Vinorelbine in Treating Patients With Advanced Solid Tumors That Have Not Responded to Treatment and Liver Dysfunction
Official Title
Pilot Pharmacokinetic Study of Dose Adjustment of Vinorelbine in Patients With Varying Degree of Liver Dysfunction
Acronym
Not provided
Organization
City of Hope Medical CenterOTHER
Status Module
Record Verification Date
Jun 2025
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
Feb 20, 1997Actual
Primary Completion Date
May 20, 2010Actual
Completion Date
May 20, 2010Actual
First Submitted Date
Oct 5, 2007
First Submission Date that Met QC Criteria
Oct 5, 2007
First Posted Date
Oct 8, 2007Estimated
Results Waived
Not provided
Results First Submitted Date
Jan 7, 2019
Results First Submitted that Met QC Criteria
Mar 6, 2019
Results First Posted Date
Mar 11, 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
Jun 24, 2025
Last Update Posted Date
Jul 2, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
City of Hope Medical CenterOTHER
Collaborators
Name
Class
National Cancer Institute (NCI)
NIH
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
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
RATIONALE: Drugs used in chemotherapy, such as vinorelbine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This pilot trial is studying the side effects and best dose of vinorelbine in treating patients with advanced solid tumors that have not responded to treatment and liver dysfunction.
Detailed Description
OBJECTIVES:
To correlate indocyanine green and lidocaine metabolism with vinorelbine ditartrate pharmacokinetics in patients with advanced, refractory solid tumors and varying degrees of liver dysfunction.
To determine the pharmacokinetics of vinorelbine ditartrate in these patients.
To test a plan of dose adjustment for vinorelbine ditartrate administration in these patients.
OUTLINE: Patients are stratified according to extent of clinical liver dysfunction (normal vs mild vs moderate vs severe).
Patients receive dose-adjusted vinorelbine ditartrate IV over 10 minutes once weekly in the absence of disease progression or unacceptable toxicity. Patients achieving an objective complete response receive 2 additional courses of study therapy.
Patients undergo blood sample collection periodically during study for pharmacokinetic and pharmacodynamic correlative studies. Blood is also collected after patients receive lidocaine IV push and indocyanine green (ICG) IV push. Samples are analyzed for whole blood and plasma concentrations of vinorelbine ditartrate and its metabolites by high performance liquid chromatography (15) or by liquid chromatography/tandem mass spectrometry assay. Samples are also analyzed for ICG clearance and lidocaine hydrochloride metabolic capacity by fluorescent polarization immunoassay.
After completion of study therapy, patients are followed periodically.
0.5 mg/kg will be administered by IV push to determine clearance
Mild Liver Dysfunction
Moderate Liver Dysfunction
Normal Liver Function
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Area Under the Curve
Pharmacokinetics were evaluated in patients with sufficient dosing information and plasma concentration versus time data over 0-24 hours following vinorelbine infusion to allow calculation of area-under-the-curve from zero to 24 hours after infusion (AUC0-24). Furthermore, dose-normalization of AUC0-24 to the standard 30 mg/m2 dose was performed to allow evaluation of the relationship between liver function and AUC of vinorelbine. Data were collected at 0 and 24 hours post-dose.
2 months post treatment
Number of Participants With Grade 3 and 4 Toxicities
Grade 3 & 4 toxicities at least possible related to study drugs during any cycle of treatment. Toxicity graded according to Common Terminology Criteria for Adverse Events version 2.0.
3 weeks after the stop of treatment
Secondary Outcomes
Not provided
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically confirmed advanced solid tumor
Any histology allowed
Refractory to standard therapy OR no standard therapy exists
Previously untreated non-small cell lung cancer allowed, provided abnormal liver function is present, defined as moderate (group 3) or severe (group 4)
Measurable disease not required
Present measurable disease requires baseline measurements within 4 weeks of study entry
Patients with acute hepatitis from viral or drug etiologies should recover to a stable baseline prior to study therapy
History of brain metastasis allowed, provided the following criteria are met:
Metastasis has been controlled by radiotherapy or surgery
Patient is not currently on corticosteroids
Neurologic status is stable
PATIENT CHARACTERISTICS:
Karnofsky performance status 70-100%
Life expectancy ≥ 2 months
ANC = 1,500/mm³
Platelet count = 100,000/mm³
Hemoglobin = 10 g/dL (transfusion to this level allowed)
Creatinine < 1.5 mg/dL OR creatinine clearance > 60 mL/ min
Patients with EKG evidence of first- or second-degree AV block or left or right bundle branch block are ineligible for the lidocaine bolus, but may otherwise be treated on this protocol
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No concurrent illness (e.g., cardiovascular, pulmonary, or central nervous system) that is poorly controlled or of such severity that the investigator deems unwise to enter the patient on protocol
Must have ability to comply with study treatment and required tests
Obstructive jaundice requires a drainage procedure prior to study treatment
PRIOR CONCURRENT THERAPY:
See Disease Characteristics
Recovered from prior therapy
At least 3 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosourea therapy)
No prior radiotherapy to > 30% of the bone marrow or more than standard adjuvant pelvic radiotherapy for rectal cancer
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
120 Years
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Joseph Chao
City of Hope Medical Center
Study Chair
Locations
Facility
Status
City
State
ZIP
Country
Contacts
City of Hope Medical Center
Duarte
California
91010-3000
United States
City of Hope Medical Group
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
All Patients
All patients with treatment-refractory solid tumors enrolled on the study.
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
0
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
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Severe Liver Dysfunction
lidocaine
Drug
1 mg/kg will be administered to determine metabolic capacity
Mild Liver Dysfunction
Moderate Liver Dysfunction
Normal Liver Function
Severe Liver Dysfunction
vinorelbine ditartrate
Drug
Varying doses ranging from 30 mg/m2 to 7.5 mg/m2 will be administered based upon liver function
Mild Liver Dysfunction
Moderate Liver Dysfunction
Normal Liver Function
Severe Liver Dysfunction
high performance liquid chromatography
Other
Used to determine plasma concentrations of vinorelbine
Mild Liver Dysfunction
Moderate Liver Dysfunction
Normal Liver Function
Severe Liver Dysfunction
intracellular fluorescence polarization analysis
Other
Used to determine concentration of lidocaine metabolic capacity
Mild Liver Dysfunction
Moderate Liver Dysfunction
Normal Liver Function
Severe Liver Dysfunction
liquid chromatography
Other
Used to determine concentrations of vinorelbine and its metabolites
Mild Liver Dysfunction
Moderate Liver Dysfunction
Normal Liver Function
Severe Liver Dysfunction
mass spectrometry
Other
Used to determine concentrations of vinorelbine and its metabolites
Mild Liver Dysfunction
Moderate Liver Dysfunction
Normal Liver Function
Severe Liver Dysfunction
pharmacological study
Other
Determination of concentrations of vinorelbine and its metabolites
Mild Liver Dysfunction
Moderate Liver Dysfunction
Normal Liver Function
Severe Liver Dysfunction
Pasadena
California
91105
United States
FG00047 subjects
Normal Liver Function
FG00011 subjects
Mild Liver Dysfunction
FG0006 subjects
Moderate Liver Dysfunction
FG00018 subjects
Severe Liver Dysfunction
FG00012 subjects
COMPLETED
FG00047 subjects
NOT COMPLETED
FG0000 subjects
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
All Patients
All patients with treatment-refractory solid tumors enrolled on the study.
Denominators
Units
Counts
Participants
BG00047
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Median
Full Range
years
Title
Denominators
Categories
Title
Measurements
BG00058(32 to 82)
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00023
Male
BG00024
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
Caucasian
Title
Measurements
BG00023
Hispanic
Title
Measurements
BG000
Region of Enrollment
Number
participants
Title
Denominators
Categories
United States
Title
Measurements
BG00047
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
Area Under the Curve
Pharmacokinetics were evaluated in patients with sufficient dosing information and plasma concentration versus time data over 0-24 hours following vinorelbine infusion to allow calculation of area-under-the-curve from zero to 24 hours after infusion (AUC0-24). Furthermore, dose-normalization of AUC0-24 to the standard 30 mg/m2 dose was performed to allow evaluation of the relationship between liver function and AUC of vinorelbine. Data were collected at 0 and 24 hours post-dose.
Vinorelbine plasma AUC0-24 data were available for a total of 30 subjects.
Posted
Median
Full Range
ng/ml x hr
2 months post treatment
ID
Title
Description
OG000
Normal
Patients were administered weekly 30mg/m2 of vinorelbine as a short IV infusion (over 10 minutes maximum).
Normal liver function was defined as bilirubin <1.5 mg/dL
OG001
Mild
Patients were administered weekly 30mg/m2, 20mg/m2 or 15mg/m2 of vinorelbine as a short IV infusion (over 10 minutes maximum).
Mild liver dysfunction defined as bilirubin <1.5 mg/dL and ≥1 of the following: AST/ALT 1.5-2.5 X ULN or ALK 1.5-3 X ULN
OG002
Moderate
Patients were administered weekly 30mg/m2 or 15mg/m2 of vinorelbine as a short IV infusion (over 10 minutes maximum).
Moderate liver dysfunction was defined as bilirubin 1.5-3.0 mg/dL and/or ≥1 of the following: AST/ALT >2.5 X ULN or ALK >3 X ULN.
OG003
Severe
Patients were administered weekly 20mg/m2 or 7.5mg/m2 of vinorelbine as a short IV infusion (over 10 minutes maximum).
Severe liver dysfunction was defined as bilirubin >3.0 mg/dL.
Units
Counts
Participants
OG00010
OG0014
OG00212
OG003
Title
Denominators
Categories
Title
Measurements
OG000271(111 to 593)
OG001537(366 to 812)
OG002341(251 to 1318)
OG003
Primary
Number of Participants With Grade 3 and 4 Toxicities
Grade 3 & 4 toxicities at least possible related to study drugs during any cycle of treatment. Toxicity graded according to Common Terminology Criteria for Adverse Events version 2.0.
Posted
Count of Participants
Participants
3 weeks after the stop of treatment
ID
Title
Description
OG000
Normal (30mg/m2)
Normal Liver Function Group with 30 mg/m2 of Vinorelbine.
OG001
Mild (30mg/m2)
Mild Liver Dysfunction Group with 30 mg/m2 of Vinorelbine.
OG002
Mild (20mg/m2)
Mild Liver Dysfunction Group with 20 mg/m2 of Vinorelbine.
OG003
Mild (15mg/m2)
Mild Liver Dysfunction Group with 15 mg/m2 of Vinorelbine.
OG004
Moderate (30mg/m2)
Moderate Liver Dysfunction Group with 30 mg/m2 of Vinorelbine.
Time Frame
Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine.
Description
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
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
Normal (30mg/m2)
Normal Liver Function Group with 30 mg/m2 of Vinorelbine.
11
11
0
11
11
11
EG001
Mild (30mg/m2)
Mild Liver Dysfunction Group with 30 mg/m2 of Vinorelbine.
1
1
0
1
1
1
EG002
Mild (20mg/m2)
Mild Liver Dysfunction Group with 20 mg/m2 of Vinorelbine.
3
3
0
3
3
3
EG003
Mild (15mg/m2)
Mild Liver Dysfunction Group with 15 mg/m2 of Vinorelbine.
2
2
0
2
2
2
EG004
Moderate (30mg/m2)
Moderate Liver Dysfunction Group with 30 mg/m2 of Vinorelbine.
8
8
3
8
7
8
EG005
Moderate (15mg/m2)
Moderate Liver Dysfunction Group with 15 mg/m2 of Vinorelbine.
10
10
0
10
10
10
EG006
Severe (20mg/m2)
Severe Liver Dysfunction Group with 20 mg/m2 of Vinorelbine.
7
7
4
7
7
7
EG007
Severe (7.5mg/m2)
Severe Liver Dysfunction Group with 7.5 mg/m2 of Vinorelbine.
5
5
0
5
5
5
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Febrile neutropenia
Blood and lymphatic system disorders
meddra10.0
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected2 at risk
EG004
Abdominal pain
Gastrointestinal disorders
meddra10.0
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
General symptom
General disorders
meddra10.0
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Catheter related infection
Infections and infestations
meddra9.0
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Infection NOS
Infections and infestations
meddra9.0
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Infection, Bacterial (COH)
Infections and infestations
COH
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Infections and infestations
meddra10.0
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Leukocyte count decreased
Investigations
meddra10.0
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Lymphopenia
Investigations
meddra9.0
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Platelet count decreased
Investigations
meddra9.0
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Dehydration
Metabolism and nutrition disorders
meddra10.0
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Hyperglycemia
Metabolism and nutrition disorders
meddra9.0
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Hypophosphatemia
Metabolism and nutrition disorders
meddra9.0
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Serum potassium decreased
Metabolism and nutrition disorders
meddra10.0
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Muscle weakness
Musculoskeletal and connective tissue disorders
meddra10.0
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
meddra10.0
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Petechiae
Skin and subcutaneous tissue disorders
meddra9.0
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Rash desquamating
Skin and subcutaneous tissue disorders
meddra10.0
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Hypotension
Vascular disorders
meddra10.0
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Cerebellar
Nervous system disorders
COH
Non-systematic Assessment
EG0002 events2 affected11 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected2 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected10 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected5 at risk
Clinical (Physical Exam)
General disorders
COH
Non-systematic Assessment
EG00015 events4 affected11 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Dysrhythmias
Cardiac disorders
COH
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Fluid Retention
General disorders
COH
Non-systematic Assessment
EG00025 events5 affected11 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Haematemesis
Gastrointestinal disorders
meddra9.0
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Hemorrhage
General disorders
COH
Non-systematic Assessment
EG00025 events5 affected11 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Infection
Infections and infestations
COH
Non-systematic Assessment
EG00025 events5 affected11 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Ischemia
Cardiac disorders
COH
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Other Misc
General disorders
COH
Non-systematic Assessment
EG00035 events4 affected11 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Pericardial
Cardiac disorders
COH
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Pulmonary
Respiratory, thoracic and mediastinal disorders
COH
Non-systematic Assessment
EG00025 events5 affected11 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Stomatitis
Skin and subcutaneous tissue disorders
COH
Non-systematic Assessment
EG00025 events5 affected11 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Weight (Food Intake)
Metabolism and nutrition disorders
COH
Non-systematic Assessment
EG00025 events5 affected11 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Clinical Coagulation
Blood and lymphatic system disorders
COH
Non-systematic Assessment
EG0007 events2 affected11 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Hemoglobin decreased
Blood and lymphatic system disorders
meddra9.0
Non-systematic Assessment
EG00012 events6 affected11 at risk
EG0011 events1 affected1 at risk
EG00233 events3 affected3 at risk
EG003
Lymphatics
Blood and lymphatic system disorders
meddra10.0
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Packed red blood cell transfusion
Blood and lymphatic system disorders
meddra9.0
Non-systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected1 at risk
EG0022 events2 affected3 at risk
EG003
Transfusion: pRBCs
Blood and lymphatic system disorders
meddra10.0
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
EF/CHF
Cardiac disorders
COH
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Palpitations
Cardiac disorders
meddra9.0
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected3 at risk
EG003
Sinus bradycardia
Cardiac disorders
meddra9.0
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Sinus tachycardia
Cardiac disorders
meddra10.0
Non-systematic Assessment
EG0002 events2 affected11 at risk
EG0010 events0 affected1 at risk
EG0022 events1 affected3 at risk
EG003
Ventricular arrhythmia
Cardiac disorders
meddra9.0
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Hearing
Ear and labyrinth disorders
COH
Non-systematic Assessment
EG0002 events2 affected11 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Eye disorder
Eye disorders
meddra10.0
Non-systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Vision
Eye disorders
COH
Non-systematic Assessment
EG0002 events2 affected11 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Abdominal pain
Gastrointestinal disorders
meddra10.0
Non-systematic Assessment
EG0001 events1 affected11 at risk
EG0011 events1 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Ascites
Gastrointestinal disorders
meddra10.0
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Constipation
Gastrointestinal disorders
COH
Non-systematic Assessment
EG00019 events6 affected11 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Diarrhea
Gastrointestinal disorders
meddra9.0
Non-systematic Assessment
EG00019 events5 affected11 at risk
EG0010 events0 affected1 at risk
EG0025 events1 affected3 at risk
EG003
Dry mouth
Gastrointestinal disorders
meddra10.0
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Dyspepsia
Gastrointestinal disorders
meddra9.0
Non-systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Esophagitis
Gastrointestinal disorders
meddra9.0
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Flatulence
Gastrointestinal disorders
meddra9.0
Non-systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Gastrointestinal disorder
Gastrointestinal disorders
meddra9.0
Non-systematic Assessment
EG0001 events1 affected11 at risk
EG0011 events1 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Mucositis oral
Gastrointestinal disorders
meddra10.0
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Nausea
Gastrointestinal disorders
COH
Non-systematic Assessment
EG00019 events6 affected11 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Vomiting
Gastrointestinal disorders
COH
Non-systematic Assessment
EG00019 events6 affected11 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Chest pain
General disorders
meddra10.0
Non-systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Chills
General disorders
meddra9.0
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Edema
General disorders
meddra10.0
Non-systematic Assessment
EG0002 events2 affected11 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Edema limbs
General disorders
meddra10.0
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Fatigue
General disorders
meddra9.0
Non-systematic Assessment
EG00017 events8 affected11 at risk
EG0012 events1 affected1 at risk
EG00213 events3 affected3 at risk
EG003
Fever
General disorders
meddra10.0
Non-systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected1 at risk
EG0022 events1 affected3 at risk
EG003
Fever (no infection)
General disorders
COH
Non-systematic Assessment
EG00010 events4 affected11 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Injection site reaction
General disorders
meddra9.0
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Oedema NOS
General disorders
meddra9.0
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected1 at risk
EG00212 events2 affected3 at risk
EG003
Pain
General disorders
meddra10.0
Non-systematic Assessment
EG0007 events4 affected11 at risk
EG0012 events1 affected1 at risk
EG0029 events1 affected3 at risk
EG003
Hepatobiliary disease
Hepatobiliary disorders
meddra9.0
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Allergy
Immune system disorders
COH
Non-systematic Assessment
EG00025 events5 affected11 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Catheter related infection
Infections and infestations
meddra10.0
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Infection NOS
Infections and infestations
meddra9.0
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Infection without neutropenia
Infections and infestations
meddra10.0
Non-systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Infections and infestations
meddra10.0
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Bruising
Injury, poisoning and procedural complications
meddra10.0
Non-systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected3 at risk
EG003
AGC
Investigations
COH
Non-systematic Assessment
EG00021 events5 affected11 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Activated partial thromboplastin time prolonged
Investigations
meddra10.0
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Alanine aminotransferase increased
Investigations
meddra10.0
Non-systematic Assessment
EG0006 events3 affected11 at risk
EG0012 events1 affected1 at risk
EG0021 events1 affected3 at risk
EG003
Alkaline Phosphatase
Investigations
COH
Non-systematic Assessment
EG00015 events4 affected11 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Alkaline phosphatase increased
Investigations
meddra10.0
Non-systematic Assessment
EG0007 events4 affected11 at risk
EG0012 events1 affected1 at risk
EG00233 events3 affected3 at risk
EG003
Amylase
Investigations
COH
Non-systematic Assessment
EG0009 events3 affected11 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Aspartate aminotransferase increased
Investigations
meddra10.0
Non-systematic Assessment
EG0005 events3 affected11 at risk
EG0012 events1 affected1 at risk
EG00233 events3 affected3 at risk
EG003
Bilirubin
Investigations
COH
Non-systematic Assessment
EG00015 events4 affected11 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Bilirubin increased
Investigations
meddra10.0
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Creatinine
Investigations
COH
Non-systematic Assessment
EG0007 events2 affected11 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Creatinine increased
Investigations
meddra9.0
Non-systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Fibrinogen
Investigations
COH
Non-systematic Assessment
EG0007 events2 affected11 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
HGB/HCT
Investigations
COH
Non-systematic Assessment
EG00023 events5 affected11 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Hyperbilirubinemia
Investigations
meddra9.0
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected3 at risk
EG003
Hypercholesterolemia
Investigations
meddra9.0
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected3 at risk
EG003
INR increased
Investigations
meddra10.0
Non-systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Leukocyte count decreased
Investigations
meddra10.0
Non-systematic Assessment
EG0004 events2 affected11 at risk
EG0012 events1 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Leukopenia
Investigations
meddra9.0
Non-systematic Assessment
EG0004 events3 affected11 at risk
EG0010 events0 affected1 at risk
EG00216 events3 affected3 at risk
EG003
Lymphocyte count decreased
Investigations
meddra10.0
Non-systematic Assessment
EG0001 events1 affected11 at risk
EG0011 events1 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Lymphopenia
Investigations
meddra9.0
Non-systematic Assessment
EG0002 events2 affected11 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Neutrophil count decreased
Investigations
meddra9.0
Non-systematic Assessment
EG0008 events5 affected11 at risk
EG0012 events1 affected1 at risk
EG0027 events2 affected3 at risk
EG003
Partial Thromboplastin Time
Investigations
COH
Non-systematic Assessment
EG0007 events2 affected11 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Platelet count decreased
Investigations
meddra10.0
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected1 at risk
EG0022 events1 affected3 at risk
EG003
Platelets
Investigations
COH
Non-systematic Assessment
EG00023 events5 affected11 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Prothrombin Time
Investigations
COH
Non-systematic Assessment
EG0007 events2 affected11 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
SGOT/SGT
Investigations
COH
Non-systematic Assessment
EG00015 events4 affected11 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Serum cholesterol increased
Investigations
meddra10.0
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
WBC
Investigations
COH
Non-systematic Assessment
EG00023 events5 affected11 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Weight gain
Investigations
meddra9.0
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Weight loss
Investigations
meddra10.0
Non-systematic Assessment
EG0002 events2 affected11 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Anorexia
Metabolism and nutrition disorders
meddra9.0
Non-systematic Assessment
EG0006 events6 affected11 at risk
EG0011 events1 affected1 at risk
EG00224 events3 affected3 at risk
EG003
Blood bicarbonate decreased
Metabolism and nutrition disorders
meddra10.0
Non-systematic Assessment
EG0003 events1 affected11 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Blood glucose increased
Metabolism and nutrition disorders
meddra10.0
Non-systematic Assessment
EG0007 events2 affected11 at risk
EG0012 events1 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Blood uric acid increased
Metabolism and nutrition disorders
meddra10.0
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Dehydration
Metabolism and nutrition disorders
meddra9.0
Non-systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Hypercalcemia
Metabolism and nutrition disorders
COH
Non-systematic Assessment
EG0009 events3 affected11 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Hyperglycemia
Metabolism and nutrition disorders
COH
Non-systematic Assessment
EG00014 events5 affected11 at risk
EG0010 events0 affected1 at risk
EG00225 events2 affected3 at risk
EG003
Hyperkalemia
Metabolism and nutrition disorders
meddra9.0
Non-systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Hypermagnesemia
Metabolism and nutrition disorders
meddra9.0
Non-systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Hypernatremia
Metabolism and nutrition disorders
meddra9.0
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Hyperuricemia
Metabolism and nutrition disorders
meddra9.0
Non-systematic Assessment
EG0002 events1 affected11 at risk
EG0010 events0 affected1 at risk
EG00213 events1 affected3 at risk
EG003
Hypoalbuminemia
Metabolism and nutrition disorders
meddra9.0
Non-systematic Assessment
EG0004 events2 affected11 at risk
EG0010 events0 affected1 at risk
EG0028 events3 affected3 at risk
EG003
Hypocalcemia
Metabolism and nutrition disorders
meddra9.0
Non-systematic Assessment
EG00012 events5 affected11 at risk
EG0010 events0 affected1 at risk
EG0022 events1 affected3 at risk
EG003
Hypoglycemia
Metabolism and nutrition disorders
COH
Non-systematic Assessment
EG0009 events3 affected11 at risk
EG0010 events0 affected1 at risk
EG0023 events2 affected3 at risk
EG003
Hypokalemia
Metabolism and nutrition disorders
meddra9.0
Non-systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected3 at risk
EG003
Hypomagnesemia
Metabolism and nutrition disorders
COH
Non-systematic Assessment
EG0009 events3 affected11 at risk
EG0010 events0 affected1 at risk
EG0024 events3 affected3 at risk
EG003
Hyponatremia
Metabolism and nutrition disorders
meddra9.0
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Hypophosphatemia
Metabolism and nutrition disorders
meddra9.0
Non-systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected1 at risk
EG0023 events1 affected3 at risk
EG003
Serum albumin decreased
Metabolism and nutrition disorders
meddra10.0
Non-systematic Assessment
EG0007 events3 affected11 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Serum calcium decreased
Metabolism and nutrition disorders
meddra10.0
Non-systematic Assessment
EG0001 events1 affected11 at risk
EG0012 events1 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Serum calcium increased
Metabolism and nutrition disorders
meddra10.0
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Serum glucose decreased
Metabolism and nutrition disorders
meddra10.0
Non-systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Serum magnesium decreased
Metabolism and nutrition disorders
meddra10.0
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Serum phosphate decreased
Metabolism and nutrition disorders
meddra10.0
Non-systematic Assessment
EG0001 events1 affected11 at risk
EG0011 events1 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Serum potassium decreased
Metabolism and nutrition disorders
meddra10.0
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Serum sodium decreased
Metabolism and nutrition disorders
meddra10.0
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Joint pain
Musculoskeletal and connective tissue disorders
meddra10.0
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Muscle weakness
Musculoskeletal and connective tissue disorders
meddra10.0
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Musculoskeletal disorder
Musculoskeletal and connective tissue disorders
meddra10.0
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
meddra10.0
Non-systematic Assessment
EG0001 events1 affected11 at risk
EG0011 events1 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Cortical/State of Consciousness
Nervous system disorders
COH
Non-systematic Assessment
EG0002 events2 affected11 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Depressed level of consciousness
Nervous system disorders
meddra9.0
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected3 at risk
EG003
Dizziness
Nervous system disorders
meddra10.0
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Headache
Nervous system disorders
COH
Non-systematic Assessment
EG0003 events3 affected11 at risk
EG0011 events1 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Ischemia cerebrovascular
Nervous system disorders
meddra9.0
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Motor Activity
Nervous system disorders
COH
Non-systematic Assessment
EG0002 events2 affected11 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Peripheral Nervous System Sensory
Nervous system disorders
COH
Non-systematic Assessment
EG0002 events2 affected11 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Peripheral motor neuropathy
Nervous system disorders
meddra9.0
Non-systematic Assessment
EG0003 events3 affected11 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected3 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
meddra10.0
Non-systematic Assessment
EG0006 events1 affected11 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected3 at risk
EG003
Speech disorder
Nervous system disorders
meddra10.0
Non-systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Taste alteration
Nervous system disorders
meddra9.0
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Tremor
Nervous system disorders
meddra9.0
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Anxiety
Psychiatric disorders
meddra10.0
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Confusion
Psychiatric disorders
meddra10.0
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Depression
Psychiatric disorders
meddra9.0
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Hallucinations
Psychiatric disorders
meddra10.0
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Ideation
Psychiatric disorders
COH
Non-systematic Assessment
EG0002 events2 affected11 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Insomnia
Psychiatric disorders
meddra9.0
Non-systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected1 at risk
EG00222 events1 affected3 at risk
EG003
Mood
Psychiatric disorders
COH
Non-systematic Assessment
EG0002 events2 affected11 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Personality change
Psychiatric disorders
meddra10.0
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Bladder pain
Renal and urinary disorders
meddra10.0
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Hematuria
Renal and urinary disorders
COH
Non-systematic Assessment
EG0007 events2 affected11 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Hematuria (in the absence of vaginal bleeding)
Renal and urinary disorders
meddra10.0
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Protein urine positive
Renal and urinary disorders
meddra10.0
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Proteinuria
Renal and urinary disorders
COH
Non-systematic Assessment
EG0007 events2 affected11 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Urinary frequency
Renal and urinary disorders
meddra10.0
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0012 events1 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Urinary retention
Renal and urinary disorders
meddra10.0
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0012 events1 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Vaginal hemorrhage
Reproductive system and breast disorders
meddra9.0
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
meddra10.0
Non-systematic Assessment
EG0005 events1 affected11 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Dyspnea
Respiratory, thoracic and mediastinal disorders
meddra10.0
Non-systematic Assessment
EG0005 events2 affected11 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected3 at risk
EG003
Hemorrhage nasal
Respiratory, thoracic and mediastinal disorders
meddra10.0
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
meddra9.0
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
meddra9.0
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
meddra9.0
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Respiratory disorder
Respiratory, thoracic and mediastinal disorders
meddra10.0
Non-systematic Assessment
EG0002 events2 affected11 at risk
EG0011 events1 affected1 at risk
EG0021 events1 affected3 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
COH
Non-systematic Assessment
EG00027 events7 affected11 at risk
EG0010 events0 affected1 at risk
EG0022 events1 affected3 at risk
EG003
Extensive Skin Rash
Skin and subcutaneous tissue disorders
COH
Non-systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Local Skin Rash
Skin and subcutaneous tissue disorders
COH
Non-systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
meddra9.0
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Rash desquamating
Skin and subcutaneous tissue disorders
meddra10.0
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Skin disorder
Skin and subcutaneous tissue disorders
meddra10.0
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Sweating
Skin and subcutaneous tissue disorders
meddra9.0
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Hypertension
Vascular disorders
COH
Non-systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Hypotension
Vascular disorders
meddra9.0
Non-systematic Assessment
EG0002 events2 affected11 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Thrombosis
Vascular disorders
meddra9.0
Non-systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
Yes
Restriction Type
Not provided
Results Disclosure Restriction on PI(s)?
Not provided
Other Details
Not provided
Point of Contact
Title
Organization
Phone
Extension
Email
Paul Frankel, Ph.D.
City of Hope
626-218-5265
pfrankel@coh.org
ID
Term
D008175
Lung Neoplasms
D002289
Carcinoma, Non-Small-Cell Lung
Ancestor Terms
ID
Term
D012142
Respiratory Tract Neoplasms
D013899
Thoracic Neoplasms
D009371
Neoplasms by Site
D009369
Neoplasms
D008171
Lung Diseases
D012140
Respiratory Tract Diseases
D002283
Carcinoma, Bronchogenic
D001984
Bronchial Neoplasms
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
D007208
Indocyanine Green
D008012
Lidocaine
D000077235
Vinorelbine
D002851
Chromatography, High Pressure Liquid
D002853
Chromatography, Liquid
D013058
Mass Spectrometry
Ancestor Terms
ID
Term
D007211
Indoles
D006574
Heterocyclic Compounds, 2-Ring
D000072471
Heterocyclic Compounds, Fused-Ring
D006571
Heterocyclic Compounds
D000083
Acetanilides
D000813
Anilides
D000577
Amides
D009930
Organic Chemicals
D000814
Aniline Compounds
D000588
Amines
D014748
Vinca Alkaloids
D046948
Secologanin Tryptamine Alkaloids
D026121
Indole Alkaloids
D000470
Alkaloids
D054836
Indolizidines
D007212
Indolizines
D002845
Chromatography
D002623
Chemistry Techniques, Analytical
D008919
Investigative Techniques
Browse Leaves
Not provided
Browse Branches
Not provided
13
Asian
Title
Measurements
BG0009
African American
Title
Measurements
BG0002
4
324
(167 to 1090)
OG005
Moderate (15mg/m2)
Moderate Liver Dysfunction Group with 15 mg/m2 of Vinorelbine.
OG006
Severe (20mg/m2)
Severe Liver Dysfunction Group with 20 mg/m2 of Vinorelbine.
OG007
Severe (7.5mg/m2)
Severe Liver Dysfunction Group with 7.5 mg/m2 of Vinorelbine.