A Dose-Escalation Study in Participants With Advanced Cancer | NCT01524224 | Trialant
NCT01524224
Sponsor
Eli Lilly and Company
Status
Completed
Last Update Posted
Apr 1, 2019Actual
Enrollment
29Actual
Phase
Phase 1
Conditions
Advanced Cancer
Interventions
LY2495655
Countries
United States
Protocol Section
Identification Module
NCT ID
Results Section
Participant Flow Module
Pre-assignment Details
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
NCT01524224
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
11207
Secondary IDs
ID
Type
Description
Link
I1Q-MC-JDDB
Other Identifier
Eli Lilly and Company
Brief Title
A Dose-Escalation Study in Participants With Advanced Cancer
Official Title
A Phase 1 Dose-Escalation Study of LY2495655, an Anti-Myostatin Monoclonal Antibody, in Patients With Advanced Cancer
Acronym
Not provided
Organization
Eli Lilly and CompanyINDUSTRY
Status Module
Record Verification Date
Jan 2019
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Jan 2008
Primary Completion Date
Nov 2012Actual
Completion Date
Jan 2016Actual
First Submitted Date
Jan 30, 2012
First Submission Date that Met QC Criteria
Jan 30, 2012
First Posted Date
Feb 1, 2012Estimated
Results Waived
Not provided
Results First Submitted Date
May 21, 2018
Results First Submitted that Met QC Criteria
Jan 4, 2019
Results First Posted Date
Apr 1, 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
Jan 4, 2019
Last Update Posted Date
Apr 1, 2019Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Eli Lilly and CompanyINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This study is a multicenter, open-label, dose-escalation phase 1 study of intravenous (IV) LY2495655 in participants with advanced cancer.
Detailed Description
This study will consist of the following parts:
Dose Escalation - Cohorts of at least 3 participants will be treated with increasing doses of LY2475655 until maximum tolerated dose (MTD) criteria are met in 1 of the 6 dose levels, or the 6th cohort is completed without meeting maximum tolerated dose criteria.
Dose Confirmation - Up to 10 more participants will be enrolled to the MTD dose level, or if it was not possible to define the MTD during dose escalation, all clinical and bioanalytical data will be reviewed to select the recommended Phase 2 dose and an up to 10 additional participants will be enrolled to this dose level.
Conditions Module
Conditions
Advanced Cancer
Keywords
Metastases
Neoplasm
Advanced Cancer
Metastatic Cancer
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
Not provided
Intervention Model
Biospecimen
No data available
No data is available for this block.
Enrollment
29Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
LY2495655
Experimental
Administered intravenously (IV) every 2 weeks (14 days) for four (4) 14 day cycles. Participants receiving clinical benefit may continue to receive treatment until one or more of the discontinuation criteria are met.
Starting dose in Part 1 (dose escalation) will be 2 mg. The dose will be subsequently increased to 7 mg, 21 mg, 70 mg, 210 mg, and 700 mg. The dose administered in Part 2 (dose confirmation) will be determined from Part 1.
Drug: LY2495655
Interventions
Name
Type
Description
Arm Group Labels
Other Names
LY2495655
Drug
administered intravenously
LY2495655
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants With One or More Drug-related Adverse Events
A summary of other non-serious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section. An AE is summarized if the onset date is on or after the first dose of study drug and within 30 days after the last dose, or it occurred before the first dose of study drug and worsened while on the therapy.
Baseline through End of Study (up to 51 months)
Secondary Outcomes
Measure
Description
Time Frame
Pharmacokinetics (PK): Area Under the Concentration-time Curve From Time 0 to 336 Hours (AUC[0-336]) of LY2495655
AUC(0-336h) is the area under the drug concentration versus time curve within a dosing interval (0-336 hours). Due to the small number per cohort (participants dropping out) calculations of the accumulation factor of exposure for repeated every-other-week dosing were based on simulated area under the drug concentration versus time curve within a dosing interval (AUCτ) instead of observed values. The 90-percentage confidence interval was calculated as the predictive interval.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
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 child bearing potential must have had a negative serum pregnancy test less than or equal to 7 days prior to the first dose of study drug
Have an estimated life expectancy of greater than 12 weeks
Have a histological or cytological diagnosis of cancer (with the exception of breast or prostate cancer) that is advanced and/or metastatic, for which no proven effective therapy exists or the participant has declined anticancer therapy OR
Have a histological or cytological diagnosis of metastatic breast or metastatic prostate cancer and receiving stable anti-hormone therapy for at least 2 months
Have adequate hematologic, hepatic, and renal function
Have a performance status of less than or equal to 2 on the Eastern Cooperative Oncology Group (ECOG) scale
Have discontinued all previous therapies for cancer, including chemotherapy, radiotherapy, or any other investigational therapy, for at least 30 days (6 weeks for mitomycin-C or nitrosoureas) prior to study enrollment and have recovered from the acute effects of therapy. Participants receiving anti-hormone therapy as specified in criteria above are not excluded
Exclusion Criteria:
Have received treatment within 30 days of the initial dose of study drug with a drug that has not received regulatory approval for any indication
Have serious preexisting medical conditions other than their cancer (at the discretion of the investigator)
Have central nervous system malignancy or metastasis (screening not required)
Have a history of severe chronic diseases that could interfere with either strength evaluation or body mass assessment during participation in this study including, but not limited to, ischemic disease (affecting the heart, brain, or extremities), uncontrolled hypertension, uncontrolled pain, severe chronic obstructive pulmonary disease, uncompensated heart failure (New York Heart Association Class III or IV), uncontrolled diabetes, or liver cirrhosis (Child-Pugh Class C)
Have a history of inherited or acquired neuromuscular diseases including multiple sclerosis, muscular dystrophies, or myasthenia gravis
Have active systemic inflammatory conditions including rheumatoid arthritis, dermatomyositis, severe arthrosis, or scleroderma
Have unstable bone lesions, or any bone instability, fusion, arthroplasty, tendon repair, synovectomy, and so on, due to any of the before-mentioned conditions or due to accident that could interfere with completion of the physical tests in this protocol
Have chronic glucocorticosteroid use greater than 10 mg of prednisone per day or equivalent
Have known positive test results for hepatitis B surface antigen (HBSAg), or hepatitis C antibodies (HCAb). Screening is not required
Have untreated hypothyroidism or hyperthyroidism
Have history of seizures, convulsions (except previous febrile convulsions), or stroke
Present with evidence of major depressive disorder, or history of obsessive compulsive disorder, significant psychiatric disease such as schizophrenia, bipolar disorder, or delirium
Have depressive symptoms associated with their cancer that require treatment with any of the excluded drugs listed in protocol
Have a previous history of discontinuation of a monoclonal antibody therapy due to allergy or severe infusion reaction
Are scheduled to start or already receive any anti-cancer hormone treatments for breast or prostate cancer in the adjuvant or neoadjuvant setting
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
7 mg LY2495655 every 2 weeks. Dose Escalation Phase
FG002
21 mg LY2495655
21 mg LY2495655 every 2 weeks. Dose Escalation Phase
FG003
70 mg LY2495655
70 mg LY2495655 every 2 weeks. Dose Escalation Phase
FG004
100 mg LY2495655
100 mg LY2495655 every 2 weeks. Dose Confirmation Phase
FG005
210 mg LY2495655
210 mg LY2495655 every 2 weeks. Dose Escalation Phase
FG006
300 mg LY2495655
300 mg LY2495655 every 2 weeks. Dose Confirmation Phase
FG007
700 mg LY2495655
700 mg LY2495655 every 2 weeks. Dose Escalation Phase
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
FG0004 subjects
FG0013 subjects
FG0023 subjects
FG0033 subjects
FG0044 subjects
FG0053 subjects
FG0063 subjects
FG0076 subjects
Received at Least One Dose of Study Drug
FG0004 subjects
FG0013 subjects
FG0023 subjects
FG0033 subjects
COMPLETED
FG0001 subjects
FG0012 subjects
FG0021 subjects
FG0031 subjects
FG004
NOT COMPLETED
FG0003 subjects
FG0011 subjects
FG0022 subjects
FG0032 subjects
FG004
Type
Comment
Reasons
Progressive Disease
FG0001 subjects
FG0010 subjects
FG0022 subjects
FG003
Baseline Characteristics Module
Baseline Analysis Population Description
All participants that received at least one dose of study drug.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
2 mg LY2495655
2 mg LY2495655 every 2 weeks. Dose Escalation Phase
BG001
7 mg LY2495655
7 mg LY2495655 every 2 weeks. Dose Escalation Phase
Denominators
Units
Counts
Participants
BG000
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Outcome Measures Module
Outcome Measures
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Number of Participants With One or More Drug-related Adverse Events
A summary of other non-serious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section. An AE is summarized if the onset date is on or after the first dose of study drug and within 30 days after the last dose, or it occurred before the first dose of study drug and worsened while on the therapy.
All participants who received at least one dose of study drug.
Posted
Count of Participants
Participants
No
Baseline through End of Study (up to 51 months)
ID
Title
Description
OG000
2 mg LY2495655
2 mg LY2495655 every 2 weeks. Dose Escalation Phase
OG001
7 mg LY2495655
Adverse Events Module
Frequency Threshold
5
Time Frame
Not provided
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
2 mg LY2495655
2 mg LY2495655 every 2 weeks. Dose Escalation Phase.
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 15.1
Systematic Assessment
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 15.1
Systematic Assessment
More Info Module
Limitations and Caveats
Not provided
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
Point of Contact
Title
Organization
Phone
Extension
Email
Chief Medical Officer
Eli Lilly and Company
800-545-5979
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
ID
Term
D009362
Neoplasm Metastasis
D009369
Neoplasms
Ancestor Terms
ID
Term
D009385
Neoplastic Processes
D010335
Pathologic Processes
D013568
Pathological Conditions, Signs and Symptoms
Browse Leaves
Not provided
Browse Branches
Not provided
Intervention Browse Module
MeSH Terms
ID
Term
C000607476
landogrozumab
Ancestor Terms
Not provided
Browse Leaves
Not provided
Browse Branches
Not provided
Sequential 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
Cycle 1 and Cycle 4 Days 1 (pre-dose, end of infusion, 2hr, 6hr, 10-12hr after the infusion ends) and Day 2, 3, 5, 8
Pharmacokinetics: Maximum Concentration (Cmax) of LY2495655
Cycle 1 and Cycle 4 Days 1 (pre-dose, end of infusion, 2hr, 6hr, 10-12hr after the infusion ends) and Day 2, 3, 5, 8
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.
New York
New York
10032
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.
Nashville
Tennessee
37203
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.
Dallas
Texas
75246
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.
The Woodlands
Texas
77380
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.
Tyler
Texas
75702
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.
Vancouver
Washington
98684
United States
FG004
4 subjects
FG0053 subjects
FG0063 subjects
FG0076 subjects
0 subjects
FG0051 subjects
FG0060 subjects
FG0070 subjects
4 subjects
FG0052 subjects
FG0063 subjects
FG0076 subjects
1 subjects
FG0042 subjects
FG0051 subjects
FG0061 subjects
FG0075 subjects
Withdrawal by Subject
FG0002 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0062 subjects
FG0070 subjects
Adverse Event
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0051 subjects
FG0060 subjects
FG0070 subjects
Physician Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG0041 subjects
FG0050 subjects
FG0060 subjects
FG0071 subjects
Sponsor Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0041 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
BG002
21 mg LY2495655
21 mg LY2495655 every 2 weeks. Dose Escalation Phase
BG003
70 mg LY2495655
70 mg LY2495655 every 2 weeks. Dose Escalation Phase
BG004
100 mg LY2495655
100 mg LY2495655 every 2 weeks. Dose Confirmation Phase
BG005
210 mg LY2495655
210 mg LY2495655 every 2 weeks. Dose Escalation Phase
BG006
300 mg LY2495655
300 mg LY2495655 every 2 weeks. Dose Confirmation Phase
BG007
700 mg LY2495655
700 mg LY2495655 every 2 weeks. Dose Escalation Phase
BG008
Total
Total of all reporting groups
4
BG0013
BG0023
BG0033
BG0044
BG0053
BG0063
BG0076
BG00829
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00075.0± 9.2
BG00178.1± 5.9
BG00275.9± 3.6
BG00367.1± 7.8
BG00462.9± 12.5
BG00578.8± 7.2
BG00670.7± 7.3
BG00767.9± 9.6
BG00871.4± 9.3
Sex: Female, Male
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Female
BG0003
BG0010
BG0021
BG0030
BG0041
BG0050
BG0062
BG0072
BG0089
Male
BG0001
BG0013
BG0022
BG0033
BG004
Race/Ethnicity, Customized
Count of Participants
Participants
No
Title
Denominators
Categories
Caucasian
Title
Measurements
BG0002
BG0013
BG0022
BG0033
BG0043
BG0053
BG0063
BG0076
BG00825
African
Title
Measurements
BG0001
BG0010
BG0021
BG003
Hispanic
Title
Measurements
BG0001
BG0010
BG0020
BG003
Region of Enrollment
Count of Participants
Participants
No
Title
Denominators
Categories
United States
Title
Measurements
BG0004
BG0013
BG0023
BG0033
BG0044
BG0053
BG0063
BG0076
BG00829
7 mg LY2495655 every 2 weeks. Dose Escalation Phase
OG002
21 mg LY2495655
21 mg LY2495655 every 2 weeks. Dose Escalation Phase
OG003
70 mg LY2495655
70 mg LY2495655 every 2 weeks. Dose Escalation Phase
OG004
100 mg LY2495655
100 mg LY2495655 every 2 weeks. Dose Confirmation Phase
OG005
210 mg LY2495655
210 mg LY2495655 every 2 weeks. Dose Escalation Phase
OG006
300 mg LY2495655
300 mg LY2495655 every 2 weeks. Dose Confirmation Phase
OG007
700 mg LY2495655
700 mg LY2495655 every 2 weeks. Dose Escalation Phase
Units
Counts
Participants
OG0004
OG0013
OG0023
OG0033
OG0044
OG0053
OG0063
OG0076
Title
Denominators
Categories
Title
Measurements
OG0001
OG0010
OG0021
OG0030
OG0041
OG0050
OG0060
OG0072
Secondary
Pharmacokinetics (PK): Area Under the Concentration-time Curve From Time 0 to 336 Hours (AUC[0-336]) of LY2495655
AUC(0-336h) is the area under the drug concentration versus time curve within a dosing interval (0-336 hours). Due to the small number per cohort (participants dropping out) calculations of the accumulation factor of exposure for repeated every-other-week dosing were based on simulated area under the drug concentration versus time curve within a dosing interval (AUCτ) instead of observed values. The 90-percentage confidence interval was calculated as the predictive interval.
All participants who received at least one dose of study drug and had evaluable pharmacokinetic data. Confidence Interval calculated as predictive interval and summarized from simulated PK profiles in 1000 virtual participants for each dose using a population PK model for LY2495655.
Posted
Median
90% Confidence Interval
micromolar*hr (µM*hr)
Cycle 1 and Cycle 4 Days 1 (pre-dose, end of infusion, 2hr, 6hr, 10-12hr after the infusion ends) and Day 2, 3, 5, 8
ID
Title
Description
OG000
2 mg LY2495655
2 mg LY2495655 every 2 weeks. Dose Escalation Phase
OG001
7 mg LY2495655
7 mg LY2495655 every 2 weeks. Dose Escalation Phase
OG002
21 mg LY2495655
21 mg LY2495655 every 2 weeks. Dose Escalation Phase
OG003
70 mg LY2495655
70 mg LY2495655 every 2 weeks. Dose Escalation Phase
OG004
100 mg LY2495655
100 mg LY2495655 every 2 weeks. Dose Confirmation Phase
OG005
210 mg LY2495655
210 mg LY2495655 every 2 weeks. Dose Escalation Phase
OG006
300 mg LY2495655
300 mg LY2495655 every 2 weeks. Dose Confirmation Phase
OG007
700 mg LY2495655
700 mg LY2495655 every 2 weeks. Dose Escalation Phase
Units
Counts
Participants
OG0004
OG0013
OG0023
OG003
Title
Denominators
Categories
Cycle 1
Title
Measurements
OG0000.426(0.309 to 0.605)
OG0011.62(1.18 to 2.35)
OG0025.36(3.87 to 7.94)
OG003
Secondary
Pharmacokinetics: Maximum Concentration (Cmax) of LY2495655
All participants who received at least one dose of study drug and had evaluable pharmacokinetic data.
Posted
Geometric Mean
Geometric Coefficient of Variation
nanomolar (nM)
Cycle 1 and Cycle 4 Days 1 (pre-dose, end of infusion, 2hr, 6hr, 10-12hr after the infusion ends) and Day 2, 3, 5, 8
ID
Title
Description
OG000
2 mg LY2495655
2 mg LY2495655 every 2 weeks. Dose Escalation Phase
OG001
7 mg LY2495655
7 mg LY2495655 every 2 weeks. Dose Escalation Phase
OG002
21 mg LY2495655
21 mg LY2495655 every 2 weeks. Dose Escalation Phase
OG003
70 mg LY2495655
70 mg LY2495655 every 2 weeks. Dose Escalation Phase
OG004
100 mg LY2495655
100 mg LY2495655 every 2 weeks. Dose Confirmation Phase
OG005
210 mg LY2495655
210 mg LY2495655 every 2 weeks. Dose Escalation Phase
OG006
300 mg LY2495655
300 mg LY2495655 every 2 weeks. Dose Confirmation Phase
OG007
700 mg LY2495655
700 mg LY2495655 every 2 weeks. Dose Escalation Phase
Units
Counts
Participants
OG0004
OG0013
OG0023
OG003
Title
Denominators
Categories
Cycle 1
ParticipantsOG0004
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG003
0
4
2
4
EG001
7 mg LY2495655
7 mg LY2495655 every 2 weeks. Dose Escalation Phase.
0
3
3
3
EG002
21 mg LY2495655
21 mg LY2495655 every 2 weeks. Dose Escalation Phase.
0
3
3
3
EG003
70 mg LY2495655
70 mg LY2495655 every 2 weeks. Dose Escalation Phase.
1
3
3
3
EG004
100 mg LY2495655
100 mg LY2495655 every 2 weeks. Dose Confirmation Phase.
1
4
4
4
EG005
210 mg LY2495655
210 mg LY2495655 every 2 weeks. Dose Escalation Phase.
2
3
2
3
EG006
300 mg LY2495655
300 mg LY2495655 every 2 weeks. Dose Confirmation Phase.
1
3
3
3
EG007
700 mg LY2495655
700 mg LY2495655 every 2 weeks. Dose Escalation Phase.
2
6
6
6
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0071 events1 affected6 at risk
Adrenal haemorrhage
Endocrine disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0041 events1 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected6 at risk
Constipation
Gastrointestinal disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected6 at risk
Liver abscess
Infections and infestations
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected4 at risk
EG0051 events1 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected6 at risk
Altered state of consciousness
Nervous system disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected4 at risk
EG0051 events1 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected6 at risk
Viith nerve paralysis
Nervous system disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0063 events1 affected3 at risk
EG0070 events0 affected6 at risk
Deep vein thrombosis
Vascular disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0071 events1 affected6 at risk
Hypertension
Vascular disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected4 at risk
EG0051 events1 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected6 at risk
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0041 events1 affected4 at risk
EG0050 events0 affected3 at risk
EG0064 events1 affected3 at risk
EG0071 events1 affected6 at risk
Tachycardia
Cardiac disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0042 events1 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected6 at risk
Eye swelling
Eye disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0042 events1 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected6 at risk
Abdominal pain
Gastrointestinal disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG0030 events0 affected3 at risk
EG0042 events1 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0077 events1 affected6 at risk
Constipation
Gastrointestinal disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0022 events1 affected3 at risk
EG0030 events0 affected3 at risk
EG00418 events2 affected4 at risk
EG0050 events0 affected3 at risk
EG0067 events1 affected3 at risk
EG0070 events0 affected6 at risk
Diarrhoea
Gastrointestinal disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0043 events1 affected4 at risk
EG0050 events0 affected3 at risk
EG0062 events1 affected3 at risk
EG0070 events0 affected6 at risk
Dysphagia
Gastrointestinal disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0043 events1 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected6 at risk
Faeces discoloured
Gastrointestinal disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected3 at risk
EG0070 events0 affected6 at risk
Flatulence
Gastrointestinal disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0072 events1 affected6 at risk
Nausea
Gastrointestinal disorders
MedDRA 15.1
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected6 at risk
Proctalgia
Gastrointestinal disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected3 at risk
EG0070 events0 affected6 at risk
Retching
Gastrointestinal disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0074 events1 affected6 at risk
Salivary hypersecretion
Gastrointestinal disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0074 events1 affected6 at risk
Vomiting
Gastrointestinal disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0022 events1 affected3 at risk
EG0034 events1 affected3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected6 at risk
Asthenia
General disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG00331 events1 affected3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0062 events1 affected3 at risk
EG0070 events0 affected6 at risk
Chest pain
General disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected6 at risk
Fatigue
General disorders
MedDRA 15.1
Systematic Assessment
EG0002 events1 affected4 at risk
EG0013 events1 affected3 at risk
EG0022 events1 affected3 at risk
EG00310 events1 affected3 at risk
EG0046 events3 affected4 at risk
EG0050 events0 affected3 at risk
EG0068 events2 affected3 at risk
EG0075 events1 affected6 at risk
Malaise
General disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0071 events1 affected6 at risk
Nodule
General disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0071 events1 affected6 at risk
Oedema peripheral
General disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG00213 events1 affected3 at risk
EG0035 events1 affected3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected6 at risk
Pain
General disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0072 events1 affected6 at risk
Pyrexia
General disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected6 at risk
Hyperbilirubinaemia
Hepatobiliary disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected4 at risk
EG0052 events1 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected6 at risk
Candidiasis
Infections and infestations
MedDRA 15.1
Systematic Assessment
EG0002 events1 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected6 at risk
Fungal skin infection
Infections and infestations
MedDRA 15.1
Systematic Assessment
EG0002 events1 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected6 at risk
Herpes virus infection
Infections and infestations
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0072 events1 affected6 at risk
Herpes zoster
Infections and infestations
MedDRA 15.1
Systematic Assessment
EG0006 events1 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected6 at risk
Influenza
Infections and infestations
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0071 events1 affected6 at risk
Nasopharyngitis
Infections and infestations
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0022 events1 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected6 at risk
Oral candidiasis
Infections and infestations
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0044 events1 affected4 at risk
EG0050 events0 affected3 at risk
EG0062 events1 affected3 at risk
EG0070 events0 affected6 at risk
Respiratory tract infection
Infections and infestations
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected6 at risk
Rhinitis
Infections and infestations
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0072 events1 affected6 at risk
Sinusitis
Infections and infestations
MedDRA 15.1
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected6 at risk
Tooth infection
Infections and infestations
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0075 events1 affected6 at risk
Upper respiratory tract infection
Infections and infestations
MedDRA 15.1
Systematic Assessment
EG0002 events1 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected6 at risk
Urinary tract infection
Infections and infestations
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0043 events2 affected4 at risk
EG0050 events0 affected3 at risk
EG0064 events1 affected3 at risk
EG0072 events1 affected6 at risk
Arthropod sting
Injury, poisoning and procedural complications
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0071 events1 affected6 at risk
Laceration
Injury, poisoning and procedural complications
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0024 events1 affected3 at risk
EG0032 events1 affected3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected6 at risk
Muscle strain
Injury, poisoning and procedural complications
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG00717 events1 affected6 at risk
Procedural pain
Injury, poisoning and procedural complications
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0012 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected4 at risk
EG0051 events1 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected6 at risk
Glucose urine present
Investigations
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG00419 events1 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected6 at risk
Weight decreased
Investigations
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0062 events1 affected3 at risk
EG0070 events0 affected6 at risk
Decreased appetite
Metabolism and nutrition disorders
MedDRA 15.1
Systematic Assessment
EG0002 events1 affected4 at risk
EG0010 events0 affected3 at risk
EG0026 events1 affected3 at risk
EG0030 events0 affected3 at risk
EG0046 events2 affected4 at risk
EG0051 events1 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected6 at risk
Dehydration
Metabolism and nutrition disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected3 at risk
EG0042 events1 affected4 at risk
EG0051 events1 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected6 at risk
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0043 events1 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected6 at risk
Hyperlipidaemia
Metabolism and nutrition disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected4 at risk
EG0051 events1 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected6 at risk
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0042 events1 affected4 at risk
EG0053 events2 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected6 at risk
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0022 events1 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected4 at risk
EG0052 events1 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected6 at risk
Increased appetite
Metabolism and nutrition disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0022 events1 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected6 at risk
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0029 events2 affected3 at risk
EG00323 events1 affected3 at risk
EG0042 events1 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected6 at risk
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0027 events2 affected3 at risk
EG0030 events0 affected3 at risk
EG0042 events1 affected4 at risk
EG0050 events0 affected3 at risk
EG0062 events1 affected3 at risk
EG0070 events0 affected6 at risk
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0071 events1 affected6 at risk
Muscle tightness
Musculoskeletal and connective tissue disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0071 events1 affected6 at risk
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0022 events1 affected3 at risk
EG0030 events0 affected3 at risk
EG0042 events1 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected6 at risk
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0012 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected6 at risk
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0063 events1 affected3 at risk
EG0070 events0 affected6 at risk
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0032 events1 affected3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0072 events1 affected6 at risk
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected3 at risk
EG0040 events0 affected4 at risk
EG0051 events1 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected6 at risk
Plantar fasciitis
Musculoskeletal and connective tissue disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0067 events1 affected3 at risk
EG0070 events0 affected6 at risk
Tendonitis
Musculoskeletal and connective tissue disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG00315 events1 affected3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected6 at risk
Benign neoplasm of thyroid gland
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG00716 events1 affected6 at risk
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 15.1
Systematic Assessment
EG0002 events1 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected6 at risk
Tumour ulceration
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0076 events1 affected6 at risk
Aphasia
Nervous system disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected4 at risk
EG0053 events1 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected6 at risk
Dizziness
Nervous system disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0041 events1 affected4 at risk
EG0051 events1 affected3 at risk
EG0060 events0 affected3 at risk
EG0072 events1 affected6 at risk
Dizziness postural
Nervous system disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected4 at risk
EG0055 events1 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected6 at risk
Dysgeusia
Nervous system disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0074 events1 affected6 at risk
Headache
Nervous system disorders
MedDRA 15.1
Systematic Assessment
EG0002 events1 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0045 events1 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected6 at risk
Hypoaesthesia
Nervous system disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG00315 events1 affected3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected6 at risk
Loss of consciousness
Nervous system disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0041 events1 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected6 at risk
Restless legs syndrome
Nervous system disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG00719 events1 affected6 at risk
Somnolence
Nervous system disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0043 events1 affected4 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected3 at risk
EG0070 events0 affected6 at risk
Spinal cord compression
Nervous system disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected6 at risk
Syncope
Nervous system disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected6 at risk
Tremor
Nervous system disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG00213 events1 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected6 at risk
Anxiety
Psychiatric disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG00717 events1 affected6 at risk
Confusional state
Psychiatric disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected6 at risk
Depression
Psychiatric disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG00418 events1 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected6 at risk
Insomnia
Psychiatric disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0048 events1 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG00719 events1 affected6 at risk
Haematuria
Renal and urinary disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0043 events1 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected6 at risk
Lower urinary tract symptoms
Renal and urinary disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0076 events1 affected6 at risk
Proteinuria
Renal and urinary disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0042 events1 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected6 at risk
Renal failure
Renal and urinary disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0043 events2 affected4 at risk
EG0050 events0 affected3 at risk
EG0066 events1 affected3 at risk
EG0070 events0 affected6 at risk
Urinary retention
Renal and urinary disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0022 events1 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected6 at risk
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0013 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0045 events1 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0071 events1 affected6 at risk
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 15.1
Systematic Assessment
EG0002 events1 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0074 events1 affected6 at risk
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0073 events1 affected6 at risk
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0042 events1 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0071 events1 affected6 at risk
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0013 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected6 at risk
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0043 events1 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected6 at risk
Ecchymosis
Skin and subcutaneous tissue disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected6 at risk
Erythema
Skin and subcutaneous tissue disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected6 at risk
Rash
Skin and subcutaneous tissue disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0033 events1 affected3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected6 at risk
Skin lesion
Skin and subcutaneous tissue disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG00713 events1 affected6 at risk
Hypotension
Vascular disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected3 at risk
EG0041 events1 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected6 at risk
Orthostatic hypotension
Vascular disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected6 at risk
Thrombophlebitis superficial
Vascular disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0072 events1 affected6 at risk
GT60
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Not provided
3
BG0053
BG0061
BG0074
BG00820
0
BG0041
BG0050
BG0060
BG0070
BG0083
0
BG0040
BG0050
BG0060
BG0070
BG0081
3
OG0043
OG0053
OG0063
OG0073
19.5
(13.8 to 28.7)
OG00428.2(20.2 to 41.6)
OG00560.4(43.2 to 89.4)
OG00686.8(62.1 to 128)
OG007204(146 to 302)
Cycle 4
Title
Measurements
OG0000.622(0.408 to 0.931)
OG0012.63(1.63 to 4.05)
OG00210.0(6.00 to 15.3)
OG00339.2(23.1 to 61.0)
OG00457.6(33.9 to 89.8)
OG005124(73.4 to 195)
OG006179(106 to 280)
OG007424(252 to 660)
3
OG0043
OG0053
OG0063
OG0073
3
ParticipantsOG0043
ParticipantsOG0053
ParticipantsOG0063
ParticipantsOG0073
Title
Measurements
OG0006.58± 7
OG00111.5± 12
OG00238.3± 20
OG003101.0± 12
OG004754.0± 37
OG005221.0± 8
OG0061360.0± 27
OG007392.0± 14
Cycle 4
ParticipantsOG0002
ParticipantsOG0013
ParticipantsOG0022
ParticipantsOG0033
ParticipantsOG0042
ParticipantsOG0053
ParticipantsOG0063
ParticipantsOG0073
Title
Measurements
OG0006.67± NACV% not calculated when n=2. Individual parameter (7.74, 5.75).
OG00112.6± 9
OG00260.2± NACV% not calculated when n=2. Individual parameter (55.62, 65.11).
OG003
165.0
± 16
OG0041020.0± NACV% not calculated when n=2. Individual parameter (768.76, 1349.52).