A Study of LY2334737 in Participants With Cancer That is... | NCT01648764 | Trialant
NCT01648764
Sponsor
Eli Lilly and Company
Status
Completed
Last Update Posted
Jun 17, 2019Actual
Enrollment
73Actual
Phase
Phase 1
Conditions
Malignant Solid Tumor
Solid Tumor
Metastatic Tumor
Interventions
LY2334737
Countries
United States
France
Germany
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
NCT01648764
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
11967
Secondary IDs
ID
Type
Description
Link
2008-000807-28
EudraCT Number
I1C-MC-JLBE
Other Identifier
Eli Lilly & Company
Brief Title
A Study of LY2334737 in Participants With Cancer That is Advanced and/or Has Spread
Official Title
Phase 1 Dose Escalation Study of LY2334737 Using 2 Dosing Regimens in Patients With Advanced and/or Metastatic Solid Tumors
Acronym
Not provided
Organization
Eli Lilly and CompanyINDUSTRY
Status Module
Record Verification Date
Mar 2019
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Sep 2008
Primary Completion Date
Nov 2012Actual
Completion Date
Nov 2012Actual
First Submitted Date
Jul 20, 2012
First Submission Date that Met QC Criteria
Jul 20, 2012
First Posted Date
Jul 24, 2012Estimated
Results Waived
Not provided
Results First Submitted Date
Mar 11, 2019
Results First Submitted that Met QC Criteria
Mar 11, 2019
Results First Posted Date
Jun 17, 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
Mar 11, 2019
Last Update Posted Date
Jun 17, 2019Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Eli Lilly and CompanyINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of this study is to evaluate two different dosing regimens of LY2334737 in participants with cancer that is advanced and/or has spread to other parts of the body. Information about side effects will be collected.
Detailed Description
This study will consist of a Dose Escalation Phase (Arms A and B) followed by a Dose Confirmation Phase.
Conditions Module
Conditions
Malignant Solid Tumor
Solid Tumor
Metastatic Tumor
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
73Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
LY2334737 - Arm A
Experimental
LY2334737 administered orally at escalating doses [40 milligrams (mg) - 200 mg] every other day for 21 days followed by 7 days without study drug (28 day treatment cycle). Participants may receive additional treatment cycles until discontinuation criterion is met.
Drug: LY2334737
LY2334737 - Arm B
Experimental
LY2334737 administered orally at escalating doses (40 mg - 200 mg) every day for 7 days followed by 7 days without study drug then repeated (28 day treatment cycle). Participants may receive additional treatment cycles until discontinuation criterion is met.
Drug: LY2334737
Interventions
Name
Type
Description
Arm Group Labels
Other Names
LY2334737
Drug
Administered orally
LY2334737 - Arm A
LY2334737 - Arm B
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Recommended Dose for Phase 2 Studies
Recommended Phase 2 dose was determined by maximum tolerated dose (MTD). The MTD was the highest dose level at which <2 out of 6 participants experienced a dose-limiting toxicity (DLT) in Cycle 1. DLT was an adverse event (AE) during Cycle 1 that was likely related to LY2334737 and fulfilled any of the following criteria: Common Terminology Criteria for Adverse Events (CTCAE) ≥Grade 3 nonhematological (except nausea/vomiting controlled with treatment); Grade 3 neutropenia with fever or any Grade 4 neutropenia with or without fever; Grade 3 thrombocytopenia with ≥Grade 2 bleeding or Grade 4 thrombocytopenia with or without bleeding; A recovery period longer than 14 days from last dose of LY2334737 to values allowing Cycle 2 to start; Other significant drug-related toxicity deemed by investigator to be dose limiting or that caused the participant to withdraw from the study. Pharmacokinetics and pharmacodynamics (PK/PD) were also taken into consideration for Phase 2 recommended dose.
Baseline up to 28 days postdose in Cycle 1 (28-day cycle)
Secondary Outcomes
Measure
Description
Time Frame
Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) for LY2334737
AUC over the dosing interval (AUC0-Ƭ) of LY2334737 for Arm A (single dose) is 0 to 48 hours postdose. AUC0-Ƭ of LY2334737 for Arm B (multiple doses) is 0 to 24 hours postdose and AUC time 0 to infinity (AUC0-∞) for LY2334737.
Cycle 1 Day 1 (C1 D1): 0.5, 1.5, 2, 3.5, 7 24 hours postdose; Cycle 1 Day 21 (C1 D21): predose, 0.5, 2, 3 to 4, 7, 24 hours postdose of 28-day cycle
Other Outcomes
Measure
Description
Time Frame
Number of Participants With Dose-Limiting Toxicity (DLT)
DLT was defined as an adverse event (AE) during Cycle 1 that was likely related to the LY2334737 and fulfilled any of the following criteria: Common Terminology Criteria for Adverse Events (CTCAE) ≥Grade 3 nonhematological (except nausea/vomiting controlled with treatment); Grade 3 neutropenia with fever or any Grade 4 neutropenia with or without fever; Grade 3 thrombocytopenia with ≥ Grade 2 bleeding or Grade 4 thrombocytopenia; with or without bleeding A recovery period longer than 14 days from the last dose of LY2334737 to values allowing Cycle 2 to start; other significant drug-related toxicity deemed by the investigator to be dose limiting or that caused the participant to withdraw from the study.
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Diagnosis of advanced and/or metastatic cancer (including lymphoma) for which no treatment of higher priority exists
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
Estimated life expectancy of more than 12 weeks
Have discontinued all previous therapies for cancer for at least 30 days (6 weeks for mitomycin-C or nitrosoureas) and recovered from acute effects of therapy
Have discontinued radiotherapy more than one week before enrolling in the study and have recovered from the acute effects of therapy
Have adequate organ function
Follow your doctor's directions and live close enough to the study site so you can continue to go to the clinic for follow-up
Are willing and able to swallow capsules and follow study procedures
Have given written informed consent prior to any study-specific procedures
Males and females with reproductive potential should use medically approved contraceptive precautions during the study and for 6 months following the last dose of study drug
Females with child-bearing potential must have had a negative urine or serum pregnancy test 7 days prior to the first dose of study drug
Exclusion Criteria:
Have gastrointestinal diseases or prior surgery that may interfere with the absorption of medication taken by mouth
Females who are pregnant or lactating
Symptomatic central nervous system malignancy or metastasis
Known positive test results in human immunodeficiency virus (HIV), hepatitis B surface antigen (HBSAg), or hepatitis C antibodies (HCAb)
Liver cirrhosis or chronic hepatitis
Acute or chronic leukemia
Are currently receiving treatment with valproic acid (VPA) and its derivatives, or if you have a history of intolerance to VPA
Known hypersensitivity to gemcitabine
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.
Philadelphia
Pennsylvania
19111
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.
Participant Flow is reporting discontinuation from study drug. Completed participants were all those who completed Cycle 1.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
40 mg LY - Arm A Dose Escalation
40 milligrams (mg) LY2334737 (LY) administered orally every other day for 21 days followed by 7 days without study drug (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
FG001
50 mg LY - Arm A Dose Escalation
50 mg LY2334737 administered orally every other day for 21 days followed by 7 days without study drug (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
FG002
60 mg LY - Arm A Dose Escalation
60 mg LY2334737 administered orally every other day for 21 days followed by 7 days without study drug (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
FG003
70 mg LY - Arm A Dose Escalation
70 mg LY2334737 administered orally every other day for 21 days followed by 7 days without study drug (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
FG004
80 mg LY - Arm A Dose Escalation
80 mg LY2334737 administered orally every other day for 21 days followed by 7 days without study drug (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
FG005
90 mg LY - Arm A Dose Escalation
90 mg LY2334737 administered orally every other day for 21 days followed by 7 days without study drug (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
FG006
100 mg LY - Arm A Dose Escalation
100 mg LY2334737 administered orally every other day for 21 days followed by 7 days without study drug (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
FG007
40 mg LY - Arm B Dose Escalation
40 mg LY2334737 administered orally every day for 7 days followed by 7 days without study drug then repeated (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
FG008
50 mg LY - Arm B Dose Escalation
50 mg LY2334737 administered orally every day for 7 days followed by 7 days without study drug then repeated (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
FG009
60 mg LY - Arm B Dose Escalation
60 mg LY2334737 administered orally every day for 7 days followed by 7 days without study drug then repeated (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
FG010
70 mg LY - Arm B Dose Escalation
70 mg LY2334737 administered orally every day for 7 days followed by 7 days without study drug then repeated (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
FG011
80 mg LY - Arm B Dose Escalation
80 mg LY2334737 administered orally every day for 7 days followed by 7 days without study drug then repeated (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
FG012
90 mg LY - Arm B Dose Escalation
90 mg LY2334737 administered orally every day for 7 days followed by 7 days without study drug then repeated (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
FG013
90 mg LY - Arm A Dose Confirmation
90 mg LY2334737 administered orally every other day for 21 days followed by 7 days without study drug (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
FG0003 subjects
FG0013 subjects
FG0023 subjects
FG0033 subjects
FG0043 subjects
FG0055 subjects
FG0069 subjects
FG0073 subjects
FG0083 subjects
FG0097 subjects
FG0103 subjects
FG0119 subjects
FG0127 subjects
FG01312 subjects
Received at Least 1 Dose of Study Drug
FG0003 subjects
FG0013 subjects
FG0023 subjects
FG0033 subjects
COMPLETED
FG0003 subjects
FG0012 subjects
FG0023 subjects
FG0033 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Progressive Disease
FG0000 subjects
FG0011 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
40 mg LY - Arm A Dose Escalation
40 milligrams (mg) LY2334737 (LY) administered orally every other day for 21 days followed by 7 days without study drug (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
BG001
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 for Phase 2 Studies
Recommended Phase 2 dose was determined by maximum tolerated dose (MTD). The MTD was the highest dose level at which <2 out of 6 participants experienced a dose-limiting toxicity (DLT) in Cycle 1. DLT was an adverse event (AE) during Cycle 1 that was likely related to LY2334737 and fulfilled any of the following criteria: Common Terminology Criteria for Adverse Events (CTCAE) ≥Grade 3 nonhematological (except nausea/vomiting controlled with treatment); Grade 3 neutropenia with fever or any Grade 4 neutropenia with or without fever; Grade 3 thrombocytopenia with ≥Grade 2 bleeding or Grade 4 thrombocytopenia with or without bleeding; A recovery period longer than 14 days from last dose of LY2334737 to values allowing Cycle 2 to start; Other significant drug-related toxicity deemed by investigator to be dose limiting or that caused the participant to withdraw from the study. Pharmacokinetics and pharmacodynamics (PK/PD) were also taken into consideration for Phase 2 recommended dose.
All participants who received at least 1 dose of study drug during dose escalation and dose confirmation treatment arms.
Posted
Number
mg every other day for 21 days
Baseline up to 28 days postdose in Cycle 1 (28-day cycle)
Adverse Events Module
Frequency Threshold
5
Time Frame
Not provided
Description
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
40 mg LY - Arm A Dose Escalation
40 milligrams (mg) LY2334737 administered orally every other day for 21 days followed by 7 days without study drug (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 15.1
Systematic Assessment
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 15.1
Systematic Assessment
More Info Module
Limitations and Caveats
Not provided
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
Point of Contact
Title
Organization
Phone
Extension
Email
Chief Medical Officer
Eli Lilly and Company
800-545-5979
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
ID
Term
D009362
Neoplasm Metastasis
Ancestor Terms
ID
Term
D009385
Neoplastic Processes
D009369
Neoplasms
D010335
Pathologic Processes
D013568
Pathological Conditions, Signs and Symptoms
Browse Leaves
Not provided
Browse Branches
Not provided
Intervention Browse Module
MeSH Terms
ID
Term
C569272
LY2334737
Ancestor Terms
Not provided
Browse Leaves
Not provided
Browse Branches
Not provided
Non-Randomized
Intervention Model
Single Group Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) for 2'2'-Difluorodeoxycytidine (dFdC)
AUC over the dosing interval (AUC0-Ƭ) of dFdC (a metabolite of LY2334737) for Arm A (following a single dose of LY2334737) AUC0-Ƭ is 0-48 hours postdose, Arm B (following multiple doses of LY2334737) AUC 0-Ƭ is 0-24 hours postdose and AUC from time 0 to infinity (AUC0-∞).
Cycle 1 Day 1 (C1 D1): 0.5, 1.5, 2, 3.5, 7 24 hours post dose; Cycle 1 Day 21 (C1 D21): predose, 0.5, 2, 3 to 4, 7, 24 hours post dose of 28-day cycle
Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) for Difluorodeoxyuridine (dFdU)
Daily AUC from time 0 to 24 hours (AUC 0-24) of dFdU (a metabolite of LY2334737) for Arm A (single dose of LY2334737) and Arm B (multiple doses of LY2334737).
Cycle 1 Day 1 (C1 D1): 0.5, 1.5, 2, 3.5, 7 24 hours postdose; Cycle 1 Day 21 (C1 D21): predose, 0.5, 2, 3 to 4, 7, 24 hours postdose of 28-day cycle
Pharmacokinetics: Maximum Plasma Concentration (Cmax)
Cmax for LY2334737 and its metabolites 2'2'-difluorodeoxycytidine (dFdC) and difluorodeoxyuridine (dFdU).
Cycle 1 Day 1 (C1 D1): 0.5, 1.5, 2, 3.5, 7 24 hours postdose; Cycle 1 Day 21 (C1 D21): predose, 0.5, 2, 3 to 4, 7, 24 hours postdose of 28-day cycle
Number of Participants With Best Overall Response (BOR)
Response defined using Response Evaluation Criteria in Solid Tumors (RECIST v1.0) criteria. Complete Response defined as disappearance of all target and non-target lesions and normalization of tumor marker level. Partial Response defined as ≥30% decrease in sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Progressive Disease (PD) defined as ≥20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions, or appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions. Stable Disease was defined as small changes that did not meet above criteria and unknown defined as response status was not known. The BOR was the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for PD the smallest measurements recorded since the treatment started).
Baseline to measured disease progression up to 33 weeks
Progression-Free Survival (PFS)
PFS was defined as the time from date of first dose to the first observation of disease progression or death due to any cause.
Due to the different tumor types, schedules and doses, the PFS was not analyzed.
Baseline to measured disease progression or death up to 33 weeks
Percentage of Participants With Changes in QT Interval (>30 Milliseconds) From Baseline
Fridericia-corrected QT (QTcF) interval corrected for heart rate was assessed using triplicate 12-lead electrocardiograms (ECGs). Change in QT interval from baseline was calculated using a time matched approach, that is change from baseline was calculated by subtracting the respective reading taken at the same nominal time on Day-1 from the reading taken on Days 1 and 21; change from baseline was calculated by subtracting the last non-missing ECG assessment on or prior to Day 1, 0.5 hours prior to dose from assessment on Day 2 and Day 22. The outlying QTcF intervals were defined using the criteria: change from baseline in mean QTcF interval >30 milliseconds
Day -1: 24.5 hours, 22 hours and 17 hours predose; Cycle 1 Days 1 and 21, 0.5 hours predose, 2 hours, 7 hours and 24 hours postdose (28-day cycles)
Percentage of Participants With Changes in R-R Interval From Baseline
Changes in R-R interval from baseline was calculated using a time matched approach, that is change from baseline was calculated by subtracting the respective reading taken at the same nominal time on Day -1 from the reading taken on Days 1 and 21; change from baseline was calculated by subtracting the last non-missing electrocardiogram (ECG) assessment on or prior to Day 1 and 0.5 hours prior to dose for Day 2 and Day 22. Percentage of participants with changes in R-R interval from baseline was calculated as the number of participants with a change not equal to 0 across all time points divided by the number of treated participants multiplied by 100.
Day -1: 24.5 hours, 22 hours and 17 hours predose; Cycle 1 Days 1 and 21: 0.5 hours predose, 2 hours, 7 hours and 24 hours postdose
Cmin for LY2334737 and its metabolite 2'2'-difluorodeoxycytidine (dFdC).
Cycle 1 Day 1 (C1 D1): 0.5, 1.5, 2, 3.5, 7, 24 hours postdose; Cycle 1 Day 21 (C1 D21): predose, 0.5, 2, 3 to 4, 7, 24 hours postdose of 28-day cycle
Cycle 1 (28-day cycle)
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.
Clichy
92118
France
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Berlin
13353
Germany
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.
Nuremberg
90419
Germany
FG004
3 subjects
FG0055 subjects
FG0069 subjects
FG0073 subjects
FG0083 subjects
FG0097 subjects
FG0103 subjects
FG0119 subjects
FG0127 subjects
FG01312 subjects
3 subjects
FG0053 subjects
FG0064 subjects
FG0073 subjects
FG0083 subjects
FG0094 subjects
FG0103 subjects
FG0114 subjects
FG0123 subjects
FG0139 subjects
0 subjects
FG0052 subjects
FG0065 subjects
FG0070 subjects
FG0080 subjects
FG0093 subjects
FG0100 subjects
FG0115 subjects
FG0124 subjects
FG0133 subjects
0 subjects
FG0040 subjects
FG0051 subjects
FG0061 subjects
FG0070 subjects
FG0080 subjects
FG0092 subjects
FG0100 subjects
FG0111 subjects
FG0122 subjects
FG0131 subjects
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0051 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0091 subjects
FG0100 subjects
FG0113 subjects
FG0121 subjects
FG0131 subjects
Death
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0061 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0131 subjects
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0062 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0121 subjects
FG0130 subjects
Investigator Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0061 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0111 subjects
FG0120 subjects
FG0130 subjects
50 mg LY - Arm A Dose Escalation
50 mg LY2334737 administered orally every other day for 21 days followed by 7 days without study drug (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
BG002
60 mg LY - Arm A Dose Escalation
60 mg LY2334737 administered orally every other day for 21 days followed by 7 days without study drug (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
BG003
70 mg LY - Arm A Dose Escalation
70 mg LY2334737 administered orally every other day for 21 days followed by 7 days without study drug (28 -ay treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
BG004
80 mg LY - Arm A Dose Escalation
80 mg LY2334737 administered orally every other day for 21 days followed by 7 days without study drug (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
BG005
90 mg LY - Arm A Dose Escalation
90 mg LY2334737 administered orally every other day for 21 days followed by 7 days without study drug (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
BG006
100 mg LY - Arm A Dose Escalation
100 mg LY2334737 administered orally every other day for 21 days followed by 7 days without study drug (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
BG007
40 mg LY - Arm B Dose Escalation
40 mg LY2334737 administered orally every day for 7 days followed by 7 days without study drug then repeated (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
BG008
50 mg LY - Arm B Dose Escalation
50 mg LY2334737 administered orally every day for 7 days followed by 7 days without study drug then repeated (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
BG009
60 mg LY - Arm B Dose Escalation
60 mg LY2334737 administered orally every day for 7 days followed by 7 days without study drug then repeated (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
BG010
70 mg LY - Arm B Dose Escalation
70 mg LY2334737 administered orally every day for 7 days followed by 7 days without study drug then repeated (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
BG011
80 mg LY - Arm B Dose Escalation
80 mg LY2334737 administered orally every day for 7 days followed by 7 days without study drug then repeated (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
BG012
90 mg LY - Arm B Dose Escalation
90 mg LY2334737 administered orally every day for 7 days followed by 7 days without study drug then repeated (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
BG013
90 mg LY2334737 - Arm A Dose Confirmation
90 mg LY2334737 administered orally every other day for 21 days followed by 7 days without study drug (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
BG014
Total
Total of all reporting groups
3
BG0013
BG0023
BG0033
BG0043
BG0055
BG0069
BG0073
BG0083
BG0097
BG0103
BG0119
BG0127
BG01312
BG01473
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00057.7± 3.8
BG00160.0± 20.3
BG00256.3± 11.2
BG00349.7± 17.2
BG00449.7± 9.6
BG00568.2± 6.2
BG00654.4± 11.1
BG00755.7± 7.2
BG00865.0± 5.0
BG00960.1± 9.3
BG01052.7± 20.0
BG01166.0± 4.6
BG01261.9± 9.8
BG01363.0± 6.4
BG01459.9± 10.4
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0001
BG0010
BG0021
BG0031
BG0040
BG0052
BG0063
BG0071
BG0080
BG0091
BG0101
BG0116
BG0124
BG0134
BG01425
Male
BG0002
BG0013
BG0022
BG0032
BG004
Race
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Caucasian
BG0003
BG0012
BG0021
BG0033
BG0043
BG0055
BG0068
BG0073
BG0082
BG0097
BG0102
BG0119
BG0127
BG01311
BG01466
African
BG0000
BG0010
BG0021
BG0030
BG004
West Asian
BG0000
BG0011
BG0020
BG0030
BG004
Hispanic
BG0000
BG0010
BG0021
BG0030
BG004
Eastern Cooperative Oncology Group (ECOG)
ECOG Performance Status: 0=asymptomatic, fully active, can carry on all predisease performance without restrictions; 1=symptomatic, fully ambulatory, but restricted in physically strenuous activity, able to perform light/sedentary tasks; 2=symptomatic, ambulatory, capable of all self-care but unable to carry out work activities, up and about more than 50% of waking hours and in bed less than 50% of day.
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
0
BG0003
BG0012
BG0023
BG0033
BG0041
BG0053
BG0064
BG0072
BG0083
BG0094
BG0101
BG0115
BG0122
BG0137
BG01443
1
BG0000
BG0011
BG0020
BG0030
BG004
2
BG0000
BG0010
BG0020
BG0030
BG004
Disease Stage
Stage III -the cancer has spread to nearby tissue or spread to far away lymph nodes. Stage IV -the cancer has spread to other organs of the body such as the other lung, brain or liver.
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Stage III
BG0000
BG0010
BG0021
BG0030
BG0040
BG0051
BG0060
BG0070
BG0080
BG0091
BG0100
BG0110
BG0120
BG0133
BG0146
Stage IV
BG0003
BG0013
BG0022
BG0033
BG004
Country of Enrollment
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
France
BG0003
BG0013
BG0023
BG0032
BG0041
BG0052
BG0065
BG0072
BG0083
BG0094
BG0102
BG0114
BG0121
BG0136
BG01441
Germany
BG0000
BG0010
BG0020
BG0031
BG004
United States
BG0000
BG0010
BG0020
BG0030
BG004
ID
Title
Description
OG000
LY2334737
LY2334737 was administered as 2 Arms A and B. Participants in treatment Arm A were administered LY2334737 orally in escalating doses of 40 to 100 milligrams (mg) of LY2334737 every other day for 21 days followed by 7 days without study drug. Participants in treatment Arm B were administered LY2334737 orally in escalating doses of 40 to 90 mg every day for 7 days followed by 7 days without study drug and then repeated. Both treatment cycles were 28 days.
Units
Counts
Participants
OG00073
Title
Denominators
Categories
Title
Measurements
OG00090
Secondary
Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) for LY2334737
AUC over the dosing interval (AUC0-Ƭ) of LY2334737 for Arm A (single dose) is 0 to 48 hours postdose. AUC0-Ƭ of LY2334737 for Arm B (multiple doses) is 0 to 24 hours postdose and AUC time 0 to infinity (AUC0-∞) for LY2334737.
All participants who received at least 1 dose of study drug and had AUC0-Ƭ and AUC0-∞ values.
Posted
Geometric Mean
Geometric Coefficient of Variation
nanograms*hours per milliliter (ng*h/mL)
Cycle 1 Day 1 (C1 D1): 0.5, 1.5, 2, 3.5, 7 24 hours postdose; Cycle 1 Day 21 (C1 D21): predose, 0.5, 2, 3 to 4, 7, 24 hours postdose of 28-day cycle
ID
Title
Description
OG000
40 mg LY - Arm A Dose Escalation
40 milligrams (mg) LY2334737 (LY) administered orally every other day for 21 days followed by 7 days without study drug (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
OG001
50 mg LY - Arm A Dose Escalation
50 mg LY2334737 administered orally every other day for 21 days followed by 7 days without study drug (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
OG002
60 mg LY - Arm A Dose Escalation
60 mg LY2334737 administered orally every other day for 21 days followed by 7 days without study drug (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
OG003
70 mg LY - Arm A Dose Escalation
70 mg LY2334737 administered orally every other day for 21 days followed by 7 days without study drug (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
OG004
80 mg LY - Arm A Dose Escalation
80 mg LY2334737 administered orally every other day for 21 days followed by 7 days without study drug (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
OG005
90 mg LY - Arm A Dose Escalation and Dose Confirmation
90 mg LY2334737 administered orally every other day for 21 days followed by 7 days without study drug (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
OG006
100 mg LY - Arm A Dose Escalation
100 mg LY2334737 administered orally every other day for 21 days followed by 7 days without study drug (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
OG007
40 mg LY - Arm B Dose Escalation
40 mg LY2334737 administered orally every day for 7 days followed by 7 days without study drug then repeated (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
OG008
50 mg LY - Arm B Dose Escalation
50 mg LY2334737 administered orally every day for 7 days followed by 7 days without study drug then repeated (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
OG009
60 mg LY - Arm B Dose Escalation
60 mg LY2334737 administered orally every day for 7 days followed by 7 days without study drug then repeated (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
OG010
70 mg LY - Arm B Dose Escalation
70 mg LY2334737 administered orally every day for 7 days followed by 7 days without study drug then repeated (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
OG011
80 mg LY - Arm B Dose Escalation
80 mg LY2334737 administered orally every day for 7 days followed by 7 days without study drug then repeated (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
OG012
90 mg LY - Arm B Dose Escalation
90 mg LY2334737 administered orally every day for 7 days followed by 7 days without study drug then repeated (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
Units
Counts
Participants
OG0003
OG0012
OG0023
OG003
Title
Denominators
Categories
C1 D1 AUC0-Ƭ
ParticipantsOG0003
ParticipantsOG0012
ParticipantsOG0023
ParticipantsOG003
Secondary
Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) for 2'2'-Difluorodeoxycytidine (dFdC)
AUC over the dosing interval (AUC0-Ƭ) of dFdC (a metabolite of LY2334737) for Arm A (following a single dose of LY2334737) AUC0-Ƭ is 0-48 hours postdose, Arm B (following multiple doses of LY2334737) AUC 0-Ƭ is 0-24 hours postdose and AUC from time 0 to infinity (AUC0-∞).
All participants who received at least 1 dose of study drug and had AUC 0-Ƭ and AUC 0-∞ values.
Posted
Geometric Mean
Geometric Coefficient of Variation
nanograms*hours/milliliter (ng*h/mL)
Cycle 1 Day 1 (C1 D1): 0.5, 1.5, 2, 3.5, 7 24 hours post dose; Cycle 1 Day 21 (C1 D21): predose, 0.5, 2, 3 to 4, 7, 24 hours post dose of 28-day cycle
ID
Title
Description
OG000
40 mg LY - Arm A Dose Escalation
40 milligrams (mg) LY2334737 (LY) administered orally every other day for 21 days followed by 7 days without study drug (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
OG001
50 mg LY - Arm A Dose Escalation
50 mg LY2334737 administered orally every other day for 21 days followed by 7 days without study drug (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
OG002
60 mg LY - Arm A Dose Escalation
60 mg LY2334737 administered orally every other day for 21 days followed by 7 days without study drug (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
OG003
70 mg LY - Arm A Dose Escalation
70 mg LY2334737 administered orally every other day for 21 days followed by 7 days without study drug (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
OG004
80 mg LY - Arm A Dose Escalation
80 mg LY2334737 administered orally every other day for 21 days followed by 7 days without study drug (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
OG005
90 mg LY - Arm A Dose Escalation and Dose Confirmation
90 mg LY2334737 administered orally every other day for 21 days followed by 7 days without study drug (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
OG006
100 mg LY - Arm A Dose Escalation
100 mg LY2334737 administered orally every other day for 21 days followed by 7 days without study drug (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
OG007
40 mg LY - Arm B Dose Escalation
40 mg LY2334737 administered orally every day for 7 days followed by 7 days without study drug then repeated (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
OG008
50 mg LY - Arm B Dose Escalation
50 mg LY2334737 administered orally every day for 7 days followed by 7 days without study drug then repeated (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
OG009
60 mg LY - Arm B Dose Escalation
60 mg LY2334737 administered orally every day for 7 days followed by 7 days without study drug then repeated (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
OG010
70 mg LY - Arm B Dose Escalation
70 mg LY2334737 administered orally every day for 7 days followed by 7 days without study drug then repeated (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
OG011
80 mg LY - Arm B Dose Escalation
80 mg LY2334737 administered orally every day for 7 days followed by 7 days without study drug then repeated (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
OG012
90 mg LY - Arm B Dose Escalation
90 mg LY2334737 administered orally every day for 7 days followed by 7 days without study drug then repeated (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
Units
Counts
Participants
OG0003
OG0012
OG0023
OG003
Title
Denominators
Categories
C1 D1 AUC 0-Ƭ
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0023
ParticipantsOG003
Secondary
Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) for Difluorodeoxyuridine (dFdU)
Daily AUC from time 0 to 24 hours (AUC 0-24) of dFdU (a metabolite of LY2334737) for Arm A (single dose of LY2334737) and Arm B (multiple doses of LY2334737).
All participants who received at least 1 dose of study drug and had AUC0-24 dFdU results.
Posted
Geometric Mean
Geometric Coefficient of Variation
nanograms*hours per milliliter (ng*h/mL)
Cycle 1 Day 1 (C1 D1): 0.5, 1.5, 2, 3.5, 7 24 hours postdose; Cycle 1 Day 21 (C1 D21): predose, 0.5, 2, 3 to 4, 7, 24 hours postdose of 28-day cycle
ID
Title
Description
OG000
40 mg LY - Arm A Dose Escalation
40 milligram (mg) LY2334737 (LY) administered orally every other day for 21 days followed by 7 days without study drug (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
OG001
50 mg LY - Arm A Dose Escalation
50 mg LY2334737 administered orally every other day for 21 days followed by 7 days without study drug (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
OG002
60 mg LY - Arm A Dose Escalation
60 mg LY2334737 administered orally every other day for 21 days followed by 7 days without study drug (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
OG003
70 mg LY - Arm A Dose Escalation
70 mg LY2334737 administered orally every other day for 21 days followed by 7 days without study drug (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
OG004
80 mg LY - Arm A Dose Escalation
80 mg LY2334737 administered orally every other day for 21 days followed by 7 days without study drug (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
OG005
90 mg LY - Arm A Dose Escalation and Dose Confirmation
90 mg LY2334737 administered orally every other day for 21 days followed by 7 days without study drug (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
OG006
100 mg LY - Arm A Dose Escalation
100 mg LY2334737 administered orally every other day for 21 days followed by 7 days without study drug (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
OG007
40 mg LY - Arm B Dose Escalation
40 mg LY2334737 administered orally every day for 7 days followed by 7 days without study drug then repeated (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
OG008
50 mg LY - Arm B Dose Escalation
50 mg LY2334737 administered orally every day for 7 days followed by 7 days without study drug then repeated (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
OG009
60 mg LY - Arm B Dose Escalation
60 mg LY2334737 administered orally every day for 7 days followed by 7 days without study drug then repeated (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
OG010
70 mg LY - Arm B Dose Escalation
70 mg LY2334737 administered orally every day for 7 days followed by 7 days without study drug then repeated (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
OG011
80 mg LY - Arm B Dose Escalation
80 mg LY2334737 administered orally every day for 7 days followed by 7 days without study drug then repeated (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
OG012
90 mg LY - Arm B Dose Escalation
90 mg LY2334737 administered orally every day for 7 days followed by 7 days without study drug then repeated (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
Units
Counts
Participants
OG0003
OG0012
OG0023
OG003
Title
Denominators
Categories
C1 D1
ParticipantsOG0003
ParticipantsOG0012
ParticipantsOG0023
ParticipantsOG003
Secondary
Pharmacokinetics: Maximum Plasma Concentration (Cmax)
Cmax for LY2334737 and its metabolites 2'2'-difluorodeoxycytidine (dFdC) and difluorodeoxyuridine (dFdU).
All participants who received at least 1 dose of study drug and had Cmax values.
Posted
Geometric Mean
Geometric Coefficient of Variation
nanogram per milliliter (ng/mL)
Cycle 1 Day 1 (C1 D1): 0.5, 1.5, 2, 3.5, 7 24 hours postdose; Cycle 1 Day 21 (C1 D21): predose, 0.5, 2, 3 to 4, 7, 24 hours postdose of 28-day cycle
ID
Title
Description
OG000
40 mg LY - Arm A Dose Escalation
40 milligrams (mg) LY2334737 (LY) administered orally every other day for 21 days followed by 7 days without study drug (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
OG001
50 mg LY - Arm A Dose Escalation
50 mg LY2334737 administered orally every other day for 21 days followed by 7 days without study drug (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
OG002
60 mg LY - Arm A Dose Escalation
60 mg LY2334737 administered orally every other day for 21 days followed by 7 days without study drug (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
OG003
70 mg LY - Arm A Dose Escalation
70 mg LY2334737 administered orally every other day for 21 days followed by 7 days without study drug (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
OG004
80 mg LY - Arm A Dose Escalation
80 mg LY2334737 administered orally every other day for 21 days followed by 7 days without study drug (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
OG005
90 mg LY - Arm A Dose Escalation and Dose Confirmation
90 mg LY2334737 administered orally every other day for 21 days followed by 7 days without study drug (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
OG006
100 mg LY - Arm A Dose Escalation
100 mg LY2334737 administered orally every other day for 21 days followed by 7 days without study drug (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
OG007
40 mg LY - Arm B Dose Escalation
40 mg LY2334737 administered orally every day for 7 days followed by 7 days without study drug then repeated (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
OG008
50 mg LY - Arm B Dose Escalation
50 mg LY2334737 administered orally every day for 7 days followed by 7 days without study drug then repeated (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
OG009
60 mg LY - Arm B Dose Escalation
60 mg LY2334737 administered orally every day for 7 days followed by 7 days without study drug then repeated (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
OG010
70 mg LY - Arm B Dose Escalation
70 mg LY2334737 administered orally every day for 7 days followed by 7 days without study drug then repeated (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
OG011
80 mg LY - Arm B Dose Escalation
80 mg LY2334737 administered orally every day for 7 days followed by 7 days without study drug then repeated (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
OG012
90 mg LY - Arm B Dose Escalation
90 mg LY2334737 administered orally every day for 7 days followed by 7 days without study drug then repeated (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
Units
Counts
Participants
OG0003
OG0012
OG0023
OG003
Title
Denominators
Categories
C1 D1-LY2334737
ParticipantsOG0003
ParticipantsOG0012
ParticipantsOG0023
ParticipantsOG003
Secondary
Number of Participants With Best Overall Response (BOR)
Response defined using Response Evaluation Criteria in Solid Tumors (RECIST v1.0) criteria. Complete Response defined as disappearance of all target and non-target lesions and normalization of tumor marker level. Partial Response defined as ≥30% decrease in sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Progressive Disease (PD) defined as ≥20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions, or appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions. Stable Disease was defined as small changes that did not meet above criteria and unknown defined as response status was not known. The BOR was the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for PD the smallest measurements recorded since the treatment started).
All participants who received at least 1 dose of study drug.
Posted
Count of Participants
Participants
No
Baseline to measured disease progression up to 33 weeks
ID
Title
Description
OG000
40 mg LY - Arm A Dose Escalation
40 milligrams (mg) LY2334737 (LY) administered orally every other day for 21 days followed by 7 days without study drug (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
OG001
50 mg LY - Arm A Dose Escalation
50 mg LY2334737 administered orally every other day for 21 days followed by 7 days without study drug (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
OG002
60 mg LY - Arm A Dose Escalation
60 mg LY2334737 administered orally every other day for 21 days followed by 7 days without study drug (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
OG003
70 mg LY - Arm A Dose Escalation
70 mg LY2334737 administered orally every other day for 21 days followed by 7 days without study drug (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
OG004
80 mg LY - Arm A Dose Escalation
80 mg LY2334737 administered orally every other day for 21 days followed by 7 days without study drug (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
OG005
90 mg LY - Arm A Dose Escalation
90 mg LY2334737 administered orally every other day for 21 days followed by 7 days without study drug (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
OG006
100 mg LY - Arm A Dose Escalation
100 mg LY2334737 administered orally every other day for 21 days followed by 7 days without study drug (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
OG007
40 mg LY - Arm B Dose Escalation
40 mg LY2334737 administered orally every day for 7 days followed by 7 days without study drug then repeated (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
OG008
50 mg LY - Arm B Dose Escalation
50 mg LY2334737 administered orally every day for 7 days followed by 7 days without study drug then repeated (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
OG009
60 mg LY - Arm B Dose Escalation
60 mg LY2334737 administered orally every day for 7 days followed by 7 days without study drug then repeated (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
OG010
70 mg LY - Arm B Dose Escalation
70 mg LY2334737 administered orally every day for 7 days followed by 7 days without study drug then repeated (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
OG011
80 mg LY - Arm B Dose Escalation
80 mg LY2334737 administered orally every day for 7 days followed by 7 days without study drug then repeated (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
OG012
90 mg LY - Arm B Dose Escalation
90 mg LY2334737 administered orally every day for 7 days followed by 7 days without study drug then repeated (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
OG013
90 mg LY - Arm A Dose Confirmation
90 mg LY2334737 administered orally every other day for 21 days followed by 7 days without study drug (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
Units
Counts
Participants
OG0003
OG0013
OG0023
OG003
Title
Denominators
Categories
Title
Measurements
Complete Response
OG0000
OG0010
OG0020
OG003
Secondary
Progression-Free Survival (PFS)
PFS was defined as the time from date of first dose to the first observation of disease progression or death due to any cause.
Due to the different tumor types, schedules and doses, the PFS was not analyzed.
Zero participants analyzed. No data collected for PFS.
Posted
Baseline to measured disease progression or death up to 33 weeks
ID
Title
Description
OG000
40 mg LY - Arm A Dose Escalation
40 milligrams (mg) LY2334737 (LY) administered orally every other day for 21 days followed by 7 days without study drug (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
OG001
50 mg LY - Arm A Dose Escalation
50 mg LY2334737 administered orally every other day for 21 days followed by 7 days without study drug (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
OG002
60 mg LY - Arm A Dose Escalation
60 mg LY2334737 administered orally every other day for 21 days followed by 7 days without study drug (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
OG003
70 mg LY - Arm A Dose Escalation
70 mg LY2334737 administered orally every other day for 21 days followed by 7 days without study drug (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
OG004
80 mg LY - Arm A Dose Escalation
80 mg LY2334737 administered orally every other day for 21 days followed by 7 days without study drug (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
OG005
90 mg LY - Arm A Dose Escalation
90 mg LY2334737 administered orally every other day for 21 days followed by 7 days without study drug (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
OG006
100 mg LY - Arm A Dose Escalation
100 mg LY2334737 administered orally every other day for 21 days followed by 7 days without study drug (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
OG007
40 mg LY - Arm B Dose Escalation
40 mg LY2334737 administered orally every day for 7 days followed by 7 days without study drug then repeated (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
OG008
50 mg LY - Arm B Dose Escalation
50 mg LY2334737 administered orally every day for 7 days followed by 7 days without study drug then repeated (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
OG009
60 mg LY - Arm B Dose Escalation
60 mg LY2334737 administered orally every day for 7 days followed by 7 days without study drug then repeated (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
OG010
70 mg LY - Arm B Dose Escalation
70 mg LY2334737 administered orally every day for 7 days followed by 7 days without study drug then repeated (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
OG011
80 mg LY - Arm B Dose Escalation
80 mg LY2334737 administered orally every day for 7 days followed by 7 days without study drug then repeated (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
OG012
90 mg LY - Arm B Dose Escalation
90 mg LY2334737 administered orally every day for 7 days followed by 7 days without study drug then repeated (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
OG013
90 mg LY - Arm A Dose Confirmation
90 mg LY2334737 administered orally every other day for 21 days followed by 7 days without study drug (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG003
Secondary
Percentage of Participants With Changes in QT Interval (>30 Milliseconds) From Baseline
Fridericia-corrected QT (QTcF) interval corrected for heart rate was assessed using triplicate 12-lead electrocardiograms (ECGs). Change in QT interval from baseline was calculated using a time matched approach, that is change from baseline was calculated by subtracting the respective reading taken at the same nominal time on Day-1 from the reading taken on Days 1 and 21; change from baseline was calculated by subtracting the last non-missing ECG assessment on or prior to Day 1, 0.5 hours prior to dose from assessment on Day 2 and Day 22. The outlying QTcF intervals were defined using the criteria: change from baseline in mean QTcF interval >30 milliseconds
All participants who received at least 1 dose of study drug.
Posted
Number
percentage of participants
Day -1: 24.5 hours, 22 hours and 17 hours predose; Cycle 1 Days 1 and 21, 0.5 hours predose, 2 hours, 7 hours and 24 hours postdose (28-day cycles)
ID
Title
Description
OG000
40 mg LY - Arm A Dose Escalation
40 milligrams (mg) LY2334737 (LY) administered orally every other day for 21 days followed by 7 days without study drug (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
OG001
50 mg LY - Arm A Dose Escalation
50 mg LY2334737 administered orally every other day for 21 days followed by 7 days without study drug (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
OG002
60 mg LY - Arm A Dose Escalation
60 mg LY2334737 administered orally every other day for 21 days followed by 7 days without study drug (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
OG003
70 mg LY - Arm A Dose Escalation
70 mg LY2334737 administered orally every other day for 21 days followed by 7 days without study drug (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
OG004
80 mg LY - Arm A Dose Escalation
80 mg LY2334737 administered orally every other day for 21 days followed by 7 days without study drug (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
OG005
90 mg LY - Arm A Dose Escalation
90 mg LY2334737 administered orally every other day for 21 days followed by 7 days without study drug (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
OG006
100 mg LY - Arm A Dose Escalation
100 mg LY2334737 administered orally every other day for 21 days followed by 7 days without study drug (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
OG007
40 mg LY - Arm B Dose Escalation
40 mg LY2334737 administered orally every day for 7 days followed by 7 days without study drug then repeated (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
OG008
50 mg LY - Arm B Dose Escalation
50 mg LY2334737 administered orally every day for 7 days followed by 7 days without study drug then repeated (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
OG009
60 mg LY - Arm B Dose Escalation
60 mg LY2334737 administered orally every day for 7 days followed by 7 days without study drug then repeated (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
OG010
70 mg LY - Arm B Dose Escalation
70 mg LY2334737 administered orally every day for 7 days followed by 7 days without study drug then repeated (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
OG011
80 mg LY - Arm B Dose Escalation
80 mg LY2334737 administered orally every day for 7 days followed by 7 days without study drug then repeated (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
OG012
90 mg LY - Arm B Dose Escalation
90 mg LY2334737 administered orally every day for 7 days followed by 7 days without study drug then repeated (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
OG013
90 mg LY - Arm A Dose Confirmation
90 mg LY2334737 administered orally every other day for 21 days followed by 7 days without study drug (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
Units
Counts
Participants
OG0003
OG0013
OG0023
OG003
Title
Denominators
Categories
Title
Measurements
OG00033.3
OG00133.3
OG0020.0
OG003
Other Pre-specified
Number of Participants With Dose-Limiting Toxicity (DLT)
DLT was defined as an adverse event (AE) during Cycle 1 that was likely related to the LY2334737 and fulfilled any of the following criteria: Common Terminology Criteria for Adverse Events (CTCAE) ≥Grade 3 nonhematological (except nausea/vomiting controlled with treatment); Grade 3 neutropenia with fever or any Grade 4 neutropenia with or without fever; Grade 3 thrombocytopenia with ≥ Grade 2 bleeding or Grade 4 thrombocytopenia; with or without bleeding A recovery period longer than 14 days from the last dose of LY2334737 to values allowing Cycle 2 to start; other significant drug-related toxicity deemed by the investigator to be dose limiting or that caused the participant to withdraw from the study.
All participants who received at least 1 dose of study drug.
Posted
Count of Participants
Participants
No
Cycle 1 (28-day cycle)
ID
Title
Description
OG000
40 mg LY - Arm A Dose Escalation
40 milligrams (mg) LY2334737 (LY) administered orally every other day for 21 days followed by 7 days without study drug (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
OG001
50 mg LY - Arm A Dose Escalation
50 mg LY2334737 administered orally every other day for 21 days followed by 7 days without study drug (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
OG002
60 mg LY - Arm A Dose Escalation
60 mg LY2334737 administered orally every other day for 21 days followed by 7 days without study drug (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
OG003
70 mg LY - Arm A Dose Escalation
70 mg LY2334737 administered orally every other day for 21 days followed by 7 days without study drug (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
OG004
80 mg LY - Arm A Dose Escalation
80 mg LY2334737 administered orally every other day for 21 days followed by 7 days without study drug (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
OG005
90 mg LY - Arm A Dose Escalation
90 mg LY2334737 administered orally every other day for 21 days followed by 7 days without study drug (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
OG006
100 mg LY - Arm A Dose Escalation
100 mg LY2334737 administered orally every other day for 21 days followed by 7 days without study drug (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
OG007
40 mg LY - Arm B Dose Escalation
40 mg LY2334737 administered orally every day for 7 days followed by 7 days without study drug then repeated (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
OG008
50 mg LY - Arm B Dose Escalation
50 mg LY2334737 administered orally every day for 7 days followed by 7 days without study drug then repeated (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
OG009
60 mg LY - Arm B Dose Escalation
60 mg LY2334737 administered orally every day for 7 days followed by 7 days without study drug then repeated (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
OG010
70 mg LY - Arm B Dose Escalation
70 mg LY2334737 administered orally every day for 7 days followed by 7 days without study drug then repeated (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
OG011
80 mg LY - Arm B Dose Escalation
80 mg LY2334737 administered orally every day for 7 days followed by 7 days without study drug then repeated (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
OG012
90 mg LY - Arm B Dose Escalation
90 mg LY2334737 administered orally every day for 7 days followed by 7 days without study drug then repeated (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
OG013
90 mg LY - Arm A Dose Confirmation
90 mg LY2334737 administered orally every other day for 21 days followed by 7 days without study drug (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
Units
Counts
Participants
OG0003
OG0013
OG0023
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG003
Secondary
Percentage of Participants With Changes in R-R Interval From Baseline
Changes in R-R interval from baseline was calculated using a time matched approach, that is change from baseline was calculated by subtracting the respective reading taken at the same nominal time on Day -1 from the reading taken on Days 1 and 21; change from baseline was calculated by subtracting the last non-missing electrocardiogram (ECG) assessment on or prior to Day 1 and 0.5 hours prior to dose for Day 2 and Day 22. Percentage of participants with changes in R-R interval from baseline was calculated as the number of participants with a change not equal to 0 across all time points divided by the number of treated participants multiplied by 100.
All participants who received at least 1 dose of study drug with R-R interval data at all time points.
Posted
Number
percentage of participants
Day -1: 24.5 hours, 22 hours and 17 hours predose; Cycle 1 Days 1 and 21: 0.5 hours predose, 2 hours, 7 hours and 24 hours postdose
ID
Title
Description
OG000
40 mg LY - Arm A Dose Escalation
40 milligrams (mg) LY2334737 (LY) administered orally every other day for 21 days followed by 7 days without study drug (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
OG001
50 mg LY - Arm A Dose Escalation
50 mg LY2334737 administered orally every other day for 21 days followed by 7 days without study drug (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
OG002
60 mg LY - Arm A Dose Escalation
60 mg LY2334737 administered orally every other day for 21 days followed by 7 days without study drug (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
OG003
70 mg LY - Arm A Dose Escalation
70 mg LY2334737 administered orally every other day for 21 days followed by 7 days without study drug (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
OG004
80 mg LY - Arm A Dose Escalation
80 mg LY2334737 administered orally every other day for 21 days followed by 7 days without study drug (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
OG005
90 mg LY - Arm A Dose Escalation
90 mg LY2334737 administered orally every other day for 21 days followed by 7 days without study drug (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
OG006
100 mg LY - Arm A Dose Escalation
100 mg LY2334737 administered orally every other day for 21 days followed by 7 days without study drug (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
OG007
40 mg LY - Arm B Dose Escalation
40 mg LY2334737 administered orally every day for 7 days followed by 7 days without study drug then repeated (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
OG008
50 mg LY - Arm B Dose Escalation
50 mg LY2334737 administered orally every day for 7 days followed by 7 days without study drug then repeated (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
OG009
60 mg LY - Arm B Dose Escalation
60 mg LY2334737 administered orally every day for 7 days followed by 7 days without study drug then repeated (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
OG010
70 mg LY - Arm B Dose Escalation
70 mg LY2334737 administered orally every day for 7 days followed by 7 days without study drug then repeated (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
OG011
80 mg LY - Arm B Dose Escalation
80 mg LY2334737 administered orally every day for 7 days followed by 7 days without study drug then repeated (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
OG012
90 mg LY - Arm B Dose Escalation
90 mg LY2334737 administered orally every day for 7 days followed by 7 days without study drug then repeated (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
OG013
90 mg LY - Arm A Dose Confirmation
90 mg LY2334737 administered orally every day for 7 days followed by 7 days without study drug (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
Cmin for LY2334737 and its metabolite 2'2'-difluorodeoxycytidine (dFdC).
All participants who received at least 1 dose of study drug and had Cmin values
Posted
Geometric Mean
Geometric Coefficient of Variation
nanograms per milliliter (ng/mL)
Cycle 1 Day 1 (C1 D1): 0.5, 1.5, 2, 3.5, 7, 24 hours postdose; Cycle 1 Day 21 (C1 D21): predose, 0.5, 2, 3 to 4, 7, 24 hours postdose of 28-day cycle
ID
Title
Description
OG000
40 mg LY - Arm A Dose Escalation
40 milligrams (mg) LY2334737 (LY) administered orally every other day for 21 days followed by 7 days without study drug (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
OG001
50 mg LY - Arm A Dose Escalation
50 mg LY2334737 administered orally every other day for 21 days followed by 7 days without study drug (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
OG002
60 mg LY - Arm A Dose Escalation
60 mg LY2334737 administered orally every other day for 21 days followed by 7 days without study drug (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
OG003
70 mg LY - Arm A Dose Escalation
70 mg LY2334737 administered orally every other day for 21 days followed by 7 days without study drug (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
OG004
80 mg LY - Arm A Dose Escalation
80 mg LY2334737 administered orally every other day for 21 days followed by 7 days without study drug (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
OG005
90 mg LY - Arm A Dose Escalation and Dose Confirmation
90 mg LY2334737 administered orally every other day for 21 days followed by 7 days without study drug (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
OG006
100 mg LY - Arm A Dose Escalation
100 mg LY2334737 administered orally every other day for 21 days followed by 7 days without study drug (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
OG007
40 mg LY - Arm B Dose Escalation
40 mg LY2334737 administered orally every day for 7 days followed by 7 days without study drug then repeated (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
OG008
50 mg LY - Arm B Dose Escalation
50 mg LY2334737 administered orally every day for 7 days followed by 7 days without study drug then repeated (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
OG009
60 mg LY - Arm B Dose Escalation
60 mg LY2334737 administered orally every day for 7 days followed by 7 days without study drug then repeated (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
OG010
70 mg LY - Arm B Dose Escalation
70 mg LY2334737 administered orally every day for 7 days followed by 7 days without study drug then repeated (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
OG011
80 mg LY - Arm B Dose Escalation
80 mg LY2334737 administered orally every day for 7 days followed by 7 days without study drug then repeated (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
OG012
90 mg LY - Arm B Dose Escalation
90 mg LY2334737 administered orally every day for 7 days followed by 7 days without study drug then repeated (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
Units
Counts
Participants
OG0003
OG0012
OG0023
OG003
Title
Denominators
Categories
C1 D1 LY
ParticipantsOG0003
ParticipantsOG0012
ParticipantsOG0023
ParticipantsOG003
2
3
3
3
EG001
50 mg LY - Arm A Dose Escalation
50 mg LY2334737 administered orally every other day for 21 days followed by 7 days without study drug (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
1
3
3
3
EG002
60 mg LY - Arm A Dose Escalation
60 mg LY2334737 administered orally every other day for 21 days followed by 7 days without study drug (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
1
3
3
3
EG003
70 mg LY - Arm A Dose Escalation
70 mg LY2334737 administered orally every other day for 21 days followed by 7 days without study drug (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
1
3
3
3
EG004
80 mg LY - Arm A Dose Escalation
80 mg LY2334737 administered orally every other day for 21 days followed by 7 days without study drug (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
1
3
3
3
EG005
90 mg LY - Arm A Dose Escalation
90 mg LY2334737 administered orally every other day for 21 days followed by 7 days without study drug (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
5
5
5
5
EG006
100 mg LY - Arm A Dose Escalation
100 mg LY2334737 administered orally every other day for 21 days followed by 7 days without study drug (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
5
9
9
9
EG007
40 mg LY - Arm B Dose Escalation
40 mg LY2334737 administered orally every day for 7 days followed by 7 days without study drug then repeated (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
1
3
3
3
EG008
50 mg LY - Arm B Dose Escalation
50 mg LY2334737 administered orally every day for 7 days followed by 7 days without study drug then repeated (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
1
3
3
3
EG009
60 mg LY - Arm B Dose Escalation
60 mg LY2334737 administered orally every day for 7 days followed by 7 days without study drug then repeated (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
2
7
7
7
EG010
70 mg LY - Arm B Dose Escalation
70 mg LY2334737 administered orally every day for 7 days followed by 7 days without study drug then repeated (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
2
3
3
3
EG011
80 mg LY - Arm B Dose Escalation
80 mg LY2334737 administered orally every day for 7 days followed by 7 days without study drug then repeated (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
5
9
9
9
EG012
90 mg LY - Arm B Dose Escalation
90 mg LY2334737 administered orally every day for 7 days followed by 7 days without study drug then repeated (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
6
7
6
7
EG013
90 mg LY - Arm A Dose Confirmation
90 mg LY2334737 administered orally every other day for 21 days followed by 7 days without study drug (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.
6
12
12
12
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected9 at risk
EG0120 events0 affected7 at risk
EG0131 events1 affected12 at risk
Abdominal pain
Gastrointestinal disorders
MedDRA 15.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0041 events1 affected3 at risk
EG0050 events0 affected5 at risk
EG0061 events1 affected9 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected9 at risk
EG0121 events1 affected7 at risk
EG0130 events0 affected12 at risk
Ascites
Gastrointestinal disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected3 at risk
EG0111 events1 affected9 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected12 at risk
Colonic obstruction
Gastrointestinal disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0091 events1 affected7 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected9 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected12 at risk
Diarrhoea
Gastrointestinal disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0061 events1 affected9 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected3 at risk
EG0111 events1 affected9 at risk
EG0121 events1 affected7 at risk
EG0130 events0 affected12 at risk
Gastric haemorrhage
Gastrointestinal disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected9 at risk
EG0120 events0 affected7 at risk
EG0131 events1 affected12 at risk
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected3 at risk
EG0111 events1 affected9 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected12 at risk
Proctocolitis
Gastrointestinal disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected9 at risk
EG0121 events1 affected7 at risk
EG0130 events0 affected12 at risk
Rectal haemorrhage
Gastrointestinal disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected9 at risk
EG0121 events1 affected7 at risk
EG0130 events0 affected12 at risk
Vomiting
Gastrointestinal disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0042 events1 affected3 at risk
EG0050 events0 affected5 at risk
EG0061 events1 affected9 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected9 at risk
EG0121 events1 affected7 at risk
EG0130 events0 affected12 at risk
Asthenia
General disorders
MedDRA 15.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected3 at risk
EG0081 events1 affected3 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected9 at risk
EG0120 events0 affected7 at risk
EG0131 events1 affected12 at risk
Disease progression
General disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected9 at risk
EG0071 events1 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected9 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected12 at risk
General physical health deterioration
General disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected5 at risk
EG0061 events1 affected9 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected9 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected12 at risk
Mucosal inflammation
General disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected9 at risk
EG0121 events1 affected7 at risk
EG0130 events0 affected12 at risk
Oedema peripheral
General disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG0031 events1 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected9 at risk
EG0120 events0 affected7 at risk
EG0131 events1 affected12 at risk
Pyrexia
General disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0061 events1 affected9 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected3 at risk
EG0111 events1 affected9 at risk
EG0121 events1 affected7 at risk
EG0130 events0 affected12 at risk
Bile duct stenosis
Hepatobiliary disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected5 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected3 at risk
EG0111 events1 affected9 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected12 at risk
Cholangitis
Hepatobiliary disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected9 at risk
EG0120 events0 affected7 at risk
EG0131 events1 affected12 at risk
Cholestasis
Hepatobiliary disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected3 at risk
EG0081 events1 affected3 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected9 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected12 at risk
Hepatic function abnormal
Hepatobiliary disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected9 at risk
EG0121 events1 affected7 at risk
EG0130 events0 affected12 at risk
Hyperbilirubinaemia
Hepatobiliary disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected5 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected9 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected12 at risk
Cytokine release syndrome
Immune system disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected9 at risk
EG0121 events1 affected7 at risk
EG0130 events0 affected12 at risk
Infection
Infections and infestations
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected9 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected12 at risk
Klebsiella bacteraemia
Infections and infestations
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected9 at risk
EG0120 events0 affected7 at risk
EG0131 events1 affected12 at risk
Pneumonia
Infections and infestations
MedDRA 15.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected5 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected7 at risk
EG0101 events1 affected3 at risk
EG0110 events0 affected9 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected12 at risk
Urinary tract infection
Infections and infestations
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected5 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected3 at risk
EG0111 events1 affected9 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected12 at risk
Blood bilirubin increased
Investigations
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected9 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected12 at risk
Electrocardiogram qt prolonged
Investigations
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected3 at risk
EG0111 events1 affected9 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected12 at risk
Troponin t increased
Investigations
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected3 at risk
EG0111 events1 affected9 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected12 at risk
Decreased appetite
Metabolism and nutrition disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0041 events1 affected3 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected9 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected12 at risk
Dehydration
Metabolism and nutrition disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0091 events1 affected7 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected9 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected12 at risk
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected5 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected9 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected12 at risk
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0061 events1 affected9 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected9 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected12 at risk
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0061 events1 affected9 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected9 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected12 at risk
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected5 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected9 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected12 at risk
Dizziness
Nervous system disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected9 at risk
EG0121 events1 affected7 at risk
EG0130 events0 affected12 at risk
Anxiety
Psychiatric disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected5 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected9 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected12 at risk
Confusional state
Psychiatric disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0061 events1 affected9 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected9 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected12 at risk
Urinary retention
Renal and urinary disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected7 at risk
EG0101 events1 affected3 at risk
EG0110 events0 affected9 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected12 at risk
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0052 events2 affected5 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected9 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected12 at risk
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0091 events1 affected7 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected9 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected12 at risk
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0091 events1 affected7 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected9 at risk
EG0121 events1 affected7 at risk
EG0131 events1 affected12 at risk
Exeresis
Surgical and medical procedures
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected9 at risk
EG0120 events0 affected7 at risk
EG0131 events1 affected12 at risk
Hypotension
Vascular disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected9 at risk
EG0121 events1 affected7 at risk
EG0130 events0 affected12 at risk
EG0004 events3 affected3 at risk
EG0011 events1 affected3 at risk
EG0022 events2 affected3 at risk
EG0031 events1 affected3 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected5 at risk
EG0060 events0 affected9 at risk
EG0071 events1 affected3 at risk
EG0082 events2 affected3 at risk
EG0093 events3 affected7 at risk
EG0103 events3 affected3 at risk
EG0111 events1 affected9 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected12 at risk
Disseminated intravascular coagulation
Blood and lymphatic system disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0061 events1 affected9 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected9 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected12 at risk
Lymphopenia
Blood and lymphatic system disorders
MedDRA 15.1
Systematic Assessment
EG0003 events2 affected3 at risk
EG0014 events3 affected3 at risk
EG0023 events2 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected9 at risk
EG0071 events1 affected3 at risk
EG0084 events3 affected3 at risk
EG0091 events1 affected7 at risk
EG0102 events2 affected3 at risk
EG0110 events0 affected9 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected12 at risk
Neutropenia
Blood and lymphatic system disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected7 at risk
EG0102 events1 affected3 at risk
EG0110 events0 affected9 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected12 at risk
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected9 at risk
EG0072 events1 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected9 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected12 at risk
Tachycardia
Cardiac disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0041 events1 affected3 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected9 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected12 at risk
Hearing impaired
Ear and labyrinth disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected9 at risk
EG0120 events0 affected7 at risk
EG0131 events1 affected12 at risk
Tinnitus
Ear and labyrinth disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0091 events1 affected7 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected9 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected12 at risk
Vertigo
Ear and labyrinth disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0061 events1 affected9 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected9 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected12 at risk
Conjunctivitis
Eye disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected5 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected9 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected12 at risk
Eyelid oedema
Eye disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected3 at risk
EG0081 events1 affected3 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected9 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected12 at risk
Abdominal discomfort
Gastrointestinal disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected9 at risk
EG0120 events0 affected7 at risk
EG0131 events1 affected12 at risk
Abdominal distension
Gastrointestinal disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0091 events1 affected7 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected9 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected12 at risk
Abdominal pain
Gastrointestinal disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0061 events1 affected9 at risk
EG0071 events1 affected3 at risk
EG0080 events0 affected3 at risk
EG0093 events3 affected7 at risk
EG0101 events1 affected3 at risk
EG0114 events4 affected9 at risk
EG0121 events1 affected7 at risk
EG0131 events1 affected12 at risk
Abdominal pain lower
Gastrointestinal disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected3 at risk
EG0111 events1 affected9 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected12 at risk
Abdominal pain upper
Gastrointestinal disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0061 events1 affected9 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0091 events1 affected7 at risk
EG0100 events0 affected3 at risk
EG0112 events2 affected9 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected12 at risk
Ascites
Gastrointestinal disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected9 at risk
EG0071 events1 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected9 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected12 at risk
Constipation
Gastrointestinal disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0042 events2 affected3 at risk
EG0051 events1 affected5 at risk
EG0063 events3 affected9 at risk
EG0071 events1 affected3 at risk
EG0081 events1 affected3 at risk
EG0090 events0 affected7 at risk
EG0101 events1 affected3 at risk
EG0113 events3 affected9 at risk
EG0121 events1 affected7 at risk
EG0131 events1 affected12 at risk
Diarrhoea
Gastrointestinal disorders
MedDRA 15.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0032 events2 affected3 at risk
EG0040 events0 affected3 at risk
EG0052 events2 affected5 at risk
EG0063 events3 affected9 at risk
EG0073 events2 affected3 at risk
EG0080 events0 affected3 at risk
EG0092 events2 affected7 at risk
EG0100 events0 affected3 at risk
EG0113 events3 affected9 at risk
EG0122 events2 affected7 at risk
EG0133 events3 affected12 at risk
Dry mouth
Gastrointestinal disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected7 at risk
EG0101 events1 affected3 at risk
EG0112 events2 affected9 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected12 at risk
Dyspepsia
Gastrointestinal disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected3 at risk
EG0111 events1 affected9 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected12 at risk
Flatulence
Gastrointestinal disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0041 events1 affected3 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0091 events1 affected7 at risk
EG0100 events0 affected3 at risk
EG0111 events1 affected9 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected12 at risk
Gastrointestinal disorder
Gastrointestinal disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected9 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected12 at risk
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected3 at risk
EG0111 events1 affected9 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected12 at risk
Haematochezia
Gastrointestinal disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected9 at risk
EG0120 events0 affected7 at risk
EG0131 events1 affected12 at risk
Melaena
Gastrointestinal disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0091 events1 affected7 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected9 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected12 at risk
Nausea
Gastrointestinal disorders
MedDRA 15.1
Systematic Assessment
EG0003 events1 affected3 at risk
EG0013 events2 affected3 at risk
EG0021 events1 affected3 at risk
EG0032 events2 affected3 at risk
EG0042 events2 affected3 at risk
EG0054 events4 affected5 at risk
EG0068 events7 affected9 at risk
EG0071 events1 affected3 at risk
EG0081 events1 affected3 at risk
EG0092 events2 affected7 at risk
EG0105 events2 affected3 at risk
EG0113 events3 affected9 at risk
EG0124 events4 affected7 at risk
EG0136 events6 affected12 at risk
Obstruction gastric
Gastrointestinal disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0041 events1 affected3 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected9 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected12 at risk
Oesophagitis
Gastrointestinal disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected9 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected12 at risk
Oral disorder
Gastrointestinal disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected9 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected12 at risk
Pancreatitis chronic
Gastrointestinal disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0091 events1 affected7 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected9 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected12 at risk
Stomatitis
Gastrointestinal disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0061 events1 affected9 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0091 events1 affected7 at risk
EG0100 events0 affected3 at risk
EG0111 events1 affected9 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected12 at risk
Subileus
Gastrointestinal disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected3 at risk
EG0111 events1 affected9 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected12 at risk
Vomiting
Gastrointestinal disorders
MedDRA 15.1
Systematic Assessment
EG0003 events2 affected3 at risk
EG0012 events2 affected3 at risk
EG0020 events0 affected3 at risk
EG0034 events1 affected3 at risk
EG0042 events2 affected3 at risk
EG0055 events5 affected5 at risk
EG0067 events6 affected9 at risk
EG0072 events2 affected3 at risk
EG0081 events1 affected3 at risk
EG0091 events1 affected7 at risk
EG0103 events2 affected3 at risk
EG0114 events4 affected9 at risk
EG0122 events2 affected7 at risk
EG0133 events3 affected12 at risk
Asthenia
General disorders
MedDRA 15.1
Systematic Assessment
EG0003 events2 affected3 at risk
EG0012 events2 affected3 at risk
EG0024 events3 affected3 at risk
EG0032 events2 affected3 at risk
EG0041 events1 affected3 at risk
EG0052 events2 affected5 at risk
EG0064 events4 affected9 at risk
EG0071 events1 affected3 at risk
EG0081 events1 affected3 at risk
EG0092 events2 affected7 at risk
EG0101 events1 affected3 at risk
EG0114 events4 affected9 at risk
EG0121 events1 affected7 at risk
EG0134 events4 affected12 at risk
Chest pain
General disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected3 at risk
EG0041 events1 affected3 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected9 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected12 at risk
Chills
General disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG0031 events1 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0062 events2 affected9 at risk
EG0072 events1 affected3 at risk
EG0080 events0 affected3 at risk
EG0092 events2 affected7 at risk
EG0101 events1 affected3 at risk
EG0113 events3 affected9 at risk
EG0121 events1 affected7 at risk
EG0133 events3 affected12 at risk
Condition aggravated
General disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected9 at risk
EG0071 events1 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected9 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected12 at risk
Face oedema
General disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected3 at risk
EG0082 events1 affected3 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected9 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected12 at risk
Fatigue
General disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected3 at risk
EG0041 events1 affected3 at risk
EG0053 events3 affected5 at risk
EG0064 events4 affected9 at risk
EG0071 events1 affected3 at risk
EG0080 events0 affected3 at risk
EG0092 events1 affected7 at risk
EG0101 events1 affected3 at risk
EG0112 events2 affected9 at risk
EG0121 events1 affected7 at risk
EG0133 events3 affected12 at risk
General physical health deterioration
General disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected3 at risk
EG0111 events1 affected9 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected12 at risk
Influenza like illness
General disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0091 events1 affected7 at risk
EG0100 events0 affected3 at risk
EG0111 events1 affected9 at risk
EG0122 events2 affected7 at risk
EG0133 events3 affected12 at risk
Mucosal inflammation
General disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0032 events2 affected3 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected5 at risk
EG0062 events2 affected9 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0091 events1 affected7 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected9 at risk
EG0121 events1 affected7 at risk
EG0133 events3 affected12 at risk
Multi-organ failure
General disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0061 events1 affected9 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected9 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected12 at risk
Oedema
General disorders
MedDRA 15.1
Systematic Assessment
EG0003 events3 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected9 at risk
EG0120 events0 affected7 at risk
EG0131 events1 affected12 at risk
Oedema peripheral
General disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected3 at risk
EG0041 events1 affected3 at risk
EG0051 events1 affected5 at risk
EG0065 events3 affected9 at risk
EG0071 events1 affected3 at risk
EG0082 events2 affected3 at risk
EG0090 events0 affected7 at risk
EG0101 events1 affected3 at risk
EG0112 events2 affected9 at risk
EG0122 events1 affected7 at risk
EG0132 events2 affected12 at risk
Pyrexia
General disorders
MedDRA 15.1
Systematic Assessment
EG0004 events2 affected3 at risk
EG0012 events2 affected3 at risk
EG0022 events2 affected3 at risk
EG0036 events3 affected3 at risk
EG0042 events1 affected3 at risk
EG0051 events1 affected5 at risk
EG0062 events2 affected9 at risk
EG0074 events2 affected3 at risk
EG0084 events3 affected3 at risk
EG0095 events4 affected7 at risk
EG0102 events2 affected3 at risk
EG0115 events4 affected9 at risk
EG0123 events3 affected7 at risk
EG0136 events6 affected12 at risk
Cholestasis
Hepatobiliary disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected3 at risk
EG0111 events1 affected9 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected12 at risk
Hepatic failure
Hepatobiliary disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0061 events1 affected9 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected9 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected12 at risk
Jaundice
Hepatobiliary disorders
MedDRA 15.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected9 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected12 at risk
Drug hypersensitivity
Immune system disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0061 events1 affected9 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected9 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected12 at risk
Bronchitis
Infections and infestations
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0091 events1 affected7 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected9 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected12 at risk
Fungal infection
Infections and infestations
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected5 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected9 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected12 at risk
Gastrointestinal infection
Infections and infestations
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected9 at risk
EG0121 events1 affected7 at risk
EG0130 events0 affected12 at risk
Genital herpes
Infections and infestations
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected9 at risk
EG0120 events0 affected7 at risk
EG0131 events1 affected12 at risk
Herpes virus infection
Infections and infestations
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0061 events1 affected9 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected9 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected12 at risk
Lung infection
Infections and infestations
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected9 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected12 at risk
Oral herpes
Infections and infestations
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0091 events1 affected7 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected9 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected12 at risk
Pyelonephritis
Infections and infestations
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected3 at risk
EG0111 events1 affected9 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected12 at risk
Sepsis
Infections and infestations
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0061 events1 affected9 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected9 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected12 at risk
Staphylococcal infection
Infections and infestations
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected9 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected12 at risk
Upper respiratory tract infection
Infections and infestations
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected7 at risk
EG0101 events1 affected3 at risk
EG0110 events0 affected9 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected12 at risk
Urinary tract infection
Infections and infestations
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected5 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0092 events2 affected7 at risk
EG0101 events1 affected3 at risk
EG0110 events0 affected9 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected12 at risk
Activated partial thromboplastin time prolonged
Investigations
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0061 events1 affected9 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected9 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected12 at risk
Alanine aminotransferase increased
Investigations
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0024 events3 affected3 at risk
EG0032 events2 affected3 at risk
EG0041 events1 affected3 at risk
EG0050 events0 affected5 at risk
EG0063 events2 affected9 at risk
EG0070 events0 affected3 at risk
EG0082 events2 affected3 at risk
EG0093 events3 affected7 at risk
EG0101 events1 affected3 at risk
EG0112 events2 affected9 at risk
EG0121 events1 affected7 at risk
EG0131 events1 affected12 at risk
Aspartate aminotransferase increased
Investigations
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0023 events2 affected3 at risk
EG0032 events2 affected3 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected5 at risk
EG0064 events3 affected9 at risk
EG0071 events1 affected3 at risk
EG0082 events2 affected3 at risk
EG0093 events3 affected7 at risk
EG0101 events1 affected3 at risk
EG0113 events3 affected9 at risk
EG0121 events1 affected7 at risk
EG0130 events0 affected12 at risk
Blood albumin decreased
Investigations
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0061 events1 affected9 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0092 events2 affected7 at risk
EG0100 events0 affected3 at risk
EG0111 events1 affected9 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected12 at risk
Blood alkaline phosphatase increased
Investigations
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG0033 events2 affected3 at risk
EG0041 events1 affected3 at risk
EG0050 events0 affected5 at risk
EG0063 events3 affected9 at risk
EG0071 events1 affected3 at risk
EG0082 events2 affected3 at risk
EG0092 events2 affected7 at risk
EG0102 events2 affected3 at risk
EG0110 events0 affected9 at risk
EG0121 events1 affected7 at risk
EG0130 events0 affected12 at risk
Blood bilirubin increased
Investigations
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0061 events1 affected9 at risk
EG0070 events0 affected3 at risk
EG0081 events1 affected3 at risk
EG0091 events1 affected7 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected9 at risk
EG0121 events1 affected7 at risk
EG0130 events0 affected12 at risk
Blood calcium decreased
Investigations
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected3 at risk
EG0111 events1 affected9 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected12 at risk
Blood creatinine increased
Investigations
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0091 events1 affected7 at risk
EG0101 events1 affected3 at risk
EG0110 events0 affected9 at risk
EG0121 events1 affected7 at risk
EG0130 events0 affected12 at risk
Blood magnesium decreased
Investigations
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected3 at risk
EG0112 events2 affected9 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected12 at risk
Blood phosphorus decreased
Investigations
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected3 at risk
EG0111 events1 affected9 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected12 at risk
Blood potassium decreased
Investigations
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected3 at risk
EG0111 events1 affected9 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected12 at risk
Blood sodium decreased
Investigations
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected9 at risk
EG0071 events1 affected3 at risk
EG0080 events0 affected3 at risk
EG0091 events1 affected7 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected9 at risk
EG0120 events0 affected7 at risk
EG0131 events1 affected12 at risk
C-reactive protein increased
Investigations
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected9 at risk
EG0121 events1 affected7 at risk
EG0130 events0 affected12 at risk
Eastern cooperative oncology group performance status worsened
Investigations
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected5 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected3 at risk
EG0111 events1 affected9 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected12 at risk
Gamma-glutamyltransferase increased
Investigations
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0061 events1 affected9 at risk
EG0070 events0 affected3 at risk
EG0082 events2 affected3 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected3 at risk
EG0111 events1 affected9 at risk
EG0121 events1 affected7 at risk
EG0130 events0 affected12 at risk
Haemoglobin decreased
Investigations
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0061 events1 affected9 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0092 events2 affected7 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected9 at risk
EG0122 events2 affected7 at risk
EG0130 events0 affected12 at risk
International normalised ratio increased
Investigations
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected9 at risk
EG0120 events0 affected7 at risk
EG0131 events1 affected12 at risk
Neutrophil count increased
Investigations
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0091 events1 affected7 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected9 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected12 at risk
Platelet count decreased
Investigations
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected9 at risk
EG0121 events1 affected7 at risk
EG0130 events0 affected12 at risk
Prothrombin time prolonged
Investigations
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0061 events1 affected9 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected9 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected12 at risk
Weight decreased
Investigations
MedDRA 15.1
Systematic Assessment
EG0002 events2 affected3 at risk
EG0012 events2 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0041 events1 affected3 at risk
EG0051 events1 affected5 at risk
EG0062 events2 affected9 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0091 events1 affected7 at risk
EG0101 events1 affected3 at risk
EG0113 events3 affected9 at risk
EG0120 events0 affected7 at risk
EG0132 events2 affected12 at risk
Decreased appetite
Metabolism and nutrition disorders
MedDRA 15.1
Systematic Assessment
EG0002 events2 affected3 at risk
EG0013 events3 affected3 at risk
EG0022 events2 affected3 at risk
EG0032 events1 affected3 at risk
EG0042 events2 affected3 at risk
EG0054 events3 affected5 at risk
EG0063 events3 affected9 at risk
EG0071 events1 affected3 at risk
EG0081 events1 affected3 at risk
EG0094 events4 affected7 at risk
EG0101 events1 affected3 at risk
EG0117 events7 affected9 at risk
EG0121 events1 affected7 at risk
EG0133 events3 affected12 at risk
Dehydration
Metabolism and nutrition disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0061 events1 affected9 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected7 at risk
EG0101 events1 affected3 at risk
EG0111 events1 affected9 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected12 at risk
Diabetic ketoacidosis
Metabolism and nutrition disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0061 events1 affected9 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected9 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected12 at risk
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected9 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected12 at risk
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0061 events1 affected9 at risk
EG0070 events0 affected3 at risk
EG0082 events2 affected3 at risk
EG0090 events0 affected7 at risk
EG0101 events1 affected3 at risk
EG0110 events0 affected9 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected12 at risk
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected9 at risk
EG0071 events1 affected3 at risk
EG0081 events1 affected3 at risk
EG0091 events1 affected7 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected9 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected12 at risk
Hyperuricaemia
Metabolism and nutrition disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected5 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected9 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected12 at risk
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA 15.1
Systematic Assessment
EG0004 events3 affected3 at risk
EG0013 events3 affected3 at risk
EG0025 events3 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected9 at risk
EG0071 events1 affected3 at risk
EG0081 events1 affected3 at risk
EG0090 events0 affected7 at risk
EG0102 events2 affected3 at risk
EG0110 events0 affected9 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected12 at risk
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0014 events2 affected3 at risk
EG0021 events1 affected3 at risk
EG0031 events1 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected7 at risk
EG0102 events2 affected3 at risk
EG0110 events0 affected9 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected12 at risk
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected9 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected12 at risk
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0013 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0063 events3 affected9 at risk
EG0072 events2 affected3 at risk
EG0081 events1 affected3 at risk
EG0090 events0 affected7 at risk
EG0101 events1 affected3 at risk
EG0111 events1 affected9 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected12 at risk
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA 15.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected9 at risk
EG0071 events1 affected3 at risk
EG0082 events1 affected3 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected9 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected12 at risk
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 15.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0013 events2 affected3 at risk
EG0021 events1 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0061 events1 affected9 at risk
EG0070 events0 affected3 at risk
EG0081 events1 affected3 at risk
EG0091 events1 affected7 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected9 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected12 at risk
Malnutrition
Metabolism and nutrition disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected3 at risk
EG0111 events1 affected9 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected12 at risk
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected7 at risk
EG0101 events1 affected3 at risk
EG0110 events0 affected9 at risk
EG0120 events0 affected7 at risk
EG0131 events1 affected12 at risk
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0042 events2 affected3 at risk
EG0050 events0 affected5 at risk
EG0061 events1 affected9 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0091 events1 affected7 at risk
EG0100 events0 affected3 at risk
EG0111 events1 affected9 at risk
EG0121 events1 affected7 at risk
EG0131 events1 affected12 at risk
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected7 at risk
EG0101 events1 affected3 at risk
EG0110 events0 affected9 at risk
EG0120 events0 affected7 at risk
EG0131 events1 affected12 at risk
Muscle twitching
Musculoskeletal and connective tissue disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected9 at risk
EG0120 events0 affected7 at risk
EG0131 events1 affected12 at risk
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected3 at risk
EG0111 events1 affected9 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected12 at risk
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected9 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected12 at risk
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0091 events1 affected7 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected9 at risk
EG0121 events1 affected7 at risk
EG0132 events2 affected12 at risk
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 15.1
Systematic Assessment
EG0002 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected9 at risk
EG0120 events0 affected7 at risk
EG0132 events2 affected12 at risk
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 15.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected5 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected9 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected12 at risk
Osteonecrosis
Musculoskeletal and connective tissue disorders
MedDRA 15.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected9 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected12 at risk
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0061 events1 affected9 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected7 at risk
EG0101 events1 affected3 at risk
EG0110 events0 affected9 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected12 at risk
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)