A Study of LY3009120 in Participants With Advanced Cancer... | NCT02014116 | Trialant
NCT02014116
Sponsor
Eli Lilly and Company
Status
Terminated
Last Update Posted
Dec 27, 2019Actual
Enrollment
51Actual
Phase
Phase 1
Conditions
Neoplasms
Neoplasm Metastasis
Melanoma
Carcinoma, Non-Small-Cell Lung
Colorectal Neoplasms
Interventions
LY3009120 capsule
Countries
United States
Australia
France
Spain
Protocol Section
Identification Module
NCT ID
NCT02014116
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
13873
Secondary IDs
ID
Type
Description
Link
I6X-MC-JBDA
Other Identifier
Eli Lilly and Company
Brief Title
A Study of LY3009120 in Participants With Advanced Cancer or Cancer That Has Spread to Other Parts of Their Body
Official Title
A Phase 1 Study of LY3009120 in Patients With Advanced or Metastatic Cancer
Acronym
Not provided
Organization
Eli Lilly and CompanyINDUSTRY
Status Module
Record Verification Date
Dec 2019
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
This trial was terminated early based on the lack of sufficient clinical efficacy observed.
Expanded Access Info
No
Start Date
Nov 26, 2013Actual
Primary Completion Date
Apr 7, 2017Actual
Completion Date
Oct 5, 2018Actual
First Submitted Date
Dec 12, 2013
First Submission Date that Met QC Criteria
Dec 17, 2013
First Posted Date
Dec 18, 2013Estimated
Results Waived
Not provided
Results First Submitted Date
Sep 17, 2019
Results First Submitted that Met QC Criteria
Dec 20, 2019
Results First Posted Date
Dec 27, 2019Actual
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 20, 2019
Last Update Posted Date
Dec 27, 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
The main purpose of this study is to see how safe the investigational drug known as LY3009120 is and whether it will work to help people with advanced cancer or cancer that has spread to other parts of the body.
Detailed Description
Not provided
Conditions Module
Conditions
Neoplasms
Neoplasm Metastasis
Melanoma
Carcinoma, Non-Small-Cell Lung
Colorectal Neoplasms
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 1
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
51Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Cohort 1 Dose Escalation
Experimental
LY3009120 50 mg given orally twice daily every 12 hours for a 28-day cycle. Participants may continue to receive study drug until discontinuation criteria are met.
Drug: LY3009120 capsule
Cohort 2 Dose Escalation
Experimental
LY3009120 100 mg given orally twice daily every 12 hours for a 28-day cycle. Participants may continue to receive study drug until discontinuation criteria are met.
Drug: LY3009120 capsule
Cohort 3 Dose Escalation
Experimental
LY3009120 200 mg given orally twice daily every 12 hours for a 28-day cycle. Participants may continue to receive study drug until discontinuation criteria are met.
Drug: LY3009120 capsule
Cohort 4 Dose Escalation
Experimental
LY3009120 400 mg given orally twice daily every 12 hours for a 28-day cycle. Participants may continue to receive study drug until discontinuation criteria are met
Drug: LY3009120 capsule
Cohort 5 Dose Escalation
Experimental
LY3009120 500 mg given orally twice daily every 12 hours for a 28-day cycle. Participants may continue to receive study drug until discontinuation criteria are met
Interventions
Name
Type
Description
Arm Group Labels
Other Names
LY3009120 capsule
Drug
Administered orally.
Cohort 1 Dose Escalation
Cohort 2 Dose Escalation
Cohort 3 Dose Escalation
Cohort 4 Dose Escalation
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Maximum Tolerated Dose (MTD) of LY3009120
Maximum tolerated dose for the recommended Phase 2 dose (RP2D) of LY3009120 that might be safely administered to participants with advanced and/or metastatic cancer. Dose-limiting toxicity (DLT) is defined as an adverse event (AE) during Cycle 1 (28 days) that was possibly related to the study drug and met 1 of the following criteria: According to the National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0: ≥Grade 3 non-hematological toxicity except nausea/vomiting, diarrhea, or constipation that can be controlled with appropriate care; Grade 3 elevations of ALT and/or AST lasting fewer than 8 days (without evidence of other hepatic injury); Grade 3 rash that resolves or improves to a Grade 2 or less within 7 days; CTCAE Grade 4 hematological toxicity of >5 days duration; Grade 4 thrombocytopenia of any duration; Grade 3 thrombocytopenia with bleeding; Grade 3 febrile neutropenia.
Cycle 1 (28 Days)
Secondary Outcomes
Measure
Description
Time Frame
Number of Participants With Tumor Response
Number of participants with tumor response using the Response Evaluation Criteria in Solid Tumors (RECIST 1.1). CR is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 millimeter (mm). PR is defined as at least a 30% decrease in the sum of diameter of target lesions. SD which is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Advanced or metastatic cancer
Other available therapies have failed to cure the cancer
The cancer that has no proven effective therapy
The cancer can be biopsied (depending on the tumor type and/or the dose of drug received, tumor biopsies may be required)
Able to swallow capsules
Exclusion Criteria:
Have active cancer in the brain or spinal cord
Have an active infection of any kind (fungal, viral, or bacterial)
Have a cancer of the blood
Are pregnant or breastfeeding
Have some types of eye problems or impairments
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 to 5 PM Eastern time (UTC/GMT - 5 hours, EST
Eli Lilly and Company
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Pinnacle Oncology Hematology
Scottsdale
Arizona
85258
United States
Massachusetts General Hospital
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
The study consisted of two parts: Part A, a dose escalation phase to determine recommend Phase 2 dose. During Part A, safety data will be assessed and used as primary criteria for dose escalation. Part B, a tumor-specific expansion of treatment groups (cohorts) for dose confirmation.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Cohort 1
50 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.
Dose Escalation Phase
FG001
Cohort 2
100 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.
Dose Escalation Phase
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
Jan 8, 2016
Jun 25, 2019
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Non-Randomized
Intervention Model
Single Group Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Drug: LY3009120 capsule
Cohort 6 Dose Escalation
Experimental
LY3009120 300 mg given orally twice daily every 12 hours for a 28-day cycle. Participants may continue to receive study drug until discontinuation criteria are met
Drug: LY3009120 capsule
Cohort A Dose Confirmation
Experimental
LY3009120 300 mg given orally twice daily every 12 hours for a 28-day cycle. Participants may continue to receive study drug until discontinuation criteria are met.
Drug: LY3009120 capsule
Cohort B Dose Confirmation
Experimental
LY3009120 300 mg given orally twice daily every 12 hours for a 28-day cycle. Participants may continue to receive study drug until discontinuation criteria are met.
Drug: LY3009120 capsule
Cohort C Dose Confirmation
Experimental
LY3009120 300 mg given orally twice daily every 12 hours for a 28-day cycle. Participants may continue to receive study drug until discontinuation criteria are met.
Drug: LY3009120 capsule
Cohort 5 Dose Escalation
Cohort 6 Dose Escalation
Cohort A Dose Confirmation
Cohort B Dose Confirmation
Cohort C Dose Confirmation
Baseline through progressive disease (Up to 7.36 months)
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3009120 Cycle 1 Day 1
PK: Maximum concentration of LY3009120 after a single oral dose Cycle 1 Day 1.
Pharmacokinetics (PK): Maximum Concentration (Cmax) at Steady State of LY3009120 Cycle 1 Day 15
PK: Maximum concentration of LY3009120 during a twice daily dosing interval at steady state, Cycle 1 Day 15.
Cycle 1 Day 15: Predose, 0.5, 1, 2, 4, 6, 8, 10 h post-dose
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3009120 Cycle 1 Day 28
PK: Maximum concentration of LY3009120 during a twice daily dosing interval at steady state, Cycle 1 Day 28.
Cycle 1 Day 28: Predose, 0.5, 1, 2, 4, 6, 8, 10 h post-dose
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC [0-∞]) of LY3009120 Cycle 1 Day 1
PK: area under the concentration versus time curve [0-∞] of LY3009120 after a single oral dose Cycle 1 Day1.
Cycle 1 Day 1: Predose, 0.5, 1, 2, 4, 6, 8, 10 h post-dose
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to the End of Dosing Interval at Steady State (AUC[0-Ï„]) of LY3009120 Cycle 1 Day 15
PK: area under the concentration versus time curve from time 0 to the end of the twice daily dosing interval at steady state [AUC0-Ï„].
Cycle 1 Day 15: Predose, 0.5, 1, 2, 4, 6, 8, 10 h post-dose
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to the End of Dosing Interval at Steady State (AUC[0-Ï„]) of LY3009120 Cycle 1 Day 28
PK: area under the concentration versus time curve from time 0 to the end of the twice daily dosing interval at steady state AUC[0-Ï„].
Cycle 1 Day 28: Predose, 0.5, 1, 2, 4, 6, 8, 10 h post-dose
Boston
Massachusetts
02114
United States
University of Texas MD Anderson Cancer Center
Houston
Texas
77030
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
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.
Villejuif
94805
France
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.
Barcelona
08035
Spain
FG002
Cohort 3
200 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.
Dose Escalation Phase
FG003
Cohort 4
400 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.
Dose Escalation Phase
FG004
Cohort 5
500 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.
Dose Escalation Phase
FG005
Cohort 6
300 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.
Dose Escalation Phase
FG006
Cohort A
300 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.
Dose Confirmation Phase
FG007
Cohort B
300 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.
Dose Confirmation Phase
FG008
Cohort C
300 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.
Dose confirmation Phase
FG0003 subjects
FG0014 subjects
FG0023 subjects
FG0037 subjects
FG0042 subjects
FG00516 subjects
FG0061 subjects
FG0075 subjects
FG00810 subjects
Received at Least One Dose of Study Drug
FG0003 subjects
FG0014 subjects
FG0023 subjects
FG0037 subjects
FG0042 subjects
FG00516 subjects
FG0061 subjects
FG0075 subjects
FG00810 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
NOT COMPLETED
FG0003 subjects
FG0014 subjects
FG0023 subjects
FG0037 subjects
FG0042 subjects
FG00516 subjects
FG0061 subjects
FG0075 subjects
FG00810 subjects
Type
Comment
Reasons
Progressive Disease
FG0003 subjects
FG0014 subjects
FG0022 subjects
FG0036 subjects
FG0041 subjects
FG00513 subjects
FG0061 subjects
FG0073 subjects
FG0087 subjects
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Death
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0031 subjects
FG004
Withdrawal Caregiver Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Physician Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
All participants who received at least one dose of study drug.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Cohort 1
50 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.
Dose Escalation Phase
BG001
Cohort 2
100 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.
Dose Escalation Phase
BG002
Cohort 3
200 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.
Dose Escalation Phase
BG003
Cohort 4
400 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.
Dose Escalation Phase
BG004
Cohort 5
500 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.
Dose Escalation Phase
BG005
Cohort 6
300 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.
Dose Escalation Phase
BG006
Cohort A
300 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.
Dose Confirmation Phase
BG007
Cohort B
300 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.
Dose Confirmation Phase
BG008
Cohort C
300 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.
Dose Confirmation Phase
BG009
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0003
BG0014
BG0023
BG0037
BG0042
BG00516
BG0061
BG0075
BG00810
BG00951
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Categorical
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
<=18 years
BG0000
BG0010
BG0020
BG003
Sex: Female, Male
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Female
BG0002
BG0012
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
Number
participants
Title
Denominators
Categories
United States
Title
Measurements
BG0003
BG0014
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
Maximum Tolerated Dose (MTD) of LY3009120
Maximum tolerated dose for the recommended Phase 2 dose (RP2D) of LY3009120 that might be safely administered to participants with advanced and/or metastatic cancer. Dose-limiting toxicity (DLT) is defined as an adverse event (AE) during Cycle 1 (28 days) that was possibly related to the study drug and met 1 of the following criteria: According to the National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0: ≥Grade 3 non-hematological toxicity except nausea/vomiting, diarrhea, or constipation that can be controlled with appropriate care; Grade 3 elevations of ALT and/or AST lasting fewer than 8 days (without evidence of other hepatic injury); Grade 3 rash that resolves or improves to a Grade 2 or less within 7 days; CTCAE Grade 4 hematological toxicity of >5 days duration; Grade 4 thrombocytopenia of any duration; Grade 3 thrombocytopenia with bleeding; Grade 3 febrile neutropenia.
All participants in Part A who received at least one dose of study drug.
Posted
Number
milligrams (mg)
Cycle 1 (28 Days)
ID
Title
Description
OG000
Part A LY3009120
Cohort 1: 50 mg LY3009210 every 12 hours (hr) in a 28-day cycle.
Cohort 2 100 mg LY3009210 every 12 hr in a 28-day cycle.
Cohort 3: 200 mg LY3009120 every 12 hr in a 28-day cycle.
Cohort 4: 400 mg LY3009120 every 12 hr in a 28-day cycle.
Cohort 5: 500 mg LY3009120 every 12 hr in a 28-day cycle.
Cohort 6: 300 mg LY3009120 every 12 hr in a 28-day cycle.
Units
Counts
Participants
OG00035
Title
Denominators
Categories
Title
Measurements
OG000300
Secondary
Number of Participants With Tumor Response
Number of participants with tumor response using the Response Evaluation Criteria in Solid Tumors (RECIST 1.1). CR is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 millimeter (mm). PR is defined as at least a 30% decrease in the sum of diameter of target lesions. SD which is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study.
All participants in Part B who received at least one dose of study drug and had post-baseline tumor assessment.
Posted
Number
participants
Baseline through progressive disease (Up to 7.36 months)
ID
Title
Description
OG000
Cohort A
300 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle
OG001
Cohort B
300 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.
OG002
Cohort C
300 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.
Secondary
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3009120 Cycle 1 Day 1
PK: Maximum concentration of LY3009120 after a single oral dose Cycle 1 Day 1.
All participants in Part A who have received at least one dose of study drug and have evaluable PK data in Cycle 1, Day 1, per protocol.
50 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.
OG001
100 mg LY3009120
100 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.
OG002
200 mg LY3009120
200 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.
OG003
300 mg LY3009120
300 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.
Secondary
Pharmacokinetics (PK): Maximum Concentration (Cmax) at Steady State of LY3009120 Cycle 1 Day 15
PK: Maximum concentration of LY3009120 during a twice daily dosing interval at steady state, Cycle 1 Day 15.
All participants in Part A who received at least one dose of study drug and have evaluable PK data for Cycle 1, Day 15, per protocol.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
Cycle 1 Day 15: Predose, 0.5, 1, 2, 4, 6, 8, 10 h post-dose
ID
Title
Description
OG000
50 mg LY3009120
50 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.
OG001
100 mg LY3009120
100 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.
OG002
200 mg LY3009120
200 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.
OG003
300 mg LY3009120
300 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.
Secondary
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3009120 Cycle 1 Day 28
PK: Maximum concentration of LY3009120 during a twice daily dosing interval at steady state, Cycle 1 Day 28.
All participants in Part A who have received at least one dose of study drug and have evaluable PK data in Cycle 1, Day 28, per protocol.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
Cycle 1 Day 28: Predose, 0.5, 1, 2, 4, 6, 8, 10 h post-dose
ID
Title
Description
OG000
50 mg LY3009120
50 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.
OG001
100 mg LY3009120
100 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.
OG002
200 mg LY3009120
200 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.
OG003
300 mg LY3009120
300 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.
Secondary
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC [0-∞]) of LY3009120 Cycle 1 Day 1
PK: area under the concentration versus time curve [0-∞] of LY3009120 after a single oral dose Cycle 1 Day1.
All participants in Part A who have received at least one dose of study drug and have evaluable PK data in Cycle 1, Day 1, per protocol.
Posted
Geometric Mean
Geometric Coefficient of Variation
nanogram times hour/milliliter(ng*hr/mL)
Cycle 1 Day 1: Predose, 0.5, 1, 2, 4, 6, 8, 10 h post-dose
ID
Title
Description
OG000
50 mg LY3009120
50 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.
OG001
100 mg LY3009120
100 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.
OG002
200 mg LY3009120
200 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.
OG003
300 mg LY3009120
300 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.
Secondary
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to the End of Dosing Interval at Steady State (AUC[0-Ï„]) of LY3009120 Cycle 1 Day 15
PK: area under the concentration versus time curve from time 0 to the end of the twice daily dosing interval at steady state [AUC0-Ï„].
All participants in Part A who have received at least one dose of study drug and have evaluable PK data in Cycle 1, Day 15, per protocol.
Posted
Geometric Mean
Geometric Coefficient of Variation
nanogram*hour/milliliter (ng*hr/mL)
Cycle 1 Day 15: Predose, 0.5, 1, 2, 4, 6, 8, 10 h post-dose
ID
Title
Description
OG000
50 mg LY3009120
50 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.
OG001
100 mg LY3009120
100 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.
OG002
200 mg LY3009120
200 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.
OG003
300 mg LY3009120
Secondary
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to the End of Dosing Interval at Steady State (AUC[0-Ï„]) of LY3009120 Cycle 1 Day 28
PK: area under the concentration versus time curve from time 0 to the end of the twice daily dosing interval at steady state AUC[0-Ï„].
All participants in Part A who have received at least one dose of study drug and have evaluable PK data in Cycle 1, Day 28, per protocol.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng*hr/mL
Cycle 1 Day 28: Predose, 0.5, 1, 2, 4, 6, 8, 10 h post-dose
ID
Title
Description
OG000
50 mg LY3009120
50 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.
OG001
100 mg LY3009120
100 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.
OG002
200 mg LY3009120
200 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.
OG003
300 mg LY3009120
300 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.
Time Frame
Baseline to Study Completion (Up to 33 months)
Description
All participants who received at least one dose of study drug.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Cohort 1
50 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.
2
3
0
3
3
3
EG001
Cohort 2
100 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.
2
4
2
4
4
4
EG002
Cohort 3
200 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.
1
3
1
3
3
3
EG003
Cohort 4
400 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.
5
7
5
7
7
7
EG004
Cohort 5
500 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.
0
2
1
2
2
2
EG005
Cohort 6
300 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.
4
16
12
16
16
16
EG006
Cohort A
300 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.
1
1
1
1
1
1
EG007
Cohort B
300 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.
4
5
5
5
5
5
EG008
Cohort C
300 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.
4
10
6
10
9
10
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Angina pectoris
Cardiac disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected2 at risk
EG0050 events0 affected16 at risk
EG0060 events0 affected1 at risk
EG0071 events1 affected5 at risk
EG0080 events0 affected10 at risk
Cardiac arrest
Cardiac disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Intestinal perforation
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Large intestine perforation
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Upper gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
General physical health deterioration
General disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Hyperthermia
General disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Oedema peripheral
General disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Pain
General disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Pyrexia
General disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Erysipelas
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Septic shock
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Pain in jaw
Musculoskeletal and connective tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected3 at risk
EG003
Cancer pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Metastases to central nervous system
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Cognitive disorder
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Haemorrhage intracranial
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Hemiparesis
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Neuralgia
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Mental status changes
Psychiatric disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Acute respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Atelectasis
Respiratory, thoracic and mediastinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Dermatitis acneiform
Skin and subcutaneous tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Palmar-plantar erythrodysaesthesia syndrome
Skin and subcutaneous tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Hypotension
Vascular disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0012 events2 affected4 at risk
EG0020 events0 affected3 at risk
EG0033 events2 affected7 at risk
EG0041 events1 affected2 at risk
EG0056 events4 affected16 at risk
EG0060 events0 affected1 at risk
EG0075 events2 affected5 at risk
EG0086 events3 affected10 at risk
Iron deficiency anaemia
Blood and lymphatic system disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Pericardial effusion
Cardiac disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Sinus tachycardia
Cardiac disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Ventricular tachycardia
Cardiac disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Hypertrophic cardiomyopathy
Congenital, familial and genetic disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Deafness
Ear and labyrinth disorders
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Eye discharge
Eye disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Eye haemorrhage
Eye disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Eye irritation
Eye disorders
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Lacrimation increased
Eye disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Macular oedema
Eye disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Periorbital oedema
Eye disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Retinal detachment
Eye disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Retinal vascular disorder
Eye disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Retinopathy
Eye disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Vision blurred
Eye disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Visual impairment
Eye disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0012 events2 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Abdominal pain lower
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected3 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Diverticulum
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Diverticulum intestinal
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Epigastric discomfort
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Gastrointestinal pain
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Gingival pain
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected3 at risk
EG003
Haematemesis
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Inguinal hernia
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0002 events2 affected3 at risk
EG0010 events0 affected4 at risk
EG0022 events2 affected3 at risk
EG003
Oesophagitis
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Retching
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected3 at risk
EG003
Umbilical hernia
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0014 events1 affected4 at risk
EG0025 events2 affected3 at risk
EG003
Asthenia
General disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Chills
General disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Facial pain
General disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Fatigue
General disorders
MedDRA 21.1
Systematic Assessment
EG0002 events1 affected3 at risk
EG0014 events3 affected4 at risk
EG0021 events1 affected3 at risk
EG003
Gait disturbance
General disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Ill-defined disorder
General disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Localised oedema
General disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Mucosal dryness
General disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Mucosal inflammation
General disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Oedema
General disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Oedema peripheral
General disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0014 events2 affected4 at risk
EG0021 events1 affected3 at risk
EG003
Pain
General disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Performance status decreased
General disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Peripheral swelling
General disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Pyrexia
General disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events1 affected4 at risk
EG0021 events1 affected3 at risk
EG003
Xerosis
General disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Bile duct obstruction
Hepatobiliary disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Cholangitis
Hepatobiliary disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Jaundice
Hepatobiliary disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Candida infection
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Cystitis
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Erysipelas
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Paronychia
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Rash pustular
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Skin infection
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected3 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Viral parotitis
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected3 at risk
EG003
Compression fracture
Injury, poisoning and procedural complications
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Face injury
Injury, poisoning and procedural complications
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Incision site pain
Injury, poisoning and procedural complications
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Activated partial thromboplastin time prolonged
Investigations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Breath sounds abnormal
Investigations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Cardiac murmur
Investigations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Lymphocyte count decreased
Investigations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Platelet count decreased
Investigations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Troponin increased
Investigations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Weight decreased
Investigations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events2 affected4 at risk
EG0021 events1 affected3 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Failure to thrive
Metabolism and nutrition disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0022 events1 affected3 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Hyperuricaemia
Metabolism and nutrition disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected3 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0022 events2 affected3 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected4 at risk
EG0021 events1 affected3 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0014 events1 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Pain in jaw
Musculoskeletal and connective tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Seborrhoeic keratosis
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Akathisia
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Cognitive disorder
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Disturbance in attention
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected3 at risk
EG003
Headache
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Hepatic encephalopathy
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Memory impairment
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Migraine with aura
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Neuralgia
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Partial seizures
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Radicular pain
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected3 at risk
EG003
Somnolence
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Speech disorder
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Agitation
Psychiatric disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Delirium
Psychiatric disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Depression
Psychiatric disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Hallucination
Psychiatric disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Mental status changes
Psychiatric disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Restlessness
Psychiatric disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0013 events1 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Choluria
Renal and urinary disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Costovertebral angle tenderness
Renal and urinary disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Hydronephrosis
Renal and urinary disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Pollakiuria
Renal and urinary disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Proteinuria
Renal and urinary disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Renal failure
Renal and urinary disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Urge incontinence
Renal and urinary disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Vulvovaginal pruritus
Reproductive system and breast disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected3 at risk
EG003
Atelectasis
Respiratory, thoracic and mediastinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected4 at risk
EG0021 events1 affected3 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events2 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Laryngospasm
Respiratory, thoracic and mediastinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Lung disorder
Respiratory, thoracic and mediastinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Nasal dryness
Respiratory, thoracic and mediastinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Pleuritic pain
Respiratory, thoracic and mediastinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected3 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Pulmonary oedema
Respiratory, thoracic and mediastinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Rhonchi
Respiratory, thoracic and mediastinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Sinus pain
Respiratory, thoracic and mediastinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected3 at risk
EG003
Upper-airway cough syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected3 at risk
EG003
Wheezing
Respiratory, thoracic and mediastinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Acne
Skin and subcutaneous tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Dermatitis acneiform
Skin and subcutaneous tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected4 at risk
EG0021 events1 affected3 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Ecchymosis
Skin and subcutaneous tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Hyperkeratosis
Skin and subcutaneous tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Nail dystrophy
Skin and subcutaneous tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Pain of skin
Skin and subcutaneous tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Palmar-plantar erythrodysaesthesia syndrome
Skin and subcutaneous tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Psoriasis
Skin and subcutaneous tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Skin hyperpigmentation
Skin and subcutaneous tissue disorders
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Skin mass
Skin and subcutaneous tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Skin plaque
Skin and subcutaneous tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Skin ulcer
Skin and subcutaneous tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Flushing
Vascular disorders
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Hypertension
Vascular disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Hypotension
Vascular disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Lymphoedema
Vascular disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Orthostatic hypotension
Vascular disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
Pallor
Vascular disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected3 at risk
EG003
This trial was terminated early based on the lack of sufficient clinical efficacy observed.