A Study for Patients With Acute Leukemia | NCT01214655 | Trialant
NCT01214655
Sponsor
Eli Lilly and Company
Status
Terminated
Last Update Posted
May 13, 2019Actual
Enrollment
33Actual
Phase
Phase 1
Conditions
Acute Leukemia
Interventions
LY2523355
Countries
United States
Protocol Section
Identification Module
NCT ID
Results Section
Participant Flow Module
Pre-assignment Details
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
NCT01214655
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
12119
Secondary IDs
ID
Type
Description
Link
I1Y-MC-JFBC
Other Identifier
Eli Lilly and Company
Brief Title
A Study for Patients With Acute Leukemia
Official Title
Phase 1 Study of LY2523355 in Patients With Acute Leukemia
Acronym
Not provided
Organization
Eli Lilly and CompanyINDUSTRY
Status Module
Record Verification Date
Sep 2017
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Primary objective has been met in the absence of clinically meaningful remissions
Expanded Access Info
No
Start Date
Jun 2008
Primary Completion Date
Feb 2011Actual
Completion Date
Feb 2011Actual
First Submitted Date
Oct 1, 2010
First Submission Date that Met QC Criteria
Oct 4, 2010
First Posted Date
Oct 5, 2010Estimated
Results Waived
Not provided
Results First Submitted Date
Sep 27, 2017
Results First Submitted that Met QC Criteria
May 10, 2019
Results First Posted Date
May 13, 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
May 10, 2019
Last Update Posted Date
May 13, 2019Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Eli Lilly and CompanyINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This study is a multicenter, nonrandomized, open-label, dose-escalation with intra-patient dose-escalation, Phase 1 study of intravenous LY2523355 to determine the dose of LY2523355 that can be safely administered to participants with acute leukemia. Part A and Part B are dose escalation of two schedules in participants with acute leukemia. Parts A and B will enroll concurrently. Part C is a dose expansion for each schedule in participants with acute myeloblastic leukemia (AML).
Detailed Description
Not provided
Conditions Module
Conditions
Acute Leukemia
Keywords
Acute Myelogenous Leukemia
Acute Lymphoblastic Leukemia
Chronic Myelogenous Leukemia,Blast Crisis
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
33Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
LY2523355 on Days 1, 2, and 3
Experimental
Starting dose was 2 milligrams per meter squared (mg/m^2) administered by a 1-hour intravenous (IV) infusion on Days 1, 2, and 3 of every 21-day Cycle.
Drug: LY2523355
LY2523355 on Days 1, 5, and 9
Experimental
Starting dose was 8 milligrams per meter squared (mg/m^2) administered by a 1-hour IV infusion over 1 hour on Days 1, 5, and 9 of every 21-day Cycle.
Drug: LY2523355
Interventions
Name
Type
Description
Arm Group Labels
Other Names
LY2523355
Drug
Administered as a 1-hour IV infusion for at least 2 cycles. Cycle length is 21 days. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criterion is met.
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Recommended Dose and Schedule for Phase 2 Studies in Acute Leukemia
The recommended dose and schedule for Phase 2 studies of LY2523355 with acute leukemia was determined by a modification of the continual reassessment method. The sample size to adequately determine the maximum tolerated dose (MTD) for both schedules in this study was a function of a priori estimates for the dose-toxicity relationship as well as the initial dose in each schedule, the rate of dose escalation, and the observed dose-toxicity relationship. Before MTD could be determined for Part B (Days 1, 5, and 9 of a 21-day cycle), this study was paused for futility analysis.
Baseline up to the end of Cycle 2 (Day 42)
Secondary Outcomes
Measure
Description
Time Frame
Number of Participants With Clinically Significant Effects
Clinically significant effects were defined as serious and other non-serious adverse events (AEs).
A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Baseline up to study completion (up to 213 days)
Other Outcomes
Measure
Description
Time Frame
Death of Participants on Study up to the Follow-up Period
The number of participants who died through the follow-up period of the study. This does not include the outcomes for the two participants who died while on treatment through Cycle 2 as captured in the Participant Flow Table.
A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Dose escalation period for both schedules:
Participants must have a confirmed diagnosis of acute leukemia regardless of sub-type and for whom experimental Phase 1 therapy is appropriate.
Are greater than or equal to 18 years of age.
Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale.
Females with childbearing potential must have had a negative urine or serum pregnancy test less than or equal to 7 days prior to the first dose of study drug.
Dose confirmation period for both schedules:
Participant must have a confirmed diagnosis of untreated acute myeloblastic leukemia (AML), should not be a candidate for standard therapy, and a clinical trial is a preferred treatment option or have acute AML that is relapsed or refractory to no more than 2 prior induction regimens. Hydroxyurea to control prior blast counts is not considered a prior regimen.
Are greater than or equal to 60 years of age.
Have a performance status of 0 or 1 on the ECOG scale.
Females with childbearing potential must have had a negative urine or serum pregnancy test less than or equal to 7 days prior to the first dose of study drug.
Exclusion Criteria:
Have received treatment within 28 days of the initial dose of study drug with a drug that has not received regulatory approval for any indication.
Participants with known central nervous system (CNS) leukemia by spinal fluid cytology or imaging. A lumbar puncture is not required unless CNS involvement is clinically suspected. Participants with signs or symptoms of leukemic meningitis or a history of leukemic meningitis must have a negative lumbar puncture within 2 weeks of study enrollment.
Have other active malignancy (with the exception of basal and squamous cell skin cancer) at time of study entry.
Have had an autologous or allogenic bone marrow transplant within 3 months. All organ toxicity must be resolved.
Have evidence of graft-versus-host disease due to an allogenic bone marrow transplant.
Have uncontrolled systemic infection.
Females who are pregnant or lactating.
Have known positive test results in human immunodeficiency virus (HIV), hepatitis B surface antigen (HBSAg), or hepatitis C antibodies (HCAb) (screening not required).
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Chicago
Illinois
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.
A participant was considered to have completed the trial if they received at 2 cycles of treatment. Participant Flow Arms represent schedule of dosing, with dose escalation, dose levels and participants who joined the dose level presented as Milestones. Study was based on best Schedule of dosing, not dose levels.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Schedule A LY2523355
Participants received a dose escalation to maximum tolerated dose (MTD) from 2 mg/m²/day to 4,5 and 6 mg/m²/day during a 1 hour (hr) infusion on Days 1,2, 3 (Schedule A) of a 21 day cycle. Participants did not have to escalate doses and participants could join at a higher dose level.
FG001
Schedule B LY2523355
Participants received a dose escalation to maximum tolerated dose (MTD) ranging from 8 mg/m²/day (starting dose) to 10,12 and 14 mg/m²/day during a 1 hour (hr) infusion on Days 1,5, 9 (Schedule B)of a 21 day cycle Participants did not have to escalate doses and participants could join at a higher dose level.
FG002
Schedule C LY2523355
Starting dose was 5 mg/m²/day administered by IV infusion over 1 hour on Days 1, 2, and 3 (Schedule C) of every 21-day Cycle.
Periods
Title
Milestones
Reasons Not Completed
Part A
Type
Comment
Milestone Data
STARTED
FG00010 subjectsTotal on Schedule A, dose days 1,2,3
FG0010 subjects
FG0020 subjects
Received 2 mg Study Drug
FG0003 subjects
FG0010 subjects
FG0020 subjects
Escalated From 2 to 4 mg/m²/Day
FG0003 subjects
FG0010 subjects
FG0020 subjects
Joined 4 mg Group
4 participants received 4 mg/m²/day
FG0001 subjects
FG0010 subjects
FG0020 subjects
Escalated From 4 mg Study Drug
FG0000 subjects
FG0010 subjects
FG0020 subjects
Joined 5 mg Study Drug
2 participants received 5 mg/m²/day
FG0002 subjects
FG0010 subjects
FG0020 subjects
Escalated From 5 mg Study Drug
FG0001 subjects
FG0010 subjects
FG0020 subjects
Joined 6 mg Group
FG0004 subjects
FG0010 subjects
FG0020 subjects
Received 6 mg Study Drug
FG0005 subjects
FG0010 subjects
FG0020 subjects
COMPLETED
FG0002 subjects
FG0010 subjects
FG0020 subjects
NOT COMPLETED
FG0008 subjects
FG0010 subjects
FG0020 subjects
Type
Comment
Reasons
Progressive Disease
FG0007 subjects
FG0010 subjects
FG0020 subjects
Physician Decision
FG000
Part B
Type
Comment
Milestone Data
STARTED
FG0000 subjectsPart A participants did not enroll in Part B. Participants in A, B, C are considered Cohorts.
FG00115 subjectsTotal on Schedule B, dose days 1,5,9
FG0020 subjects
Received at Least 1 Dose of Study Drug
Part C
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0028 subjectsTotal on Schedule C, dose days 1,2,3
Received at Least 1 Dose of 5 mg/m²/Day
FG000
Baseline Characteristics Module
Baseline Analysis Population Description
Participants who received at least one dose of study medication (LY2523355).
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Schedule A LY2523355
Starting dose was 2 milligrams per meter squared per day (mg/m^2/day) administered by intravenous (IV) infusion over 1 hour on Days 1, 2, and 3 of every 21-day Cycle.
BG001
Schedule B LY2523355
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
Recommended Dose and Schedule for Phase 2 Studies in Acute Leukemia
The recommended dose and schedule for Phase 2 studies of LY2523355 with acute leukemia was determined by a modification of the continual reassessment method. The sample size to adequately determine the maximum tolerated dose (MTD) for both schedules in this study was a function of a priori estimates for the dose-toxicity relationship as well as the initial dose in each schedule, the rate of dose escalation, and the observed dose-toxicity relationship. Before MTD could be determined for Part B (Days 1, 5, and 9 of a 21-day cycle), this study was paused for futility analysis.
Participants who received at least one dose of study medication (LY2523355).
Posted
Number
mg/m^2/day; Days 1, 2, and 3
Baseline up to the end of Cycle 2 (Day 42)
ID
Title
Description
OG000
LY2523355
Escalating doses starting at 2 milligrams per meter squared per day (mg/m^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1, 2, and 3 of every 21-day Cycle in Part A of the study. Escalating doses starting at 8 mg/m^2/day administered by a 1-hour IV infusion on Days 1, 5, and 9 of every 21-day Cycle in Part B of the study. Dose of 5 mg/m^2/day administered by a 1-hour IV infusion on Days 1, 2, and 3 of every 21-day Cycle in Part C of the study.
Adverse Events Module
Frequency Threshold
5
Time Frame
Not provided
Description
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Cohort 1 LY2523355 2 mg/m^2/Day, Days 1, 2, and 3
Dose was 2 milligrams per meter squared per day (mg/m^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1, 2, and 3 of every 21-day Cycle.
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 13.0
Systematic Assessment
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 13.0
Systematic Assessment
More Info Module
Limitations and Caveats
Before MTD could be determined for Part B (Days 1, 5, and 9 of a 21-day cycle), this study was paused for futility analysis. The decision was made to close the study because of evident toxicity and lack of efficacy.
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Point of Contact
Title
Organization
Phone
Extension
Email
Chief Medical Officer
Eli Lilly and Company
800-545-5979
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
ID
Term
D015470
Leukemia, Myeloid, Acute
D054198
Precursor Cell Lymphoblastic Leukemia-Lymphoma
D015464
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
D001752
Blast Crisis
Ancestor Terms
ID
Term
D007951
Leukemia, Myeloid
D007938
Leukemia
D009370
Neoplasms by Histologic Type
D009369
Neoplasms
Browse Leaves
Not provided
Browse Branches
Not provided
Intervention Browse Module
MeSH Terms
ID
Term
C000591843
litronesib
Ancestor Terms
Not provided
Browse Leaves
Not provided
Browse Branches
Not provided
Non-Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
LY2523355 on Days 1, 2, and 3
LY2523355 on Days 1, 5, and 9
Pharmacokinetics, Maximum Plasma Concentration (Cmax), Single Dose
The maximum plasma concentration (Cmax) was the maximum plasma concentration obtained from the plasma concentration versus time curves of LY2523355 were calculated to assess intra and intercycle variability, depending on dosage cycle.
Pharmacokinetics, Maximum Plasma Concentration (Cmax), Multiple Dose
The maximum plasma concentration (Cmax) was the maximum plasma concentration obtained from the plasma concentration versus time curves of LY2523355. Multiple dose LY2523355 plasma Cmax values are shown at each dose level for both schedules of administration (Day 3 of Cycle 1 for the Day 1, 2, and 3 schedule of administration and Day 9 of Cycle 1 for the Days 1, 5, and 9 schedule of administration). The maximum plasma concentration (Cmax) was the maximum plasma concentration obtained from the plasma concentration versus time curves of LY2523355 were calculated to assess intra and intercycle variability, depending on dosage cycle.
Days 3 (Parts A or C) or 9 (Part B), Cycle 1: Predose, 1 hour (hr), 2 hr, 3 hr, 4 hr, 6 hr, 8, hr, 12 hr, 24 hr, 48 hr, 72 hr postdose
Pharmacokinetics, Area Under the Concentration Versus Time Curve (AUC), Single Dose
The AUC(0-24) was calculated from area under the plasma concentration versus time curves of LY2523355 from time zero to 24 hours.
The AUC(0-inf) was calculated from area under the plasma concentration versus time curves of LY2523355 from time zero to infinity.
Single dose LY2523355 AUC values are shown for each dose level for Day 1 of Cycle 1 for both schedules of administration. When only individual participant parameters are available or N=2, for a given dose, the AUC CV is not calculated for that dose group and is not presented (4 milligrams per meter squared per day [mg/m^2/day], 14 mg/m^2/day, 12 mg/m^2/day and 16 mg/m^2/day). Individual data will be presented.
Pharmacokinetics, Area Under the Concentration Versus Time (AUC), Multiple Dose
The AUC(0-24) was calculated from area under the plasma concentration versus time curves of LY2523355 from time zero to 24 hours.
The AUC(0-inf) was calculated from area under the plasma concentration versus time curves of LY2523355 from time zero to infinity..
Multiple dose LY2523355 AUC values are shown at each dose level for both schedules of administration (Day 3 of Cycle 1 for the Day 1, 2, and 3 schedule of administration and Day 9 of Cycle 1 for the Days 1, 5, and 9 schedule of administration). When only individual participant parameters are available or N=2, for a given dose, the AUC CV is not calculated for that dose group and is not presented (4 milligrams per meter squared per day [mg/m^2/day], 12 mg/m^2/day, and 14 mg/m^2/day). Individual data will be presented.
Days 3 (Parts A or C) or 9 (Part B):Predose, 1 hour (hr), 2 hr, 3 hr, 4 hr, 6 hr, 8, hr, 12 hr, 24 hr 48 hr, 72 hr postdose
Percentage of Participants With a Response for Acute Myelogenous Leukemia Using The Revised International Working Group Criteria
Response rate for participants with acute myelogenous leukemia include the proportion of participants who achieved a morphologic complete remission, morphologic complete remission with incomplete blood count recovery, cytogenetic complete remission, molecular complete remission, or partial remission. The Revised International Working Group Criteria was used to determine response rate for participants with acute myelogenous leukemia.
Baseline up to disease progression or discontinuation (up to 213 days)
Response Rates for Chronic Myelogenous Leukemia in Blast Crisis (Complete Hematologic Response, no Evidence of Leukemia, Return to Chronic Phase)
Response rate for participants with chronic myelogenous leukemia in blast crisis include the proportion of participants who achieved a complete hematologic response, had no evidence of leukemia, or had returned to chronic phase. The criteria outlined in Cohen 2005 (Cohen MH, Johnson JR, Pazdur R. 2005. U.S. Food and Drug Administration Drug Approval Summary: conversion of imatinib mesylate (STI571; Gleevec) tablets from accelerated approval to full approval. Clin Cancer Res. 11(1):12-19.) was used to determine response rate for participants with chronic myelogenous leukemia in blast crisis.
Baseline up to disease progression or discontinuation (up to 213 days)
Response Rate (Percentage) for Acute Lymphoblastic Leukemia Using The Revised International Working Group Criteria
Response rate for participants with acute lymphoblastic leukemia include the proportion of participants who achieved a morphologic complete remission, morphologic complete remission with incomplete blood count recovery, cytogenetic complete remission, molecular complete remission, or partial remission. The Revised International Working Group Criteria was used to determine response rate for participants with acute lymphoblastic leukemia by early treatment assessment, morphologic leukemia-free state (less than 5% blasts in an aspirate sample with marrow spicules and with a count of at least 200 nucleated cells) and morphologic complete remission (and have an absolute neutrophil count of more than 1000 per microliter and platelets of 100,000 per microliter.
Baseline up to disease progression or discontinuation (up to 213 days)
Baseline up to end of treatment follow-up (up to 213 days)
United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Indianapolis
Indiana
United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Boston
Massachusetts
United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Nashville
Tennessee
United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Houston
Texas
United States
1 subjects
FG0010 subjects
FG0020 subjects
FG0000 subjects
FG00115 subjects
FG0020 subjects
Recieved 8 mg/m²/Day Study Drug
FG0000 subjects
FG0014 subjects
FG0020 subjects
Escalated From 8 to 10 mg/m²/Day
FG0000 subjects
FG0012 subjects
FG0020 subjects
Joined 10 mg/m²/Day Study D
5 participants received 10 mg/m²/day Study Drug
FG0000 subjects
FG0013 subjects
FG0020 subjects
Escalated to 12 mg/m²/Day
FG0000 subjects
FG0012 subjects
FG0020 subjects
Joined 12 mg/m²/Day
7 participants received 12 mg/m²/day Study Drug
FG0000 subjects
FG0015 subjects
FG0020 subjects
Escalated From 12 to 14 mg/m²/Day
FG0000 subjects
FG0011 subjects
FG0020 subjects
Joined 14 mg/m²/Day
4 participants received 14 mg/m²/day Study Drug
FG0000 subjects
FG0013 subjects
FG0020 subjects
COMPLETED
FG0000 subjects
FG0012 subjects
FG0020 subjects
NOT COMPLETED
FG0000 subjects
FG00113 subjects
FG0020 subjects
Type
Comment
Reasons
Progressive disease
FG0000 subjects
FG00110 subjects
FG0020 subjects
Death
FG0000 subjects
FG0011 subjects
FG0020 subjects
Withdrawal by Subject
FG0000 subjects
FG0012 subjects
FG0020 subjects
0 subjects
FG0010 subjects
FG0028 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0021 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0027 subjects
Type
Comment
Reasons
Progressive Disease
FG0000 subjects
FG0010 subjects
FG0025 subjects
Death
FG0000 subjects
FG0010 subjects
FG0021 subjects
Physician Decision
FG0000 subjects
FG0010 subjects
FG0021 subjects
Starting dose was 8 mg/m^2/day administered by IV infusion over 1 hour on Days 1, 5, and 9 of every 21-day Cycle.
BG002
Schedule C LY2523355
Starting dose was 5 mg/m^2/day administered by IV infusion over 1 hour on Days 1, 2, and 3 of every 21-day Cycle.
No participants in Part C escalated from their initial dose.
BG003
Total
Total of all reporting groups
10
BG00115
BG0028
BG00333
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00063.2± 19.43
BG00165.3± 12.98
BG00270.7± 5.75
BG00366.0± 13.98
Sex: Female, Male
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Female
BG0006
BG0013
BG0025
BG00314
Male
BG0004
BG00112
BG0023
BG00319
Race/Ethnicity, Customized
Count of Participants
Participants
No
Title
Denominators
Categories
Caucasian
Title
Measurements
BG0007
BG00114
BG0027
BG00328
African
Title
Measurements
BG0002
BG0010
BG0021
BG003
Hispanic
Title
Measurements
BG0000
BG0011
BG0020
BG003
Native American
Title
Measurements
BG0000
BG0010
BG0020
BG003
East Asian
Title
Measurements
BG0001
BG0010
BG0020
BG003
West Asian
Title
Measurements
BG0000
BG0010
BG0020
BG003
Region of Enrollment
Count of Participants
Participants
No
Title
Denominators
Categories
United States
Title
Measurements
BG00010
BG00115
BG0028
BG00333
Eastern Cooperative Oncology Group (ECOG) Performance Status
Eastern Cooperative Oncology Group (ECOG) Performance Status classifies patients according to their functional impairment. Scores range from 0 (Fully Active) to 5 (Death) as follows: 0 - Fully Active; 1 - Ambulatory, Restricted Strenuous Activity; 2 - Ambulatory, No Work Activities; 3 - Partially Confined to Bed, Limited Self Care; 4 - Completely Disabled; and 5 - Dead.
Count of Participants
Participants
No
Title
Denominators
Categories
ECOG Status 0
Title
Measurements
BG0006
BG0012
BG0021
BG0039
ECOG Status 1
Title
Measurements
BG0004
BG0017
BG0026
BG003
ECOG Status 2
Title
Measurements
BG0000
BG0016
BG0021
BG003
Units
Counts
Participants
OG00033
Title
Denominators
Categories
Title
Measurements
OG0005
Secondary
Number of Participants With Clinically Significant Effects
Clinically significant effects were defined as serious and other non-serious adverse events (AEs).
A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Participants who received at least one dose of study medication (LY2523355).
Posted
Count of Participants
Participants
No
Baseline up to study completion (up to 213 days)
ID
Title
Description
OG000
Schedule A LY2523355
Escalating doses starting at 2 milligrams per meter squared per day (mg/m^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1, 2, and 3 of every 21-day Cycle in Part A of the study.
OG001
Schedule B LY2523355
Starting dose was 8 mg/m^2/day administered by IV infusion over 1 hour on Days 1, 5, and 9 of every 21-day Cycle.
OG002
Schedule C LY2523355
Starting dose was 5 mg/m^2/day administered by IV infusion over 1 hour on Days 1, 2, and 3 of every 21-day Cycle.
Units
Counts
Participants
OG00010
OG00115
OG0028
Title
Denominators
Categories
Title
Measurements
OG0007
OG0019
OG0024
Secondary
Pharmacokinetics, Maximum Plasma Concentration (Cmax), Single Dose
The maximum plasma concentration (Cmax) was the maximum plasma concentration obtained from the plasma concentration versus time curves of LY2523355 were calculated to assess intra and intercycle variability, depending on dosage cycle.
Participants who received one dose of LY2523355 on Day 1 of Cycle 1(Schedule A,B,C) with evaluable pharmacokinetic data to enable determination of the LY2523355 plasma Cmax on Day 1. Schedule A,C data was combined for 5 mg, 2 participants received and incorrect dose of 6 mg and 16 mg are included in data.
2 milligrams per meter squared per day (mg/m^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1, 2, and 3 of every 21-day cycle.
OG001
Schedule A 4 mg LY2524455
4 milligrams per meter squared per day (mg/m^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1, 2, and 3 of every 21-day cycle.
OG002
Schedule A,C 5 mg LY2523355
Schedule A 5 milligrams per meter squared per day (mg/m^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1, 2, and 3 of every 21-day Cycle in Part A and Part C combined.
OG003
Schedule A 6 mg LY2523355
6 milligrams per meter squared per day (mg/m^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1, 2, and 3 of every 21-day cycle.
OG004
Schedule B 8 mg LY2523355
8 milligrams per meter squared per day (mg/m^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1, 5, and 9 of every 21-day cycle.
OG005
Schedule B 10 mg LY2523355
10 milligrams per meter squared per day (mg/m^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1, 5, and 9 of every 21-day cycle.
OG006
Schedule B 12 mg LY2523355
12 milligrams per meter squared per day (mg/m^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1,5, and 9 of every 21-day cycle.
OG007
Schedule B 14 mg 2523355
14 milligrams per meter squared per day (mg/m^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1, 5, and 9 of every 21-day cycle.
OG008
Schedule B 16 mg LY2523355
16 mg/m²/day was inadvertently given to a participant.
Units
Counts
Participants
OG0003
OG0011
OG0027
OG003
Title
Denominators
Categories
Title
Measurements
OG000198± 1410
OG001895± NAN=1, individual data presented
OG002240± 420
OG003
Secondary
Pharmacokinetics, Maximum Plasma Concentration (Cmax), Multiple Dose
The maximum plasma concentration (Cmax) was the maximum plasma concentration obtained from the plasma concentration versus time curves of LY2523355. Multiple dose LY2523355 plasma Cmax values are shown at each dose level for both schedules of administration (Day 3 of Cycle 1 for the Day 1, 2, and 3 schedule of administration and Day 9 of Cycle 1 for the Days 1, 5, and 9 schedule of administration). The maximum plasma concentration (Cmax) was the maximum plasma concentration obtained from the plasma concentration versus time curves of LY2523355 were calculated to assess intra and intercycle variability, depending on dosage cycle.
Participants who received more than one dose of LY2523355 with evaluable pharmacokinetic data, Schedules A,B,C.
Posted
Geometric Mean
Geometric Coefficient of Variation
nanograms per milliliter (ng/mL)
Days 3 (Parts A or C) or 9 (Part B), Cycle 1: Predose, 1 hour (hr), 2 hr, 3 hr, 4 hr, 6 hr, 8, hr, 12 hr, 24 hr, 48 hr, 72 hr postdose
ID
Title
Description
OG000
Schedule A Day 3 2 mg LY2523355
2 milligrams per meter squared per day (mg/m^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1, 2, and 3 of every 21-day cycle
OG001
Schedule A Day 3 4 mg LY2523355
4 milligrams per meter squared per day (mg/m^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1, 2, and 3 of every 21-day cycle
OG002
Schedule A/C Day 3 5 mg LY2523355
5 milligrams per meter squared per day (mg/m^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1, 2, and 3 of every 21-day cycle.
OG003
Schedule A Day 3 6 mg LY2523355
6 milligrams per meter squared per day (mg/m^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1, 2, and 3 of every 21-day cycle.
OG004
Schedule B Day 9 8 mg LY2523355
8 milligrams per meter squared per day (mg/m^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1, 5, and 9 of every 21-day cycle
OG005
Schedule B Day 9 10 mg LY2523355
10 milligrams per meter squared per day (mg/m^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1, 5, and 9 of every 21-day cycle
OG006
Schedule B Day 9 12 mg LY2523355
12 milligrams per meter squared per day (mg/m^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1, 2, and 3 of every 21-day Cycle in Part A, Part B and Part C.
OG007
Schedule B Day 9 14 mg LY2523355
14 milligrams per meter squared per day (mg/m^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1,5, and 9 of every 21-day cycle
Units
Counts
Participants
OG0003
OG0011
OG0029
OG003
Title
Denominators
Categories
Title
Measurements
OG00043.1± 46
OG0012440± NAN=1, Individual parameter listed
OG002439± 391
OG003
Secondary
Pharmacokinetics, Area Under the Concentration Versus Time Curve (AUC), Single Dose
The AUC(0-24) was calculated from area under the plasma concentration versus time curves of LY2523355 from time zero to 24 hours.
The AUC(0-inf) was calculated from area under the plasma concentration versus time curves of LY2523355 from time zero to infinity.
Single dose LY2523355 AUC values are shown for each dose level for Day 1 of Cycle 1 for both schedules of administration. When only individual participant parameters are available or N=2, for a given dose, the AUC CV is not calculated for that dose group and is not presented (4 milligrams per meter squared per day [mg/m^2/day], 14 mg/m^2/day, 12 mg/m^2/day and 16 mg/m^2/day). Individual data will be presented.
Participants who received one dose of LY2523355 on Day 1 of Cycle 1 with evaluable pharmacokinetic data to enable calculation of the LY2523355 AUC on Day 1 of Cycle 1.Schedule A,C data was combined for 5 mg, 2 participants received and incorrect dose of 6 mg and 16 mg are included in data.
2 milligrams per meter squared per day (mg/m^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1, 2, and 3 of every 21-day cycle
OG001
Schedule A Day 1 4 mg LY2524455
4 milligrams per meter squared per day (mg/m^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1, 2, and 3 of every 21-day cycle
OG002
Schedule A,C Day 1 5 mg LY2523355
5 milligrams per meter squared per day (mg/m^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1, 2, and 3 of every 21-day Cycle in Part A and Part C combined.
OG003
Schedule A Day 1 6 mg LY2523355
6 milligrams per meter squared per day (mg/m^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1, 2, and 3 of every 21-day cycle
OG004
Schedule B Day 1 8 mg LY2523355
8 milligrams per meter squared per day (mg/m^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1, 5, and 9 of every 21-day cycle.
OG005
Schedule B Day 1 10 mg LY2523355
10 milligrams per meter squared per day (mg/m^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1, 5, and 9 of every 21-day cycle.
OG006
Schedule B Day 1 12 mg LY2523355
12 milligrams per meter squared per day (mg/m^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1,5, and 9 of every 21-day cycle.
OG007
Schedule B Day 1 14 mg 2523355
14 milligrams per meter squared per day (mg/m^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1, 5, and 9 of every 21-day cycle.
OG008
Schedule B Day 1 16 mg LY2523355
16 mg/m²/day was inadvertently given to a participant.
Units
Counts
Participants
OG0003
OG0011
OG0029
OG003
Title
Denominators
Categories
The AUC(0-24)
Title
Measurements
OG000278± 209
OG0013420± NAN=1, individual data presented
OG002473± 163
OG003
Secondary
Pharmacokinetics, Area Under the Concentration Versus Time (AUC), Multiple Dose
The AUC(0-24) was calculated from area under the plasma concentration versus time curves of LY2523355 from time zero to 24 hours.
The AUC(0-inf) was calculated from area under the plasma concentration versus time curves of LY2523355 from time zero to infinity..
Multiple dose LY2523355 AUC values are shown at each dose level for both schedules of administration (Day 3 of Cycle 1 for the Day 1, 2, and 3 schedule of administration and Day 9 of Cycle 1 for the Days 1, 5, and 9 schedule of administration). When only individual participant parameters are available or N=2, for a given dose, the AUC CV is not calculated for that dose group and is not presented (4 milligrams per meter squared per day [mg/m^2/day], 12 mg/m^2/day, and 14 mg/m^2/day). Individual data will be presented.
Participants who received more than one dose of LY2523355 with evaluable pharmacokinetic data on Cycle 1 Day 3 or Day 9, schedule dependent.
Posted
Geometric Mean
Geometric Coefficient of Variation
nanograms hours per milliliter (ng*h/mL)
Days 3 (Parts A or C) or 9 (Part B):Predose, 1 hour (hr), 2 hr, 3 hr, 4 hr, 6 hr, 8, hr, 12 hr, 24 hr 48 hr, 72 hr postdose
ID
Title
Description
OG000
Schedule A Day 3 2 mg LY2523355
2 milligrams per meter squared per day (mg/m^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1, 2, and 3 of every 21-day cycle
OG001
Schedule A Day 3 4 mg LY2523355
4 milligrams per meter squared per day (mg/m^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1, 2, and 3 of every 21-day cycle
OG002
Schedule A/C Day 3 5 mg LY2523355
5 milligrams per meter squared per day (mg/m^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1, 2, and 3 of every 21-day cycle.
OG003
Schedule A Day 3 6 mg LY2523355
6 milligrams per meter squared per day (mg/m^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1, 2, and 3 of every 21-day cycle.
OG004
Schedule B Day 9 8 mg LY2523355
8 milligrams per meter squared per day (mg/m^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1, 5, and 9 of every 21-day cycle
OG005
Schedule B Day 9 10 mg LY2523355
10 milligrams per meter squared per day (mg/m^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1, 5, and 9 of every 21-day cycle
OG006
Schedule B Day 9 12 mg LY2523355
12 milligrams per meter squared per day (mg/m^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1, 2, and 3 of every 21-day Cycle in Part A, Part B and Part C.
OG007
Schedule B Day 9 14 mg LY2523355
14 milligrams per meter squared per day (mg/m^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1,5, and 9 of every 21-day cycle
Units
Counts
Participants
OG0003
OG0011
OG0029
OG003
Title
Denominators
Categories
AUC(0-24)
Title
Measurements
OG000134± 38
OG0012540± NAIndividual parameter listed
OG002696± 126
OG003
Secondary
Percentage of Participants With a Response for Acute Myelogenous Leukemia Using The Revised International Working Group Criteria
Response rate for participants with acute myelogenous leukemia include the proportion of participants who achieved a morphologic complete remission, morphologic complete remission with incomplete blood count recovery, cytogenetic complete remission, molecular complete remission, or partial remission. The Revised International Working Group Criteria was used to determine response rate for participants with acute myelogenous leukemia.
Participants with acute myelogenous leukemia who received at least one dose of study medication (LY2523355).
Posted
Number
percentage of responders
Baseline up to disease progression or discontinuation (up to 213 days)
ID
Title
Description
OG000
Schedule A LY2523355 Days 1, 2, and 3
Starting dose was 2 milligrams per meter squared per day (mg/m^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1, 2, and 3 of every 21-day Cycle.
Four of the 10 participants enrolled in Part A escalated from their initial dose after the first cycle (3 participants escalated from 2 to 4 mg/m^2/day and 1 participant escalated from 5 to 6 mg/m^2/day).
OG001
Schedule B LY2523355 Days 1, 5, and 9
Starting dose was 8 mg/m^2/day administered by a 1-hour IV infusion on Days 1, 5, and 9 of every 21-day Cycle.
Five of the 15 participants enrolled in Part B escalated from their initial dose after the first cycle (2 participants escalated from 8 to 10 mg/m^2/day, 1 participant escalated from 8 to 12 mg/m^2/day, 1 participant escalated from 10 to 12 mg/m^2/day, and 1 participant escalated from 12 to 14 mg/m^2/day).
OG002
Schedule C LY2523355 Days 1, 2, and 3
Starting dose was 5 mg/m^2/day administered by a 1-hour IV infusion on Days 1, 5, and 9 of every 21-day Cycle.
No participants in Part C escalated from their initial dose.
Units
Counts
Participants
OG0005
OG0019
OG0028
Title
Denominators
Categories
Title
Measurements
OG0000.0
OG00111.1
OG00212.5
Secondary
Response Rates for Chronic Myelogenous Leukemia in Blast Crisis (Complete Hematologic Response, no Evidence of Leukemia, Return to Chronic Phase)
Response rate for participants with chronic myelogenous leukemia in blast crisis include the proportion of participants who achieved a complete hematologic response, had no evidence of leukemia, or had returned to chronic phase. The criteria outlined in Cohen 2005 (Cohen MH, Johnson JR, Pazdur R. 2005. U.S. Food and Drug Administration Drug Approval Summary: conversion of imatinib mesylate (STI571; Gleevec) tablets from accelerated approval to full approval. Clin Cancer Res. 11(1):12-19.) was used to determine response rate for participants with chronic myelogenous leukemia in blast crisis.
Participants with chronic myelogenous leukemia in blast crisis who received at least one dose of study medication (LY2523355).
Posted
Number
percentage of responders
Baseline up to disease progression or discontinuation (up to 213 days)
ID
Title
Description
OG000
Schedule A LY2523355 Days 1, 2, and 3
Starting dose was 2 milligrams per meter squared per day (mg/m^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1, 5, and 9 of every 21-day Cycle.
Four of the 10 participants enrolled in Part A escalated from their initial dose after the first cycle (3 participants escalated from 2 to 4 mg/m^2/day and 1 participant escalated from 5 to 6 mg/m^2/day).
OG001
Schedule B LY2523355 Days 1, 5, and 9
Starting dose was 8 mg/m^2/day administered by a 1-hour IV infusion on Days 1, 5, and 9 of every 21-day Cycle.
Five of the 15 participants enrolled in Part B escalated from their initial dose after the first cycle (2 participants escalated from 8 to 10 mg/m^2/day, 1 participant escalated from 8 to 12 mg/m^2/day, 1 participant escalated from 10 to 12 mg/m^2/day, and 1 participant escalated from 12 to 14 mg/m^2/day).
OG002
Schedule C LY2523355 Days 1, 2, and 3
Starting dose was 5 mg/m^2/day administered by a 1-hour IV infusion on Days 1, 5, and 9 of every 21-day Cycle.
No participants in Part C escalated from their initial dose.
Units
Counts
Participants
OG0000
OG0011
OG0020
Title
Denominators
Categories
Title
Measurements
OG0010
Secondary
Response Rate (Percentage) for Acute Lymphoblastic Leukemia Using The Revised International Working Group Criteria
Response rate for participants with acute lymphoblastic leukemia include the proportion of participants who achieved a morphologic complete remission, morphologic complete remission with incomplete blood count recovery, cytogenetic complete remission, molecular complete remission, or partial remission. The Revised International Working Group Criteria was used to determine response rate for participants with acute lymphoblastic leukemia by early treatment assessment, morphologic leukemia-free state (less than 5% blasts in an aspirate sample with marrow spicules and with a count of at least 200 nucleated cells) and morphologic complete remission (and have an absolute neutrophil count of more than 1000 per microliter and platelets of 100,000 per microliter.
Participants with acute lymphoblastic leukemia who received at least one dose of study medication (LY2523355).
Posted
Number
percentage of responders
Baseline up to disease progression or discontinuation (up to 213 days)
ID
Title
Description
OG000
Schedule A LY2523355 Days 1, 2, and 3
Starting dose was 2 milligrams per meter squared per day (mg/m^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1, 5, and 9 of every 21-day Cycle.
Four of the 10 participants enrolled in Part A escalated from their initial dose after the first cycle (3 participants escalated from 2 to 4 mg/m^2/day and 1 participant escalated from 5 to 6 mg/m^2/day).
OG001
Schedule B LY2523355 Days 1, 5, and 9
Starting dose was 8 mg/m^2/day administered by a 1-hour IV infusion on Days 1, 5, and 9 of every 21-day Cycle.
Five of the 15 participants enrolled in Part B escalated from their initial dose after the first cycle (2 participants escalated from 8 to 10 mg/m^2/day, 1 participant escalated from 8 to 12 mg/m^2/day, 1 participant escalated from 10 to 12 mg/m^2/day, and 1 participant escalated from 12 to 14 mg/m^2/day).
OG002
Schedule C LY2523355 Days 1, 2, and 3
Starting dose was 5 mg/m^2/day administered by a 1-hour IV infusion on Days 1, 5, and 9 of every 21-day Cycle.
No participants in Part C escalated from their initial dose.
Units
Counts
Participants
OG0004
OG0010
OG0020
Title
Denominators
Categories
Title
Measurements
OG00025.0
Other Pre-specified
Death of Participants on Study up to the Follow-up Period
The number of participants who died through the follow-up period of the study. This does not include the outcomes for the two participants who died while on treatment through Cycle 2 as captured in the Participant Flow Table.
A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Participants who received at least one dose of study medication (LY2523355).
Posted
Count of Participants
Participants
No
Baseline up to end of treatment follow-up (up to 213 days)
ID
Title
Description
OG000
Schedule LY2523355 Days 1, 2, and 3
Starting dose was 2 milligrams per meter squared per day (mg/m^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1, 5, and 9 of every 21-day Cycle.
Four of the 10 participants enrolled in Part A escalated from their initial dose after the first cycle (3 participants escalated from 2 to 4 mg/m^2/day and 1 participant escalated from 5 to 6 mg/m^2/day).
OG001
Schedule B LY2523355 Days 1, 5, and 9
Starting dose was 8 mg/m^2/day administered by a 1-hour IV infusion on Days 1, 5, and 9 of every 21-day Cycle.
Five of the 15 participants enrolled in Part B escalated from their initial dose after the first cycle (2 participants escalated from 8 to 10 mg/m^2/day, 1 participant escalated from 8 to 12 mg/m^2/day, 1 participant escalated from 10 to 12 mg/m^2/day, and 1 participant escalated from 12 to 14 mg/m^2/day).
OG002
Schedule C LY2523355 Days 1, 2, and 3
Starting dose was 5 mg/m^2/day administered by a 1-hour IV infusion on Days 1, 5, and 9 of every 21-day Cycle.
No participants in Part C escalated from their initial dose.
Units
Counts
Participants
OG00010
OG00115
OG0028
Title
Denominators
Categories
Title
Measurements
OG0001
OG0014
OG0020
1
3
3
3
EG001
Cohort 1 LY2523355 4 mg/m^2/Day, Days 1, 2, and 3
Dose was 4 mg/m^2/day administered by a 1-hour IV infusion on Days 1, 2, and 3 of every 21-day Cycle.
3
4
3
4
EG002
Cohort 1 LY2523355 5 mg/m^2/Day, Days 1, 2, and 3
Dose was 5 mg/m^2/day administered by a 1-hour IV infusion on Days 1, 2, and 3 of every 21-day Cycle.
1
2
2
2
EG003
Cohort 1 LY2523355 6 mg/m^2/Day, Days 1, 2, and 3
Dose was 6 mg/m^2/day administered by a 1-hour IV infusion on Days 1, 2, and 3 of every 21-day Cycle.
3
5
5
5
EG004
Cohort 2 LY2523355 8 mg/m^2/Day, Days 1, 5, and 9
Dose was 8 mg/m^2/day administered by a 1-hour IV infusion on Days 1, 5, and 9 of every 21-day Cycle.
2
4
3
4
EG005
Cohort 2 LY2523355 10 mg/m^2/Day, Days 1, 5, and 9
Dose was 10 mg/m^2/day administered by a 1-hour IV infusion on Days 1, 5, and 9 of every 21-day Cycle.
1
5
5
5
EG006
Cohort 2 LY2523355 12 mg/m^2/Day, Days 1, 5, and 9
Dose was 12 mg/m^2/day administered by a 1-hour IV infusion on Days 1, 5, and 9 of every 21-day Cycle.
3
7
7
7
EG007
Cohort 2 LY2523355 14 mg/m^2/Day, Days 1, 5, and 9
Dose was 14 mg/m^2/day administered by a 1-hour IV infusion on Days 1, 5, and 9 of every 21-day Cycle.
3
4
4
4
EG008
Cohort 3 LY2523355 5 mg/m^2/Day, Days 1, 2, and 3
Dose was 5 mg/m^2/day administered by a 1-hour IV infusion on Days 1, 2, and 3 of every 21-day Cycle.
4
8
8
8
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected2 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected5 at risk
EG0061 events1 affected7 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected8 at risk
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events2 affected4 at risk
EG0021 events1 affected2 at risk
EG0032 events2 affected5 at risk
EG0041 events1 affected4 at risk
EG0051 events1 affected5 at risk
EG0061 events1 affected7 at risk
EG0070 events0 affected4 at risk
EG0085 events2 affected8 at risk
Cardiac failure congestive
Cardiac disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected2 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected8 at risk
Diarrhoea
Gastrointestinal disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected2 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected4 at risk
EG0081 events1 affected8 at risk
Oesophagitis
Gastrointestinal disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected2 at risk
EG0031 events1 affected5 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected8 at risk
Pancreatitis
Gastrointestinal disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected2 at risk
EG0031 events1 affected5 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected8 at risk
Stomatitis
Gastrointestinal disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected2 at risk
EG0031 events1 affected5 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected8 at risk
Mucosal inflammation
General disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected2 at risk
EG0031 events1 affected5 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected5 at risk
EG0061 events1 affected7 at risk
EG0071 events1 affected4 at risk
EG0081 events1 affected8 at risk
Pyrexia
General disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected2 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected5 at risk
EG0061 events1 affected7 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected8 at risk
Bacteraemia
Infections and infestations
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected2 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected4 at risk
EG0081 events1 affected8 at risk
Pneumonia
Infections and infestations
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected2 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected4 at risk
EG0081 events1 affected8 at risk
Sepsis
Infections and infestations
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected2 at risk
EG0030 events0 affected5 at risk
EG0041 events1 affected4 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected7 at risk
EG0071 events1 affected4 at risk
EG0081 events1 affected8 at risk
Dehydration
Metabolism and nutrition disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected2 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected7 at risk
EG0071 events1 affected4 at risk
EG0080 events0 affected8 at risk
Pharyngeal haemorrhage
Respiratory, thoracic and mediastinal disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected2 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected7 at risk
EG0071 events1 affected4 at risk
EG0080 events0 affected8 at risk
Deep vein thrombosis
Vascular disorders
MedDRA 13.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected2 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected8 at risk
EG0000 events0 affected3 at risk
EG0011 events1 affected4 at risk
EG0021 events1 affected2 at risk
EG0033 events3 affected5 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected5 at risk
EG0061 events1 affected7 at risk
EG0071 events1 affected4 at risk
EG0083 events3 affected8 at risk
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected2 at risk
EG0031 events1 affected5 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected7 at risk
EG0071 events1 affected4 at risk
EG0080 events0 affected8 at risk
Leukocytosis
Blood and lymphatic system disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected2 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected5 at risk
EG0062 events2 affected7 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected8 at risk
Leukopenia
Blood and lymphatic system disorders
MedDRA 13.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0013 events3 affected4 at risk
EG0020 events0 affected2 at risk
EG0032 events2 affected5 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected8 at risk
Neutropenia
Blood and lymphatic system disorders
MedDRA 13.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0012 events2 affected4 at risk
EG0021 events1 affected2 at risk
EG0031 events1 affected5 at risk
EG0041 events1 affected4 at risk
EG0050 events0 affected5 at risk
EG0063 events3 affected7 at risk
EG0070 events0 affected4 at risk
EG0082 events2 affected8 at risk
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 13.0
Systematic Assessment
EG0002 events2 affected3 at risk
EG0012 events2 affected4 at risk
EG0021 events1 affected2 at risk
EG0032 events2 affected5 at risk
EG0040 events0 affected4 at risk
EG0051 events1 affected5 at risk
EG0061 events1 affected7 at risk
EG0071 events1 affected4 at risk
EG0082 events2 affected8 at risk
Atrial fibrillation
Cardiac disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected2 at risk
EG0030 events0 affected5 at risk
EG0041 events1 affected4 at risk
EG0050 events0 affected5 at risk
EG0061 events1 affected7 at risk
EG0070 events0 affected4 at risk
EG0081 events1 affected8 at risk
Pericardial effusion
Cardiac disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected2 at risk
EG0030 events0 affected5 at risk
EG0041 events1 affected4 at risk
EG0051 events1 affected5 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected8 at risk
Tachycardia
Cardiac disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected2 at risk
EG0032 events2 affected5 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected5 at risk
EG0061 events1 affected7 at risk
EG0071 events1 affected4 at risk
EG0081 events1 affected8 at risk
Vision blurred
Eye disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected2 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected5 at risk
EG0062 events2 affected7 at risk
EG0072 events2 affected4 at risk
EG0080 events0 affected8 at risk
Abdominal pain upper
Gastrointestinal disorders
MedDRA 13.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected2 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected8 at risk
Constipation
Gastrointestinal disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected2 at risk
EG0031 events1 affected5 at risk
EG0041 events1 affected4 at risk
EG0050 events0 affected5 at risk
EG0062 events2 affected7 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected8 at risk
Diarrhoea
Gastrointestinal disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0022 events1 affected2 at risk
EG0032 events2 affected5 at risk
EG0040 events0 affected4 at risk
EG0051 events1 affected5 at risk
EG0064 events4 affected7 at risk
EG0072 events2 affected4 at risk
EG0080 events0 affected8 at risk
Haemorrhoids
Gastrointestinal disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected2 at risk
EG0031 events1 affected5 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected5 at risk
EG0061 events1 affected7 at risk
EG0071 events1 affected4 at risk
EG0080 events0 affected8 at risk
Nausea
Gastrointestinal disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected4 at risk
EG0021 events1 affected2 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected4 at risk
EG0052 events2 affected5 at risk
EG0062 events2 affected7 at risk
EG0072 events2 affected4 at risk
EG0084 events3 affected8 at risk
Oral pain
Gastrointestinal disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected2 at risk
EG0031 events1 affected5 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected7 at risk
EG0071 events1 affected4 at risk
EG0081 events1 affected8 at risk
Proctalgia
Gastrointestinal disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected2 at risk
EG0031 events1 affected5 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected8 at risk
Stomatitis
Gastrointestinal disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected2 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected5 at risk
EG0061 events1 affected7 at risk
EG0071 events1 affected4 at risk
EG0082 events2 affected8 at risk
Vomiting
Gastrointestinal disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected4 at risk
EG0021 events1 affected2 at risk
EG0031 events1 affected5 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected5 at risk
EG0061 events1 affected7 at risk
EG0071 events1 affected4 at risk
EG0082 events2 affected8 at risk
Asthenia
General disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected2 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected4 at risk
EG0051 events1 affected5 at risk
EG0061 events1 affected7 at risk
EG0070 events0 affected4 at risk
EG0081 events1 affected8 at risk
Chills
General disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected2 at risk
EG0030 events0 affected5 at risk
EG0041 events1 affected4 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected7 at risk
EG0071 events1 affected4 at risk
EG0081 events1 affected8 at risk
Fatigue
General disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected2 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected4 at risk
EG0051 events1 affected5 at risk
EG0060 events0 affected7 at risk
EG0072 events2 affected4 at risk
EG0083 events3 affected8 at risk
Mucosal inflammation
General disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected2 at risk
EG0031 events1 affected5 at risk
EG0041 events1 affected4 at risk
EG0052 events2 affected5 at risk
EG0061 events1 affected7 at risk
EG0071 events1 affected4 at risk
EG0083 events3 affected8 at risk
Oedema peripheral
General disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected2 at risk
EG0032 events2 affected5 at risk
EG0041 events1 affected4 at risk
EG0050 events0 affected5 at risk
EG0061 events1 affected7 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected8 at risk
Pyrexia
General disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected2 at risk
EG0031 events1 affected5 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected5 at risk
EG0062 events2 affected7 at risk
EG0073 events3 affected4 at risk
EG0087 events4 affected8 at risk
Anal abscess
Infections and infestations
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected2 at risk
EG0031 events1 affected5 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected8 at risk
Contusion
Injury, poisoning and procedural complications
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected2 at risk
EG0031 events1 affected5 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected4 at risk
EG0082 events2 affected8 at risk
Haemoglobin decreased
Investigations
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected2 at risk
EG0031 events1 affected5 at risk
EG0040 events0 affected4 at risk
EG0053 events3 affected5 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected8 at risk
Platelet count decreased
Investigations
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected2 at risk
EG0031 events1 affected5 at risk
EG0040 events0 affected4 at risk
EG0051 events1 affected5 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected8 at risk
Decreased appetite
Metabolism and nutrition disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected2 at risk
EG0031 events1 affected5 at risk
EG0042 events2 affected4 at risk
EG0052 events2 affected5 at risk
EG0061 events1 affected7 at risk
EG0072 events2 affected4 at risk
EG0083 events3 affected8 at risk
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 13.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected2 at risk
EG0032 events2 affected5 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected8 at risk
Hyperuricaemia
Metabolism and nutrition disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected2 at risk
EG0030 events0 affected5 at risk
EG0041 events1 affected4 at risk
EG0051 events1 affected5 at risk
EG0061 events1 affected7 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected8 at risk
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected2 at risk
EG0030 events0 affected5 at risk
EG0041 events1 affected4 at risk
EG0051 events1 affected5 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected8 at risk
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected2 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected5 at risk
EG0061 events1 affected7 at risk
EG0070 events0 affected4 at risk
EG0081 events1 affected8 at risk
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected2 at risk
EG0031 events1 affected5 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected5 at risk
EG0061 events1 affected7 at risk
EG0070 events0 affected4 at risk
EG0081 events1 affected8 at risk
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 13.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected2 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected8 at risk
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected2 at risk
EG0031 events1 affected5 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected4 at risk
EG0082 events2 affected8 at risk
Dizziness
Nervous system disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected2 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected4 at risk
EG0051 events1 affected5 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected4 at risk
EG0081 events1 affected8 at risk
Anxiety
Psychiatric disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected2 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected5 at risk
EG0061 events1 affected7 at risk
EG0071 events1 affected4 at risk
EG0080 events0 affected8 at risk
Insomnia
Psychiatric disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected2 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected5 at risk
EG0062 events2 affected7 at risk
EG0072 events2 affected4 at risk
EG0080 events0 affected8 at risk
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected2 at risk
EG0032 events2 affected5 at risk
EG0040 events0 affected4 at risk
EG0051 events1 affected5 at risk
EG0060 events0 affected7 at risk
EG0072 events2 affected4 at risk
EG0081 events1 affected8 at risk
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected2 at risk
EG0032 events2 affected5 at risk
EG0040 events0 affected4 at risk
EG0051 events1 affected5 at risk
EG0061 events1 affected7 at risk
EG0072 events2 affected4 at risk
EG0082 events2 affected8 at risk
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected2 at risk
EG0031 events1 affected5 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected7 at risk
EG0072 events2 affected4 at risk
EG0081 events1 affected8 at risk
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected2 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected5 at risk
EG0061 events1 affected7 at risk
EG0071 events1 affected4 at risk
EG0081 events1 affected8 at risk
Wheezing
Respiratory, thoracic and mediastinal disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected2 at risk
EG0031 events1 affected5 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected7 at risk
EG0071 events1 affected4 at risk
EG0081 events1 affected8 at risk
Alopecia
Skin and subcutaneous tissue disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected2 at risk
EG0031 events1 affected5 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected4 at risk
EG0082 events2 affected8 at risk
Blister
Skin and subcutaneous tissue disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected2 at risk
EG0031 events1 affected5 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected5 at risk
EG0061 events1 affected7 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected8 at risk
Ecchymosis
Skin and subcutaneous tissue disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected2 at risk
EG0032 events2 affected5 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected8 at risk
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected2 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected7 at risk
EG0072 events2 affected4 at risk
EG0083 events2 affected8 at risk
Rash
Skin and subcutaneous tissue disorders
MedDRA 13.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected2 at risk
EG0031 events1 affected5 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected5 at risk
EG0061 events1 affected7 at risk
EG0070 events0 affected4 at risk
EG0082 events1 affected8 at risk
Restriction Type
GT60
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Not provided
D006402
Hematologic Diseases
D006425
Hemic and Lymphatic Diseases
D007945
Leukemia, Lymphoid
D008232
Lymphoproliferative Disorders
D008206
Lymphatic Diseases
D007160
Immunoproliferative Disorders
D007154
Immune System Diseases
D009196
Myeloproliferative Disorders
D001855
Bone Marrow Diseases
D002908
Chronic Disease
D020969
Disease Attributes
D010335
Pathologic Processes
D013568
Pathological Conditions, Signs and Symptoms
D002471
Cell Transformation, Neoplastic
D063646
Carcinogenesis
D009385
Neoplastic Processes
3
1
0
1
0
17
7
6
OG0045
OG0053
OG0064
OG0072
OG0081
391
± 254
OG004169± 47
OG005354± 66
OG006254± 18
OG007NA± NAN=2,individual values presented (263 and 657), no CV calculated due to N of 2