Safety and Tolerability of IC83/LY2603618 Administered Af... | NCT00415636 | Trialant
NCT00415636
Sponsor
Eli Lilly and Company
Status
Completed
Last Update Posted
Oct 19, 2018Actual
Enrollment
31Actual
Phase
Phase 1
Conditions
Cancer
Interventions
IC83/LY2603618
IC83/LY2603618
IC83/LY2603618
IC83/LY2603618
IC83/LY2603618
pemetrexed
pemetrexed
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT00415636
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
11911
Secondary IDs
ID
Type
Description
Link
I2I-MC-JMMB
Other Identifier
Eli Lilly and Company
Brief Title
Safety and Tolerability of IC83/LY2603618 Administered After Pemetrexed 500 mg/m2 Every 21 Days in Patients With Cancer
Official Title
A Phase 1 Dose-Escalation Study to Examine the Safety and Tolerability of IC83/LY2603618 Administered After Pemetrexed 500 mg/m2 Every 21 Days in Patients With Cancer
Acronym
Not provided
Organization
Eli Lilly and CompanyINDUSTRY
Status Module
Record Verification Date
Mar 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
Jan 2007
Primary Completion Date
Mar 2010Actual
Completion Date
Jul 2010Actual
First Submitted Date
Dec 21, 2006
First Submission Date that Met QC Criteria
Dec 21, 2006
First Posted Date
Dec 25, 2006Estimated
Results Waived
Not provided
Results First Submitted Date
Feb 17, 2018
Results First Submitted that Met QC Criteria
Mar 26, 2018
Results First Posted Date
Oct 19, 2018Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Mar 26, 2018
Last Update Posted Date
Oct 19, 2018Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Eli Lilly and CompanyINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of this study is to evaluate the safety and tolerability of IC83/LY2603618 for the treatment of cancer.
Detailed Description
Not provided
Conditions Module
Conditions
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
31Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
LY2603618 40 mg/m^2 (4.5-hour infusion)
Experimental
LY2603618 40 milligrams per square meter (mg/m^2) was administered over the duration of 4.5 hours (30-minute bolus followed by a 4-hour infusion). Dose modifications were not allowed.
Drug: IC83/LY2603618
Drug: pemetrexed
LY2603618 40 mg/m^2 (1-hour infusion)
Experimental
Based on pharmacokinetic (PK) data from Cohort 1 (LY2603618 40 mg/m^2 [4.5-hour infusion]), the LY2603618 40 mg/m^2 dose in Cohort 2 (LY2603618 40 mg/m^2 [1-hour infusion]) was repeated, but the dose was administered over the duration of 1 hour. Dose modifications were not allowed.
Drug: IC83/LY2603618
Drug: pemetrexed
LY2603618 70 mg/m^2
Experimental
Beginning with Cohort 3 (LY2603618 70 mg/m^2), dose modifications were allowed. LY2603618 70 mg/m^2 was administered over the course of 1 hour.
Drug: IC83/LY2603618
Drug: pemetrexed
LY2603618 105 mg/m^2
Experimental
Cohort 4: LY2603618 105 mg/m^2 administered over the duration of 1 hour.
Drug: IC83/LY2603618
Drug: pemetrexed
LY2603618 150 mg/m^2
Experimental
Interventions
Name
Type
Description
Arm Group Labels
Other Names
IC83/LY2603618
Drug
40 mg/m^2 Day 1 and Day 9 of Cycle 1, Day 2 of subsequent cycles, unlimited 21-day cycles. Dose finding study: dose is escalated after a minimum of 6 participants receive 40 mg/m^2.
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants With Adverse Events (AEs)
Summary tables of serious AEs (SAEs) and all other non-serious adverse events (AEs) are located in the Reported Adverse Event Module.
baseline up to 24 months
Secondary Outcomes
Measure
Description
Time Frame
Pharmacokinetic (PK) Parameter: Maximum Observed Plasma Concentration (Cmax) of IC83/LY2603618
Cmax was estimated from the plasma concentration data of LY2603618 versus time profiles.
Day 1 and Day 9 of Cycle 1
Pharmacokinetic (PK) Parameter: Area Under the IC83/LY2603618 Plasma Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞])
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Has at least one lesion that can be evaluated by Response Evaluation Criteria In Solid Tumors (RECIST)
Has fully recovered from all toxicities due to the following:
Local radiation therapy that ended at least 14 days prior to Cycle 1, Day 1.
Surgery.
Has a life expectancy of at least 3 months.
Negative serum pregnancy test.
Exclusion Criteria:
Is pregnant or breastfeeding.
Is a woman of childbearing potential unwilling to use an approved, effective means of contraception according to the institution's standards.
Is a man of childbearing potential unwilling to use an approved, effective means of contraception according to the institution's standards.
Has a history of brain metastases, unless adequately treated and without radiologic evidence of progressive disease for at least 3 months after completion of therapy.
Has a known active infection.
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9AM-5PM 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.
Scottsdale
Arizona
85258
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
Not provided
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
LY2603618 40 mg/m^2 (4.5-hour Infusion)
LY2603618 40 milligrams per square meter (mg/m^2) was administered over the duration of 4.5 hours (30-minute bolus followed by a 4-hour infusion). Dose modifications were not allowed.
FG001
LY2603618 40 mg/m^2 (1-hour Infusion)
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
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
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Non-Randomized
Intervention Model
Single Group Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Cohort 5: LY2603618 150 mg/m^2 administered over the duration of 1 hour.
Drug: IC83/LY2603618
Drug: pemetrexed
LY2603618 195 mg/m^2
Experimental
Cohort 6: LY2603618 195 mg/m^2 administered over the duration of 1 hour.
Drug: IC83/LY2603618
Drug: pemetrexed
LY2603618 40 mg/m^2 (1-hour infusion)
LY2603618 40 mg/m^2 (4.5-hour infusion)
IC83/LY2603618
Drug
70 mg/m^2 Day 1 and Day 9 of Cycle 1, Day 2 of subsequent cycles, unlimited 21-day cycles.
LY2603618 70 mg/m^2
IC83/LY2603618
Drug
105 mg/m^2 Day 1 and Day 9 of Cycle 1, Day 2 of subsequent cycles, unlimited 21-day cycles.
LY2603618 105 mg/m^2
IC83/LY2603618
Drug
150 mg/m^2 Day 1 and Day 9 of Cycle 1, Day 2 of subsequent cycles, unlimited 21-day cycles.
LY2603618 150 mg/m^2
IC83/LY2603618
Drug
195 mg/m^2 Day 1 and Day 9 of Cycle 1, Day 2 of subsequent cycles, unlimited 21-day cycles.
LY2603618 195 mg/m^2
pemetrexed
Drug
pemetrexed 500 mg/m^2, intravenous (IV), Day 8 of Cycle 1, Day 1 of subsequent cycles, unlimited 21-day cycles
LY2603618 40 mg/m^2 (4.5-hour infusion)
Alimta
LY231514
pemetrexed
Drug
pemetrexed 500 mg/m^2 IV, Day 8 of Cycle 1, Day 1 of subsequent cycles, unlimited 21-day cycles
LY2603618 105 mg/m^2
LY2603618 150 mg/m^2
LY2603618 195 mg/m^2
LY2603618 40 mg/m^2 (1-hour infusion)
LY2603618 70 mg/m^2
AUC[0-∞] was calculated from the plasma concentration data of LY2603618 versus time profiles.
Day 1 and Day 9 of Cycle 1
Percentage of Participants With Best Overall Response
Percentage of participants with tumor response (best confirmed overall response) assessed as complete response (CR) or partial response (PR) to treatment according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria. CR=disappearance of all target lesions; PR=30% decrease in sum of longest diameter of target lesions; Progressive Disease (PD)=20% increase in sum of longest diameter of target lesions; Stable Disease (SD) =small changes that do not meet above criteria. Best Overall Response (%)=number of participants with CR+PR/number of participants in treatment arm * 100.
baseline up to 24 months
United States
Based on pharmacokinetic (PK) data from Cohort 1 (LY2603618 40 mg/m^2 [4.5-hour infusion]), LY2603618 40 mg/m^2 dose in Cohort 2 (LY2603618 40 mg/m^2 [1-hour infusion]) was repeated, but the dose was administered over the duration of 1 hour. Dose modifications were not allowed.
FG002
LY2603618 70 mg/m^2
Beginning with Cohort 3 (LY2603618 70 mg/m^2), dose modifications were allowed. LY2603618 70 mg/m^2 was administered over the course of 1 hour.
FG003
LY2603618 105 mg/m^2
LY2603618 105 mg/m^2 administered over the duration of 1 hour.
FG004
LY2603618 150 mg/m^2
LY2603618 150 mg/m^2 administered over the duration of 1 hour.
FG005
LY2603618 195 mg/m^2
LY2603618 195 mg/m^2 administered over the duration of 1 hour.
FG0003 subjects
FG0013 subjects
FG0023 subjects
FG00313 subjects
FG0046 subjects
FG0053 subjects
COMPLETED
FG0002 subjectsCompleted = Participant received 2 cycles of treatment
FG0013 subjectsCompleted = Participant received 2 cycles of treatment
FG0022 subjectsCompleted = Participant received 2 cycles of treatment
FG0037 subjectsCompleted = Participant received 2 cycles of treatment
FG0044 subjectsCompleted = Participant received 2 cycles of treatment
FG0051 subjectsCompleted = Participant received 2 cycles of treatment
NOT COMPLETED
FG0001 subjects
FG0010 subjects
FG0021 subjects
FG0036 subjects
FG0042 subjects
FG0052 subjects
Type
Comment
Reasons
Symptomatic deterioration
FG0001 subjects
FG0010 subjects
FG0021 subjects
FG0032 subjects
FG0040 subjects
FG0051 subjects
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Disease progression
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0033 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
LY2603618 40 mg/m^2 (4.5-hour Infusion)
LY2603618 40 milligrams per square meter (mg/m^2) was administered over the duration of 4.5 hours (30-minute bolus followed by a 4-hour infusion). Dose modifications were not allowed.
BG001
LY2603618 40 mg/m^2 (1-hour Infusion)
Based on pharmacokinetic (PK) data from Cohort 1 (LY2603618 40 mg/m^2 [4.5-hour infusion]), LY2603618 40 mg/m^2 dose in Cohort 2 (LY2603618 40 mg/m^2 [1-hour infusion]) was repeated, but the dose was administered over the duration of 1 hour. Dose modifications were not allowed.
BG002
LY2603618 70 mg/m^2
Beginning with Cohort 3 (LY2603618 70 mg/m^2), dose modifications were allowed. LY2603618 70 mg/m^2 was administered over the course of 1 hour.
BG003
LY2603618 105 mg/m^2
LY2603618 105 mg/m^2 administered over the duration of 1 hour.
BG004
LY2603618 150 mg/m^2
LY2603618 150 mg/m^2 administered over the duration of 1 hour.
BG005
LY2603618 195 mg/m^2
LY2603618 195 mg/m^2 administered over the duration of 1 hour.
BG006
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0003
BG0013
BG0023
BG00313
BG0046
BG0053
BG00631
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00049.0± 6.24
BG00158.0± 10.54
BG00248.3± 16.07
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0003
BG0011
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0000
BG0010
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Region of Enrollment
Count of Participants
Participants
Title
Denominators
Categories
United States
Title
Measurements
BG0003
BG0013
BG002
Primary Cancer Type
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Breast
BG0003
BG0011
BG002
Eastern Cooperative Oncology Group (ECOG) Rating at Screening
Classifies participants according to their functional impairment. Scores range from 0 to 5: 0=Fully Active; 1=Ambulatory, Restricted Strenuous Activity; 2=Ambulatory, No Work Activities; 3=Partially Confined to Bed, Limited Self Care; 4=Completely Disabled; 5=Death.
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
ECOG Rating 0
BG0002
BG001
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Number of Participants With Adverse Events (AEs)
Summary tables of serious AEs (SAEs) and all other non-serious adverse events (AEs) are located in the Reported Adverse Event Module.
The safety population was comprised of all participants who received any amount of LY2603618.
Posted
Count of Participants
Participants
No
baseline up to 24 months
ID
Title
Description
OG000
LY2603618 40 mg/m^2 (4.5-hour Infusion)
4.5-hour intravenous (IV) infusion of IC83/LY2603618 40 mg/m^2
OG001
LY2603618 40 mg/m^2 (1-hour Infusion)
1.0-hour IV infusion of IC83/LY2603618 40 mg/m^2
OG002
LY2603618 70 mg/m^2
1.0-hour IV infusion of IC83/LY2603618 70 mg/m^2
OG003
LY2603618 105 mg/m^2
1.0-hour IV infusion of IC83/LY2603618 105 mg/m^2
OG004
LY2603618 150 mg/m^2
1.0-hour IV infusion of IC83/LY2603618 150 mg/m^2
OG005
LY2603618 195 mg/m^2
1.0-hour IV infusion of IC83/LY2603618 195 mg/m^2
Units
Counts
Participants
OG0003
OG0013
OG0023
OG003
Title
Denominators
Categories
Other Non-Serious Adverse Events (AEs)
Title
Measurements
OG0003
OG0013
OG0023
OG003
Secondary
Pharmacokinetic (PK) Parameter: Maximum Observed Plasma Concentration (Cmax) of IC83/LY2603618
Cmax was estimated from the plasma concentration data of LY2603618 versus time profiles.
Pharmacokinetic (PK) analyses were conducted for individual participants who received at least 1 dose of study drug and had PK samples collected.
Posted
Mean
Standard Deviation
nanograms per millimeter (ng/mL)
Day 1 and Day 9 of Cycle 1
ID
Title
Description
OG000
LY2603618 40 mg/m^2 (4.5-hour Infusion)
4.5-hour intravenous (IV) infusion of IC83/LY2603618 40 mg/m^2 on Day 1 (alone) and Day 9 of Cycle 1.
OG001
LY2603618 40 mg/m^2 (1-hour Infusion)
1.0-hour IV infusion of IC83/LY2603618 40 mg/m^2 on Day 1 (alone) and Day 9 of Cycle 1.
OG002
LY2603618 70 mg/m^2
1.0-hour IV infusion of IC83/LY2603618 70 mg/m^2 on Day 1 (alone) and Day 9 of Cycle 1.
OG003
LY2603618 105 mg/m^2
1.0-hour IV infusion of IC83/LY2603618 105 mg/m^2 on Day 1 (alone) and Day 9 of Cycle 1.
Secondary
Pharmacokinetic (PK) Parameter: Area Under the IC83/LY2603618 Plasma Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞])
AUC[0-∞] was calculated from the plasma concentration data of LY2603618 versus time profiles.
Pharmacokinetic (PK) analyses were conducted for individual participants who received at least 1 dose of study drug and had PK samples collected.
Posted
Mean
Standard Deviation
nanograms*hour per milliliter (ng*h/mL)
Day 1 and Day 9 of Cycle 1
ID
Title
Description
OG000
LY2603618 40 mg/m^2 (4.5-hour Infusion)
4.5-hour intravenous (IV) infusion of IC83/LY2603618 40 mg/m^2 on Day 1 (alone) and Day 9 of Cycle 1.
OG001
LY2603618 40 mg/m^2 (1-hour Infusion)
1.0-hour IV infusion of IC83/LY2603618 40 mg/m^2 on Day 1 (alone) and Day 9 of Cycle 1.
OG002
LY2603618 70 mg/m^2
1.0-hour IV infusion of IC83/LY2603618 70 mg/m^2 on Day 1 (alone) and Day 9 of Cycle 1.
OG003
LY2603618 105 mg/m^2
Secondary
Percentage of Participants With Best Overall Response
Percentage of participants with tumor response (best confirmed overall response) assessed as complete response (CR) or partial response (PR) to treatment according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria. CR=disappearance of all target lesions; PR=30% decrease in sum of longest diameter of target lesions; Progressive Disease (PD)=20% increase in sum of longest diameter of target lesions; Stable Disease (SD) =small changes that do not meet above criteria. Best Overall Response (%)=number of participants with CR+PR/number of participants in treatment arm * 100.
A modified intent-to-treat population (mITT) was used to summarize the data for tumor response. The mITT population consisted of all participants who received any dose of study drug and had at least 1 nonmissing postbaseline tumor response assessment.
Posted
Number
Percentage of participants
baseline up to 24 months
ID
Title
Description
OG000
LY2603618 40 mg/m^2 (4.5 Hours)
4.5-hour IV infusion of IC83/LY2603618 40 mg/m^2
OG001
LY2603618 40 mg/m^2 (1 Hour)
1.0-hour IV infusion of IC83/LY2603618 40 mg/m^2
OG002
LY2603618 70 mg/m^2
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
LY2603618 40 mg/m^2 (4.5-hour Infusion)
LY2603618 40 milligrams per square meter (mg/m^2) was administered over the duration of 4.5 hours (30-minute bolus followed by a 4-hour infusion). Dose modifications were not allowed.
1
3
3
3
EG001
LY2603618 40 mg/m^2 (1-hour Infusion)
Based on pharmacokinetic (PK) data from Cohort 1 (LY2603618 40 mg/m^2 [4.5-hour infusion]), LY2603618 40 mg/m^2 dose in Cohort 2 (LY2603618 40 mg/m^2 [1-hour infusion]) was repeated, but the dose was administered over the duration of 1 hour. Dose modifications were not allowed.
0
3
3
3
EG002
LY2603618 70 mg/m^2
Beginning with Cohort 3 (LY2603618 70 mg/m^2), dose modifications were allowed. LY2603618 70 mg/m^2 was administered over the course of 1 hour.
2
3
3
3
EG003
LY2603618 105 mg/m^2
LY2603618 105 mg/m^2 administered over the duration of 1 hour.
8
13
13
13
EG004
LY2603618 150 mg/m^2
LY2603618 150 mg/m^2 administered over the duration of 1 hour.
4
6
6
6
EG005
LY2603618 195 mg/m^2
LY2603618 195 mg/m^2 administered over the duration of 1 hour.
2
3
3
3
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected13 at risk
EG0041 events1 affected6 at risk
EG0051 events1 affected3 at risk
Leukopenia
Blood and lymphatic system disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Pancytopenia
Blood and lymphatic system disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Cardiac arrest
Cardiac disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Lower gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Pancreatitis acute
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Fatigue
General disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Infusion related reaction
General disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Pyrexia
General disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Hepatic cyst
Hepatobiliary disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0022 events1 affected3 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Hip fracture
Injury, poisoning and procedural complications
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Convulsion
Nervous system disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Aspiration
Respiratory, thoracic and mediastinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Pneumonia aspiration
Respiratory, thoracic and mediastinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Respiratory distress
Respiratory, thoracic and mediastinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Lymphoedema
Vascular disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events1 affected3 at risk
EG0024 events1 affected3 at risk
EG0031 events1 affected13 at risk
EG0045 events3 affected6 at risk
EG0051 events1 affected3 at risk
Leukopenia
Blood and lymphatic system disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events1 affected3 at risk
EG0023 events1 affected3 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0022 events1 affected3 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Sinus tachycardia
Cardiac disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Ventricular extrasystoles
Cardiac disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Cerumen impaction
Ear and labyrinth disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Ear pain
Ear and labyrinth disorders
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Tinnitus
Ear and labyrinth disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Conjunctival pallor
Eye disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Lacrimation increased
Eye disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Photophobia
Eye disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Vision blurred
Eye disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0022 events1 affected3 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Abnormal faeces
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0002 events1 affected3 at risk
EG0013 events2 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0012 events1 affected3 at risk
EG0022 events1 affected3 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0023 events1 affected3 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Frequent bowel movements
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Gastrointestinal sounds abnormal
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Gingival pain
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Haematemesis
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Haematochezia
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Lip blister
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Melaena
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0003 events2 affected3 at risk
EG0012 events2 affected3 at risk
EG0026 events3 affected3 at risk
EG003
Oesophageal obstruction
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Proctalgia
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0022 events1 affected3 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0025 events3 affected3 at risk
EG003
Catheter site pain
General disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Catheter site pruritus
General disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Chest discomfort
General disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Chest pain
General disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Chills
General disorders
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Fatigue
General disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0015 events3 affected3 at risk
EG0023 events3 affected3 at risk
EG003
General physical health deterioration
General disorders
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Generalised oedema
General disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Influenza like illness
General disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Malaise
General disorders
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Mucosal inflammation
General disorders
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Oedema peripheral
General disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Pyrexia
General disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Tenderness
General disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Thirst
General disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Seasonal allergy
Immune system disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Bacterial infection
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Candidiasis
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Catheter site infection
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0023 events1 affected3 at risk
EG003
Folliculitis
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Tooth infection
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Vulvovaginal candidiasis
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Muscle strain
Injury, poisoning and procedural complications
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Blood pressure diastolic increased
Investigations
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Breath sounds abnormal
Investigations
MedDRA 12.0
Systematic Assessment
EG0002 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Cardiac murmur
Investigations
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Haemoglobin decreased
Investigations
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events2 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Heart rate irregular
Investigations
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Lymph node palpable
Investigations
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Weight decreased
Investigations
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0022 events1 affected3 at risk
EG003
Weight increased
Investigations
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0023 events1 affected3 at risk
EG003
Anorexia
Metabolism and nutrition disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0022 events2 affected3 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0022 events1 affected3 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Malnutrition
Metabolism and nutrition disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Metabolic acidosis
Metabolism and nutrition disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0023 events2 affected3 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Malignant ascites
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Melanocytic naevus
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA 12.0
Systematic Assessment
EG0003 events2 affected3 at risk
EG0011 events1 affected3 at risk
EG0022 events2 affected3 at risk
EG003
Headache
Nervous system disorders
MedDRA 12.0
Systematic Assessment
EG0003 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Sinus headache
Nervous system disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Syncope
Nervous system disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Tremor
Nervous system disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events2 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Depression
Psychiatric disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Mental disorder
Psychiatric disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Incontinence
Renal and urinary disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Micturition urgency
Renal and urinary disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Renal failure
Renal and urinary disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Renal failure acute
Renal and urinary disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Breast mass
Reproductive system and breast disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Penile swelling
Reproductive system and breast disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Scrotal pain
Reproductive system and breast disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0022 events1 affected3 at risk
EG003
Scrotal swelling
Reproductive system and breast disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Vaginal discharge
Reproductive system and breast disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0012 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Nasal mucosal disorder
Respiratory, thoracic and mediastinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Paranasal sinus hypersecretion
Respiratory, thoracic and mediastinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Pleuritic pain
Respiratory, thoracic and mediastinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Rales
Respiratory, thoracic and mediastinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Sinus congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Campbell de morgan spots
Skin and subcutaneous tissue disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Night sweats
Skin and subcutaneous tissue disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Petechiae
Skin and subcutaneous tissue disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Photosensitivity reaction
Skin and subcutaneous tissue disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Pigmentation disorder
Skin and subcutaneous tissue disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Skin exfoliation
Skin and subcutaneous tissue disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Skin odour abnormal
Skin and subcutaneous tissue disorders
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Flushing
Vascular disorders
MedDRA 12.0
Systematic Assessment
EG0002 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Haematoma
Vascular disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Hot flush
Vascular disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Hypertension
Vascular disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Jugular vein thrombosis
Vascular disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Lymphoedema
Vascular disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0025 events2 affected3 at risk
EG003
Vena cava thrombosis
Vascular disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
GT60
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Not provided
Point of Contact
Title
Organization
Phone
Extension
Email
Chief Medical Officer
Eli Lilly and Company
800-545-5979
ID
Term
D009369
Neoplasms
Ancestor Terms
Not provided
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
D000068437
Pemetrexed
Ancestor Terms
ID
Term
D006147
Guanine
D007042
Hypoxanthines
D011688
Purinones
D011687
Purines
D006574
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
Browse Leaves
Not provided
Browse Branches
Not provided
1 subjects
FG0050 subjects
1 subjects
FG0050 subjects
0 subjects
FG0051 subjects
60.6
± 9.95
BG00463.5± 11.04
BG00555.7± 18.77
BG00658.1± 11.73
2
BG0035
BG0043
BG0051
BG00615
Male
BG0000
BG0012
BG0021
BG0038
BG0043
BG0052
BG00616
0
BG0031
BG0040
BG0050
BG0061
Not Hispanic or Latino
BG0003
BG0013
BG0023
BG00312
BG0046
BG0053
BG00630
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
0
BG0030
BG0040
BG0051
BG0061
Asian
BG0001
BG0010
BG0020
BG0030
BG0040
BG0050
BG0061
Native Hawaiian or Other Pacific Islander
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
Black or African American
BG0000
BG0010
BG0021
BG0030
BG0040
BG0050
BG0061
White
BG0002
BG0013
BG0022
BG00313
BG0046
BG0052
BG00628
More than one race
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
3
BG00313
BG0046
BG0053
BG00631
1
BG0030
BG0041
BG0050
BG0066
Non-small Cell Lung
BG0000
BG0010
BG0020
BG0031
BG0040
BG0050
BG0061
Pancreatic
BG0000
BG0010
BG0020
BG0033
BG0042
BG0051
BG0066
Other
BG0000
BG0012
BG0022
BG0039
BG0043
BG0052
BG00618
1
BG0020
BG0034
BG0041
BG0050
BG0068
ECOG Rating 1
BG0001
BG0012
BG0023
BG0039
BG0045
BG0053
BG00623
13
OG0046
OG0053
13
OG0046
OG0053
Serious Adverse Events (SAEs)
Title
Measurements
OG0001
OG0010
OG0022
OG0038
OG0044
OG0052
OG004
LY2603618 150 mg/m^2
1.0-hour IV infusion of IC83/LY2603618 150 mg/m^2 on Day 1 (alone) and Day 9 of Cycle 1.
OG005
LY2603618 195 mg/m^2
1.0-hour IV infusion of IC83/LY2603618 195 mg/m^2 on Day 1 (alone) and Day 9 of Cycle 1.
Units
Counts
Participants
OG0003
OG0013
OG0023
OG00313
OG0046
OG0053
Title
Denominators
Categories
Day 1
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG00313
ParticipantsOG0046
ParticipantsOG0053
Title
Measurements
OG000578± 181
OG0011560± 358
OG0022310± 1330
OG003
Day 9
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG00312
1.0-hour IV infusion of IC83/LY2603618 105 mg/m^2 on Day 1 (alone) and Day 9 of Cycle 1.
OG004
LY2603618 150 mg/m^2
1.0-hour IV infusion of IC83/LY2603618 150 mg/m^2 on Day 1 (alone) and Day 9 of Cycle 1.
OG005
LY2603618 195 mg/m^2
1.0-hour IV infusion of IC83/LY2603618 195 mg/m^2 on Day 1 (alone) and Day 9 of Cycle 1.