Panitumumab Combination Study With Rilotumumab or Ganitum... | NCT00788957 | Trialant
NCT00788957
Sponsor
NantBioScience, Inc.
Status
Completed
Last Update Posted
Aug 7, 2024Actual
Enrollment
177Actual
Phase
Phase 1Phase 2
Conditions
Colon Cancer
Colorectal Cancer
Gastrointestinal Cancer
Metastatic Colorectal Cancer
Rectal Cancer
Interventions
Panitumumab
Ganitumab
Rilotumumab
Placebo
Countries
Not provided
Protocol Section
Identification Module
NCT ID
NCT00788957
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
20060447
Secondary IDs
Not provided
Brief Title
Panitumumab Combination Study With Rilotumumab or Ganitumab in Wild-type Kirsten Rat Sarcoma Virus Oncogene Homolog (KRAS) Metastatic Colorectal Cancer (mCRC)
Official Title
A Randomized, Phase 1b/2 Trial of AMG 102 or AMG 479 in Combination With Panitumumab Versus Panitumumab Alone in Subject With Wild-Type KRAS Metastatic Colorectal Cancer
Acronym
Not provided
Organization
NantBioScience, Inc.INDUSTRY
Status Module
Record Verification Date
Jul 2024
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
Oct 27, 2008Actual
Primary Completion Date
Jul 23, 2010Actual
Completion Date
Jul 23, 2010Actual
First Submitted Date
Oct 23, 2008
First Submission Date that Met QC Criteria
Nov 10, 2008
First Posted Date
Nov 11, 2008Estimated
Results Waived
Not provided
Results First Submitted Date
Mar 24, 2015
Results First Submitted that Met QC Criteria
Jun 23, 2015
Results First Posted Date
Jul 20, 2015Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Mar 26, 2014
Certification/Extension First Submitted that Passed QC Review
Mar 26, 2014
Certification/Extension First Posted Date
Apr 22, 2014Estimated
Last Update Submitted Date
Jul 12, 2024
Last Update Posted Date
Aug 7, 2024Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
NantBioScience, Inc.INDUSTRY
Collaborators
Not provided
Oversight Module
No data available
No data is available for this block.
Description Module
Brief Summary
This study is a global, multicenter, open-label phase 1b and randomized, double-blinded, 2 part, phase 2 study designed to evaluate the safety and efficacy of rilotumumab or ganitumab in combination with panitumumab versus panitumumab alone in patients with metastatic colorectal cancer whose tumors are wild-type KRAS status.
Detailed Description
This study consisted of 3 parts:
Part 1: determination of the tolerable dose of rilotumumab in combination with panitumumab to be administered in Part 2.
Part 2: Comparison of the safety and efficacy of rilotumumab or ganitumab in combination with panitumumab versus that of panitumumab alone. In Part 2, participants were randomized 1:1:1 into 3 cohorts: 6 mg/kg panitumumab plus 10 mg/kg rilotumumab, 6 mg/kg panitumumab plus 12 mg/kg ganitumab, or 6 mg/kg panitumumab and placebo (panitumumab alone cohort). Panitumumab was administered open-label, and rilotumumab and ganitumab were double-blinded.
Part 3: Exploratory evaluation of the safety and efficacy of the rilotumumab and ganitumab monotherapy following treatment with panitumumab in Part 2. In Part 3, eligible participants who terminated panitumumab treatment in the Panitumumab Alone arm of Part 2 due to disease progression or intolerability could be randomized 1:1 into 2 double-blind cohorts: 10 mg/kg rilotumumab or 12 mg/kg ganitumab.
Participants who permanently discontinued all the investigational products completed a safety follow-up visit 30 days and a follow-up visit 60 days after the last dose of investigational product. Participants were followed for radiographic disease progression and survival every 3 months after the 30-day safety follow-up visit for up to 2 years after the last participant was enrolled in Part 2.
Conditions Module
Conditions
Colon Cancer
Colorectal Cancer
Gastrointestinal Cancer
Metastatic Colorectal Cancer
Rectal Cancer
Keywords
panitumumab
vectibix
AMG 102
AMG 479
colon cancer
rectal cancer
colorectal cancer
metastatic colorectal cancer
EGFR inhibitor
IGF inhibitor
c-MET inhibitor
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 1Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
177Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Part 1: Panitumumab + Rilotumumab
Experimental
Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
Drug: Panitumumab
Drug: Rilotumumab
Part 2: Panitumumab Alone
Active Comparator
Participants received panitumumab 6 mg/kg and placebo by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
Drug: Panitumumab
Part 2: Panitumumab + Rilotumumab
Experimental
Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
Drug: Panitumumab
Drug: Rilotumumab
Drug: Placebo
Part 2: Panitumumab + Ganitumab
Experimental
Participants received panitumumab 6 mg/kg and ganitumab 12 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
Drug: Panitumumab
Drug: Ganitumab
Drug: Placebo
Part 3: Rilotumumab
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Panitumumab
Drug
Panitumumab for intravenous infusion
Part 1: Panitumumab + Rilotumumab
Part 2: Panitumumab + Ganitumab
Part 2: Panitumumab + Rilotumumab
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Part 1: Number of Participants With Dose-limiting Toxicities (DLT)
A DLT is defined as any grade 3 or 4 rilotumumab-related or combination (panitumumab and rilotumumab)-related adverse event or laboratory abnormality that is deemed clinically significant by the investigator
7 weeks
Part 2: Percentage of Participants With an Objective Response
An objective response is defined as a confirmed complete (CR) or partial response (PR) no less than 4 weeks after the criteria for response are first met, determined by the investigator considering the radiologic response of all existing target and non-target lesions, evidence of new lesions, and cytology evaluation (as appropriate) according to the Modified-Response Evaluation Criteria In Solid Tumors (RECIST) v1.0 criteria: CR: Disappearance of all target and non-target and no new lesions. PR: At least a 30% decrease in the size of target lesions with no increase in non-target lesions, or, the disappearance of all target lesions and persistence of one or more non-target lesion(s) not qualifying for either CR or progressive disease. Participants without a post-baseline assessment were considered non-responders. Tumor assessments up to the initiation of another anti-tumor therapy including the Part 3 treatment, if applicable, were used.
From the date of first dose until the data cut-off date of 23 July 2010. Median follow-up time was 30 weeks.
Secondary Outcomes
Measure
Description
Time Frame
Duration of Response - Part 2
Time from the confirmed objective response to disease progression per the modified RECIST v1.0 criteria.
From the date of first dose until the data cut-off date of 23 July 2010. Median follow-up time was 30 weeks.
Time to Response - Part 2
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
metastatic adenocarcinoma of the colon or rectum
wild-type KRAS tumor status
radiographic evidence of disease progression during or following treatment with irinotecan and/or oxaliplatin containing chemotherapy for mCRC
measurable disease >/= 20 mm per Response Evaluation Criteria In Solid Tumors (RECIST)
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
adequate laboratory values
Exclusion Criteria:
history of central nervous system (CNS) metastases
history of another primary cancer, unless:
curatively resected non-melanomatous skin cancer
curatively treated cervical carcinoma in situ
other primary solid tumor treated with curative intent and no known active disease present for >/= 5 years
Van Cutsem E, Eng C, Nowara E, Swieboda-Sadlej A, Tebbutt NC, Mitchell E, Davidenko I, Stephenson J, Elez E, Prenen H, Deng H, Tang R, McCaffery I, Oliner KS, Chen L, Gansert J, Loh E, Smethurst D, Tabernero J. Randomized phase Ib/II trial of rilotumumab or ganitumab with panitumumab versus panitumumab alone in patients with wild-type KRAS metastatic colorectal cancer. Clin Cancer Res. 2014 Aug 15;20(16):4240-50. doi: 10.1158/1078-0432.CCR-13-2752. Epub 2014 Jun 11.
In Part 2 participants were randomized in a 1:1:1 ratio to the 3 double-blinded treatment arms. In Part 3, participants randomized to Panitumumab Alone in Part 2 and with disease progression or intolerability were re-randomized 1:1 into 2 double-blind groups.
Clinically significant laboratory findings were considered adverse events, so the protocol endpoint "Incidence of all AEs and clinical laboratory abnormalities" was not analyzed separately but was included in the AE data
Recruitment Details
First patient enrolled 27 October 2008; last patient enrolled 05 February 2010. In Part 1, participants with wild-type KRAS metastatic colorectal cancer received open-label rilotumumab and panitumumab to identify a tolerable dose of rilotumumab for Part 2 of the study. Participants enrolled in Part 1 were not eligible for randomization in Part 2.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Part 1: Panitumumab + Rilotumumab
Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
FG001
Part 2: Panitumumab Alone
Periods
Title
Milestones
Reasons Not Completed
Part 1
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot_SAP
Yes
Yes
No
Study Protocol and Statistical Analysis Plan
Jun 17, 2013
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Australia
Austria
Belgium
Canada
France
Italy
Poland
Russia
Spain
United Kingdom
United States
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Triple
Masking Description
Not provided
Who Masked
ParticipantCare ProviderInvestigator
Experimental
Participants randomized to Panitumumab Alone in Part 2 who had disease progression (radiographic or clinical) or intolerability were re-randomized in Part 3 to receive rilotumumab 10 mg/kg every 2 weeks until disease progression, intolerability, withdrawal, death, or sponsor decision.
Drug: Rilotumumab
Drug: Placebo
Part 3: Ganitumab
Experimental
Participants randomized to Panitumumab Alone in Part 2 who had disease progression (radiographic or clinical) or intolerability were re-randomized in Part 3 to receive ganitumab 12 mg/kg every 2 weeks until disease progression, intolerability, withdrawal, death, or sponsor decision.
Drug: Ganitumab
Drug: Placebo
Part 2: Panitumumab Alone
Vectibix®
Ganitumab
Drug
Ganitumab for intravenous infusion
Part 2: Panitumumab + Ganitumab
Part 3: Ganitumab
AMG 479
Rilotumumab
Drug
Rilotumumab for intravenous infusion
Part 1: Panitumumab + Rilotumumab
Part 2: Panitumumab + Rilotumumab
Part 3: Rilotumumab
AMG 102
Placebo
Drug
Placebo intravenous infusion
Part 2: Panitumumab + Ganitumab
Part 2: Panitumumab + Rilotumumab
Part 3: Ganitumab
Part 3: Rilotumumab
Time from the first dose of investigational product to the date of first confirmed objective response. Calculated only for subject with a confirmed objective response
From the date of first dose until the data cut-off date of 23 July 2010. Median follow-up time was 30 weeks.
Disease Control Rate - Part 2
The incidence of confirmed objective response or stable disease. Stable disease cannot be established prior to study day 49 (calculated from the date of first dose of investigational product), ie, the earliest protocol scheduled tumor assessment
From the date of first dose until the data cut-off date of 23 July 2010. Median follow-up time was 30 weeks.
Progression-free Survival (PFS) - Part 2
Time from the first dose of investigational product to the date of disease progression per the modified RECIST v1.0 criteria or death
From the date of first dose until the data cut-off date of 23 July 2010. Median follow-up time was 30 weeks.
On-treatment Progression-free Survival (PFS) - Part 2
Time from the first dose of investigational product to the date of disease progression per the modified RECIST v1.0 criteria or death during the treatment period (from the first to last dose of investigational product). Radiographic progression within 28 days since last dose of study therapy (last component of combination therapy) up to the initiation of another anti-tumor therapy, including the Part 3 treatment, if applicable, or death within 28 days since last dose of study therapy.
From the date of first dose until the data cut-off date of 23 July 2010. Up to 56 weeks.
Overall Survival - Part 2
The interval in months from the first dose of investigational product to the date of death.
From the date of first dose until the data cut-off date of 23 July 2010. Median follow-up time was 30 weeks.
Cmin, Cmax of Panitumumab
Cmin = minimum drug concentration during a dosing interval; Cmax = maximum observed drug concentration during a dosing interval
14 days
Cmin, Cmax, for Rilotumumab
Cmin = minimum drug concentration during a dosing interval; Cmax = maximum observed drug concentration during a dosing interval
14 days
Cmin for Panitumumab - Part 2
Cmin = minimum drug concentration during a dosing interval
Up to 23 weeks
Cmax for Panitumumab - Part 2
Cmax = maximum observed drug concentration during a dosing interval
Up to 23 weeks
Cmin for Rilotumumab - Part 2
Cmin = minimum drug concentration during a dosing interval
Up to 23 weeks
Cmax for Rilotumumab - Part 2
Cmax = maximum observed drug concentration during a dosing interval
Up to 23 weeks
Cmin for Ganitumab - Part 2
Cmin = minimum drug concentration during a dosing interval
Up to 23 weeks
Cmax for Ganitumab - Part 2
Cmax = maximum observed drug concentration during a dosing interval
Up to 23 weeks
Total Anti-Panitumumab Antibody Incidence - Part 2
Ratio of the number of subjects with at least one positive antibody result at baseline (or at any post-baseline or long-term follow-up time point) to the number of subjects with at least one immunoassay results at baseline (or at any post-baseline or long term follow-up time point). Measured by either Biacore or ELISA.
First dose of any study drug and before 120 days of last dose of study drugs; up to 1 year, eight months
Total Anti-AMG 102 Antibody Incidence - Part 2
Ratio of the number of subjects with at least one positive antibody result at baseline (or at any post-baseline or long-term follow-up time point) to the number of subjects with at least one immunoassay results at baseline (or at any post-baseline or long term follow-up time point). Measured by MSD.
First dose of any study drug and before 120 days of last dose of study drugs, up to 1 year, eight months.
Total Anti-AMG 479 Antibody Incidence - Part 2
Ratio of the number of subjects with at least one positive antibody result at baseline (or at any post-baseline or long-term follow-up time point) to the number of subjects with at least one immunoassay results at baseline (or at any post-baseline or long term follow-up time point). Measured by MSD.
First dose of any study drug and before 120 days of last dose of study drugs, up to 1 year, eight months.
AUC for Rilotumumab
AUC = area under the drug concentration-time curve during a dosing interval
14 Days
AUC for Panitumumab
AUC = area under the drug concentration-time curve during a dosing interval
14 Days
Derived
Peeters M, Kafatos G, Taylor A, Gastanaga VM, Oliner KS, Hechmati G, Terwey JH, van Krieken JH. Prevalence of RAS mutations and individual variation patterns among patients with metastatic colorectal cancer: A pooled analysis of randomised controlled trials. Eur J Cancer. 2015 Sep;51(13):1704-13. doi: 10.1016/j.ejca.2015.05.017. Epub 2015 Jun 3.
Participants received panitumumab 6 mg/kg and placebo by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
FG002
Part 2: Panitumumab + Rilotumumab
Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
FG003
Part 2: Panitumumab + Ganitumab
Participants received panitumumab 6 mg/kg and ganitumab 12 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
FG004
Part 3: Rilotumumab
Participants randomized to Panitumumab Alone in Part 2 who had disease progression (radiographic or clinical) or intolerability were re-randomized in Part 3 to receive rilotumumab 10 mg/kg every 2 weeks until disease progression, intolerability, withdrawal, death, or sponsor decision.
FG005
Part 3: Ganitumab
Participants randomized to Panitumumab Alone in Part 2 who had disease progression (radiographic or clinical) or intolerability were re-randomized in Part 3 to receive ganitumab 12 mg/kg every 2 weeks until disease progression, intolerability, withdrawal, death, or sponsor decision.
FG00011 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
COMPLETED
FG0002 subjectsCompleted the safety follow-up visit
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
NOT COMPLETED
FG0009 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
Type
Comment
Reasons
Death
FG0008 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
Lost to Follow-up
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Part 2
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG00148 subjects
FG00248 subjects
FG00346 subjects
FG0040 subjects
FG0050 subjects
COMPLETED
FG0000 subjects
FG0016 subjectsCompleted the safety follow-up visit at the end of the study
FG0024 subjectsCompleted the safety follow-up visit
FG003
NOT COMPLETED
FG0000 subjects
FG00142 subjects
FG00244 subjects
FG00341 subjects
FG004
Type
Comment
Reasons
Withdrawal by Subject
FG0000 subjects
FG0019 subjects
FG0025 subjects
FG003
Part 3
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG00413 subjects
FG00511 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Safety analysis set, including participants who received at least one dose of respective investigational product in the corresponding parts of the study.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Part 1: Panitumumab + Rilotumumab
Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
BG001
Part 2: Panitumumab Alone
Participants received panitumumab 6 mg/kg and placebo by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
BG002
Part 2: Panitumumab + Rilotumumab
Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
BG003
Part 2: Panitumumab + Ganitumab
Participants received panitumumab 6 mg/kg and ganitumab 12 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
BG004
Part 3: Rilotumumab
Participants randomized to Panitumumab Alone in Part 2 who had disease progression (radiographic or clinical) or intolerability were re-randomized in Part 3 to receive rilotumumab 10 mg/kg every 2 weeks until disease progression, intolerability, withdrawal, death, or sponsor decision.
BG005
Part 3: Ganitumab
Participants randomized to Panitumumab Alone in Part 2 who had disease progression (radiographic or clinical) or intolerability were re-randomized in Part 3 to receive ganitumab 12 mg/kg every 2 weeks until disease progression, intolerability, withdrawal, death, or sponsor decision.
BG006
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00011
BG00148
BG00248
BG00346
BG00413
BG00511
BG006177
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
Part 1 Participants
Title
Measurements
BG00056.5± 13.8
BG001NA± NA
BG002NA± NA
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0006
BG00120
BG002
Race/Ethnicity, Customized
Hispanic/Latino was collected as Race Category.
Number
participants
Title
Denominators
Categories
White or Caucasian
Title
Measurements
BG00011
BG00145
BG002
Subjects With Wild-Type KRAS Metastatic Colorectal Cancer
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
BG00011
BG00148
BG002
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
Part 1: Number of Participants With Dose-limiting Toxicities (DLT)
A DLT is defined as any grade 3 or 4 rilotumumab-related or combination (panitumumab and rilotumumab)-related adverse event or laboratory abnormality that is deemed clinically significant by the investigator
The first 6 DLT evaluable participants, including participants who received at least 2 doses of panitumumab and rilotumumab as scheduled (ie, Week 1 and 3) and have a minimum 28 days follow-up for safety or, have received at least 1 dose of panitumumab and rilotumumab and had a DLT within the first 28 days on study.
Posted
Number
participants
7 weeks
ID
Title
Description
OG000
Part 1: Panitumumab + Rilotumumab
Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
Units
Counts
Participants
OG0006
Title
Denominators
Categories
Title
Measurements
OG0000
Primary
Part 2: Percentage of Participants With an Objective Response
An objective response is defined as a confirmed complete (CR) or partial response (PR) no less than 4 weeks after the criteria for response are first met, determined by the investigator considering the radiologic response of all existing target and non-target lesions, evidence of new lesions, and cytology evaluation (as appropriate) according to the Modified-Response Evaluation Criteria In Solid Tumors (RECIST) v1.0 criteria: CR: Disappearance of all target and non-target and no new lesions. PR: At least a 30% decrease in the size of target lesions with no increase in non-target lesions, or, the disappearance of all target lesions and persistence of one or more non-target lesion(s) not qualifying for either CR or progressive disease. Participants without a post-baseline assessment were considered non-responders. Tumor assessments up to the initiation of another anti-tumor therapy including the Part 3 treatment, if applicable, were used.
Efficacy analysis set (enrolled participants who received at least one dose of respective investigational product in the corresponding parts of the study) with measurable baseline disease.
Posted
Number
95% Confidence Interval
percentage of participants
From the date of first dose until the data cut-off date of 23 July 2010. Median follow-up time was 30 weeks.
ID
Title
Description
OG000
Part 2: Panitumumab Alone
Participants received panitumumab 6 mg/kg and placebo by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
OG001
Secondary
Duration of Response - Part 2
Time from the confirmed objective response to disease progression per the modified RECIST v1.0 criteria.
Only subjects with confirmed response
Posted
Median
95% Confidence Interval
Months
From the date of first dose until the data cut-off date of 23 July 2010. Median follow-up time was 30 weeks.
ID
Title
Description
OG000
Part 2: Panitumumab Alone
Participants received panitumumab 6 mg/kg and placebo by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
OG001
Part 2: Panitumumab + Rilotumumab
Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
OG002
Part 2: Panitumumab + Ganitumab
Participants received panitumumab 6 mg/kg and ganitumab 12 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
Secondary
Time to Response - Part 2
Time from the first dose of investigational product to the date of first confirmed objective response. Calculated only for subject with a confirmed objective response
Only subjects with confirmed response
Posted
Median
95% Confidence Interval
Months
From the date of first dose until the data cut-off date of 23 July 2010. Median follow-up time was 30 weeks.
ID
Title
Description
OG000
Part 2: Panitumumab Alone
Participants received panitumumab 6 mg/kg and placebo by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
OG001
Part 2: Panitumumab + Rilotumumab
Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
OG002
Part 2: Panitumumab + Ganitumab
Participants received panitumumab 6 mg/kg and ganitumab 12 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
Secondary
Disease Control Rate - Part 2
The incidence of confirmed objective response or stable disease. Stable disease cannot be established prior to study day 49 (calculated from the date of first dose of investigational product), ie, the earliest protocol scheduled tumor assessment
Posted
Number
95% Confidence Interval
percentage of participants
From the date of first dose until the data cut-off date of 23 July 2010. Median follow-up time was 30 weeks.
ID
Title
Description
OG000
Part 2: Panitumumab Alone
Participants received panitumumab 6 mg/kg and placebo by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
OG001
Part 2: Panitumumab + Rilotumumab
Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
OG002
Part 2: Panitumumab + Ganitumab
Participants received panitumumab 6 mg/kg and ganitumab 12 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
Secondary
Progression-free Survival (PFS) - Part 2
Time from the first dose of investigational product to the date of disease progression per the modified RECIST v1.0 criteria or death
Posted
Median
95% Confidence Interval
Months
From the date of first dose until the data cut-off date of 23 July 2010. Median follow-up time was 30 weeks.
ID
Title
Description
OG000
Part 2: Panitumumab Alone
Participants received panitumumab 6 mg/kg and placebo by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
OG001
Part 2: Panitumumab + Rilotumumab
Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
OG002
Part 2: Panitumumab + Ganitumab
Participants received panitumumab 6 mg/kg and ganitumab 12 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
Secondary
On-treatment Progression-free Survival (PFS) - Part 2
Time from the first dose of investigational product to the date of disease progression per the modified RECIST v1.0 criteria or death during the treatment period (from the first to last dose of investigational product). Radiographic progression within 28 days since last dose of study therapy (last component of combination therapy) up to the initiation of another anti-tumor therapy, including the Part 3 treatment, if applicable, or death within 28 days since last dose of study therapy.
Posted
Median
95% Confidence Interval
Months
From the date of first dose until the data cut-off date of 23 July 2010. Up to 56 weeks.
ID
Title
Description
OG000
Part 2: Panitumumab Alone
Participants received panitumumab 6 mg/kg and placebo by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
OG001
Part 2: Panitumumab + Rilotumumab
Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
OG002
Part 2: Panitumumab + Ganitumab
Participants received panitumumab 6 mg/kg and ganitumab 12 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
Secondary
Overall Survival - Part 2
The interval in months from the first dose of investigational product to the date of death.
Posted
Median
95% Confidence Interval
Months
From the date of first dose until the data cut-off date of 23 July 2010. Median follow-up time was 30 weeks.
ID
Title
Description
OG000
Part 2: Panitumumab Alone
Participants received panitumumab 6 mg/kg and placebo by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
OG001
Part 2: Panitumumab + Rilotumumab
Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
OG002
Part 2: Panitumumab + Ganitumab
Participants received panitumumab 6 mg/kg and ganitumab 12 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
Units
Counts
Secondary
Cmin, Cmax of Panitumumab
Cmin = minimum drug concentration during a dosing interval; Cmax = maximum observed drug concentration during a dosing interval
PK population
Posted
Median
Full Range
μg/mL
14 days
ID
Title
Description
OG000
Part 1: Panitumumab + Rilotumumab
Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
Units
Counts
Participants
OG0006
Secondary
Cmin, Cmax, for Rilotumumab
Cmin = minimum drug concentration during a dosing interval; Cmax = maximum observed drug concentration during a dosing interval
PK population
Posted
Median
Full Range
μg/mL
14 days
ID
Title
Description
OG000
Part 1: Panitumumab + Rilotumumab
Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
Units
Counts
Participants
OG0006
Secondary
Cmin for Panitumumab - Part 2
Cmin = minimum drug concentration during a dosing interval
PK population Measure of dispersion is %CV
Posted
Mean
Standard Deviation
μg/mL
Up to 23 weeks
ID
Title
Description
OG000
Part 2: Panitumumab Alone
Participants received panitumumab 6 mg/kg and placebo by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
OG001
Part 2: Panitumumab + Rilotumumab
Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
OG002
Part 2: Panitumumab + Ganitumab
Participants received panitumumab 6 mg/kg and ganitumab 12 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
Units
Counts
Secondary
Cmax for Panitumumab - Part 2
Cmax = maximum observed drug concentration during a dosing interval
PK population Measure of dispersion is %CV
Posted
Mean
Standard Deviation
μg/mL
Up to 23 weeks
ID
Title
Description
OG000
Part 2: Panitumumab Alone
Participants received panitumumab 6 mg/kg and placebo by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
OG001
Part 2: Panitumumab + Rilotumumab
Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
OG002
Part 2: Panitumumab + Ganitumab
Participants received panitumumab 6 mg/kg and ganitumab 12 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
Units
Counts
Secondary
Cmin for Rilotumumab - Part 2
Cmin = minimum drug concentration during a dosing interval
PK population Measure of dispersion is %CV
Posted
Mean
Standard Deviation
μg/mL
Up to 23 weeks
ID
Title
Description
OG000
Part 2: Panitumumab + Rilotumumab
Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
Units
Counts
Participants
OG00043
Secondary
Cmax for Rilotumumab - Part 2
Cmax = maximum observed drug concentration during a dosing interval
PK population Measure of dispersion is %CV
Posted
Mean
Standard Deviation
μg/ml
Up to 23 weeks
ID
Title
Description
OG000
Part 2: Panitumumab + Rilotumumab
Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
Units
Counts
Participants
OG00043
Secondary
Cmin for Ganitumab - Part 2
Cmin = minimum drug concentration during a dosing interval
PK population Measure of dispersion is %CV
Posted
Mean
Standard Deviation
μg/ml
Up to 23 weeks
ID
Title
Description
OG000
Part 2: Panitumumab + Ganitumab
Participants received panitumumab 6 mg/kg and ganitumab 12 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
Units
Counts
Participants
OG00042
Secondary
Cmax for Ganitumab - Part 2
Cmax = maximum observed drug concentration during a dosing interval
PK population Measure of dispersion is %CV
Posted
Mean
Standard Deviation
μg/mL
Up to 23 weeks
ID
Title
Description
OG000
Part 2: Panitumumab + Ganitumab
Participants received panitumumab 6 mg/kg and ganitumab 12 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
Units
Counts
Participants
OG00042
Secondary
Total Anti-Panitumumab Antibody Incidence - Part 2
Ratio of the number of subjects with at least one positive antibody result at baseline (or at any post-baseline or long-term follow-up time point) to the number of subjects with at least one immunoassay results at baseline (or at any post-baseline or long term follow-up time point). Measured by either Biacore or ELISA.
Posted
Number
percentage of participants
First dose of any study drug and before 120 days of last dose of study drugs; up to 1 year, eight months
ID
Title
Description
OG000
Part 2: Panitumumab Alone
Participants received panitumumab 6 mg/kg and placebo by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
OG001
Part 2: Panitumumab + Rilotumumab
Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
OG002
Part 2: Panitumumab + Ganitumab
Participants received panitumumab 6 mg/kg and ganitumab 12 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
Secondary
Total Anti-AMG 102 Antibody Incidence - Part 2
Ratio of the number of subjects with at least one positive antibody result at baseline (or at any post-baseline or long-term follow-up time point) to the number of subjects with at least one immunoassay results at baseline (or at any post-baseline or long term follow-up time point). Measured by MSD.
Only subjects having AMG-102 treatment in part 2 were measured for antibody incidence.
Posted
Number
percentage of participants
First dose of any study drug and before 120 days of last dose of study drugs, up to 1 year, eight months.
ID
Title
Description
OG000
Part 2: Panitumumab + Rilotumumab
Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
Units
Counts
Participants
OG000
Secondary
Total Anti-AMG 479 Antibody Incidence - Part 2
Ratio of the number of subjects with at least one positive antibody result at baseline (or at any post-baseline or long-term follow-up time point) to the number of subjects with at least one immunoassay results at baseline (or at any post-baseline or long term follow-up time point). Measured by MSD.
Only subjects having AMG-479 treatment in part 2 were measured for antibody incidence.
Posted
Number
percentage of participants
First dose of any study drug and before 120 days of last dose of study drugs, up to 1 year, eight months.
ID
Title
Description
OG000
Part 2: Panitumumab + Ganitumab
Participants received panitumumab 6 mg/kg and ganitumab 12 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
Units
Counts
Participants
OG000
Secondary
AUC for Rilotumumab
AUC = area under the drug concentration-time curve during a dosing interval
PK population
Posted
Median
Full Range
day•μg/mL
14 Days
ID
Title
Description
OG000
Part 1: Panitumumab + Rilotumumab
Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
Units
Counts
Participants
OG0006
Secondary
AUC for Panitumumab
AUC = area under the drug concentration-time curve during a dosing interval
PK Population
Posted
Median
Full Range
day•μg/mL
14 Days
ID
Title
Description
OG000
Part 1: Panitumumab + Rilotumumab
Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
Units
Counts
Participants
OG0006
Time Frame
All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
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
Part 1: Panitumumab + Rilotumumab
Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
8
11
5
11
11
11
EG001
Part 2: Panitumumab Alone
Participants received panitumumab 6 mg/kg and placebo by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
32
48
11
48
42
48
EG002
Part 2: Panitumumab + Rilotumumab
Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
35
48
9
48
47
48
EG003
Part 2: Panitumumab + Ganitumab
Participants received panitumumab 6 mg/kg and ganitumab 12 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
37
46
9
46
44
46
EG004
Part 3: Rilotumumab
Participants randomized to Panitumumab Alone in Part 2 who had disease progression (radiographic or clinical) or intolerability were re-randomized in Part 3 to receive rilotumumab 10 mg/kg every 2 weeks until disease progression, intolerability, withdrawal, death, or sponsor decision.
8
13
6
13
11
13
EG005
Part 3: Ganitumab
Participants randomized to Panitumumab Alone in Part 2 who had disease progression (radiographic or clinical) or intolerability were re-randomized in Part 3 to receive ganitumab 12 mg/kg every 2 weeks until disease progression, intolerability, withdrawal, death, or sponsor decision.
8
11
2
11
9
11
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
Systematic Assessment
EG0001 affected11 at risk
EG0012 affected48 at risk
EG0020 affected48 at risk
EG0030 affected46 at risk
EG0040 affected13 at risk
EG0051 affected11 at risk
Arrhythmia supraventricular
Cardiac disorders
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected48 at risk
EG0021 affected48 at risk
EG003
Abdominal pain
Gastrointestinal disorders
Systematic Assessment
EG0000 affected11 at risk
EG0012 affected48 at risk
EG0020 affected48 at risk
EG003
Ascites
Gastrointestinal disorders
Systematic Assessment
EG0000 affected11 at risk
EG0011 affected48 at risk
EG0021 affected48 at risk
EG003
Constipation
Gastrointestinal disorders
Systematic Assessment
EG0000 affected11 at risk
EG0011 affected48 at risk
EG0020 affected48 at risk
EG003
Diarrhoea
Gastrointestinal disorders
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected48 at risk
EG0020 affected48 at risk
EG003
Intestinal obstruction
Gastrointestinal disorders
Systematic Assessment
EG0001 affected11 at risk
EG0011 affected48 at risk
EG0021 affected48 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
Systematic Assessment
EG0000 affected11 at risk
EG0011 affected48 at risk
EG0020 affected48 at risk
EG003
Upper gastrointestinal haemorrhage
Gastrointestinal disorders
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected48 at risk
EG0020 affected48 at risk
EG003
Fatigue
General disorders
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected48 at risk
EG0021 affected48 at risk
EG003
General physical health deterioration
General disorders
Systematic Assessment
EG0001 affected11 at risk
EG0010 affected48 at risk
EG0020 affected48 at risk
EG003
Pyrexia
General disorders
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected48 at risk
EG0021 affected48 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected48 at risk
EG0021 affected48 at risk
EG003
Pneumonia
Infections and infestations
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected48 at risk
EG0021 affected48 at risk
EG003
Sepsis
Infections and infestations
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected48 at risk
EG0021 affected48 at risk
EG003
Staphylococcal sepsis
Infections and infestations
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected48 at risk
EG0020 affected48 at risk
EG003
Hip fracture
Injury, poisoning and procedural complications
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected48 at risk
EG0021 affected48 at risk
EG003
Eastern cooperative oncology group performance status worsened
Investigations
Systematic Assessment
EG0000 affected11 at risk
EG0011 affected48 at risk
EG0020 affected48 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected48 at risk
EG0020 affected48 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected48 at risk
EG0020 affected48 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected48 at risk
EG0021 affected48 at risk
EG003
Cancer pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected48 at risk
EG0021 affected48 at risk
EG003
Colorectal cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected48 at risk
EG0023 affected48 at risk
EG003
Metastases to central nervous system
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 affected11 at risk
EG0012 affected48 at risk
EG0020 affected48 at risk
EG003
Metastases to liver
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 affected11 at risk
EG0011 affected48 at risk
EG0020 affected48 at risk
EG003
Neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected48 at risk
EG0020 affected48 at risk
EG003
Cerebrovascular accident
Nervous system disorders
Systematic Assessment
EG0001 affected11 at risk
EG0010 affected48 at risk
EG0021 affected48 at risk
EG003
Loss of consciousness
Nervous system disorders
Systematic Assessment
EG0000 affected11 at risk
EG0011 affected48 at risk
EG0020 affected48 at risk
EG003
Renal failure acute
Renal and urinary disorders
Systematic Assessment
EG0000 affected11 at risk
EG0011 affected48 at risk
EG0020 affected48 at risk
EG003
Urinary retention
Renal and urinary disorders
Systematic Assessment
EG0000 affected11 at risk
EG0011 affected48 at risk
EG0020 affected48 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 affected11 at risk
EG0011 affected48 at risk
EG0021 affected48 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected48 at risk
EG0021 affected48 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected48 at risk
EG0021 affected48 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected48 at risk
EG0021 affected48 at risk
EG003
Deep vein thrombosis
Vascular disorders
Systematic Assessment
EG0000 affected11 at risk
EG0011 affected48 at risk
EG0021 affected48 at risk
EG003
Colorectal cancer metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0001 affected11 at risk
EG0010 affected48 at risk
EG0020 affected48 at risk
EG003
Dermatitis acneiform
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0001 affected11 at risk
EG0010 affected48 at risk
EG0020 affected48 at risk
EG003
Capillary leak syndrome
Vascular disorders
Systematic Assessment
EG0001 affected11 at risk
EG0010 affected48 at risk
EG0020 affected48 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected48 at risk
EG0020 affected48 at risk
EG003
Disease progression
General disorders
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected48 at risk
EG0020 affected48 at risk
EG003
Enterococcal infection
Infections and infestations
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected48 at risk
EG0020 affected48 at risk
EG003
Hydronephrosis
Renal and urinary disorders
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected48 at risk
EG0020 affected48 at risk
EG003
Hypercreatininaemia
Renal and urinary disorders
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected48 at risk
EG0020 affected48 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
Systematic Assessment
EG0001 affected11 at risk
EG0017 affected48 at risk
EG0022 affected48 at risk
EG0031 affected46 at risk
EG0043 affected13 at risk
EG0053 affected11 at risk
Thrombocytopenia
Blood and lymphatic system disorders
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected48 at risk
EG0023 affected48 at risk
EG003
Conjunctivitis
Eye disorders
Systematic Assessment
EG0001 affected11 at risk
EG0010 affected48 at risk
EG0026 affected48 at risk
EG003
Abdominal pain
Gastrointestinal disorders
Systematic Assessment
EG0002 affected11 at risk
EG0017 affected48 at risk
EG0025 affected48 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
Systematic Assessment
EG0001 affected11 at risk
EG0011 affected48 at risk
EG0025 affected48 at risk
EG003
Constipation
Gastrointestinal disorders
Systematic Assessment
EG0006 affected11 at risk
EG00111 affected48 at risk
EG0025 affected48 at risk
EG003
Diarrhoea
Gastrointestinal disorders
Systematic Assessment
EG0004 affected11 at risk
EG0015 affected48 at risk
EG0027 affected48 at risk
EG003
Dry mouth
Gastrointestinal disorders
Systematic Assessment
EG0000 affected11 at risk
EG0011 affected48 at risk
EG0020 affected48 at risk
EG003
Gingival bleeding
Gastrointestinal disorders
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected48 at risk
EG0023 affected48 at risk
EG003
Nausea
Gastrointestinal disorders
Systematic Assessment
EG0004 affected11 at risk
EG0018 affected48 at risk
EG0024 affected48 at risk
EG003
Stomatitis
Gastrointestinal disorders
Systematic Assessment
EG0002 affected11 at risk
EG0011 affected48 at risk
EG0024 affected48 at risk
EG003
Vomiting
Gastrointestinal disorders
Systematic Assessment
EG0002 affected11 at risk
EG0017 affected48 at risk
EG0023 affected48 at risk
EG003
Asthenia
General disorders
Systematic Assessment
EG0003 affected11 at risk
EG0017 affected48 at risk
EG0024 affected48 at risk
EG003
Chills
General disorders
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected48 at risk
EG0020 affected48 at risk
EG003
Fatigue
General disorders
Systematic Assessment
EG0004 affected11 at risk
EG00110 affected48 at risk
EG0024 affected48 at risk
EG003
Infusion related reaction
General disorders
Systematic Assessment
EG0002 affected11 at risk
EG0010 affected48 at risk
EG0020 affected48 at risk
EG003
Mucosal inflammation
General disorders
Systematic Assessment
EG0003 affected11 at risk
EG0013 affected48 at risk
EG0026 affected48 at risk
EG003
Oedema peripheral
General disorders
Systematic Assessment
EG0002 affected11 at risk
EG0016 affected48 at risk
EG0029 affected48 at risk
EG003
Pyrexia
General disorders
Systematic Assessment
EG0000 affected11 at risk
EG0014 affected48 at risk
EG0022 affected48 at risk
EG003
Paronychia
Infections and infestations
Systematic Assessment
EG0004 affected11 at risk
EG0017 affected48 at risk
EG00215 affected48 at risk
EG003
Aspartate aminotransferase increased
Investigations
Systematic Assessment
EG0000 affected11 at risk
EG0013 affected48 at risk
EG0021 affected48 at risk
EG003
Weight decreased
Investigations
Systematic Assessment
EG0000 affected11 at risk
EG0012 affected48 at risk
EG0021 affected48 at risk
EG003
Weight increased
Investigations
Systematic Assessment
EG0000 affected11 at risk
EG0013 affected48 at risk
EG0021 affected48 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
Systematic Assessment
EG0002 affected11 at risk
EG0018 affected48 at risk
EG00210 affected48 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
Systematic Assessment
EG0000 affected11 at risk
EG0014 affected48 at risk
EG0021 affected48 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
Systematic Assessment
EG0000 affected11 at risk
EG0011 affected48 at risk
EG0024 affected48 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
Systematic Assessment
EG0001 affected11 at risk
EG0010 affected48 at risk
EG0023 affected48 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
Systematic Assessment
EG0002 affected11 at risk
EG0015 affected48 at risk
EG0026 affected48 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
Systematic Assessment
EG0001 affected11 at risk
EG00110 affected48 at risk
EG00213 affected48 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0000 affected11 at risk
EG0014 affected48 at risk
EG0024 affected48 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0002 affected11 at risk
EG0013 affected48 at risk
EG0024 affected48 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0002 affected11 at risk
EG0012 affected48 at risk
EG0023 affected48 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0000 affected11 at risk
EG0013 affected48 at risk
EG0020 affected48 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0001 affected11 at risk
EG0012 affected48 at risk
EG0023 affected48 at risk
EG003
Headache
Nervous system disorders
Systematic Assessment
EG0001 affected11 at risk
EG0016 affected48 at risk
EG0020 affected48 at risk
EG003
Lethargy
Nervous system disorders
Systematic Assessment
EG0000 affected11 at risk
EG0011 affected48 at risk
EG0023 affected48 at risk
EG003
Anxiety
Psychiatric disorders
Systematic Assessment
EG0000 affected11 at risk
EG0014 affected48 at risk
EG0020 affected48 at risk
EG003
Depression
Psychiatric disorders
Systematic Assessment
EG0000 affected11 at risk
EG0014 affected48 at risk
EG0020 affected48 at risk
EG003
Insomnia
Psychiatric disorders
Systematic Assessment
EG0003 affected11 at risk
EG0015 affected48 at risk
EG0025 affected48 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0002 affected11 at risk
EG0011 affected48 at risk
EG0023 affected48 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0002 affected11 at risk
EG0011 affected48 at risk
EG0027 affected48 at risk
EG003
Acne
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected48 at risk
EG0024 affected48 at risk
EG003
Dermatitis acneiform
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0006 affected11 at risk
EG00116 affected48 at risk
EG00217 affected48 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0004 affected11 at risk
EG0017 affected48 at risk
EG00211 affected48 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0003 affected11 at risk
EG0013 affected48 at risk
EG0024 affected48 at risk
EG003
Nail disorder
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0002 affected11 at risk
EG0010 affected48 at risk
EG0023 affected48 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0005 affected11 at risk
EG00112 affected48 at risk
EG00210 affected48 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0004 affected11 at risk
EG00125 affected48 at risk
EG00228 affected48 at risk
EG003
Skin fissures
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0003 affected11 at risk
EG0018 affected48 at risk
EG0027 affected48 at risk
EG003
Dry eye
Eye disorders
Systematic Assessment
EG0002 affected11 at risk
EG0010 affected48 at risk
EG0022 affected48 at risk
EG003
Oedema
General disorders
Systematic Assessment
EG0001 affected11 at risk
EG0010 affected48 at risk
EG0022 affected48 at risk
EG003
Infection
Infections and infestations
Systematic Assessment
EG0001 affected11 at risk
EG0010 affected48 at risk
EG0022 affected48 at risk
EG003
Urinary tract infection
Infections and infestations
Systematic Assessment
EG0001 affected11 at risk
EG0012 affected48 at risk
EG0022 affected48 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0001 affected11 at risk
EG0012 affected48 at risk
EG0022 affected48 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0002 affected11 at risk
EG0011 affected48 at risk
EG0022 affected48 at risk
EG003
Dermatitis
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0001 affected11 at risk
EG0011 affected48 at risk
EG0022 affected48 at risk
EG003
Hypertrichosis
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0003 affected11 at risk
EG0012 affected48 at risk
EG0020 affected48 at risk
EG003
Pain of skin
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0003 affected11 at risk
EG0012 affected48 at risk
EG0020 affected48 at risk
EG003
Hypertension
Vascular disorders
Systematic Assessment
EG0003 affected11 at risk
EG0011 affected48 at risk
EG0022 affected48 at risk
EG003
Tachycardia
Cardiac disorders
Systematic Assessment
EG0002 affected11 at risk
EG0011 affected48 at risk
EG0020 affected48 at risk
EG003
Ear pain
Ear and labyrinth disorders
Systematic Assessment
EG0001 affected11 at risk
EG0010 affected48 at risk
EG0020 affected48 at risk
EG003
Hypoacusis
Ear and labyrinth disorders
Systematic Assessment
EG0001 affected11 at risk
EG0010 affected48 at risk
EG0020 affected48 at risk
EG003
Otorrhoea
Ear and labyrinth disorders
Systematic Assessment
EG0001 affected11 at risk
EG0010 affected48 at risk
EG0020 affected48 at risk
EG003
Tinnitus
Ear and labyrinth disorders
Systematic Assessment
EG0001 affected11 at risk
EG0010 affected48 at risk
EG0020 affected48 at risk
EG003
Eye irritation
Eye disorders
Systematic Assessment
EG0001 affected11 at risk
EG0010 affected48 at risk
EG0021 affected48 at risk
EG003
Keratitis
Eye disorders
Systematic Assessment
EG0001 affected11 at risk
EG0010 affected48 at risk
EG0020 affected48 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
Systematic Assessment
EG0001 affected11 at risk
EG0010 affected48 at risk
EG0020 affected48 at risk
EG003
Anal inflammation
Gastrointestinal disorders
Systematic Assessment
EG0001 affected11 at risk
EG0010 affected48 at risk
EG0020 affected48 at risk
EG003
Cheilitis
Gastrointestinal disorders
Systematic Assessment
EG0002 affected11 at risk
EG0011 affected48 at risk
EG0020 affected48 at risk
EG003
Dyspepsia
Gastrointestinal disorders
Systematic Assessment
EG0001 affected11 at risk
EG0012 affected48 at risk
EG0021 affected48 at risk
EG003
Dysphagia
Gastrointestinal disorders
Systematic Assessment
EG0001 affected11 at risk
EG0010 affected48 at risk
EG0020 affected48 at risk
EG003
Gingival pain
Gastrointestinal disorders
Systematic Assessment
EG0001 affected11 at risk
EG0010 affected48 at risk
EG0021 affected48 at risk
EG003
Peritoneal haemorrhage
Gastrointestinal disorders
Systematic Assessment
EG0001 affected11 at risk
EG0010 affected48 at risk
EG0020 affected48 at risk
EG003
Face oedema
General disorders
Systematic Assessment
EG0001 affected11 at risk
EG0012 affected48 at risk
EG0020 affected48 at risk
EG003
Facial pain
General disorders
Systematic Assessment
EG0001 affected11 at risk
EG0010 affected48 at risk
EG0020 affected48 at risk
EG003
General physical health deterioration
General disorders
Systematic Assessment
EG0001 affected11 at risk
EG0011 affected48 at risk
EG0020 affected48 at risk
EG003
Inflammation
General disorders
Systematic Assessment
EG0001 affected11 at risk
EG0010 affected48 at risk
EG0020 affected48 at risk
EG003
Hepatic pain
Hepatobiliary disorders
Systematic Assessment
EG0001 affected11 at risk
EG0010 affected48 at risk
EG0020 affected48 at risk
EG003
Drug hypersensitivity
Immune system disorders
Systematic Assessment
EG0001 affected11 at risk
EG0010 affected48 at risk
EG0020 affected48 at risk
EG003
Anogenital warts
Infections and infestations
Systematic Assessment
EG0001 affected11 at risk
EG0010 affected48 at risk
EG0020 affected48 at risk
EG003
Candidiasis
Infections and infestations
Systematic Assessment
EG0001 affected11 at risk
EG0010 affected48 at risk
EG0021 affected48 at risk
EG003
Pneumonia
Infections and infestations
Systematic Assessment
EG0002 affected11 at risk
EG0010 affected48 at risk
EG0020 affected48 at risk
EG003
Skin bacterial infection
Infections and infestations
Systematic Assessment
EG0001 affected11 at risk
EG0010 affected48 at risk
EG0020 affected48 at risk
EG003
Staphylococcal infection
Infections and infestations
Systematic Assessment
EG0002 affected11 at risk
EG0010 affected48 at risk
EG0020 affected48 at risk
EG003
Vulvovaginal mycotic infection
Infections and infestations
Systematic Assessment
EG0001 affected11 at risk
EG0010 affected48 at risk
EG0020 affected48 at risk
EG003
Contrast media reaction
Injury, poisoning and procedural complications
Systematic Assessment
EG0001 affected11 at risk
EG0010 affected48 at risk
EG0020 affected48 at risk
EG003
Eye injury
Injury, poisoning and procedural complications
Systematic Assessment
EG0001 affected11 at risk
EG0010 affected48 at risk
EG0020 affected48 at risk
EG003
Procedural vomiting
Injury, poisoning and procedural complications
Systematic Assessment
EG0001 affected11 at risk
EG0010 affected48 at risk
EG0020 affected48 at risk
EG003
Blood calcium decreased
Investigations
Systematic Assessment
EG0002 affected11 at risk
EG0010 affected48 at risk
EG0020 affected48 at risk
EG003
Blood magnesium decreased
Investigations
Systematic Assessment
EG0001 affected11 at risk
EG0010 affected48 at risk
EG0021 affected48 at risk
EG003
Blood potassium decreased
Investigations
Systematic Assessment
EG0001 affected11 at risk
EG0010 affected48 at risk
EG0021 affected48 at risk
EG003
Blood pressure increased
Investigations
Systematic Assessment
EG0001 affected11 at risk
EG0010 affected48 at risk
EG0020 affected48 at risk
EG003
Body temperature increased
Investigations
Systematic Assessment
EG0001 affected11 at risk
EG0010 affected48 at risk
EG0020 affected48 at risk
EG003
Breath sounds abnormal
Investigations
Systematic Assessment
EG0001 affected11 at risk
EG0010 affected48 at risk
EG0020 affected48 at risk
EG003
Platelet count decreased
Investigations
Systematic Assessment
EG0001 affected11 at risk
EG0010 affected48 at risk
EG0020 affected48 at risk
EG003
Dehydration
Metabolism and nutrition disorders
Systematic Assessment
EG0001 affected11 at risk
EG0010 affected48 at risk
EG0020 affected48 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
Systematic Assessment
EG0001 affected11 at risk
EG0010 affected48 at risk
EG0020 affected48 at risk
EG003
Intervertebral disc protrusion
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0001 affected11 at risk
EG0010 affected48 at risk
EG0020 affected48 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0001 affected11 at risk
EG0010 affected48 at risk
EG0021 affected48 at risk
EG003
Myopathy
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0001 affected11 at risk
EG0010 affected48 at risk
EG0020 affected48 at risk
EG003
Pyogenic granuloma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0002 affected11 at risk
EG0010 affected48 at risk
EG0020 affected48 at risk
EG003
Dizziness
Nervous system disorders
Systematic Assessment
EG0001 affected11 at risk
EG0012 affected48 at risk
EG0021 affected48 at risk
EG003
Neuropathy peripheral
Nervous system disorders
Systematic Assessment
EG0001 affected11 at risk
EG0012 affected48 at risk
EG0021 affected48 at risk
EG003
Paraesthesia
Nervous system disorders
Systematic Assessment
EG0001 affected11 at risk
EG0011 affected48 at risk
EG0020 affected48 at risk
EG003
Polyneuropathy
Nervous system disorders
Systematic Assessment
EG0002 affected11 at risk
EG0012 affected48 at risk
EG0020 affected48 at risk
EG003
Oliguria
Renal and urinary disorders
Systematic Assessment
EG0001 affected11 at risk
EG0010 affected48 at risk
EG0020 affected48 at risk
EG003
Genital tract inflammation
Reproductive system and breast disorders
Systematic Assessment
EG0001 affected11 at risk
EG0010 affected48 at risk
EG0020 affected48 at risk
EG003
Hiccups
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0001 affected11 at risk
EG0011 affected48 at risk
EG0020 affected48 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0001 affected11 at risk
EG0011 affected48 at risk
EG0020 affected48 at risk
EG003
Nasal oedema
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0001 affected11 at risk
EG0010 affected48 at risk
EG0020 affected48 at risk
EG003
Pharyngeal inflammation
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0001 affected11 at risk
EG0010 affected48 at risk
EG0020 affected48 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0002 affected11 at risk
EG0010 affected48 at risk
EG0020 affected48 at risk
EG003
Hirsutism
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0001 affected11 at risk
EG0012 affected48 at risk
EG0021 affected48 at risk
EG003
Ingrowing nail
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0001 affected11 at risk
EG0010 affected48 at risk
EG0021 affected48 at risk
EG003
Koilonychia
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0002 affected11 at risk
EG0010 affected48 at risk
EG0020 affected48 at risk
EG003
Palmar-plantar erythrodysaesthesia syndrome
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0001 affected11 at risk
EG0011 affected48 at risk
EG0021 affected48 at risk
EG003
Skin hyperpigmentation
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0001 affected11 at risk
EG0011 affected48 at risk
EG0020 affected48 at risk
EG003
Skin oedema
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0001 affected11 at risk
EG0010 affected48 at risk
EG0020 affected48 at risk
EG003
Capillary leak syndrome
Vascular disorders
Systematic Assessment
EG0001 affected11 at risk
EG0010 affected48 at risk
EG0020 affected48 at risk
EG003
Glucose tolerance impaired
Metabolism and nutrition disorders
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected48 at risk
EG0020 affected48 at risk
EG003
Alanine aminotransferase increased
Investigations
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected48 at risk
EG0020 affected48 at risk
EG003
Blood alkaline phosphatase increased
Investigations
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected48 at risk
EG0020 affected48 at risk
EG003
Hypersensitivity
Immune system disorders
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected48 at risk
EG0020 affected48 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected48 at risk
EG0020 affected48 at risk
EG003
Confusional state
Psychiatric disorders
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected48 at risk
EG0020 affected48 at risk
EG003
Dysarthria
Nervous system disorders
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected48 at risk
EG0020 affected48 at risk
EG003
Flushing
Vascular disorders
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected48 at risk
EG0020 affected48 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected48 at risk
EG0020 affected48 at risk
EG003
Glycosylated haemoglobin increased
Endocrine disorders
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected48 at risk
EG0020 affected48 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected48 at risk
EG0020 affected48 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected48 at risk
EG0020 affected48 at risk
EG003
Hyperthyroidism
Endocrine disorders
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected48 at risk
EG0020 affected48 at risk
EG003
Hyperuricaemia
Metabolism and nutrition disorders
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected48 at risk
EG0020 affected48 at risk
EG003
Hyponatraemia
Investigations
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected48 at risk
EG0020 affected48 at risk
EG003
Infusion site inflammation
General disorders
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected48 at risk
EG0020 affected48 at risk
EG003
Jaundice
Hepatobiliary disorders
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected48 at risk
EG0020 affected48 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected48 at risk
EG0020 affected48 at risk
EG003
Localised oedema
General disorders
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected48 at risk
EG0020 affected48 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected48 at risk
EG0020 affected48 at risk
EG003
Renal failure chronic
Renal and urinary disorders
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected48 at risk
EG0020 affected48 at risk
EG003
Renal impairment
Renal and urinary disorders
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected48 at risk
EG0020 affected48 at risk
EG003
Somnolence
Nervous system disorders
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected48 at risk
EG0020 affected48 at risk
EG003
Tremor
Nervous system disorders
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected48 at risk
EG0020 affected48 at risk
EG003
Vulvovaginal candidiasis
Infections and infestations
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected48 at risk
EG0020 affected48 at risk
EG003
Part 3 of the study did not reach the accrual goal. Only 24 out of the 42 planned subjects received treatment in Part 3 of the study.
FG0051 subjectsCompleted the safety follow-up visit
9 subjects
FG00510 subjects
0 subjects
FG0040 subjects
FG0052 subjects
Death
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0048 subjects
FG0058 subjects
On-study at time of data cut-off
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0041 subjects
FG0050 subjects
NA
± NA
BG004NA± NA
BG005NA± NA
BG00656.5± 13.8
Part 2 Participants
Title
Measurements
BG000NA± NA
BG00155.0± 12.5
BG00262.1± 7.5
BG00362.0± 9.7
BG004NA± NA
BG005NA± NA
BG00659.7± 10.6
Part 3 Participants
Title
Measurements
BG000NA± NA
BG001NA± NA
BG002NA± NA
BG003NA± NA
BG00454.8± 13.9
BG00552.0± 11.3
BG00653.5± 12.6
19
BG00321
BG0043
BG0056
BG00675
Male
BG0005
BG00128
BG00229
BG00325
BG00410
BG0055
BG006102
47
BG00345
BG00413
BG00510
BG006171
Black or African American
Title
Measurements
BG0000
BG0010
BG0021
BG0031
BG0040
BG0050
BG0062
Hispanic or Latino
Title
Measurements
BG0000
BG0011
BG0020
BG0030
BG0040
BG0050
BG0061
Asian
Title
Measurements
BG0000
BG0011
BG0020
BG0030
BG0040
BG0050
BG0061
Other
Title
Measurements
BG0000
BG0011
BG0020
BG0030
BG0040
BG0051
BG0062
48
BG00346
BG00413
BG00511
BG006177
Part 2: Panitumumab + Rilotumumab
Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
OG002
Part 2: Panitumumab + Ganitumab
Participants received panitumumab 6 mg/kg and ganitumab 12 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
Units
Counts
Participants
OG00048
OG00148
OG00246
Title
Denominators
Categories
Title
Measurements
OG00021(10.5 to 35.0)
OG00131(18.7 to 46.3)
OG00222(10.9 to 36.4)
Units
Counts
Participants
OG00010
OG00115
OG00210
Title
Denominators
Categories
Title
Measurements
OG0003.7(3.6 to NA)Not estimable as number of responding subjects and number with events was too small to calculate upper confidence interval.
OG0015.1(3.7 to 5.6)
OG0023.7(3.6 to 5.8)
Units
Counts
Participants
OG00010
OG00115
OG00210
Title
Denominators
Categories
Title
Measurements
OG0001.8(1.6 to 2.5)
OG0011.6(1.6 to 1.7)
OG0021.7(1.6 to 1.7)
Units
Counts
Participants
OG00048
OG00148
OG00246
Title
Denominators
Categories
Title
Measurements
OG00056(41 to 71)
OG00171(56 to 83)
OG00261(45 to 75)
Units
Counts
Participants
OG00048
OG00148
OG00246
Title
Denominators
Categories
Title
Measurements
OG0003.7(2.5 to 5.3)
OG0015.2(3.6 to 5.4)
OG0025.3(2.7 to 5.7)
Units
Counts
Participants
OG00048
OG00148
OG00246
Title
Denominators
Categories
Title
Measurements
OG0003.8(2.5 to 5.3)
OG0015.3(3.6 to 5.4)
OG0025.3(2.7 to 5.7)
Participants
OG00048
OG00148
OG00246
Title
Denominators
Categories
Title
Measurements
OG000NA(8.6 to NA)Median and upper CIs are not estimable due to small number of subjects with events in time period.
OG001NA(9.6 to NA)Median and upper CIs are not estimable due to small number of subjects with events in time period.
OG002NA(7.1 to NA)Median and upper CIs are not estimable due to small number of subjects with events in time period.