A Study of LY2090314 in Patients With Advanced or Metasta... | NCT01287520 | Trialant
NCT01287520
Sponsor
Eli Lilly and Company
Status
Completed
Last Update Posted
Feb 25, 2019Actual
Enrollment
41Actual
Phase
Phase 1
Conditions
Advanced Cancer
Interventions
LY2090314
pemetrexed
Carboplatin
ranitidine
Countries
United States
Protocol Section
Identification Module
NCT ID
Results Section
Participant Flow Module
Pre-assignment Details
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
NCT01287520
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
11613
Secondary IDs
ID
Type
Description
Link
I2H-MC-JWYA
Other Identifier
Eli Lilly and Company
Brief Title
A Study of LY2090314 in Patients With Advanced or Metastatic Cancer
Official Title
Phase 1 Dose Escalation Study of LY2090314 in Patients With Advanced or Metastatic Cancer in Combination With Pemetrexed and Carboplatin
Acronym
Not provided
Organization
Eli Lilly and CompanyINDUSTRY
Status Module
Record Verification Date
Oct 2018
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
Nov 2007
Primary Completion Date
Apr 2011Actual
Completion Date
Apr 2011Actual
First Submitted Date
Jan 28, 2011
First Submission Date that Met QC Criteria
Jan 31, 2011
First Posted Date
Feb 1, 2011Estimated
Results Waived
Not provided
Results First Submitted Date
Oct 17, 2018
Results First Submitted that Met QC Criteria
Oct 17, 2018
Results First Posted Date
Feb 25, 2019Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Oct 17, 2018
Last Update Posted Date
Feb 25, 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 determine a recommended Phase 2 dose and dosing regimen of LY2090314 in combination with pemetrexed and carboplatin in patients with advanced/metastatic cancer. Part A of this study will consist of dose escalation of the study regimen, and Part B will consist of an expanded cohort to confirm the dose provided from Part A.
Detailed Description
Not provided
Conditions Module
Conditions
Advanced Cancer
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
41Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
LY2090314/pemetrexed/carboplatin
Experimental
Part A, Cycle 1 (28 days): Intravenous doses of LY2090314 starting at 10 milligram (mg) were given on Day 1 followed by 10 mg LY2090314, 500 milligram per square meter (mg/m^2) pemetrexed (intravenous dose), and 5 or 6 area under the concentration-time curve (AUC) intravenous dose of carboplatin on Day 8.
Part A, Cycle 2 (21 days): Pemetrexed and carboplatin given on Day 1 at the same dose administered in Cycle 1.
Part A, Cycle 3 (21 days) and beyond: LY2090314, Pemetrexed and carboplatin were given on Day 1 at the same dose administered in Cycle 1. LY2090314 doses were escalated until the maximum tolerated dose (MTD) was reached.
Part B: Dose determined in Part A was administered. Participants were allowed to continue the combination treatment if they were receiving therapeutic benefit until they fulfilled one of the criteria for discontinuation.
Recommended Phase 2 MTD was determined, when a dose limiting toxicity (DLT) occurred in 1 of 3 participants, the cohort was to be expanded to 6 participants. If a DLT occurred in 2 or more participants, accrual to the cohort was stopped, as the MTD was exceeded. A DLT was defined as an adverse event (AE) occurring in Cycle 1 (28 days) that was possibly related to study drug and met 1 of the following criteria: According to the National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0, ≥Grade 3 nonhematologic toxicity (except for nausea/vomiting without maximal symptomatic/prophylactic treatment) possibly or likely related to the study medication;CTCAE Grade 4 hematological toxicity of >5 days duration; Febrile neutropenia; CTCAE Grade 4 thrombocytopenia; CTCAE ≥Grade 2 thrombocytopenia plus bleeding; CTCAE ≥Grade 3 prolonged QTc interval.
Baseline up to Day 28 (Cycle 1)
Secondary Outcomes
Measure
Description
Time Frame
Pharmacokinetic (PK) Parameter: Area Under the Concentration-Time Curve From Time 0 Hour to Infinity (AUC0-∞) of LY2090314
AUC0-∞ was calculated from the area under the concentration versus time curve from time 0 to infinity of LY2090314 when administered alone.
Cycle 1 Day 1 of a 28 day cycle
PK Parameter: AUC0-∞ of LY2090314 Coadministered With Pemetrexed (Pem) and Carboplatin (Carb)
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Have a performance status of less than or equal to 2 on the Eastern Cooperative Oncology Group (ECOG) scale
Have a life expectancy of greater than or equal to 12 weeks
Males and females with reproductive potential agree to use medically approved contraceptive precautions during the trial and for 3 months following the last dose of study drug
Have histological or cytological evidence of a diagnosis of cancer that is advanced and/or metastatic disease for which no proven effective therapy exists
Have the presence of measurable or nonmeasurable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST)
Have adequate hematologic, hepatic, and renal function
Have discontinued all previous therapies for cancer, including chemotherapy, radiotherapy, cancer-related hormonal therapy, or other investigational therapy for at least 30 days (6 weeks for mitomycin-C or nitrosoureas) prior to study enrollment and recovered from the acute effects of therapy.
Exclusion Criteria:
Have received treatment within 30 days of the initial dose of study drug with a drug that has not received regulatory approval for any indication
Have serious preexisting medical conditions (left to discretion of investigator)
Have one of the following conduction abnormalities: Corrected time between start of Q wave and end of T wave (QTc) prolongation >450 millisecond (msec) on screening electrocardiogram (ECG), previous history of QTc prolongation with another medication that required discontinuation, congenital long-QT-syndrome, or left bundle branch block (LBBB)
Are taking any concomitant medication that may cause QTc prolongation, or induce Torsades de Pointes
Have systolic blood pressure greater than or equal to 140 millimeters of Mercury (mm Hg), and diastolic blood pressure greater than or equal to 90 mm Hg that is not controlled by medical therapy
Have serious cardiac condition, such as myocardial infarction within 6 months, angina, or heart disease, as defined by the New York Heart Association Class II or higher; have history of arrhythmia that is symptomatic or requires treatment
Have chronic atrial fibrillation and/or bradycardia
Have uncorrected electrolyte disorders including potassium <3.4 molar equivalent per liter (mEq/L) (<3.4 millimole per liter [mmol/l]), calcium <8.4 milligram per deciliter (mg/dL) (2.1 mmol/L), or magnesium <1.2 mg/dL (<0.62 mmol/L)
Have symptomatic central nervous system (CNS) malignancy or metastasis (screening not required)
Have a hematologic malignancy
Females who are pregnant or lactating
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
25 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.
Gray JE, Infante JR, Brail LH, Simon GR, Cooksey JF, Jones SF, Farrington DL, Yeo A, Jackson KA, Chow KH, Zamek-Gliszczynski MJ, Burris HA 3rd. A first-in-human phase I dose-escalation, pharmacokinetic, and pharmacodynamic evaluation of intravenous LY2090314, a glycogen synthase kinase 3 inhibitor, administered in combination with pemetrexed and carboplatin. Invest New Drugs. 2015 Dec;33(6):1187-96. doi: 10.1007/s10637-015-0278-7. Epub 2015 Sep 25.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
No data available
No data is available for this block.
The reasons for discontinuation listed in the participant flow are the reasons the participant discontinued treatment and a participant was considered to have "completed" the trial if they discontinued treatment due to progressive disease or an adverse event.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
LY 10/Carb 5/Pem 500 (Cohort 1)
Cycle 1 Day 1 of 28-day cycle: 10 milligrams (mg) LY2090314 (LY) administered by intravenous infusion.
Cycle 1 Day 8 of 28-day cycle: 500 milligrams per meter squared (mg/m^2) pemetrexed (Pem) administered by intravenous infusion followed by Area Under the Time Curve (AUC) 5 milligrams per milliliter times minutes (mg/mL * min) carboplatin (Carb) administered by intravenous infusion.
Cycle 2 and beyond: Day 1 of 21-day cycle: 500 mg/m^2 Pem administered by intravenous infusion followed by AUC 5 mg/mL * min Carb administered by intravenous infusion followed by 10 mg LY2090314 administered by intravenous infusion.
FG001
LY 10/Carb 6/Pem 500 (Cohort 2)
Cycle 1 Day 1 of 28-day cycle: 10 mg LY2090314 by intravenous infusion.
Cycle 1 Day 8 of 28-day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion.
Cycle 2 and beyond: Day 1 of 21-day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion followed by 10 mg LY2090314 by intravenous infusion.
FG002
LY 20/Carb 6/Pem 500 (Cohort 3)
Cycle 1 Day 1 of 28-day cycle: 20 mg LY2090314 by intravenous infusion.
Cycle 1 Day 8 of 28-day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion.
Cycle 2 and beyond: Day 1 of 21-day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion followed by 20 mg LY2090314 by intravenous infusion.
FG003
LY 40/Carb 6/Pem 500 (Cohort 4)
Cycle 1 Day 1 of 28-day cycle: 40 mg LY2090314 by intravenous infusion.
Cycle 1 Day 8 of 28-day cycle 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion followed by 40 mg LY2090314 by intravenous infusion.
Cycle 2 Day 1 of 21-day cycle: AUC 6 mg/mL * min Carb by intravenous infusion followed by 500 mg/m^2 Pem by intravenous infusion.
Cycle 3 and beyond: Day 1 of 21 day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion followed by 40 mg LY2090314 by intravenous infusion.
FG004
LY 80/Carb 6/Pem 500 (Cohort 5)
Cycle 1 Day 1 of 28 -ay cycle: 80 mg LY2090314 by intravenous infusion.
Cycle 1 Day 8 of 28-day cycle 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion followed by 80 mg LY2090314 by intravenous infusion.
Cycle 2 Day 1 of 21-day cycle: AUC 6 mg/mL * min Carb by intravenous infusion followed by 500 mg/m^2 Pem by intravenous infusion.
Cycle 3 up and beyond: Day 1 of 21 day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion followed by 80 mg LY2090314 by intravenous infusion
FG005
LY 120/Carb 6/Pem 500 -(Cohort 6)
Cycle 1 Day 1 of 28-day cycle: 120 mg LY2090314 by intravenous infusion.
Cycle 1 Day 8 of 28-day cycle 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion followed by 120 mg LY2090314 by intravenous infusion.
Cycle 2 Day 1 of 21-day cycle: AUC 6 mg/mL * min Carb by intravenous infusion followed by 500 mg/m^2 Pem by intravenous infusion.
Cycle 3 and beyond: Day 1 of 21-day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion followed by 120 mg LY2090314 by intravenous infusion.
FG006
LY 80/Carb 6/Pem 500 + R50 (Cohort 7)
Cycle 1 Day 1 of 28-day cycle: pretreated with 50 mg ranitidine (R50) intravenous, 80 mg LY2090314 by intravenous infusion.
Cycle 1 Day 8 of 28-day cycle 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb intravenous infusion followed by 50 mg ranitidine intravenous pretreatment and 80 mg LY2090314 by intravenous infusion.
Cycle 2 Day 1 of 21-day cycle: AUC 6 mg/mL * min Carb by intravenous infusion followed by 500 mg/m^2 Pem IV infusion.
Cycle 3 and beyond: Day 1 of 21-day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion followed by 50 mg ranitidine intravenous pretreatment and 80 mg LY2090314 intravenous infusion.
Based on I2H-MC-JWYA Protocol Amendment (d) approved 11 March 2010, 50 mg ranitidine was given as a pretreatment to LY2090314 as prophylaxis for stomach pain.
FG007
LY 60/Carb 6/Pem 500 + R50 (Cohort 8)
Cycle 1 Day 1 of 28-day cycle: pretreated with 50 mg ranitidine intravenous, 60 mg LY2090314 by IV infusion.
Cycle 1 Day 8 of 28-day cycle 500 mg/m^2 Pem by intravenous infusion followed by AUC 6mg/mL * min Carb intravenous infusion followed by 50 mg ranitidine intravenous pretreatment and 60 mg LY2090314 by intravenous infusion.
Cycle 2 Day 1 of 21-day cycle: AUC 6 mg/mL * min Carb by intravenous infusion followed by 500 mg/m^2 Pem intravenous infusion.
Cycle 3 and beyond: Day 1 of 21-day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion followed by 50 mg ranitidine intravenous pretreatment and 60 mg LY2090314 intravenous infusion.
Based on I2H-MC-JWYA Protocol Amendment (d) approved 11 March 2010, 50 mg ranitidine was given as a pretreatment to LY2090314 as prophylaxis for stomach pain.
FG008
LY 40/Carb 6/Pem 500 + R50 (Cohort 9)
Cycle 1 Day 1 of 28-day cycle: pretreated with 50 mg ranitidine intravenous, 40 mg LY2090314 by intravenous infusion.
Cycle 1 Day 8 of 28-day cycle 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb intravenous infusion followed by 50 mg ranitidine intravenous pretreatment and 40 mg LY2090314 by intravenous infusion.
Cycle 2 Day 1 of 21-day cycle: AUC 6 mg/mL * min Carb by intravenous infusion followed by 500 mg/m^2 Pem intravenous infusion.
Cycle 3 and beyond: Day 1 of 21-day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion followed by 50 mg ranitidine IV pretreatment and 40 mg LY2090314 intravenous infusion.
Based on I2H-MC-JWYA Protocol Amendment (d) approved 11 March 2010, 50 mg ranitidine was given as a pretreatment to LY2090314 as prophylaxis for stomach pain.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
FG0003 subjects
FG0017 subjectsOne participant who received study drug but did not complete Cycle 1 was replaced.
FG0025 subjects
FG0037 subjectsOne participant who received study drug but did not complete Cycle 1 was replaced.
FG0043 subjects
FG0054 subjects
FG0062 subjects
FG0075 subjects
FG0085 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0003 subjects
FG0017 subjects
FG0025 subjects
FG0037 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0002 subjects
FG0012 subjects
FG0022 subjects
FG003
Baseline Characteristics Module
Baseline Analysis Population Description
All randomized participants who received at least 1 dose of study drug.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
LY 10/Carb 5/Pem 500 (Cohort 1)
Cycle 1 Day 1 of 28-day cycle: 10 mg LY2090314 by intravenous infusion.
Cycle 1 Day 8 of 28-day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 5 mg/mL * min Carb by intravenous infusion.
Cycle 2 up to Cycle 9: Day 1 of 21-day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 5 mg/mL * min Carb by intravenous infusion followed by 10 mg LY2090314 by intravenous infusion.
Recommended Phase 2 MTD was determined, when a dose limiting toxicity (DLT) occurred in 1 of 3 participants, the cohort was to be expanded to 6 participants. If a DLT occurred in 2 or more participants, accrual to the cohort was stopped, as the MTD was exceeded. A DLT was defined as an adverse event (AE) occurring in Cycle 1 (28 days) that was possibly related to study drug and met 1 of the following criteria: According to the National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0, ≥Grade 3 nonhematologic toxicity (except for nausea/vomiting without maximal symptomatic/prophylactic treatment) possibly or likely related to the study medication;CTCAE Grade 4 hematological toxicity of >5 days duration; Febrile neutropenia; CTCAE Grade 4 thrombocytopenia; CTCAE ≥Grade 2 thrombocytopenia plus bleeding; CTCAE ≥Grade 3 prolonged QTc interval.
Safety population: all participants who have received at least 1 dose of the study drug.
Posted
Number
milligrams (mg)
Baseline up to Day 28 (Cycle 1)
ID
Title
Description
Adverse Events Module
Frequency Threshold
5
Time Frame
Not provided
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
LY 10/Carb 5/Pem 500 (Cohort 1)
Cycle 1 Day 1 of 28 day cycle: 10 mg LY2090314 administered by intravenous infusion.
Cycle 1 Day 8 of 28 day cycle: 500 mg/m^2 Pem administered by intravenous infusion followed by AUC 5 mg/mL * min Carb administered by intravenous infusion.
Cycle 2 up to Cycle 9: Day 1 of 21 day cycle: 500 mg/m^2 Pem administered by intravenous infusion followed by AUC 5 mg/mL * min Carb administered by intravenous infusion followed by 10 mg LY2090314 administered by intravenous infusion.
Per I2H-MC-JWYA Protocol Amendment (d) approved 11 March 2010, 50 mg ranitidine given as pretreatment to LY2090314 for stomach pain.
LY2090314/pemetrexed/carboplatin
AUC0-∞ was calculated from the area under the concentration versus time curves of LY2090314 from time zero to infinity when coadministered with Pem and Carb.
Cycle 1 Day 8 of a 28-day cycle or Cycle 2 Day 1 of a 21-day cycle
PK Parameter: Maximum Plasma Concentration (Cmax) of LY2090314
Cycle 1 Day 1 of a 28-day cycle
PK Parameter: Maximum Plasma Concentration (Cmax) of LY2090314 Coadministered With Pemetrexed (Pem) and Carboplatin (Carb)
Cycle 1 Day 8 of a 28-day cycle or Cycle 2 Day 1 of a 21-day cycle
Number of Participants With Best Overall Tumor Response
Best overall observed tumor response at any point during the study until disease progression/recurrence defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response (CR) was defined as the disappearance of all target and non-target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 millimeter (mm) and normalization of tumor marker level of non-target lesions; Partial Response (PR) was defined as at least 30% decrease in sum of longest diameter of target lesions; Progressive Disease (PD) was defined as at least 20% increase in sum of longest diameter of target lesions and minimum 5 mm increase over nadir; Stable Disease (SD) was defined as small changes that did not meet above criteria.
Baseline up to Cycle 9 (Cycle 1 was 28 days, Cycles 2 to 9 were 21 days)
Pharmacokinetic (PK) Parameter: Area Under the Concentration-Time Curve From Time 0 Hour to Infinity (AUC0-∞) of Pemetrexed (Pem)
AUC0-∞ was calculated from the area under the concentration versus time curves of Pem given as a single dose with Carb (doublet therapy) and when co-administered with Carb and LY2090314 (triplet therapy).
Cycle 1 Day 8 of 28-day cycle and Cycle 2 up to Cycle 10 Day 1 of 21-day cycle
PK Parameter: Maximum Plasma Concentration (Cmax) of Pemetrexed (Pem)
Cmax of Pem given as a single dose with Carb (doublet therapy) and when coadministered with Carb and LY2090314 (triplet therapy).
Cycle 1 Day 8 of 28-day cycle and Cycle 2 up to Cycle 10 Day 1 of 21-day cycle
PK Parameter: AUC0-∞ of Free Carboplatin (Carb)
AUC0-∞ of free Carb was calculated from the area under the concentration versus time curves of Carb given as a single dose with Pem (doublet therapy) and when co-administered with Pem and LY2090314 (triplet therapy).
Cycle 1 Day 8 of 28-day cycle and Cycle 2 up to Cycle 9: Day 1 of 21-day cycle
PK Parameter: Cmax of Free Carboplatin
Cmax of free Carb given as a single dose with Pem (doublet therapy) and when co-administered with Pem and LY2090314 (triplet therapy).
Cycle 1, Day 8 of 28-day cycle and Cycle 2 up to Cycle 9: Day 1 of 21-day cycle
Pharmacodynamic (PD) Changes in Beta-Catenin (β-catenin)
PD change from baseline to endpoint (up to Cycle 9) in β-catenin levels in peripheral blood mononuclear cells (PBMCs) following the administration of LY2090314 given alone and in combination with Pem and Carb. This outcome measure was not analyzed due to insufficient data.
Baseline, Cycle 1 , Day 1 of a 28-day cycle and Cycle 2 up to Cycle 9: Day 1 of 21-day cycles
United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Nashville
Tennessee
United States
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
3 subjects
FG0054 subjects
FG0062 subjects
FG0075 subjects
FG0085 subjects
1 subjects
FG0041 subjects
FG0052 subjects
FG0060 subjects
FG0072 subjects
FG0080 subjects
Physician Decision
FG0001 subjects
FG0011 subjects
FG0022 subjects
FG0030 subjects
FG0041 subjects
FG0051 subjects
FG0060 subjects
FG0071 subjects
FG0080 subjects
Progressive disease
FG0000 subjects
FG0014 subjects
FG0021 subjects
FG0036 subjects
FG0041 subjects
FG0050 subjects
FG0062 subjects
FG0072 subjects
FG0084 subjects
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0051 subjects
FG0060 subjects
FG0070 subjects
FG0081 subjects
BG001
LY 10/Carb 6/Pem 500 (Cohort 2)
Cycle 1 Day 1 of 28-day cycle: 10 mg LY2090314 by intravenous infusion.
Cycle 1 Day 8 of 28-day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion.
Cycle 2 up to Cycle 9: Day 1 of 21-day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion followed by 10 mg LY2090314 by intravenous infusion.
BG002
LY 20/Carb 6/Pem 500 (Cohort 3)
Cycle 1 Day 1 of 28-day cycle: 20 mg LY2090314 by intravenous infusion.
Cycle 1 Day 8 of 28-day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion.
Cycle 2 up to Cycle 9: Day 1 of 21-day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion followed by 20 mg LY2090314 by intravenous infusion.
BG003
LY 40/Carb 6/Pem 500 (Cohort 4)
Cycle 1 Day 1 of 28-day cycle: 40 mg LY2090314 by intravenous infusion.
Cycle 1 Day 8 of 28-day cycle 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion followed by 40 mg LY2090314 by intravenous infusion.
Cycle 2 Day 1 of 21-day cycle: AUC 6 mg/mL * min Carb by intravenous infusion followed by 500 mg/m^2 Pem by intravenous infusion.
Cycle 3 up to Cycle 9: Day 1 of 21-day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion followed by 40 mg LY2090314 by intravenous infusion.
BG004
LY 80/Carb 6/Pem 500 (Cohort 5)
Cycle 1 Day 1 of 28-day cycle: 80 mg LY2090314 by intravenous infusion.
Cycle 1 Day 8 of 28-day cycle 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion followed by 80 mg LY2090314 by intravenous infusion.
Cycle 2 Day 1 of 21-day cycle: AUC 6 mg/mL * min Carb by intravenous infusion followed by 500 mg/m^2 Pem by intravenous infusion.
Cycle 3 up to Cycle 9: Day 1 of 21-day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion followed by 80 mg LY2090314 by intravenous infusion.
BG005
LY 120/Carb 6/Pem 500 (Cohort 6)
Cycle 1 Day 1 of 28-day cycle: 120 mg LY2090314 by intravenous infusion.
Cycle 1 Day 8 of 28-day cycle 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion followed by 120 mg LY2090314 by intravenous infusion.
Cycle 2 Day 1 of 21-day cycle: AUC 6 mg/mL * min Carb by intravenous infusion followed by 500 mg/m^2 Pem by intravenous infusion.
Cycle 3 up to Cycle 9: Day 1 of 21-day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion followed by 120 mg LY2090314 by intravenous infusion.
BG006
LY 80/Carb 6/Pem 500 + R50 (Cohort 7)
Cycle 1 Day 1 of 28-day cycle: pretreated with 50 mg ranitidine intravenous, 80 mg LY2090314 by intravenous infusion.
Cycle 1 Day 8 of 28-day cycle 500 mg/m^2 Pem by intravenous infusion followed by AUC 6mg/mL * min Carb intravenous infusion followed by 50 mg ranitidine intravenous pretreatment and 80 mg LY2090314 by intravenous infusion.
Cycle 2 Day 1 of 21-day cycle: AUC 6 mg/mL * min Carb by intravenous infusion followed by 500 mg/m^2 Pem intravenous infusion.
Cycle 3 up to Cycle 10: Day 1 of 21-day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion followed by 50 mg ranitidine intravenous pretreatment and 80 mg LY2090314 intravenous infusion.
Based on I2H-MC-JWYA Protocol Amendment (d) approved 11 March 2010, 50 mg ranitidine was given as a pretreatment to LY2090314 as prophylaxis for stomach pain.
BG007
LY 60/Carb 6/Pem 500 + R50 (Cohort 8)
Cycle 1 Day 1 of 28-day cycle: pretreated with 50 mg ranitidine intravenous, 60 mg LY2090314 by intravenous infusion.
Cycle 1 Day 8 of 28-day cycle 500 mg/m^2 Pem by intravenous infusion followed by AUC 6mg/mL * min Carb intravenous infusion followed by 50 mg ranitidine intravenous pretreatment and 60 mg LY2090314 by intravenous infusion.
Cycle 2 Day 1 of 21-day cycle: AUC 6 mg/mL * min Carb by intravenous infusion followed by 500 mg/m^2 Pem intravenous infusion.
Cycle 3 up to Cycle 9: Day 1 of 21-day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion followed by 50 mg ranitidine intravenous pretreatment and 60 mg LY2090314 intravenous infusion.
Based on I2H-MC-JWYA Protocol Amendment (d) approved 11 March 2010, 50 mg ranitidine was given as a pretreatment to LY2090314 as prophylaxis for stomach pain.
BG008
LY 40/Carb 6/Pem 500 + R50 (Cohort 9)
Cycle 1 Day 1 of 28-day cycle: pretreated with 50 mg ranitidine intravenous, 40 mg LY2090314 by intravenous infusion.
Cycle 1 Day 8 of 28-day cycle 500 mg/m^2 Pem by intravenous infusion followed by AUC 6mg/mL * min Carb intravenous infusion followed by 50 mg ranitidine intravenous pretreatment and 40 mg LY2090314 by intravenous infusion.
Cycle 2 Day 1 of 21-day cycle: AUC 6 mg/mL * min Carb by intravenous infusion followed by 500 mg/m^2 Pem intravenous infusion.
Cycle 3 up to Cycle 9: Day 1 of 21-day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion followed by 50 mg ranitidine intravenous pretreatment and 40 mg LY2090314 intravenous infusion.
Based on I2H-MC-JWYA Protocol Amendment (d) approved 11 March 2010, 50 mg ranitidine was given as a pretreatment to LY2090314 as prophylaxis for stomach pain.
BG009
Total
Total of all reporting groups
3
BG0017
BG0025
BG0037
BG0043
BG0054
BG0062
BG0075
BG0085
BG00941
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00055.81± 11.88
BG00155.27± 9.19
BG00259.31± 5.62
BG00358.32± 8.95
BG00457.35± 7.59
BG00556.73± 7.52
BG00655.39± 9.86
BG00758.78± 9.06
BG00861.35± 4.41
BG00957.79± 7.65
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0002
BG0013
BG0025
BG0033
BG0042
BG0050
BG0060
BG0073
BG0080
BG00918
Male
BG0001
BG0014
BG0020
BG0034
BG004
Race/Ethnicity, Customized
Number
participants
Title
Denominators
Categories
African
Title
Measurements
BG0000
BG0010
BG0021
BG0030
BG0041
BG0050
BG0060
BG0070
BG0080
BG0092
Caucasian
Title
Measurements
BG0003
BG0016
BG0024
BG003
Hispanic
Title
Measurements
BG0000
BG0011
BG0020
BG003
Region of Enrollment
Number
participants
Title
Denominators
Categories
United States
Title
Measurements
BG0003
BG0017
BG0025
BG0037
BG0043
BG0054
BG0062
BG0075
BG0085
BG00941
Body Surface Area
Mean
Standard Deviation
meters squared (m^2)
Title
Denominators
Categories
Title
Measurements
BG0001.76± 0.11
BG0012.10± 0.13
BG0021.66± 0.14
BG0031.94± 0.29
BG0041.77± 0.46
BG0052.11± 0.33
BG0062.07± 0.14
BG0071.90± 0.30
BG0082.04± 0.15
BG0091.94± 0.27
Eastern Cooperative Oncology Group (ECOG) performance
ECOG - Classified participants according to their functional impairment. Scores ranged from 0 to 5: 0=Fully Active, No Restrictions; 1=Ambulatory, Able to Perform Light Work Activities (for example, light house work), Restricted Strenuous Activity; 2=Ambulatory, All Self Care, No Work Activities; 3=Partially Confined to Bed (>50% of waking hours), Limited Self Care; 4=Completely Disabled, Totally Bedridden; 5=Death
Number
participants
Title
Denominators
Categories
0
Title
Measurements
BG0003
BG0015
BG0025
BG0037
BG0042
BG0054
BG0062
BG0073
BG0085
BG00936
1
Title
Measurements
BG0000
BG0012
BG0020
BG003
Basis of Diagnosis
Number
participants
Title
Denominators
Categories
Cytological
Title
Measurements
BG0001
BG0011
BG0021
BG0031
BG0042
BG0050
BG0061
BG0071
BG0080
BG0098
Histopathological
Title
Measurements
BG0002
BG0016
BG0024
BG003
Initial Pathological Tumor Diagnosis
Number
participants
Title
Denominators
Categories
Mesothelioma
Title
Measurements
BG0002
BG0013
BG0021
BG0030
BG0040
BG0051
BG0060
BG0071
BG0081
BG0099
Non-small cell lung carcinoma (NSCLC)
Title
Measurements
BG0000
BG0010
BG0023
BG003
Leimyosarcoma
Title
Measurements
BG0000
BG0012
BG0020
BG003
Esophagus
Title
Measurements
BG0000
BG0010
BG0020
BG003
Lung adenocarcinoma
Title
Measurements
BG0000
BG0010
BG0020
BG003
Rectum
Title
Measurements
BG0000
BG0011
BG0020
BG003
Small cell lung carcinoma (SCLC)
Title
Measurements
BG0000
BG0010
BG0020
BG003
Gastric
Title
Measurements
BG0000
BG0010
BG0020
BG003
Head and neck
Title
Measurements
BG0001
BG0010
BG0020
BG003
Adenocarcinoma not otherwise specified (NOS)
Title
Measurements
BG0000
BG0011
BG0020
BG003
Colon
Title
Measurements
BG0000
BG0010
BG0021
BG003
Breast
Title
Measurements
BG0000
BG0010
BG0020
BG003
Pancreas
Title
Measurements
BG0000
BG0010
BG0020
BG003
Cancer NOS
Title
Measurements
BG0000
BG0010
BG0020
BG003
Gall bladder
Title
Measurements
BG0000
BG0010
BG0020
BG003
Thymoma
Title
Measurements
BG0000
BG0010
BG0020
BG003
Adenoid
Title
Measurements
BG0000
BG0010
BG0020
BG003
Bile duct
Title
Measurements
BG0000
BG0010
BG0020
BG003
OG000
LY2090314/Pemetrexed/Carboplatin
Cycle 1 (28 days)
Cohorts 1 to 3
Cycle 1 Day 1: 10-20 mg LY2090314 by intravenous infusion.
Cycle 1 Day 8: 500 mg/m^2 Pem by intravenous infusion followed by AUC 5 or 6 mg/mL * min Carb by intravenous infusion.
Cohorts 4 to 9, Cohorts 7 to 9 were pretreated with 50 mg ranitidine intravenous-Cycle 1 Day 1: 40-120 mg LY2090314 by intravenous infusion.
-Cycle 1 Day 8: 500 mg/m^2 by Pem intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion followed by 40-120 mg LY2090314 by intravenous infusion.
Units
Counts
Participants
OG00041
Title
Denominators
Categories
Title
Measurements
OG00040
Secondary
Pharmacokinetic (PK) Parameter: Area Under the Concentration-Time Curve From Time 0 Hour to Infinity (AUC0-∞) of LY2090314
AUC0-∞ was calculated from the area under the concentration versus time curve from time 0 to infinity of LY2090314 when administered alone.
All participants who received at least 1 dose of LY2090314 and had evaluable AUC0-∞ data, excluding 2 participants (1 in dose groups LY80 and 1 in dose group LY120) who received the wrong dose of LY2090314.
Posted
Geometric Mean
Geometric Coefficient of Variation
nanograms*hour per milliliter
Cycle 1 Day 1 of a 28 day cycle
ID
Title
Description
OG000
LY 10/Carb 5 or Carb 6/Pem 500 (Cohorts 1 and 2)
Cycle 1 Day 1 of 28-day cycle: 10 mg LY2090314 by intravenous infusion.
Cycle 1 Day 8 of 28-day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 5 (Cohort 1) or AUC 6 (Cohort 2) mg/mL * min Carb by intravenous infusion.
Cycle 2 up to Cycle 9: Day 1 of 21-day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 5 (Cohort 1) or AUC 6 (Cohort 2) mg/mL * min Carb by intravenous infusion followed by 10 mg LY2090314 by intravenous infusion.
OG001
LY 20/Carb 6/Pem 500 (Cohort 3)
Cycle 1 Day 1 of 28-day cycle: 20 mg LY2090314 by intravenous infusion.
Cycle 1 Day 8 of 28-day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion.
Cycle 2 up to Cycle 9: Day 1 of 21-day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion followed by 20 mg LY2090314 by intravenous infusion.
OG002
LY 40/Carb 6/Pem 500 (Cohorts 4 and 9)
Cycle 1 Day 1 of 28-day cycle: 40 mg LY2090314 by intravenous infusion.
Cycle 1 Day 8 of 28-day cycle 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion followed by 40 mg LY2090314 by intravenous infusion.
Cycle 2 Day 1 of 21-day cycle: AUC 6 mg/mL * min Carb by intravenous infusion-followed by 500 mg/m^2 Pem by intravenous infusion.
Cycle 3 up to Cycle 9: Day 1 of 21-day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion followed by 49 mg LY2090314 by intravenous infusion.
Cohort 9, LY2090314 pretreated with 50 mg ranitidine intravenous.
Based on I2H-MV-JWYA Protocol Amendment (d) approved 11 March 2010, 50 mg ranitidine was given as a pretreatment to LY2090314 as prophylaxis for stomach pain.
OG003
LY 80/Carb 6/Pem 500 (Cohorts 5 and 7)
Cycle 1 Day 1 of 28-day cycle: 80 mg LY2090314 by intravenous infusion.
Cycle 1 Day 8 of 28-day cycle 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion followed by 80 mg LY2090314 by intravenous infusion.
Cycle 2 Day 1 of 21-day cycle: AUC 6 mg/mL * min Carb by intravenous infusion followed by 500 mg/m^2 Pem by intravenous infusion.
Cycle 3 up to Cycle 10: Day 1 of 21-day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion followed by 80 mg LY2090314 by intravenous infusion.
Cohort 7, LY2090314 pretreated with 50 mg ranitidine intravenous.
Based on I2H-MV-JWYA Protocol Amendment (d) approved 11 March 2010, 50 mg ranitidine was given as a pretreatment to LY2090314 as prophylaxis for stomach pain.
OG004
LY 120/Carb 6/Pem 500 (Cohort 6)
Cycle 1 Day 1 of 28-day cycle: 120 mg LY2090314 by intravenous infusion.
Cycle 1 Day 8 of 28-day cycle 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion followed by 120 mg LY2090314 by intravenous infusion.
Cycle 2 Day 1 of 21-day cycle: AUC 6 mg/mL * min Carb by intravenous infusion followed by 500 mg/m^2 by Pem intravenous infusion.
Cycle 3 up to Cycle 9: Day 1 of 21-day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion followed by 120 mg LY2090314 by intravenous infusion.
OG005
LY 60/Carb 6/Pem 500 + R50 (Cohort 8)
Cycle 1 Day 1 of 28-day cycle: pretreated with 50 mg ranitidine intravenous, 60 mg LY2090314 by intravenous infusion.
Cycle 1 Day 8 of 28-day cycle 500 mg/m^2 Pem by intravenous infusion followed by AUC 6mg/mL * min Carb intravenous infusion followed by 50 mg ranitidine intravenous pretreatment and 60 mg LY2090314 by intravenous infusion.
Cycle 2 Day 1 of 21-day cycle: AUC 6 mg/mL * min Carb by intravenous infusion followed by 500 mg/m^2 Pem intravenous infusion.
Cycle 3 up to Cycle 9: Day 1 of 21-day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion followed by pretreatment with 50 mg ranitidine intravenous and 60 mg LY2090314 intravenous infusion.
Based on I2H-MC-JWYA Protocol Amendment (d) approved 11 March 2010, 50 mg ranitidine was given as a pretreatment to LY2090314 as prophylaxis for stomach pain.
Units
Counts
Participants
OG00010
OG0015
OG00211
OG003
Title
Denominators
Categories
Title
Measurements
OG000216± 26.3
OG001427± 21.8
OG002976± 42.6
OG003
Secondary
PK Parameter: AUC0-∞ of LY2090314 Coadministered With Pemetrexed (Pem) and Carboplatin (Carb)
AUC0-∞ was calculated from the area under the concentration versus time curves of LY2090314 from time zero to infinity when coadministered with Pem and Carb.
All participants who received at least 1 dose LY2090314 coadministered with Pem and Carb and had enough samples to allow estimation of AUC0-∞ parameters excluding 2 participants (1 in dose groups LY80 and 1 in dose group LY120) who received the incorrect dose of LY2090314.
Posted
Geometric Mean
Geometric Coefficient of Variation
nanograms*hour per milliliter
Cycle 1 Day 8 of a 28-day cycle or Cycle 2 Day 1 of a 21-day cycle
ID
Title
Description
OG000
LY 10/Carb 5 or Carb 6/Pem 500 (Cohorts 1 and 2)
Cycle 1 Day 1 of 28-day cycle: 10 mg LY2090314 by intravenous infusion.
Cycle 1 Day 8 of 28-day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 5 (Cohort 1) or AUC 6 (Cohort 2) mg/mL * min Carb by intravenous infusion.
Cycle 2 up to Cycle 9: Day 1 of 21-day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 5 (Cohort 1) or AUC 6 (Cohort 2) mg/mL * min Carb by intravenous infusion followed by 10 mg LY2090314 by intravenous infusion.
OG001
LY 20/Carb 6/Pem 500 (Cohort 3)
Cycle 1 Day 1 of 28-day cycle: 20 mg LY2090314 by intravenous infusion.
Cycle 1 Day 8 of 28-day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion.
Cycle 2 up to Cycle 9: Day 1 of 21-day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion followed by 20 mg LY2090314 by intravenous infusion.
OG002
LY 40/Carb 6/Pem 500 (Cohorts 4 and 9)
Cycle 1 Day 1 of 28-day cycle: 40 mg LY2090314 by intravenous infusion.
Cycle 1 Day 8 of 28-day cycle 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion followed by 40 mg LY2090314 by intravenous infusion.
Cycle 2 Day 1 of 21-day cycle: AUC 6 mg/mL * min Carb by intravenous infusion followed by 500 mg/m^2 Pem by intravenous infusion.
Cycle 3 up to Cycle 9: Day 1 of 21-day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion followed by 40 mg LY2090314 by intravenous infusion.
Cohort 9, LY2090314 pretreated with 50 mg ranitidine intravenous.
Based on I2H-MC-JWYa Protocol Amendment (d) approved 11 March 2010, 50 mg ranitidine was given as a pretreatment to LY2090314 as prophylaxis for stomach pain.
OG003
LY 80/Carb 6/Pem 500 (Cohorts 5 and 7)
Cycle 1 Day 1 of 28-day cycle: 80 mg LY2090314 by intravenous infusion.
Cycle 1 Day 8 of 28-day cycle 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion followed by 80 mg LY2090314 by intravenous infusion.
Cycle 2 Day 1 of 21-day cycle: AUC 6 mg/mL * min Carb by intravenous infusion followed by 500 mg/m^2 Pem by intravenous infusion.
Cycle 3 up to Cycle 10: Day 1 of 21-day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion followed by 80 mg LY2090314 by intravenous infusion.
Cohort 7, LY2090314 pretreated with 50 mg ranitidine intravenous.
Based on I2H-MC-JWYA Protocol Amendment (d) approved 11 March 2010, 50 mg ranitidine was given as a pretreatment to LY2090314 as prophylaxis for stomach pain.
OG004
LY 120/Carb 6/Pem 500 (Cohort 6)
Cycle 1 Day 1 of 28-day cycle: 120 mg LY2090314 by intravenous infusion.
Cycle 1 Day 8 of 28-day cycle 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion followed by 120 mg LY2090314 by intravenous infusion.
Cycle 2 Day 1 of 21-day cycle: AUC 6 mg/mL * min Carb by intravenous infusion followed by 500 mg/m^2 by Pem intravenous infusion.
Cycle 3 up to Cycle 9: Day 1 of 21-day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion followed by 120 mg LY2090314 by intravenous infusion.
OG005
LY 60/Carb 6/Pem 500 + R50 (Cohort 8)
Cycle 1 Day 1 of 28-day cycle: pretreated with 50 mg ranitidine intravenous, 60 mg LY2090314 by intravenous infusion.
Cycle 1 Day 8 of 28-day cycle 500 mg/m^2 Pem by intravenous infusion followed by AUC 6mg/mL * min Carb intravenous infusion followed by 50 mg ranitidine intravenous pretreatment and 60 mg LY2090314 by intravenous infusion.
Cycle 2 Day 1 of 21-day cycle: AUC 6 mg/mL * min Carb by intravenous infusion followed by 500 mg/m^2 Pem intravenous infusion.
Cycle 3 up to Cycle 9: Day 1 of 21-day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion followed by pretreatment with 50 mg ranitidine intravenous and 60 mg LY2090314 intravenous infusion.
Based on I2H-MC-JWYA Protocol Amendment (d) approved 11 March 2010, 50 mg ranitidine was given as a pretreatment to LY2090314 as prophylaxis for stomach pain.
Units
Counts
Participants
OG00010
OG0014
OG0029
OG003
Title
Denominators
Categories
Title
Measurements
OG000192± 48.2
OG001404± 33.2
OG002938± 33.5
OG003
Secondary
PK Parameter: Maximum Plasma Concentration (Cmax) of LY2090314
All participants who received at least 1 dose of LY2090314 and had evaluable AUC0-∞ data, excluding 2 participants (1 in dose groups LY80 and 1 in dose group LY120) who received the incorrect dose of LY2090314.
Posted
Geometric Mean
Geometric Coefficient of Variation
nanograms per milliliter
Cycle 1 Day 1 of a 28-day cycle
ID
Title
Description
OG000
LY 10/Carb 5 or Carb 6/Pem 500 (Cohorts 1 and 2)
Cycle 1 Day 1 of 28-day cycle: 10 mg LY2090314 by intravenous infusion.
Cycle 1 Day 8 of 28-day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 5 (Cohort 1) or AUC 6 (Cohort 2) mg/mL * min Carb by intravenous infusion.
Cycle 2 up to Cycle 9: Day 1 of 21-day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 5 (Cohort 1) or AUC 6 (Cohort 2) mg/mL * min Carb by intravenous infusion followed by 10 mg LY2090314 by intravenous infusion.
OG001
LY 20/Carb 6/Pem 500 (Cohort 3)
Cycle 1 Day 1 of 28-day cycle: 20 mg LY2090314 by intravenous infusion.
Cycle 1 Day 8 of 28-day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion.
Cycle 2 up to Cycle 9: Day 1 of 21-day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion followed by LY2090314 20 mg by intravenous infusion.
OG002
LY 40/Carb 6/Pem 500 (Cohorts 4 and 9 )
Cycle 1 Day 1 of 28-day cycle: 40 mg LY2090314 by intravenous infusion.
Cycle 1 Day 8 of 28-day cycle 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion followed by 40 mg LY2090314 by intravenous infusion.
Cycle 2 Day 1 of 21-day cycle: AUC 6 mg/mL * min Carb by intravenous infusion followed by 500 mg/m^2 Pem by intravenous infusion.
Cycle 3 up to Cycle 9: Day 1 of 21-day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion followed by 49 mg LY2090314 by intravenous infusion.
Cohort 9, LY2090314 pretreated with 50 mg ranitidine IV. Based on I2H-MC-JWYA Protocol Amendment (d) approved 11 March 2010, 50 mg ranitidine was given as a pretreatment to LY2090314 as prophylaxis for stomach pain.
OG003
LY 80/Carb 6/Pem 500 (Cohorts 5 and 7
Cycle 1 Day 1 of 28-day cycle: 80 mg LY2090314 by intravenous infusion.
Cycle 1 Day 8 of 28-day cycle 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion followed by 80 mg LY2090314 by intravenous infusion.
Cycle 2 Day 1 of 21-day cycle: AUC 6 mg/mL * min Carb by intravenous infusion followed by 500 mg/m^2 Pem by intravenous infusion.
Cycle 3 up to Cycle 10: Day 1 of 21-day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion followed by 80 mg LY2090314 by intravenous infusion.
Cohort 7, LY2090314 pretreated with 50 mg ranitidine IV.
Based on I2H-MC-JWYA Protocol Amendment (d) approved 11 March 2010, 50 mg ranitidine was given as a pretreatment to LY2090314 as prophylaxis for stomach pain.
OG004
LY 120/Carb 6/Pem 500 (Cohort 6)
Cycle 1 Day 1 of 28-day cycle: 120 mg LY2090314 by intravenous infusion.
Cycle 1 Day 8 of 28-day cycle 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion followed by 120 mg LY2090314 by intravenous infusion.
Cycle 2 Day 1 of 21-day cycle: AUC 6 mg/mL * min Carb by intravenous infusion followed by 500 mg/m^2 by Pem intravenous infusion.
Cycle 3 up to Cycle 9: Day 1 of 21-day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion followed by 120 mg LY2090314 by intravenous infusion.
OG005
LY 60/Carb 6/Pem 500 + R50 (Cohort 8)
Cycle 1 Day 1 of 28-day cycle: pretreated with 50 mg ranitidine intravenous, 60 mg LY2090314 by IV infusion.
Cycle 1 Day 8 of 28-day cycle 500 mg/m^2 Pem by intravenous infusion followed by AUC 6mg/mL * min Carb intravenous infusion followed by 50 mg ranitidine intravenous pretreatment and 60 mg LY2090314 by intravenous infusion.
Cycle 2 Day 1 of 21-day cycle: AUC 6 mg/mL * min Carb by intravenous infusion followed by 500 mg/m^2 Pem intravenous infusion.
Cycle 3 up to Cycle 9: Day 1 of 21-day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion followed by pretreatment with 50 mg ranitidine intravenous and 60 mg LY2090314 intravenous infusion.
Based on I2H-MC-JWYA Protocol Amendment (d) approved 11 March 2010, 50 mg ranitidine was given as a pretreatment to LY2090314 as prophylaxis for stomach pain.
Units
Counts
Participants
OG00010
OG0015
OG00211
OG003
Title
Denominators
Categories
Title
Measurements
OG000122± 21.5
OG001246± 29.0
OG002603± 47.7
OG003
Secondary
PK Parameter: Maximum Plasma Concentration (Cmax) of LY2090314 Coadministered With Pemetrexed (Pem) and Carboplatin (Carb)
All participants who received at least 1 dose of LY2090314 and had evaluable AUC0-∞ data, excluding 2 participants (1 in dose groups LY80 and 1 in dose group LY120) who received the incorrect dose of LY2090314.
Posted
Geometric Mean
Geometric Coefficient of Variation
nanograms per milliliter
Cycle 1 Day 8 of a 28-day cycle or Cycle 2 Day 1 of a 21-day cycle
ID
Title
Description
OG000
LY 10/Carb 5 or Carb 6/Pem 500 (Cohorts 1 and 2)
Cycle 1 Day 1 of 28-day cycle: 10 mg LY2090314 by intravenous infusion.
Cycle 1 Day 8 of 28-day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 5 (Cohort 1) or AUC 6 (Cohort 2) mg/mL * min Carb by intravenous infusion.
Cycle 2 up to Cycle 9: Day 1 of 21-day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 5 (Cohort 1) or AUC 6 (Cohort 2) mg/mL * min Carb by intravenous infusion followed by 10 mg LY2090314 by intravenous infusion.
OG001
LY 20/Carb 6/Pem 500 (Cohort 3)
Cycle 1 Day 1 of 28-day cycle: 20 mg LY2090314 by intravenous infusion.
Cycle 1 Day 8 of 28-day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion.
Cycle 2 up to Cycle 9: Day 1 of 21-day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion followed by 20 mg LY2090314 by intravenous infusion.
OG002
LY 40/Carb 6/Pem 500 (Cohorts 4 and 9)
Cycle 1 Day 1 of 28-day cycle: 40 mg LY2090314 by intravenous infusion.
Cycle 1 Day 8 of 28-day cycle 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion followed by 40 mg LY2090314 by intravenous infusion.
Cycle 2 Day 1 of 21-day cycle: AUC 6 mg/mL * min Carb by intravenous infusion followed by 500 mg/m^2 Pem by intravenous infusion.
Cycle 3 up to Cycle 10: Day 1 of 21-day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion followed by 40 mg LY2090314 by intravenous infusion.
Cohort 9, LY2090314 pretreated with 50 mg ranitidine intravenous.
Based on I2H-MC-JWYA Protocol Amendment (d) approved 11 March 2010, 50 mg ranitidine was given as a pretreatment to LY2090314 as prophylaxis for stomach pain.
OG003
LY 80/Carb 6/Pem 500 (Cohorts 5 and 7)
Cycle 1 Day 1 of 28-day cycle: 80 mg LY2090314 by intravenous infusion.
Cycle 1 Day 8 of 28-day cycle 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion followed by 80 mg LY2090314 by intravenous infusion.
Cycle 2 Day 1 of 21-day cycle: AUC 6 mg/mL * min Carb by intravenous infusion followed by 500 mg/m^2 Pem by intravenous infusion.
Cycle 3 up to Cycle 10: Day 1 of 21-day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion followed by 80 mg LY2090314 by intravenous infusion.
Cohort 7, LY2090314 pretreated with 50 mg ranitidine IV.
Based on I2H-MC-JWYA Protocol Amendment (d) approved 11 March 2010, 50 mg ranitidine was given as a pretreatment to LY2090314 as prophylaxis for stomach pain.
OG004
LY 120/Carb 6/Pem 500 (Cohort 6)
Cycle 1 Day 1 of 28-day cycle: 120 mg LY2090314 by intravenous infusion.
Cycle 1 Day 8 of 28-day cycle 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion followed by 120 mg LY2090314 by intravenous infusion.
Cycle 2 Day 1 of 21-day cycle: AUC 6 mg/mL * min Carb by intravenous infusion followed by 500 mg/m^2 by Pem intravenous infusion.
Cycle 3 up to Cycle 9: Day 1 of 21-day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion followed by 120 mg LY2090314 by intravenous infusion.
OG005
LY 60/Carb 6/Pem 500 + R50 (Cohort 8)
Cycle 1 Day 1 of 28-day cycle: pretreated with 50 mg ranitidine intravenous, 60 mg LY2090314 by intravenous infusion.
Cycle 1 Day 8 of 28-day cycle 500 mg/m^2 Pem by intravenous infusion followed by AUC 6mg/mL * min Carb intravenous infusion followed by 50 mg ranitidine intravenous pretreatment and 60 mg LY2090314 by intravenous infusion.
Cycle 2 Day 1 of 21-day cycle: AUC 6 mg/mL * min Carb by intravenous infusion followed by 500 mg/m^2 Pem intravenous infusion.
Cycle 3 up to Cycle 9: Day 1 of 21-day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion followed by pretreatment with 50 mg ranitidine intravenous and 60 mg LY2090314 intravenous infusion.
Based on I2H-MC_JWYA Protocol Amendment (d) approved 11 March 2010, 50 mg ranitidine was given as a pretreatment to LY2090314 as prophylaxis for stomach pain.
Units
Counts
Participants
OG00010
OG0014
OG0029
OG003
Title
Denominators
Categories
Title
Measurements
OG000106± 57.5
OG001271± 62.5
OG002657± 44.1
OG003
Secondary
Number of Participants With Best Overall Tumor Response
Best overall observed tumor response at any point during the study until disease progression/recurrence defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response (CR) was defined as the disappearance of all target and non-target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 millimeter (mm) and normalization of tumor marker level of non-target lesions; Partial Response (PR) was defined as at least 30% decrease in sum of longest diameter of target lesions; Progressive Disease (PD) was defined as at least 20% increase in sum of longest diameter of target lesions and minimum 5 mm increase over nadir; Stable Disease (SD) was defined as small changes that did not meet above criteria.
Analysis population: all participants who received at least 1 dose of study drug and had tumor response assessment.
Posted
Number
participants
Baseline up to Cycle 9 (Cycle 1 was 28 days, Cycles 2 to 9 were 21 days)
ID
Title
Description
OG000
LY 10/Carb 5/Pem 500 (Cohort 1)
Cycle 1 Day 1 of 28-day cycle: 10 mg LY2090314 by intravenous infusion.
Cycle 1 Day 8 of 28-day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 5 mg/mL * min Carb by intravenous infusion.
Cycle 2 up to Cycle 9: Day 1 of 21-day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 5 mg/mL * min Carb by intravenous infusion followed by 10 mg LY2090314 by intravenous infusion.
OG001
LY 10/Carb 6/Pem 500 (Cohort 2)
Cycle 1 Day 1 of 28-day cycle: 10 mg LY2090314 by intravenous infusion.
Cycle 1 Day 8 of 28-day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion.
Cycle 2 up to Cycle 9: Day 1 of 21-day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion followed by 10 mg LY2090314 by intravenous infusion.
OG002
LY 20/Carb 6/Pem 500 (Cohort 3)
Cycle 1 Day 1 of 28-day cycle: 20 mg LY2090314 by intravenous infusion.
Cycle 1 Day 8 of 28-day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion.
Cycle 2 up to Cycle 9: Day 1 of 21-day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion followed by 20 mg LY2090314 by intravenous infusion.
OG003
LY 40/Carb 6/Pem 500 (Cohort 4)
Cycle 1 Day 1 of 28-day cycle: 40 mg LY2090314 by intravenous infusion.
Cycle 1 Day 8 of 28-day cycle 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion followed by 40 mg LY2090314 by intravenous infusion.
Cycle 2 Day 1 of 21-day cycle: AUC 6 mg/mL * min Carb by intravenous infusion followed by 500 mg/m^2 Pem by intravenous infusion.
Cycle 3 up to Cycle 9: Day 1 of 21-day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion followed by 40 mg LY2090314 by intravenous infusion.
OG004
LY 80/Carb 6/Pem 500 (Cohort 5)
Cycle 1 Day 1 of 28-day cycle: 80 mg LY2090314 by intravenous infusion.
Cycle 1 Day 8 of 28-day cycle 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion followed by 80 mg LY2090314 by intravenous infusion.
Cycle 2 Day 1 of 21-day cycle: AUC 6 mg/mL * min Carb by intravenous infusion followed by 500 mg/m^2 Pem by intravenous infusion.
Cycle 3 up to Cycle 9: Day 1 of 21-day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion followed by 80 mg LY2090314 by intravenous infusion.
OG005
LY 120/Carb 6/Pem 500 (Cohort 6)
Cycle 1 Day 1 of 28-day cycle: 120 mg LY2090314 by intravenous infusion.
Cycle 1 Day 8 of 28-day cycle 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion followed by 120 mg LY2090314 by intravenous infusion.
Cycle 2 Day 1 of 21-day cycle: AUC 6 mg/mL * min Carb by intravenous infusion followed by 500 mg/m^2 Pem by intravenous infusion.
Cycle 3 up to Cycle 9: Day 1 of 21-day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion followed by 120 mg LY2090314 by intravenous infusion.
OG006
LY 80/Carb 6/Pem 500 + R50 (Cohort 7)
Cycle 1 Day 1 of 28-day cycle: pretreated with 50 mg ranitidine intravenous, 80 mg LY2090314 by intravenous infusion.
Cycle 1 Day 8 of 28-day cycle 500 mg/m^2 Pem by intravenous infusion followed by AUC 6mg/mL * min Carb intravenous infusion followed by 50 mg ranitidine intravenous pretreatment and 80 mg LY2090314 by intravenous infusion.
Cycle 2 Day 1 of 21-day cycle: AUC 6 mg/mL * min Carb by intravenous infusion followed by 500 mg/m^2 Pem intravenous infusion.
Cycle 3 up to Cycle 10: Day 1 of 21-day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion followed by 50 mg ranitidine intravenous pretreatment and 80 mg LY2090314 IV infusion.
Based on I2H-MC-JWYA Protocol Amendment (d) approved 11 March 2010, 50 mg ranitidine was given as a pretreatment to LY2090314 as prophylaxis for stomach pain.
OG007
LY 60/Carb 6/Pem 500 + R50 (Cohort 8)
Cycle 1 Day 1 of 28-day cycle: pretreated with 50 mg ranitidine intravenous, 60 mg LY2090314 by intravenous infusion.
Cycle 1 Day 8 of 28-day cycle 500 mg/m^2 Pem by intravenous infusion followed by AUC 6mg/mL * min Carb intravenous infusion followed by 50 mg ranitidine intravenous pretreatment and 60 mg LY2090314 by intravenous infusion.
Cycle 2 Day 1 of 21-day cycle: AUC 6 mg/mL * min Carb by intravenous infusion followed by 500 mg/m^2 Pem intravenous infusion.
Cycle 3 up to Cycle 9: Day 1 of 21-day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion followed by 50 mg ranitidine intravenous pretreatment and 60 mg LY2090314 intravenous infusion.
Based on I2H-MC-JWYA Protocol Amendment (d) approved 11 March 2010, 50 mg ranitidine was given as a pretreatment to LY2090314 as prophylaxis for stomach pain.
OG008
LY 40/Carb 6/Pem 500 + R50 (Cohort 9)
Cycle 1 Day 1 of 28-day cycle: pretreated with 50 mg ranitidine intravenous, 40 mg LY2090314 by intravenous infusion.
Cycle 1 Day 8 of 28-day cycle 500 mg/m^2 Pem by intravenous infusion followed by AUC 6mg/mL * min Carb intravenous infusion followed by 50 mg ranitidine intravenous pretreatment and 40 mg LY2090314 by intravenous infusion.
Cycle 2 Day 1 of 21-day cycle: AUC 6 mg/mL * min Carb by intravenous infusion followed by 500 mg/m^2 intravenous Pem infusion.
Cycle 3 up to Cycle 9: Day 1 of 21-day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min by Carb intravenous infusion followed by 50 mg ranitidine intravenous pretreatment and 40 mg LY2090314 intravenous infusion.
Based on I2H-MC-JWYA Protocol Amendment (d) approved 11 March 2010, 50 mg ranitidine was given as a pretreatment to LY2090314 as prophylaxis for stomach pain.
Units
Counts
Participants
OG0003
OG0017
OG0025
OG003
Title
Denominators
Categories
CR
Title
Measurements
OG0000
OG0010
OG0020
OG003
Secondary
Pharmacokinetic (PK) Parameter: Area Under the Concentration-Time Curve From Time 0 Hour to Infinity (AUC0-∞) of Pemetrexed (Pem)
AUC0-∞ was calculated from the area under the concentration versus time curves of Pem given as a single dose with Carb (doublet therapy) and when co-administered with Carb and LY2090314 (triplet therapy).
All participants who were treated with Pem and Carb (doublet therapy) or who were treated with Pem, Carb and LY2090314 (triplet therapy) and had evaluable AUC0-∞ Pem data.
Posted
Geometric Mean
Geometric Coefficient of Variation
hours*nanograms/milliliter/ milligram
Cycle 1 Day 8 of 28-day cycle and Cycle 2 up to Cycle 10 Day 1 of 21-day cycle
ID
Title
Description
OG000
Pemetrexed (Doublet Therapy)
Pem with Carb
Participants in Cohorts 1, 2 and 3 were administered 500 mg/m^2 Pem and AUC 5 or AUC 6 mg/mL * min Carb on Cycle 1, Day 8 of 28-day cycle by intravenous infusion.
Participants in Cohorts 4 through 9 were administered 500 mg/m^2 Pem and AUC 6 mg/mL * min Carb by intravenous infusion on Cycle 2 Day 1 of 21-day cycle
OG001
Pemetrexed (Triplet Therapy)
Pem with Carb and LY2090314
Participants in Cohorts 1, 2 and 3 were administered 500 mg/m^2 Pem by intravenous infusion followed by AUC 5 or AUC 6 mg/mL * min Carb by intravenous infusion followed by 10 mg up to 20 mg LY2090314 by intravenous infusion on Cycle 2 up to Cycle 10: Day 1 of 21-day cycle.
Participants in Cohorts 4 through 9 were administered 500 mg/m^2 Pem and AUC 6 mg/mL * min Carb by intravenous infusion followed by 40 mg up to 120 mg of LY2090314 by intravenous infusion on Cycle 1, Day 8 of 28-day cycle and Cycle 3 up to Cycle 10: Day 1 of 21-day cycle.
Based on I2H-MC-JWYA Protocol Amendment (D) approved 11 March 2010, 50 mg ranitidine was given as a pretreatment to LY2090314 as prophylaxis for stomach pain to participants in Cohorts 7, 8 and 9.
Units
Counts
Participants
OG00033
OG00136
Title
Denominators
Categories
Title
Measurements
OG000212± 34.4
OG001202± 37.5
Secondary
PK Parameter: Maximum Plasma Concentration (Cmax) of Pemetrexed (Pem)
Cmax of Pem given as a single dose with Carb (doublet therapy) and when coadministered with Carb and LY2090314 (triplet therapy).
All participants who were treated with Pem and Carb (doublet therapy) or who were treated with Pem, Carb and LY2090314 (triplet therapy) and had evaluable Cmax Pem data.
Posted
Geometric Mean
Geometric Coefficient of Variation
nanogram per milliliter per milligram
Cycle 1 Day 8 of 28-day cycle and Cycle 2 up to Cycle 10 Day 1 of 21-day cycle
ID
Title
Description
OG000
Pemetrexed (Doublet Therapy)
Pem with Carb
Participants in Cohorts 1, 2 and 3 were administered 500 mg/m^2 Pem and AUC 5 or AUC 6 mg/mL * min Carb on Cycle 1, Day 8 of 28-day cycle by intravenous infusion.
Participants in Cohorts 4 through 9 were administered 500 mg/m^2 Pem and AUC 6 mg/mL * min Carb by intravenous infusion on Cycle 2 Day 1 of 21-day cycle
OG001
Pemetrexed (Triplet Therapy)
Pem with Carb and LY2090317
Participants in Cohorts 1, 2 and 3 were administered 500 mg/m^2 Pem by intravenous infusion followed by AUC 5 or AUC 6 mg/mL * min Carb by intravenous infusion followed by 10 mg up to 20 mg LY2090314 by intravenous infusion on Cycle 2 up to Cycle 10: Day 1 of 21-day cycle.
Participants in Cohorts 4 through 9 were administered 500 mg/m^2 Pem and AUC 6 mg/mL * min Carb by intravenous infusion followed by 40 mg up to 120 mg of LY2090314 by intravenous infusion on Cycle 1, Day 8 of 28-day cycle and Cycle 3 up to Cycle 10: Day 1 of 21-day cycle.
Based on I2H-MC-JWYA Protocol Amendment (d) approved 11 March 2010, 50 mg ranitidine was given as a pretreatment to LY2090314 as prophylaxis for stomach pain to participants in Cohorts 7, 8 and 9.
Units
Counts
Participants
OG00033
OG00136
Title
Denominators
Categories
Title
Measurements
OG000109± 38.0
OG001108± 43.1
Secondary
PK Parameter: AUC0-∞ of Free Carboplatin (Carb)
AUC0-∞ of free Carb was calculated from the area under the concentration versus time curves of Carb given as a single dose with Pem (doublet therapy) and when co-administered with Pem and LY2090314 (triplet therapy).
All participants who were treated with Pem and Carb (doublet therapy) or Pem, Carb and LY2090314 (triplet therapy) and who had evaluable Carb AUC0-∞ data.
Posted
Geometric Mean
Geometric Coefficient of Variation
hours*nanograms per milliliter per mg
Cycle 1 Day 8 of 28-day cycle and Cycle 2 up to Cycle 9: Day 1 of 21-day cycle
ID
Title
Description
OG000
Carboplatin (Doublet Therapy)
Carb and Pem
Participants in Cohorts 1, 2 and 3 were administered 500 mg/m^2 Pem and AUC 5 or AUC 6 mg/mL * min Carb on Cycle 1, Day 8 of 28-day cycle by intravenous infusion.
Participants in Cohorts 4 through 9 were administered 500 mg/m^2 Pem and AUC 6 mg/mL * min Carb by intravenous infusion on Cycle 2 Day 1 of 21-day cycle
OG001
Carboplatin (Triplet Therapy)
Carb with Pem and LY2090314
Participants in Cohorts 1, 2 and 3 were administered 500 mg/m^2 Pem by intravenous infusion followed by AUC 5 or AUC 6 mg/mL * min Carb by intravenous infusion followed by 10 mg up to 20 mg LY2090314 by intravenous infusion on Cycle 2 up to Cycle 9: Day 1 of 21-day cycle.
Participants in Cohorts 4 through 9 were administered 500 mg/m^2 Pem and AUC 6 mg/mL * min Carb by intravenous infusion followed by 40 mg up to 120 mg of LY2090314 by intravenous infusion on Cycle 1, Day 8 of 28-day cycle and Cycle 3 up to Cycle 9: Day 1 of 21-day cycle.
Based on I2H-MC-JWYA Protocol Amendment (d) approved 11 March 2010, 50 mg ranitidine was given as a pretreatment to LY2090314 as prophylaxis for stomach pain to participants in Cohorts 7, 8 and 9.
Units
Counts
Participants
OG00032
OG00135
Title
Denominators
Categories
Title
Measurements
OG00081.6± 41.8
OG00188.1± 49.2
Secondary
PK Parameter: Cmax of Free Carboplatin
Cmax of free Carb given as a single dose with Pem (doublet therapy) and when co-administered with Pem and LY2090314 (triplet therapy).
All participants who were treated with Pem and Carb (doublet therapy) or who were treated with Pem, Carb and LY2090314 (triplet therapy) and had evaluable Carb Cmax data.
Posted
Geometric Mean
Geometric Coefficient of Variation
nanograms/milliliter/milligram
Cycle 1, Day 8 of 28-day cycle and Cycle 2 up to Cycle 9: Day 1 of 21-day cycle
ID
Title
Description
OG000
Carboplatin (Doublet Therapy)
Carb and Pem
Participants in Cohorts 1, 2 and 3 were administered 500 mg/m^2 Pem and AUC 5 or AUC 6 mg/mL * min Carb on Cycle 1, Day 8 of 28-day cycle by intravenous infusion.
Participants in Cohorts 4 through 9 were administered 500 mg/m^2 Pem and AUC 6 mg/mL * min Carb by intravenous infusion on Cycle 2 Day 1 of 21-day cycle
OG001
Carboplatin (Triplet Therapy)
Carb and Pem with LY2090314
Participants in Cohorts 1, 2 and 3 were administered 500 mg/m^2 Pem by intravenous infusion followed by AUC 5 or AUC 6 mg/mL * min Carb by intravenous infusion followed by 10 mg up to 20 mg LY2090314 by intravenous infusion on Cycle 2 up to Cycle 9: Day 1 of 21-day cycle.
Participants in Cohorts 4 through 9 were administered 500 mg/m^2 Pem and AUC 6 mg/mL * min Carb by intravenous infusion followed by 40 mg up to 120 mg of LY2090314 by intravenous infusion on Cycle 1, Day 8 of 28-day cycle and Cycle 3 up to Cycle 10: Day 1 of 21-day cycle.
Based on I2H-MC-JWYA Protocol Amendment (d) approved 11 March 2010, 50 mg ranitidine was given as a pretreatment to LY2090314 as prophylaxis for stomach pain to participants in Cohorts 7, 8 and 9.
Units
Counts
Participants
OG00032
OG00135
Title
Denominators
Categories
Title
Measurements
OG00024.0± 43.9
OG00125.5± 46.0
Secondary
Pharmacodynamic (PD) Changes in Beta-Catenin (β-catenin)
PD change from baseline to endpoint (up to Cycle 9) in β-catenin levels in peripheral blood mononuclear cells (PBMCs) following the administration of LY2090314 given alone and in combination with Pem and Carb. This outcome measure was not analyzed due to insufficient data.
There was insufficient data from participants who received at least 1 dose of LY2090314 to perform β-catenin modeling, thus zero participants were analyzed.
Posted
Baseline, Cycle 1 , Day 1 of a 28-day cycle and Cycle 2 up to Cycle 9: Day 1 of 21-day cycles
ID
Title
Description
OG000
LY 10/Carb 5/Pem 500 (Cohort 1)
Cycle 1 Day 1 of 28-day cycle: 10 mg LY2090314 by intravenous infusion.
Cycle 1 Day 8 of 28-day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 5 mg/mL * min Carb by IV infusion.
Cycle 2 up to Cycle 9: Day 1 of 21-day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 5 mg/mL * min Carb by intravenous infusion followed by 10 mg LY2090314 by intravenous infusion.
OG001
LY 10/Carb 6/Pem 500 (Cohort 2)
Cycle 1 Day 1 of 28-day cycle: 10 mg LY2090314 by IV infusion.
Cycle 1 Day 8 of 28-day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion.
Cycle 2 up to Cycle 9: Day 1 of 21-day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion followed by 10 mg LY2090314 by intravenous infusion.
OG002
LY 20/Carb 6/Pem 500 (Cohort 3)
Cycle 1 Day 1 of 28-day cycle: 20 mg LY2090314 by intravenous infusion.
Cycle 1 Day 8 of 28 -ay cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion.
Cycle 2 up to Cycle 9: Day 1 of 21-day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion followed by 20 mg LY2090314 by intravenous infusion.
OG003
LY 40/Carb 6/Pem 500 (Cohort 4)
Cycle 1 Day 1 of 28-day cycle: 40 mg LY2090314 by intravenous infusion.
Cycle 1 Day 8 of 28-day cycle 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion followed by 40 mg LY2090314 by intravenous infusion.
Cycle 2 Day 1 of 21-day cycle: AUC 6 mg/mL * min Carb by intravenous infusion followed by 500 mg/m^2 Pem by intravenous infusion.
Cycle 3 up to Cycle 9: Day 1 of 21-day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion followed by 40 mg LY2090314 by intravenous infusion.
OG004
LY 80/Carb 6/Pem 500 (Cohort 5)
Cycle 1 Day 1 of 28-day cycle: 80 mg LY2090314 by intravenous infusion.
Cycle 1 Day 8 of 28-day cycle 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion followed by 80 mg LY2090314 by intravenous infusion.
Cycle 2 Day 1 of 21-day cycle: AUC 6 mg/mL * min Carb by intravenous infusion followed by 500 mg/m^2 Pem by intravenous infusion.
Cycle 3 up to Cycle 9: Day 1 of 21-day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion followed by 80 mg LY2090314 by intravenous infusion.
OG005
LY 120/Carb 6/Pem 500 (Cohort 6)
Cycle 1 Day 1 of 28-day cycle: 120 mg LY2090314 mg by intravenous infusion.
Cycle 1 Day 8 of 28-day cycle 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion followed by 120 mg LY2090314 by intravenous infusion.
Cycle 2 Day 1 of 21-day cycle: AUC 6 mg/mL * min Carb by intravenous infusion followed by 500 mg/m^2 Pem by intravenous infusion.
Cycle 3 up to Cycle 9: Day 1 of 21-day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion followed by 120 mg LY2090314 by intravenous infusion.
OG006
LY 80/Carb 6/Pem 500 + R50 (Cohort 7)
Cycle 1 Day 1 of 28-day cycle: pretreated with 50 mg ranitidine intravenous, 80 mg LY2090314 by intravenous infusion.
Cycle 1 Day 8 of 28-day cycle 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb intravenous infusion followed by 50 mg ranitidine intravenous pretreatment and 80 mg LY2090314 by intravenous infusion.
Cycle 2 Day 1 of 21-day cycle: AUC 6 mg/mL * min Carb by intravenous infusion followed by 500 mg/m^2 Pem intravenous infusion.
Cycle 3 up to Cycle 10: Day 1 of 21-day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion followed by 50 mg ranitidine intravenous pretreatment and 80 mg LY2090314 intravenous infusion.
Based on I2H-MC-JWYA Protocol Amendment (d) approved 11 March 2010, 50 mg ranitidine was given as a pretreatment to LY2090314 as prophylaxis for stomach pain.
OG007
LY 60/Carb 6/Pem 500 + R50 (Cohort 8)
Cycle 1 Day 1 of 28-day cycle: pretreated with 50 mg ranitidine intravenous, 60 mg LY2090314 by intravenous infusion.
Cycle 1 Day 8 of 28-day cycle 500 mg/m^2 Pem by intravenous infusion followed by AUC 6mg/mL * min Carb intravenous infusion followed by 50 mg ranitidine intravenous pretreatment and 60 mg LY2090314 by intravenous infusion.
Cycle 2 Day 1 of 21-day cycle: AUC 6 mg/mL * min Carb by intravenous infusion followed by 500 mg/m^2 Pem intravenous infusion.
Cycle 3 up to Cycle 9: Day 1 of 21-day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion followed by 50 mg ranitidine IV pretreatment and 60 mg LY2090314 intravenous infusion.
Based on I2H-MC-JWYA Protocol Amendment (d) approved 11 March 2010, 50 mg ranitidine was given as a pretreatment to LY2090314 as prophylaxis for stomach pain.
OG008
LY 40/Carb 6/Pem 500 + R50 (Cohort 9)
Cycle 1 Day 1 of 28-day cycle: pretreated with 50 mg ranitidine intravenous, 40 mg LY2090314 by intravenous infusion.
Cycle 1 Day 8 of 28-day cycle 500 mg/m^2 Pem by intravenous infusion followed by AUC 6mg/mL * min Carb intravenous infusion followed by 50 mg ranitidine intravenous pretreatment and 40 mg LY2090314 by intravenous infusion.
Cycle 2 Day 1 of 21-day cycle: AUC 6 mg/mL * min Carb by intravenous infusion followed by 500 mg/m^2 Pem intravenous infusion.
Cycle 3 up to Cycle 9: Day 1 of 21-day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion followed by 50 mg ranitidine intravenous pretreatment and 40 mg LY2090314 intravenous infusion.
Based on I2H-MC-JWYA Protocol Amendment (d) approved 11 March 2010, 50 mg ranitidine was given as a pretreatment to LY2090314 as prophylaxis for stomach pain.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG003
1
3
3
3
EG001
LY 10/Carb 6/Pem 500 (Cohort 2)
Cycle 1 Day 1 of 28 day cycle: 10 mg LY2090314 by intravenous infusion.
Cycle 1 Day 8 of 28 day cycle: 500 mg/m^2 by Pem intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion.
Cycle 2 up to Cycle 9: Day 1 of 21 day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion followed by 10 mg LY2090314 by intravenous infusion.
3
7
7
7
EG002
LY 20/Carb 6/Pem 500 (Cohort 3)
Cycle 1 Day 1 of 28 day cycle: 20 mg LY2090314 by intravenous infusion.
Cycle 1 Day 8 of 28 day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion.
Cycle 2 up to Cycle 9: Day 1 of 21 day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion followed by 20 mg LY2090314 by intravenous infusion.
3
5
5
5
EG003
LY 40/Carb 6/Pem 500 (Cohort 4)
Cycle 1 Day 1 of 28 day cycle: 40 mg LY2090314 by intravenous infusion.
Cycle 1 Day 8 of 28 day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion followed by 40 mg LY2090314 by intravenous infusion.
Cycle 2 Day 1 of 21 day cycle: AUC 6 mg/mL * min Carb by intravenous infusion followed by 500 mg/m^2 Pem by intravenous infusion.
Cycle 3 up to Cycle 9: Day 1 of 21 day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion followed by 40 mg LY2090314 by intravenous infusion.
2
7
7
7
EG004
LY 80/Carb 6/Pem 500 (Cohort 5)
Cycle 1 Day 1 of 28 day cycle: 80 mg LY2090314 by intravenous infusion.
Cycle 1 Day 8 of 28 day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion followed by 80 mg LY2090314 by intravenous infusion.
Cycle 2 Day 1 of 21 day cycle: AUC 6 mg/mL * min Carb by intravenous infusion followed by 500 mg/m^2 Pem by intravenous infusion.
Cycle 3 up to Cycle 9: Day 1 of 21 day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion followed by 80 mg LY2090314 by intravenous infusion.
1
3
3
3
EG005
LY 120/Carb 6/Pem 500 (Cohort 6)
Cycle 1 Day 1 of 28 day cycle: 120 mg LY2090314 by intravenous infusion.
Cycle 1 Day 8 of 28 day cycle: 500 mg/m^Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion followed by 120 mg LY2090314 by intravenous infusion.
Cycle 2 Day 1 of 21 day cycle: AUC 6 mg/mL * min Carb by intravenous infusion followed by 500 mg/m^2 Pem by intravenous infusion.
Cycle 3 up to Cycle 9: Day 1 of 21 day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion followed by 120 mg LY2090314 by intravenous infusion.
1
4
3
4
EG006
LY 80/Carb 6/Pem 500 + R50 (Cohort 7)
Cycle 1 Day 1 of 28 day cycle: pretreated with 50 mg ranitidine intravenous, 80 mg LY2090314 by intravenous infusion.
Cycle 1 Day 8 of 28 day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 6mg/mL * min Carb intravenous infusion followed by 50 mg ranitidine intravenous pretreatment and 80 mg LY2090314 by intravenous infusion.
Cycle 2 Day 1 of 21 day cycle: AUC 6 mg/mL * min Carb by intravenous infusion followed by 500 mg/m^2 Pem intravenous infusion.
Cycle 3 up to Cycle 9: Day 1 of 21 day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion followed by 50 mg ranitidine intravenous pretreatment and 80 mg LY2090314 intravenous infusion.
Based on I2H-MV-JWYA Protocol Amendment (d) approved 11 March 2010, 50 mg ranitidine was given as a pretreatment to LY2090314 as prophylaxis for stomach pain.
1
2
2
2
EG007
LY 60/Carb 6/Pem 500 + R50 (Cohort 8)
Cycle 1 Day 1 of 28 day cycle: pretreated with 50 mg ranitidine intravenous, 60 mg LY2090314 by intravenous infusion.
Cycle 1 Day 8 of 28 day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 6mg/mL * min Carb intravenous infusion followed by 50 mg ranitidine intravenous pretreatment and 60 mg LY2090314 by intravenous infusion.
Cycle 2 Day 1 of 21 day cycle: AUC 6 mg/mL * min Carb by intravenous infusion followed by 500 mg/m^2 Pem intravenous infusion.
Cycle 3 up to Cycle 9: Day 1 of 21 day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion followed by 50 mg ranitidine intravenous pretreatment and 60 mg LY2090314 intravenous infusion.
Based on I2H-MV-JWYA Protocol Amendment (d) approved 11 March 2010, 50 mg ranitidine was given as a pretreatment to LY2090314 as prophylaxis for stomach pain.
0
5
5
5
EG008
LY 40/Carb 6/Pem 500 + R50 (Cohort 9)
Cycle 1 Day 1 of 28 day cycle: pretreated with 50 mg ranitidine intravenous, 40 mg LY2090314 by intravenous infusion.
Cycle 1 Day 8 of 28 day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 6mg/mL * min Carb intravenous infusion followed by 50 mg ranitidine intravenous pretreatment and 40mmg LY2090314 40 mg by intravenous infusion.
Cycle 2 Day 1 of 21 day cycle: AUC 6 mg/mL * min Carb by intravenous infusion followed by 500 mg/m^2 Pem intravenous infusion.
Cycle 3 up to Cycle 9: Day 1 of 21 day cycle: 500 mg/m^2 Pem by intravenous infusion followed by AUC 6 mg/mL * min Carb by intravenous infusion followed by 50 mg ranitidine intravenous pretreatment and 40 mg LY2090314 intravenous infusion.
Based on I2H-MV-JWYA Protocol Amendment (d) approved 11 March 2010, 50 mg ranitidine was given as a pretreatment to LY2090314 as prophylaxis for stomach pain.
1
5
5
5
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected4 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
Nausea
Gastrointestinal disorders
14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected7 at risk
EG0041 events1 affected3 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
Rectal haemorrhage
Gastrointestinal disorders
14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected5 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
Vomiting
Gastrointestinal disorders
14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected7 at risk
EG0041 events1 affected3 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
Chest pain
General disorders
14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0061 events1 affected2 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
Pyrexia
General disorders
14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected5 at risk
EG0031 events1 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
Pneumonia
Infections and infestations
14.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0081 events1 affected5 at risk
Pseudomembranous colitis
Infections and infestations
14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected5 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
Dehydration
Metabolism and nutrition disorders
14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG0031 events1 affected7 at risk
EG0041 events1 affected3 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
Back pain
Musculoskeletal and connective tissue disorders
14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG0031 events1 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
Panic attack
Psychiatric disorders
14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected5 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
Dyspnoea
Respiratory, thoracic and mediastinal disorders
14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
Pleural effusion
Respiratory, thoracic and mediastinal disorders
14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
Deep vein thrombosis
Vascular disorders
14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected5 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
EG0003 events2 affected3 at risk
EG0018 events6 affected7 at risk
EG0025 events5 affected5 at risk
EG0035 events5 affected7 at risk
EG0043 events2 affected3 at risk
EG0050 events0 affected4 at risk
EG0061 events1 affected2 at risk
EG0074 events4 affected5 at risk
EG0085 events3 affected5 at risk
Leukocytosis
Blood and lymphatic system disorders
14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0061 events1 affected2 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
Leukopenia
Blood and lymphatic system disorders
14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0014 events4 affected7 at risk
EG0021 events1 affected5 at risk
EG0038 events3 affected7 at risk
EG0043 events2 affected3 at risk
EG0050 events0 affected4 at risk
EG0062 events1 affected2 at risk
EG0072 events2 affected5 at risk
EG0082 events1 affected5 at risk
Lymphopenia
Blood and lymphatic system disorders
14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0014 events4 affected7 at risk
EG0021 events1 affected5 at risk
EG0034 events3 affected7 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected4 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
Neutropenia
Blood and lymphatic system disorders
14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0017 events4 affected7 at risk
EG0026 events2 affected5 at risk
EG00314 events5 affected7 at risk
EG0044 events3 affected3 at risk
EG0050 events0 affected4 at risk
EG0061 events1 affected2 at risk
EG0076 events3 affected5 at risk
EG0084 events2 affected5 at risk
Thrombocytopenia
Blood and lymphatic system disorders
14.0
Systematic Assessment
EG0002 events2 affected3 at risk
EG0018 events3 affected7 at risk
EG0023 events2 affected5 at risk
EG00317 events6 affected7 at risk
EG0045 events2 affected3 at risk
EG0050 events0 affected4 at risk
EG0065 events2 affected2 at risk
EG0078 events4 affected5 at risk
EG0089 events3 affected5 at risk
Bundle branch block left
Cardiac disorders
14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0081 events1 affected5 at risk
Cardiac flutter
Cardiac disorders
14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0081 events1 affected5 at risk
Palpitations
Cardiac disorders
14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected7 at risk
EG0041 events1 affected3 at risk
EG0050 events0 affected4 at risk
EG0061 events1 affected2 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
Tinnitus
Ear and labyrinth disorders
14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected5 at risk
EG0031 events1 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
Asthenopia
Eye disorders
14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0081 events1 affected5 at risk
Cataract
Eye disorders
14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0081 events1 affected5 at risk
Eye irritation
Eye disorders
14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG0031 events1 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0061 events1 affected2 at risk
EG0071 events1 affected5 at risk
EG0080 events0 affected5 at risk
Lacrimation increased
Eye disorders
14.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0061 events1 affected2 at risk
EG0071 events1 affected5 at risk
EG0080 events0 affected5 at risk
Vision blurred
Eye disorders
14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0061 events1 affected2 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
Visual impairment
Eye disorders
14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected7 at risk
EG0041 events1 affected3 at risk
EG0051 events1 affected4 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
Vitreous floaters
Eye disorders
14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected2 at risk
EG0071 events1 affected5 at risk
EG0080 events0 affected5 at risk
Abdominal discomfort
Gastrointestinal disorders
14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0081 events1 affected5 at risk
Abdominal distension
Gastrointestinal disorders
14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected7 at risk
EG0041 events1 affected3 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
Abdominal pain
Gastrointestinal disorders
14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected5 at risk
EG0033 events3 affected7 at risk
EG0043 events2 affected3 at risk
EG0052 events2 affected4 at risk
EG0061 events1 affected2 at risk
EG0072 events2 affected5 at risk
EG0080 events0 affected5 at risk
Abdominal pain lower
Gastrointestinal disorders
14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected2 at risk
EG0071 events1 affected5 at risk
EG0080 events0 affected5 at risk
Abdominal pain upper
Gastrointestinal disorders
14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events2 affected7 at risk
EG0020 events0 affected5 at risk
EG0032 events2 affected7 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected4 at risk
EG0060 events0 affected2 at risk
EG0072 events1 affected5 at risk
EG0081 events1 affected5 at risk
Ascites
Gastrointestinal disorders
14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected2 at risk
EG0071 events1 affected5 at risk
EG0080 events0 affected5 at risk
Constipation
Gastrointestinal disorders
14.0
Systematic Assessment
EG0002 events2 affected3 at risk
EG0011 events1 affected7 at risk
EG0022 events2 affected5 at risk
EG0032 events2 affected7 at risk
EG0043 events2 affected3 at risk
EG0050 events0 affected4 at risk
EG0062 events2 affected2 at risk
EG0070 events0 affected5 at risk
EG0082 events2 affected5 at risk
Diarrhoea
Gastrointestinal disorders
14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected7 at risk
EG0021 events1 affected5 at risk
EG0032 events2 affected7 at risk
EG0042 events2 affected3 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected2 at risk
EG0071 events1 affected5 at risk
EG0081 events1 affected5 at risk
Dyspepsia
Gastrointestinal disorders
14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0022 events2 affected5 at risk
EG0031 events1 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0061 events1 affected2 at risk
EG0071 events1 affected5 at risk
EG0080 events0 affected5 at risk
Dysphagia
Gastrointestinal disorders
14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected5 at risk
EG0031 events1 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected2 at risk
EG0071 events1 affected5 at risk
EG0080 events0 affected5 at risk
Flatulence
Gastrointestinal disorders
14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected7 at risk
EG0041 events1 affected3 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected2 at risk
EG0071 events1 affected5 at risk
EG0081 events1 affected5 at risk
Haematochezia
Gastrointestinal disorders
14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected5 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
Haemorrhoids
Gastrointestinal disorders
14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected5 at risk
EG0031 events1 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
Nausea
Gastrointestinal disorders
14.0
Systematic Assessment
EG0003 events1 affected3 at risk
EG0018 events6 affected7 at risk
EG0025 events3 affected5 at risk
EG0035 events4 affected7 at risk
EG0041 events1 affected3 at risk
EG0051 events1 affected4 at risk
EG0063 events2 affected2 at risk
EG0073 events2 affected5 at risk
EG0085 events3 affected5 at risk
Retching
Gastrointestinal disorders
14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG0031 events1 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
Toothache
Gastrointestinal disorders
14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected7 at risk
EG0041 events1 affected3 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
Vomiting
Gastrointestinal disorders
14.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0012 events2 affected7 at risk
EG0023 events2 affected5 at risk
EG0034 events3 affected7 at risk
EG0043 events3 affected3 at risk
EG0051 events1 affected4 at risk
EG0063 events2 affected2 at risk
EG0071 events1 affected5 at risk
EG0080 events0 affected5 at risk
Asthenia
General disorders
14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected7 at risk
EG0021 events1 affected5 at risk
EG0031 events1 affected7 at risk
EG0041 events1 affected3 at risk
EG0051 events1 affected4 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0081 events1 affected5 at risk
Catheter site phlebitis
General disorders
14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected5 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
Chest discomfort
General disorders
14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG0031 events1 affected7 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected4 at risk
EG0061 events1 affected2 at risk
EG0070 events0 affected5 at risk
EG0081 events1 affected5 at risk
Chest pain
General disorders
14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events2 affected7 at risk
EG0020 events0 affected5 at risk
EG0031 events1 affected7 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected4 at risk
EG0061 events1 affected2 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
Chills
General disorders
14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected7 at risk
EG0022 events2 affected5 at risk
EG0031 events1 affected7 at risk
EG0041 events1 affected3 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected2 at risk
EG0072 events2 affected5 at risk
EG0081 events1 affected5 at risk
Fatigue
General disorders
14.0
Systematic Assessment
EG0003 events3 affected3 at risk
EG0018 events6 affected7 at risk
EG0026 events5 affected5 at risk
EG0036 events5 affected7 at risk
EG0042 events2 affected3 at risk
EG0050 events0 affected4 at risk
EG0061 events1 affected2 at risk
EG0074 events4 affected5 at risk
EG0084 events4 affected5 at risk
Influenza like illness
General disorders
14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0081 events1 affected5 at risk
Infusion site reaction
General disorders
14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected5 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
Mucosal inflammation
General disorders
14.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected7 at risk
EG0022 events2 affected5 at risk
EG0032 events2 affected7 at risk
EG0042 events1 affected3 at risk
EG0050 events0 affected4 at risk
EG0062 events2 affected2 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
Nodule
General disorders
14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected4 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
Oedema peripheral
General disorders
14.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0011 events1 affected7 at risk
EG0021 events1 affected5 at risk
EG0031 events1 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0061 events1 affected2 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
Pyrexia
General disorders
14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0014 events3 affected7 at risk
EG0026 events3 affected5 at risk
EG0032 events2 affected7 at risk
EG0042 events1 affected3 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected2 at risk
EG0071 events1 affected5 at risk
EG0083 events2 affected5 at risk
Drug hypersensitivity
Immune system disorders
14.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
Hypersensitivity
Immune system disorders
14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected2 at risk
EG0071 events1 affected5 at risk
EG0080 events0 affected5 at risk
Gastroenteritis
Infections and infestations
14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected7 at risk
EG0041 events1 affected3 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
Lung infection
Infections and infestations
14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
Nasopharyngitis
Infections and infestations
14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0081 events1 affected5 at risk
Streptococcal bacteraemia
Infections and infestations
14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG0031 events1 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
Urinary tract infection
Infections and infestations
14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG0034 events2 affected7 at risk
EG0041 events1 affected3 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0081 events1 affected5 at risk
Incision site pain
Injury, poisoning and procedural complications
14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected5 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
Infusion related reaction
Injury, poisoning and procedural complications
14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected5 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected2 at risk
EG0075 events2 affected5 at risk
EG0080 events0 affected5 at risk
Scratch
Injury, poisoning and procedural complications
14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected2 at risk
EG0071 events1 affected5 at risk
EG0080 events0 affected5 at risk
Alanine aminotransferase increased
Investigations
14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected7 at risk
EG0023 events2 affected5 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
Antineutrophil cytoplasmic antibody increased
Investigations
14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0061 events1 affected2 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
Aspartate aminotransferase increased
Investigations
14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected7 at risk
EG0021 events1 affected5 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
Blood alkaline phosphatase increased
Investigations
14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected5 at risk
EG0031 events1 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
Blood creatinine increased
Investigations
14.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected2 at risk
EG0071 events1 affected5 at risk
EG0080 events0 affected5 at risk
Blood culture positive
Investigations
14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected7 at risk
EG0041 events1 affected3 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
Blood glucose increased
Investigations
14.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
Blood magnesium decreased
Investigations
14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0062 events1 affected2 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
Blood urine present
Investigations
14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG0031 events1 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
Electrocardiogram qt prolonged
Investigations
14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected4 at risk
EG0060 events0 affected2 at risk
EG0071 events1 affected5 at risk
EG0080 events0 affected5 at risk
Glomerular filtration rate decreased
Investigations
14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG0031 events1 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
Haematocrit decreased
Investigations
14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0081 events1 affected5 at risk
Haemoglobin decreased
Investigations
14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0081 events1 affected5 at risk
Neutrophil count decreased
Investigations
14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0061 events1 affected2 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
Weight decreased
Investigations
14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
White blood cell count decreased
Investigations
14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected2 at risk
EG0071 events1 affected5 at risk
EG0084 events3 affected5 at risk
White blood cell count increased
Investigations
14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0061 events1 affected2 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
Decreased appetite
Metabolism and nutrition disorders
14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0013 events3 affected7 at risk
EG0022 events2 affected5 at risk
EG0034 events4 affected7 at risk
EG0043 events2 affected3 at risk
EG0051 events1 affected4 at risk
EG0061 events1 affected2 at risk
EG0073 events3 affected5 at risk
EG0080 events0 affected5 at risk
Dehydration
Metabolism and nutrition disorders
14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG0032 events2 affected7 at risk
EG0044 events2 affected3 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
Hypercalcaemia
Metabolism and nutrition disorders
14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0081 events1 affected5 at risk
Hyperglycaemia
Metabolism and nutrition disorders
14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0016 events4 affected7 at risk
EG0021 events1 affected5 at risk
EG0034 events3 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0061 events1 affected2 at risk
EG0070 events0 affected5 at risk
EG0081 events1 affected5 at risk
Hyperkalaemia
Metabolism and nutrition disorders
14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG0031 events1 affected7 at risk
EG0041 events1 affected3 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0081 events1 affected5 at risk
Hyperphosphatasaemia
Metabolism and nutrition disorders
14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events2 affected7 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
Hypoalbuminaemia
Metabolism and nutrition disorders
14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG0031 events1 affected7 at risk
EG0041 events1 affected3 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
Hypomagnesaemia
Metabolism and nutrition disorders
14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected5 at risk
EG0034 events1 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0081 events1 affected5 at risk
Hyponatraemia
Metabolism and nutrition disorders
14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected5 at risk
EG0033 events3 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0061 events1 affected2 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
Type 2 diabetes mellitus
Metabolism and nutrition disorders
14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0081 events1 affected5 at risk
Arthralgia
Musculoskeletal and connective tissue disorders
14.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG0032 events1 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
Back pain
Musculoskeletal and connective tissue disorders
14.0
Systematic Assessment
EG0002 events2 affected3 at risk
EG0013 events2 affected7 at risk
EG0020 events0 affected5 at risk
EG0032 events2 affected7 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected4 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0082 events2 affected5 at risk
Bone pain
Musculoskeletal and connective tissue disorders
14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG0031 events1 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
Muscular weakness
Musculoskeletal and connective tissue disorders
14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG0031 events1 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected5 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
Myalgia
Musculoskeletal and connective tissue disorders
14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events1 affected7 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected7 at risk
EG0041 events1 affected3 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0081 events1 affected5 at risk
Pain in extremity
Musculoskeletal and connective tissue disorders
14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected5 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0061 events1 affected2 at risk
EG0070 events0 affected5 at risk
EG0081 events1 affected5 at risk
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected5 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
Burning sensation
Nervous system disorders
14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
Dizziness
Nervous system disorders
14.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG0032 events2 affected7 at risk
EG0041 events1 affected3 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected2 at risk
EG0071 events1 affected5 at risk
EG0082 events2 affected5 at risk
Dysgeusia
Nervous system disorders
14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG0031 events1 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected2 at risk
EG0071 events1 affected5 at risk
EG0080 events0 affected5 at risk
Headache
Nervous system disorders
14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected7 at risk
EG0022 events2 affected5 at risk
EG0033 events3 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0081 events1 affected5 at risk
Hypogeusia
Nervous system disorders
14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
Neuropathy peripheral
Nervous system disorders
14.0
Systematic Assessment
EG0003 events3 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG0031 events1 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0081 events1 affected5 at risk
Paraesthesia
Nervous system disorders
14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
Peripheral sensory neuropathy
Nervous system disorders
14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected5 at risk
EG0031 events1 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0061 events1 affected2 at risk
EG0070 events0 affected5 at risk
EG0081 events1 affected5 at risk
Somnolence
Nervous system disorders
14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG0031 events1 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
Syncope
Nervous system disorders
14.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
Agitation
Psychiatric disorders
14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG0031 events1 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
Anxiety
Psychiatric disorders
14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG0031 events1 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
Confusional state
Psychiatric disorders
14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected5 at risk
EG0032 events2 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
Insomnia
Psychiatric disorders
14.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected7 at risk
EG0041 events1 affected3 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected2 at risk
EG0071 events1 affected5 at risk
EG0080 events0 affected5 at risk
Dysuria
Renal and urinary disorders
14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected5 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
Renal pain
Renal and urinary disorders
14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0081 events1 affected5 at risk
Urinary retention
Renal and urinary disorders
14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0081 events1 affected5 at risk
Vaginal haemorrhage
Reproductive system and breast disorders
14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected5 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
Vulvovaginal pruritus
Reproductive system and breast disorders
14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG0031 events1 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
Cough
Respiratory, thoracic and mediastinal disorders
14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0013 events3 affected7 at risk
EG0022 events2 affected5 at risk
EG0033 events3 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0081 events1 affected5 at risk
Dyspnoea
Respiratory, thoracic and mediastinal disorders
14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0014 events3 affected7 at risk
EG0022 events2 affected5 at risk
EG0037 events4 affected7 at risk
EG0041 events1 affected3 at risk
EG0051 events1 affected4 at risk
EG0060 events0 affected2 at risk
EG0072 events2 affected5 at risk
EG0082 events2 affected5 at risk
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected7 at risk
EG0041 events1 affected3 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
Epistaxis
Respiratory, thoracic and mediastinal disorders
14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG0031 events1 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected2 at risk
EG0071 events1 affected5 at risk
EG0081 events1 affected5 at risk
Hiccups
Respiratory, thoracic and mediastinal disorders
14.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
Hypoxia
Respiratory, thoracic and mediastinal disorders
14.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0061 events1 affected2 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
Nasal congestion
Respiratory, thoracic and mediastinal disorders
14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
Nasal mucosal discolouration
Respiratory, thoracic and mediastinal disorders
14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0081 events1 affected5 at risk
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events2 affected7 at risk
EG0020 events0 affected5 at risk
EG0031 events1 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0081 events1 affected5 at risk
Paranasal sinus hypersecretion
Respiratory, thoracic and mediastinal disorders
14.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected2 at risk
EG0072 events2 affected5 at risk
EG0080 events0 affected5 at risk
Productive cough
Respiratory, thoracic and mediastinal disorders
14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0081 events1 affected5 at risk
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0061 events1 affected2 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
Rhinalgia
Respiratory, thoracic and mediastinal disorders
14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0081 events1 affected5 at risk
Sinus congestion
Respiratory, thoracic and mediastinal disorders
14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected5 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
Wheezing
Respiratory, thoracic and mediastinal disorders
14.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
Alopecia
Skin and subcutaneous tissue disorders
14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events2 affected7 at risk
EG0020 events0 affected5 at risk
EG0031 events1 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0081 events1 affected5 at risk
Hyperhidrosis
Skin and subcutaneous tissue disorders
14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected5 at risk
EG0030 events0 affected7 at risk
EG0041 events1 affected3 at risk
EG0051 events1 affected4 at risk
EG0060 events0 affected2 at risk
EG0071 events1 affected5 at risk
EG0080 events0 affected5 at risk
Hypoaesthesia facial
Skin and subcutaneous tissue disorders
14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0062 events1 affected2 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
Night sweats
Skin and subcutaneous tissue disorders
14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG0031 events1 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected2 at risk
EG0071 events1 affected5 at risk
EG0081 events1 affected5 at risk
Pruritus
Skin and subcutaneous tissue disorders
14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0022 events2 affected5 at risk
EG0031 events1 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0061 events1 affected2 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
Rash
Skin and subcutaneous tissue disorders
14.0
Systematic Assessment
EG0002 events1 affected3 at risk
EG0014 events4 affected7 at risk
EG0021 events1 affected5 at risk
EG0032 events2 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0061 events1 affected2 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
Rash erythematous
Skin and subcutaneous tissue disorders
14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG0032 events1 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
Rash pruritic
Skin and subcutaneous tissue disorders
14.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
Skin disorder
Skin and subcutaneous tissue disorders
14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected7 at risk
EG0041 events1 affected3 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
Frontal sinus operation
Surgical and medical procedures
14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0081 events1 affected5 at risk
Flushing
Vascular disorders
14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected2 at risk
EG0072 events2 affected5 at risk
EG0080 events0 affected5 at risk
Hypertension
Vascular disorders
14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG0031 events1 affected7 at risk
EG0041 events1 affected3 at risk
EG0051 events1 affected4 at risk
EG0060 events0 affected2 at risk
EG0071 events1 affected5 at risk
EG0080 events0 affected5 at risk
Hypotension
Vascular disorders
14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG0031 events1 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
GT60
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Not provided
Heterocyclic Compounds, 2-Ring
D000072471
Heterocyclic Compounds, Fused-Ring
D006571
Heterocyclic Compounds
D005971
Glutamates
D024342
Amino Acids, Acidic
D000596
Amino Acids
D000602
Amino Acids, Peptides, and Proteins
D000600
Amino Acids, Dicarboxylic
D056831
Coordination Complexes
D009930
Organic Chemicals
D005663
Furans
D006573
Heterocyclic Compounds, 1-Ring
1
BG0054
BG0062
BG0072
BG0085
BG00923
7
BG0042
BG0054
BG0062
BG0075
BG0085
BG00938
0
BG0040
BG0050
BG0060
BG0070
BG0080
BG0091
0
BG0041
BG0050
BG0060
BG0072
BG0080
BG0095
6
BG0041
BG0054
BG0061
BG0074
BG0085
BG00933
1
BG0041
BG0050
BG0060
BG0071
BG0081
BG0097
0
BG0040
BG0051
BG0060
BG0070
BG0080
BG0093
1
BG0041
BG0050
BG0060
BG0071
BG0080
BG0093
0
BG0040
BG0050
BG0061
BG0071
BG0081
BG0093
0
BG0040
BG0051
BG0060
BG0070
BG0080
BG0092
1
BG0040
BG0050
BG0060
BG0070
BG0081
BG0092
0
BG0041
BG0050
BG0060
BG0070
BG0081
BG0092
0
BG0040
BG0050
BG0060
BG0070
BG0080
BG0091
0
BG0040
BG0050
BG0060
BG0070
BG0080
BG0091
0
BG0040
BG0050
BG0060
BG0070
BG0080
BG0091
1
BG0040
BG0050
BG0060
BG0070
BG0080
BG0091
1
BG0040
BG0050
BG0060
BG0070
BG0080
BG0091
1
BG0040
BG0050
BG0060
BG0070
BG0080
BG0091
1
BG0040
BG0050
BG0060
BG0070
BG0080
BG0091
0
BG0040
BG0051
BG0060
BG0070
BG0080
BG0091
0
BG0040
BG0050
BG0061
BG0070
BG0080
BG0091
0
BG0040
BG0050
BG0060
BG0071
BG0080
BG0091
5
OG0043
OG0055
1870
± 76.7
OG0043310± 18.7
OG0051600± 47.3
3
OG0041
OG0055
1830
± 7.84
OG0042190± NA1 participant analyzed, therefore, unable to calculate geometric coefficient of variation.
OG0051570± 36.5
5
OG0043
OG0055
898
± 50.5
OG0041700± 63.2
OG005881± 53.3
3
OG0041
OG0055
1150
± 27.8
OG004768± NA1 participant analyzed, therefore, unable to calculate geometric coefficient of variation.