A Study of LY2157299 in Participants With Hepatocellular... | NCT01246986 | Trialant
NCT01246986
Sponsor
Eli Lilly and Company
Status
Completed
Last Update Posted
Jan 12, 2021Actual
Enrollment
204Actual
Phase
Phase 2
Conditions
Carcinoma, Hepatocellular
Interventions
LY2157299
Sorafenib
Ramucirumab
Countries
United States
Australia
France
Germany
Italy
New Zealand
Spain
Protocol Section
Identification Module
NCT ID
NCT01246986
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
13665
Secondary IDs
ID
Type
Description
Link
H9H-MC-JBAK
Other Identifier
Eli Lilly and Company
2010-022338-10
EudraCT Number
Brief Title
A Study of LY2157299 in Participants With Hepatocellular Carcinoma
Official Title
Phase 2 Study of LY2157299 in Patients With Hepatocellular Carcinoma
Acronym
Not provided
Organization
Eli Lilly and CompanyINDUSTRY
Status Module
Record Verification Date
Jan 2020
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
Mar 30, 2011Actual
Primary Completion Date
Jun 6, 2019Actual
Completion Date
Dec 24, 2019Actual
First Submitted Date
Nov 1, 2010
First Submission Date that Met QC Criteria
Nov 23, 2010
First Posted Date
Nov 24, 2010Estimated
Results Waived
Not provided
Results First Submitted Date
Jun 4, 2020
Results First Submitted that Met QC Criteria
Aug 5, 2020
Results First Posted Date
Aug 7, 2020Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Dec 21, 2020
Last Update Posted Date
Jan 12, 2021Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Eli Lilly and CompanyINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of this study is to estimate the median time to progression in participants with hepatocellular carcinoma (HCC) when treated with LY2157299 as monotherapy and in combination with sorafenib or ramucirumab.
Detailed Description
The study consists of four Parts: Part A where HCC participants with an increased alpha-fetoprotein (AFP) level will be treated with either 160 milligrams (mg) LY2157299 or 300 mg LY2157299. Part B where HCC participants with a normal AFP level will be treated with 300 mg LY2157299, Part C where treatment-naïve HCC participants will be treated with 160 mg LY2157299 + sorafenib or 300 mg LY2157299 + sorafenib, and Part D where HCC participants will be treated with either 160 mg or 300 mg LY2157299 + ramucirumab.
Participants who continue to receive benefit from treatment at the time that the study is considered completed, may enter the treatment extension period and continue to receive the study treatment. The end of the study is the date of last visit or last scheduled procedure for the last active subject in the study.
Conditions Module
Conditions
Carcinoma, Hepatocellular
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
204Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Part A Cohort 1-160 milligram (mg) LY2157299
Experimental
Per the protocol, following an interim analysis, the decision was taken to no longer randomize participants to the 160 mg LY2157299 arm. As of May 25,2012, all newly enrolled participants will receive 300 mg LY2157299.
80 mg LY2157299 given orally twice daily (BID) for 14 days followed by 14 days off (28-day cycle).
Participants will continue to receive until disease progression, unacceptable toxicity, or another withdrawal criterion is met.
Drug: LY2157299
Part A Cohort 2 - 300 mg LY2157299
Experimental
150 mg LY2157299 given orally BID for 14 days followed by 14 days off (28-day cycle).
Participants will continue to receive until disease progression, unacceptable toxicity, or another withdrawal criterion is met.
Drug: LY2157299
Drug: Sorafenib
Part B - 300 mg LY2157299
Experimental
150 mg LY2157299 given orally BID for 14 days followed by 14 days off (28-day cycle).
Participants will continue to receive until disease progression, unacceptable toxicity, or another withdrawal criterion is met.
Drug: LY2157299
Part C Cohort 1 - 160 mg LY2157299 + 800 mg Sorafenib
Experimental
80 mg LY2157299 given orally BID on Days 1 to 14 in combination with 400 mg Sorafenib BID on days 1 to 28 (28-day cycle).
Participants will continue to receive until disease progression, unacceptable toxicity, or another withdrawal criterion is met.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
LY2157299
Drug
Administered orally
Part A Cohort 1-160 milligram (mg) LY2157299
Part A Cohort 2 - 300 mg LY2157299
Part B - 300 mg LY2157299
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Change From Baseline in Relationship of Biomarker Alpha-fetoprotein (AFP) to Overall Survival (OS)
Biomarker response was defined as a > 20% decrease in the biomarker AFP from baseline during 8 weeks of treatment. Data presented is median overall survival of those participants who achieved the defined biomarker response. Participants enrolled in Part A had a baseline AFP level of >1.5 upper limit normal (ULN). Participants enrolled in Part B had baseline AFP level <1.5 ULN.
Baseline, discontinuation from any cause (Up to 83 months)
Change From Baseline in Relationship of Biomarker Transforming Growth Factor - Beta (TGF-β) to Overall Survival (OS)
Biomarker response was defined as a > 20% decrease in the biomarker TGF-B from baseline. Data presented is median overall survival of those participants who achieved biomarker response.
Baseline,discontinuation from any cause (Up to 83 months)
Time to Progression (TTP)
TTP is measured from the date of first dose to the first date of progression of disease based on the investigator review of tumor response using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). Progression is defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum on study (including the baseline sum if that is the smallest). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of 1 or more new lesions is also considered progression.
Randomization to date of first measured progressive disease (Up to 36 Weeks)
Secondary Outcomes
Measure
Description
Time Frame
Population Pharmacokinetics (PK) Mean Population Clearance of Galunisertib
Population mean (between-subject coefficient variance [CV %]) apparent clearance.
Have histological evidence of a diagnosis of HCC not amenable to curative surgery
Part A: Serum alpha fetoprotein greater than or equal to 1.5 Upper Limits of Normal, Part B: Serum alpha fetoprotein less than 1.5 Upper Limits of Normal. Not applicable for Part C or D
Child-Pugh Stage: A or B7 for Parts A & B, A for Part C, and D
Have the presence of measurable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST 1.1). A lesion that has been previously treated by local therapy will qualify as a measurable or evaluable lesion if there was demonstrable progression following locoregional therapy
Have given written informed consent prior to any study-specific procedures
Have adequate hematologic, hepatic and renal function
Have a performance status of equal to or less than 1 on the Eastern Cooperative Oncology Group (ECOG) scale
For Parts A & B: Have received sorafenib and have progressed or were intolerant to sorafenib or are ineligible for sorafenib treatment. For Part C: not received previous systemic treatment. For Part D: have received sorafenib and have progressed or were intolerant to sorafenib or are ineligible for sorafenib treatment or have not received prior systemic treatment.
For Parts A, B, and D: have discontinued sorafenib for at least 2 weeks
Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures
Males and females with reproductive potential must agree to use medically approved contraceptive precautions during the trial and for 3 months following the last dose of study drug
Females with childbearing potential must have had a negative serum pregnancy test less than or equal to 7 days prior to the first dose of study drug
Are able to swallow capsules or tablets
Exclusion Criteria:
Are currently enrolled in, or discontinued within the last 28 days from a clinical trial involving an investigational drug or device or not approved use of a drug or device (other than the study drug used in this study), or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
Known HCC with fibro-lamellar or mixed histology
Presence of clinically relevant ascites
History of liver transplant requiring increased immunosuppressive therapy. (Participants on maintenance immunosuppressive therapy after liver transplant are eligible for Part A & B)
Have received more than 1 line of systemic treatment in Parts A, B and D
Have moderate or severe cardiac disease:
Have the presence of cardiac disease, including a myocardial infarction within 6 months prior to study entry, unstable angina pectoris, New York Heart Association (NYHA) Class III/IV congestive heart failure, or uncontrolled hypertension
Have documented major electrocardiogram (ECG) abnormalities at the investigator's discretion
Have major abnormalities documented by echocardiography with Doppler
Have predisposing conditions that are consistent with development of aneurysms of the ascending aorta or aortic stress
Have serious preexisting medical conditions that, in the opinion of the investigator, that cannot be adequately controlled with appropriate therapy or would preclude participation in this study
Females who are pregnant or lactating
Have a history of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix) unless in complete remission and off all therapy for that disease for a minimum of 3 years. At the discretion of the investigator, hormone-refractory prostate cancer participants who are stable on GnRH agonist therapy and breast cancer participants who are stable on antiestrogen therapy may have that treatment continued
Have active infection that would interfere with the study objectives or influence study compliance
For Part C, have a known hypersensitivity to sorafenib or its excipients
For Part D, have a serious illness or medical condition(s), including but not limited to the following:
The participant has undergone major surgery within 28 days prior to randomization or has undergone central venous access device placement within 7 days prior to randomization
The participant has uncontrolled arterial hypertension ≥150 / ≥90 millimeters of mercury (mm Hg) despite standard medical management
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Giannelli G, Santoro A, Kelley RK, Gane E, Paradis V, Cleverly A, Smith C, Estrem ST, Man M, Wang S, Lahn MM, Raymond E, Benhadji KA, Faivre S. Biomarkers and overall survival in patients with advanced hepatocellular carcinoma treated with TGF-betaRI inhibitor galunisertib. PLoS One. 2020 Mar 25;15(3):e0222259. doi: 10.1371/journal.pone.0222259. eCollection 2020.
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 who had progressive disease or death are defined as completed. Per the protocol, following an interim analysis, the decision was taken to no longer randomize participants to the 160 mg LY2157299 arm.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Part A Cohort 1 - 160 mg LY2157299
80 mg LY2157299 given orally twice daily (BID) for 14 days followed by 14 days off (28-day cycle).
FG001
Part A Cohort 2 - 300 mg LY2157299
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Aug 18, 2016
May 26, 2020
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Switzerland
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Non-Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Drug: LY2157299
Drug: Sorafenib
Part C Cohort 2 - 300 mg LY2157299 + 800 mg Sorafenib
Experimental
150 mg LY2157299 given orally BID on Days 1 to 14 in combination with 400 mg Sorafenib BID on days 1 to 28 (28-day cycle).
Participants will continue to receive until disease progression, unacceptable toxicity, or another withdrawal criterion is met.
Drug: LY2157299
Drug: Sorafenib
Part D Cohort 1 - 160 mg LY2157299 + 8 mg/kg Ramucirumab
Experimental
80 mg LY2157299 given orally BID on days 1 to 14 in combination with ramucirumab 8 mg/kilogram (kg) intravenous (IV) on days 1 and 15 (28-day cycle).
Participants will continue to receive until disease progression, unacceptable toxicity, or another withdrawal criterion is met.
Drug: LY2157299
Drug: Ramucirumab
Part D Cohort 2 - 300 mg LY2157299 + 8 mg/kg Ramucirumab
Experimental
150 mg LY2157299 given orally BID on days 1 to 14 in combination with ramucirumab 8 mg/kg IV on days 1 and 15 (28-day cycle).
Participants will continue to receive until disease progression, unacceptable toxicity, or another withdrawal criterion is met.
Drug: LY2157299
Drug: Ramucirumab
Part C Cohort 1 - 160 mg LY2157299 + 800 mg Sorafenib
Part C Cohort 2 - 300 mg LY2157299 + 800 mg Sorafenib
Part D Cohort 1 - 160 mg LY2157299 + 8 mg/kg Ramucirumab
Part D Cohort 2 - 300 mg LY2157299 + 8 mg/kg Ramucirumab
Sorafenib
Drug
Administered orally
Part A Cohort 2 - 300 mg LY2157299
Part C Cohort 1 - 160 mg LY2157299 + 800 mg Sorafenib
Part C Cohort 2 - 300 mg LY2157299 + 800 mg Sorafenib
Ramucirumab
Drug
Administered IV
Part D Cohort 1 - 160 mg LY2157299 + 8 mg/kg Ramucirumab
Part D Cohort 2 - 300 mg LY2157299 + 8 mg/kg Ramucirumab
LY30098016
Recommended Dose for Phase 3 Hepatocellular Carcinoma (HCC) Trials
Cycle 1 (28 Days)
Overall Survival (OS)
OS duration is measured from the date of first dose to the date of death from any cause.
Randomization to date of death from any cause (Up to 83 months)
Progression Free Survival (PFS)
PFS duration is measure from the date of first dose to the first date of objective progression of disease or death from any cause. Progression is defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum on study (including the baseline sum if that is the smallest). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of 1 or more new lesions is also considered progression.
Randomization to measured progressive disease or death from any cause (Up to 45 Weeks)
Percentage of Participants Achieving an Objective Response (Response Rate)
The percentage of participants who achieved best overall response of either Complete Response (CR) or Partial Response (PR). The overall response rate for each dose with be estimated by dividing the number of confirmed responders by the number of participants who received at least one dose of study drug. Per RECIST v.1.0 criteria CR is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to < 10 millimeter (mm). Tumor-marker results must have normalized. PR is defined as at least 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters.
Randomization to measured progressive disease (Up to 36 Weeks)
Duration of Tumor Response (DoR)
DoR is measured from the date of the first objective status assessment of a Complete Response (CR) or Partial Response (PR), as determined by RECIST v1.1, to the first date of objective progression of disease or death from any cause. CR is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to < 10 millimeter (mm). Tumor-marker results must have normalized. PR is defined as at least 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters. Progression is defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum on study (including the baseline sum if that is the smallest). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of 1 or more new lesions is also considered progression.
Time of response to measured progressive disease or death from any cause (Up to 84 Weeks)
Time to Treatment Failure (TTF)
TTF is measured from the date of first dose until the date of discontinuation of study treatment due to adverse event, progression of disease, or death from any cause.
Randomization to the date of discontinuation of study treatment due to adverse event, progression of disease, or death from any cause (Up to 75 Weeks)
Change From Baseline in Functional Assessment of Cancer Therapy, Hepatobiliary (FACT-Hep) Sub-scores and Total Score
FACT-Hep consists of 45 items in five subscales (1) physical well-being (PWB) score rage 0 -28; (2) social well-being (SWB) score range 0-28; (3) emotional well-being (EWB) score range 0-24; (4) functional well-being (FWB) score range 0-28; and (5) the hepatobiliary cancer subscale (HCS) Score range 0-72; FACT-Hep score range 1-180, and Trial-Outcome Index (TOI) score range 1-128, to assess health related quality of life in participants with cancer. Higher scores reflect a better health state.
Baseline, Day 1 Cycle 4
Time to Worsening (TTW) of Symptoms (FACT-Hep)
Time to worsening of symptoms used minimally important differences to evaluate Physical Well Being (PWB), Functional Well Being (FWB), Hepatocellular Cancer Symptoms (HCS), National Comprehensive Cancer Network (NCCN)/FACT Hepatocellular Symptoms (FHS), Trial-Outcome Index (TOI). PWB time to worsening was defined as participants who had change in a subscale of ≥ 2 point decrease from baseline; FWB time to worsening was defined as participants who had change in a subscale of ≥ 2 point decrease from baseline; HCS time to worsening was defined as participants who had change in a subscale of ≥ 5 point decrease from baseline; FHS time to worsening was defined as participants who had change in a subscale of ≥ 2 point decrease from baseline; TOI time to Worsening was defined as participants who had change in the subscale of ≥ 7 point decrease from baseline.
Baseline to the worsening of symptoms (up to 567 days)
San Francisco
California
94158
United States
Georgetown University Medical Center
Washington D.C.
District of Columbia
20007
United States
MD Anderson Cancer Center Orlando
Orlando
Florida
32806
United States
Northwestern University
Chicago
Illinois
60611
United States
Indiana Univ Melvin & Bren Simon Cancer Center
Indianapolis
Indiana
46202
United States
Lahey Clinic Medical Center
Burlington
Massachusetts
01805
United States
Weill Cornell Medical College
New York
New York
10021
United States
Memorial Sloan Kettering Cancer Center
New York
New York
10065
United States
Thomas Jefferson University
Philadelphia
Pennsylvania
19107
United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Nedlands
Western Australia
6009
Australia
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.
Greenslopes
4120
Australia
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Heidelberg
3084
Australia
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St Leonards
2065
Australia
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Brest
29609
France
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Caen
14033
France
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Clichy
92110
France
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Créteil
94010
France
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Lille
59037
France
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Lyon
69317
France
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Marseille
13273
France
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Montpellier
34295
France
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Paris
75012
France
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Pessac
33604
France
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Saint-Etienne
42055
France
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Saint-Herblain
44805
France
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Strasbourg
67085
France
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Vandœuvre-lès-Nancy
54511
France
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Berlin
13353
Germany
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Cologne
50937
Germany
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Erlangen
91054
Germany
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Göttingen
37075
Germany
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Mainz
55131
Germany
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Münster
48149
Germany
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Bari
70124
Italy
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Rome
00168
Italy
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Rozzano
20089
Italy
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Auckland
1023
New Zealand
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Barcelona
08035
Spain
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Madrid
28007
Spain
Derived
Addepalli A, Kalyani S, Singh M, Bandyopadhyay D, Mohan KN. CalPen (Calculator of Penetrance), a web-based tool to estimate penetrance in complex genetic disorders. PLoS One. 2020 Jan 29;15(1):e0228156. doi: 10.1371/journal.pone.0228156. eCollection 2020.
Faivre S, Santoro A, Kelley RK, Gane E, Costentin CE, Gueorguieva I, Smith C, Cleverly A, Lahn MM, Raymond E, Benhadji KA, Giannelli G. Novel transforming growth factor beta receptor I kinase inhibitor galunisertib (LY2157299) in advanced hepatocellular carcinoma. Liver Int. 2019 Aug;39(8):1468-1477. doi: 10.1111/liv.14113. Epub 2019 Jun 3.
Li S, Yang F, Ren X. Immunotherapy for hepatocellular carcinoma. Drug Discov Ther. 2015 Oct;9(5):363-71. doi: 10.5582/ddt.2015.01054.
150 mg LY2157299 given orally BID for 14 days followed by 14 days off (28-day cycle).
FG002
Part B - 300 mg LY2157299
150 mg LY2157299 given orally BID for 14 days followed by 14 days off (28-day cycle).
FG003
Part C Cohort 1 - 160 mg LY2157299 + Sorafenib
80 mg LY2157299 given orally BID on Days 1 to 14 in combination with 400 mg Sorafenib BID on days 1 to 28 (28-day cycle).
FG004
Part C Cohort 2 - 300 mg LY2157299 + Sorafenib
150 mg LY2157299 given orally BID on Days 1 to 14 in combination with 400 mg Sorafenib BID on days 1 to 28 (28-day cycle).
FG005
Part D Cohort 1 - 160 mg LY2157299 + Ramucirumab
80 mg LY2157299 given orally BID on days 1 to 14 in combination with ramucirumab 8 mg/kilogram (kg) intravenous (IV) on days 1 and 15 (28-day cycle).
FG006
Part D Cohort 2 - 300 mg LY2157299 + Ramucirumab
150 mg LY2157299 given twice orally BID on days 1 to 14 in combination with ramucirumab 8 mg/kg IV on days 1 and 15 (28-day cycle).
FG00037 subjects
FG00172 subjects
FG00240 subjects
FG0033 subjects
FG00444 subjects
FG0053 subjects
FG0065 subjects
Received at Least 1 Dose of Study Drug
FG00037 subjects
FG00172 subjects
FG00240 subjects
FG0033 subjects
FG00444 subjects
FG0053 subjects
FG0065 subjects
COMPLETED
FG00034 subjects
FG00167 subjects
FG00234 subjects
FG0033 subjects
FG00440 subjects
FG0052 subjects
FG0065 subjects
NOT COMPLETED
FG0003 subjects
FG0015 subjects
FG0026 subjects
FG0030 subjects
FG0044 subjects
FG0051 subjects
FG0060 subjects
Type
Comment
Reasons
Lost to Follow-up
FG0000 subjects
FG0011 subjects
FG0023 subjects
FG0030 subjects
FG0040 subjects
FG0051 subjects
FG0060 subjects
Withdrawal by Subject
FG0003 subjects
FG0014 subjects
FG0023 subjects
FG0030 subjects
FG004
All enrolled participants.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Part A Cohort 1 - 160 mg LY2157299
80 mg LY2157299 given orally BID for 14 days followed by 14 days off (28-day cycle)..
BG001
Part A Cohort 2 - 300 mg LY2157299
150mg LY2157299 given orally BID for 14 days followed by 14 days off (28-day cycle).
BG002
Part B - 300 mg LY2157299
150 mg LY2157299 given orally BID for 14 days followed by 14 days off (28-day cycle).
BG003
Part C Cohort 1 - 160 mg LY2157299 + Sorafenib
80 mg LY2157299 given orally BID on Days 1 to 14 in combination with 400 mg Sorafenib BID on days 1 to 28 (28-day cycle).
BG004
Part C Cohort 2 - 300 mg LY2157299 + Sorafenib
150 mg LY2157299 given orally BID on Days 1 to 14 in combination with 400 mg Sorafenib BID on days 1 to 28 (28-day cycle).
BG005
Part D Cohort 1 - 160 mg LY2157299 + Ramucirumab
80 mg LY2157299 given orally BID on days 1 to 14 in combination with ramucirumab 8 mg/kilogram (kg) intravenous (IV) on days 1 and 15 (28-day cycle).
BG006
Part D Cohort 2 - 300 mg LY2157299 + Ramucirumab
150 mg LY2157299 given twice BID on days 1 to 14 in combination with ramucirumab 8 mg/kg IV on days 1 and 15 (28-day cycle).
BG007
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00037
BG00172
BG00240
BG0033
BG00444
BG0053
BG0065
BG007204
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
BG00063.4± 10.8
BG00163.3± 10.8
BG00268.1± 9.6
BG003
Sex: Female, Male
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Female
BG0005
BG00113
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
New Zealand
Title
Measurements
BG0002
BG0015
BG002
Alpha-Fetoprotein
Count of Participants
Participants
No
Title
Denominators
Categories
< 200 nanograms per Liter (µg/L)
Title
Measurements
BG0009
BG00123
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Change From Baseline in Relationship of Biomarker Alpha-fetoprotein (AFP) to Overall Survival (OS)
Biomarker response was defined as a > 20% decrease in the biomarker AFP from baseline during 8 weeks of treatment. Data presented is median overall survival of those participants who achieved the defined biomarker response. Participants enrolled in Part A had a baseline AFP level of >1.5 upper limit normal (ULN). Participants enrolled in Part B had baseline AFP level <1.5 ULN.
All participants who received at least one dose of study drug, achieved a >20% reduction in biomarker AFP, and had evaluable post-baseline biomarker data. Due to low enrollment into Part C Cohort - 160 mg reporting group, Kaplan Meier analysis for OS was not conducted in this subgroup. Per protocol, Part D collected safety data only.
Posted
Median
95% Confidence Interval
Months
Baseline, discontinuation from any cause (Up to 83 months)
ID
Title
Description
OG000
Part A Cohort 1 - 160 mg LY2157299
80 mg LY2157299 given orally BID for 14 days followed by 14 days off (28-day cycle) for Cohort 1.
OG001
Part A Cohort 2 - 300 mg LY2157299
150 mg LY2157299 given orally BID for 14 days followed by 14 days off (28-day cycle).
OG002
Part B LY2157299
150 mg LY2157299 given orally BID for 14 days followed by 14 days off (28-day cycle).
OG003
Part C LY2157299
150 mg LY2157299 given orally BID for 14 days followed by 14 days off (28-day cycle).
Units
Counts
Participants
OG0008
OG00114
OG00210
OG003
Title
Denominators
Categories
Title
Measurements
OG00019.0(1.5 to 25.1)
OG00121.5(2.9 to 34.2)
OG00224.2(3.0 to NA)Part B 95% Confidence Interval (CI) upper limit non-estimable
Primary
Change From Baseline in Relationship of Biomarker Transforming Growth Factor - Beta (TGF-β) to Overall Survival (OS)
Biomarker response was defined as a > 20% decrease in the biomarker TGF-B from baseline. Data presented is median overall survival of those participants who achieved biomarker response.
All participants who received at least one dose of study drug, achieved a >20% reduction in biomarker TGF-β and had evaluable post-baseline biomarker data. Due to low enrollment in Part C Cohort 1 - 160 mg reporting group, Kaplan Meier analysis for OS was not conducted in this subgroup. Per protocol, Part D collected safety data only.
Posted
Median
95% Confidence Interval
Months
Baseline,discontinuation from any cause (Up to 83 months)
ID
Title
Description
OG000
Part A Cohort 1 - 160 mg LY2157299
80 mg LY2157299 given orally BID for 14 days followed by 14 days off (28-day cycle) for Cohort 1.
OG001
Part A Cohort 2 - 300 mg LY2157299
150 mg LY2157299 given orally BID for 14 days followed by 14 days off (28-day cycle) for Cohort 2.
OG002
Part B LY2157299
150 mg LY2157299 given orally BID for 14 days followed by 14 days off (28-day cycle).
Primary
Time to Progression (TTP)
TTP is measured from the date of first dose to the first date of progression of disease based on the investigator review of tumor response using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). Progression is defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum on study (including the baseline sum if that is the smallest). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of 1 or more new lesions is also considered progression.
All participants who receive at least one dose of study drug. Per protocol, Part D collected safety data only.
Posted
Median
90% Confidence Interval
Weeks
Randomization to date of first measured progressive disease (Up to 36 Weeks)
ID
Title
Description
OG000
Part A Cohort 1 - 160 mg LY2157299
80 mg LY2157299 given orally BID for 14 days followed by 14 days off (28-day cycle).
OG001
Part A Cohort 2 - 300 mg LY2157299
150 mg LY2157299 given orally BID for 14 days followed by 14 days off (28-day cycle).
OG002
Part B - 300 mg LY2157299
150 mg LY2157299 given orally BID for 14 days followed by 14 days off (28-day cycle).
Secondary
Population Pharmacokinetics (PK) Mean Population Clearance of Galunisertib
Population mean (between-subject coefficient variance [CV %]) apparent clearance.
All participants who received at least one dose of study drug, regardless of dose, with evaluable PK data. Per protocol, Part D collected safety data only.
LY2157299 given orally BID for 14 days followed by 14 days off (28-day cycle).
Units
Counts
Participants
OG000
Secondary
Recommended Dose for Phase 3 Hepatocellular Carcinoma (HCC) Trials
All participants in Part A and Part B.
Posted
Number
milligrams (mg)
Cycle 1 (28 Days)
ID
Title
Description
OG000
LY2157299
LY2157299 given orally BID for 14 days followed by 14 days off (28-day cycle).
Units
Counts
Participants
OG00074
Title
Denominators
Categories
Secondary
Overall Survival (OS)
OS duration is measured from the date of first dose to the date of death from any cause.
All participants who received at least one dose of study drug. Per protocol, Part D collected safety data only.
Posted
Median
90% Confidence Interval
Weeks
Randomization to date of death from any cause (Up to 83 months)
ID
Title
Description
OG000
Part A Cohort 1 - 160 mg LY2157299
80 mg LY2157299 given orally BID for 14 days followed by 14 days off (28-day cycle).
OG001
Part A Cohort 2 - 300 mg LY2157299
150 mg LY2157299 given orally BID for 14 days followed by 14 days off (28-day cycle).
OG002
Part B - 300 mg LY2157299
150 mg LY2157299 given orally BID for 14 days followed by 14 days off (28-day cycle).
OG003
Part C Cohort 1 - 160 mg LY2157299 + Sorafenib
80 mg LY2157299 given orally BID on Days 1 to 14 in combination with 400 mg Sorafenib BID on days 1 to 28 (28-day cycle).
Secondary
Progression Free Survival (PFS)
PFS duration is measure from the date of first dose to the first date of objective progression of disease or death from any cause. Progression is defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum on study (including the baseline sum if that is the smallest). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of 1 or more new lesions is also considered progression.
All participants who received at least one dose of study drug. Per protocol, Part D collected safety data only.
Posted
Median
90% Confidence Interval
Weeks
Randomization to measured progressive disease or death from any cause (Up to 45 Weeks)
ID
Title
Description
OG000
Part A Cohort 1 - 160 mg LY2157299
80 mg LY2157299 given orally BID for 14 days followed by 14 days off (28-day cycle).
OG001
Part A Cohort 2 - 300 mg LY2157299
150 mg LY2157299 given orally BID for 14 days followed by 14 days off (28-day cycle).
OG002
Part B - 300 mg LY2157299
150 mg LY2157299 given orally 150 mg LY2157299 given orally BID for 14 days followed by 14 days off (28-day cycle).
Secondary
Percentage of Participants Achieving an Objective Response (Response Rate)
The percentage of participants who achieved best overall response of either Complete Response (CR) or Partial Response (PR). The overall response rate for each dose with be estimated by dividing the number of confirmed responders by the number of participants who received at least one dose of study drug. Per RECIST v.1.0 criteria CR is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to < 10 millimeter (mm). Tumor-marker results must have normalized. PR is defined as at least 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters.
All participants who received at least one dose of study drug. Per protocol, Part D collected safety data only.
Posted
Number
percentage of participants
Randomization to measured progressive disease (Up to 36 Weeks)
ID
Title
Description
OG000
Part A Cohort 1 - 160 mg LY2157299
80 mg LY2157299 given orally BID for 14 days followed by 14 days off (28-day cycle).
OG001
Part A Cohort 2 - 300 mg LY2157299
150 mg LY2157299 given orally BID for 14 days followed by 14 days off (28-day cycle).
OG002
Part B - 300 mg LY2157299
Secondary
Duration of Tumor Response (DoR)
DoR is measured from the date of the first objective status assessment of a Complete Response (CR) or Partial Response (PR), as determined by RECIST v1.1, to the first date of objective progression of disease or death from any cause. CR is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to < 10 millimeter (mm). Tumor-marker results must have normalized. PR is defined as at least 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters. Progression is defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum on study (including the baseline sum if that is the smallest). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of 1 or more new lesions is also considered progression.
All participants who received at least one dose of study drug with assessment of CR or PR. Per protocol, Part D collected safety data only.
Posted
Median
90% Confidence Interval
Weeks
Time of response to measured progressive disease or death from any cause (Up to 84 Weeks)
ID
Title
Description
OG000
Part A Cohort 1 - 160 mg LY2157299
80 mg LY2157299 given orally BID for 14 days followed by 14 days off (28-day cycle).
OG001
Part A Cohort 2 - 300 mg LY2157299
Secondary
Time to Treatment Failure (TTF)
TTF is measured from the date of first dose until the date of discontinuation of study treatment due to adverse event, progression of disease, or death from any cause.
All participants who received at least one dose of study drug. Per protocol, Part D collected safety data only.
Posted
Median
90% Confidence Interval
Weeks
Randomization to the date of discontinuation of study treatment due to adverse event, progression of disease, or death from any cause (Up to 75 Weeks)
ID
Title
Description
OG000
Part A Cohort 1 - 160 mg LY2157299
80 mg LY2157299 given orally BID for 14 days followed by 14 days off (28-day cycle).
OG001
Part A Cohort 2 - 300 mg LY2157299
150 mg LY2157299 given orally BID for 14 days followed by 14 days off (28-day cycle).
OG002
Part B - 300 mg LY2157299
150 mg LY2157299 given orally BID for 14 days followed by 14 days off (28-day cycle).
OG003
Part C Cohort 1 - 160 mg LY2157299 + Sorafenib
Secondary
Change From Baseline in Functional Assessment of Cancer Therapy, Hepatobiliary (FACT-Hep) Sub-scores and Total Score
FACT-Hep consists of 45 items in five subscales (1) physical well-being (PWB) score rage 0 -28; (2) social well-being (SWB) score range 0-28; (3) emotional well-being (EWB) score range 0-24; (4) functional well-being (FWB) score range 0-28; and (5) the hepatobiliary cancer subscale (HCS) Score range 0-72; FACT-Hep score range 1-180, and Trial-Outcome Index (TOI) score range 1-128, to assess health related quality of life in participants with cancer. Higher scores reflect a better health state.
All participants with baseline and one post-baseline FACT-Hep Questionnaire in Cycles 2, 3, or 4. Per protocol, Part D collected safety data only.
Posted
Mean
Standard Deviation
units on a scale
Baseline, Day 1 Cycle 4
ID
Title
Description
OG000
Part A Cohort 1 - 160 mg LY2157299
80 mg LY2157299 given orally BID for 14 days followed by 14 days off (28-day cycle).
OG001
Part A Cohort 2 - 300 mg LY2157299
150 mg LY2157299 given orally BID for 14 days followed by 14 days off (28-day cycle).
OG002
Part B - 300 mg LY2157299
150 mg LY2157299 given orally BID for 14 days followed by 14 days off (28-day cycle).
Secondary
Time to Worsening (TTW) of Symptoms (FACT-Hep)
Time to worsening of symptoms used minimally important differences to evaluate Physical Well Being (PWB), Functional Well Being (FWB), Hepatocellular Cancer Symptoms (HCS), National Comprehensive Cancer Network (NCCN)/FACT Hepatocellular Symptoms (FHS), Trial-Outcome Index (TOI). PWB time to worsening was defined as participants who had change in a subscale of ≥ 2 point decrease from baseline; FWB time to worsening was defined as participants who had change in a subscale of ≥ 2 point decrease from baseline; HCS time to worsening was defined as participants who had change in a subscale of ≥ 5 point decrease from baseline; FHS time to worsening was defined as participants who had change in a subscale of ≥ 2 point decrease from baseline; TOI time to Worsening was defined as participants who had change in the subscale of ≥ 7 point decrease from baseline.
All participants who completed a baseline and one post-baseline FACT-Hep TTW questionnaire. Due to low enrollment in Part C Cohort 1 - 160 mg reporting group, time-to-event analysis for TTW was not conducted for this subgroup. Per protocol, Part D collected safety data only.
Posted
Median
95% Confidence Interval
Days
Baseline to the worsening of symptoms (up to 567 days)
ID
Title
Description
OG000
Part A Cohort 1 - 160 mg LY2157299
80 mg LY2157299 given orally BID for 14 days followed by 14 days off (28-day cycle).
OG001
Part A Cohort 2 - 300 mg LY2157299
Time Frame
Baseline up to 41.5 months
Description
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
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
Part A Cohort 1 - 160 mg LY2157299
80 mg LY2157299 given orally BID for 14 days followed by 14 days off (28-day cycle).
33
37
15
37
32
37
EG001
Part A Cohort 2 - 300 mg LY2157299
150 mg LY2157299 given orally BID for 14 days followed by 14 days off (28-day cycle).
63
72
36
72
64
72
EG002
Part B - 300 mg LY2157299
150 mg LY2157299 given orally BID for 14 days followed by 14 days off (28-day cycle).
26
40
16
40
38
40
EG003
Part C Cohort 1 - 160 mg LY2157299 + Sorafenib
80 mg LY2157299 given orally BID on days 1 to 14 in combination with 400 mg Sorafenib BID on days 1 to 28 (28-day cycle).
3
3
3
3
3
3
EG004
Part C Cohort 2 - 300 mg LY2157299 + Sorafenib
150 mg LY2157299 given orally BID on days 1 to 14 in combination with 400 mg Sorafenib BID on days 1 to 28 (28-day cycle).
36
44
28
44
44
44
EG005
Part D Cohort 1 - 160 mg LY2157299 + Ramucirumab
80 mg LY2157299 given orally BID on days 1 to 14 in combination with ramucirumab 8 mg/kg IV on days 1 and 15 (28-day cycle).
2
3
1
3
3
3
EG006
Part D Cohort 2 - 300 mg LY2157299 + Ramucirumab
150 mg LY2157299 given orally BID on days 1 to 14 in combination with ramucirumab 8 mg/kg IV on days 1 and 15 (28-day cycle).
5
5
2
5
5
5
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 22.0
Systematic Assessment
EG0002 events2 affected37 at risk
EG00116 events7 affected72 at risk
EG0025 events3 affected40 at risk
EG0032 events1 affected3 at risk
EG0049 events6 affected44 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected5 at risk
Neutropenia
Blood and lymphatic system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected37 at risk
EG0011 events1 affected72 at risk
EG0020 events0 affected40 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected37 at risk
EG0010 events0 affected72 at risk
EG0021 events1 affected40 at risk
EG003
Acute coronary syndrome
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected37 at risk
EG0010 events0 affected72 at risk
EG0020 events0 affected40 at risk
EG003
Acute myocardial infarction
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected37 at risk
EG0010 events0 affected72 at risk
EG0020 events0 affected40 at risk
EG003
Angina unstable
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected37 at risk
EG0010 events0 affected72 at risk
EG0020 events0 affected40 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected37 at risk
EG0010 events0 affected72 at risk
EG0020 events0 affected40 at risk
EG003
Atrial thrombosis
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected37 at risk
EG0010 events0 affected72 at risk
EG0021 events1 affected40 at risk
EG003
Cardiac failure
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected37 at risk
EG0010 events0 affected72 at risk
EG0020 events0 affected40 at risk
EG003
Left ventricular dysfunction
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected37 at risk
EG0011 events1 affected72 at risk
EG0020 events0 affected40 at risk
EG003
Left ventricular failure
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected37 at risk
EG0010 events0 affected72 at risk
EG0020 events0 affected40 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected37 at risk
EG0012 events1 affected72 at risk
EG0020 events0 affected40 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected37 at risk
EG0013 events3 affected72 at risk
EG0021 events1 affected40 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected37 at risk
EG0011 events1 affected72 at risk
EG0020 events0 affected40 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0002 events2 affected37 at risk
EG0016 events4 affected72 at risk
EG0021 events1 affected40 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected37 at risk
EG0011 events1 affected72 at risk
EG0020 events0 affected40 at risk
EG003
Duodenal ulcer
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected37 at risk
EG0010 events0 affected72 at risk
EG0020 events0 affected40 at risk
EG003
Gastric ulcer
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected37 at risk
EG0010 events0 affected72 at risk
EG0020 events0 affected40 at risk
EG003
Gastric varices haemorrhage
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected37 at risk
EG0011 events1 affected72 at risk
EG0022 events1 affected40 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected37 at risk
EG0012 events1 affected72 at risk
EG0021 events1 affected40 at risk
EG003
Haematemesis
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected37 at risk
EG0010 events0 affected72 at risk
EG0021 events1 affected40 at risk
EG003
Intestinal obstruction
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected37 at risk
EG0011 events1 affected72 at risk
EG0020 events0 affected40 at risk
EG003
Intra-abdominal haemorrhage
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected37 at risk
EG0010 events0 affected72 at risk
EG0020 events0 affected40 at risk
EG003
Large intestinal haemorrhage
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected37 at risk
EG0010 events0 affected72 at risk
EG0020 events0 affected40 at risk
EG003
Lower gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected37 at risk
EG0010 events0 affected72 at risk
EG0020 events0 affected40 at risk
EG003
Melaena
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected37 at risk
EG0011 events1 affected72 at risk
EG0020 events0 affected40 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected37 at risk
EG0011 events1 affected72 at risk
EG0020 events0 affected40 at risk
EG003
Oesophageal varices haemorrhage
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected37 at risk
EG0011 events1 affected72 at risk
EG0021 events1 affected40 at risk
EG003
Pancreatitis
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected37 at risk
EG0011 events1 affected72 at risk
EG0020 events0 affected40 at risk
EG003
Peritoneal haematoma
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected37 at risk
EG0011 events1 affected72 at risk
EG0020 events0 affected40 at risk
EG003
Peritoneal haemorrhage
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected37 at risk
EG0011 events1 affected72 at risk
EG0021 events1 affected40 at risk
EG003
Rectal haemorrhage
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected37 at risk
EG0013 events1 affected72 at risk
EG0020 events0 affected40 at risk
EG003
Small intestinal haemorrhage
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected37 at risk
EG0012 events1 affected72 at risk
EG0020 events0 affected40 at risk
EG003
Subileus
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected37 at risk
EG0010 events0 affected72 at risk
EG0020 events0 affected40 at risk
EG003
Upper gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected37 at risk
EG0011 events1 affected72 at risk
EG0024 events2 affected40 at risk
EG003
Varices oesophageal
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected37 at risk
EG0011 events1 affected72 at risk
EG0023 events2 affected40 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected37 at risk
EG0011 events1 affected72 at risk
EG0020 events0 affected40 at risk
EG003
Asthenia
General disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected37 at risk
EG0011 events1 affected72 at risk
EG0020 events0 affected40 at risk
EG003
Chest discomfort
General disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected37 at risk
EG0010 events0 affected72 at risk
EG0020 events0 affected40 at risk
EG003
General physical health deterioration
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected37 at risk
EG0010 events0 affected72 at risk
EG0020 events0 affected40 at risk
EG003
Pain
General disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected37 at risk
EG0010 events0 affected72 at risk
EG0020 events0 affected40 at risk
EG003
Pyrexia
General disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected37 at risk
EG0012 events2 affected72 at risk
EG0020 events0 affected40 at risk
EG003
Acute hepatic failure
Hepatobiliary disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected37 at risk
EG0010 events0 affected72 at risk
EG0020 events0 affected40 at risk
EG003
Gallbladder rupture
Hepatobiliary disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected37 at risk
EG0010 events0 affected72 at risk
EG0021 events1 affected40 at risk
EG003
Hepatic failure
Hepatobiliary disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected37 at risk
EG0012 events2 affected72 at risk
EG0020 events0 affected40 at risk
EG003
Hepatic haematoma
Hepatobiliary disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected37 at risk
EG0010 events0 affected72 at risk
EG0020 events0 affected40 at risk
EG003
Hepatic haemorrhage
Hepatobiliary disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected37 at risk
EG0012 events2 affected72 at risk
EG0020 events0 affected40 at risk
EG003
Hepatic pain
Hepatobiliary disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected37 at risk
EG0012 events2 affected72 at risk
EG0021 events1 affected40 at risk
EG003
Hepatorenal syndrome
Hepatobiliary disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected37 at risk
EG0010 events0 affected72 at risk
EG0020 events0 affected40 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected37 at risk
EG0010 events0 affected72 at risk
EG0020 events0 affected40 at risk
EG003
Jaundice cholestatic
Hepatobiliary disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected37 at risk
EG0010 events0 affected72 at risk
EG0020 events0 affected40 at risk
EG003
Portal vein thrombosis
Hepatobiliary disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected37 at risk
EG0011 events1 affected72 at risk
EG0020 events0 affected40 at risk
EG003
Anal abscess
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected37 at risk
EG0010 events0 affected72 at risk
EG0020 events0 affected40 at risk
EG003
Arthritis bacterial
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected37 at risk
EG0010 events0 affected72 at risk
EG0021 events1 affected40 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected37 at risk
EG0010 events0 affected72 at risk
EG0022 events1 affected40 at risk
EG003
Diverticulitis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected37 at risk
EG0010 events0 affected72 at risk
EG0020 events0 affected40 at risk
EG003
Endocarditis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected37 at risk
EG0010 events0 affected72 at risk
EG0020 events0 affected40 at risk
EG003
Liver abscess
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected37 at risk
EG0010 events0 affected72 at risk
EG0020 events0 affected40 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected37 at risk
EG0010 events0 affected72 at risk
EG0021 events1 affected40 at risk
EG003
Lung infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected37 at risk
EG0010 events0 affected72 at risk
EG0020 events0 affected40 at risk
EG003
Osteomyelitis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected37 at risk
EG0010 events0 affected72 at risk
EG0021 events1 affected40 at risk
EG003
Peritonitis bacterial
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected37 at risk
EG0010 events0 affected72 at risk
EG0020 events0 affected40 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected37 at risk
EG0014 events4 affected72 at risk
EG0020 events0 affected40 at risk
EG003
Sepsis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected37 at risk
EG0011 events1 affected72 at risk
EG0020 events0 affected40 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected37 at risk
EG0010 events0 affected72 at risk
EG0020 events0 affected40 at risk
EG003
Wound infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected37 at risk
EG0010 events0 affected72 at risk
EG0020 events0 affected40 at risk
EG003
Cervical vertebral fracture
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected37 at risk
EG0010 events0 affected72 at risk
EG0020 events0 affected40 at risk
EG003
Concussion
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected37 at risk
EG0010 events0 affected72 at risk
EG0021 events1 affected40 at risk
EG003
Exposure during pregnancy
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected37 at risk
EG0010 events0 affected72 at risk
EG0020 events0 affected40 at risk
EG003
Femur fracture
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected37 at risk
EG0011 events1 affected72 at risk
EG0021 events1 affected40 at risk
EG003
Pelvic fracture
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected37 at risk
EG0010 events0 affected72 at risk
EG0020 events0 affected40 at risk
EG003
Post procedural haemorrhage
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected37 at risk
EG0010 events0 affected72 at risk
EG0020 events0 affected40 at risk
EG003
Radiation pneumonitis
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected37 at risk
EG0010 events0 affected72 at risk
EG0020 events0 affected40 at risk
EG003
Shunt stenosis
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected37 at risk
EG0011 events1 affected72 at risk
EG0020 events0 affected40 at risk
EG003
Toxicity to various agents
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected37 at risk
EG0011 events1 affected72 at risk
EG0021 events1 affected40 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected37 at risk
EG0010 events0 affected72 at risk
EG0020 events0 affected40 at risk
EG003
Liver function test abnormal
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected37 at risk
EG0010 events0 affected72 at risk
EG0020 events0 affected40 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected37 at risk
EG0010 events0 affected72 at risk
EG0020 events0 affected40 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected37 at risk
EG0011 events1 affected72 at risk
EG0020 events0 affected40 at risk
EG003
Fluid retention
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected37 at risk
EG0010 events0 affected72 at risk
EG0020 events0 affected40 at risk
EG003
Hyperammonaemia
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected37 at risk
EG0010 events0 affected72 at risk
EG0020 events0 affected40 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected37 at risk
EG0011 events1 affected72 at risk
EG0020 events0 affected40 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected37 at risk
EG0012 events2 affected72 at risk
EG0020 events0 affected40 at risk
EG003
Chondrocalcinosis pyrophosphate
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected37 at risk
EG0010 events0 affected72 at risk
EG0020 events0 affected40 at risk
EG003
Joint effusion
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected37 at risk
EG0010 events0 affected72 at risk
EG0020 events0 affected40 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected37 at risk
EG0010 events0 affected72 at risk
EG0020 events0 affected40 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected37 at risk
EG0011 events1 affected72 at risk
EG0020 events0 affected40 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected37 at risk
EG0010 events0 affected72 at risk
EG0020 events0 affected40 at risk
EG003
Malignant ascites
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected37 at risk
EG0011 events1 affected72 at risk
EG0020 events0 affected40 at risk
EG003
Malignant neoplasm progression
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected37 at risk
EG0010 events0 affected72 at risk
EG0021 events1 affected40 at risk
EG003
Neoplasm progression
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected37 at risk
EG0010 events0 affected72 at risk
EG0020 events0 affected40 at risk
EG003
Pancreatic neuroendocrine tumour
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected37 at risk
EG0010 events0 affected72 at risk
EG0020 events0 affected40 at risk
EG003
Second primary malignancy
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected37 at risk
EG0010 events0 affected72 at risk
EG0020 events0 affected40 at risk
EG003
Squamous cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected37 at risk
EG0010 events0 affected72 at risk
EG0020 events0 affected40 at risk
EG003
Squamous cell carcinoma of lung
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected37 at risk
EG0010 events0 affected72 at risk
EG0020 events0 affected40 at risk
EG003
Squamous cell carcinoma of skin
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected37 at risk
EG0010 events0 affected72 at risk
EG0020 events0 affected40 at risk
EG003
Tumour haemorrhage
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected37 at risk
EG0011 events1 affected72 at risk
EG0020 events0 affected40 at risk
EG003
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0003 events2 affected37 at risk
EG0010 events0 affected72 at risk
EG0020 events0 affected40 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected37 at risk
EG0010 events0 affected72 at risk
EG0021 events1 affected40 at risk
EG003
Embolic stroke
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected37 at risk
EG0010 events0 affected72 at risk
EG0020 events0 affected40 at risk
EG003
Encephalopathy
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected37 at risk
EG0012 events2 affected72 at risk
EG0020 events0 affected40 at risk
EG003
Haemorrhage intracranial
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected37 at risk
EG0011 events1 affected72 at risk
EG0020 events0 affected40 at risk
EG003
Hepatic encephalopathy
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0003 events2 affected37 at risk
EG0011 events1 affected72 at risk
EG0021 events1 affected40 at risk
EG003
Loss of consciousness
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected37 at risk
EG0010 events0 affected72 at risk
EG0020 events0 affected40 at risk
EG003
Presyncope
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected37 at risk
EG0011 events1 affected72 at risk
EG0020 events0 affected40 at risk
EG003
Transient ischaemic attack
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected37 at risk
EG0010 events0 affected72 at risk
EG0021 events1 affected40 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA 22.0
Systematic Assessment
EG0002 events1 affected37 at risk
EG0010 events0 affected72 at risk
EG0020 events0 affected40 at risk
EG003
Disorientation
Psychiatric disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected37 at risk
EG0010 events0 affected72 at risk
EG0020 events0 affected40 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected37 at risk
EG0012 events2 affected72 at risk
EG0020 events0 affected40 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected37 at risk
EG0010 events0 affected72 at risk
EG0020 events0 affected40 at risk
EG003
Prerenal failure
Renal and urinary disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected37 at risk
EG0010 events0 affected72 at risk
EG0020 events0 affected40 at risk
EG003
Renal disorder
Renal and urinary disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected37 at risk
EG0011 events1 affected72 at risk
EG0020 events0 affected40 at risk
EG003
Renal impairment
Renal and urinary disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected37 at risk
EG0011 events1 affected72 at risk
EG0020 events0 affected40 at risk
EG003
Renal injury
Renal and urinary disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected37 at risk
EG0010 events0 affected72 at risk
EG0020 events0 affected40 at risk
EG003
Urinary retention
Renal and urinary disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected37 at risk
EG0011 events1 affected72 at risk
EG0020 events0 affected40 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected37 at risk
EG0011 events1 affected72 at risk
EG0023 events1 affected40 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected37 at risk
EG0011 events1 affected72 at risk
EG0020 events0 affected40 at risk
EG003
Pneumonia aspiration
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected37 at risk
EG0010 events0 affected72 at risk
EG0021 events1 affected40 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected37 at risk
EG0010 events0 affected72 at risk
EG0021 events1 affected40 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected37 at risk
EG0010 events0 affected72 at risk
EG0022 events2 affected40 at risk
EG003
Pulmonary infarction
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected37 at risk
EG0010 events0 affected72 at risk
EG0020 events0 affected40 at risk
EG003
Pulmonary oedema
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected37 at risk
EG0010 events0 affected72 at risk
EG0020 events0 affected40 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected37 at risk
EG0010 events0 affected72 at risk
EG0020 events0 affected40 at risk
EG003
Drug eruption
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected37 at risk
EG0010 events0 affected72 at risk
EG0021 events1 affected40 at risk
EG003
Dry gangrene
Vascular disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected37 at risk
EG0010 events0 affected72 at risk
EG0020 events0 affected40 at risk
EG003
Shock haemorrhagic
Vascular disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected37 at risk
EG0011 events1 affected72 at risk
EG0020 events0 affected40 at risk
EG003
Thrombosis
Vascular disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected37 at risk
EG0010 events0 affected72 at risk
EG0020 events0 affected40 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 22.0
Systematic Assessment
EG00022 events9 affected37 at risk
EG00123 events13 affected72 at risk
EG00220 events10 affected40 at risk
EG0034 events1 affected3 at risk
EG00417 events12 affected44 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected5 at risk
Neutropenia
Blood and lymphatic system disorders
MedDRA 22.0
Systematic Assessment
EG0009 events3 affected37 at risk
EG0014 events3 affected72 at risk
EG0021 events1 affected40 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 22.0
Systematic Assessment
EG0002 events2 affected37 at risk
EG0012 events2 affected72 at risk
EG0029 events3 affected40 at risk
EG003
Tinnitus
Ear and labyrinth disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected37 at risk
EG0010 events0 affected72 at risk
EG0023 events3 affected40 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected37 at risk
EG0011 events1 affected72 at risk
EG0021 events1 affected40 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0003 events2 affected37 at risk
EG0012 events2 affected72 at risk
EG0025 events5 affected40 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0007 events7 affected37 at risk
EG00112 events11 affected72 at risk
EG00210 events8 affected40 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected37 at risk
EG00110 events7 affected72 at risk
EG0024 events4 affected40 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0007 events5 affected37 at risk
EG0018 events8 affected72 at risk
EG0023 events2 affected40 at risk
EG003
Barrett's oesophagus
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected37 at risk
EG0010 events0 affected72 at risk
EG0020 events0 affected40 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0006 events5 affected37 at risk
EG00114 events11 affected72 at risk
EG0027 events7 affected40 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0008 events5 affected37 at risk
EG00113 events10 affected72 at risk
EG00215 events11 affected40 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected37 at risk
EG0014 events4 affected72 at risk
EG0022 events2 affected40 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0003 events2 affected37 at risk
EG0010 events0 affected72 at risk
EG0021 events1 affected40 at risk
EG003
Gingival bleeding
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected37 at risk
EG0010 events0 affected72 at risk
EG0020 events0 affected40 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG00011 events6 affected37 at risk
EG00121 events15 affected72 at risk
EG0029 events9 affected40 at risk
EG003
Portal hypertensive gastropathy
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected37 at risk
EG0010 events0 affected72 at risk
EG0020 events0 affected40 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected37 at risk
EG0013 events3 affected72 at risk
EG0020 events0 affected40 at risk
EG003
Varices oesophageal
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected37 at risk
EG0012 events2 affected72 at risk
EG0021 events1 affected40 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0006 events6 affected37 at risk
EG00117 events12 affected72 at risk
EG00211 events6 affected40 at risk
EG003
Asthenia
General disorders
MedDRA 22.0
Systematic Assessment
EG0006 events5 affected37 at risk
EG0016 events6 affected72 at risk
EG0028 events4 affected40 at risk
EG003
Chills
General disorders
MedDRA 22.0
Systematic Assessment
EG0003 events3 affected37 at risk
EG0013 events2 affected72 at risk
EG0020 events0 affected40 at risk
EG003
Fatigue
General disorders
MedDRA 22.0
Systematic Assessment
EG00010 events9 affected37 at risk
EG00117 events14 affected72 at risk
EG00215 events14 affected40 at risk
EG003
Influenza like illness
General disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected37 at risk
EG0011 events1 affected72 at risk
EG0024 events4 affected40 at risk
EG003
Localised oedema
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected37 at risk
EG0011 events1 affected72 at risk
EG0020 events0 affected40 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected37 at risk
EG0012 events2 affected72 at risk
EG0021 events1 affected40 at risk
EG003
Oedema peripheral
General disorders
MedDRA 22.0
Systematic Assessment
EG0006 events5 affected37 at risk
EG00116 events14 affected72 at risk
EG00217 events12 affected40 at risk
EG003
Pain
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected37 at risk
EG0011 events1 affected72 at risk
EG0020 events0 affected40 at risk
EG003
Pyrexia
General disorders
MedDRA 22.0
Systematic Assessment
EG0004 events2 affected37 at risk
EG0018 events6 affected72 at risk
EG0022 events2 affected40 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
MedDRA 22.0
Systematic Assessment
EG0005 events3 affected37 at risk
EG0013 events3 affected72 at risk
EG0021 events1 affected40 at risk
EG003
Portal vein thrombosis
Hepatobiliary disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected37 at risk
EG0011 events1 affected72 at risk
EG0020 events0 affected40 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected37 at risk
EG0013 events3 affected72 at risk
EG0024 events4 affected40 at risk
EG003
Furuncle
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected37 at risk
EG0010 events0 affected72 at risk
EG0020 events0 affected40 at risk
EG003
Lung infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected37 at risk
EG0010 events0 affected72 at risk
EG0021 events1 affected40 at risk
EG003
Post abortion infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected4 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected37 at risk
EG0011 events1 affected72 at risk
EG0021 events1 affected40 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected37 at risk
EG0012 events2 affected72 at risk
EG0022 events1 affected40 at risk
EG003
Vaginal infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected4 at risk
EG003
Viral infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected37 at risk
EG0010 events0 affected72 at risk
EG0020 events0 affected40 at risk
EG003
Vulvovaginal candidiasis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected4 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected37 at risk
EG0010 events0 affected72 at risk
EG0020 events0 affected40 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 22.0
Systematic Assessment
EG0003 events2 affected37 at risk
EG0013 events3 affected72 at risk
EG0022 events2 affected40 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected37 at risk
EG0011 events1 affected72 at risk
EG0021 events1 affected40 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected37 at risk
EG0013 events3 affected72 at risk
EG0022 events2 affected40 at risk
EG003
Haemoglobin decreased
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected37 at risk
EG0010 events0 affected72 at risk
EG0020 events0 affected40 at risk
EG003
Weight decreased
Investigations
MedDRA 22.0
Systematic Assessment
EG0005 events4 affected37 at risk
EG0018 events8 affected72 at risk
EG00217 events10 affected40 at risk
EG003
Weight increased
Investigations
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected37 at risk
EG0018 events7 affected72 at risk
EG0021 events1 affected40 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0007 events6 affected37 at risk
EG0018 events7 affected72 at risk
EG0027 events7 affected40 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0004 events3 affected37 at risk
EG0012 events1 affected72 at risk
EG0020 events0 affected40 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected37 at risk
EG0014 events3 affected72 at risk
EG0023 events2 affected40 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected37 at risk
EG0011 events1 affected72 at risk
EG0021 events1 affected40 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0005 events3 affected37 at risk
EG0013 events3 affected72 at risk
EG0025 events5 affected40 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0003 events2 affected37 at risk
EG0019 events5 affected72 at risk
EG0022 events1 affected40 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0002 events2 affected37 at risk
EG0013 events2 affected72 at risk
EG0027 events5 affected40 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected37 at risk
EG0010 events0 affected72 at risk
EG0020 events0 affected40 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected37 at risk
EG0013 events2 affected72 at risk
EG0021 events1 affected40 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected37 at risk
EG0011 events1 affected72 at risk
EG0021 events1 affected40 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected37 at risk
EG0013 events3 affected72 at risk
EG0022 events1 affected40 at risk
EG003
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected37 at risk
EG0010 events0 affected72 at risk
EG0021 events1 affected40 at risk
EG003
Malignant ascites
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected37 at risk
EG0015 events5 affected72 at risk
EG0021 events1 affected40 at risk
EG003
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0004 events4 affected37 at risk
EG0011 events1 affected72 at risk
EG0021 events1 affected40 at risk
EG003
Embolic stroke
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected37 at risk
EG0010 events0 affected72 at risk
EG0020 events0 affected40 at risk
EG003
Headache
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected37 at risk
EG0014 events4 affected72 at risk
EG0025 events5 affected40 at risk
EG003
Hepatic encephalopathy
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0002 events2 affected37 at risk
EG0010 events0 affected72 at risk
EG0020 events0 affected40 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0003 events3 affected37 at risk
EG0010 events0 affected72 at risk
EG0020 events0 affected40 at risk
EG003
Somnolence
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0002 events2 affected37 at risk
EG0011 events1 affected72 at risk
EG0020 events0 affected40 at risk
EG003
Taste disorder
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected37 at risk
EG0010 events0 affected72 at risk
EG0020 events0 affected40 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected37 at risk
EG0014 events4 affected72 at risk
EG0020 events0 affected40 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA 22.0
Systematic Assessment
EG0002 events2 affected37 at risk
EG0011 events1 affected72 at risk
EG0020 events0 affected40 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 22.0
Systematic Assessment
EG0002 events2 affected37 at risk
EG0016 events5 affected72 at risk
EG0024 events4 affected40 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected37 at risk
EG0010 events0 affected72 at risk
EG0020 events0 affected40 at risk
EG003
Nocturia
Renal and urinary disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected37 at risk
EG0012 events2 affected72 at risk
EG0020 events0 affected40 at risk
EG003
Erectile dysfunction
Reproductive system and breast disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected32 at risk
EG0010 events0 affected59 at risk
EG0020 events0 affected36 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0003 events3 affected37 at risk
EG0015 events5 affected72 at risk
EG0024 events3 affected40 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0003 events3 affected37 at risk
EG00110 events9 affected72 at risk
EG0027 events6 affected40 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0003 events1 affected37 at risk
EG0012 events2 affected72 at risk
EG0023 events3 affected40 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected37 at risk
EG0011 events1 affected72 at risk
EG0021 events1 affected40 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected37 at risk
EG0011 events1 affected72 at risk
EG0020 events0 affected40 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected37 at risk
EG0013 events3 affected72 at risk
EG0021 events1 affected40 at risk
EG003
Erythema multiforme
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected37 at risk
EG0011 events1 affected72 at risk
EG0021 events1 affected40 at risk
EG003
Night sweats
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0002 events2 affected37 at risk
EG0010 events0 affected72 at risk
EG0020 events0 affected40 at risk
EG003
Palmar-plantar erythrodysaesthesia syndrome
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected37 at risk
EG0011 events1 affected72 at risk
EG0021 events1 affected40 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0009 events7 affected37 at risk
EG00110 events9 affected72 at risk
EG00210 events8 affected40 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected37 at risk
EG0011 events1 affected72 at risk
EG0020 events0 affected40 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0003 events3 affected37 at risk
EG0011 events1 affected72 at risk
EG0022 events2 affected40 at risk
EG003
Skin exfoliation
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected37 at risk
EG0010 events0 affected72 at risk
EG0020 events0 affected40 at risk
EG003
Skin lesion
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected37 at risk
EG0010 events0 affected72 at risk
EG0020 events0 affected40 at risk
EG003
Flushing
Vascular disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected37 at risk
EG0013 events2 affected72 at risk
EG0020 events0 affected40 at risk
EG003
Haematoma
Vascular disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected37 at risk
EG0011 events1 affected72 at risk
EG0021 events1 affected40 at risk
EG003
Hypertension
Vascular disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected37 at risk
EG0011 events1 affected72 at risk
EG0022 events2 affected40 at risk
EG003
Per the protocol, following an interim analysis, the decision was taken to no longer randomize participants to the 160 mg LY2157299 arm.