A Study of LY3164530 in Participants With Cancer | NCT02221882 | Trialant
NCT02221882
Sponsor
Eli Lilly and Company
Status
Completed
Last Update Posted
Oct 23, 2019Actual
Enrollment
29Actual
Phase
Phase 1
Conditions
Neoplasms
Neoplasm Metastasis
Interventions
LY3164530
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
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Derived Section
Miscellaneous Info Module
Version Holder
NCT02221882
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
15279
Secondary IDs
ID
Type
Description
Link
I7H-MC-JNBA
Other Identifier
Eli Lilly and Company
Brief Title
A Study of LY3164530 in Participants With Cancer
Official Title
A Phase 1 Study of LY3164530, a Bispecific Antibody Targeting Mesenchymal-Epithelial Transition Factor (MET) and Epidermal Growth Factor Receptor (EGFR), in Patients With Advanced or Metastatic Cancer
Acronym
Not provided
Organization
Eli Lilly and CompanyINDUSTRY
Status Module
Record Verification Date
Oct 2019
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Aug 2014
Primary Completion Date
Mar 7, 2017Actual
Completion Date
Mar 7, 2017Actual
First Submitted Date
Aug 19, 2014
First Submission Date that Met QC Criteria
Aug 19, 2014
First Posted Date
Aug 21, 2014Estimated
Results Waived
Not provided
Results First Submitted Date
Jun 28, 2019
Results First Submitted that Met QC Criteria
Oct 22, 2019
Results First Posted Date
Oct 23, 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
Oct 22, 2019
Last Update Posted Date
Oct 23, 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 evaluate the safety of a study drug known as LY3164530 in participants with cancer that is advanced and/or has spread to another part(s) of the body.
Detailed Description
Not provided
Conditions Module
Conditions
Neoplasms
Neoplasm Metastasis
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
29Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
LY3164530
Experimental
LY3164530 in escalating dose cohorts given intravenously (IV) once on Days 1 and 15 or on Days 1, 8, 15, and 22 of a 28-day cycle. Participants may continue to receive study drug until discontinuation criteria are met.
Drug: LY3164530
Interventions
Name
Type
Description
Arm Group Labels
Other Names
LY3164530
Drug
Administered IV.
LY3164530
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Recommended Phase 2 Dose of LY3164530: Maximum Tolerated Dose (MTD)
Recommended Phase 2 Dose of LY3164530: MTD
Cycle 1 (Cycle = 28 days)
Secondary Outcomes
Measure
Description
Time Frame
Maximum Serum Concentration (Cmax) of LY3164530 Epidermal Growth Factor Receptor (EGFR) Specific ELISA Assay
Cmax in Schedule (Sched) 1 Cycle 1 (C1) and Cycle 2 (C2) and Sched. 2 C1 and C2 dose escalation based on EGFR specific ELISA assay.
Pharmacokinetic (PK) Time Frame Schedule 1:Cycle 1 and 2 (Day 1): Predose; Mid-infusion; End of infusion; 2 hours (hrs), 4hrs, 6hrs, 24 ±4hrs post-infusion; Day 3: anytime during day; Day 8 ±1 : anytime during day. Day 15: Pre-dose, End of infusion; 2hrs, 4hrs, 6hrs post-infusion; Day 22 ±2: anytime during day. Cycles 3-6: Pre-dose, End of infusion.
PK Time Frame: Schedule 2: Cycle 1 and 2 (Day 1): Predose; Mid-infusion; End of infusion; 2hrs, 4hrs, 6hrs, 24 ±4hrs post-infusion (Cycle 1); Day 3: anytime during day; Day 8: Pre-dose; End of infusion; Day 22: Pre-dose; End of infusion; 2hrs, 4hrs, 6hrs, 24 ±4hrs post-infusion (Cycle 1); Day 24: anytime during day. Cycles 3-6: Pre-dose; End of Infusion.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria
Have advanced or metastatic cancer and be an appropriate candidate for experimental therapy.
Have adequate organ function.
Prior Treatments:
Systemic treatments: Must have discontinued previous systemic treatments for cancer and recovered from the acute effects of therapy. Participants must have discontinued:
Cytotoxic therapies or targeted agents that are small molecule inhibitors for 5 half-lives or at least 28 days.
Mitomycin-C or nitrosourea therapy for at least 42 days and biologic agents for at least 28 days.
Radiation therapy and surgery must be completed 4 weeks prior to therapy, except for limited field radiation therapy, which must be completed 2 weeks before therapy.
If participant is of reproductive potential, must agree to use medically approved contraceptive precautions during the study and for three months following the last dose of study drug.
If the participant is a female of childbearing potential, must have had a negative serum or urine pregnancy test within 14 days of the first dose of study drug and must not be breast feeding.
Exclusion Criteria:
Must not have taken an unapproved drug as treatment for any indication within the last 28 days prior to starting study treatment.
Must not have an active symptomatic fungal, bacterial or viral infection, including human immunodeficiency virus (HIV) or Hepatitis A, B, or C.
Must not have a serious preexisting medical conditions or concomitant disorders.
Must not have leukemia.
Must not have QT interval of >470 millisecond.
Must not have a serious cardiac condition, such as congestive heart failure, unstable angina pectoris, or heart attack within the last 3 months.
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
Pinnacle Oncology Hematology
Scottsdale
Arizona
85258
United States
University of Texas MD Anderson Cancer Center
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.
Participants, who completed at least 1 cycle of treatment or discontinued due to an adverse event during Cycle 1 and completed the required post-treatment safety assessment, were considered to have completed the study.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
300 mg LY3164530 Schedule 1
300 mg LY3164530 given intravenously (IV) on Days 1 and 15 of each 28 day cycle.
FG001
600 mg LY3164530 Schedule 1
600 mg LY3164530 given IV on Days 1, and 15 of each 28 day cycle.
FG002
1000 mg LY3164530 Schedule 1
1000 mg LY3164530 given IV on Days 1 and 15 of each 28 day cycle.
FG003
1250 mg LY3164530 Schedule 1
1250 mg LY3164530 given IV on Days 1 and 15 of each 28 day cycle.
FG004
500 mg LY3164530 Schedule 2
500 mg LY3164530 given IV on Days 1, 8, 15, and 22 of each 28 day cycle.
FG005
600 mg LY3164530 Schedule 2
600 mg LY3164530 given IV on Days 1, 8, 15, and 22 of each 28 day cycle.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
FG0003 subjects
FG0013 subjects
FG00211 subjects
FG0033 subjects
FG0045 subjects
FG0054 subjects
Received at Least One Dose of Study Drug
FG0003 subjects
FG0013 subjects
FG00211 subjects
FG0033 subjects
COMPLETED
FG0003 subjects
FG0012 subjects
FG0027 subjects
FG0031 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0011 subjects
FG0024 subjects
FG0032 subjects
FG004
Type
Comment
Reasons
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0024 subjects
FG003
Baseline Characteristics Module
Baseline Analysis Population Description
All participants who received at least one dose of study drug.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
300 mg LY3164530 Schedule 1
300 mg LY3164530 given intravenously (IV) on Days 1 and 15 of each 28 day cycle.
BG001
600 mg LY3164530 Schedule 1
600 mg LY3164530 given IV on Days 1, and 15 of each 28 day cycle.
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, Categorical
Count of Participants
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
Recommended Phase 2 Dose of LY3164530: Maximum Tolerated Dose (MTD)
Recommended Phase 2 Dose of LY3164530: MTD
All participants who receive at least one dose of study drug.
Posted
Number
milligrams (mg)
Cycle 1 (Cycle = 28 days)
ID
Title
Description
OG000
Schedule 1
LY3164530 in escalating dose cohorts of 300mg, 600mg, 1000mg and 1250mg given intravenously (IV) once on Days 1, 8, 15, and 22 of a 28-day cycle.
OG001
Schedule 2
LY3164530 in escalating dose cohorts of 500 mg or 600 mg given intravenously (IV) once on Days 1 and 15 of a 28-day cycle.
Adverse Events Module
Frequency Threshold
5
Time Frame
Baseline Through Study Completion (Up to 6 Months)
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
300 mg LY3164530 Schedule 1
300 mg LY3164530 given intravenously (IV) on Days 1 and 15 of each 28 day cycle.
Cycle 1 predose (Day 1) up to Cycle 6 end of infusion (Day 1)
Maximum Serum Concentration (Cmax) of LY3164530 Mesenchymal-Epithelial Transition Factor (MET) Specific ELISA Assay
Cmax in Schedule 1 Cycles 1 and 2 and Schedule 2 Cycles 1 and 2 based on the MET-specific ELISA assay.
Pharmacokinetic (PK) Time Frame Schedule 1:Cycle 1 and 2 (Day 1): Predose; Mid-infusion; End of infusion; 2 hours (hrs), 4hrs, 6hrs, 24 ±4hrs post-infusion; Day 3: anytime during day; Day 8 ±1 : anytime during day. Day 15: Pre-dose, End of infusion; 2hrs, 4hrs, 6hrs post-infusion; Day 22 ±2: anytime during day. Cycles 3-6: Pre-dose, End of infusion.
PK Time Frame: Schedule 2: Cycle 1 and 2 (Day 1): Predose; Mid-infusion; End of infusion; 2hrs, 4hrs, 6hrs, 24 ±4hrs post-infusion (Cycle 1); Day 3: anytime during day; Day 8: Pre-dose; End of infusion; Day 22: Pre-dose; End of infusion; 2hrs, 4hrs, 6hrs, 24 ±4hrs post-infusion (Cycle 1); Day 24: anytime during day. Cycles 3-6: Pre-dose; End of Infusion.
Cycle 1 predose (Day 1) up to Cycle 6 end of infusion (Day 1)
Area Under the Serum Concentration-Time Curve (AUC[0-τ]) of LY3164530 EGFR Specific ELISA Assay
Area under the serum concentration-time curve of LY3164530 over the dosing interval (AUC[0-τ]) from time 0 to 336 hours (τ) [Schedule 1] or from time 0-168 hours (τ) [Schedule 2].
Pharmacokinetic (PK) Time Frame Schedule 1:Cycle 1 and 2 (Day 1): Predose; Mid-infusion; End of infusion; 2 hours (hrs), 4hrs, 6hrs, 24 ±4hrs post-infusion; Day 3: anytime during day; Day 8 ±1 : anytime during day. Day 15: Pre-dose, End of infusion; 2hrs, 4hrs, 6hrs post-infusion; Day 22 ±2: anytime during day. Cycles 3-6: Pre-dose, End of infusion.
PK Time Frame: Schedule 2: Cycle 1 and 2 (Day 1): Predose; Mid-infusion; End of infusion; 2hrs, 4hrs, 6hrs, 24 ±4hrs post-infusion (Cycle 1); Day 3: anytime during day; Day 8: Pre-dose; End of infusion; Day 22: Pre-dose; End of infusion; 2hrs, 4hrs, 6hrs, 24 ±4hrs post-infusion (Cycle 1); Day 24: anytime during day. Cycles 3-6: Pre-dose; End of Infusion.
Cycle 1 predose (Day 1) up to Cycle 6 end of infusion (Day 1)
Area Under the Serum Concentration-Time Curve (AUC[0-τ]) of LY3164530 MET Specific ELISA Assay
Area under the serum concentration-time curve of LY3164530 over the dosing interval (AUC[0-τ]) from time 0 to 336 hours (τ) [Schedule 1] or from time 0-168 hours (τ) [Schedule 2].
Pharmacokinetic (PK) Time Frame Schedule 1:Cycle 1 and 2 (Day 1): Predose; Mid-infusion; End of infusion; 2 hours (hrs), 4hrs, 6hrs, 24 ±4hrs post-infusion; Day 3: anytime during day; Day 8 ±1 : anytime during day. Day 15: Pre-dose, End of infusion; 2hrs, 4hrs, 6hrs post-infusion; Day 22 ±2: anytime during day. Cycles 3-6: Pre-dose, End of infusion.
PK Time Frame: Schedule 2: Cycle 1 and 2 (Day 1): Predose; Mid-infusion; End of infusion; 2hrs, 4hrs, 6hrs, 24 ±4hrs post-infusion (Cycle 1); Day 3: anytime during day; Day 8: Pre-dose; End of infusion; Day 22: Pre-dose; End of infusion; 2hrs, 4hrs, 6hrs, 24 ±4hrs post-infusion (Cycle 1); Day 24: anytime during day. Cycles 3-6: Pre-dose; End of Infusion.
Cycle 1 predose (Day 1) up to Cycle 6 end of infusion (Day 1)
Number of Participants With Tumor Response
Number of Participants with Tumor Response
Baseline Through Study Completion (Up to 6 Months)
Houston
Texas
77030
United States
The START Center for Cancer Care
San Antonio
Texas
78229
United States
FG004
5 subjects
FG0054 subjects
3 subjects
FG0052 subjects
2 subjects
FG0052 subjects
2 subjects
FG0042 subjects
FG0052 subjects
Death
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
BG002
1000 mg LY3164530 Schedule 1
1000 mg LY3164530 given IV on Days 1 and 15 of each 28 day cycle.
BG003
1250 mg LY3164530 Schedule 1
1250 mg LY3164530 given IV on Days 1 and 15 of each 28 day cycle.
BG004
500 mg LY3164530 Schedule 2
500 mg LY3164530 given IV on Days 1, 8, 15, and 22 of each 28 day cycle.
BG005
600 mg LY3164530 Schedule 2
600 mg LY3164530 given IV on Days 1, 8, 15, and 22 of each 28 day cycle.
BG006
Total
Total of all reporting groups
3
BG0013
BG00211
BG0033
BG0045
BG0054
BG00629
Participants
No
Title
Denominators
Categories
Title
Measurements
<=18 years
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
Between 18 and 65 years
BG0002
BG0013
BG0025
BG0032
BG004
>=65 years
BG0001
BG0010
BG0026
BG0031
BG004
Sex: Female, Male
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Female
BG0002
BG0010
BG0023
BG0032
BG0042
BG0053
BG00612
Male
BG0001
BG0013
BG0028
BG0031
BG004
Ethnicity (NIH/OMB)
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0000
BG0012
BG0023
BG0030
BG0041
BG0051
BG0067
Not Hispanic or Latino
BG0003
BG0011
BG0028
BG0033
BG004
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG004
Race (NIH/OMB)
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
Asian
BG0000
BG0010
BG0020
BG0030
BG004
Native Hawaiian or Other Pacific Islander
BG0000
BG0010
BG0020
BG0030
BG004
Black or African American
BG0000
BG0010
BG0020
BG0030
BG004
White
BG0003
BG0013
BG00211
BG0033
BG004
More than one race
BG0000
BG0010
BG0020
BG0030
BG004
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG004
Region of Enrollment
Count of Participants
Participants
Title
Denominators
Categories
United States
Title
Measurements
BG0003
BG0013
BG00211
BG0033
BG0045
BG0054
BG00629
Units
Counts
Participants
OG00020
OG0019
Title
Denominators
Categories
Title
Measurements
OG0001000
OG001500
Secondary
Maximum Serum Concentration (Cmax) of LY3164530 Epidermal Growth Factor Receptor (EGFR) Specific ELISA Assay
Cmax in Schedule (Sched) 1 Cycle 1 (C1) and Cycle 2 (C2) and Sched. 2 C1 and C2 dose escalation based on EGFR specific ELISA assay.
Pharmacokinetic (PK) Time Frame Schedule 1:Cycle 1 and 2 (Day 1): Predose; Mid-infusion; End of infusion; 2 hours (hrs), 4hrs, 6hrs, 24 ±4hrs post-infusion; Day 3: anytime during day; Day 8 ±1 : anytime during day. Day 15: Pre-dose, End of infusion; 2hrs, 4hrs, 6hrs post-infusion; Day 22 ±2: anytime during day. Cycles 3-6: Pre-dose, End of infusion.
PK Time Frame: Schedule 2: Cycle 1 and 2 (Day 1): Predose; Mid-infusion; End of infusion; 2hrs, 4hrs, 6hrs, 24 ±4hrs post-infusion (Cycle 1); Day 3: anytime during day; Day 8: Pre-dose; End of infusion; Day 22: Pre-dose; End of infusion; 2hrs, 4hrs, 6hrs, 24 ±4hrs post-infusion (Cycle 1); Day 24: anytime during day. Cycles 3-6: Pre-dose; End of Infusion.
All participants who received at least one dose of study drug and had evaluable PK data.
Posted
Geometric Mean
Geometric Coefficient of Variation
microgram per milliliter (µg/mL )
Cycle 1 predose (Day 1) up to Cycle 6 end of infusion (Day 1)
ID
Title
Description
OG000
300 mg LY3164530 Schedule 1
300 mg LY3164530 given intravenously (IV) on Days 1 and 15 of each 28 day cycle.
OG001
600 mg LY3164530 Schedule 1
600 mg LY3164530 given IV on Days 1, and 15 of each 28 day cycle.
OG002
1000 mg LY3164530 Schedule 1
1000 mg LY3164530 given IV on Days 1 and 15 of each 28 day cycle.
OG003
1250 mg LY3164530 Schedule 1
1250 mg LY3164530 given IV on Days 1 and 15 of each 28 day cycle.
OG004
500 mg LY3164530 Schedule 2
500 mg LY3164530 given IV on Days 1, 8, 15, and 22 of each 28 day cycle.
OG005
600 mg LY3164530 Schedule 2
600 mg LY3164530 given IV on Days 1, 8, 15, and 22 of each 28 day cycle.
Units
Counts
Participants
OG0003
OG0013
OG00211
OG003
Title
Denominators
Categories
Schedule 1 Cycle 1 Day 1; Schedule 2 Cycle 1 Day 1
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG00211
ParticipantsOG003
Secondary
Maximum Serum Concentration (Cmax) of LY3164530 Mesenchymal-Epithelial Transition Factor (MET) Specific ELISA Assay
Cmax in Schedule 1 Cycles 1 and 2 and Schedule 2 Cycles 1 and 2 based on the MET-specific ELISA assay.
Pharmacokinetic (PK) Time Frame Schedule 1:Cycle 1 and 2 (Day 1): Predose; Mid-infusion; End of infusion; 2 hours (hrs), 4hrs, 6hrs, 24 ±4hrs post-infusion; Day 3: anytime during day; Day 8 ±1 : anytime during day. Day 15: Pre-dose, End of infusion; 2hrs, 4hrs, 6hrs post-infusion; Day 22 ±2: anytime during day. Cycles 3-6: Pre-dose, End of infusion.
PK Time Frame: Schedule 2: Cycle 1 and 2 (Day 1): Predose; Mid-infusion; End of infusion; 2hrs, 4hrs, 6hrs, 24 ±4hrs post-infusion (Cycle 1); Day 3: anytime during day; Day 8: Pre-dose; End of infusion; Day 22: Pre-dose; End of infusion; 2hrs, 4hrs, 6hrs, 24 ±4hrs post-infusion (Cycle 1); Day 24: anytime during day. Cycles 3-6: Pre-dose; End of Infusion.
All participants who received at least one dose of study drug and had evaluable PK data.
Posted
Geometric Mean
Geometric Coefficient of Variation
µg/mL
Cycle 1 predose (Day 1) up to Cycle 6 end of infusion (Day 1)
ID
Title
Description
OG000
300 mg LY3164530 Schedule 1
300 mg LY3164530 given intravenously (IV) on Days 1 and 15 of each 28 day cycle.
OG001
600 mg LY3164530 Schedule 1
600 mg LY3164530 given IV on Days 1, and 15 of each 28 day cycle.
OG002
1000 mg LY3164530 Schedule 1
1000 mg LY3164530 given IV on Days 1 and 15 of each 28 day cycle.
OG003
1250 mg LY3164530 Schedule 1
1250 mg LY3164530 given IV on Days 1 and 15 of each 28 day cycle.
OG004
500 mg LY3164530 Schedule 2
500 mg LY3164530 given IV on Days 1, 8, 15, and 22 of each 28 day cycle.
OG005
600 mg LY3164530 Schedule 2
600 mg LY3164530 given IV on Days 1, 8, 15, and 22 of each 28 day cycle.
Units
Counts
Participants
OG0003
OG0013
OG00211
OG003
Title
Denominators
Categories
Schedule 1 Cycle 1 Day 1; Schedule 2 Cycle 1 Day 1
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG00211
ParticipantsOG003
Secondary
Area Under the Serum Concentration-Time Curve (AUC[0-τ]) of LY3164530 EGFR Specific ELISA Assay
Area under the serum concentration-time curve of LY3164530 over the dosing interval (AUC[0-τ]) from time 0 to 336 hours (τ) [Schedule 1] or from time 0-168 hours (τ) [Schedule 2].
Pharmacokinetic (PK) Time Frame Schedule 1:Cycle 1 and 2 (Day 1): Predose; Mid-infusion; End of infusion; 2 hours (hrs), 4hrs, 6hrs, 24 ±4hrs post-infusion; Day 3: anytime during day; Day 8 ±1 : anytime during day. Day 15: Pre-dose, End of infusion; 2hrs, 4hrs, 6hrs post-infusion; Day 22 ±2: anytime during day. Cycles 3-6: Pre-dose, End of infusion.
PK Time Frame: Schedule 2: Cycle 1 and 2 (Day 1): Predose; Mid-infusion; End of infusion; 2hrs, 4hrs, 6hrs, 24 ±4hrs post-infusion (Cycle 1); Day 3: anytime during day; Day 8: Pre-dose; End of infusion; Day 22: Pre-dose; End of infusion; 2hrs, 4hrs, 6hrs, 24 ±4hrs post-infusion (Cycle 1); Day 24: anytime during day. Cycles 3-6: Pre-dose; End of Infusion.
All participants who received at least one dose of study drug and had evaluable PK data.
Posted
Geometric Mean
Geometric Coefficient of Variation
micrograms*milliliter per hour(µg*mL/hr)
Cycle 1 predose (Day 1) up to Cycle 6 end of infusion (Day 1)
ID
Title
Description
OG000
300 mg LY3164530 Schedule 1
300 mg LY3164530 given intravenously (IV) on Days 1 and 15 of each 28 day cycle.
OG001
600 mg LY3164530 Schedule 1
600 mg LY3164530 given IV on Days 1, and 15 of each 28 day cycle.
OG002
1000 mg LY3164530 Schedule 1
1000 mg LY3164530 given IV on Days 1 and 15 of each 28 day cycle.
OG003
1250 mg LY3164530 Schedule 1
1250 mg LY3164530 given IV on Days 1 and 15 of each 28 day cycle.
OG004
500 mg LY3164530 Schedule 2
500 mg LY3164530 given IV on Days 1, 8, 15, and 22 of each 28 day cycle.
OG005
600 mg LY3164530 Schedule 2
600 mg LY3164530 given IV on Days 1, 8, 15, and 22 of each 28 day cycle.
Units
Counts
Participants
OG0003
OG0013
OG00211
OG003
Title
Denominators
Categories
Schedule 1 Cycle 1 Day 1; Schedule 2 Cycle 1 Day 1
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG00211
ParticipantsOG003
Secondary
Area Under the Serum Concentration-Time Curve (AUC[0-τ]) of LY3164530 MET Specific ELISA Assay
Area under the serum concentration-time curve of LY3164530 over the dosing interval (AUC[0-τ]) from time 0 to 336 hours (τ) [Schedule 1] or from time 0-168 hours (τ) [Schedule 2].
Pharmacokinetic (PK) Time Frame Schedule 1:Cycle 1 and 2 (Day 1): Predose; Mid-infusion; End of infusion; 2 hours (hrs), 4hrs, 6hrs, 24 ±4hrs post-infusion; Day 3: anytime during day; Day 8 ±1 : anytime during day. Day 15: Pre-dose, End of infusion; 2hrs, 4hrs, 6hrs post-infusion; Day 22 ±2: anytime during day. Cycles 3-6: Pre-dose, End of infusion.
PK Time Frame: Schedule 2: Cycle 1 and 2 (Day 1): Predose; Mid-infusion; End of infusion; 2hrs, 4hrs, 6hrs, 24 ±4hrs post-infusion (Cycle 1); Day 3: anytime during day; Day 8: Pre-dose; End of infusion; Day 22: Pre-dose; End of infusion; 2hrs, 4hrs, 6hrs, 24 ±4hrs post-infusion (Cycle 1); Day 24: anytime during day. Cycles 3-6: Pre-dose; End of Infusion.
All participants who received at least one dose of study drug and had evaluable PK data.
Posted
Geometric Mean
Geometric Coefficient of Variation
µg*hr/mL
Cycle 1 predose (Day 1) up to Cycle 6 end of infusion (Day 1)
ID
Title
Description
OG000
300 mg LY3164530 Schedule 1
300 mg LY3164530 given intravenously (IV) on Days 1 and 15 of each 28 day cycle.
OG001
600 mg LY3164530 Schedule 1
600 mg LY3164530 given IV on Days 1, and 15 of each 28 day cycle.
OG002
1000 mg LY3164530 Schedule 1
1000 mg LY3164530 given IV on Days 1 and 15 of each 28 day cycle.
OG003
1250 mg LY3164530 Schedule 1
1250 mg LY3164530 given IV on Days 1 and 15 of each 28 day cycle.
OG004
500 mg LY3164530 Schedule 2
500 mg LY3164530 given IV on Days 1, 8, 15, and 22 of each 28 day cycle.
OG005
600 mg LY3164530 Schedule 2
600 mg LY3164530 given IV on Days 1, 8, 15, and 22 of each 28 day cycle.
Units
Counts
Participants
OG0003
OG0013
OG00211
OG003
Title
Denominators
Categories
Schedule 1 Cycle 1 Day 1; Schedule 2 Cycle 1 Day 1
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG00211
ParticipantsOG003
Secondary
Number of Participants With Tumor Response
Number of Participants with Tumor Response
All participants who received at least one dose of study drug and had at least one post-baseline tumor assessment.
Posted
Count of Participants
Participants
No
Baseline Through Study Completion (Up to 6 Months)
ID
Title
Description
OG000
300mg LY3164530 Schedule 1
300 mg LY3164530 given intravenously (IV) on Days 1 and 15 of each 28 day cycle.
OG001
600 mg LY3164530 Schedule 1
600 mg LY3164530 given IV on Days 1, and 15 of each 28 day cycle.
OG002
1000 mg LY3164530 Schedule 1
1000 mg LY3164530 given IV on Days 1 and 15 of each 28 day cycle.
OG003
1250 mg LY3164530 Schedule 1
1000 mg LY3164530 given IV on Days 1 and 15 of each 28 day cycle.
OG004
500 mg LY3164530 Schedule 2
500 mg LY3164530 given IV on Days 1, 8, 15, and 22 of each 28 day cycle.
OG005
600 mg LY3164530 Schedule 2
600 mg LY3164530 given IV on Days 1, 8, 15, and 22 of each 28 day cycle
Units
Counts
Participants
OG0003
OG0013
OG0029
OG003
Title
Denominators
Categories
Complete Response
Title
Measurements
OG0000
OG0010
OG0020
OG003
0
3
0
3
3
3
EG001
600 mg LY3164530 Schedule 1
600 mg LY3164530 given IV on Days 1, and 15 of each 28 day cycle.
1
3
1
3
3
3
EG002
1000 mg LY3164530 Schedule 1
1000 mg LY3164530 given IV on Days 1 and 15 of each 28 day cycle.
0
11
3
11
11
11
EG003
1250 mg LY3164530 Schedule 1
1250 mg LY3164530 given IV on Days 1 and 15 of each 28 day cycle.
0
3
0
3
3
3
EG004
500 mg LY3164530 Schedule 2
500 mg LY3164530 given IV on Days 1, 8, 15, and 22 of each 28 day cycle.
0
5
0
5
5
5
EG005
600 mg LY3164530 Schedule 2
600 mg LY3164530 given IV on Days 1, 8, 15, and 22 of each 28 day cycle.
0
4
0
4
4
4
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected11 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
Cellulitis
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected11 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
Pneumonia
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected11 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
Urosepsis
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected11 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
Hypotension
Vascular disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected11 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0022 events1 affected11 at risk
EG0033 events1 affected3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
Leukocytosis
Blood and lymphatic system disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0022 events2 affected11 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
Palpitations
Cardiac disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected11 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected5 at risk
EG0051 events1 affected4 at risk
Supraventricular tachycardia
Cardiac disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected11 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
Tachycardia
Cardiac disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected11 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
Eye pain
Eye disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected11 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
Ocular hyperaemia
Eye disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected11 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
Trichomegaly
Eye disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected3 at risk
EG0041 events1 affected5 at risk
EG0050 events0 affected4 at risk
Visual impairment
Eye disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected11 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
Abdominal pain
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0023 events1 affected11 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected5 at risk
EG0052 events1 affected4 at risk
Abdominal pain upper
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected11 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
Aphthous ulcer
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected5 at risk
EG0051 events1 affected4 at risk
Ascites
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected11 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected5 at risk
EG0053 events1 affected4 at risk
Constipation
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected11 at risk
EG0032 events1 affected3 at risk
EG0042 events1 affected5 at risk
EG0050 events0 affected4 at risk
Diarrhoea
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0024 events3 affected11 at risk
EG0030 events0 affected3 at risk
EG0041 events1 affected5 at risk
EG0059 events1 affected4 at risk
Dyschezia
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected5 at risk
EG0051 events1 affected4 at risk
Dysphagia
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected11 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected11 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
Gingival bleeding
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected5 at risk
EG0051 events1 affected4 at risk
Haemorrhoids
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected3 at risk
EG0041 events1 affected5 at risk
EG0050 events0 affected4 at risk
Lip dry
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected3 at risk
EG0041 events1 affected5 at risk
EG0050 events0 affected4 at risk
Nausea
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0023 events3 affected11 at risk
EG0031 events1 affected3 at risk
EG0042 events2 affected5 at risk
EG0052 events1 affected4 at risk
Oesophageal spasm
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected11 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
Oral contusion
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
Salivary hypersecretion
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected11 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
Small intestinal obstruction
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected11 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
Stomatitis
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected11 at risk
EG0030 events0 affected3 at risk
EG0046 events4 affected5 at risk
EG0053 events2 affected4 at risk
Swollen tongue
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected3 at risk
EG0041 events1 affected5 at risk
EG0050 events0 affected4 at risk
Tongue eruption
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected5 at risk
EG0051 events1 affected4 at risk
Vomiting
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0022 events1 affected11 at risk
EG0030 events0 affected3 at risk
EG0041 events1 affected5 at risk
EG0051 events1 affected4 at risk
Asthenia
General disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected5 at risk
EG0051 events1 affected4 at risk
Catheter site pruritus
General disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected3 at risk
EG0041 events1 affected5 at risk
EG0050 events0 affected4 at risk
Chills
General disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0022 events2 affected11 at risk
EG0030 events0 affected3 at risk
EG0041 events1 affected5 at risk
EG0051 events1 affected4 at risk
Fatigue
General disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0025 events3 affected11 at risk
EG0033 events2 affected3 at risk
EG0047 events3 affected5 at risk
EG00515 events2 affected4 at risk
Mucosal inflammation
General disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected5 at risk
EG0051 events1 affected4 at risk
Nodule
General disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected3 at risk
EG0041 events1 affected5 at risk
EG0050 events0 affected4 at risk
Non-cardiac chest pain
General disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected11 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
Oedema peripheral
General disorders
MedDRA 20.0
Systematic Assessment
EG0004 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0025 events4 affected11 at risk
EG0030 events0 affected3 at risk
EG0042 events2 affected5 at risk
EG0053 events3 affected4 at risk
Pyrexia
General disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0022 events2 affected11 at risk
EG0030 events0 affected3 at risk
EG0041 events1 affected5 at risk
EG0052 events2 affected4 at risk
Anorectal infection
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected11 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
Cellulitis
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected11 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
Conjunctivitis
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected5 at risk
EG0051 events1 affected4 at risk
Diverticulitis
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected5 at risk
EG0051 events1 affected4 at risk
Enterocolitis infectious
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected3 at risk
EG0041 events1 affected5 at risk
EG0050 events0 affected4 at risk
Folliculitis
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected3 at risk
EG0043 events1 affected5 at risk
EG0050 events0 affected4 at risk
Nail infection
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected3 at risk
EG0042 events1 affected5 at risk
EG0051 events1 affected4 at risk
Paronychia
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0024 events4 affected11 at risk
EG0032 events2 affected3 at risk
EG0044 events2 affected5 at risk
EG0052 events2 affected4 at risk
Rash pustular
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0032 events1 affected3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
Skin candida
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0024 events1 affected11 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
Skin infection
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected5 at risk
EG0052 events1 affected4 at risk
Vulvovaginal mycotic infection
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
Wound infection
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected3 at risk
EG0041 events1 affected5 at risk
EG0050 events0 affected4 at risk
Fall
Injury, poisoning and procedural complications
MedDRA 20.0
Systematic Assessment
EG0004 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected3 at risk
EG0041 events1 affected5 at risk
EG0050 events0 affected4 at risk
Femur fracture
Injury, poisoning and procedural complications
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected5 at risk
EG0051 events1 affected4 at risk
Joint dislocation
Injury, poisoning and procedural complications
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected3 at risk
EG0041 events1 affected5 at risk
EG0050 events0 affected4 at risk
Laceration
Injury, poisoning and procedural complications
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected3 at risk
EG0041 events1 affected5 at risk
EG0050 events0 affected4 at risk
Skin abrasion
Injury, poisoning and procedural complications
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
Sunburn
Injury, poisoning and procedural complications
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected3 at risk
EG0041 events1 affected5 at risk
EG0050 events0 affected4 at risk
Tendon rupture
Injury, poisoning and procedural complications
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected5 at risk
EG0051 events1 affected4 at risk
Blood alkaline phosphatase increased
Investigations
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0025 events2 affected11 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
Blood bilirubin increased
Investigations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected5 at risk
EG0052 events1 affected4 at risk
Blood creatinine increased
Investigations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected11 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
Electrocardiogram qt prolonged
Investigations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected3 at risk
EG0041 events1 affected5 at risk
EG0050 events0 affected4 at risk
Gamma-glutamyltransferase increased
Investigations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0024 events2 affected11 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected5 at risk
EG0051 events1 affected4 at risk
Lymphocyte count decreased
Investigations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected11 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
Transaminases increased
Investigations
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
Weight decreased
Investigations
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected11 at risk
EG0030 events0 affected3 at risk
EG0041 events1 affected5 at risk
EG0051 events1 affected4 at risk
Weight increased
Investigations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected11 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
Decreased appetite
Metabolism and nutrition disorders
MedDRA 20.0
Systematic Assessment
EG0002 events2 affected3 at risk
EG0010 events0 affected3 at risk
EG0025 events3 affected11 at risk
EG0031 events1 affected3 at risk
EG0042 events1 affected5 at risk
EG0050 events0 affected4 at risk
Dehydration
Metabolism and nutrition disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected11 at risk
EG0030 events0 affected3 at risk
EG0045 events2 affected5 at risk
EG0053 events1 affected4 at risk
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0023 events2 affected11 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG00210 events3 affected11 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0028 events3 affected11 at risk
EG0032 events1 affected3 at risk
EG00411 events3 affected5 at risk
EG0051 events1 affected4 at risk
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG00226 events6 affected11 at risk
EG0037 events2 affected3 at risk
EG00417 events5 affected5 at risk
EG0054 events2 affected4 at risk
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0026 events2 affected11 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
Iron deficiency
Metabolism and nutrition disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected11 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0022 events2 affected11 at risk
EG0030 events0 affected3 at risk
EG0041 events1 affected5 at risk
EG0051 events1 affected4 at risk
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected11 at risk
EG0030 events0 affected3 at risk
EG0042 events2 affected5 at risk
EG0053 events2 affected4 at risk
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected11 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected3 at risk
EG0047 events2 affected5 at risk
EG0053 events2 affected4 at risk
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0022 events2 affected11 at risk
EG0030 events0 affected3 at risk
EG0041 events1 affected5 at risk
EG0050 events0 affected4 at risk
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected5 at risk
EG0051 events1 affected4 at risk
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected3 at risk
EG0043 events2 affected5 at risk
EG0051 events1 affected4 at risk
Musculoskeletal stiffness
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected5 at risk
EG0051 events1 affected4 at risk
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected5 at risk
EG0052 events1 affected4 at risk
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected5 at risk
EG0051 events1 affected4 at risk
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0022 events1 affected11 at risk
EG0030 events0 affected3 at risk
EG0042 events2 affected5 at risk
EG0051 events1 affected4 at risk
Tendon disorder
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected3 at risk
EG0041 events1 affected5 at risk
EG0050 events0 affected4 at risk
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 20.0
Systematic Assessment
EG0002 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected11 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
Akathisia
Nervous system disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0022 events1 affected11 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
Ataxia
Nervous system disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
Dizziness
Nervous system disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected3 at risk
EG0042 events2 affected5 at risk
EG0051 events1 affected4 at risk
Dysgeusia
Nervous system disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0022 events2 affected11 at risk
EG0030 events0 affected3 at risk
EG0041 events1 affected5 at risk
EG0050 events0 affected4 at risk
Horner's syndrome
Nervous system disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected3 at risk
EG0041 events1 affected5 at risk
EG0050 events0 affected4 at risk
Neuropathy peripheral
Nervous system disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected11 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
Paraesthesia
Nervous system disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected5 at risk
EG0051 events1 affected4 at risk
Anxiety
Psychiatric disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected3 at risk
EG0044 events2 affected5 at risk
EG0050 events0 affected4 at risk
Depression
Psychiatric disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0031 events1 affected3 at risk
EG0044 events2 affected5 at risk
EG0051 events1 affected4 at risk
Insomnia
Psychiatric disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected11 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
Dysuria
Renal and urinary disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
Urinary tract disorder
Renal and urinary disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected3 at risk
EG0042 events1 affected5 at risk
EG0050 events0 affected4 at risk
Urinary tract pain
Renal and urinary disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0021 events1 affected11 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
Scrotal oedema
Reproductive system and breast disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected11 at risk
EG0030 events0 affected3 at risk
EG0041 events1 affected5 at risk
EG0050 events0 affected4 at risk
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0022 events1 affected11 at risk
EG0030 events0 affected3 at risk
EG0043 events2 affected5 at risk
EG0050 events0 affected4 at risk
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0002 events2 affected3 at risk
EG0010 events0 affected3 at risk
EG0024 events4 affected11 at risk
EG0030 events0 affected3 at risk
EG0042 events1 affected5 at risk
EG0052 events2 affected4 at risk
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected5 at risk
EG0051 events1 affected4 at risk
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected11 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected3 at risk
EG0041 events1 affected5 at risk
EG0050 events0 affected4 at risk
Nasal crusting
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected5 at risk
EG0051 events1 affected4 at risk
Nasal dryness
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected5 at risk
EG0051 events1 affected4 at risk
Nasal inflammation
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected5 at risk
EG0051 events1 affected4 at risk
Nasal mucosal ulcer
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected11 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
Pleuritic pain
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected11 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
Pneumomediastinum
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected11 at risk
EG0030 events0 affected3 at risk
EG0041 events1 affected5 at risk
EG0050 events0 affected4 at risk
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0021 events1 affected11 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events2 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
Upper respiratory tract congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected3 at risk
EG0041 events1 affected5 at risk
EG0050 events0 affected4 at risk
Upper-airway cough syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected11 at risk
EG0030 events0 affected3 at risk
EG0041 events1 affected5 at risk
EG0050 events0 affected4 at risk
Dermal cyst
Skin and subcutaneous tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected3 at risk
EG0041 events1 affected5 at risk
EG0050 events0 affected4 at risk
Dermatitis acneiform
Skin and subcutaneous tissue disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0017 events3 affected3 at risk
EG0021 events1 affected11 at risk
EG0032 events1 affected3 at risk
EG0044 events1 affected5 at risk
EG0053 events1 affected4 at risk
Dry skin
Skin and subcutaneous tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0022 events2 affected11 at risk
EG0030 events0 affected3 at risk
EG0043 events3 affected5 at risk
EG0053 events2 affected4 at risk
Erythema
Skin and subcutaneous tissue disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
Excessive granulation tissue
Skin and subcutaneous tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected5 at risk
EG0051 events1 affected4 at risk
Hirsutism
Skin and subcutaneous tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0031 events1 affected3 at risk
EG0041 events1 affected5 at risk
EG0050 events0 affected4 at risk
Ingrowing nail
Skin and subcutaneous tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected11 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected5 at risk
EG0053 events1 affected4 at risk
Onycholysis
Skin and subcutaneous tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0022 events1 affected11 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected5 at risk
EG0051 events1 affected4 at risk
Palmar-plantar erythrodysaesthesia syndrome
Skin and subcutaneous tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected3 at risk
EG0041 events1 affected5 at risk
EG0050 events0 affected4 at risk
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0023 events1 affected11 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
Pruritus generalised
Skin and subcutaneous tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected5 at risk
EG0051 events1 affected4 at risk
Rash
Skin and subcutaneous tissue disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected11 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0012 events1 affected3 at risk
EG00227 events9 affected11 at risk
EG0032 events1 affected3 at risk
EG00415 events4 affected5 at risk
EG00513 events3 affected4 at risk
Skin disorder
Skin and subcutaneous tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected5 at risk
EG0051 events1 affected4 at risk
Skin exfoliation
Skin and subcutaneous tissue disorders
MedDRA 20.0
Systematic Assessment
EG0002 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected5 at risk
EG0051 events1 affected4 at risk
Skin fissures
Skin and subcutaneous tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0022 events1 affected11 at risk
EG0032 events1 affected3 at risk
EG0047 events4 affected5 at risk
EG0052 events1 affected4 at risk
Skin lesion
Skin and subcutaneous tissue disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
Skin mass
Skin and subcutaneous tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected3 at risk
EG0041 events1 affected5 at risk
EG0050 events0 affected4 at risk
Hypotension
Vascular disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected11 at risk
EG0030 events0 affected3 at risk
EG0042 events2 affected5 at risk
EG0050 events0 affected4 at risk
Orthostatic hypotension
Vascular disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected3 at risk
EG0041 events1 affected5 at risk
EG0050 events0 affected4 at risk
Peripheral venous disease
Vascular disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
GT60
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Not provided
3
BG0052
BG00617
2
BG0052
BG00612
3
BG0051
BG00617
4
BG0053
BG00622
0
BG0050
BG0060
0
BG0051
BG0061
0
BG0050
BG0060
0
BG0050
BG0060
5
BG0053
BG00628
0
BG0050
BG0060
0
BG0050
BG0060
3
OG0045
OG0054
3
ParticipantsOG0045
ParticipantsOG0054
Title
Measurements
OG00085.1± 38
OG001122± 12
OG002367± 52
OG003496± 30
OG004226± 20
OG005255± 21
Schedule 1 Cycle 1 Day 15;Schedule 2 Cycle 1Day 22
ParticipantsOG0002
ParticipantsOG0013
ParticipantsOG00211
ParticipantsOG0033
ParticipantsOG0045
ParticipantsOG0053
Title
Measurements
OG000NA± NAGeometric mean and coefficient of variation (CV) not calculated for 2 participants; individual participants values reported: 119.55 and 66.36.
OG001147± 15
OG002348± 34
OG003
Schedule 1 Cycle 2 Day 1; Schedule 2 Cycle 2 Day 1
ParticipantsOG0001
ParticipantsOG0012
ParticipantsOG0029
ParticipantsOG0031
ParticipantsOG0045
ParticipantsOG0052
Title
Measurements
OG00072.19± NACoefficient of variation was not calculated for 1 participant.
OG001NA± NAGeometric mean and CV not calculated for 2 participants; individual participants values reported: 115.02 and 135.38.
OG002357± 35
OG003
3
OG0045
OG0054
3
ParticipantsOG0045
ParticipantsOG0054
Title
Measurements
OG00082.5± 41
OG001124± 15
OG002365± 46
OG003498± 33
OG004208± 23
OG005221± 21
Schedule 1 Cycle 1 Day 15;Schedule 2 Cycle 1Day 22
ParticipantsOG0002
ParticipantsOG0013
ParticipantsOG00211
ParticipantsOG0033
ParticipantsOG0045
ParticipantsOG0053
Title
Measurements
OG000NA± NAGeometric mean and CV not calculated for 2 participants; individual values reported: 127.21 and 73.21.
OG001136± 12
OG002346± 33
OG003
Schedule 1 Cycle 2 Day 1; Schedule 2 Cycle 2 Day 1
ParticipantsOG0001
ParticipantsOG0012
ParticipantsOG0029
ParticipantsOG0031
ParticipantsOG0045
ParticipantsOG0052
Title
Measurements
OG00072.32± NAThe coefficient of variation was not calculated for 1 participant.
OG001NA± NAGeometric mean and CV not calculated for 2 participants; individual participants values reported:123.84 and 143.68.
OG002353± 27
OG003
3
OG0045
OG0054
3
ParticipantsOG0044
ParticipantsOG0054
Title
Measurements
OG0005580± 28
OG0019870± 23
OG00237000± 42
OG00357500± 28
OG00416700± 37
OG00519800± 21
Schedule 1 Cycle 1 Day 15;Schedule 2 Cycle 1 Day 2
ParticipantsOG0002
ParticipantsOG0013
ParticipantsOG00210
ParticipantsOG0033
ParticipantsOG0045
ParticipantsOG0053
Title
Measurements
OG000NA± NAGeometric mean and CV not calculated for 2 participants; individual values reported: 13100 and 7170.
OG00113700± 15
OG00242700± 39
OG003
Schedule 1 Cycle 2 Day 1; Schedule 2 Cycle 2 Day 1
ParticipantsOG0001
ParticipantsOG0012
ParticipantsOG0028
ParticipantsOG0031
ParticipantsOG0045
ParticipantsOG0052
Title
Measurements
OG0006690± NAThe coefficient of variation was not calculated for 1 participant.
OG001NA± NAGeometric mean and CV not calculated for 2 participants; individual values reported: 12100 and 13300.
OG00243000± 55
OG003
3
OG0045
OG0054
3
ParticipantsOG0045
ParticipantsOG0054
Title
Measurements
OG0006150± 26
OG00110900± 27
OG00237500± 41
OG00357300± 31
OG00416300± 22
OG00517500± 20
Schedule 1 Cycle 1 Day 15;Schedule 2 Cycle 1 Day 2
ParticipantsOG0002
ParticipantsOG0013
ParticipantsOG00211
ParticipantsOG0033
ParticipantsOG0045
ParticipantsOG0053
Title
Measurements
OG000NA± NAGeometric mean and CV not calculated for 2 participants; individual values reported: 12200 and 7260.
OG00112900± 14
OG00243000± 34
OG003
Schedule 1 Cycle 2 Day 1; Schedule 2 Cycle 2 Day 1
ParticipantsOG0001
ParticipantsOG0012
ParticipantsOG0028
ParticipantsOG0031
ParticipantsOG0045
ParticipantsOG0052
Title
Measurements
OG0006800± NAThe coefficient of variation was not calculated for 1 participant.
OG001NA± NAGeometric mean and CV not calculated for 2 participants; individual values reported: 11800 and 13300.
OG00244700± 45
OG003
3
OG0045
OG0054
0
OG0040
OG0050
Partial Response
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0042
OG0051
Stable Disease
Title
Measurements
OG0001
OG0011
OG0026
OG0031
OG0041
OG0052
Progressive Disease
Title
Measurements
OG0002
OG0012
OG0023
OG0032
OG0042
OG0051
615
± 38
OG004262± 35
OG005350± 20
468.9
± NA
Coefficient of variation was not calculated for 1 participant.
OG004270± 32
OG005NA± NAGeometric mean and CV not calculated for 2 participants; individual participants values reported: 547.9 and 431.2.
587
± 35
OG004260± 32
OG005317± 17
400.9
± NA
The coefficient of variation was not calculated for 1 participant.
OG004258± 27
OG005NA± NAGeometric mean and CV not calculated for 2 participants; individual participants values reported: 541.5 and 347.0.
81400
± 31
OG00425500± 35
OG00534900± 31
51500
± NA
The coefficient of variation was not calculated for 1 participant.
OG00426300± 35
OG005NA± NAGeometric mean and CV not calculated for 2 participants; individual values reported: 31900 and 41300.
82000
± 33
OG00424800± 29
OG00531200± 30
46400
± NA
The coefficient of variation was not calculated for 1 participant.
OG00424800± 34
OG005NA± NAGeometric mean and CV not calculated for 2 participants; individual values reported: 29500 and 36700.