indicated an improvement in participant's condition.
Baseline, 64 weeks
Percentage of Participants Who Achieved an European League Against Rheumatism Rating of 28-Joint Arthritic Condition (EULAR28) Response at 12 Weeks (Part A)
EULAR Responder Index based on 28 joint counts categorizes clinical response based on improvement from baseline in DAS28-CRP. DAS28-CRP scores range from 1.0-9.4, where lower scores indicated less disease activity. High disease activity: DAS28-CRP >5.1, low disease activity: DAS28-CRP ≤3.2, and remission: DAS28-CRP <2.6. Participants are categorized as EULAR responders or non-responders based on improvement of DAS28-CRP scores from baseline. EULAR DAS28-CRP responder index defines a good (absolute: ≤3.2 and >1.2 improvement from baseline), moderate (absolute: >3.2 and ≤5.1 and >0.6 and ≤1.2 improvement from baseline), or no response (absolute: >5.1 and ≤0.6 improvement from baseline). Percentage of participants calculated as = (number of good +moderate responders) / (number of participants treated) * 100.
Baseline up to 12 weeks
Percentage of Participants Who Achieved an EULAR28 Response at 64 Weeks (Part B)
EULAR Responder Index based on 28 joint counts categorizes clinical response based on improvement from baseline in DAS28-CRP. DAS28-CRP scores range from 1.0-9.4, where lower scores indicated less disease activity. High disease activity: DAS28-CRP >5.1, low disease activity: DAS28-CRP <3.2, and remission: DAS28-CRP <2.6. Participants are categorized as EULAR responders or non-responders based on improvement of DAS28-CRP scores from baseline. EULAR DAS28-CRP Responder Index defines a good (absolute: ≤3.2 and >1.2 improvement from baseline), moderate (absolute: >3.2 and ≤5.1 and >0.6 and ≤1.2 improvement from baseline), or no response (absolute: >5.1 and ≤0.6 improvement from baseline). Percentage of participants calculated as = (number of good +moderate responders) / (number of participants treated) * 100.
Baseline up to 64 weeks
Mean Change in Simplified Disease Activity Index (SDAI) Responses up to 12 Weeks (Part A)
The SDAI is the numerical sum of 5 outcome parameters: TJC28, SJC28, patient and physician global assessment of disease activity and CRP. The equation used to calculate the SDAI:SDAI=SJC28+TJC28+PtGADA-VAS+PhGA-VAS+CRP where PtGADA-VAS=PtGADA-VAS / 10 and PhGA-VAS=PhGA-VAS / 10, with lower values indicating fewer symptoms.
Baseline up to 12 weeks
Mean Change in SDAI Responses up to 64 Weeks (Part B)
The SDAI is the numerical sum of 5 outcome parameters: TJC28, SJC28, PtGADA, PhGA, and CRP. The equation used to calculate the SDAI:
SDAI=SJC28+TJC28+PtGADA-VAS+PhGA-VAS+CRP where PtGADA-VAS=PtGADA -VAS/ 10 and PhGA-VAS=PhGA-VAS/ 10, with lower values indicating fewer symptoms.
Baseline, 64 weeks
Mean Change in Health Assessment Questionnaire - Disability Index (HAQ-DI) Responses up to 12 Weeks (Part A)
HAQ-DI was a participant-reported questionnaire that consisted of 24 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the week using response categories: without any difficulty (0), with some difficulty (1), with much difficulty (2), and unable to do (3). The highest score for any question in a category was the score of that category unless special aids or devices or help from another person was required. Answers for at least 6 of the 8 domains were required. Otherwise, HAQ-DI score was considered missing. The HAQ-DI score was the sum of the category scores divided by the number of categories scored, with a possible scores range from 0 to 3, 0 being without any difficulty and 3 being unable to do.
Baseline, 12 weeks
Mean Change in HAQ-DI Responses up to 64 Weeks (Part B)
HAQ-DI was a participant-reported questionnaire that consisted of 24 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the week using response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). The highest score for any question in a category was the score of that category unless special aids or devices or help from another person was required. Answers for at least 6 of the 8 domains were required. Otherwise, HAQ-DI score was considered missing. The HAQ-DI score was the sum of the category scores divided by the number of categories scored, with a possible scores range from 0 to 3, 0 being without any difficulty and 3 being unable to do.
Baseline, 64 weeks
Mean Value of ACR-N Response (Part A)
The ACR-N Response Index is a continuous measure of clinical, laboratory, and functional measures in RA to characterize the percentage of improvement from baseline in RA disease activity. This index is defined as the lowest of either: a) percent change in TJC, b) percent change in SJC, or c) median percent change of the remaining 5 ACR core criteria (HAQ-DI, CRP, PAAP-VAS, PtGADA-VAS, or PhGA-VAS). A participant with an ACR-N of "X" has improvement of at least "X%" in tender and swollen joints and a median improvement of at least "X%" in the 5 remaining ACR core criteria. Since ACR-N is a continuous measure, the mean values are reported instead of the originally registered percentage of participants.
Baseline up to 12 weeks
Mean Value of ACR-N Response (Part B)
The ACR-N Response Index is a continuous measure of clinical, laboratory, and functional measures in RA to characterize the percentage of improvement from baseline in RA disease activity. This index is defined as the lowest of either: a) percent change in TJC, b) percent change in SJC, or c) median percent change of the remaining 5 ACR core criteria (HAQ-DI, CRP, PAAP-VAS, PtGADA-VAS, or PhGA-VAS). A participant with an ACR-N of "X" has improvement of at least "X%" in tender and swollen joints and a median improvement of at least "X%" in the 5 remaining ACR core criteria. Since ACR-N is a continuous measure, the mean values are reported instead of the originally registered percentage of participants.
Baseline up to 64 weeks
Percentage of Participants Who Achieved a DAS28 Remission at 12 Weeks (Part A)
DAS modified included the DAS28 that consisted of a composite score of the following variables: TJC28, SJC28, CRP (mg/L), and PtGADA on a 0 to 100 mm VAS: 0 mm (no arthritis activity) to 100 mm (extremely active arthritis). DAS28 calculated as: DAS28-CRP = 0.56(square root of TJC28)+0.28(square root of SJC28)+0.36[ln(CRP +1)]+0.014(VAS)+0.96. For remission, DAS28 is <2.6. Percentage of participants = (number of participants with DAS28 remission) / (number of participants treated) * 100.
Baseline up to 12 weeks
Percentage of Participants Who Achieved a DAS28 Remission at 64 Weeks (Part B)
DAS modified included the DAS28 that consisted of a composite score of the following variables: TJC28, SJC28, CRP (mg/L), and PtGADA-VAS on a 0 to 100 mm VAS: 0 mm (no arthritis activity) to 100 mm (extremely active arthritis). DAS28 calculated as: DAS28-CRP = 0.56(sqrt of TJC28)+0.28(sqrt of SJC28)+0.36[ln(CRP +1)]+0.014(VAS)+0.96. For remission, DAS28 is <2.6. Percentage of participants = (number of participants with DAS 28 remission) / (number of participants treated) * 100.
Baseline up to 64 weeks
Percentage of Participants Who Achieved an SDAI Remission at 12 Weeks (Part A)
The SDAI is the numerical sum of 5 outcome parameters: TJC28, SJC28, PtGADA, PhGA and CRP. The equation used to calculate the SDAI:
SDAI=SJC28+TJC28+PtGADA-VAS+PhGA-VAS+CRP where PtGADA-VAS=PtGADA -VAS/ 10 and PhGA-VAS=PhGA-VAS / 10. Definition of remission is SDAI ≤ 3.3. Percentage of participants = (number of responders) / (number of participants treated) * 100
Baseline up to 12 weeks
Percentage of Participants Who Achieved an SDAI Remission at 64 Weeks (Part B)
The SDAI is the numerical sum of 5 outcome parameters: TJC28, SJC28, PtGADA, PhGA, and CRP. The equation used to calculate the SDAI:
SDAI=SJC28+TJC28+PtGADA-VAS+PhGA-VAS+CRP where PtGADA-VAS=PtGADA-VAS / 10 and PhGA-VAS=PhGA-VAS / 10. Definition of remission is SDAI ≤ 3.3. Percentage of participants = (number of responders) / (number of participants treated) * 100
Baseline up to 64 weeks
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve at a Dosing Interval at Steady State (AUCtau,ss) of LY3009104
Steady state is achieved when the rate of drug input is equal to the rate of drug elimination. The AUC(tau,ss) at 1 dosing interval is the average concentration of the drug at steady state multiplied by the time of the dosing interval.
Weeks (Wks) 0, 8, 12, or 20: Predose, 15 to 30 minutes and 1 to 3 hours postdose; Wks 2 or 4 and 15 or 16: Predose; Wks 28, 40, 52, or 64: random single sample.
PK: Maximum Concentration at Steady State of Dosing (Cmax,ss) of LY3009104
Wks 0, 8, 12, or 20: Predose, 15 to 30 minutes and 1 to 3 hours postdose; Wks 2 or 4 and 15 or 16: Predose; Wks 28, 40, 52, or 64: random single sample.
Japan
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.
Fukuoka
812-0025
Japan
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.
Hiroshima
730-0017
Japan
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.
Hokkaido
063-0811
Japan
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.
Hyōgo
673-1462
Japan
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.
Ibaraki
316-0035
Japan
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.
Kagoshima
890-0067
Japan
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.
Kanagawa
252-0392
Japan
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.
Nagasaki
857-1165
Japan
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.
Okayama
700-8607
Japan
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.
Osaka
586-8521
Japan
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.
Ōita
870-0823
Japan
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.
Tokyo
130-0013
Japan
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.
Toyama
933-0874
Japan
Derived
Combe B, Balsa A, Sarzi-Puttini P, Tony HP, de la Torre I, Rogai V, Durand F, Witt S, Zhong J, Dougados M. Efficacy and safety data based on historical or pre-existing conditions at baseline for patients with active rheumatoid arthritis who were treated with baricitinib. Ann Rheum Dis. 2019 Aug;78(8):1135-1138. doi: 10.1136/annrheumdis-2018-214261. Epub 2019 Mar 6. No abstract available.
Taylor PC, Kremer JM, Emery P, Zuckerman SH, Ruotolo G, Zhong J, Chen L, Witt S, Saifan C, Kurzawa M, Otvos JD, Connelly MA, Macias WL, Schlichting DE, Rooney TP, de Bono S, McInnes IB. Lipid profile and effect of statin treatment in pooled phase II and phase III baricitinib studies. Ann Rheum Dis. 2018 Jul;77(7):988-995. doi: 10.1136/annrheumdis-2017-212461. Epub 2018 Feb 20.
Tanaka Y, Ishii T, Cai Z, Schlichting D, Rooney T, Macias W. Efficacy and safety of baricitinib in Japanese patients with active rheumatoid arthritis: A 52-week, randomized, single-blind, extension study. Mod Rheumatol. 2018 Jan;28(1):20-29. doi: 10.1080/14397595.2017.1307899. Epub 2017 Apr 25.
Tanaka Y, Emoto K, Cai Z, Aoki T, Schlichting D, Rooney T, Macias W. Efficacy and Safety of Baricitinib in Japanese Patients with Active Rheumatoid Arthritis Receiving Background Methotrexate Therapy: A 12-week, Double-blind, Randomized Placebo-controlled Study. J Rheumatol. 2016 Mar;43(3):504-11. doi: 10.3899/jrheum.150613. Epub 2016 Feb 1.
Participants on background methotrexate therapy administered 2 x 1-mg baricitinib (LY3009104) capsules orally once daily for 12 weeks.
FG002
Part A: 4 mg Baricitinib (LY3009104)
Participants on background methotrexate therapy administered 1 x 4-mg baricitinib (LY3009104) capsule +1 identical placebo capsule, orally once daily for 12 weeks.
FG003
Part A: 8 mg Baricitinib (LY3009104)
Participants on background methotrexate therapy administered 2 x 4-mg baricitinib (LY3009104) capsules orally once daily for 12 weeks.
FG004
Part A: Placebo
Participants on background methotrexate therapy administered 2 placebo capsules, orally once daily for 12 weeks.
Participants on background methotrexate therapy who were administered 1 x 1-mg LY3009104 capsule +1 identical placebo capsule, orally once daily for 12 weeks in Part A received 4 mg LY3009104 and 1 placebo tablet orally once daily for 52 weeks in Part B.
Participants on background methotrexate therapy who were administered 2 x 1-mg baricitinib (LY3009104) capsules orally once daily for 12 weeks in Part A received 4 mg baricitinib (LY3009104) and 1 placebo tablet orally once daily for 52 weeks in Part B.
Participants on background methotrexate therapy who were administered 1 x 4-mg baricitinib (LY3009104) capsule + 1 identical placebo capsule, orally once daily for 12 weeks in Part A received 4 mg baricitinib (LY3009104) and 1 placebo tablet orally once daily for 52 weeks in Part B.
FG008
Part B: Placebo /4 mg Baricitinib (LY3009104)
Participants on background methotrexate therapy who were administered 2 placebo capsules orally once daily for 12 weeks in Part A received 4 mg baricitinib (LY3009104) and 1 placebo tablet orally once daily for 52 weeks in Part B.
Participants on background methotrexate therapy who were administered 1 x 1-mg baricitinib (LY3009104) capsule + 1 identical placebo capsule orally once daily for 12 weeks in Part A received 2 x 4 mg baricitinib (LY3009104) tablets orally once daily for 52 weeks in Part B.
Participants on background methotrexate therapy who were administered 2 x 1-mg baricitinib (LY3009104) capsules orally once daily for 12 weeks in Part A received 2 x 4 mg baricitinib (LY3009104) tablets orally once daily for 52 weeks in Part B.
Participants on background methotrexate therapy who were administered 2 x 4-mg baricitinib (LY3009104) capsules orally once daily for 12 weeks in Part A received 2 x 4 mg baricitinib (LY3009104) tablets orally once daily for 52 weeks in Part B.
FG012
Part B: Placebo / 8 mg Baricitinib (LY3009104)
Participants on background methotrexate therapy who were administered 2 placebo capsules orally once daily for 12 weeks in Part A received 2 x 4 mg baricitinib (LY3009104) tablets orally once daily for 52 weeks in Part B.
FG00024 subjects
FG00124 subjects
FG00224 subjects
FG00324 subjects
FG00449 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
Received at Least 1 Dose of Study Drug
FG00024 subjects
FG00124 subjects
FG00224 subjects
FG00324 subjects
FG00449 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
COMPLETED
FG00023 subjects
FG00124 subjects
FG00223 subjects
FG00324 subjects
FG00448 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
NOT COMPLETED
FG0001 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG0041 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
Type
Comment
Reasons
Adverse Event
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0041 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Part B (Extension Period)
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG00512 subjects
FG00612 subjects
FG00723 subjects
FG00824 subjects
FG00911 subjects
FG01012 subjects
FG01124 subjects
FG01224 subjects
Received at Least 1 Dose of Study Drug
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
All randomized participants who received any amount of study treatment. All participants who completed Part A were re-randomized to 4 mg or 8 mg in Part B.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Part A: 1 mg Baricitinib (LY3009104)
Participants on background methotrexate therapy were administered 1 mg baricitinib (LY3009104) orally once daily for 12 weeks in Part A and received 4 mg or 8 mg baricitinib (LY3009104) tablets orally once daily for 52 weeks in Part B.
BG001
Part A: 2 mg Baricitinib (LY3009104)
Participants on background methotrexate therapy were administered 2 mg baricitinib (LY3009104) orally once daily for 12 weeks in Part A and received 4 mg or 8 mg baricitinib (LY3009104) tablets orally once daily for 52 weeks in Part B.
BG002
Part A: 4 mg Baricitinib (LY3009104)
Participants on background methotrexate therapy were administered 4 mg baricitinib (LY3009104) orally once daily for 12 weeks in Part A and received 4 mg or 8 mg baricitinib (LY3009104) tablets orally once daily for 52 weeks in Part B.
BG003
Part A: 8 mg Baricitinib (LY3009104)
Participants on background methotrexate therapy were administered 8 mg baricitinib (LY3009104) orally once daily for 12 weeks in Part A and received 4 mg or 8 mg baricitinib (LY3009104) tablets orally once daily for 52 weeks in Part B.
BG004
Part A: Placebo
Participants on background methotrexate therapy were administered placebo orally once daily for 12 weeks in Part A and received 4 mg or 8 mg baricitinib (LY3009104) tablets orally once daily for 52 weeks in Part B.
BG005
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00024
BG00124
BG00224
BG00324
BG00449
BG005145
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
BG00052.7± 12.8
BG00156.1± 11.5
BG00257.5± 10.4
BG003
Sex: Female, Male
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Female
BG00022
BG00121
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0000
BG0010
BG002
Race (NIH/OMB)
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Region of Enrollment
Count of Participants
Participants
No
Title
Denominators
Categories
Japan
Title
Measurements
BG00024
BG00124
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
Percentage of Participants in the 4 mg and 8 mg Dose Groups Who Achieved an American College of Rheumatology 20 (ACR20) Responder Index Response Baseline Through Week 12 .
ACR20 responders are participants with at least 20% improvement from baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: Health Assessment Questionnaire-Disability Index (HAQ-DI) which measured participants perceived degree of difficulty performing daily activities, C-reactive Protein (CRP) and erythrocyte sedimentation rate (ESR), Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS) , Patient's Global Assessment of Disease Activity-VAS (PtGADA-VAS), and Physician's Global Assessment of Disease Activity-VAS (PhGA-VAS). Missing values were imputed using Non-Responder Imputation (NRI), where non-responders were participants who discontinued the study prior to the completion of Part A. Percentage of participants achieving ACR20 response = (number of ACR20 responders) /(number of participants treated) * 100.
All participants who received at least 1 dose of 4 mg, 8 mg baricitinib (LY3009104) or placebo in Part A as per protocol for combined analysis .
Posted
Number
percentage of participants
12 weeks
ID
Title
Description
OG000
Part A: Combined 4 mg and 8 mg Baricitinib (LY3009104)
Participants on background methotrexate therapy administered 1- 4 mg baricitinib (LY3009104) capsule +1 identical placebo capsule or 2 x 4-mg baricitinib (LY3009104) capsules, orally once daily for 12 weeks.
OG001
Part A: Placebo
Participants on background methotrexate therapy administered 2 placebo capsules, orally once daily for 12 weeks.
Units
Counts
Participants
OG00048
OG00149
Title
Denominators
Categories
Title
Measurements
OG00077
OG00131
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Regression, Logistic
<0.001
Superiority or Other (legacy)
Secondary
Percentage of Participants Who Achieved an ACR20 Response at 64 Weeks
ACR20 responders are participants with at least 20% improvement from baseline for TJC, SJC, and at least 3 of the 5 remaining core set measures: HAQ-DI which measured participants perceived degree of difficulty performing daily activities, CRP and ESR, PAAP-VAS, PtGADA-VAS, or PhGA-VAS. Missing values were imputed using NRI, where non-responders were participants who discontinued the study prior to the completion of Part B. Percentage of participants achieving ACR20 response = (number of ACR20 responders) / (number of participants treated) * 100.
All participants who received any amount of study drug in Part B.
Posted
Number
percentage of participants
Baseline up to 64 weeks
ID
Title
Description
OG000
Combined 4 mg Baricitinib (LY3009104) (Part B)
Participants on background methotrexate therapy who were administered 1 mg, 2 mg, 4 mg baricitinib (LY3009104) capsule or placebo capsule, orally once daily for 12 weeks in Part A received 4 mg baricitinib (LY3009104) and 1 placebo tablet orally once daily for 52 weeks in Part B.
OG001
Combined 8 mg Baricitinib (LY3009104) (Part B)
Participants on background methotrexate therapy who were administered 1 mg, 2 mg, 8 mg baricitinib (LY3009104) capsule or placebo capsule, orally once daily for 12 weeks in Part A received 2 x 4 mg baricitinib (LY3009104) tablets orally once daily for 52 weeks in Part B.
Secondary
Percentage of Participants Who Achieved an ACR70 Response at 12 Weeks (Part A)
ACR70 responders were participants with at least 70% improvement from baseline for TJC, SJC, and at least 3 of the 5 remaining core set measures: HAQ-DI, CRP, PAAP-VAS, PtGADA-VAS, or PhGA-VAS. Missing values were imputed using NRI, where non-responders were participants who discontinued the study prior to the completion of Part A. Percentage of participants achieving ACR70 response=(number of ACR70 responders / number of participants treated) * 100.
All participants who received any study drug in Part A.
Posted
Number
percentage of participants
Baseline up to 12 weeks
ID
Title
Description
OG000
1 mg Baricitinib (LY3009104)
Participants on background methotrexate therapy administered 1 x 1-mg baricitinib (LY3009104) capsule + 1 identical placebo capsule, orally once daily for 12 weeks.
OG001
2 mg Baricitinib (LY3009104)
Participants on background methotrexate therapy administered 2 x 1-mg baricitinib (LY3009104) capsules orally once daily for 12 weeks.
OG002
4 mg Baricitinib (LY3009104)
Participants on background methotrexate therapy administered 1 x 4-mg baricitinib (LY3009104) capsule +1 identical placebo capsule, orally once daily for 12 weeks.
Secondary
Percentage of Participants Who Achieved an ACR70 Response at 64 Weeks (Part B)
ACR70 responders were participants with at least 70% improvement from baseline for TJC, SJC, and at least 3 of the 5 remaining core set measures: HAQ-DI, CRP, PAAP-VAS, PtGADA-VAS, or PhGA-VAS. Missing values were imputed using NRI, where non-responders were participants who discontinued the study prior to the completion of Part B. Percentage of participants achieving ACR70 response=(number of ACR70 responders) / (number of participants treated) * 100.
All participants who received any study drug in Part B.
Posted
Number
percentage of participants
Baseline up to 64 weeks
ID
Title
Description
OG000
Combined 4 mg Baricitinib (LY3009104)
Participants on background methotrexate therapy who were administered 1 mg, 2 mg, 4 mg baricitinib (LY3009104) capsule or identical placebo capsule, orally once daily for 12 weeks in Part A received 4 mg baricitinib (LY3009104) and 1 placebo tablet orally once daily for 52 weeks in Part B.
OG001
Combined 8 mg Baricitinib (LY3009104)
Participants on background methotrexate therapy who were administered 1 mg, 2 mg, 8 mg baricitinib (LY3009104) capsules orally once daily for 12 weeks in Part A received 2 x 4 mg baricitinib (LY3009104) tablets orally once daily for 52 weeks in Part B.
Secondary
Mean Change From Baseline to Week 12 in Disease Activity Score (DAS) Based on the 28 Diarthrodial Joint Count and CRP Level (DAS28-CRP)
DAS modified included the DAS28 that consisted of a composite score of the following variables: tender joint count out of 28 (TJC28), swollen joint count out of 28 (SJC28), CRP [milligrams per liter (mg/L)], and PtGADA on a 0 to 100 millimeter (mm) VAS (0mm=no arthritis activity to 100 mm= extremely active arthritis). DAS28 calculated as: DAS28-CRP = 0.56(square root of TJC28)+0.28(square root of SJC28)+0.36[ln(CRP +1)]+0.014(VAS)+0.96. A decrease in DAS28-CRP indicated an improvement in participant's condition.
All randomized participants who received any study drug in Part A and had DAS28-CRP evaluated at analysis time points. The last non-missing post-baseline value in Part A was used.
Posted
Mean
Standard Deviation
units on a scale
Baseline, 12 weeks
ID
Title
Description
OG000
1 mg Baricitinib (LY3009104)
Participants on background methotrexate therapy administered 1 x 1-mg baricitinib (LY3009104) capsule + 1 identical placebo capsule, orally once daily for 12 weeks.
OG001
2 mg Baricitinib (LY3009104)
Participants on background methotrexate therapy administered 2 x 1-mg baricitinib (LY3009104) capsules orally once daily for 12 weeks.
OG002
Secondary
Mean Change From Baseline to Week 64 in DAS Based on the 28 Diarthrodial Joint Count and CRP Level (DAS28-CRP)
DAS modified included the 28 diarthroidal joint count (DAS28) that consisted of a composite score of the following variables: TJC28, SJC28, CRP (mg/L), and PtGADA on a 0 to 100 mm VAS (0mm=no arthritis activity to 100 mm= extremely active arthritis). DAS28 calculated as: DAS28-CRP = 0.56(square root of TJC28)+0.28(square root of SJC28)+0.36[ln(CRP +1)]+0.014(VAS)+0.96. A decrease in DAS28-CRP indicated an improvement in participant's condition.
All randomized participants who received any study drug in Part B and had DAS28-CRP evaluated at analysis time points. The last non-missing post-baseline value in Part B was used.
Posted
Mean
Standard Deviation
units on a scale
Baseline, 64 weeks
ID
Title
Description
OG000
Combined 4 mg Baricitinib (LY3009104)
Participants on background methotrexate therapy who were administered 1 mg, 2 mg, 4 mg baricitinib (LY3009104) capsule or identical placebo capsule, orally once daily for 12 weeks in Part A received 4 mg baricitinib (LY3009104) and 1 placebo tablet orally once daily for 52 weeks in Part B.
OG001
Combined 8 mg Baricitinib (LY3009104)
Participants on background methotrexate therapy who were administered 1 mg, 2 mg, 8 mg baricitinib (LY3009104) capsules orally once daily for 12 weeks in Part A received 2 x 4 mg baricitinib (LY3009104) tablets orally once daily for 52 weeks in Part B.
Secondary
Percentage of Participants Who Achieved an European League Against Rheumatism Rating of 28-Joint Arthritic Condition (EULAR28) Response at 12 Weeks (Part A)
EULAR Responder Index based on 28 joint counts categorizes clinical response based on improvement from baseline in DAS28-CRP. DAS28-CRP scores range from 1.0-9.4, where lower scores indicated less disease activity. High disease activity: DAS28-CRP >5.1, low disease activity: DAS28-CRP ≤3.2, and remission: DAS28-CRP <2.6. Participants are categorized as EULAR responders or non-responders based on improvement of DAS28-CRP scores from baseline. EULAR DAS28-CRP responder index defines a good (absolute: ≤3.2 and >1.2 improvement from baseline), moderate (absolute: >3.2 and ≤5.1 and >0.6 and ≤1.2 improvement from baseline), or no response (absolute: >5.1 and ≤0.6 improvement from baseline). Percentage of participants calculated as = (number of good +moderate responders) / (number of participants treated) * 100.
All participants who received any amount of study drug in Part A.
Posted
Number
percentage of participants
Baseline up to 12 weeks
ID
Title
Description
OG000
1 mg Baricitinib (LY3009104)
Participants on background methotrexate therapy administered 1 x 1-mg baricitinib (LY3009104) capsule + 1 identical placebo capsule, orally once daily for 12 weeks.
OG001
2 mg Baricitinib (LY3009104)
Participants on background methotrexate therapy administered 2 x 1-mg baricitinib (LY3009104) capsules orally once daily for 12 weeks.
Secondary
Percentage of Participants Who Achieved an EULAR28 Response at 64 Weeks (Part B)
EULAR Responder Index based on 28 joint counts categorizes clinical response based on improvement from baseline in DAS28-CRP. DAS28-CRP scores range from 1.0-9.4, where lower scores indicated less disease activity. High disease activity: DAS28-CRP >5.1, low disease activity: DAS28-CRP <3.2, and remission: DAS28-CRP <2.6. Participants are categorized as EULAR responders or non-responders based on improvement of DAS28-CRP scores from baseline. EULAR DAS28-CRP Responder Index defines a good (absolute: ≤3.2 and >1.2 improvement from baseline), moderate (absolute: >3.2 and ≤5.1 and >0.6 and ≤1.2 improvement from baseline), or no response (absolute: >5.1 and ≤0.6 improvement from baseline). Percentage of participants calculated as = (number of good +moderate responders) / (number of participants treated) * 100.
All participants who received any amount of study drug in Part B.
Posted
Number
percentage of participants
Baseline up to 64 weeks
ID
Title
Description
OG000
Combined 4 mg Baricitinib (LY3009104)
Participants on background methotrexate therapy who were administered 1 mg, 2 mg, 4 mg baricitinib (LY3009104) capsule or identical placebo capsule, orally once daily for 12 weeks in Part A received 4 mg baricitinib (LY3009104) and 1 placebo tablet orally once daily for 52 weeks in Part B.
OG001
Combined 8 mg Baricitinib (LY3009104)
Participants on background methotrexate therapy who were administered 1 mg, 2 mg, 8 mg baricitinib (LY3009104) capsules orally once daily for 12 weeks in Part A received 2 x 4 mg baricitinib (LY3009104) tablets orally once daily for 52 weeks in Part B.
Secondary
Mean Change in Simplified Disease Activity Index (SDAI) Responses up to 12 Weeks (Part A)
The SDAI is the numerical sum of 5 outcome parameters: TJC28, SJC28, patient and physician global assessment of disease activity and CRP. The equation used to calculate the SDAI:SDAI=SJC28+TJC28+PtGADA-VAS+PhGA-VAS+CRP where PtGADA-VAS=PtGADA-VAS / 10 and PhGA-VAS=PhGA-VAS / 10, with lower values indicating fewer symptoms.
All participants who received any amount of study drug in Part A and had SDAI data at analysis time points. The last non-missing post-baseline value in Part A was used.
Posted
Mean
Standard Deviation
units on a scale
Baseline up to 12 weeks
ID
Title
Description
OG000
1 mg Baricitinib (LY3009104)
Participants on background methotrexate therapy administered 1 x 1-mg baricitinib (LY3009104) capsule + 1 identical placebo capsule, orally once daily for 12 weeks.
OG001
2 mg Baricitinib (LY3009104)
Participants on background methotrexate therapy administered 2 x 1-mg baricitinib (LY3009104) capsules orally once daily for 12 weeks.
OG002
4 mg Baricitinib (LY3009104)
Participants on background methotrexate therapy administered 1 x 4-mg baricitinib (LY3009104) capsule +1 identical placebo capsule, orally once daily for 12 weeks.
Secondary
Mean Change in SDAI Responses up to 64 Weeks (Part B)
The SDAI is the numerical sum of 5 outcome parameters: TJC28, SJC28, PtGADA, PhGA, and CRP. The equation used to calculate the SDAI:
SDAI=SJC28+TJC28+PtGADA-VAS+PhGA-VAS+CRP where PtGADA-VAS=PtGADA -VAS/ 10 and PhGA-VAS=PhGA-VAS/ 10, with lower values indicating fewer symptoms.
All participants who received any amount of study drug in Part B and had data for SDAI at analysis time points. The last non-missing post-baseline value in Part B was used.
Posted
Mean
Standard Deviation
units on a scale
Baseline, 64 weeks
ID
Title
Description
OG000
Combined 4 mg Baricitinib (LY3009104)
Participants on background methotrexate therapy who were administered 1 mg, 2 mg, 4 mg baricitinib (LY3009104) capsule or identical placebo capsule, orally once daily for 12 weeks in Part A received 4 mg baricitinib (LY3009104) and 1 placebo tablet orally once daily for 52 weeks in Part B.
OG001
Combined 8 mg Baricitinib (LY3009104)
Participants on background methotrexate therapy who were administered 1 mg, 2 mg, 8 mg baricitinib (LY3009104) capsules orally once daily for 12 weeks in Part A received 2 x 4 mg baricitinib (LY3009104) tablets orally once daily for 52 weeks in Part B.
Secondary
Mean Change in Health Assessment Questionnaire - Disability Index (HAQ-DI) Responses up to 12 Weeks (Part A)
HAQ-DI was a participant-reported questionnaire that consisted of 24 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the week using response categories: without any difficulty (0), with some difficulty (1), with much difficulty (2), and unable to do (3). The highest score for any question in a category was the score of that category unless special aids or devices or help from another person was required. Answers for at least 6 of the 8 domains were required. Otherwise, HAQ-DI score was considered missing. The HAQ-DI score was the sum of the category scores divided by the number of categories scored, with a possible scores range from 0 to 3, 0 being without any difficulty and 3 being unable to do.
All participants who received any amount of study drug in Part A and had HAQ-DI evaluated at analysis time points. The last non-missing post-baseline value in Part A was used.
Posted
Mean
Standard Deviation
units on a scale
Baseline, 12 weeks
ID
Title
Description
OG000
1 mg Baricitinib (LY3009104)
Participants on background methotrexate therapy administered 1 x 1-mg baricitinib (LY3009104) capsule + 1 identical placebo capsule, orally once daily for 12 weeks.
OG001
2 mg Baricitinib (LY3009104)
Secondary
Mean Change in HAQ-DI Responses up to 64 Weeks (Part B)
HAQ-DI was a participant-reported questionnaire that consisted of 24 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the week using response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). The highest score for any question in a category was the score of that category unless special aids or devices or help from another person was required. Answers for at least 6 of the 8 domains were required. Otherwise, HAQ-DI score was considered missing. The HAQ-DI score was the sum of the category scores divided by the number of categories scored, with a possible scores range from 0 to 3, 0 being without any difficulty and 3 being unable to do.
All participants who received any amount of study drug in Part B and had HAQ-DI evaluated at analysis time points. The last non-missing post-baseline value in Part B was used.
Posted
Mean
Standard Deviation
units on a scale
Baseline, 64 weeks
ID
Title
Description
OG000
Combined 4 mg Baricitinib (LY3009104)
Participants on background methotrexate therapy who were administered 1 mg, 2 mg, 4 mg baricitinib (LY3009104) capsule or identical placebo capsule, orally once daily for 12 weeks in Part A received 4 mg baricitinib (LY3009104) and 1 placebo tablet orally once daily for 52 weeks in Part B.
OG001
Combined 8 mg Baricitinib (LY3009104)
Secondary
Mean Value of ACR-N Response (Part A)
The ACR-N Response Index is a continuous measure of clinical, laboratory, and functional measures in RA to characterize the percentage of improvement from baseline in RA disease activity. This index is defined as the lowest of either: a) percent change in TJC, b) percent change in SJC, or c) median percent change of the remaining 5 ACR core criteria (HAQ-DI, CRP, PAAP-VAS, PtGADA-VAS, or PhGA-VAS). A participant with an ACR-N of "X" has improvement of at least "X%" in tender and swollen joints and a median improvement of at least "X%" in the 5 remaining ACR core criteria. Since ACR-N is a continuous measure, the mean values are reported instead of the originally registered percentage of participants.
All participants who received any study drug in Part A and had baseline and at least one post baseline ACR-N response measure. LOCF was used to impute missing post-baseline values.
Posted
Mean
Standard Deviation
percentage of responders
Baseline up to 12 weeks
ID
Title
Description
OG000
1 mg Baricitinib (LY3009104)
Participants on background methotrexate therapy administered 1 x 1-mg baricitinib (LY3009104) capsule + 1 identical placebo capsule, orally once daily for 12 weeks.
OG001
2 mg Baricitinib (LY3009104)
Participants on background methotrexate therapy administered 2 x 1-mg baricitinib (LY3009104) capsules orally once daily for 12 weeks.
Secondary
Mean Value of ACR-N Response (Part B)
The ACR-N Response Index is a continuous measure of clinical, laboratory, and functional measures in RA to characterize the percentage of improvement from baseline in RA disease activity. This index is defined as the lowest of either: a) percent change in TJC, b) percent change in SJC, or c) median percent change of the remaining 5 ACR core criteria (HAQ-DI, CRP, PAAP-VAS, PtGADA-VAS, or PhGA-VAS). A participant with an ACR-N of "X" has improvement of at least "X%" in tender and swollen joints and a median improvement of at least "X%" in the 5 remaining ACR core criteria. Since ACR-N is a continuous measure, the mean values are reported instead of the originally registered percentage of participants.
All participants who received any study drug in Part B and had baseline and at least one post baseline ACR-N response measure. LOCF was used to impute missing post-baseline values.
Posted
Mean
Standard Deviation
percentage of responders
Baseline up to 64 weeks
ID
Title
Description
OG000
Combined 4 mg Baricitinib (LY3009104)
Participants on background methotrexate therapy who were administered 1 mg, 2 mg, 4 mg baricitinib (LY3009104) capsule or identical placebo capsule, orally once daily for 12 weeks in Part A received 4 mg baricitinib (LY3009104) and 1 placebo tablet orally once daily for 52 weeks in Part B.
OG001
Combined 8 mg Baricitinib (LY3009104)
Participants on background methotrexate therapy who were administered 1 mg, 2 mg, 8 mg baricitinib (LY3009104) capsules orally once daily for 12 weeks in Part A received 2 x 4 mg baricitinib (LY3009104) tablets orally once daily for 52 weeks in Part B.
Secondary
Percentage of Participants Who Achieved a DAS28 Remission at 12 Weeks (Part A)
DAS modified included the DAS28 that consisted of a composite score of the following variables: TJC28, SJC28, CRP (mg/L), and PtGADA on a 0 to 100 mm VAS: 0 mm (no arthritis activity) to 100 mm (extremely active arthritis). DAS28 calculated as: DAS28-CRP = 0.56(square root of TJC28)+0.28(square root of SJC28)+0.36[ln(CRP +1)]+0.014(VAS)+0.96. For remission, DAS28 is <2.6. Percentage of participants = (number of participants with DAS28 remission) / (number of participants treated) * 100.
All participants who received any amount of study treatment in Part A.
Posted
Number
percentage of participants
Baseline up to 12 weeks
ID
Title
Description
OG000
1 mg Baricitinib (LY3009104)
Participants on background methotrexate therapy administered 1 x 1-mg baricitinib (LY3009104) capsule + 1 identical placebo capsule, orally once daily for 12 weeks.
OG001
2 mg Baricitinib (LY3009104)
Participants on background methotrexate therapy administered 2 x 1-mg baricitinib (LY3009104) capsules orally once daily for 12 weeks.
OG002
4 mg Baricitinib (LY3009104)
Participants on background methotrexate therapy administered 1 x 4-mg baricitinib (LY3009104) capsule +1 identical placebo capsule, orally once daily for 12 weeks.
Secondary
Percentage of Participants Who Achieved a DAS28 Remission at 64 Weeks (Part B)
DAS modified included the DAS28 that consisted of a composite score of the following variables: TJC28, SJC28, CRP (mg/L), and PtGADA-VAS on a 0 to 100 mm VAS: 0 mm (no arthritis activity) to 100 mm (extremely active arthritis). DAS28 calculated as: DAS28-CRP = 0.56(sqrt of TJC28)+0.28(sqrt of SJC28)+0.36[ln(CRP +1)]+0.014(VAS)+0.96. For remission, DAS28 is <2.6. Percentage of participants = (number of participants with DAS 28 remission) / (number of participants treated) * 100.
All participants who received any amount of study drug in Part B.
Posted
Number
percentage of participants
Baseline up to 64 weeks
ID
Title
Description
OG000
Combined 4 mg Baricitinib (LY3009104)
Participants on background methotrexate therapy who were administered 1 mg, 2 mg, 4 mg baricitinib (LY3009104) capsule or identical placebo capsule, orally once daily for 12 weeks in Part A received 4 mg baricitinib (LY3009104) and 1 placebo tablet orally once daily for 52 weeks in Part B.
OG001
Combined 8 mg Baricitinib (LY3009104)
Participants on background methotrexate therapy who were administered 1 mg, 2 mg, 8 mg baricitinib (LY3009104) capsules orally once daily for 12 weeks in Part A received 2 x 4 mg baricitinib (LY3009104) tablets orally once daily for 52 weeks in Part B.
Secondary
Percentage of Participants Who Achieved an SDAI Remission at 12 Weeks (Part A)
The SDAI is the numerical sum of 5 outcome parameters: TJC28, SJC28, PtGADA, PhGA and CRP. The equation used to calculate the SDAI:
SDAI=SJC28+TJC28+PtGADA-VAS+PhGA-VAS+CRP where PtGADA-VAS=PtGADA -VAS/ 10 and PhGA-VAS=PhGA-VAS / 10. Definition of remission is SDAI ≤ 3.3. Percentage of participants = (number of responders) / (number of participants treated) * 100
All participants who received any amount of study drug in Part A.
Posted
Number
percentage of participants
Baseline up to 12 weeks
ID
Title
Description
OG000
1 mg Baricitinib (LY3009104)
Participants on background methotrexate therapy administered 1 x 1-mg baricitinib (LY3009104) capsule + 1 identical placebo capsule, orally once daily for 12 weeks.
OG001
2 mg Baricitinib (LY3009104)
Participants on background methotrexate therapy administered 2 x 1-mg baricitinib (LY3009104) capsules orally once daily for 12 weeks.
OG002
4 mg Baricitinib (LY3009104)
Participants on background methotrexate therapy administered 1 x 4-mg baricitinib (LY3009104) capsule +1 identical placebo capsule, orally once daily for 12 weeks.
Secondary
Percentage of Participants Who Achieved an SDAI Remission at 64 Weeks (Part B)
The SDAI is the numerical sum of 5 outcome parameters: TJC28, SJC28, PtGADA, PhGA, and CRP. The equation used to calculate the SDAI:
SDAI=SJC28+TJC28+PtGADA-VAS+PhGA-VAS+CRP where PtGADA-VAS=PtGADA-VAS / 10 and PhGA-VAS=PhGA-VAS / 10. Definition of remission is SDAI ≤ 3.3. Percentage of participants = (number of responders) / (number of participants treated) * 100
All participants who received any amount of study drug in Part B.
Posted
Number
percentage of participants
Baseline up to 64 weeks
ID
Title
Description
OG000
Combined 4 mg Baricitinib (LY3009104)
Participants on background methotrexate therapy who were administered 1 mg, 2 mg, 4 mg baricitinib (LY3009104) capsule or identical placebo capsule, orally once daily for 12 weeks in Part A received 4 mg baricitinib (LY3009104) and 1 placebo tablet orally once daily for 52 weeks in Part B.
OG001
Combined 8 mg Baricitinib (LY3009104)
Participants on background methotrexate therapy who were administered 1 mg, 2 mg, 8 mg baricitinib (LY3009104) capsules orally once daily for 12 weeks in Part A received 2 x 4 mg baricitinib (LY3009104) tablets orally once daily for 52 weeks in Part B.
Secondary
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve at a Dosing Interval at Steady State (AUCtau,ss) of LY3009104
Steady state is achieved when the rate of drug input is equal to the rate of drug elimination. The AUC(tau,ss) at 1 dosing interval is the average concentration of the drug at steady state multiplied by the time of the dosing interval.
All participants who received any study drug and had evaluable data for AUC(tau,ss).
Posted
Geometric Mean
Geometric Coefficient of Variation
nanomoles*hour (nM*h)
Weeks (Wks) 0, 8, 12, or 20: Predose, 15 to 30 minutes and 1 to 3 hours postdose; Wks 2 or 4 and 15 or 16: Predose; Wks 28, 40, 52, or 64: random single sample.
ID
Title
Description
OG000
1 mg Baricitinib (LY3009104)
Participants on background methotrexate therapy administered 1 x 1-mg baricitinib (LY3009104) capsule + 1 identical placebo capsule, orally once daily for 12 weeks.
OG001
2 mg Baricitinib (LY3009104)
Participants on background methotrexate therapy administered 2 x 1-mg baricitinib (LY3009104) capsules orally once daily for 12 weeks.
OG002
4 mg Baricitinib (LY3009104)
Participants on background methotrexate therapy administered 1 x 4-mg baricitinib (LY3009104) capsule +1 identical placebo capsule, orally once daily for 12 weeks.
Secondary
PK: Maximum Concentration at Steady State of Dosing (Cmax,ss) of LY3009104
All participants who received any study drug and had evaluable Cmax data.
Posted
Geometric Mean
Geometric Coefficient of Variation
nM
Wks 0, 8, 12, or 20: Predose, 15 to 30 minutes and 1 to 3 hours postdose; Wks 2 or 4 and 15 or 16: Predose; Wks 28, 40, 52, or 64: random single sample.
ID
Title
Description
OG000
1 mg Baricitinib (LY3009104)
Participants on background methotrexate therapy administered 1 x 1-mg baricitinib (LY3009104) capsule + 1 identical placebo capsule, orally once daily for 12 weeks.
OG001
2 mg Baricitinib (LY3009104)
Participants on background methotrexate therapy administered 2 x 1-mg baricitinib (LY3009104) capsules orally once daily for 12 weeks.
OG002
4 mg Baricitinib (LY3009104)
Participants on background methotrexate therapy administered 1 x 4-mg baricitinib (LY3009104) capsule +1 identical placebo capsule, orally once daily for 12 weeks.
OG003
8 mg Baricitinib (LY3009104)
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
Participants on background methotrexate therapy administered 2 placebo capsules, orally once daily for 12 weeks.
1
49
26
49
EG001
1 mg Baricitinib (LY3009104)
Participants on background methotrexate therapy administered 1 x 1-mg baricitinib (LY3009104) capsule + 1 identical placebo capsule, orally once daily for 12 weeks.
0
24
11
24
EG002
2 mg Baricitinib (LY3009104)
Participants on background methotrexate therapy administered 2 x 1-mg baricitinib (LY3009104) capsules orally once daily for 12 weeks.
1
24
12
24
EG003
4 mg Baricitinib (LY3009104)
Participants on background methotrexate therapy administered 1 x 4-mg baricitinib (LY3009104) capsule +1 identical placebo capsule, orally once daily for 12 weeks.
0
24
13
24
EG004
8 mg Baricitinib (LY3009104)
Participants on background methotrexate therapy administered 2 x 4-mg baricitinib (LY3009104) capsules orally once daily for 12 weeks.
1
24
17
24
EG005
Placebo / 4 mg Baricitinib (LY3009104)
Participants on background methotrexate therapy who were administered placebo capsule, orally once daily for 12 weeks in Part A received 4 mg baricitinib (LY3009104) and 1 placebo tablet orally once daily for 52 weeks in Part B.
Participants on background methotrexate therapy who were administered 1 mg baricitinib (LY3009104) capsule, orally once daily for 12 weeks in Part A received 4 mg baricitinib (LY3009104) and 1 placebo tablet orally once daily for 52 weeks in Part B.
Participants on background methotrexate therapy who were administered 2 mg baricitinib (LY3009104) capsule, orally once daily for 12 weeks in Part A received 4 mg baricitinib (LY3009104) and 1 placebo tablet orally once daily for 52 weeks in Part B.
Participants on background methotrexate therapy who were administered 4 mg baricitinib (LY3009104) capsule, orally once daily for 12 weeks in Part A received 4 mg baricitinib (LY3009104) and 1 placebo tablet orally once daily for 52 weeks in Part B.
3
23
22
23
EG009
Placebo /8 mg Baricitinib (LY3009104)
Participants on background methotrexate therapy who were administered placebo capsule, orally once daily for 12 weeks in Part A received 2 x 4 mg baricitinib (LY3009104) tablets orally once daily for 52 weeks in Part B.
Participants on background methotrexate therapy who were administered 1 mg baricitinib (LY3009104) capsule, orally once daily for 12 weeks in Part A received 2 x 4 mg baricitinib (LY3009104) tablets orally once daily for 52 weeks in Part B.
Participants on background methotrexate therapy who were administered 2 mg baricitinib (LY3009104) capsule, orally once daily for 12 weeks in Part A received 2 x 4 mg baricitinib (LY3009104) tablets orally once daily for 52 weeks in Part B.
Participants on background methotrexate therapy who were administered 8 mg baricitinib (LY3009104) capsule, orally once daily for 12 weeks in Part A received 2 x 4 mg baricitinib (LY3009104) tablets orally once daily for 52 weeks in Part B.
6
24
23
24
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Angina pectoris
Cardiac disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG0030 events0 affected24 at risk
EG0040 events0 affected24 at risk
EG0050 events0 affected24 at risk
EG0060 events0 affected12 at risk
EG0070 events0 affected12 at risk
EG0080 events0 affected23 at risk
EG0090 events0 affected23 at risk
EG0100 events0 affected11 at risk
EG0110 events0 affected12 at risk
EG0121 events1 affected24 at risk
Myocardial infarction
Cardiac disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Meniere's disease
Ear and labyrinth disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Cataract
Eye disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Large intestine polyp
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Pancreatitis acute
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0021 events1 affected24 at risk
EG003
Cholecystitis
Hepatobiliary disorders
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Pneumocystis jirovecii pneumonia
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Clavicle fracture
Injury, poisoning and procedural complications
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Forearm fracture
Injury, poisoning and procedural complications
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Ulna fracture
Injury, poisoning and procedural complications
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Rectal cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Cerebral haemorrhage
Nervous system disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Viith nerve paralysis
Nervous system disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Interstitial lung disease
Respiratory, thoracic and mediastinal disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 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
EG0000 events0 affected49 at risk
EG0011 events1 affected24 at risk
EG0020 events0 affected24 at risk
EG0031 events1 affected24 at risk
EG0041 events1 affected24 at risk
EG0050 events0 affected24 at risk
EG0060 events0 affected12 at risk
EG0071 events1 affected12 at risk
EG0082 events1 affected23 at risk
EG0091 events1 affected23 at risk
EG0100 events0 affected11 at risk
EG0110 events0 affected12 at risk
EG0121 events1 affected24 at risk
Haemorrhagic anaemia
Blood and lymphatic system disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Iron deficiency anaemia
Blood and lymphatic system disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Lymphopenia
Blood and lymphatic system disorders
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected49 at risk
EG0010 events0 affected24 at risk
EG0021 events1 affected24 at risk
EG003
Pancytopenia
Blood and lymphatic system disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Arrhythmia
Cardiac disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Bradycardia
Cardiac disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Sinus tachycardia
Cardiac disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Ventricular extrasystoles
Cardiac disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Birth mark
Congenital, familial and genetic disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Deafness neurosensory
Ear and labyrinth disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Tinnitus
Ear and labyrinth disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Thyroid mass
Endocrine disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Thyroiditis
Endocrine disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Thyroiditis chronic
Endocrine disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0021 events1 affected24 at risk
EG003
Cataract
Eye disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Conjunctivitis
Eye disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Dry eye
Eye disorders
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Aphthous stomatitis
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Cheilitis
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Dental caries
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0011 events1 affected24 at risk
EG0021 events1 affected24 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Duodenal ulcer
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Food poisoning
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Gastric polyps
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Gastric ulcer
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0011 events1 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Gastritis atrophic
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Gastritis erosive
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Hyperchlorhydria
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Mouth ulceration
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Pancreatitis chronic
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Periodontal disease
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0021 events1 affected24 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Chest discomfort
General disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Chest pain
General disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Fatigue
General disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Malaise
General disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Mass
General disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Oedema
General disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Oedema peripheral
General disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Pyrexia
General disorders
MedDRA 16.1
Systematic Assessment
EG0002 events2 affected49 at risk
EG0011 events1 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Gallbladder polyp
Hepatobiliary disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Hepatic cyst
Hepatobiliary disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Hepatic function abnormal
Hepatobiliary disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0023 events3 affected24 at risk
EG003
Hepatic steatosis
Hepatobiliary disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0011 events1 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Liver injury
Hepatobiliary disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Allergy to arthropod sting
Immune system disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Seasonal allergy
Immune system disorders
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Acute tonsillitis
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Appendicitis
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Bacteriuria
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Chronic sinusitis
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0011 events1 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Cystitis
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0002 events2 affected49 at risk
EG0010 events0 affected24 at risk
EG0021 events1 affected24 at risk
EG003
Diverticulitis
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Eczema impetiginous
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Empyema
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Enteritis infectious
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0011 events1 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Enterocolitis bacterial
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Folliculitis
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Fungal paronychia
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Fungal skin infection
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Furuncle
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Gastroenteritis norovirus
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Gastroenteritis viral
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Genital herpes
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Gingivitis
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Helicobacter infection
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Herpes simplex
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0011 events1 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Herpes virus infection
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Influenza
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected49 at risk
EG0011 events1 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Molluscum contagiosum
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0007 events6 affected49 at risk
EG0012 events2 affected24 at risk
EG0022 events2 affected24 at risk
EG003
Oesophageal candidiasis
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Oral herpes
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Paronychia
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Periodontitis
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Pertussis
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected49 at risk
EG0011 events1 affected24 at risk
EG0021 events1 affected24 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Pulpitis dental
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Rhinitis
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Skin candida
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Skin infection
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Tinea pedis
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Tinea versicolour
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Tonsillitis
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected49 at risk
EG0012 events1 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Viral infection
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Viral rash
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Vulval abscess
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Arthropod bite
Injury, poisoning and procedural complications
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Arthropod sting
Injury, poisoning and procedural complications
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Chillblains
Injury, poisoning and procedural complications
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Foot fracture
Injury, poisoning and procedural complications
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Humerus fracture
Injury, poisoning and procedural complications
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Laceration
Injury, poisoning and procedural complications
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Ligament sprain
Injury, poisoning and procedural complications
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Lip injury
Injury, poisoning and procedural complications
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Rib fracture
Injury, poisoning and procedural complications
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Sternal fracture
Injury, poisoning and procedural complications
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Thermal burn
Injury, poisoning and procedural complications
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Tooth fracture
Injury, poisoning and procedural complications
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Blood cholesterol increased
Investigations
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRA 16.1
Systematic Assessment
EG0002 events2 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Catheterisation cardiac
Investigations
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Cell marker increased
Investigations
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Colonoscopy
Investigations
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Electrocardiogram st-t segment abnormal
Investigations
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Endoscopy
Investigations
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Eosinophil count increased
Investigations
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Glomerular filtration rate decreased
Investigations
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Hepatic enzyme abnormal
Investigations
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Lipids abnormal
Investigations
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Liver function test abnormal
Investigations
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0011 events1 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Low density lipoprotein increased
Investigations
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Lymphocyte count decreased
Investigations
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Oesophagogastroduodenoscopy
Investigations
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Transaminases increased
Investigations
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Weight decreased
Investigations
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Weight increased
Investigations
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Dyslipidaemia
Metabolism and nutrition disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0021 events1 affected24 at risk
EG003
Hypercholesterolaemia
Metabolism and nutrition disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Hyperlipidaemia
Metabolism and nutrition disorders
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected49 at risk
EG0011 events1 affected24 at risk
EG0021 events1 affected24 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0021 events1 affected24 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Intervertebral disc degeneration
Musculoskeletal and connective tissue disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Intervertebral disc protrusion
Musculoskeletal and connective tissue disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Lumbar spinal stenosis
Musculoskeletal and connective tissue disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Osteoporosis
Musculoskeletal and connective tissue disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Spinal column stenosis
Musculoskeletal and connective tissue disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Spinal osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Pyogenic granuloma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Skin papilloma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Uterine leiomyoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Cubital tunnel syndrome
Nervous system disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0021 events1 affected24 at risk
EG003
Dizziness postural
Nervous system disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Headache
Nervous system disorders
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Hyposmia
Nervous system disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Intercostal neuralgia
Nervous system disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Migraine
Nervous system disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Sciatica
Nervous system disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Syncope
Nervous system disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Visual field defect
Nervous system disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Anxiety disorder
Psychiatric disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Dysphoria
Psychiatric disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0021 events1 affected24 at risk
EG003
Head banging
Psychiatric disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Hypertonic bladder
Renal and urinary disorders
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Leukocyturia
Renal and urinary disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Pollakiuria
Renal and urinary disorders
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Renal cyst
Renal and urinary disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Renal impairment
Renal and urinary disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Dysmenorrhoea
Reproductive system and breast disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected21 at risk
EG003
Menstrual disorder
Reproductive system and breast disorders
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected39 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected21 at risk
EG003
Ovarian cyst
Reproductive system and breast disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected21 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Hyperventilation
Respiratory, thoracic and mediastinal disorders
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Interstitial lung disease
Respiratory, thoracic and mediastinal disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0021 events1 affected24 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0011 events1 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Upper respiratory tract inflammation
Respiratory, thoracic and mediastinal disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Acne
Skin and subcutaneous tissue disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Acne cystic
Skin and subcutaneous tissue disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Angioedema
Skin and subcutaneous tissue disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Dermal cyst
Skin and subcutaneous tissue disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0021 events1 affected24 at risk
EG003
Dermatitis contact
Skin and subcutaneous tissue disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Drug eruption
Skin and subcutaneous tissue disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected49 at risk
EG0011 events1 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Eczema asteatotic
Skin and subcutaneous tissue disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Haemorrhage subcutaneous
Skin and subcutaneous tissue disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Hyperkeratosis
Skin and subcutaneous tissue disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Miliaria
Skin and subcutaneous tissue disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Photosensitivity reaction
Skin and subcutaneous tissue disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0011 events1 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Toxic skin eruption
Skin and subcutaneous tissue disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Xanthoma
Skin and subcutaneous tissue disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0021 events1 affected24 at risk
EG003
Cholecystectomy
Surgical and medical procedures
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Coronary angioplasty
Surgical and medical procedures
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Drug delivery device implantation
Surgical and medical procedures
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
External fixation of fracture
Surgical and medical procedures
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Gastrointestinal endoscopic therapy
Surgical and medical procedures
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Internal fixation of fracture
Surgical and medical procedures
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Intraocular lens implant
Surgical and medical procedures
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Medical device removal
Surgical and medical procedures
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Open reduction of fracture
Surgical and medical procedures
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Removal of foreign body
Surgical and medical procedures
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Tooth extraction
Surgical and medical procedures
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Wound treatment
Surgical and medical procedures
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Hypertension
Vascular disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0021 events1 affected24 at risk
EG003
Phlebitis
Vascular disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0023 events1 affected24 at risk
EG003
Varicose vein
Vascular disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 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
D001172
Arthritis, Rheumatoid
Ancestor Terms
ID
Term
D001168
Arthritis
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
D000073893
Sugars
C000596027
baricitinib
D008727
Methotrexate
Ancestor Terms
ID
Term
D002241
Carbohydrates
D000630
Aminopterin
D011622
Pterins
D011621
Pteridines
D006574
Heterocyclic Compounds, 2-Ring
D000072471
Heterocyclic Compounds, Fused-Ring
D006571
Heterocyclic Compounds
Browse Leaves
Not provided
Browse Branches
Not provided
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG004
0 subjects
FG00512 subjects
FG00612 subjects
FG00723 subjects
FG00824 subjects
FG00911 subjects
FG01012 subjects
FG01124 subjects
FG01223 subjects1 participant discontinued prior to receiving study drug
0 subjects
FG00510 subjects
FG0067 subjects
FG00718 subjects
FG00820 subjects
FG0098 subjects
FG01010 subjects
FG01118 subjects
FG01218 subjects
0 subjects
FG0052 subjects
FG0065 subjects
FG0075 subjects
FG0084 subjects
FG0093 subjects
FG0102 subjects
FG0116 subjects
FG0126 subjects
0 subjects
FG0040 subjects
FG0052 subjects
FG0065 subjects
FG0075 subjects
FG0083 subjects
FG0093 subjects
FG0101 subjects
FG0116 subjects
FG0123 subjects
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0081 subjects
FG0090 subjects
FG0101 subjects
FG0110 subjects
FG0123 subjects
53.6
± 11.3
BG00451.1± 12.0
BG00553.6± 11.8
19
BG00317
BG00439
BG005118
Male
BG0002
BG0013
BG0025
BG0037
BG00410
BG00527
0
BG0030
BG0040
BG0050
Not Hispanic or Latino
BG00024
BG00124
BG00224
BG00324
BG00449
BG005145
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
0
BG0030
BG0040
BG0050
Asian
BG00024
BG00124
BG00224
BG00324
BG00449
BG005145
Native Hawaiian or Other Pacific Islander
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
Black or African American
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
White
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
More than one race
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
24
BG00324
BG00449
BG005145
Units
Counts
Participants
OG00071
OG00170
Title
Denominators
Categories
Title
Measurements
OG00066
OG00173
OG003
8 mg Baricitinib (LY3009104)
Participants on background methotrexate therapy administered 2 x 4-mg baricitinib (LY3009104) capsules orally once daily for 12 weeks.
OG004
Placebo
Participants on background methotrexate therapy administered 2 placebo capsules, orally once daily for 12 weeks.
Units
Counts
Participants
OG00024
OG00124
OG00224
OG00324
OG00449
Title
Denominators
Categories
Title
Measurements
OG00013
OG00129
OG00229
OG00321
OG0040
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
OG002
OG003
OG004
Cochran-Armitage trend test
0.009
2-Sided
Superiority or Other (legacy)
Units
Counts
Participants
OG00071
OG00170
Title
Denominators
Categories
Title
Measurements
OG00037
OG00134
4 mg Baricitinib (LY3009104)
Participants on background methotrexate therapy administered 1 x 4-mg baricitinib (LY3009104) capsule +1 identical placebo capsule, orally once daily for 12 weeks.
OG003
8 mg Baricitinib (LY3009104)
Participants on background methotrexate therapy administered 2 x 4-mg baricitinib (LY3009104) capsules orally once daily for 12 weeks.
OG004
Placebo
Participants on background methotrexate therapy administered 2 placebo capsules, orally once daily for 12 weeks.
Units
Counts
Participants
OG00024
OG00124
OG00224
OG00324
OG00449
Title
Denominators
Categories
Title
Measurements
OG000-1.52± 0.970
OG001-2.02± 1.072
OG002-2.09± 1.105
OG003-1.96± 0.947
OG004-0.60± 1.204
Units
Counts
Participants
OG00071
OG00170
Title
Denominators
Categories
Title
Measurements
OG000-2.44± 1.152
OG001-2.48± 1.109
OG002
4 mg Baricitinib (LY3009104)
Participants on background methotrexate therapy administered 1 x 4-mg baricitinib (LY3009104) capsule +1 identical placebo capsule, orally once daily for 12 weeks.
OG003
8 mg Baricitinib (LY3009104)
Participants on background methotrexate therapy administered 2 x 4-mg baricitinib (LY3009104) capsules orally once daily for 12 weeks.
OG004
Placebo
Participants on background methotrexate therapy administered 2 placebo capsules, orally once daily for 12 weeks.
Units
Counts
Participants
OG00024
OG00124
OG00224
OG00324
OG00449
Title
Denominators
Categories
Title
Measurements
OG00083
OG00188
OG00292
OG00392
OG00447
Units
Counts
Participants
OG00071
OG00170
Title
Denominators
Categories
Title
Measurements
OG00094
OG00194
OG003
8 mg Baricitinib (LY3009104)
Participants on background methotrexate therapy administered 2 x 4-mg baricitinib (LY3009104) capsules orally once daily for 12 weeks.
OG004
Placebo
Participants on background methotrexate therapy administered 2 placebo capsules, orally once daily for 12 weeks.
Units
Counts
Participants
OG00024
OG00124
OG00224
OG00324
OG00449
Title
Denominators
Categories
Title
Measurements
OG000-13.11± 8.918
OG001-16.85± 9.517
OG002-18.17± 9.202
OG003-18.02± 8.293
OG004-4.54± 13.113
Units
Counts
Participants
OG00071
OG00170
Title
Denominators
Categories
Title
Measurements
OG000-20.42± 9.671
OG001-21.33± 10.318
Participants on background methotrexate therapy administered 2 x 1-mg baricitinib (LY3009104) capsules orally once daily for 12 weeks.
OG002
4 mg Baricitinib (LY3009104)
Participants on background methotrexate therapy administered 1 x 4-mg baricitinib (LY3009104) capsule +1 identical placebo capsule, orally once daily for 12 weeks.
OG003
8 mg Baricitinib (LY3009104)
Participants on background methotrexate therapy administered 2 x 4-mg baricitinib (LY3009104) capsules orally once daily for 12 weeks.
OG004
Placebo
Participants on background methotrexate therapy administered 2 placebo capsules, orally once daily for 12 weeks.
Units
Counts
Participants
OG00024
OG00124
OG00224
OG00324
OG00449
Title
Denominators
Categories
Title
Measurements
OG000-0.302± 0.3336
OG001-0.396± 0.4759
OG002-0.469± 0.3463
OG003-0.422± 0.3646
OG004-0.077± 0.3552
Participants on background methotrexate therapy who were administered 1 mg, 2 mg, 8 mg baricitinib (LY3009104) capsules orally once daily for 12 weeks in Part A received 2 x 4 mg baricitinib (LY3009104) tablets orally once daily for 52 weeks in Part B.
Units
Counts
Participants
OG00071
OG00170
Title
Denominators
Categories
Title
Measurements
OG000-0.498± 0.4779
OG001-0.568± 0.6203
OG002
4 mg Baricitinib (LY3009104)
Participants on background methotrexate therapy administered 1 x 4-mg baricitinib (LY3009104) capsule +1 identical placebo capsule, orally once daily for 12 weeks.
OG003
8 mg Baricitinib (LY3009104)
Participants on background methotrexate therapy administered 2 x 4-mg baricitinib (LY3009104) 4 capsules orally once daily for 12 weeks.
OG004
Placebo
Participants on background methotrexate therapy administered 2 placebo capsules, orally once daily for 12 weeks.
Units
Counts
Participants
OG00023
OG00124
OG00223
OG00324
OG00448
Title
Denominators
Categories
Title
Measurements
OG00028.76± 38.65
OG00142.48± 39.52
OG00245.17± 33.75
OG00325.58± 130.02
OG004-9.98± 58.10
Units
Counts
Participants
OG00055
OG00154
Title
Denominators
Categories
Title
Measurements
OG00061.14± 30.70
OG00161.07± 33.22
OG003
8 mg Baricitinib (LY3009104)
Participants on background methotrexate therapy administered 2 x 4-mg baricitinib (LY3009104) capsules orally once daily for 12 weeks.
OG004
Placebo
Participants on background methotrexate therapy administered 2 placebo capsules, orally once daily for 12 weeks.
Units
Counts
Participants
OG00024
OG00124
OG00224
OG00324
OG00449
Title
Denominators
Categories
Title
Measurements
OG00033
OG00133
OG00242
OG00350
OG00422
Units
Counts
Participants
OG00071
OG00170
Title
Denominators
Categories
Title
Measurements
OG00066
OG00166
OG003
8 mg Baricitinib (LY3009104)
Participants on background methotrexate therapy administered 2 x 4-mg baricitinib (LY3009104) capsules orally once daily for 12 weeks.
OG004
Placebo
Participants on background methotrexate therapy administered 2 placebo capsules, orally once daily for 12 weeks.
Units
Counts
Participants
OG00024
OG00124
OG00224
OG00324
OG00449
Title
Denominators
Categories
Title
Measurements
OG0004
OG00129
OG00217
OG00317
OG0048
Units
Counts
Participants
OG00071
OG00170
Title
Denominators
Categories
Title
Measurements
OG00039
OG00139
OG003
8 mg Baricitinib (LY3009104)
Participants on background methotrexate therapy administered 2 x 4-mg baricitinib (LY3009104) capsules orally once daily for 12 weeks.
Units
Counts
Participants
OG00024
OG00124
OG00248
OG00347
Title
Denominators
Categories
Title
Measurements
OG000237± 28.8
OG001525± 21
OG0021020± 32.5
OG0031900± 24.1
Participants on background methotrexate therapy administered 2 x 4-mg baricitinib (LY3009104) capsules orally once daily for 12 weeks.