A Study of LY3022855 In Participants With Breast or Prost... | NCT02265536 | Trialant
NCT02265536
Sponsor
Eli Lilly and Company
Status
Completed
Last Update Posted
Oct 28, 2024Actual
Enrollment
34Actual
Phase
Phase 1
Conditions
Neoplasms
Neoplasm Metastasis
Interventions
LY3022855
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
NCT02265536
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
15441
Secondary IDs
ID
Type
Description
Link
I5F-MC-JSCB
Other Identifier
Eli Lilly and Company
Brief Title
A Study of LY3022855 In Participants With Breast or Prostate Cancer
Official Title
Phase 1 Study to Identify the Immunomodulatory Activity of LY3022855 (IMC-CS4) in Patients With Advanced, Refractory Breast or Prostate Cancer
Acronym
Not provided
Organization
Eli Lilly and CompanyINDUSTRY
Status Module
Record Verification Date
Oct 2024
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
May 1, 2015Actual
Primary Completion Date
Nov 3, 2017Actual
Completion Date
Nov 3, 2017Actual
First Submitted Date
Sep 24, 2014
First Submission Date that Met QC Criteria
Oct 10, 2014
First Posted Date
Oct 16, 2014Estimated
Results Waived
Not provided
Results First Submitted Date
Nov 11, 2022
Results First Submitted that Met QC Criteria
Oct 24, 2024
Results First Posted Date
Oct 28, 2024Actual
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 24, 2024
Last Update Posted Date
Oct 28, 2024Actual
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 learn more about how the investigational drug, LY3022855, affects the immune system in participants with advanced breast or prostate cancer that has not responded to other treatments. Treatment may last up to 6 cycles (cycle = 6 weeks).
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
34Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
LY3022855 1.25 mg/kg Q2W
Experimental
1.25 milligram per kilogram (mg/kg) LY3022855 administered intravenously (IV), once every two weeks (Q2W). Treatment is 6 week cycle. Participants may receive multiple cycles if they are deriving clinical benefit.
Drug: LY3022855
LY3022855 1.0 mg/kg WK1_2_4_5
Experimental
1.0 mg/kg LY3022855 administered IV on Weeks 1, 2, 4, and 5 of a 6-week cycle. Participants may receive multiple cycles if they are deriving clinical benefit.
Drug: LY3022855
LY3022855 100 mg Q2W
Experimental
100 mg of LY3022855 administered IV once every two weeks of a 6-week cycle. Participants may receive multiple cycles if they are deriving clinical benefit.
Drug: LY3022855
LY3022855 100 mg QW
Experimental
100 mg of LY3022855 administered IV. once a week (QW) of a 6-week cycle. Participants may receive multiple cycles if they are deriving clinical benefit.
Drug: LY3022855
Interventions
Name
Type
Description
Arm Group Labels
Other Names
LY3022855
Drug
Administered IV
LY3022855 1.0 mg/kg WK1_2_4_5
LY3022855 1.25 mg/kg Q2W
LY3022855 100 mg Q2W
LY3022855 100 mg QW
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentage Change From Baseline in Peripheral Blood Immune Cell (PBIC) Subsets
The immunomodulatory activity of the drug was documented by examining markers that include, but are not limited to: Live-Dead, Cluster of Differentiation 3 (CD3), CD4, CD8, CD14, CD16, Foxhead Box p3 (FoxP3), PD-1, Ki-67, Cytotoxic T-Lymphocyte Antigen 4 (CTLA-4), Human Leukocyte Antigen-D-relate (HLA-DR), T-cell immunoglobulin and mucin-3 (TIM-3), lymphocyte-activation gene 3 (LAG-3), and Inducible T-cell COStimulator (ICOS). The expression of these markers was quantified by flow cytometric analysis with an antibody panel.
Baseline to Day 8 after 1st dose
Percentage Change From Baseline in Serum Cytokines
The immunomodulatory activity of the drug was measured in participants with advanced, refractory breast or prostate cancers using serum cytokines. Serum cytokine levels was determined by MSD multiplex cytokine immunoassay technology or ELISA, and that may include but not be limited to Interleukin 6 (IL-6), IL-8, IL-10 and Tumor necrosis factor (TNF-α).
Baseline to Day 8 after 1st dose
Serum Cytokine Levels
The immunomodulatory activity of the drug was measured in participants with advanced, refractory breast or prostate cancers using serum cytokines. Serum cytokines will be determined by MSD multiplex cytokine immunoassay or ELISA. The markers to be measured using these technologies include, but are not limited to: CSF-1, IFN-γ, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12p70, IL-13, IL-34, and TNF-α.
Day 8
Secondary Outcomes
Measure
Description
Time Frame
Pharmacokinetics (PK): Area Under the Concentration Curve of LY3022855
Area under the concentration versus time curve from time zero to tau (τ) of LY3022855 (AUC[0- τ]), where tau is dosing interval of (0-14 days).
0, 1, 4, 24, 48, 72 and 168 hours post dose on Day 1 and Day 29
Percentage of Participants With a Best Overall Disease Control Response (Disease Control Rate)
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Confirmed diagnosis of advanced, refractory breast or prostate cancer that is evaluable by radiologic testing. Participants must have experienced tumor progression on or treatment intolerance to at least one prior therapy and have declined or are ineligible for a standard treatment.
For participants with metastatic castrate-resistant prostate cancer only:
Must continue ongoing androgen deprivation therapy with castrate levels of serum testosterone <50 nanogram/deciliter (ng/dL) determined within 4 weeks prior to starting treatment
If receiving an antiandrogen as part of first-line hormonal therapy, must have shown progression of disease off the antiandrogen prior to enrollment
Must be willing to continue androgen deprivation therapy while on study, if no prior orchiectomy
Must meet at least 1 of the following 3 criteria for progressive metastatic disease, according to Prostate Cancer Working Group 2 (PCWG2) criteria:
A rise in prostate-specific antigen (minimal value 2 ng/milliliter (mL); ≥3 consecutive rising values)
≥2 new metastases on transaxial imaging or radionuclide bone scan
Soft tissue progression
Replacement hormone therapy initiated before study entry is permitted
For participants with breast cancer only:
May continue ongoing antiestrogen therapy
Replacement hormone therapy initiated before study entry is permitted
May continue ongoing trastuzumab therapy
Have adequate organ and hematologic function, including: Hepatic: Bilirubin ≤1.5 × the upper limit of normal (ULN), and alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3.0 × ULN. For participants with tumor involvement of the liver, AST and ALT ≤5.0 × ULN are acceptable. For participants with tumor involvement of the bone, alkaline phosphatase ≤5.0 × ULN is acceptable. Renal: Serum creatinine ≤2.0 × ULN. Absolute neutrophil count (ANC) ≥1.0 × 10^9/liter (L). Hemoglobin ≥9 grams per deciliter (5.58 millimoles per liter). Platelets ≥90 × 10^9/L.
Have Eastern Cooperative Oncology Group (ECOG) performance status of ≤2.
Have discontinued all disease-modifying therapy for the primary cancer >28 days prior to initiation of study treatment. In addition, clinically significant toxicities associated with any prior therapy for the primary cancer, including investigational treatments, have resolved or stabilized to Grade ≤1 toxicity >28 days prior to initiation of study treatment with the exception of neuropathy, which must have resolved to Grade ≤2. Continuation of a stable dose (minimum of 28 days prior to study entry) of denosumab or bisphosphonate is permitted on study.
Willing and able to comply with study procedures including 1 baseline and 1 posttreatment tumor biopsy procedure.
Male participants: Agree to use a reliable method of birth control and to not donate sperm during the study and for at least 12 weeks following last dose of study drug or country requirements, whichever is longer.
Female participants: Are women of child-bearing potential who test negative for pregnancy within 7 days prior to enrollment based on a urine or serum pregnancy test and agree to use a reliable method of birth control during the study and for 12 weeks following the last dose of the study drug and also must not be breastfeeding, OR are postmenopausal women.
Have an estimated life expectancy that, in the judgment of the investigator, will permit the patient to complete 1 cycle of treatment.
May have received treatment with an investigational product or non-approved use of a drug (other than the study drug used in this study) or device for non-cancer indications; however, not within 28 days prior to the initial dose of study drug.
Exclusion Criteria:
Have received treatment within 28 days prior to the initial dose of study drug with an investigational product or non-approved use of a drug or device (other than the study drug/device used in this study) for non-cancer indications or are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
Have serious preexisting medical conditions (left to the discretion of the investigator).
Have symptomatic central nervous system (CNS) malignancy or metastasis.
Have an active fungal, bacterial, and/or known viral infection, including human immunodeficiency virus (HIV) or viral (B or C) hepatitis.
Have any of the following cardiovascular conditions:
Symptomatic coronary artery disease currently or within the past 6 months,
Have a second active primary malignancy that, in the judgment of the investigator or sponsor, may affect the interpretation of the results.
Confirmed left ventricular ejection fraction ≤50% or any cardiac insufficiency > New York Heart Association (NYHA) class II currently or within the past 6 months,
Uncontrolled hypertension (>170/100 millimeter of mercury [mm Hg]) currently or within the past 7 days, or
Serious cardiac arrhythmia (well-controlled atrial fibrillation is permitted) currently or within the past 6 months.
Have a second active primary malignancy that, in the judgment of the investigator or sponsor, may affect the interpretation of the results.
Are unwilling or unable to participate in tumor biopsies.
Have corrected QT interval of >500 millisecond (msec) on screening electrocardiogram (ECG).
Have received treatment with agents specifically targeting colony stimulating factor 1 (CSF-1) or CSF-1R, including imatinib, nilotinib, and sunitinib.
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)
Autio KA, Klebanoff CA, Schaer D, Kauh JSW, Slovin SF, Adamow M, Blinder VS, Brahmachary M, Carlsen M, Comen E, Danila DC, Doman TN, Durack JC, Fox JJ, Gluskin JS, Hoffman DM, Kang S, Kang P, Landa J, McAndrew PF, Modi S, Morris MJ, Novosiadly R, Rathkopf DE, Sanford R, Chapman SC, Tate CM, Yu D, Wong P, McArthur HL. Immunomodulatory Activity of a Colony-stimulating Factor-1 Receptor Inhibitor in Patients with Advanced Refractory Breast or Prostate Cancer: A Phase I Study. Clin Cancer Res. 2020 Nov 1;26(21):5609-5620. doi: 10.1158/1078-0432.CCR-20-0855. Epub 2020 Aug 26.
See Also Links
Label
URL
A Study of LY3022855 In Participants With Breast or Prostate Cancer
Completers included participants who died from any cause or disease progression and participants who were alive and on study (either on study treatment or in long term follow-up) at study conclusion.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
LY3022855 - 1.25 mg/kg Q2W Breast Cancer
Participants received 1.25 milligram per kilogram (mg/kg) of LY3022855 administered intravenously (IV) once every two weeks (Q2W) of a 6-week cycle.
FG001
LY3022855 - 1.0 mg/kg WK1_2_4_5 Breast Cancer
Participants received 1.0 mg/kg of LY3022855 administered IV on Weeks
1, 2, 4, and 5 of a 6-week cycle.
FG002
LY3022855 - 100 mg Q2W Breast Cancer
Participants received 100 mg of LY3022855 administered IV once every two weeks of a 6-week cycle.
FG003
LY3022855 - 100 mg QW Breast Cancer
Participants received 100 mg of LY3022855 administered IV once weekly (QW) of a 6-week cycle.
FG004
LY3022855 - 1.25 mg/kg Q2W Prostate Cancer
Participants received 1.25 mg/kg of LY3022855 administered IV once every two weeks of a 6-week cycle.
FG005
LY3022855 - 1.0 mg/kg WK1_2_4_5 Prostate Cancer
Participants received 1.0 mg/kg of LY3022855 administered IV on Weeks
1, 2, 4, and 5 of a 6-week cycle.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
FG0006 subjects
FG0015 subjects
FG0025 subjects
FG0036 subjects
FG0048 subjects
FG0054 subjects
Received at Least 1 Dose of Study Drug
FG0006 subjects
FG0015 subjects
FG0025 subjects
FG0036 subjects
COMPLETED
FG0005 subjects
FG0012 subjects
FG0025 subjects
FG0036 subjects
FG004
NOT COMPLETED
FG0001 subjects
FG0013 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG003
Baseline Characteristics Module
Baseline Analysis Population Description
All enrolled participants
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
LY3022855 - 1.25 mg/kg Q2W Breast Cancer
Participants received 1.25 mg/kg of LY3022855 administered IV once every two weeks of a 6-week cycle.
BG001
LY3022855 - 1.0 mg/kg WK1_2_4_5 Breast Cancer
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
Percentage Change From Baseline in Peripheral Blood Immune Cell (PBIC) Subsets
The immunomodulatory activity of the drug was documented by examining markers that include, but are not limited to: Live-Dead, Cluster of Differentiation 3 (CD3), CD4, CD8, CD14, CD16, Foxhead Box p3 (FoxP3), PD-1, Ki-67, Cytotoxic T-Lymphocyte Antigen 4 (CTLA-4), Human Leukocyte Antigen-D-relate (HLA-DR), T-cell immunoglobulin and mucin-3 (TIM-3), lymphocyte-activation gene 3 (LAG-3), and Inducible T-cell COStimulator (ICOS). The expression of these markers was quantified by flow cytometric analysis with an antibody panel.
All enrolled participants who received at least one dose of study drug and have baseline and post baseline data for peripheral blood immune cell subsets.
Posted
Median
Inter-Quartile Range
Percent Change
Baseline to Day 8 after 1st dose
ID
Title
Description
OG000
LY3022855 - 1.25 mg/kg Q2W Breast Cancer
Adverse Events Module
Frequency Threshold
5
Time Frame
Up To 133 Weeks
Description
All enrolled participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
LY3022855 - 1.25 mg/kg Q2W Breast Cancer
Participants received 1.25 mg/kg of LY3022855 administered IV once every two weeks of a 6-week cycle.
Disease control rate is the percentage of participants with a confirmed CR, PR or SD, as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.1. CR is the disappearance of all target and non-target lesions; PR is a ≥30% decrease in sum of longest diameter of target lesions without new lesion and progression of non-target lesion; SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease. Disease control rate is calculated as a total number of participants with CR or PR or SD divided by the total number of participants treated, then multiplied by 100.
Baseline up to 6 cycles (cycle = 6 weeks)
New York
New York
10065
United States
FG004
8 subjects
FG0054 subjects
5 subjects
FG0054 subjects
3 subjects
FG0050 subjects
0 subjects
FG0041 subjects
FG0050 subjects
Physician Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0042 subjects
FG0050 subjects
Withdrawal by Subject
FG0000 subjects
FG0013 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
Participants received 1.0 mg/kg of LY3022855 administered IV on weeks 1, 2, 4, and 5 of a 6-week cycle.
BG002
LY3022855 - 100 mg Q2W Breast Cancer
Participants received 100 mg of LY3022855 administered IV once every two weeks of a 6-week cycle.
BG003
LY3022855 - 100 mg QW Breast Cancer
Participants received 100 mg of LY3022855 administered IV once weekly of a 6-week cycle.
BG004
LY3022855 - 1.25 mg/kg Q2W Prostate Cancer
Participants received 1.25 mg/kg of LY3022855 administered IV once every two weeks of a 6-week cycle.
BG005
LY3022855 - 1.0 mg/kg WK1_2_4_5 Prostate Cancer
Participants received 1.0 mg/kg of LY3022855 administered IV on Weeks 1, 2, 4, and 5 of a 6-week cycle.
BG006
Total
Total of all reporting groups
6
BG0015
BG0025
BG0036
BG0048
BG0054
BG00634
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00053.5± 16.6
BG00155.4± 11.8
BG00254.8± 10.7
BG00358.3± 16.1
BG00469.8± 8.3
BG00571.0± 9.2
BG00660.7± 13.7
Sex: Female, Male
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Female
BG0006
BG0015
BG0023
BG0036
BG0040
BG0050
BG00620
Male
BG0000
BG0010
BG0022
BG0030
BG004
Ethnicity (NIH/OMB)
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0001
BG0010
BG0020
BG0030
BG0040
BG0050
BG0061
Not Hispanic or Latino
BG0005
BG0015
BG0025
BG0036
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
BG0001
BG0010
BG0021
BG0035
BG004
Native Hawaiian or Other Pacific Islander
BG0000
BG0010
BG0020
BG0030
BG004
Black or African American
BG0000
BG0010
BG0021
BG0031
BG004
White
BG0004
BG0015
BG0023
BG0030
BG004
More than one race
BG0000
BG0010
BG0020
BG0030
BG004
Unknown or Not Reported
BG0001
BG0010
BG0020
BG0030
BG004
Region of Enrollment
Count of Participants
Participants
No
Title
Denominators
Categories
United States
Title
Measurements
BG0006
BG0015
BG0025
BG0036
BG0048
BG0054
BG00634
Body Mass Index (BMI)
Mean
Standard Deviation
Kilogram/Meter^2 (kg/m^2)
Title
Denominators
Categories
Title
Measurements
BG00027.3± 6.0
BG00126.5± 6.0
BG00224.2± 4.8
BG00325.1± 4.5
BG00427.8± 3.4
BG00528.6± 6.2
BG00626.6± 4.9
Participants received 1.25 milligram per kilogram (mg/kg) of LY3022855 administered intravenously (IV) once every two weeks (Q2W) of a 6-week cycle.
OG001
LY3022855 - 1.0 mg/kg WK1_2_4_5 Breast Cancer
Participants received 1.0 mg/kg of LY3022855 administered IV on Weeks
1, 2, 4, and 5 of a 6-week cycle.
OG002
LY3022855 - 100 mg Q2W Breast Cancer
Participants received 100 mg of LY3022855 administered IV once every two weeks of a 6-week cycle.
OG003
LY3022855 - 100 mg QW Breast Cancer
Participants received 100 mg of LY3022855 administered IV once weekly (QW) of a 6-week cycle.
OG004
LY3022855 - 1.25 mg/kg Q2W Prostate Cancer
Participants received 1.25 mg/kg of LY3022855 administered IV once every two weeks of a 6-week cycle.
OG005
LY3022855 - 1.0 mg/kg WK1_2_4_5 Prostate Cancer
Participants received 1.0 mg/kg of LY3022855 administered IV on Weeks
1, 2, 4, and 5 of a 6-week cycle.
Units
Counts
Participants
OG0006
OG0015
OG0025
OG0036
OG0048
OG0054
Title
Denominators
Categories
C14_HLA_DR_%
ParticipantsOG0005
ParticipantsOG0013
ParticipantsOG0022
ParticipantsOG0032
ParticipantsOG0048
ParticipantsOG0052
Title
Measurements
OG000-10.31(-39.58 to -9.05)
OG0015.12(1.54 to 26.3)
OG002-16.39(-21.73 to -11.05)
OG003
LIVE_CELL_Count (CNT)
ParticipantsOG0006
ParticipantsOG0014
ParticipantsOG0024
ParticipantsOG0034
CD3_CNT
ParticipantsOG0006
ParticipantsOG0014
ParticipantsOG0024
ParticipantsOG0034
CD3_LIVE_%
ParticipantsOG0006
ParticipantsOG0014
ParticipantsOG0024
ParticipantsOG0034
CD4_CD3_%
ParticipantsOG0006
ParticipantsOG0014
ParticipantsOG0024
ParticipantsOG0034
CD4_CNT
ParticipantsOG0006
ParticipantsOG0014
ParticipantsOG0024
ParticipantsOG0034
CD8_CD3_%
ParticipantsOG0006
ParticipantsOG0014
ParticipantsOG0024
ParticipantsOG0034
CD8_CD4_RATIO
ParticipantsOG0006
ParticipantsOG0014
ParticipantsOG0024
ParticipantsOG0034
CD8_CNT
ParticipantsOG0006
ParticipantsOG0014
ParticipantsOG0024
ParticipantsOG0034
CD8_FOXP3_RATIO
ParticipantsOG0006
ParticipantsOG0014
ParticipantsOG0024
ParticipantsOG0034
CTLA4_CD4_%
ParticipantsOG0006
ParticipantsOG0014
ParticipantsOG0024
ParticipantsOG0034
CTLA4_CD8_%
ParticipantsOG0006
ParticipantsOG0014
ParticipantsOG0024
ParticipantsOG0034
FOXP3_CD4_%
ParticipantsOG0006
ParticipantsOG0014
ParticipantsOG0024
ParticipantsOG0034
FOXP3_CD8_%
ParticipantsOG0006
ParticipantsOG0014
ParticipantsOG0024
ParticipantsOG0034
FOXP3_CNT
ParticipantsOG0006
ParticipantsOG0014
ParticipantsOG0024
ParticipantsOG0034
ICOS_CD4_%
ParticipantsOG0006
ParticipantsOG0014
ParticipantsOG0024
ParticipantsOG0034
ICOS_CD8_%
ParticipantsOG0006
ParticipantsOG0014
ParticipantsOG0024
ParticipantsOG0034
KI67_CD4_%
ParticipantsOG0006
ParticipantsOG0014
ParticipantsOG0024
ParticipantsOG0034
KI67_CD8_%
ParticipantsOG0006
ParticipantsOG0014
ParticipantsOG0024
ParticipantsOG0034
LAG3_CD4_%
ParticipantsOG0006
ParticipantsOG0014
ParticipantsOG0024
ParticipantsOG0034
LAG3_CD8_%
ParticipantsOG0006
ParticipantsOG0014
ParticipantsOG0024
ParticipantsOG0034
PD1_CD4_%
ParticipantsOG0006
ParticipantsOG0014
ParticipantsOG0024
ParticipantsOG0034
PD1_CD8_%
ParticipantsOG0006
ParticipantsOG0014
ParticipantsOG0024
ParticipantsOG0034
TIM3_CD4_%
ParticipantsOG0006
ParticipantsOG0014
ParticipantsOG0024
ParticipantsOG0034
TIM3_CD8_%
ParticipantsOG0006
ParticipantsOG0014
ParticipantsOG0024
ParticipantsOG0034
CD14DIM_CD16BR_%
ParticipantsOG0005
ParticipantsOG0013
ParticipantsOG0024
ParticipantsOG0034
Primary
Percentage Change From Baseline in Serum Cytokines
The immunomodulatory activity of the drug was measured in participants with advanced, refractory breast or prostate cancers using serum cytokines. Serum cytokine levels was determined by MSD multiplex cytokine immunoassay technology or ELISA, and that may include but not be limited to Interleukin 6 (IL-6), IL-8, IL-10 and Tumor necrosis factor (TNF-α).
All enrolled participants who received at least one dose of study drug and have baseline and post baseline data for Serum Cytokines.
Posted
Median
Inter-Quartile Range
Percent Change
Baseline to Day 8 after 1st dose
ID
Title
Description
OG000
LY3022855 - 1.25 mg/kg Q2W Breast Cancer
Participants received 1.25 milligram per kilogram (mg/kg) of LY3022855 administered intravenously (IV) once every two weeks (Q2W) of a 6-week cycle.
OG001
LY3022855 - 1.0 mg/kg WK1_2_4_5 Breast Cancer
Participants received 1.0 mg/kg of LY3022855 administered IV on Weeks
1, 2, 4, and 5 of a 6-week cycle.
OG002
LY3022855 - 100 mg Q2W Breast Cancer
Participants received 100 mg of LY3022855 administered IV once every two weeks of a 6-week cycle.
OG003
LY3022855 - 100 mg QW Breast Cancer
Participants received 100 mg of LY3022855 administered IV once weekly (QW) of a 6-week cycle.
OG004
LY3022855 - 1.25 mg/kg Q2W Prostate Cancer
Participants received 1.25 mg/kg of LY3022855 administered IV once every two weeks of a 6-week cycle.
OG005
LY3022855 - 1.0 mg/kg WK1_2_4_5 Prostate Cancer
Participants received 1.0 mg/kg of LY3022855 administered IV on Weeks
1, 2, 4, and 5 of a 6-week cycle.
Units
Counts
Participants
OG0006
OG0015
OG0025
OG003
Title
Denominators
Categories
TNF-α
ParticipantsOG0005
ParticipantsOG0014
ParticipantsOG0021
ParticipantsOG003
Primary
Serum Cytokine Levels
The immunomodulatory activity of the drug was measured in participants with advanced, refractory breast or prostate cancers using serum cytokines. Serum cytokines will be determined by MSD multiplex cytokine immunoassay or ELISA. The markers to be measured using these technologies include, but are not limited to: CSF-1, IFN-γ, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12p70, IL-13, IL-34, and TNF-α.
All enrolled participants who received at least one dose of study drug and have baseline and post baseline data for Serum Cytokines.
Posted
Median
Inter-Quartile Range
nanograms per liter (ng/L)
Day 8
ID
Title
Description
OG000
LY3022855 - 1.25 mg/kg Q2W Breast Cancer
Participants received 1.25 milligram per kilogram (mg/kg) of LY3022855 administered intravenously (IV) once every two weeks (Q2W) of a 6-week cycle.
OG001
LY3022855 - 1.0 mg/kg WK1_2_4_5 Breast Cancer
Participants received 1.0 mg/kg of LY3022855 administered IV on Weeks
1, 2, 4, and 5 of a 6-week cycle.
OG002
LY3022855 - 100 mg Q2W Breast Cancer
Participants received 100 mg of LY3022855 administered IV once every two weeks of a 6-week cycle.
OG003
LY3022855 - 100 mg QW Breast Cancer
Participants received 100 mg of LY3022855 administered IV once weekly (QW) of a 6-week cycle.
OG004
LY3022855 - 1.25 mg/kg Q2W Prostate Cancer
Participants received 1.25 mg/kg of LY3022855 administered IV once every two weeks of a 6-week cycle.
OG005
LY3022855 - 1.0 mg/kg WK1_2_4_5 Prostate Cancer
Participants received 1.0 mg/kg of LY3022855 administered IV on Weeks
1, 2, 4, and 5 of a 6-week cycle.
Units
Counts
Participants
OG0006
OG0014
OG0025
OG003
Title
Denominators
Categories
CSF-1
Title
Measurements
OG000308460(182347.5 to 358665)
OG00123564.3(511.4 to 70952.5)
OG002290520(792.8 to 328780)
Secondary
Pharmacokinetics (PK): Area Under the Concentration Curve of LY3022855
Area under the concentration versus time curve from time zero to tau (τ) of LY3022855 (AUC[0- τ]), where tau is dosing interval of (0-14 days).
All enrolled participants who received at least one dose of study drug and have evaluable PK data for AUC.
Posted
Geometric Mean
Geometric Coefficient of Variation
hours*micrograms/mL
0, 1, 4, 24, 48, 72 and 168 hours post dose on Day 1 and Day 29
ID
Title
Description
OG000
LY3022855 - 1.25 mg/kg Q2W
Participants received 1.25 mg/kg of LY3022855 administered IV once every two weeks of a 6-week cycle.
OG001
LY3022855 - 1.0 mg/kg WK1_2_4_5
Participants received 1.0 mg/kg of LY3022855 administered IV on weeks 1, 2, 4, and 5 of a 6-week cycle.
OG002
LY3022855 - 100 mg Q2W
Participants received 100 mg of LY3022855 administered IV once every two weeks of a 6-week cycle.
OG003
LY3022855 - 100 mg QW
Participants received 100 mg of LY3022855 administered IV once weekly of a 6-week cycle.
Units
Counts
Participants
OG0006
OG0015
OG0024
OG003
Title
Denominators
Categories
Day 1
ParticipantsOG0006
ParticipantsOG0015
ParticipantsOG0024
ParticipantsOG003
Secondary
Percentage of Participants With a Best Overall Disease Control Response (Disease Control Rate)
Disease control rate is the percentage of participants with a confirmed CR, PR or SD, as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.1. CR is the disappearance of all target and non-target lesions; PR is a ≥30% decrease in sum of longest diameter of target lesions without new lesion and progression of non-target lesion; SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease. Disease control rate is calculated as a total number of participants with CR or PR or SD divided by the total number of participants treated, then multiplied by 100.
All enrolled participants who received at least one dose of study drug and have baseline and post-baseline data for disease control rate.
Posted
Number
95% Confidence Interval
Percentage of Participants
Baseline up to 6 cycles (cycle = 6 weeks)
ID
Title
Description
OG000
LY3022855 - 1.25 mg/kg Q2W Breast Cancer
Participants received 1.25 mg/kg of LY3022855 administered IV once every two weeks of a 6-week cycle.
OG001
LY3022855 - 1.0 mg/kg WK1_2_4_5 Breast Cancer
Participants received 1.0 mg/kg of LY3022855 administered IV on weeks 1, 2, 4, and 5 of a 6-week cycle.
OG002
LY3022855 - 100 mg Q2W Breast Cancer
Participants received 100 mg of LY3022855 administered IV once every two weeks of a 6-week cycle.
OG003
LY3022855 - 100 mg QW Breast Cancer
Participants received 100 mg of LY3022855 administered IV once weekly of a 6-week cycle.
OG004
LY3022855 - 1.25 mg/kg Q2W Prostate Cancer
Participants received 1.25 mg/kg of LY3022855 administered IV once every two weeks of a 6-week cycle.
OG005
LY3022855 - 1.0 mg/kg WK1_2_4_5 Prostate Cancer
Participants received 1.0 mg/kg of LY3022855 administered IV on Weeks 1, 2, 4, and 5 of a 6-week cycle.
Units
Counts
Participants
OG0006
OG0015
OG0025
OG003
Title
Denominators
Categories
Title
Measurements
OG00050(15.3 to 84.7)
OG0010(0 to 0)
OG00220(1 to 65.7)
OG003
0
6
2
6
6
6
EG001
LY3022855 - 1.0 mg/kg WK1_2_4_5 Breast Cancer
Participants received 1.0 mg/kg of LY3022855 administered IV on weeks 1, 2, 4, and 5 of a 6-week cycle.
1
5
1
5
5
5
EG002
LY3022855 - 100 mg Q2W Breast Cancer
Participants received 100 mg of LY3022855 administered IV once every two weeks of a 6-week cycle.
1
5
1
5
5
5
EG003
LY3022855 - 100 mg QW Breast Cancer
Participants received 100 mg of LY3022855 administered IV once weekly of a 6-week cycle.
1
6
1
6
6
6
EG004
LY3022855 - 1.25 mg/kg Q2W Prostate Cancer
Participants received 1.25 mg/kg of LY3022855 administered IV once every two weeks of a 6-week cycle.
0
8
4
8
8
8
EG005
LY3022855 - 1.0 mg/kg WK1_2_4_5 Prostate Cancer
Participants received 1.0 mg/kg of LY3022855 administered IV on Weeks 1, 2, 4, and 5 of a 6-week cycle.
0
4
0
4
4
4
EG0001 events1 affected6 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected4 at risk
Cardiomyopathy
Cardiac disorders
MedDRA 18.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected4 at risk
Dysphagia
Gastrointestinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected6 at risk
EG0041 events1 affected8 at risk
EG0050 events0 affected4 at risk
Large intestinal obstruction
Gastrointestinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected6 at risk
EG0041 events1 affected8 at risk
EG0050 events0 affected4 at risk
Chest pain
General disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected5 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected4 at risk
Disease complication
General disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected4 at risk
Fatigue
General disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected6 at risk
EG0041 events1 affected8 at risk
EG0050 events0 affected4 at risk
Pain
General disorders
MedDRA 18.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected4 at risk
Pyrexia
General disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG0031 events1 affected6 at risk
EG0041 events1 affected8 at risk
EG0050 events0 affected4 at risk
Bacteraemia
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG0031 events1 affected6 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected4 at risk
Infection
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected6 at risk
EG0042 events1 affected8 at risk
EG0050 events0 affected4 at risk
Femur fracture
Injury, poisoning and procedural complications
MedDRA 18.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected4 at risk
Spinal fracture
Injury, poisoning and procedural complications
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected6 at risk
EG0041 events1 affected8 at risk
EG0050 events0 affected4 at risk
Gamma-glutamyltransferase increased
Investigations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected5 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected4 at risk
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected5 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected4 at risk
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected6 at risk
EG0042 events1 affected8 at risk
EG0050 events0 affected4 at risk
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 18.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected4 at risk
Tumour haemorrhage
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected4 at risk
Brain oedema
Nervous system disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected6 at risk
EG0041 events1 affected8 at risk
EG0050 events0 affected4 at risk
Encephalopathy
Nervous system disorders
MedDRA 18.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected4 at risk
Confusional state
Psychiatric disorders
MedDRA 18.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected4 at risk
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected5 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected4 at risk
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected5 at risk
EG0030 events0 affected6 at risk
EG0041 events1 affected8 at risk
EG0050 events0 affected4 at risk
EG0002 events1 affected6 at risk
EG0014 events1 affected5 at risk
EG0022 events2 affected5 at risk
EG0031 events1 affected6 at risk
EG0042 events2 affected8 at risk
EG0052 events1 affected4 at risk
Sinus tachycardia
Cardiac disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected5 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected4 at risk
Dry eye
Eye disorders
MedDRA 18.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0012 events1 affected5 at risk
EG0021 events1 affected5 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected4 at risk
Eye oedema
Eye disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected5 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected4 at risk
Eye swelling
Eye disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected5 at risk
EG0031 events1 affected6 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected4 at risk
Periorbital oedema
Eye disorders
MedDRA 18.1
Systematic Assessment
EG0004 events3 affected6 at risk
EG0011 events1 affected5 at risk
EG0021 events1 affected5 at risk
EG0031 events1 affected6 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected4 at risk
Vision blurred
Eye disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected5 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected4 at risk
Abdominal distension
Gastrointestinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected5 at risk
EG0021 events1 affected5 at risk
EG0031 events1 affected6 at risk
EG0040 events0 affected8 at risk
EG0051 events1 affected4 at risk
Abdominal pain
Gastrointestinal disorders
MedDRA 18.1
Systematic Assessment
EG0003 events1 affected6 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG0032 events1 affected6 at risk
EG0040 events0 affected8 at risk
EG0052 events1 affected4 at risk
Abdominal pain upper
Gastrointestinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected8 at risk
EG0052 events1 affected4 at risk
Constipation
Gastrointestinal disorders
MedDRA 18.1
Systematic Assessment
EG0002 events2 affected6 at risk
EG0012 events1 affected5 at risk
EG0021 events1 affected5 at risk
EG0032 events2 affected6 at risk
EG0046 events5 affected8 at risk
EG0051 events1 affected4 at risk
Diarrhoea
Gastrointestinal disorders
MedDRA 18.1
Systematic Assessment
EG0002 events1 affected6 at risk
EG0012 events2 affected5 at risk
EG0020 events0 affected5 at risk
EG0032 events1 affected6 at risk
EG0044 events3 affected8 at risk
EG0050 events0 affected4 at risk
Dry mouth
Gastrointestinal disorders
MedDRA 18.1
Systematic Assessment
EG0002 events1 affected6 at risk
EG0010 events0 affected5 at risk
EG0022 events2 affected5 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected4 at risk
Dyspepsia
Gastrointestinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG0031 events1 affected6 at risk
EG0041 events1 affected8 at risk
EG0050 events0 affected4 at risk
Flatulence
Gastrointestinal disorders
MedDRA 18.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected5 at risk
EG0032 events1 affected6 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected4 at risk
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected6 at risk
EG0042 events1 affected8 at risk
EG0050 events0 affected4 at risk
Nausea
Gastrointestinal disorders
MedDRA 18.1
Systematic Assessment
EG0002 events2 affected6 at risk
EG0016 events3 affected5 at risk
EG0023 events3 affected5 at risk
EG0032 events2 affected6 at risk
EG0044 events3 affected8 at risk
EG0053 events2 affected4 at risk
Stomatitis
Gastrointestinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected4 at risk
Vomiting
Gastrointestinal disorders
MedDRA 18.1
Systematic Assessment
EG0002 events2 affected6 at risk
EG0015 events2 affected5 at risk
EG0022 events2 affected5 at risk
EG0032 events2 affected6 at risk
EG0041 events1 affected8 at risk
EG0051 events1 affected4 at risk
Chest pain
General disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected5 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected8 at risk
EG0051 events1 affected4 at risk
Fatigue
General disorders
MedDRA 18.1
Systematic Assessment
EG0004 events3 affected6 at risk
EG0013 events3 affected5 at risk
EG0024 events3 affected5 at risk
EG0034 events3 affected6 at risk
EG00410 events7 affected8 at risk
EG0052 events2 affected4 at risk
Gait disturbance
General disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG0031 events1 affected6 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected4 at risk
Oedema peripheral
General disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected6 at risk
EG0041 events1 affected8 at risk
EG0050 events0 affected4 at risk
Pain
General disorders
MedDRA 18.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0012 events2 affected5 at risk
EG0025 events1 affected5 at risk
EG0030 events0 affected6 at risk
EG0045 events4 affected8 at risk
EG0052 events1 affected4 at risk
Pyrexia
General disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected4 at risk
Bronchitis
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG0031 events1 affected6 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected4 at risk
Clostridium difficile infection
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected6 at risk
EG0041 events1 affected8 at risk
EG0050 events0 affected4 at risk
Cystitis
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG0031 events1 affected6 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected4 at risk
Urinary tract infection
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG0033 events2 affected6 at risk
EG0041 events1 affected8 at risk
EG0050 events0 affected4 at risk
Procedural pain
Injury, poisoning and procedural complications
MedDRA 18.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected4 at risk
Activated partial thromboplastin time prolonged
Investigations
MedDRA 18.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected4 at risk
Alanine aminotransferase increased
Investigations
MedDRA 18.1
Systematic Assessment
EG0004 events2 affected6 at risk
EG0010 events0 affected5 at risk
EG0023 events1 affected5 at risk
EG0035 events2 affected6 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected4 at risk
Amylase increased
Investigations
MedDRA 18.1
Systematic Assessment
EG0003 events1 affected6 at risk
EG0010 events0 affected5 at risk
EG0023 events2 affected5 at risk
EG0031 events1 affected6 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected4 at risk
Aspartate aminotransferase increased
Investigations
MedDRA 18.1
Systematic Assessment
EG0008 events2 affected6 at risk
EG0010 events0 affected5 at risk
EG0023 events2 affected5 at risk
EG0034 events2 affected6 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected4 at risk
Blood alkaline phosphatase increased
Investigations
MedDRA 18.1
Systematic Assessment
EG0004 events1 affected6 at risk
EG0010 events0 affected5 at risk
EG0023 events2 affected5 at risk
EG0033 events2 affected6 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected4 at risk
Blood bilirubin increased
Investigations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected5 at risk
EG0023 events2 affected5 at risk
EG0032 events1 affected6 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected4 at risk
Blood creatine phosphokinase increased
Investigations
MedDRA 18.1
Systematic Assessment
EG0005 events1 affected6 at risk
EG0010 events0 affected5 at risk
EG0027 events2 affected5 at risk
EG0036 events3 affected6 at risk
EG0042 events2 affected8 at risk
EG0050 events0 affected4 at risk
Blood lactate dehydrogenase increased
Investigations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected6 at risk
EG0041 events1 affected8 at risk
EG0050 events0 affected4 at risk
C-reactive protein increased
Investigations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected6 at risk
EG0041 events1 affected8 at risk
EG0050 events0 affected4 at risk
Gamma-glutamyltransferase increased
Investigations
MedDRA 18.1
Systematic Assessment
EG0005 events2 affected6 at risk
EG0011 events1 affected5 at risk
EG0023 events2 affected5 at risk
EG0033 events2 affected6 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected4 at risk
Lipase increased
Investigations
MedDRA 18.1
Systematic Assessment
EG0002 events2 affected6 at risk
EG0010 events0 affected5 at risk
EG0027 events3 affected5 at risk
EG0032 events2 affected6 at risk
EG0041 events1 affected8 at risk
EG0050 events0 affected4 at risk
Neutrophil count decreased
Investigations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected8 at risk
EG0051 events1 affected4 at risk
Platelet count decreased
Investigations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected5 at risk
EG0022 events2 affected5 at risk
EG0032 events2 affected6 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected4 at risk
Prostatic specific antigen increased
Investigations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected0 at risk
EG0010 events0 affected0 at risk
EG0020 events0 affected2 at risk
EG0030 events0 affected0 at risk
EG0041 events1 affected8 at risk
EG0050 events0 affected4 at risk
Weight decreased
Investigations
MedDRA 18.1
Systematic Assessment
EG0002 events2 affected6 at risk
EG0010 events0 affected5 at risk
EG0022 events1 affected5 at risk
EG0030 events0 affected6 at risk
EG0041 events1 affected8 at risk
EG0050 events0 affected4 at risk
White blood cell count decreased
Investigations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG0032 events2 affected6 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected4 at risk
Decreased appetite
Metabolism and nutrition disorders
MedDRA 18.1
Systematic Assessment
EG0003 events3 affected6 at risk
EG0011 events1 affected5 at risk
EG0026 events2 affected5 at risk
EG0031 events1 affected6 at risk
EG0045 events4 affected8 at risk
EG0053 events2 affected4 at risk
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected6 at risk
EG0041 events1 affected8 at risk
EG0050 events0 affected4 at risk
Hyperuricaemia
Metabolism and nutrition disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected5 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected4 at risk
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected5 at risk
EG0031 events1 affected6 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected4 at risk
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA 18.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected5 at risk
EG0031 events1 affected6 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected4 at risk
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG0031 events1 affected6 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected4 at risk
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected5 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected4 at risk
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 18.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected5 at risk
EG0022 events2 affected5 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected4 at risk
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0013 events1 affected5 at risk
EG0023 events2 affected5 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected4 at risk
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected5 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected4 at risk
Groin pain
Musculoskeletal and connective tissue disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected8 at risk
EG0052 events1 affected4 at risk
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected4 at risk
Muscle twitching
Musculoskeletal and connective tissue disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected5 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected4 at risk
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected5 at risk
EG0031 events1 affected6 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected4 at risk
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 18.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected6 at risk
EG0041 events1 affected8 at risk
EG0051 events1 affected4 at risk
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG0031 events1 affected6 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected4 at risk
Malignant melanoma in situ
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected4 at risk
Malignant neoplasm progression
Neoplasms benign, malignant and unspecified (incl cysts and polyps)